Proposed National Priorities for Health (2021)
Past Opportunities to Provide Input
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
-
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
In June 2021, the PCORI Board of Governors voted to release for public comment five proposed National Priorities for Health. After a 60-day public comment period in the summer of 2021 and various meetings and regional convenings on research and health, PCORI refined the proposed National Priorities for Health to reflect the substantial input received from a wide range of stakeholders. Read more about the proposed National Priorities for Health in English or Spanish.
In English (.pdf) En Español (pdf)
In October 2021, the Board adopted the National Priorities for Health.
Submitted Comments
Submitted
8/28/21 13:45
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
The opportunity exists to create/support/advance a *national* LHS that would be tailorable to the condition and the patient. A cloud-based system would overcome local installation issues. Integration with EMRs possible. Importantly, LHSs should include patient-friendly UIs and patient-centered methods for development. Patients should have access to their data. Ideally, offered at no cost. The LHS could deploy digital treatments and thereby address and reduce care disparities.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
A truly national LHS that is untethered from a specific healthcare organization or commercial interests requires dedicated funding.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
PCORI could support a national LHS that is patient-centered and readily available to anyone with internet connection. The LHS would aggregate data and supply researchers with unprecedented data quality. PCORI would lead improved access to care through the platform while collecting outcomes data. Efficient conduct of pragmatic and comparative effectiveness clinical science.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
An LHS that is open-source, available to researchers/clinicians/organizations with minimal restrictions, cloud-based, patient-centered and patient integrated, tailorable, free from commerical interests, with a focus on using the LHS platform to deliver patient education, support and digital treatments. CHOIR is one such model platform that has all of these capabilities. CHOIR is available at no cost. Translation to a fully *national* cloud-based system would require financial support with a huge ROI.
Name and/or Organization
Beth Darnall
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/28/21 13:11
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
No! Healthcare data should remain private. The healthcare industry should not share anyone's personal data. And yes this data DOES get into the hands of 3rd, 4th, 5th, etc party nonprofits whereas there's no limit to availability or govt grant monies we are spending and funneling to all these nonprofits. Its already happening. These nonprofits that run these profitable businesses are ran by inexperienced folks that have no respect for privacy and are not medical people that have been trained in HIPAA, ADA, PRIVACY .... Most that handle the paperwork are minimum wage people that have no clue in respecting privacy or the liability of sharing personal data.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Challenges? Keeping american citizens healthcare data private which is impossible
For the full set of National Priorities: What other comments do you have?
Privacy , Hipaa, ADA compliant. See comments above.
Name and/or Organization
na
Community
Patient
Patient Group
Patient/Consumer
Submitted
8/28/21 12:18
For the full set of National Priorities: What other comments do you have?
Please see attached for all of the above.
Name and/or Organization
Leah M. Levey Hill, Weary Luna Innovations, LLC/Veteran
Community
Stakeholder
Stakeholder Community
Industry
File Upload
https://www.pcori.org/sites/default/files/webform/19726/DHHS 2022 Prop.Pri - Google Docs.pdf
Submitted
8/27/21 22:23
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
See full PDF attached
Name and/or Organization
Academy of Integrative Health & Medicine
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/AIHM PCORI Letter.pdf
Submitted
8/27/21 20:10
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
I think the challenge is to get our existing system to recognize that therapies such as massage are patient centered, effective and less costly. Older people could benefit immeasurably from chiropractic and massage as opposed to routine PT. PT has a role but I think it’s overused and costly
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Getting the medical profession and insurance companies to recognize and support alternate therapies such as medical massage.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Your role is to support improved access to these therapies and get them payed for like other therapies.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Recognition of these other important adjuncts to present day “fis it with a pill”
Name and/or Organization
anonympous
Community
Patient
Patient Group
Patient
Submitted
8/27/21 17:39
Name and/or Organization
Alliance for Aging Research
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
Submitted
8/27/21 17:39
Name and/or Organization
FasterCures
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
https://www.pcori.org/sites/default/files/webform/19726/Public Comment_8-27-21_FasterCures.pdf
Submitted
8/27/21 17:39
Name and/or Organization
American Academy of Sleep Medicine
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/Public-Comment_8-27-21_AASM.pdf
Submitted
8/27/21 17:39
Name and/or Organization
Society for Academic Emergency Medicine (SAEM) AND American College of Emergency Physicians (ACEP)
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/Public-Comment_8-28-21_SAEM-and-ACEP.pdf
Submitted
8/27/21 17:39
Name and/or Organization
Partnership to Improve Patient Care
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
https://www.pcori.org/sites/default/files/webform/19726/Public Comment_8-27-21_PIPC.pdf
Submitted
8/27/21 17:12
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
IRB rejected a clinical trial that would test an algorithm, a personalized approach on what was causing cognitive decline, rather than testing a single drug. (The First Survivors of Alzheimer’s, Dale E. Bredesen, M.D.) There is a growing, largely unknown, underfunded contingent of health and wellness communities that are transforming healthcare, primarily operating under the moniker of Functional Medicine. This industry of dedicated practitioners, clinicians, educators, researchers and vendors are healing people where others have given up. https://www.youtube.com/watch?v=c7HYZWXkfjg
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Resistance to change through the dominance and momentum of traditional medicine systems. Essential nutrition education is lacking at medical educational institutions and few if any exams exist on the topic. Lack of common industry association to organize entities representing more than 70 medical care models having patient outcome as a common goal.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Pioneering new research models on methodologies for evaluating complex emerging system solutions Building momentum and inspiration for other non-traditional strategies. Legitimization of emerging innovations through peer-reviewed research.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Publishing evidence of documented data showing positive health outcomes in patients in situations where standard of care doctors have declared recovery impossible. Building a repository of emerging medical practices that establish new patient-centered-outcome research categories Ultimately building a strong case for essential nutrition education at all medical educational institutions and as a required topic on exams
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Shift populations toward healthier patient outcomes Dr/Patient interactions, relationships and insurance reimbursements measured/determined based on patient outcomes
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
People want to be healthy but don’t know how The current healthcare system sets patients on a path towards outcomes by focusing on symptoms treatment, not identifying the cause.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Shifting research funding toward practices that are focused on health outcome success, not the number of visits or procedures.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Large populations and the medical community deeply understanding the many factors that influence health and wellbeing Increased insurance reimbursements for wellness behaviors
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Genome mapping offers new answers and pinpoint solutions Technology offers new ‘live’ information Employers are elevating the new value of healthy employees Electronic medical records, social media, artificial intelligence learning systems, and quality educational communications are available from medical practitioners
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Functional Medicine alternatives are largely unknown to stakeholders, practitioners and patients.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Inviting investments in research that makes a case for investing in a healthy population in order to reduce the economic impact of COVID and future pandemics. Bringing science and medical practice in better alignment https://nutritionfacts.org/2019/09/24/how-could-there-be-such-a-disconnect-between-the-science-and-medical-practice/ Pioneering in research that builds a strong case for investing in medical training, novel use of technology, genome-based solutions, all to improve dissemination, implementation, and communication of patient-centered outcomes.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Increased public awareness, relevancy, application and normalization of functional medicine solutions. Reduced healthcare costs, a healthier population, improved mental health. (One in five dollars in the entire US economy is spent on health care.) http://time.com/longform/food-best-medicine/
Achieve Health Equity: What are the opportunities?
There is a desperate need to change health equity conditions in the US 70 percent of deaths, or more than 1.7 million deaths, a year are caused by chronic disease. mostly the result of our toxic food system. More African Americans, Hispanics, and poor people are killed by bad food than anything else.
Achieve Health Equity: What are the challenges?
Seventy-five percent of the SNAP benefits are used for ultra-processed food and ten percent for soda (or about $7 billion a year). Race-based advertising and targeting of minorities by food companies, or what are referred to as social determinants, explain these health disparities, not race. About 23 million Americans live in food deserts. https://medium.com/@drmarkhyman/the-hidden-form-of-racism-that-no-one-is-talking-about-ddb5c0431b1c
Achieve Health Equity: What is PCORI’s unique role or contribution?
With healthcare stakeholders as equitable partners, PCORI is uniquely positioned to influence public policy for health by challenging these stakeholders to offer solutions to this embarrassing situation.
Achieve Health Equity: What does success look like?
PCORI works with Peter Diamandis and his team to develop criteria, raise funds and offer a Health Equity X-PRIZE to organizations that implement and test long-term solutions to undo social injustices among the most vulnerable communities.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
70% of the population are trending towards being (chronically ill), but if you catch them at the right time you can arrest those behavior changes and you can move them into the healthy group. (James Maskell, Functional Forum) People want to be healthy but don’t know how
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Long-time health-related habits are difficult to change without the correct frame of mind, realizing that food is medicine, support from family and friends, being fit and resilient, and adopting a functional medicine life plan. Much of our health and wellness knowledge is influenced by commercial interests Successful nutritional and lifestyle health is accomplished with a trained medical team.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Building a case for increasing knowledge and receptivity of unhealthy populations to achieve the necessary personal change by supporting and encouraging research on nutrition, improving the immune system and the efficacy of functional medicine. https://www.mindbodygreen.com/articles/new-approach-to-immunity
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Equipping 10% of the population with the knowledge to distinguish right from wrong when making health and wellness decisions Moving the needle in all the areas affected to accelerate becoming a healthy world much faster than most can imagine Bumping the trajectory of US health by establishing a sustainable a “new normal” for living a healthy life
For the full set of National Priorities: What other comments do you have?
Thank you for the opportunity to offer input toward these noble, ambitious goals.
Name and/or Organization
Michael Dziak, Life by Natural Causes
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/27/21 16:32
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
People like me who live with misunderstood post-viral neuroimmune diseases like ME/CFS and Long Covid desperately need clinical trials to discover what existing FDA-approved drugs can improve patient quality of life. Previously healthy an in my 30s, I am now severely disabled with ME/CFS resulting from my confirmed case of COVID-19 in June 2020. I've lost my livelihood (after 10+ years in the workforce and an ivy league graduate school education) and my ability to communicate with friends and family on the phone. I am homebound and physically and mentally incapacitated, and I have very little ability to do anything in a day. I am rarely able to cook, clean, shower, or get my mail. I feel ill all of the time. I have lost 14+ months of my life. We cannot afford to wait for scientists to understand every aspect of ME/CFS triggered by COVID-19 ("Long Covid"), a complex, multi-system illness, before exploring and gathering evidence on treatments that could quickly be applied to help restore some semblance of quality of life for people like me.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Lack of data and peer-reviewed publications due to historical underfunding is a huge barrier to getting proper medical care for people like me with debilitating post-viral nueroimmune illnesses. We also run a serious risk of Long Covid researchers ignoring the body of research that already exists on ME/CFS and dysautonomia, which will mean wasted resources and a longer time to develop effective treatments, effectively shortening the usable life years for Americans like me.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI needs to bring together ME/CFS doctors, patients, and stakeholder communities with scientists who are conducting research on Long Covid or aspiring/applying for funding for Long Covid research. The vast majority of scientists endeavoring to study Long Covid do not have the same knowledge as practitioners and patient advocacy groups who have been working with and researching the ME/CFS patient population for decades. PCORI can and should play a role by bringing these two groups--researchers newly interested in Long Covid and ME/CFS experts-- together. So far this really isn't happening-- there is a huge knowledge gap and we are 1.5 years into the long covid pandemic. We clearly need PCORI to facilitate this.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Improved medical education and clinical performance for Long Covid, ME/CFS, and other post-viral neuroimmune diseases.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Create a platform for scientists from different disciplines to come together to discuss how their Long Covid research fits into a larger picture. Long Covid is a multi-systemic illness but most scientists are focused on one body system in their research. This siloed approach to scientific understanding is insufficient and counterproductive.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Continuing education opportunities for primary care physicians and "Post Covid clinics" within hospital systems. As a patient who has now visited 4 such clinics, I can tell you that the clinics are still learning from Long Covid patients and have extremely little to offer us. Most patients I've spoken with have found such clinics to be a complete waste of our time and energy. Even worse, primary care physicians have demonstrated zero knowledge about Long Covid and most have not demonstrated any sense of responsibility to continue their own education and learn about this condition. PCORI can organize continuing education or other programs to make it the norm for MDs to be educated about long covid and other post-viral chronic illnesses. Currently it is not the norm. This is mainly because 85% of patients with these illnesses are women and thus our condition has not been taken seriously historically. If the medical field and the government had paid more attention to people suffering like I am over the past few decades, Long Covid might be completely treatable or curable by now. This is a real shame. The United States can and must do better.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Continuing education opportunities for primary care physicians and "Post Covid clinics" within hospital systems. As a patient who has now visited 4 such clinics, I can tell you that the clinics are still learning from Long Covid patients and have extremely little to offer us. Most patients I've spoken with have found such clinics to be a complete waste of our time and energy. Even worse, primary care physicians have demonstrated zero knowledge about Long Covid and most have not demonstrated any sense of responsibility to continue their own education and learn about this condition. PCORI can organize continuing education or other programs to make it the norm for MDs to be educated about long covid and other post-viral chronic illnesses. Currently it is not the norm. This is mainly because 85% of patients with these illnesses are women and thus our condition has not been taken seriously historically. If the medical field and the government had paid more attention to people suffering like me over the past few decades, Long Covid might be completely treatable or curable by now. This historical neglect is shameful to put it lightly. The United States can and must do better.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Continuing education opportunities for primary care physicians and "Post Covid clinics" within hospital systems. As a patient who has now visited 4 such clinics, I can tell you that the clinics are still learning from Long Covid patients and have extremely little to offer us. Most patients I've spoken with have found such clinics to be a complete waste of our time and energy. Even worse, primary care physicians have demonstrated zero knowledge about Long Covid and most have not demonstrated any sense of responsibility to continue their own education and learn about this condition. PCORI can organize continuing education or other programs to make it the norm for MDs to be educated about long covid and other post-viral chronic illnesses. Currently it is not the norm. This is mainly because 85% of patients with these illnesses are women and thus our condition has not been taken seriously historically. If the medical field and the government had paid more attention to people suffering like I am over the past few decades, Long Covid might be completely treatable or curable by now. This is a real shame. The United States can and must do better.
Achieve Health Equity: What are the opportunities?
Long Covid, like other chronic, post-viral autoimmune illnesses, disproportionately affects women. As a result, the condition has been overlooked and underfunded for decades while women who were previously productive, well-adjusted members of society lose everything in their lives and basically languish away in our beds. This is so incredibly shameful. This country and the US medical establishment needs to begin prioritizing women's illnesses yesterday.
Achieve Health Equity: What are the challenges?
Please see above.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Please see above.
Achieve Health Equity: What does success look like?
Please see above.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Please see above.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Please see above.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Please see above.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Please see above.
For the full set of National Priorities: What other comments do you have?
Please see above.
Name and/or Organization
Christine Jamieson
Community
Patient
Patient Group
Patient
Submitted
8/27/21 16:30
Name and/or Organization
American Occupational Therapy Association
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
https://www.pcori.org/sites/default/files/webform/19726/PCORI_AOTA Letter_2021.pdf
Submitted
8/27/21 16:24
Name and/or Organization
Martha Nolan, HealthyWomen
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/HealthyWomen PCORI National Priorities.pdf
Submitted
8/27/21 16:15
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Nemours Children’s Health (Nemours) urges PCORI to invest more funding for PEDSnet to enhance research approaches that would help the research community to effectively treat, manage, and tailor our care to meet the needs of pediatric patients. PCORI plays a crucial role in the advancement of pediatric patient-centered outcomes research with its leadership in PEDSnet, one of PCORnet’s active Clinical Research Networks (CRNs). Nemours is grateful for PCORI’s funding of PEDSnet, in which Nemours participates along with eight other children’s health systems. Through PEDSnet, our institutions can gather enormous and previously inaccessible amounts of data to help design care that can save children’s lives and realize the vision of PEDSnet as the nation’s leading pediatric Learning Health System. A recently published retrospective cohort study in JAMA Pediatrics underscores the power of using large data sets to identify disparities. Researchers in the study used PEDSnet data – electronic health records (EHRs) of 135,794 pediatric patients from Nemours and the six other participating children’s health systems – to study the prevalence and impact of the coronavirus on children. (1) Though children are less likely to contract the SARS-CoV-2 virus, the study underscores disproportionately high rates of infection and worse health outcomes in children of Black, Hispanic, and Asian descent. This research corroborates other data that shows that people of color contract the virus and develop severe symptoms at a disproportionally higher rate, making up more than half of COVID-19 deaths in the United States. We still are learning every day about the short-term and long-term impact of COVID-19. PEDSnet presents a unique opportunity to advance our understanding of the virus’ impact on our youngest generation. Further, there is an opportunity to utilize EHRs in PEDSnet to advance research in health inequities. Additional funds for PEDSnet could be used to enhance EHR data collection and research methodologies such as advancing collection of patient-reported outcome data in EHRs; developing geocoded datasets to better understand the impact of social determinants of health (SDOH) and environment on child health; advancing research to test the impact of EHR-based interventions on health care delivery, and utilizing mixed-methods research that combines qualitative data with quantitative EHR data to better understand intervention outcomes and potential causes for inequities. Another important area of opportunity is to leverage the power of PEDSnet to move towards a precision medicine model that could reduce the impact of chronic diseases on child health by using artificial intelligence and machine learning (AI/ML). AI/ML can evaluate population-level data to find factors that contribute to disease, such as biomarkers or sociomarkers, as well as protective factors. It can also develop predictive tools, risk stratification models, and geographic targeting approaches, which are critical as the nation continues to move into value-based and population-level health care. However, application of AI/ML at scale with large structured datasets like the PEDSnet common data model when combined with less structured data such as physician’s notes, patient reported outcomes, and environmental/SDOH data requires sustained investment in human as well as computational infrastructure. Nemours believes that it is critically important for PCORI to build up and scale AI/ML efforts to realize the potential for resources such as PEDSnet to truly improve overall child health and reduce costs associated with pediatric chronic disease management. The additional investment in PEDSnet could be allocated for: o advancing research support and training to: further identify and mitigate inequities associated with COVID-19 in the pediatric population; Enhance EHR data collection methodology and utilization to advance research in health inequities; o developing AI predictive models that could reduce the impact of chronic diseases in children; and o increasing workforce diversity through the PEDSnet Scholars Program (see comments in Priority 4: Accelerate Progress Toward an Integrated Learning Health System).
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Nemours encourages PCORI to recognize that there are many different types of health systems, each with its own unique approach to disseminating and communicating health research results into practice. For example, an academic medical center might approach implementation differently than a local community health center. PCORI should fund comparative effectiveness research (CER) studies to investigate the effectiveness of different delivery and implementation strategies on different types of health systems. Should PCORI fund such studies, we ask that PCORI include pediatric health systems separate from adult health systems, given that we serve different patient populations with their own distinct health care needs.
Achieve Health Equity: What are the opportunities?
As a pediatric health system working towards health equity and a just healthcare system that is accessible and effective for all, Nemours appreciates PCORI’s inclusion of health equity as a priority. While many health systems are collecting data related to SDOH, there is currently not a robust set of research that informs the field regarding how to address what we discover in the data in order to help improve health outcomes. We believe this is an important opportunity area that merits further study. Research has made advances in measuring disparities through the comparison of patient outcomes stratified by demographic data (race, ethnicity, and zip codes). However, measuring disparities alone will not get us to the goal of achieving health equity and justice. To advance efforts to achieve health equity, we need to look at upstream SDOH factors including systemic barriers such as racism, educational attainment, socio-economic status, food access, stable housing, etc. These factors can impact a person’s quality of life and health. Further, we need to look at interventions that address upstream SDOH factors, and ultimately their impact on health outcomes.
Achieve Health Equity: What are the challenges?
While there is great opportunity in focusing on achieving health equity as a core priority area, there are challenges that should be addressed. There are very few CER studies on interventions to address these upstream SDOH factors and the subsequent impact of those interventions on overall health. Nemours understands that there are several challenges to implementing this type of research. First, individuals have needs across several SDOH factors and have family and community context. It is very difficult to test and measure complex multifactorial, causal pathways from upstream SDOH factors to interventions to outcomes. Second, these studies can span decades given the long lag time for health outcomes to show. These types of CER studies are very costly and could take years to complete. The costs of the studies could take up much of PCORI’s budget, which we recognize is a major challenge. With limited resources to address this major challenge, we propose an alternative approach. There is growing evidence that interventions in early childhood such as providing quality nutrition and education access to low-income children are cost-effective and can yield long-term positive health outcomes for children and their families. The data from these interventions show accrued health-related benefits into adulthood. Nemours recommends that PCORI fund CER studies focused on existing early childhood interventions, that have already been well researched, and the long-term health outcomes and health care cost savings associated with such interventions. By targeting existing interventions, particularly where there is already research data on outcomes, and using the CER approach to examine these interventions, PCORI could identify which early childhood interventions will work best for which population groups.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Nemours encourages PCORI to look beyond health systems and invest in a “learning health community” (LHC) approach. PCORI could establish a grant program to support health systems implementing strategies to improve the health of the communities that they serve through multi-sector cross-collaboration with patients and entities that impact SDOH, including food, housing, education, and nutrition. An LHC approach provides health providers, researchers, and hospital administrators the opportunity to engage in ongoing communication with community leaders and patients to foster trust and improve health outcomes. Several health systems, including Nemours, have started to implement LHC approaches. However, a multi-sector cross-collaboration approach like LHC faces many challenges including differing objectives, timelines, and fiscal pressures. To overcome these challenges, health systems doing this work need funding support. PCORI’s funding would enable health systems to sustain their work in LHC to improve the health of the communities they serve. Nemours urges PCORI to include targeted funding for children’s health systems doing work on LHC approaches. The funding would help to set up a strong foundation for children's long-term health and developmental trajectories.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Nemours commends PCORI’s leadership in fostering the next generation of pediatric learning health system (LHS) researchers through the PEDSnet Scholars Program, the K12 career development fellowship program funded by PCORI and the Agency for Healthcare Research and Quality (AHRQ). We support the program’s goal to expand LHS science and research through providing early-career faculty with research supports and mentorship to improve healthcare quality and outcomes in pediatrics. At Nemours, our PEDSnet Scholars have successfully worked with multidisciplinary groups of mentors, through the PEDSnet Network, to help them expand on their methodological expertise in LHS science and research. By having access to all of PEDSnet’s resources and mentors, our scholars can establish themselves as LHS researchers and quickly learn from the shared data to inform practice. We believe the fellowship program can help advance PCORI’s priority of accelerating progress toward an integrated LHS. Nemours recommends that PCORI work with AHRQ to consider further investments in the PEDSnet Scholars Program to fund additional fellowships. Moreover, PCORI should prioritize additional fellowship awards to qualified early-career LHS researchers from diverse backgrounds and populations that have historically been under-represented in pediatric research. This would create a more diverse pediatric research workforce that would truly represent the diversity in the pediatric population we have in our country.
For the full set of National Priorities: What other comments do you have?
As one of the nation’s largest multistate pediatric health systems, Nemours respectfully urges PCORI to place pediatrics among its national priorities and final research agenda. Nemours strongly supports research efforts to engage the pediatric population to deepen our understanding of the challenges and opportunities in comparative effectiveness research on children and their families. While we are encouraged by PCORI’s current funding in pediatrics, such as with PEDSnet, we recommend increased funding, considering that children comprise approximately 22% of the US population. The early years of a child’s life provide substantial opportunities to build a foundation of strong health, education, and economic outcomes for future generations. Early childhood and adolescence are also critical times of development when one’s lived experiences can have long-lasting effects on lifelong health and wellbeing. Evidence on adverse childhood experiences – such as domestic violence, parent mental illness or having an incarcerated family member – are strong indicators of poor adult health, health risk behaviors, and chronic diseases. , We can reduce and/or address many of our nation’s most prevalent causes of illness if we begin in childhood. Continued underinvestment in children across all federal programs would be a missed opportunity for our collective future. Furthermore, we urge PCORI to consider the integral role that families of patients play in patient outcomes. Nemours recommends that PCORI broaden its definition of who the “patient” is, to be more inclusive of families and caregivers. In pediatrics, we often see how parents, caregivers, and siblings can be significantly impacted by the illness of a family member. For example, our providers and researchers have seen cases where if a parent or caregiver is depressed, the pediatric patient’s care management could be impacted as a result of the depression. Another example is when a sibling has a chronic or sudden, serious illness, the other child’s health and well-being could be impacted as a result of that diagnosis and treatment. We would be doing a disservice to our patients if we do not take into account their families’ needs. Further, Nemours urges PCORI to fund research for family-centered care (FCC), especially in pediatrics. FCC is similar to patient-centered care in its inclusive partnership approach to health care decision-making between patients, their families, and health care providers. However, FCC has a stronger focus on integrating patients’ families into the health care conversation. Medical societies, health care systems, and state and federal governments have started to recognize FCC approaches as integral to patient health. Lastly, Nemours encourages PCORI to conduct an analysis of its funding allocations over the last ten years to identify key gaps or under-investments in pediatrics. This would allow PCORI to target its funding to unfunded or underfunded areas that could further address health inequities such as pediatric health issues.
Name and/or Organization
Nemours Children's Health
Community
Stakeholder
Stakeholder Community
Hospitals and Health Systems
File Upload
Submitted
8/27/21 16:13
Name and/or Organization
Arthritis Foundation
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
https://www.pcori.org/sites/default/files/webform/19726/AF Comments on PCORI Principles 2021.pdf
Submitted
8/27/21 15:27
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Telehealth has been a remarkable innovation in health care. I would hope that PCORI will explore different modalities of telehealth, including healthcare by phone with provider, video with provider, and asynchronous care with a provider.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Primary care continues to be a profoundly under researched area because clinics are not paid appropriately, and as a result they have to see more patients in less time. This puts a squeeze on any innovation or opportunities for research. Primary care clinics or patients willing to participate in research to explore whether innovations work need to be adequately compensated, and compensated more than the specialty fields.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI should be prioritizing access to healthcare to improve the health of the people. Primary care is the key to increased access, and thus PCORI should be prioritizing applications that study primary care populations.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Success looks like increased access to health care for all, less burn out of healthcare providers.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
There are a number of PBRNs that have set up ways to collaborate and share medical record information
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Even with PBRNs, there are a lot of institutional barriers to data use agreements. Efforts to get research going is arduous.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
PCORI can establish opportunities for researchers to apply to PCOR-Net to analyze data from large populations.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
success includes infrastructure that is not just about disease, but about populations -- like primary care patients.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Implementation science is an important field that should be prioritized by PCORI.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Patient engagement is working, but there still is not that much evidence to show the extent to which having patients and other stakeholders engaged in research helps disseminate information
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI should create or fund ways in which researchers include measures about impact of patients and other stakeholders on teams. Is there a way to measure that information is disseminated faster when there is engagement?
Achieve Health Equity: What are the opportunities?
Health equity appears to be an important area to address for academic researchers.
Achieve Health Equity: What are the challenges?
It is hard to recruit a diverse population into research studies.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI can insist on research plans that ensure diverse populations are included on the engagement team, as well as enrolled as participants in research studies.
Achieve Health Equity: What does success look like?
We demonstrate that the disparities between certain populations have improved, that we find strategies that work to improve the health of marginalized and undeserved communities.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
There are a number of existing models in which PCORI could glean from about how to establish learning collaboratives
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
This requires time from those involved in the learning-- and would need to be prioritized
For the full set of National Priorities: What other comments do you have?
I hope that PCORI can prioritize primary care. PRimary care is essential for reducing disparities in our society, but is rarely funded. I also hope that PCORI prioritizes reproductive health. I am saddened that more women die in childbirth now than when I was a medical student 20 years ago. How is it possible that our knowledge over the last 20 years has brought us BACKWARDS in terms of helping the lives of women?? PCORI needs to prioritize ensuring that the discoveries of research that is funded by PCORI is implemented into policy, so PCORI should encourage researchers to also be connected to policy centers.
Name and/or Organization
Emily Godfrey
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/27/21 15:14
Name and/or Organization
National Society of Genetic Counselors
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
Submitted
8/27/21 15:08
Name and/or Organization
American Society of Acupuncturists & National Certification Commission for Acupuncture & Oriental Medicine
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
Submitted
8/27/21 15:01
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
PCORI has opportunities to support real world pragmatic trials specific to older adults in tandem with other funding agencies that are modeled on the recent STRIDE trail. In doing so, PCORI should be careful to ensure that research networks are constructed in a way that ensures inclusion of historically under-represented populations and heterogeneous populations with a range of health status, including those with multiple chronic conditions and functional changes (cognitive and physical). For older adults, it would be important for PCORI to consider studies that compare interventions with usual care. An example of usual care would be alerting a clinician that a medication that a patient is on is bad via fax and not providing guidance on alternatives. Another example is the lack of a whole person approach and coordination of care across specialties which can lead to poor outcomes particularly in people with multiple chronic conditions who see multiple specialists.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
An opportunity to address common EHR-related challenges would be the development and dissemination of standard templates to collect patient-reported outcomes or other health measures that matter to patients yet are not documented consistently (e.g., function, symptoms). Another opportunity is the validation of algorithms to extract proxies for these measures from the health record. A third opportunity is to support development of interoperability between disease-specific registries which would provide improved data on how the totality of care a person receives leads or does not lead to outcomes that matter to the patient.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
The American Geriatrics Society (AGS) sees the use of health records as a way to improve health research as a huge challenge. The system can be opaque and is not specifically designed for research. We imagine there are people at multiple institutions trying to tackle this issue and that there may be an opportunity for institutions to learn from each other. Not having long wait periods (over a year) for a data request would be an example of a success. One potential resource for gaining a better understanding of how to harness the power of real- world data to inform research is the Department of Veterans Affairs (VA) Office of Electronic Health Record Modernization (OEHRM). Other challenges include the slow progress in achieving interoperability between and across health systems; patchy nature of EHR adoption in long-term care settings; difficulties using medication data for research purposes, and difficulties in pulling data into data registries. An additional significant challenge to understanding the whole person is that data are captured by specialty/procedure and many Americans are cared for by clinicians in multiple settings with no EHR connectivity between those systems.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
The American Geriatrics Society (AGS) believes the push to create visual abstracts will be one way to improve communication of research results to diverse audiences.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
A significant challenge to conveying research results is that there is no widely used framework for sharing data with members of the public nor is their guidance as to the need to convey data in a way that does not lead to either overstatements or understatements of the risks and benefits. A current real-world case is how data from the aducanumab trials was reported out to the public.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI could play an important role in creating standards for communicating research results to the public that ensure that benefits are not over-stated and risks understated. This role could expand beyond science to include guidance for journalists and others who translate scientific findings for the public.
Achieve Health Equity: What are the opportunities?
The American Geriatrics Society (AGS) believes there is a valuable opportunity here to expand the traditional focus of health equity to also promote equitable treatment and research that is inclusive of all older adults. Ageism remains a socially acceptable and widespread form of bias, and this has been reflected in scholarship by direct and indirect exclusion of older adults from research (thus making the results of uncertain applicability to this population), and by the relative neglect of outcomes that are of special importance to this population. For example, preservation of functional status, quality of life, goal-concordant care are all areas often neglected. This focus would add to, not replace, other important foci of health equity. These principles can and should be interlaced with the other priorities as well.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI has played a critical role in increasing the inclusion of patients in the identification of important research questions and development of study designs that will lead to data that matters to patients. AGS believes that PCORI should continue to build on the work that it has been doing to better engage patients in identifying the research that is needed. One expansion that would be important to older adults is to prioritize engagement of family caregivers – particularly those who are caring for older adults. Although we have made a great deal of progress in ensuring that research reflects community engagement, there is still a need to provide training to investigators as to how to meaningful engage community members in a way that ensures that their voices are heard. In addition, more support is needed for training community members to be effective members of advisory boards and study partners. Attention should be given to helping both community members and investigators understand and break through the power structures that exist when bringing together lay people and highly trained and credentialed investigators. These structures are often invisible and difficult to navigate – even more so for people of color and for people with sensory or cognitive impairment. One area where PCORI could play an important role is on the additional funding that is required to conduct truly inclusive research. There is a correlation between someone’s ability to participate in a trial and their functional status as well as socioeconomic factors. A real world example is an older adult with mild cognitive impairment who is unable to get to a study site on their own and whose primary care giver works an hourly wage job and is unable to get time off to accompany them. Another example is a younger person with cancer who has a job with fixed hours and who is already grappling with time off that they might need for treatment. PCORI could lead efforts to redesign how we approach research design and implementation so that we are maximizing participation regardless of socioeconomic status or functional limitations.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
The American Geriatrics Society (AGS) believes that community-based services will be an important aspect of making progress toward an integrated learning health system. How can health systems work better with long term care facilities, clinicians who are not affiliated with the system, group practices, and FHQCs, agencies and centers serving older adults in the community, caregiving-focused organizations, home care services, and other services. Given patchwork funding, optimizing such supports to improve care is a challenge. Also, coming to consensus about what changes are needed poses another challenge. In terms of the health of the public, as exemplified by the recent COVID19 pandemic, there is a distinct lack of attention to the full range of older adults in national advice that is developed to guide states and communities.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
One opportunity for PCORI is to fund state-based learning networks that cut across health care, social services, private practice clinicians, and public health agencies. One important component of this approach is to recognize the need for a technology infrastructure that better connects people and also the pressing need to improve planning for disaster and other public health emergencies.
Name and/or Organization
Erin Obrusniak, American Geriatrics Society
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/27/21 14:55
Name and/or Organization
Lamaze International
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
Submitted
8/27/21 14:46
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
The priority should be not only dissemination of information and data but the dissemination of accurate dissemination of information and data. Errors and inaccuracies are widespread in EHRs and other areas of healthcare. Patients can help identify and resolve many errors. This becomes even more important as the use of artificial intelligence in decision making and the processing of information increases. We are already beginning to see how errors and miscommunication can diminish trust in systems. Attention to inaccuracies and errors in data, on the other hand, can build trust in institutions.
Name and/or Organization
Ethan Katsh, Director, National Center for Technology and Dispute Resolution
Community
Patient
Patient Group
Patient/Consumer
Submitted
8/27/21 13:28
Name and/or Organization
Society for Vascular Surgery
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/PCORI priorities - SVS response Aug 2021.pdf
Submitted
8/27/21 13:26
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
To enhance the infrastructure for patient-centered outcomes, in particularly to a pandemic situation, PCORI can enable a conducive environment and knowledge-sharing platform so that practicing, as opposed to clinical, doctors can take observations and feedback from patients on emerging and available COVID related solutions to feed back to NIH and the research community. The knowledge from patient experiences of these COVID solutions complement that from clinical trials and may often be of more value as it reflects real life situations, which are not accounted for in idealized clinical trials. While more rigorous, the clinical trials do not work at a pace that is fast enough to provide emergency solutions that are appropriate in situations like pandemics, where we have incomplete information.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
The main challenge towards developing emergency use solutions is an over-emphasis of clinical trials like the ACTIV-6, which are lengthy and costly, and are not consistent for patient-centered approaches to medicine. The ACTIV-6 trials do not provide a timely mechanism for patient feedback on COVID solutions that NIH and the research community can use to develop emergency solutions. Moreover, ACTIV-6 is designed for a normal situation where the urgency to find a treatment is not present. More broadly, rigid adherence to liability rules - and hence priority for clinical trials - during pandemics hinder the development of novel and unexplored treatments that can provide timely solutions to save lives. Too often, these rules are shaped by the pharmaceutical industries and not the needs of the patients nor for legitmate safety concerns.
Name and/or Organization
Anonymous
Community
Stakeholder
Submitted
8/27/21 13:09
For the full set of National Priorities: What other comments do you have?
The NHC Comments on the national priorities are attached. Thank you for the opportunity to provide input.
Name and/or Organization
National Health Council
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
Submitted
8/27/21 12:23
Name and/or Organization
American Academy of Pediatrics
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/AAP PCORI Letter 8.27.21.pdf
Submitted
8/27/21 11:41
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
ASN encourages PCORI to support increasing patient choice and accelerating innovation that is best for patients. Kidney failure treatments, in particular, are preference sensitive, mandating that patients and their care partners have access to sufficient knowledge, technology, and expertise to engage in the care they feel will best allow them to achieve their life goals. ASN recommends that PCORI support research that examine how to: 1. Increase patient choice in kidney care options and environments, including telehealth, home dialysis, self-care dialysis, in-center dialysis, conservative care, and transplant. 2. Support programs to accelerate development of – and patient access to – new kidney diagnostics, therapeutics, and devices, ending decades of relative stagnation of innovation in kidney care. Patient Choice Telehealth Early in the COVID-19 public health emergency (PHE), public health officials realized that health care delivery needed to pivot rapidly towards delivering health care via telehealth and away from in-person encounters—a strategy designed to minimize exposure to the virus for vulnerable patients and the health-care professionals providing care. At the start of the PHE, with stay-at-home orders in place and warnings on the risk for severe illness from COVID-19, fee-for-service (FFS) in-person visits for primary care fell precipitously in March 2020. According to a report issued by HHS in April 2020, nearly one-half (43.5%) of Medicare primary care visits were provided through telehealth compared with less than one percent (0.1%) in February before the PHE began. In nephrology, significant adjustments to telehealth in the PHE included waivers for care of patients undergoing dialysis. Adjustments specific to dialysis included the suspension of the required one quarterly in-person visit for home dialysis, the suspension of the one monthly in-person exam for in-center dialysis as long as the patient was deemed stable, and the ability to conduct telehealth visits while patients are receiving in-center dialysis treatments. ASN believes the United States is at an inflection point regarding telehealth. Telehealth along with remote patient monitoring have great potential to transform care delivery. However, it is necessary for the nation to make a commitment to preventing the “digital divide” from becoming yet another long-lasting disparity in health care. Some patients experience poor access to necessary technologies and are not able to fully benefit from new digital tools or expanded access to telehealth. This “digital divide” has only been accentuated during the pandemic. Low-income patients and the elderly may encounter connectivity and broadband issues more frequently, or not have appropriate access to communication devices. For all the reasons above, ASN recommends that PCORI support research that explores opportunities in telehealth—especially how the potential positive impact of audio only telehealth when visual and audio is not present for patients those without broadband access, the elderly, and lower-income households. Home Dialysis Patients with kidney failure undergoing dialysis can do so at an in-center facility or at home. There are two types of home dialysis: peritoneal dialysis (PD) and home hemodialysis (HHD). PD treatment uses a special solution infused into and then drained from the individual’s abdominal cavity to filter blood and remove waste. Hemodialysis (HD) is a treatment in which an artificial membrane, known as a hemodialyzer, is used to filter the blood. HD is the most common type of treatment used in dialysis facilities, but it can also be done at home. At the end of 2018, there were only 69,000 patients performing dialysis in the home, or approximately 12.5% of all dialysis patients, the rest were receiving in-center hemodialysis. Nearly 85% of patients utilizing home dialysis performed peritoneal dialysis. While the portion of patients performing home dialysis in the United States is slowly increasing, the country lags behind many other industrialized countries. Home dialysis offers significant clinical, socioeconomic, and quality of life advantages. Home patients are associated with better survival rates, better preservation of residual kidney function, and fewer low blood pressure episodes. Home dialysis also provides many patients with greater autonomy and flexibility over their care. These patients can choose when they dialyze, reduce their dependence on transportation, and improve their financial stability if it allows the patient to continue to work. One study found that home dialysis patients are five times more likely to hold employment than patients who dialyze in-center. Despite the benefits of home dialysis, data show much lower rates of home dialysis for Americans of color. From 2005 to 2013, Black patients were 30% less likely and Latinx patients 19% less likely than white patients to start on peritoneal dialysis (PD), an effect that was attenuated when adjusting for socioeconomic factors, while minority groups were between 7% and 35% less likely to receive HHD. The finding that socioeconomic status attenuates this relationship highlights modifiable inequities in home dialysis. Innovation Kidney X KidneyX is a public-private partnership between HHS and ASN to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. KidneyX is incentivizing innovators to fill unmet patient needs through a series of prize competitions, de-risking the commercialization process by fostering coordination among federal agencies and creating a sense of urgency on behalf of patients and families. To date, KidneyX has awarded 61 prizes to patients, care providers, clinicians, community health workers, academic researchers, small and large businesses, spanning over 22 states. Solutions have ranged from patient-developed innovations, safer and more convenient methods for in-home dialysis, tools to sustain kidney care during COVID-19 and future pandemics, and early steps toward a wearable or implantable artificial kidney. KidneyX is a true public-private partnership: ASN has already committed $25 million to KidneyX and is securing additional private funding and is committed to matching federal funding to achieve a total $250 million in the first five years. Since its inception, KidneyX has demonstrated the success of its public-private prize funding model, delivering on its mission of accelerating innovation in kidney care, attracting new innovators and investors to the kidney space, and broadening the availability of novel ideas and capital to improve the lives of the 37,000,000 Americans with kidney diseases. Building on this success, KidneyX launched the Artificial Kidney Prize in 2020, the first of a multiphase prize to accelerate the development of the first wearable or implantable artificial kidney. Winners of Phase 1 of the Artificial Kidney Prize will be announced in September 2021. ASN encourages PCORI to prioritize innovation for people with kidney diseases by exploring partnership opportunities KidneyX to steward innovations so they can also be accessed by the people and families who needed them the most, and work across the kidney community to identify solutions and engage a broad spectrum of innovators to pursue their development.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
ASN encourages PCORI to ensure research participants reflect the kidney patient population, and consider research limitations that will prevent equity in research that explores opportunities to increase telehealth and home dialysis including: • Lack of home or stable home environment. • Limited space in the home due to size and/or number of residents. • Expense of adapting plumbing and electrical systems. • Increased expense of water and electricity. • Patient living alone without the support of a care partner. • Lack of home assistance paid by Medicare and private payers. • Lack of training especially for those who “crash” into dialysis. • Lack of confidence and/or patient’s physical limitations.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI has a unique role as a convener in research with its ability to seek guidance from a wide range of stakeholders, including those traditionally not in the healthcare space, while ensuring that the patient’s voice has a prominent and active role.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
ASN believes that PCORI can contribute to a better understanding of patient preferences and promising interventions.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
ASN supports PCORI’s efforts to use real-world data to improve the nation’s capacity for health research. Asynchronous and wearable technology is increasingly being adopted by healthcare professionals and the patients they treat, further studies must be undertaken to compare these differing technologies and their potential. ASN supports PCORI’s efforts to expand “the number and diversity of people and communities who lead or partner in research”. ASN is pleased to see PCORI address systemic challenges and barriers affecting the workforce and PCORI-supported research community as these efforts will have a significant impact on improving the nation’s kidney health. Kidney diseases disproportionately affect those that are disenfranchised, and ASN advocates tirelessly for efforts to reduce health disparities and to develop a medical research and physician workforce that reflects the patient population it serves. ASN encourages PCORI to determine its support for initiatives by ensuring that each initiative adheres to achieving a diverse workforce representative of the kidney patient population, and recommends that PCORI support efforts: 1. Sustaining existing, and promoting new, mentorship programs for underrepresented minorities in research. 2. Increasing access to application submission resources, changes to application submission instructions/guidance, interactions with and support from PCORI staff during application process as these will help transcend the gap in resources of the parent institutions. 3. Targeting funding for underrepresented minority faculty in the basic science and translational research funding spaces to encourage greater involvement and scientific contribution from these historically disadvantaged groups. 4. Providing full transparency on the current diversity of funded investigators as well as the portfolio dedicated to health equity and health disparity research.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
PCORI has a unique role as a government-sponsored organization to collaborate and disseminate information to stakeholders typically not involved in health research.
Achieve Health Equity: What are the opportunities?
While health inequities and disparities challenge the US health care system in several ways, ASN’s comments focus on the epidemic of chronic kidney disease (CKD). This epidemic impacts more than 37,000,000 Americans, 90% of whom are unaware that they have kidney diseases. Kidney diseases are the ninth leading cause of death in the United States, causing more deaths than breast cancer. These deaths are in part due to an extremely high risk of cardiovascular disease (CVD) associated with CKD as well as a high risk of progression to kidney failure—a permanent form of kidney disease that impacts more than 800,000 people in the United States. Unfortunately, kidney diseases and kidney failure are more common among Black people, Hispanic or Latinx people, Native or Indigenous Americans, people in lower income brackets, and among the elderly—communities that have been disproportionately affected by the COVID-19 pandemic. Preliminary Medicare claims and observational data show that the COVID-19 pandemic has worsened existing disparities among CKD populations and that acute kidney injury from COVID-19 can cause or exacerbate kidney diseases. For those individuals who progress to kidney failure, Black Americans are 3.7 times more likely to develop kidney failure than white Americans, and Latinx Americans are 1.5 times more likely to develop kidney failure than non-Hispanic or Latinx Americans. Further, Black, Indigenous American, and Latinx Americans are less likely to receive a kidney transplant or initiate home dialysis as discussed in greater detail later in this letter. Additionally, Black, Asian, Native Hawaiian or Pacific Islander (NHPI), and multiracial populations were more likely to be diagnosed later in the CKD disease process. For example, compared to 58% of white patients, 74% of Black Americans were not diagnosed with kidney failure (also called End-Stage Renal Disease [ESRD]) until their kidney dysfunction was so advanced that their estimated glomerular filtration rate (eGFR) was less than 10 mL/min/1.73 m². Often poorer and sicker than other Medicare beneficiaries, dialysis patients rely on federal and state subsidies and welfare programs, such as Medicaid. In 2018, ESRD beneficiaries made up about 1% of total Medicare enrollment and 2.5% of dual-eligible enrollment. The dual-eligible population may also have different social risks, with associated implications for health outcomes and service use. Dually eligible beneficiaries with kidney failure are more often Black Americans, Latinx Americans, Indigenous Americans, or NHPIs and have higher costs compared to non-dual eligible beneficiaries, despite similar utilization patterns to their non-dual-eligible counterparts. The systemic barriers to accessing basic healthcare likely play a substantial role among individuals of lower socioeconomic status, including those who will rely on Medicaid, developing kidney disease and progressing to kidney failure. For example, Medicare-Medicaid dual eligibility status has been found to correlate with a lower likelihood of care for patients with kidney diseases who are ultimately progress to kidney failure. The intersection between COVID-19 and kidney diseases also caused untold devastation. Americans on dialysis are more likely to be hospitalized for COVID-19 than other Medicare beneficiaries, and those hospitalized due to COVID-19 are nearly three times more likely to die . Therefore, Black and Latinx Americans are more likely to have kidney disease, are more likely to be on dialysis, are more susceptible to COVID-19 infection, and are more susceptible to death from this virus. Further, COVID-19 can cause kidney dysfunction. A recent national study of US veterans with no prior history of kidney disease who became hospitalized with COVID-19 showed that approximately 30% of the patients experienced acute kidney injury . To truly change these dynamics, ASN recommends that PCORI evaluate patient-centered comparative clinical effectiveness research opportunities by ensuring that each initiative adheres to the following basic principles: • Advancing the issues that people with kidney disease confront now. • Addressing the lack of innovation that has been, and still is present in kidney care. • Improving conditions around disparities for children and adults with kidney disease. • Creating new solutions for people with kidney disease that can be embraced by the community (e.g., easily translated into policy and practice). • Achieving a diverse workforce representative of the kidney patient population.
Achieve Health Equity: What are the challenges?
The roots of disparities among those with or at risk for kidney diseases are deep and multifactorial, spanning from inequities in disease detection and prevention to access to optimal therapies for kidney failure such as transplantation and home dialysis, and these disparities are closely linked to social determinants of health and systemic racism on a national level. These disparities will not be adequately addressed in the absence of dismantling these inequitable structures in and outside of health care, however, the kidney health disparities discussed below can and must begin to be addressed through federal health care policy.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI has a unique role as a convener in research with its ability to seek guidance from a wide range of stakeholders, including those traditionally not in the healthcare space, while ensuring that the patient’s voice has a prominent and active role.
Achieve Health Equity: What does success look like?
What does “achieving equity and eliminating disparities” ultimately look like? Even if the answer to that question may not be able to be fully expressed in this comment letter, ASN hopes the steps described will advance our society further along this path. While the recommendations herein may seem incremental, that makes them no less essential. The first essential step in kidney care is already underway that can be reviewed, supported, and disseminated by PCORI. Medical Algorithms Examination of the use of race in clinical decision-making algorithms, such as the Kidney Donor Profile Index (KDPI) and estimated glomerular filtration rate (eGFR), is currently underway by the kidney community. ASN and the National Kidney Foundation (NKF) created a task force in 2020 to specifically address this issue with its final report expected later this year. ASN unequivocally reaffirms that race is a social, not a biological, construct, and the society remains committed to ensuring that racial and ethnic biases do not affect the diagnosis and treatment of kidney diseases. As stated in a letter to ASN membership in March 2021, “ASN asserts that 1) race modifiers should not be included in equations to estimate kidney function and 2) current race-based equations should be replaced by a suitable approach that is accurate, inclusive, and standardized in every laboratory in the United States.” Any such approach must not differentially introduce bias, inaccuracy, or inequalities. Data Collection Existing data already convey a disturbing landscape of disparity in kidney care from social determinants of health (SDoH) to diagnosis to kidney transplantation. Data collection now needs to focus on what “moves the needle” on these issues. ASN encourages PCORI to support research that collects data that does just that by collecting more data on the “why” of low rates of home dialysis and home dialysis retention. This can be aided by more research and assessment of patient experience and patient-reported outcomes that are impactful on individuals’ wellbeing. ASN also urges more systematic ascertainment of social determinants of health data, including the most common non-clinical barriers to home dialysis, such as housing or financial insecurity, minimal caregiver support, other mental and certain physical illnesses, or advanced age. This information will help identify barriers to equitable care and develop policies to overcome these barriers.
Name and/or Organization
Ryan Murray
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/27/21 11:06
Name and/or Organization
Jennifer Bright, Innovation and Value Initiative
Community
Stakeholder
Stakeholder Community
Health Researcher
File Upload
Submitted
8/27/21 10:44
Name and/or Organization
Michael Sieverts
Community
Patient
Patient Group
Patient
File Upload
https://www.pcori.org/sites/default/files/webform/19726/PCORI-Comments-MCS-August-2021.pdf
Submitted
8/27/21 10:33
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Please see attached PDF
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Please see attached PDF
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Please see attached PDF
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Please see attached PDF
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Please see attached PDF
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Please see attached PDF
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Please see attached PDF
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Please see attached PDF
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Please see attached PDF
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Please see attached PDF
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Please see attached PDF
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Please see attached PDF
Achieve Health Equity: What are the opportunities?
Please see attached PDF
Achieve Health Equity: What are the challenges?
Please see attached PDF
Achieve Health Equity: What is PCORI’s unique role or contribution?
Please see attached PDF
Achieve Health Equity: What does success look like?
Please see attached PDF
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Please see attached PDF
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Please see attached PDF
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Please see attached PDF
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Please see attached PDF
For the full set of National Priorities: What other comments do you have?
Please see attached PDF
Name and/or Organization
National Multiple Sclerosis Society
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
Submitted
8/27/21 10:29
Name and/or Organization
AcademyHealth
Community
Stakeholder
Stakeholder Community
Health Researcher
File Upload
Submitted
8/27/21 10:07
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
PCORI has an opportunity to increase evidence for emerging innovations in health. For instance, the CMMI Strong Start study looked at three innovations in prenatal care and found evidence that midwifery care provided in birth centers improves outcomes. These types of projects build on existing evidence to advance underutilized care models, such as midwifery care provided in birth centers.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Challenges include lack of funding and qualified personnel for research and QI projects as well as a lack of community engagement efforts on the part of providers and health systems.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI has the funding to support research and QI projects that would demonstrate the effectiveness of existing interventions and create new evidence for emerging innovations in heath. In addition, PCORI designs and funds projects to be responsive to the needs and desires of patients.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Success looks like an expansion of interventions and innovations such as CMMI Strong Start so that support will grow along with the confirmation of the evidence for midwifery care.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Analysis of health care use data demonstrated that the presence of midwives in a hospital unit is associated with lower hospital cesarean rates. An analysis of the level of structural integration of midwifery through state policy and associated population health outcomes found that states that used policy levers to integrate midwifery had significantly higher rates of spontaneous vaginal birth, vaginal birth after cesarean, and breastfeeding and lower rates of cesarean, preterm birth, low birth weight infants, and neonatal death. There was also an association between midwifery integration and reduced racial disparities in outcomes. Recent single-center studies and financial analyses have demonstrated the reduction in cesarean rates observed with increased midwifery care also reduces costs to the hospital and health system, both initially and downstream.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
There are several challenges to scaling up midwifery, including restrictive regulatory language as a condition of licensure and practice, inequity in third-party reimbursement structures, a shortage of preceptors and access to clinical sites, financial barriers to midwifery education, and the narrow midwifery workforce pipeline. ACNM encourages the larger maternal health stakeholder community and those with a vested interest in optimizing the performance of healthcare systems to achieve the “Triple Aim” of improved care, reduced cost, and patient satisfaction, to champion proposals that better integrate advanced practice midwives across the care continuum.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
PCORI has capacity to study outcomes of midwifery led care and systems that have integrated midwives. This research may accelerate scaling up of proven perinatal care models led by midwives.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Midwifery becomes the standard of care for sexual and reproductive health care in order to improve perinatal outcomes.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Opportunities for advancing the science of dissemination, implementation, and health communication include creating collaborations between stakeholders, such as health professionals (midwives?), researchers, and community members to help prioritize what should be disseminated and implemented with respect to community needs and clinical practice.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Challenges include the lack of funding for stakeholder meetings and projects as well as resistance of systems and providers to change behavior based on the evidence.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI creates opportunities for patient and community engagement with the health care system and providers so that their wants and needs are heard as research is designed and carried out.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Success is an increase in uptake of research supported clinical practices that are important to and influence the health of the community.
Achieve Health Equity: What are the opportunities?
To achieve health equity in maternal health, the burgeoning body of patient-centered research supports just and effective utilization of our resources. Specifically, midwifery is an under-utilized often overlooked workforce that has the potential to greatly reduce overall maternal mortality and close the racial gap. Patient-centered care is midwifery. Listening to and partnering with patients are central to the way we provide care. Shared-decision making is at the core of what we do. Midwifery care has been proven to increase breastfeeding rates, increase satisfaction with birth, decrease preterm birth and the incidence of cesarean birth. Yet just under ten percent of all U.S. births are attended by midwives. With great societal interest in solving the maternity care crisis in this country we have the opportunity to transform our current system and invest in proven solutions. Midwifery is just one of those solutions, but it is an integral part of reversing the upward trend of maternal death in this country.
Achieve Health Equity: What are the challenges?
Racism in health care is at epidemic levels. Pregnant people and their infants are at greater risk of illness and death than they were twenty years ago. Much of this risk has to do with how the system currently operates and how little input pregnant people have in their care. By centering patients and collaborating with people of childbearing age, we learn the impact of racism from their lived experiences. The challenge is that midwives and nurses, physicians and doulas can’t protect patients and their families from all the effects of racism on the health of families. Applying a lens of midwifery over a goal of health equity, engaging with communities and using midwives' expertise combined with the expertise of patients can reform not only healthcare delivery but families and our communities for resilience and thriving.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI has the funding, mission and vision to make sure patients have the information they need to make the best decisions for themselves. When the research is guided by their input, the most useful information can be attained. Along with PCORI’s stated commitment to equity diversity and inclusion, this is unlike any other organization in the country. Choosing to include a patient-centered focus on efforts to reduce maternal mortality will have long-lasting positive effects on our nation.
Achieve Health Equity: What does success look like?
Success looks like fantastic outcomes for mothers and infants, despite racism. A workforce who is committed to anti-racism efforts and equity in healthcare. Lower cesarean section rates. Higher satisfaction and more confident parents. Patients who are engaged and empowered. Practice that follows the research. More midwives and birth centers.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Interprofessional education (IPE) for advanced practice midwives and medical residents is low hanging fruit. ACNM and ACOG are continuing to partner to develop IPE funded by a Josiah H. Macy Foundation grant. The IPE model of care has real potential to reform and improve how maternity care is provided in the United States; however, it cannot be fully realized without the ability for midwives to be educated inside hospitals.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Challenges for IPE include the inability to receive adequate reimbursement for time and expertise in developing and executing these programs. Advanced practice midwives are not visible in GME funding for education.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
PCORI can design and fund IPE for advanced practice midwives and residents. Midwives educate residents in hospitals without being able to educate midwives in these same hospitals. PCORI could facilitate development of IPE by funding more programs.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Programs across the country that educate advanced practice midwives and residents together.
Name and/or Organization
American College of Nurse-Midwives
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/27/21 8:24
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Looking at health and wellbeing from a different lens, the community. How do they see their health? Is it lab numbers or what they are able to do to live? Existing interventions include: Massage therapy. Emerging innovations: Massage therapy for body awareness/body literacy - engaging people to connect with their bodies monthly, increases body awareness and agency for individuals to navigate the healthcare system. This allows that limited time with a primary care physician one time a year to be more effective.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
There are no funding mechanisms in our current healthcare system that support massage therapies involvement in healthcare. Massage therapy associations have avoided developing levels of care/engagement: Spa relaxation massage is different than therapeutic/medical massage, all are beneficial, but the public does not know who or where to go. "Barriers to access and perceptions of massage therapy among patients receiving services at a public hospital system in Northeast Ohio" poster presentation
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Developing Community Research opportunities through Community Based Research Networks: Specifically fund more community partners directly as the full leaders of their projects in their community. Currently academic researchers hold all the power, there is no doubt that academic researchers hold important skills and experience that can make research projects successful. But when it comes to fully engaged research, they must begin to accept a much more level partnership if they expect systems to change. Allowing the community to pick their researcher vs the researcher picking their project will go a long way in having patient involvement
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
To start having 25% of the grants going to community partners leading research projects and increasing to a 50/50 distribution for PI. Utilizing the current Ambassador program and members that have been volunteering for years with minimal stipends would be a great start.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Develop funding for Community Based Research hubs where community members are paid their fair salary and incidentals just as academic are paid. Funding People and their time along with collaborative infrastructures. Developing pay scales not only on academic achievement, but on life involvement and impact to subject matter. Include youth in the planning and PAY THEM! They are our future, they should be involved. Youth Participatory Action Research (YPAR) in schools. Providing funding for community organizations, currently many academic institutions receive 35-60% of grant funding off the top, yet community organizations receive 5-13%.ntals , led by the co
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Determining what people are worth, since they are priceless in this situation. Utilizing models where salaries are determined by years of involvement, skills, impact and education may would be beneficial in engaging the community.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Have paid community roles within the Ambassador program that develop skills similar to the academic model. Engaging people from top down and bottom up!
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
50/50 split for academic/community PI's
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Involve the community from the start. Include youth, especially through YPAR Take the time to learn what Health means to the community. Add Well-Being, and learn what that means to the community.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Time and Money that can all be alleviated by engaging the community from the start.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Funding qualitative research projects to understand Health and Well-being in the community. Look at models like journey mapping - map peoples journey through healthcare, both good and bad. Who are they engaging with along the way
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
50/50 split for academic/community PI's. Communities and people developing agency and taking health and well-being into their own hands and supporting others on the path.
Achieve Health Equity: What are the opportunities?
Involve the community from the start. Include youth, especially through YPAR Take the time to learn what Health means to the community. Add Well-Being, and learn what that means to the community. CHANGE THE LENS: Research opportunities and what is working vs disparities and what is wrong.
Achieve Health Equity: What are the challenges?
Time and Money that can all be alleviated by engaging the community from the start and paying them a fair wage! WE spend too much money on identifying what is wrong. Change reduce disparity to develop opportunity.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Funding Community Based Research Hubs and developing an IRB for Community members Funding qualitative research projects to understand Health and Well-being in the community. Look at models like journey mapping - map peoples journey through healthcare, at all economic levels. Who are they engaging with along the way, what is the same and different.
Achieve Health Equity: What does success look like?
50/50 split for academic/community PI's. Communities and people developing agency and taking health and well-being into their own hands and supporting others on the path. Not all communities paths will be the same, but the health and well-being will equal out
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Engage Youth! YPAR in schools. WHoleHealth Education in k-12
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Too much focus on numbers and data that do not contribute to health and wellbeing vs experiential learning.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Developing opportunities for youth to be PI's on youth projects
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
50% of projects on Youth are led by youth.
For the full set of National Priorities: What other comments do you have?
Engage the community
Name and/or Organization
Diane Mastnardo
Community
Patient
Patient Group
Patient/Consumer
Submitted
8/26/21 17:33
For the full set of National Priorities: What other comments do you have?
Thank you for the opportunity to provide feedback to the PCORI strategic plan. As a collaboration of patient advocacy groups that support families affected by rare genetic diseases and neurodevelopmental disorders (www.alliancegenda.org), AGENDA appreciates the patient centric approach that is utilized by PCORI. We hope these suggestions to the national strategic plan inform your research priorities as well as help refine the priorities set forth on your website. While this may be done with the research agenda, there are very little specifics presented in the national priorities. While these are great priorities, the goals under some of these priorities are still rather vague and in our opinion, not measureable or specific. It has been unclear to many patient advocates what the value of some of the projects have been or how they have move research ahead. For example “enhance infrastructure”….what does this mean? Advance the scientific evidence for and the practice of dissemination, iimplementation and health communication. In our experience, it has been very time-consuming to identify specific best-practices that have emerged from dissemination awards. We suggest some changes to this strategic priority. First, we recommend considering all PCOR dissemination/implementation/communication projects, whether or not they were originally funded by PCORI. Second, we recommend including additional filters, such as "social media" or setting such as "conference,", "clinic," "telehealth," to make it easier to find relevant dissemination/implementation/communication practices. How is this a new priority? What will you do differently to improve your dissemination plan? In the past, the dissemination grants have been focused on PCORI – funded projects and we feel this is a mistake. We also suggest developing a more user friendly PCOR-net. We understand and appreciate that a lot of work has gone into the development of the frame and the organization of the materials, but the audience it has been directed to is unclear. It is too complicated to be directed at the lay stakeholder community, and not specific enough to be informative to the scientific community. This could fall under “Advance the Science of Dissemination, Implementation and Health Communication”. There should be comparative effectiveness research under the above priority The fifth priority is an Integrated Learning Health System. While we totally support this type of system, why is it it’s own priority? Should this not be a goal under one or multiple of the other priorities? There needs to be an additional priority of sharing best practices, which includes non-PCORI funded projects. Still, PCORI funded projects are disease-specific, still work in silos based on disease of interest or gene of interest. The opportunity to focus on an overarching symptom like intellectual disability was a fantastic opportunity for this type of research and we look forward to hearing about what projects were funded under that specific call. Things learned from PCORI grants should be scaleable and able to be replicated. They are not described well enough in PCOR-net to do that now. There is little information anywhere other than scientific publications (which I know are encouraged but not mandated under an award) to find anything that can be truly replicable. This should be a priority for PCORI. Finally, the topic of “patient centered research” is starting to lose it’s meaning and importance. What is it? How do you define it? The research that is funded by PCORI sometimes fits the boundaries of what is commonly known as “patient centered”, but sometimes it does not. The role of patient advocacy groups needs to be elevated in the priorities for PCORI. Right now, “patient centered” does not have much gravitas in the plan.
Name and/or Organization
Alliance for the Genetic Etiologies of Neurodevelopmental Disorders and Autism
Community
Patient
Submitted
8/26/21 17:00
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
There are many opportunities in terms of interventions and innovations, but none is more important then resolving the complex and inefficient payment systems that are bogging down businesses and the economy; blocking effective and affordable care for individuals; and failing to ensure public health and safety.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
There are three major challenges: 1) The commercial sector (insurance companies, hospitals, pharma, device manufacturers, and service providers) resist anything that threatens their profits. 2) The professional sector (physicians, medical professional, hospital administrators, lawyers, and some professional association leaders) resist anything that threatens their income or their autonomy. 3) The government sector (public health agencies, medical schools, Medicare, Medicaid, VA, Marketplace, and such) are considerably less powerful than commercial and professional sectors, and also interested in preserving their budgets and autonomy. So basically, the development and implementation of a better health system is faced with the age-old challenges of human greed and selfishness. FOR PCORI, however, the Worse Challenge May Be that it’s funding stream comes from the very stakeholders it needs to redirect. PCORI is susceptible to being a “PAC” [Political Action Committee] for the corporate interests which fund it, via IRS fees. FOR THE PUBLIC, a major challenge has become navigating an increasingly complex system, which uses Government Entities (like the IRS and Healthcare.gov Marketplace) as healthcare henchmen, carrying out the “dirty work” of insurance companies. You want to buy health insurance on the Marketplace, but have a disability? You are denied the option of buying a policy, and are instead routed to Medicaid, which then screens for income limits, and denies access too. You might get a pay raise at work, or want a part-time job? Stop! More money will affect your Marketplace insurance subsidies, and might make you completely ineligible; the IRS decides. If staying healthy is important, the rational choices become don’t earn too much money; forget wholesome “family values”; fracture families to survive. Despite improvements made over the years, the present system remains unacceptable.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI is uniquely perched between stakeholders and patients to study and recommend (1) system changes, (2) policies, and delivery methods--- three categories identified in the scope PCORI’s national priorities. PCORI’s collaborative environment COULD produce a truly effective health system, which would protect public health; care seamlessly for individuals; at significantly lower costs than we are doing now. But look at research produced and reported so far. Often, the recommendations cut costs for insurers, and reduce medical services provided to patients. PCORI needs to involve significantly more patients, caregivers, and patient advocates who understand what is at stake; what’s possible; and the opposition they are up against.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Existing evidence, for more the effective interventions and delivery system innovations than those currently imposed in the United States, will be acknowledged and accepted. For starters, there would be “One and Done Enrollment”. When the United States accomplishes a successful health system, people would be enrolled when they are born or legally immigrate, and remain continuously covered for essential health services for their entire lives. We will see our entire economy function more effectively when roadblocks to healthcare are eliminated. We must work together to PUT AN END TO barriers, such as: annual enrollments; wasteful jockeying between plans; employers trying to guess which policy will be best for circumstances they can’t anticipate; cruel cherry-picking of “customers” pointless means-testing and income restrictions; and prior authorizations. Success will result in improved access, higher quality care, and more efficient operations. There will be less human suffering, and fewer deaths due to a lack of health care.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
For better or worse, Covid has broken down data silos, and is accelerating Big Data in the health sector. PCORI must wisely balance the opportunity to be a champion for public concerns, and an agent of corporate interests.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
People do not have access to the healthcare they need, making many kinds of research invalid. There are too many roadblocks to receiving care, largely due to failed “cost-saving” efforts (blocking care is costing more than providing care would). Without access to care, people are not connected to the health system, so the “infrastructure” has no effect. Research is impaired by limited patient enrollment; poor patient engagement; discontinuous records; and system fragmentation. The public is losing trust in health systems, data systems, and government. As a result, people increasingly adopt health practices and treatments that are not provided or recorded in traditional health settings. There’s no way to capture and examine health data taking place outside a health care setting. Home remedies, internet advice, herbal cures, will be overlooked in research; yet such will increasingly become important since people can’t afford science-based medicine, and no longer trust a failing health system.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
PCORI could study and report who receives appropriate medical care, to restore trust. Which models of coverage provide the best outcomes --- Medicaid, Medicare, Employer Insurance, Market Insurance, or something else?. Compare the results of for-profit and government programs, if PCORI is permitted to make such an analysis. Explain why health outcomes in our country consistently fall below that of other industrialized countries. Objectively and honestly expose system failures where they exist, and gather examples of success. Move us rapidly to success. Prove to the public—if possible--Electronic Medical Records—will not be misused. Provide accurate information and assurances of data security (hard to do given the frequency of data breaches). Explain how a patient’s health costs --- and that of future generations as well--- won’t be impacted by an individual’s medical record, or family’s genetic heritage.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
In a successful infrastructure and research arrangement, People will have good and lasting relationships with health professionals (instead of networks constantly flipping, being renegotiated, and changed… disrupting continuity, relationships, and trust needed for better outcomes). From established relationships, better data can safely be collected. Privacy will be protected. Individuals and communities will be better informed. Success results in good health.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Health issues are central to current events and issues. Innovations are occurring rapidly. Information changes quickly. Consensus building will be key.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
People feel threatened. Society is polarized. Differences of opinion have become divisive. People are experiencing message overloads and burn out. There are many information sources, and alternative distractions. Trust needs to be restored. Restoring trust requires respected leadership, integrity, accuracy, honesty, and actions compatible with improving the safety and effectiveness of the health system.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI is uniquely positioned to build consensus, and facilitate collaborations.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
PCORI needs to increase representation of private citizens, the general public, and individuals impacted by their health research and guidance. PCORI should consult reading and communication specialists, to produce materials that are comprehensible to the general public. At least some of PCORI’s products need to be distilled, simplified, and shared at an eighth-grade comprehension level, possibly fifth grade. Public awareness of PCORI, and its role in guiding the direction of health, should be increased. PCORI should seek highly qualified webinar panelists, who will challenge PCORI’s assumptions, and provide truly helpful commentary.
Achieve Health Equity: What are the opportunities?
We are faced with unprecedented developments in diagnoses, treatments, and long-term management of diseases, and every closer to the promise of personalized health care. There is greater awareness and public compassion for the issues of health equity.
Achieve Health Equity: What are the challenges?
“It’s the economy, stupid.” Actually, it WAS the economics; now it is more a matter of political and social will. The Congressional Budget Office, and numerous other reports have now shown equity is not only financially feasible, but also desperately needed to reduce GDP spending on health care. Oppositional greed and the fear of change are core challenges. Emphasis solely on racial arguments—instead of the root problems of greed and fear—is divisive, and impeding success.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Illuminate core challenges. Lessen divisiveness.
Achieve Health Equity: What does success look like?
All citizens and legal immigrants will receive all necessary medical services and appropriate care in a timely manner, without cost barriers, bankruptcies, or need for Go Fund Me accounts. All residents (regardless of legal status) will receive medical services and care needed for public health and safety; and compassionate care for injuries and emergencies--but for now, may need to rely on charitable care for chronic conditions—in order to gain public support and back immigration policies. Similarly, in a consensus building compromise, controversial services --- such as abortion on demand (not medically necessary or appropriate)—may remain legal, but not publicly funded. Insurance can be marketed for elective services, not covered in the public health system.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
A learning health system includes: a secure and effective health data infrastructure; care improvement objectives; supportive policies; and engaged participants. The data infrastructure is growing rapidly; PCORI research guides objectives; policies are mostly supportive; and participation can be increased with improved health equity.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
The security, privacy, and stewardship of data is critical to a Learning Health System. Also, objectives must be ethical, moral, and just; as well as evidenced based. “The convergence of electronic personal health information, clinically annotated EHRs, and molecular medicine in an interconnected framework will help to realize the promise of both personalized medicine and personalized care (Abernehty et al;, 2010; Nalder and Downing, 2010)…to succeed, the system must ensure privacy, security, and individual control of personal health information for the patient….”
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Explain distinctions between Electronic Health Records (EHR) and Personal Health Records (PHR), and how privacy is assured in a Learning Health System. Also, provide honest, accurate, assurances on how insurers do or do not utilize HERs and PHRs, particularly if a for-profit system design is retained. Genomics is a key enabler of individualized care, but problems with analysis, storage, and transfer of data; process and knowledge management; and patient provider representation are daunting challenges (Millwood, 2018, May 8; Health Affairs, PubMed; review of Williams, Marc S, et al, 2018; Patient-Centered Precision Health In A Learning Health Care System: Geisinger's Genomic Medicine Experience.), PCORI is uniquely charged to address.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Human life is valued. Laws of nature are respected. People enjoy freedom and good health. Harmony exists. Integrity is respected. Truth prevails. A Health Learning System is utilized wisely and fairly; or it is not implemented at all.
For the full set of National Priorities: What other comments do you have?
Health care is a social good, human necessity, and positive economic stimulus. Get it right.
Name and/or Organization
Lin Bincle
Community
Patient
Patient Group
Caregiver/Family member of patient
Submitted
8/26/21 16:57
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
o To close the gap more quickly between existing knowledge and new knowledge from innovations o Advances in technology, electronic health records, and policy advances need to consider the role of nurses and impact on nurses’ work. o The COVID-19 pandemic allowed many innovations in healthcare, such as telehealth, to emerge or become more mainstream. It will be important to continue support for innovation in healthcare to continue advancing the accessibility and quality of healthcare provided. Expanding the scope of stakeholders engaged in PCORI’s work will be key to achieving this goal. o To examine new and existing technologies in light of their impact on nursing and bedside practice. New technologies have the potential to help create new staffing models that help alleviate shortages of providers such as nurses, other ancillary healthcare workers, and support staff. o To examine changes in leadership models associated with business leaders over multiple units and mergers of hospitals into larger healthcare systems. There is very little science to guide these changes, yet practice and system changes are occurring rapidly.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
o This initiative speaks to improved healthcare delivery and patient outcomes. One challenge would be to discern the role of professional nurses in redesigning healthcare systems. o Assuring the availability of adequate research funding for nurse researchers. o Healthcare delivery is not standardized, thus innovations for practice in rural areas, critical access hospitals, etc., may be excluded in this initiative. o This initiative targets geographic areas to reduce health disparities, which is important to improve patient outcomes, but the role of acute and critical care nurse in these areas can be both a challenge and opportunity. For example, a new care delivery method could utilize acute and critical care nurses who have advanced knowledge. o Innovation incubators are not established in all health systems. It will be important to provide support to create these incubator sites as well as support the research and innovation that is a product of the site. Building these resources will enable research in this area to progress.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
o Leveraging clinical effectiveness research to close the gap between what is known and what is being discovered, and providing pragmatic approaches to asking and answering research questions. o Leveraging partnerships will be key in achieving this outcome. PCORI can use key partnerships to engage the public in their research.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
o Success would ensure that the work of nurses (professional knowledge and skill-based practice) is considered in the studies focused on improving healthcare practice, technologic advances, and diagnostics. o Nurses are present in the reshaping of healthcare teams and delivery systems as emerging innovations are moved forward.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
o Clinician burnout is addressed in this priority. This provides an opportunity to understand from a scientific perspective what objective criteria are needed for healthy work environments. o Advocate for nurses to be included in the design of studies, especially studies seeking to improve healthcare systems infrastructure or those intended to advance healthcare systems and policy decisions. o Use training institutions to ensure proper infrastructure is provided for clinicians. This could include pre-licensure nurses, post-licensure, rural nurses, and APRNs. o Recruit and engage acute and critical care patients and families into research o Policy and practices for working together with patients and families provide an opportunity to reexamine visitation, family/significant other presences, and co-care planning during acute and critical illness. o Engage nurse academicians and nurse clinicians as partners. o Engage in patient-clinician decisions so that outcomes are aligned with patient goals.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
o Statement of real-world data is a concern because EHRs are poorly designed. Nursing care, critical thinking, professional work can be “missing” in EHR data. This will prevent meaningful understanding of nurses’ work. o Poorly coordinated care is not well defined, thus understanding the opportunities for improving infrastructure to better coordinate care may be challenging. o Learning health systems rely on meaningful data from EHR inclusive of data from all disciplines that provide care towards patient goals/outcomes. o A strategy to achieve this goal is to develop and expand the universe of engaged patients and communities in research. However, as a result of the COVID pandemic and the rapidly changing knowledge and guidance about the pandemic, many people are wary of science, especially those with health disparities. This may be a barrier to achieving this goal. o Disconnects between academic research infrastructure and hospital operations
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
o The patient’s “voice” is actively incorporated into all aspects of care, rounds, goals, and decisions o Electronic health record data is an accurate reflection of each healthcare professional’s role, function, and actions toward patient outcomes. o Training institutions provide diverse learning opportunities, yet deliver, consistent content to advance the knowledge of learners in diverse roles, geographic locations, and healthcare systems. o A developed cadre of nurses with PCORI expertise to be competitive with funding
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
o Simply stated, to improve the focuses on the science of dissemination, implementation, and health communication to inform healthcare decisions and improve outcomes o Address known and emerging concerns and impediments to evidence-based practice, dissemination, and implementation of best practices o Ensure best-evidence guides/resources are provided to acute and critical care nurses in a continuous, timely fashion to inform practice o Implementation strategies are in great demand o See nurses as central to person-centered and engaged care planning to drive care decisions o Create dissemination strategies that are inclusive of all healthcare professionals’ contributions to health
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
o Effectively communicating research findings in ways tailored to diverse audiences that will facilitate uptake/use of evidence o Lack of a body of evidence for effective implementation strategies across diverse settings and populations o Updating evidence-based practice into clinical practice
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
o Leverage clinical effectiveness research to move evidence into practice more quickly and cohesively
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
o Healthcare clinicians and patient/families seek best evidence to guide care decisions and develop goals of care o Acute and critical care nurses are nimble in understanding how to implement best practices to advance practice and optimize care provided to patients/families o Evidence-based practice is how we practice and is no longer a “project” to be completed
Achieve Health Equity: What are the opportunities?
o Continue to advocate through community-based organizations, possibly using the American Association of Critical-Care Nurses chapters and regional conferences o See nurses as central to clinical effectiveness research initiatives to advance systems-level emphasis addressing health equity o Advance clinical practice and the nursing profession through research that explores disproportionate/disadvantaged populations inclusive of nurses’ professional development opportunities o Engaging with acute and critical care nurses within and across communities to better understand how to meet diverse patient/population health needs so that care is holistic, safe, free from harm or stigma, and aligns with patient goals o Examine how biological, behavioral, environmental, sociocultural and other factors interact and determine a person’s health trajectory and outcomes.
Achieve Health Equity: What are the challenges?
o Identifying implicit bias, diversity, equity, inclusion, as they relate to healthcare access, overcoming stigma for some populations, and reimbursement/ability to afford care o Improving nurses’ professional development in diversity, equity, and inclusion is a start to address health equity, but the larger systemic challenges are significant. o Underserved groups such as Black, Latinx and Indigenous persons, persons with disabilities, persons who live in a rural area and those who live in persistent poverty have unique health needs. As a result, they often experience disparities in health outcomes. It may be difficult to enroll or engage these types of people in research due to their lack of access and/or mistrust of healthcare. Yet, their representation is crucial.
Achieve Health Equity: What is PCORI’s unique role or contribution?
o Getting Congressional funding/support for research, especially clinical effectiveness research, to address healthcare equity challenges
Achieve Health Equity: What does success look like?
o Healthcare access and outcomes are not dependent on gender, race, ethnic, or geographic variables o Incorporating constructs of discrimination across all domains of research to optimize health equity and eliminate health disparities
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
o Reduce healthcare system fragmentation for the patient/family to achieve health and well-being. o Possible connections between community and acute/critical care systems to keep patients moving forward toward healthcare goals. Learning health system connection to facilitate transition, updates, changes between these two points of care o Electronic health record and integrated learning systems include nursing work, and critical thinking/reasoning are evidenced in data mining systems o Expansion of telemedicine/tele-ICU as a possible mechanism to facilitate elements of the learning health system o Development of learning health systems do not require nursing time for EHR tasks that remove the nurse from care of the patient o Collaborate with multidisciplinary groups in educating the future acute and critical care workforce
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
o Learning health systems are somewhat new. Healthcare systems may/may not work with different insurance support systems and may lack social supports in the community. o Public health and hospitals are not fully connected entities and there is a need to establish a more cohesive system to provide learning health systems o The role of the acute and critical care nurses is unclear in this priority.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
o Clinical effectiveness research focused on identifying synergistic opportunities to actualize/operationalize learning health systems o Require research that encompasses all elements of learning health systems (organization, community, individual) to determine the best strategies
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
o Healthcare experiences are seamless. Patients in the community needing care can gain access easily: the healthcare system is aware the patient is coming, knows the person’s history and current treatment plan (patient doesn’t have to fill out same forms with each admission, etc.). At time of discharge, community services are updated, medications and DME arrive at person’s dwelling, and the cycle continues without “hiccups.” o Data analytic tools are multidimensional to provide truly informed real-time decisions.
For the full set of National Priorities: What other comments do you have?
• Overall, the PCORI National Priorities are diverse and strive to address healthcare inequities, healthcare system barriers-infrastructure, advance translation/implementation of best evidence into practice, and person-centered care/involvement.
Name and/or Organization
American Association of Critical-Care Nurses
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/26/21 16:39
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Early detection consists of a prostate specific antigen (PSA) blood test and digital rectal exam (DRE), plus calculating additional risk factors and using emerging genetic and genomic testing to map out the potential severity of the disease. Unfortunately, the United States Preventive Services Task Force (USPSTF), whose evaluations of preventive services determine insurance coverage of those services, has historically undervalued the PSA test, for many years discouraging its use. The USPSTF’s recommendation is especially troubling for those at highest risk of prostate cancer, including men with a family history, African American men, and those with BRCA gene mutations. Failure to use the primary existing screening tools means that too many men are diagnosed in the later stages of prostate cancer.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI’s emphasis on the patient experience at the center of research gives the organization a unique perspective that can greatly inform bodies like the USPSTF.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Centering research on existing patients with a focus on outcomes and patient experience is an excellent opportunity to glean new data that can help patients in the future, without unnecessary duplication.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
We believe there are valuable opportunities in this area to use health education to overcome stigma and discomfort with screening, especially in hard-to-reach populations.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
A lack of disease awareness and potential preventive actions disproportionately besets underrepresented communities.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI can contribute best by centering patients in research on the best ways to reach vulnerable populations.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Improved individual disease awareness and knowledge will lead to improved access to quality care and better outcomes for men diagnosed with prostate cancer.
Achieve Health Equity: What are the challenges?
Cancer affects minority communities at a higher rate than non-minority groups. This holds true for prostate cancer as well. For example, African-American men are twice as likely as Caucasian men to die of prostate cancer, and Hispanic men have worse access to screening and care.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI should consider building on the work of other prostate cancer research programs devoted to health equity, such as the ongoing RESPOND study. In addition, it is vital to be engaged with trusted patient groups to translate the information gained from research into action by individuals using culturally competent messaging.
Achieve Health Equity: What does success look like?
Improved prostate cancer outcomes require the elimination of inequities in the healthcare system.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
ZERO applauds PCORI's priority of an integrated Learning Health System. It will provide a fuller picture and help better define the problem regarding social service impacts from disease.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
To incorporate only data from government-run social service providers could miss a large portion of the aid provided.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
PCORI should consider avenues for the submission of data from private organizations that coordinate delivery of many of the social services required by patients with cancer and other diseases and conditions, in addition to data from public sources.
For the full set of National Priorities: What other comments do you have?
We applaud PCORI for the substantial amount of work that they have done already for prostate cancer, especially to evaluate the patient experience of different treatments. However, we do want to draw attention to the need for additional research that would help improve early detection methods and procedures.
Name and/or Organization
ZERO - The End of Prostate Cancer
Community
Stakeholder
Stakeholder Community
Policymaker
File Upload
Submitted
8/26/21 16:08
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
The patient perspective in all research has become increasingly important and valued. Enhancing the infrastructure to support patient centered outcomes research within credible, trusted not for profit organizations will not only accelerate patient centered outcomes research, but it will lead to more harmonized and user-friendly data collection. The COPD Foundation has been able to build on the infrastructure of the COPD Patient Powered Research Network (COPD PPRN) that was initially enabled by PCORI through the patient powered research network funding. The infrastructure has enabled 10 studies, each with a focus on patient centered outcomes.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
A main challenge, but also a potential opportunity, is the ability to ensure that patient advocacy groups have the ability and funding to create robust and flexible infrastructures to enable them to partner on studies and patient centered outcomes research.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
PCORI’s support of patient powered research networks was novel and a critical step towards developing infrastructures to support patient engagement and participation in research. In order to build on this, PCORI is in a unique position to be able to require patient reported outcomes and partnership with relevant patient advocacy groups for all PCORI funded studies. This commitment to patient centered outcomes research is at the core of PCORI’s mission and this will help to solidify this commitment and ensure that the patient voice is not just a mention, but rather central to all PCORI studies.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Ensuring that patients are engaged, empowered and educated is what success looks like. The COPD Foundation continues to build on our PCORI funded projects, including the COPD PPRN BRIDGE project - Bridging the GAP between Patients/Caregivers and COPD Research, a Eugene Washington Engagement Award. BRIDGE resulted in not only a confirmation of the critical importance of inclusion of the patient voice, but tangible resources including a training guide on how to participate in research: for patients, designed by patients and a research list prioritized by patients. Success looks like ensuring that patients have a voice and are provided training how to share their voice with research teams and ensure that they are a valuable and equal member of the team.
For the full set of National Priorities: What other comments do you have?
Thank you for the opportunity to provide a comment on the PCORI National Priorities. We commend PCORI for including priorities that are broad and encompass the critical issues. The COPD Foundation encourages PCORI to ensure that these priorities be applied to the benefit of people with chronic lung disease. While we are incredibly appreciative to PCORI for support for studies, to date, chronic lung disease has received less than 5% of total PCORI funding. COPD is the 3rd leading cause of death in the US and over 37 million individuals in the US are living with chronic lung disease including COPD and asthma. COVID-19 and the undeniably substantial, yet fully unknown, impact on lung health further highlights that lung disease cannot continue to remain underrepresented. The COPD Foundation strongly advocates for funding for lung conditions proportional to the public health burden and we ask that PCORI consider including experts in chronic lung disease on the Governing Board and Methodology Committee.
Name and/or Organization
COPD Foundation
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/26/21 14:20
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
We need to examine patient outcomes to determine the ongoing use of telehealth. It can be and method to increase participation for some population and for others may be a barrier and we need to explore who can benefit from telehealth who experiences this method as a barrier and why.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
The physical infrastructure can play a role in access to ongoing research and health care. With the new infrastructure bill passing (hopefully) the Congress it is important to explore opportunities to increase health equity through the resources of this bill. We know that climate change is impacting communities of color and we need to find creative ways to tell individual stories to build infrastructure to improve long-term health outcomes in these communities.
Name and/or Organization
Christine Brown, MS OTR/L
Community
Stakeholder
Stakeholder Community
Hospitals and Health Systems
Submitted
8/26/21 12:37
Name and/or Organization
College of Health Solutions at Arizona State University
Community
Stakeholder
Stakeholder Community
Health Researcher
File Upload
Submitted
8/26/21 12:33
Name and/or Organization
National Council on Disability
Community
Stakeholder
Stakeholder Community
Policymaker
File Upload
Submitted
8/26/21 10:44
For the full set of National Priorities: What other comments do you have?
I write in the "all priorities" box because my comments cut clearly across two of the five core areas: Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research and Achieve Health Equity. Both of these are described with better engagement and involvement of community partners. And indeed, with equity, we could well say that more full engagement is a mark of success - true equity is not a feature of one piece of the puzzle or another, but only exists when all aspects of the system are indeed equitable. With that, my strong recommendation is to fund more community partners directly as the full leaders of their projects in their community. When academic researchers hold all the power, that is perpetuating the current systems of inequity and superficial engagement. There is no doubt that making final decisions of spending are often the top level of decision-making in any project. In addition, moving towards better engagement and equity demands that academic partners fully embrace that local knowledge inside communities is real knowledge, and that the communities they wish to serve do have people and systems capable of making decisions about projects. Academic researchers hold important skills and experience that can make research projects successful. But when it comes to fully engaged research, they must begin to accept a much more level partnership if they expect systems to change. Funding community partners directly as the leads of community-academic partnerships is a vital way to create the systems change PCORI is working towards.
Name and/or Organization
University of Kentucky
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/26/21 9:42
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Please include poorly understood and stigmatized diseases such as ME/CFS, post-treatment Lyme and fibromyalgia, as well as newly emerging long COVID.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Lack of government funded research on neglected diseases like ME/CFS, post-treatment Lyme and fibromyalgia. NIH needs to issue RFA's specifically for these diseases with dedicated funding. Maybe PCORI can nudge them.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
The patient voice has long been ignored or dismissed. PCORI can help bridge the gap between patients and medical researchers/clinicians.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Success looks like someone with ME/CFS, post-treatment Lyme, fibromylgia or long COVID going to a doctor and being believed, supported and provided with effective treatment.
Name and/or Organization
Leah Williams
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/26/21 6:28
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
As PCORI creates the next set of funding opportunities for patient-centered comparative clinical effectiveness research, the Health Care Education Association recommends that research projects have some requirement to collaborate with the patient education experts or patient education department at the institution where the research will occur. Patient education experts have knowledge on research-based strategies to impact patient knowledge and healthy behaviors. Patient education experts guide patients and staff through the education process (assessment, planning, implementation and evaluation) which focuses on the needs of patient populations. Low Health literacy impacts all four of the Institute of Health Care Improvements Quadruple AIM (Cost, Quality, patient and healthcare professional satisfaction) Each of these elements are typical elements of healthcare research.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
The Health Care Education Association sees the main challenge is researchers are not always aware of (or actively seeking out) stakeholders that are experts in evidence-based patient education strategies. Also, researchers may not know how to teach patients simply or even understand what simple patient education looks like. When PCORI-funded research projects do not tap into this existing expertise, there are potential gaps and missed opportunities that researchers may not recognize. Patient education professionals are acutely aware of the challenges of working with patients with various levels of health knowledge and literacy. Failure to include patient education that enables shared decision making and informed consent may inadvertently impact the outcome of the research conducted and the patient's understanding of the benefits and risks.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI’s unique role is to influence how comparative clinical effectiveness research projects are designed by adding required or suggested collaboration structures. Given this unique position, Health Care Education Association recommends that some of PCORI’s funding opportunities require or strongly recommend the inclusion of existing patient education resources as advisors or co-leaders of a project.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
The Health Care Education Association is made up of patient education experts who define success as having evidence-based strategies to effectively communicate about and disseminate results of PCORI funded research. HCEA has developed guidelines which include recommended interventions for effectively educating patients and other learners. These guideline recommendations are applicable to dissemination of research. In addition, patient education experts utilize multiple implementation strategies (i.e., health literacy precautions, plain language, etc.) and are well versed on best practices and evidence related to health communication.
Name and/or Organization
Health Care Education Association
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/25/21 22:20
Achieve Health Equity: What are the opportunities?
By achieving health equity, we will be able to contribute to maximizing the potential of our world’s most priced resource, people.
Achieve Health Equity: What are the challenges?
Systemic racism, sexism and ableism, which are prejudiced ideas ingrained and encoded into every societal power structure, shape the behaviors and decisions of many, in turn impacting the health outcomes of people with and without privilege. While changing the system, policies and culture is the biggest challenge to face, it is the most important one to undertake.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI ought to leverage its privilege, reputation, financial resources, time and talents to, not only encourage, but expect that every organization who aspires to engage in collaborations with PCORI will show actionable commitments to healthcare equity via antiracism actions, and the implementation of policies that address the social determinants of health.
Achieve Health Equity: What does success look like?
Success will be achieved when nobody can find statistically significant differences in healthcare outcomes based on race, gender, sex, socioeconomic status, etc.
Name and/or Organization
Dr. Clari Borrero-Mejias
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/25/21 19:34
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Patients, who are trained and supported as authors of peer-reviewed publications, could help address the “…challenges to the communication and uptake of evidence-based practice.” (PCORI National Proposed Priorities for Health, June 2021, p. 9). Patient authors can ensure the patient voice is heard through the peer-reviewed literature and, by contributing to plain language summaries of these publications, patient authors can also help disseminate the key findings to broader audiences. Given the impact of peer-reviewed publications on clinical guidelines and patient outcomes, as well as the increasing recognition of the value of patients as researchers, excluding patients from the opportunity to become authors cannot be justified. ‘Nothing about us without us’ applies to the publication ecosystem – patients can and should be authors of publications.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Patient authorship is an ‘innovation’ in medical publishing and, as with any innovation, there are challenges. Patient leaders who want to become authors face challenges related to having sufficient time, training, support, and resources, as well as the challenge of being ignored or criticised by those who do not believe that patients can or should be authors. Evidence on patient authorship could help identify and address these challenges, and prove to the doubters that patients can be authors. The evidence base on patient authorship is limited, but growing. Our systematic review on this topic, published with patient authors, provided 21 recommendations to help maximize the benefits and minimize the risks of patient authorship (https://pubmed.ncbi.nlm.nih.gov/32587753/ ). A narrative review has also provided practical guidance on patient authorship (https://pubmed.ncbi.nlm.nih.gov/32637153/). In response to the challenges voiced by patient author pioneers, we have also partnered with leading patient advocates to co-create the first publications training course for patient advocates. The course is free, online, audio-enabled, and evidence-based (https://wecanadvocate.eu/patients-in-publications/)
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI could provide a unique, timely, and impactful contribution to advancing the ‘patient authorship’ evidence base via two key initiatives: a) Identify PCORI-funded publications, included in the PCORI Health Literature Explorer Database, that include patient authors. https://www.pcori.org/engagement/engagement-literature Doing so would provide PCORI and its research partners with a database of patient-authored publications that could then be used to facilitate research on patient authorship. Without a readily obtained, robust, and reproducible dataset, research on patient authorship will continue to be difficult to do. b) Provide research funding to patient leaders and their research colleagues to conduct quantitative and qualitative research on patient authorship and, importantly to publish their findings. The funding requirements could include the need to use the GRIPP2 reporting guidelines, which have been specifically designed to help authors share their insights on patient involvement in research (https://www.bmj.com/content/358/bmj.j3453) and could also encourage patient authors to include ‘patient author’ or ‘patient partner’ as at least one of their affiliations on the publication as this could help others find patient-authored publications via the PubMed Advanced Search interface.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
PCORI could report metrics on patient authorship that would likely demonstrate a clear and verifiable increase in the number of peer-reviewed publications with patient authors. This growing evidence base on patient authorship would be a mark of success in and of itself, but would also facilitate further research on patient authorship (eg, by providing a dataset on patient-authored publications). Through patient authorship, patients could play a key role in advancing the science of dissemination, implementation, and health communication!
Name and/or Organization
Professor Karen Woolley
Community
Stakeholder
Stakeholder Community
Training Institution
Submitted
8/25/21 15:22
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
I would like to suggest that PCORI add to and expand the focus on necessary enhancements to medical education/CME to improve the D&I of medical evidence. I would also suggest that on the patient/caregiver focus that PCORI identify key needs to improve overall health literacy and what might be necessary for accessible programs to help patients expand their health knowledge. It could also include what sort of health literacy is needed as part of general public information campaigns and how might things like school curricula be modified to expand general health literacy. How might improving literacy and receptivity make D& I easier?
For the full set of National Priorities: What other comments do you have?
I would add to all areas a consideration for the differential impact of various delivery system innovations and payment structures. How might the organization of healthcare delivery through an individual system result in different outcomes for patients? How might different payment models; such as value-based design or paying for total cost of care effect outcomes? These considerations should be woven into research wherever possible.
Name and/or Organization
Kevin Fahey, independent consultant
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/25/21 14:21
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
ACUPUNCTURE! As an existing (and affordable) health modality, acupuncture has the potential to become a first line of preventive medicine in America. The cost of supplies for one acupuncture visit is typically less than $1 based on per/needle cost. Acupuncture is safe and extremely effective (as per 1000's of evidence based research studies & papers). Acupuncture could be easily incorporated into the current healthcare system and has the potential to save millions of dollars on unnecessary tests and procedures. Acupuncture is effective at helping the brain to calm the pain response and encourage the body to produce more of it's own endogenous opioids for pain relief. Encouraging people to use acupuncture as a first line of defense would alleviate the burden on the healthcare system. Acupuncture is used widely around the world in hospitals and clinics, for example the UK, Germany & China.
Name and/or Organization
Milwaukee Community Acupuncture
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/25/21 9:38
Name and/or Organization
Healthcare Leadership Council
Community
Stakeholder
Stakeholder Community
Industry
File Upload
https://www.pcori.org/sites/default/files/webform/19726/HLC PCORI National Prorities Letter.pdf
Submitted
8/25/21 9:22
For the full set of National Priorities: What other comments do you have?
Please see attached comments.
Name and/or Organization
Moms Clean Air Force by Dominique Browning and Almeta E. Cooper
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
Submitted
8/24/21 22:54
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Misunderstood diseases such as ME/CFS have been insufficiently explored. Much more needs to be known about this disease, since it is expected than roughly 1 in 10 COVID patients will experience ME/CFS onset.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
The main challenge is the stigma associated with ME/CFS and the fact that many people are under the false impression that the disease is psychogenic.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Consider evidence that relates to modern case definitions for ME/CFS. This would include randomized trials as well as patient surveys and scientific studies.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Communication between the CDC and medical associations / public health departments needs to be vastly improved. There is currently no mechanism for CDC to communicate urgent (non-emergency) situations to health entities.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Overcome resistance of CDC to fulfill its responsibility to communicate urgent situations. ME/CFS is a prime example. CDC does not aggressively reach out to health entities, but rather invites them to round tables.
Achieve Health Equity: What are the opportunities?
Aside from the talked-about discounting of BIPOC populations, there is significant disparity in the research of diseases affecting women versus those affecting men. Information on this gender disparity in NIH funding has recently been published in J. Women's Health.
Achieve Health Equity: What are the challenges?
Historically the medical community has discounted women's health issues, typifying such issues as being hysteria, or other euphemisms. Women must be taken seriously.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Force NIH to re-assess its priorities and procedures to assure health equity.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Improve communication among health entities. Strongly encourage and provide infrastructure for telehealth - physician visits, mentoring, etc.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Physician bias toward wanting in-person visits.
Name and/or Organization
Arthur A Mirin, PhD
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/24/21 18:53
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
As a Global Ambassador for Long Covid Kids USA and a Mother of a 12yo Long Covid patient, approaching 1yr with Symptoms, we need to have better access to Pediatric PASC Multi Subspecialty Care. They are getting difficult to get in, find and still states have none for these children. Educate HCP'S to know what PASC in Children is, and community. They are not getting better.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
HCP'S have little to none Knowledge of PASC in Children, some here in NC never have heard of it, still or refuse to acknowledge only to compound the mental health along with Neuropsychological changed. IE "Gaslighting"
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
We have close to 20,000 members Globally supporting Long Covid Kids
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Multi-subspecialty, continued chronic illnesses therapy, encouragement and take the extra 15m to actually listen to the parent or child without psychological opinions and dismiss. These children are becoming suicidal because no one will believe or help.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Build Clinics for Pediatric Post Covid Care within PCCU
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Education or knowledge of PASC, Dysautonomia, PANS, PANDAS and this is a multi systemic disease. No they aren't contagious
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
To help connect with children with PASC, listen, educate Healthcare Professionals, Provide Empathy
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Patient, Parent and Doctor working together towards outcomes that will sustain a healthy routine
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Education of Pediatric PASC, EDUCATION, EDUCATION, EDUCATION
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Being honest here, Intellectual Greed
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Connecting Parents with resources in each state
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Advancement of PASC, Knowledge of Advancement in Autoimmune Disorders
Achieve Health Equity: What are the opportunities?
KIDS NEED CARE
Achieve Health Equity: What are the challenges?
Little Research as of now.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Doesn't matter if 1% get PASC or 75% BELIEVE AND SUPPORT
Achieve Health Equity: What does success look like?
Trust and less frustration of parents and children with Long Covid
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Education is the key
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Doctors don't take the time
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Education
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Knowledge
For the full set of National Priorities: What other comments do you have?
We have a silent pandemic within a pediatric surge of Delta. These children are coming out with rare and debilitating lifetime chronic illnesses. With each mutation, the conditions are worse. Symptoms DO vary from Adults
Name and/or Organization
Melissa Lynch Long Covid Advocate for Kids
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/24/21 18:30
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Work with clinical and non-clinical graduate programs (MS, PhD) to teach students who PCORI is and about PCOR. It's still a relatively new that our future investigators will only start thinking and operating this way if they're exposed to it.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Partner with colleges and universities to work on building a course or seminar or some other exposure to to PCOR and PCORI.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
national standards or guidelines for implementing PCOR and patient/family partnerships; each network/institution/investigator shouldn't have to re-invent the wheel
Name and/or Organization
Gillette Children's Specialty Healthcar
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/24/21 18:11
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Recognize nonallopathic modalities as legitimate (often superior) treatments to allopathic indifference and ignorance. This is long overdue. The mainstream medical establishment's opposition to holistic healthcare has done incalculable harm to people suffering from complex, chronic, multisystemic illnesses.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Put an end to the dominance of the Big Pharma lobby in healthcare policy. Case in point: NAC's withdrawal from the OTC market by the FDA under pressure from the drug-industry lobby.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Affordable care--both allopathic and nonallopathic for everyone in this country.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
In the case of Long COVID and other so-called "mysterious" illnesses, acknowledge the legitimacy of cases in the absence of positive lab test results since such tests are often neither available nor accurate. People are sick. This is real.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Funding models based on corporate profit.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Nonpharmaceutical approaches prioritized, supported, and disseminated.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Shift the paradigm from top-down, doctor-/drug-dependent, passive-patient healthcare to empower people themselves.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
A healthy, knowledgeable, empowered population instead of a sick, ignorant, passive one.
Achieve Health Equity: What are the opportunities?
Treat nonallopathic care and allopathic care as equivalent from a regulatory perspective. For instance, HSA/MSA rules need to change to include payments to nonallopathic practitioners on par with visits to allopathic practitioners.
Achieve Health Equity: What are the challenges?
Overcoming opposition from entrenched interests such as the AMA, Big Pharma, hospitals, etc.
Achieve Health Equity: What does success look like?
My HSA pays for the holistic healthcare that I choose for myself, not only the allopathic care that I don't want.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Open up to incorporate promising modalities/treatments from around the world; encourage people to learn about/take charge of their own health.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
A sick, uninformed, disempowered population makes too much money for Big Pharma and other entrenched institutional interests in our current (un)healthcare system.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Bring in truly independent-minded leadership without ties to the status quo to do things radically differently.
For the full set of National Priorities: What other comments do you have?
Tax the heck out of junk food, cigarettes, etc. and use the money to support programs such as sustainable farming, fresh-food markets/consumer education in food desserts, and herbal practitioners.
Name and/or Organization
Maya Lea
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/24/21 16:43
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
BCBSA supports PCORI’s aim of strengthening and expanding its work on both emerging innovations and existing interventions. Increasingly innovative interventions are entering the market and clinical practices. These new innovations have preliminary evidence, open questions, and little understanding of effectiveness relative to existing care, benefit to patients, and which patients may benefit. We suggest PCORI consider research on the following high-priority emerging innovations: A. Novel therapies: This includes technically complex, typically high-cost, and potentially transformative therapies such as gene replacement therapies. There is typically uncertainty about durability, and there may be concerns in balancing up-front costs with long-term benefit. B. Software as medical devices: The FDA pre-certification pilot may allow medical devices to enter the market for which the underlying operating algorithm is unknown, and the health outcome effects have not been demonstrated. C. Digital therapeutics: Prescription software products may enter the market although the product is intended to treat a condition with evidence only on narrow or short-term effects. We agree with PCORI’s inclusion of the study of unintended consequences, adverse events, widened disparities in care outcomes, and other related factors associated with existing and emerging innovations.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Systematic information about implementation has enormous potential for clinicians, health systems and health plans to improve quality and equity of care. Many evidence-based practices are under-utilized in general or inequitably utilized across populations. PCORI is in a position to add value to this area, and we support its focus on developing the evidence base for dissemination and implementation in conjunction with CER.
Achieve Health Equity: What are the opportunities?
BCBSA supports and shares PCORIs commitment to improving equity in health care access and outcomes. We suggest that PCORI call for understanding the potential differences or impact in comparative effectiveness by race and ethnicity across all its research. We agree with PCORI’s efforts to strengthen methodology standards to support representation of populations disproportionately affected by disparities, but encourage PCORI to be more direct in this approach. We suggest PCORI strengthen the wording so that the priority ensures that research representation of those disproportionately affected by health disparities is sufficient to ensure that meaningful and statistically valid conclusions can be drawn about the relative effectiveness by race, ethnicity, income and other variables. We also recommend that PCORI add a strategy on addressing the specific issues that may confront underserved and disadvantaged communities, how to better dissemination and education for providers and patients, and related issues.
Name and/or Organization
Blue Cross and Blue Shield Association
Community
Stakeholder
Stakeholder Community
Payer
File Upload
https://www.pcori.org/sites/default/files/webform/19726/PCORI Priorities Comment Letter 8.24.21.pdf
Submitted
8/24/21 16:33
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. That data could be critical to understanding related emerging diseases, like Long COVID.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Stigma, bias, sexism and racism are fundamental barriers to most existing interventions that are still not widely accepted. Lacking data and peer-reviewed publications due to underfunding are also key barriers.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Bridging the gap between patients/stakeholder communities and researchers in order to best identify under represented interventions or emerging innovations.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Improved medical education and clinical performance for Long Covid and other misunderstood diseases, like ME/CFS
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. That data could be critical to understanding related emerging diseases, like Long COVID.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Stigma, bias, sexism and racism are fundamental barriers to most existing interventions that are still not widely accepted. Lacking data and peer-reviewed publications due to underfunding are also key barriers.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Bridging the gap between patients/stakeholder communities and researchers in order to best identify under represented interventions or emerging innovations.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Improved medical education and clinical performance for Long Covid and other misunderstood diseases, like ME/CFS
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. That data could be critical to understanding related emerging diseases, like Long COVID.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Stigma, bias, sexism and racism are fundamental barriers to most existing interventions that are still not widely accepted. Lacking data and peer-reviewed publications due to underfunding are also key barriers.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Bridging the gap between patients/stakeholder communities and researchers in order to best identify under represented interventions or emerging innovations.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Improved medical education and clinical performance for Long Covid and other misunderstood diseases, like ME/CFS
Achieve Health Equity: What are the opportunities?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. That data could be critical to understanding related emerging diseases, like Long COVID.
Achieve Health Equity: What are the challenges?
Stigma, bias, sexism and racism are fundamental barriers to most existing interventions that are still not widely accepted. Lacking data and peer-reviewed publications due to underfunding are also key barriers.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Bridging the gap between patients/stakeholder communities and researchers in order to best identify under represented interventions or emerging innovations.
Achieve Health Equity: What does success look like?
Improved medical education and clinical performance for Long Covid and other misunderstood diseases, like ME/CFS
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. That data could be critical to understanding related emerging diseases, like Long COVID.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Stigma, bias, sexism and racism are fundamental barriers to most existing interventions that are still not widely accepted. Lacking data and peer-reviewed publications due to underfunding are also key barriers.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Bridging the gap between patients/stakeholder communities and researchers in order to best identify under represented interventions or emerging innovations.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Improved medical education and clinical performance for Long Covid and other misunderstood diseases, like ME/CFS
For the full set of National Priorities: What other comments do you have?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. We need research, education, and equitable access for quality care, now more than ever with Long Covid.
Name and/or Organization
Billy Hanlon
Community
Patient
Patient Group
Patient
Submitted
8/24/21 15:13
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Misunderstood diseases like ME/CFS have poor evidence regarding existing interventions. That data could be critical to understanding related emerging diseases, like Long COVID.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Stigma, bias, sexism and racism are fundamental barriers to most existing interventions that are still not widely accepted. Lacking data and peer-reviewed publications due to underfunding are also key barriers.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Bridging the gap between patients /stakeholder communities and researchers in order to best identify under represented interventions or emerging innovations.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Improved medical education and clinical performance for long covid and other misunderstood diseases
Name and/or Organization
Solve ME/CFS Initiative
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/24/21 14:58
For the full set of National Priorities: What other comments do you have?
The American Academy of Physical Medicine is the national medical specialty organization representing more than 9,000 physicians who are specialists in physical medicine and rehabilitation (PM&R). PM&R physicians, also known as physiatrists, are medical experts in treating a wide variety of conditions affecting the brain, spinal cord, nerves, bones, joints, ligaments, muscles, and tendons. PM&R physicians evaluate and treat injuries, illnesses, and disabilities, and are experts in designing comprehensive, patient-centered treatment plans. On behalf of our members, we thank PCORI for providing the opportunity for us to comment on your national priorities. Overall, we support all the priorities and the strategies you have outlined to work on them now and in the future. AAPM&R urges PCORI to really focus on incorporating smaller, non-academic, and integrated healthcare systems into your work. While we understand much of cutting-edge work sparks from these large academic institutions, translating what happens in those settings into other settings is extremely difficult. In addition, we would like to see more transparency in promoting the use of Clinical Data Registries in meeting some of the PCORI national priorities. AAPM&R is one of the many specialty societies that has built a Clinical Data Registry to capture data that matters to us, our clinician members, and their patients. We believe registries are important technological partners that can contribute to the research base, however, there needs to be a larger focus on interoperability and infrastructure. Collecting uniform data from the EMR that is meaningful to clinicians and patients comes with many challenges; therefore AAPM&R’s Clinical Data Registry has deployed a Patient-Reported Outcomes module to collect patient generated data. Collecting such data is essential to drive patient-centered outcomes research and creates many workflow challenges on overly extended systems. While regulatory bodies are eager to advance this work and value-based payment systems, AAPM&R believes that without the proper infrastructure in place, it is a disservice to patients and clinicians. While we know this work comes with many challenges, AAPM&R is eager to work with PCORI and would love the opportunity to contribute and work in partnership with you, especially when it comes to achieving health equity and integrating patient-centered outcomes.
Name and/or Organization
The American Academy of Physical Medicine and Rehabilitation
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/24/21 11:27
Name and/or Organization
Association of American Medical Colleges (AAMC)
Community
Stakeholder
File Upload
Submitted
8/24/21 10:27
Name and/or Organization
Council of Academic Family Medicine
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/Final response to PCORI priorities.pdf
Submitted
8/23/21 10:22
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
1. improve understanding of how interventions work in the real world (beyond pivotal RCT) - focus on top causes of morbidity/mortality in US 2. incorporate mental/behavioral health measure in every study. Integrate mind and body health through research
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Inclusivity and diversity in future studies will require proactive work to recruit diverse study participants.....investment required
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
1.Provide structure for patient involvement across the research process 2.Focus on the utilzation end of intervention research
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Accepted standards for use of real world data in evaluation of interventions results in faster, more inclusive RCTs.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
NEW CDC budget for data infrastructure creates an opportunity to partner public and personal health research/goals. integrate public health into current healthcare systems.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Infrastructure efforts must solve rural access.....partnering with other Fed departments can help make this happen. incoherent electronic health record structures must be fixed
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Focus on people, not tech for tech sake. Be strong PCORI!
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
EHRs reflect coordinated efforts to integrate mind/body/public health and can be used effectively in real world research at national and local level.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Explore roles of public and private organisations in public health; move beyond nudge factor to more active roles
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Resistance to government as solution
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Focus on people, not infrastructure for infrastructure sake.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Shift in public attitudes toward public over individual benefit of healthcare
Achieve Health Equity: What are the opportunities?
Engagement of people of color in research process....untapped opportunities in latino and asian communities, Black leadership, youth
Achieve Health Equity: What are the challenges?
Lack of research and science literacy, esp outside of academic catchment areas
Achieve Health Equity: What is PCORI’s unique role or contribution?
Structures in place for public engagement.....work to engage primary care
Achieve Health Equity: What does success look like?
Increase in public support for effectiveness research and increase in adoption of evidence by health systems
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Investment in real-world health research; Investment in integration of social measures into health outcomes research
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Silos and lack of understanding of role of social determinants of health; data integration challenges
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Focus on outcomes over novelty
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Integration of social and health interventions for those most in need of services
Name and/or Organization
Cynthia Joyce
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/22/21 14:05
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
We have tremendous potential to improve health and reduce costs by eliminating useless, or minimally useful, interventions. The science needs to both identify these interventions (many of which are known), but more importantly, it needs to discover ways to change both medical and consumer culture to reduce use of pointless surgeries and medications. Psychologists, sociologists, nurses, anthropologists, and consumers must be involved to make this happen.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Challenges include: 1. electronic health records, driven by billing and regulatory requirements, that fail to enhance care 2. financial pressures that make it difficult for administrators to effect change in entrenched systems 3. inattention to interventions that do not fit into existing billing taxonomies; this includes nearly all of nursing practice
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
1. Spread word about available funding and think broadly about eligible investigators and organizations. (If we keep asking the same people the same questions, we will get the same answers.) 2. Provide expert consultation for organizations and investigators who have not traditionally received large research grants. Focus on women's health, non-pharmacological interventions, and BIPOC investigators (in other words, traditionally underfunded foci.) 3. Encourage acceptance of quantitative and community-based action/participatory research as the most appropriate scientific approaches to certain problems. 4.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
1. A health care culture that values exercise interventions, massage, guided imagery, counseling and educating (for example) as health interventions that are as valuable as invasive procedures. 2. More equitable distribution of treatment for acute and chronic conditions, manifested as improved average life span, and/or quality of life. 3. Decreased overhead expenditures in health care.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
1. Fund health disciplines equitably; medicine gets much more in taxpayer dollars than other disciplines, which limits the availability of higher education to physical therapists, nurses,clinical psychologists, and others. We need interdisciplinary approaches, and this would help. 2. Trans-disciplinary education could encourage a broader selection of therapeutic options for many illnesses. One barrier to this is money; e.g., nurses can't afford to pay physicians to teach in our schools. A system where exchanges of faculty can occur without payment within universities would help.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
1. Entrenched systems where those in charge have much to lose from change. Creating incentives to change, even in the presence of poor health outcomes for the poor, BIPOC people and women, will be challenging. 2. Politicians who lack the will to regulate health care, knowing it may not be popular with their donors. 3. Citizens who remain tied to traditions in health that do not work for the whole population, such as physicians always being in charge and drugs being the solution to most problems.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
1. Universities that have research grants available (intramural or extramural) to all health disciplines, prioritizing those with the most direct patient contact. 2. Scholarships for poorer students, to ensure we get the best in health care, not the richest. 3. Greater affordability of health-related college degrees for all students.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
1. Greater use of multi-disciplinary approaches to health. 2. Reduction in use of non-evidence-based interventions. 3. Increased numbers of underserved people reached by health communications, and more people changing their behavior as a result. Information alone is not therapeutic ; it only helps if followed by behavior change. 4. Intermediary outcome: a broader array of health care providers seeing patients, practicing independently and doing research that is not focused on medical practice. I would prioritize independent physical therapy and nursing therapeutics.
Achieve Health Equity: What are the opportunities?
Talk to the underserved. Stop making panels loaded with wealthy white men.
Achieve Health Equity: What are the challenges?
1. We don't yet know how more health care providers from varying disciplines will enhance health. This should be treated as a scientific question. 2. Existing barriers to practice posed by the need for a physician order to access physical therapy, occupational therapy, home nursing care, and other types of health care. One discipline having the power to control access to nearly all others is not working.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI, and others, must show that those who are currently well-served in our health care system will also benefit from enhanced health equity. Demonstration projects that enhance health, clean up blighted communities, and free up dollars for popular projects are a suggestion.
Name and/or Organization
Teresa Goodell, PhD, RN
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/21/21 14:57
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
In addition to the Strategies listed in the PCORI Priorities document, we recognize that with COVID, there has been rapid adoption of digital and on-line therapies. These therapies enhances access to groups previously underserved by geography, socioeconomic status, etc. There are opportunities to embed these therapies in LHS platforms, study effectiveness, and use results to enhance the therapies in an interactive fashion. Additionally, there are opportunities to create platforms that both reside "on premise" at clinical institutions (ie. academic, community practice) as well as have a national public-facing component. This model enhances access to therapies and greatly increases data collection. For instance, we have laid the ground-work on both of these opportunities through the development of CHOIR (HTTP://choir.stanford.edu). CHOIR runs locally at multiple academic institutions in the US and Canada and we are preparing a national release of a public facing version. This will include integration of effective digital/on-line therapies that were proven in NIH funded studies. Our current efforts focus on the assessment and treatment of chronic pain. However, the platform has been extended to multiple medical conditions.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Flexible funding opportunities that allow development and testing and optimization. Our current efforts were mostly funded by philanthropy. Support from PCORI would greatly accelerate efforts.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Locally integrated system with connections to EMR via SMART on FHIR combined/connected with national public facing system promoting broad collection of high-quality evidence combined with easy access to effective digital therapies.
Name and/or Organization
Sean Mackey MD, PhD - Stanford University, Division of Pain Medicine
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/21/21 13:58
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Others will focus on their specific disease interests. I think the more compelling area of focus of more general - CER of AI as opposed to and as supplemental to traditional diagnostic/treatment tools. Of particular interest in this area are equity issues (see below) and optimal strategies for including AI models into diagnostic/treatment processes. I would also like to see some research into optimal strategies for including patient knowledge into diagnostic/treatment processes.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Major challenges are inertia and it's evil twin - the enthusiasm for the use of the poorly tested.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI is optimally positioned to fund projects that lead the way and create incentives for more CER research. Given the myriad of diseases and proposed treatments (not to mention diagnostic tools) a critical issues for patients and one still poorly developed is information that establishes the value of contending treatments - both for patients and for providers.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
An acceleration of CER research and it's fuller penetration into all levels of clinical (and self-care) practice.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Obviously enhanced funding priorities. Patient engagement is good, but could be improved by more systematic development of "Patient Centered" priorities from patients, and somewhat less from disease advocacy organizations.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
No more needs to be said about funding. One of the challenges of greater patient effective patient priority (see equity issue) is that patients are volunteers who have other lives and priorities - so tangible support (which almost necessarily means some funding (though not necessarily direct payment to them) will be necessary.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
PCORI is practically the definition of how to do it - keep it up and publicize the process and outcomes more. I do think PCORI could provide "workshops" for other funding organizations on the processes and success it has developed.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
More research - more outcomes that demonstrably establish improvements in healthcare outcomes.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Better documentation and utilization of functional communication networks - to patients/caregivers and to providers, and inclusion of results/progress in publicly available media. Use what people use, not what's easy for you to use!
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Too much data in too many places and increasing amounts of conflicting and seriously erroneous data. Need to establish "gold standard" information channels that are widely promoted and readily available.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI has a strong early stage model that about as effective as any - now there needs to be refinements as noted above to improve the quality of the D,H, and HC.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Greater utilization of high quality (as shown by CER) tools and treatments and decreased utilization of lower quality. Thus, generally better outcomes in general and more specifically in those areas where PCORI has funded research.
Achieve Health Equity: What are the opportunities?
Let me count the ways!!!! Greater funding and focus on underserved people/communities and diseases. Greater engagement of underserved populations in the development of research funding priorities and in the research and in the review of proposals. There are challenges there, but in the meantime making clear equity as a priority and "training" of all involved to ensure they accept and understand how to implement equity priorities.
Achieve Health Equity: What are the challenges?
For starters "achieve" is a nice ida but unrealistic - how about "advance" or "improve" health equity? The underserved are generally the hardest to get involved and activated so they can be effective participants - - - and those who have historically been involved, despite best intentions are often challenged to understand the reality and shift mindsets to be effective. The loudest and most articulate voices and the easiest to engage and often have limited ability to understand and effectively respond to equity challenges (and that includes people like me!).
Achieve Health Equity: What is PCORI’s unique role or contribution?
This is a big rock and a steep hill. It's a long term challenge that will progress by generally small steps. PCORI has and should accelerate it's activities in all the ways mentioned here to help build momentum - and let others know what has been done that works!
Achieve Health Equity: What does success look like?
Inequities decrease - this included in greater participation of representatives of underserved communities in all PCORI functions. Funding should have priorities for issues that are disproportionately present in underserved communities.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
If would be fun to ask everyone who answers this to define an Learning Health System - great concept, not sure there is a particularly good shared understanding of what that is and how it operates. Essential to a LHS is having those who function know the consequences of their actions - feedback. There are more opportunities for improvement in such recursive systems than I could even begin to discuss here. One of the problems is that there is such a fire hose of information all the time for healthcare professionals (and most everyone else) that it is difficult to get effective focus on consequences of actions. As one who has worked a great deal with NQF and CMS (among many others) I am still struggling to understand the extent to which the extensive documentation and evaluation is actually contributing to improved quality as opposed to adding obstructive clutter. The same in a different form is a problem for patients and their participation/contribution to LHS - too much information (some accurate and some not, thanks to social connections and media and Dr. Google), too little knowledge of the realities of health systems and ability to effectively engage. Greater effective patient participation in creating an ILHS is essential and also every challenging due to limitations from both patient and provider sides. I've been working with various levels of health systems for over 15 years as a patient with a PhD in a loosely medically related field (Cognitive Neuroscience) and have many very experienced colleagues with similar sorts of backgrounds and experience - and it can still be a challenge to get to the "integrated" part. I commend PCORI as the best model for creation of such systems specifically in CER. I think PCORI's greatest opportunity to continue what it's doing and to "export" it's model to others in healthcare and to refine the feedback systems in its work.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Silos! - not just within healthcare, but among all the players who are or should be a part of an ILHS. Many of the players in an ILHS speak different languages (all English, and then there are the others) and have very different priorities and "demand characteristics" in what they do. Making progress for all the appropriate players to have a decent understanding of one another is a challenge and requires patience and persistence. Obviously the equity issue is a big one here.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
PCORI is (in my opinion) the best model of having all the players working together on common tasks - advisory boards, merit review, etc. I don't know any better may to build the infrastructure for an effective ILHS than stared effort of a common task about which everyone cares. NQF is working on this and getting better.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Progress - is all respects and at all levels. Evidence that learning has improved for the SYSTEM, not just individuals or individual parts of the system. There are so many "ultra stabilizing" features of healthcare that systemic change is very difficult - but without it progress will be limited. Ultimately, in the spirit of the PCORI mission, success looks like the acceleration of improvements in healthcare via its CER mission with full functional participation of all stakeholders.
For the full set of National Priorities: What other comments do you have?
I commend you for the effort and the thoughtful solicitation and consideration of comments!
Name and/or Organization
David Andrews
Community
Patient
Patient Group
Patient
Submitted
8/21/21 9:20
Achieve Health Equity: What are the opportunities?
I would greatly encourage LGBTQ+ individuals to be included in the part about health equity.
Name and/or Organization
Kathryn Lowe
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/20/21 23:31
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
As PCORI evaluates existing and emerging innovations in clinical care interventions, systems changes, and healthcare delivery, ACCP suggests a focus on team-based care delivery, e.g., comprehensive medication management, to advance innovative models leveraging expertise of all care team members working collaboratively in a coordinated, patient-centered approach.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
ACCP applauds PCORI’s intent to expand CER prioritization to include targeted research funding of new diagnostic and therapeutic interventions, such as pharmacogenomic testing. We encourage PCORI to consider research for the clinical care interventions surrounding these diagnostics and therapeutic approaches. As pharmacogenomic testing can better inform personalized treatment decisions, interpretation of testing results and subsequent interventions by qualified clinicians is key to effective application of this testing. The need for additional education and training may be a barrier for broader access to this clinical service, but leveraging the expertise of care team members, e.g., clinical pharmacists, can alleviate the workload of medication-focused interventions and improve the quality of care.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
ACCP appreciates the opportunity for PCORI to build a strong and sustainable PCOR workforce pipeline that represents the diverse backgrounds of individuals in the health research ecosystem, including patients, communities, clinicians, researchers, purchasers, payers, members of industry, hospitals and health systems, policy makers, and training institutions, that together represent the research workforce. ACCP encourages PCORI to consider clinicians and researchers from all health professional programs, including those professions that may have been previously underrepresented as investigators in outcomes research.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
ACCP agrees with PCORI’s suggested strategies to address this priority including the intent to: 1) fund CER studies of delivery or implementation strategies, 2) communicate research findings effectively and in ways tailored to diverse audiences, 3) actively deliver information to targeted audiences that informs healthcare discussions and decisions, and 4) promote the uptake of research findings into practice to contribute to improved health care and health. A framework for communicating research findings and innovative care delivery for broader uptake could facilitate and expedite practice transformation efforts towards better care.
Achieve Health Equity: What are the opportunities?
Health equity is very important to ACCP and its members, as clinical pharmacists strive to deliver high quality care to those who need it. ACCP encourages PCORI to further identify approaches to improve healthcare access, particularly in supporting outcomes research focused on team-based care models. The opportunity exists to further support research in team-based telehealth, which allows patients to receive care without geographic limits. ACCP encourages PCORI to further identify approaches to improve healthcare access, particularly in supporting outcomes research focused on team-based care models that improve team efficiency, alleviate clinician burden, and enhance access to care. With this improved access, patients can be more engaged in their care and reach their therapeutic goals.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
ACCP strongly encourages PCORI to pursue its suggested strategy to implement research on precision and personalized medicine and whole-person health into practice, which should include pharmacogenetic testing and comprehensive medication management (CMM) services. When integrated within a CMM program, pharmacogenomic testing allows for individually tailored and delivered medical care based on the unique characteristics of patients’ unique genetic profiles together with their lifestyle and environment. As PCORI evaluates care delivery strategies and payment mechanisms that have a direct impact on improved patient-centered health outcomes, priority should be placed on team-based care models that improve team efficiency, enhance access to care, enhance health outcomes, and improve the patient experience.
For the full set of National Priorities: What other comments do you have?
ACCP supports the full set of National Priorities for Health proposed by PCORI We applaud PCORI’s inclusion of health equity in these priorities as it aligns with the research interests and patient-centered clinical practice of our members to provide high-quality care to all patients. With the completion of the Comprehensive Medication Management in Primary Care study funded by a $2.4 million ACCP grant, our organization recognizes and appreciates the science of implementation, dissemination, and health communication to accelerate the movement of comparative clinical effectiveness research results into practice. ACCP is particularly interested in the mention of funding new preventive, diagnostic, prognostic, and therapeutic interventions, e.g., genomic testing, as well as implementing research on precision and personalized medicine and whole-person health into practice. Pharmacogenomics (PGx) is the study of how a person’s genetic makeup can affect their response to a drug. Appropriate diagnosis and access to advanced diagnostics like PGx testing is essential to correct therapy. Currently, testing is routine only for certain conditions, such as HIV and some cancers, but integrating PGx results into other commonly prescribed therapies that include medications like opioids, anti-depressants and cardiac medications can reduce cost and improve patient outcomes through comprehensive medication management (CMM). Together, PGx applications, as a component of CMM, delivers the personalized medicine approach that helps patients and those who care for them make better-informed decisions about their treatments to achieve medication optimization.
Name and/or Organization
American College of Clinical Pharmacy
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
Submitted
8/20/21 11:58
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Given the increasing number of cancer survivors in the US, there are opportunities to improve treatment side effect management and patient health-related quality of life by encouraging Comparative Effectiveness Research among evidence-based, integrative medicine therapies. Results of this research provide clinicians and patients alike with treatment decision-making guidance in addressing management of cancer-related symptoms like insomnia, pain, chemo-induced peripheral neuropathy, anxiety and depression, hot flashes, and fatigue.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
The existing interventions often need to be adapted for the unique physical, emotional, and logistic challenges of patients and families impacted by cancer. Many of the mind-body integrative medicine therapies (e.g., acupuncture, yoga, meditation, music therapy) may have been found efficacious in non-cancer populations, but their effectiveness compared with one another or against other therapies such as psychological interventions or fitness interventions are not known. In addition, we don’t know how best combine these approaches to help patients who deal with multiple challenges such as pain comorbid with insomnia and fatigue. Lastly, with the COVID-19 pandemic, many interventions have been transitioned to virtual delivery. How we can best use these treatments effectively during the trajectory cancer journey (diagnosis, treatment, survivorship, palliative care) remain to be defined. In addition, innovative telehealth delivery methods for integrative oncology mind-body therapies have been shown effective in improving mood, self-agency and quality of life for people with cancer, but challenges remain. For example, online and virtual interventions could be investigated through methods which consider both the deleterious effects on mood and health of excessive screen time/digital addiction, and the unequal access certain cancer populations have to telehealth.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI’s emphasize on funding CER trials and patient/stakeholder engagement is critical to inform evidence-based and patient-centered decision-making to incorporate integrative medicine approaches into cancer treatment and survivorship care. Further, PCORI supports the research community form meaningful and lasting relationships and build trust with diverse cancer communities which will help transform the research findings in the reality of patient lives.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Patients and families can choose the right integrative treatment or treatment packages (combining several approaches) to help them manage challenge symptoms (e.g. pain, fatigue, insomnia, anxiety), improve quality of life, functional wellbeing, and possible survival. In addition, biological, social, and cultural differences are appreciated for choosing the right treatment for the right person rather than a one-size-fits-all approach.
Achieve Health Equity: What are the opportunities?
Opportunities are many to invite applications for comparative effectiveness research (CER) trials of evidence-based integrative oncology therapies for improved health-related quality of life in cancer populations with unique needs, such as people of color, the elderly, adolescent/young adult, people with advanced cancer, from rural areas, veterans, and those from communities of low socio-economic status. Trials need to make effort to engage and reach out to the underserved populations.
Achieve Health Equity: What are the challenges?
Accessibility challenges in telehealth delivery, for example, are as follows: rural or poorer participants may not have smart devices or internet connectivity, multi-generational households may lack space for a telehealth session, and the elderly may need extra support/training in video communications technology use. Another challenge is the need for building trust with communities suffering disproportionately heavy cancer health burdens. Community with low resources may not have integrative medicine delivery system; therefore, creative partnership or delivery model (such as group-based treatments rather than individual treatments for therapies like acupuncture) may be more appropriate.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI can encourage such trials to include methods of providing access to as many cancer populations as possible, e.g., providing tablets for delivery of virtual music therapy. PCORI can set aside additional supplemental funding for researchers to engage community sites serving underserved populations. Since these settings are often very under-resourced, it will require extra time/effort for investigators to conduct research in these settings. Often, it takes years of effort and time to build relationships with underserved communities. PCORI can have additional funding set aside to reward research teams who are exemplary in engaging underserved communities so these relationship can be further grown to inform future research and practice change.
Achieve Health Equity: What does success look like?
Research questions would be informed by diverse groups of cancer communities. Research participants would represent the demographics of the whole United States. The research results would be disseminated and implemented in diverse settings. The goal of achieving equitable access to high-quality integrative oncology modalities can only be achieved when access continues even after the trial ends, and where community relationships of trust and respect can grow.
For the full set of National Priorities: What other comments do you have?
The mission of the Society for Integrative Oncology (SIO) is to improve the lives of people affected by cancer through the integration of evidence-informed complementary therapies into standard cancer care. As a society, we value the contribution of PCORI and appreciate the opportunity to provide our input on behalf of cancer patients, survivors, and their families who desire to safely and appropriately incorporate integrative approaches to improve their health & wellbeing. With 550 members from over 40 countries, the SIO also has an active cohort of patient advocates committed to this mission.
Name and/or Organization
Ting Bao, Md, DABMA, MS, President of the Society for Integrative Oncology
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
Submitted
8/20/21 7:55
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
GDP economy is poor fit for universal healthcare and education.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Very young, memory impaired, and other communication challenges have their pain discounted because they can not easily use 10 level memory based pain scales. How can www.MyPainAlert.com help your effort.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Less stress, more input from patient and family. Less stress, less debate for healthcare providers.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Improving patient to provider communication
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Bureaucratic inertia. Clinicians time and effort required to understand patient. 3rd party interference.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Everyone regardless of disability able to communicate pain care needs and get relief.
Achieve Health Equity: What are the opportunities?
Use technology to ask disenfranchised and disabled their needs
Achieve Health Equity: What are the challenges?
One size fits all treatment assumed as only possible treatment
Name and/or Organization
Gail Goldstein CCC-SLP
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/19/21 16:03
Achieve Health Equity: What are the challenges?
Any of the other things don’t mean anything if you can’t afford it. There are people dying because they can’t afford meds. Medical costs are supposedly the highest cause of bankruptcy in the US. Insurance companies are calling the shots, forcing doctors into non-medical decisions, dictating care based on cost - substandard care for more money.
Name and/or Organization
anonymous
Community
Patient
Patient Group
Caregiver/Family member of patient
Submitted
8/18/21 16:49
Name and/or Organization
SPAN and Family Voices NJ
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
File Upload
Submitted
8/18/21 16:41
Name and/or Organization
Society of Critical Care Medicine
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
Submitted
8/18/21 1:26
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
The opportunities that arise from accelerating progress towards an integrated learning health system are EHRs (electronic health records) and MHRs (medical health records), along with federated learning systems. As federated learning systems consist of a learning model that is a robust machine which doesn’t include the use of data sharing. But does allow data security, data privacy and rights to data access and heterogenous data to be addressed. While EHRs and MHRs are known to improve patient and care coordination care, along with increasing patient participation. Especially since they are emerging innovations within data and it's aspects and are also easily accessible through multiple computer systems.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
The challenges that occur from accelerating progress towards an integrated learning system would be an organizational culture, limited supply of skilled individuals along with funding learning activities. These challenges can be overcome through implementing research within learning health systems, which includes proper funding and time dedicated into health system decision making. This also includes the need or increase of patients along with the rapid growth of technology as it is needed to make major improvements within the healthcare system.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
PCORI is known for its decision making within making improvements towards the healthcare system, improving patient care and addressing other challenges that arise in today's healthcare system. So PCORIs contribution and/or unique role would be to actually provide funding for patient-centered and CER (Comparative Effective Research), especially since it is considered as the Patient Centered Outcomes Research Institute. So in other words, the unique role or contribution would be to actually work on implementing federated learning systems and do research on that to see if it improves or impacts patient care and advancements/improvements within the healthcare system.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Success towards an integrated learning health system would be when progress is actually made towards an integrated learning health system. In which the barriers would actually be addressed successfully which would have a positive impact towards the healthcare system and those who are involved. This would also include proper funding for research and use of technology for advancement, along with patients actually getting treatment and service efficiently.
Name and/or Organization
Mueez Karimi
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/16/21 16:47
Name and/or Organization
American Society for Radiation Oncology (ASTRO)
Community
Stakeholder
Stakeholder Community
Clinician
File Upload
Submitted
8/16/21 5:34
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Reduce environmental impact of health care on health—treating patients should not indirectly exacerbate others acute and chronic diseases
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Lack of understanding of scientific nuance in general population
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Moonshot efforts—take big risks for big rewards in health care. No one does this (outside of a few tech companies and VC firms that probably shouldn’t) and incremental changes in health care are often not enough
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Acceptance into clinical practice with scientific justification
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Easily customizable algorithms with access into large databases
Name and/or Organization
UVA Health
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/15/21 23:39
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Better diagnostic technology.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Addressing low hanging fruit for population health.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Getting pernicious anemia diagnosed.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Deploy $15 test.
Name and/or Organization
pernicious anemia society of america
Community
Patient
Patient Group
Patient
Submitted
8/15/21 18:57
For the full set of National Priorities: What other comments do you have?
I think that this is the best set of national priorities in existence for a funder in the healthcare space. The priorities are realistic, clearly defined and actionable. Since PCORI became a funder of many research initiatives that have one or more of these goals, I have seen noticeable improvements in patient centricity, stakeholder inclusion and focus on reducing health inequities when reviewing studies proposed to or funded by PCORI. In conversations about meaningful patient-centered research, people now believe that PCORI will actually fund research that no other entity will consider - and it's research that really matters, done in a way that really makes key stakeholders partners and collaborators, including patients. I LOVE the national priorities for the future and hope to find ways to help support their realization. THANKS TO ALL OF YOU FOR THE TIME, ENERGY, TALENT and $ YOU INVEST TO IMPROVE HEALTH AND WELLBEING FOR ALL OF US!
Name and/or Organization
Eva May
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/15/21 15:02
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Emphasis on the use of digital technologies as emerging innovations is important as the place abs role of digital innovations is yet unclear in health delivery.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Success will depend on which stakeholder will answer this question. Success needs to be defined per stakeholder group. For instance, success for a patient who has chronic pain may be being able to not hurt, for the physician is to adhere to the pain medication and for the health system is to not use the emergency room.
Name and/or Organization
Jane Hankins
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/13/21 11:48
For the full set of National Priorities: What other comments do you have?
Missing from the above list, although touching on many of the proposed priorities, is a deeper understanding of advanced primary care that transcends the boundaries of office practices and includes a broad set of community services, acting as a single system for each community. Within those communities, populations with multiple chronic conditions, especially inclusive of mental health/behavioral health conditions, are in desperate need of a health system that places them at the center of an advanced primary care community of service.
Name and/or Organization
Constance van Eeghen, University of Vermont
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/13/21 10:16
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
To increase health equity access to the underserved and to improve the way healthcare is practiced around the world. Innovations need to be assessed for their effectiveness in comparison to existing interventions. Enhancement of infrastructure to improve the research process which leads to more effective study results thus improving the healthcare system and people’s health. PCORI can connect the elements of research between agencies by providing a framework for analysis to improve coordinated care.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Cost is the biggest factor as well as the amount of time required to research and analyze data and coordinate care.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
To take emerging innovations that have some efficacy but haven’t been translated into care and follow them through from inception to translation.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Closing the gaps between what is known and what is unknown. This will improve health equity.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
To improve the infrastructure of research in the U.S. by improving research study results and creating partnerships and coordination with other agencies. The ability to respond to patient needs of improved health in a more efficient manner by improving the existing infrastructure.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
There are missed opportunities when the health research infrastructure does not effectively connect with the healthcare system resulting in disparities and poorly coordinated care.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
To integrate patient- centered outcomes of research findings into learning health systems. Also, the advancement of PCOR methods can access and utilize real world data to expand the universe of engaged patients, clinician partners, and representative leadership.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
The enhancement of technology to track real world data by promoting accessibility, quality, and research standardization while maintaining security and privacy.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
To advance the real world use of research results and strategies for dissemination among various audiences. The goal is to inform patients and clinicians of research results. Thus, utilizing technology to provide audiences with crucial info and opportunities for treatment.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Creating an information infrastructure of research results and recommendations will take considerable resources of time, investment, and coordination activities.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
To speed the uptake of evidence early in the research process.
Achieve Health Equity: What are the opportunities?
To advance health equity in the U.S. by improving information dissemination of research.
Achieve Health Equity: What are the challenges?
Social determinants of health such as infrastructure (access to internet), transportation, and housing still remain as obstacles. Collaboration with social services will be difficult as it is an already underfunded and understaffed group.
Achieve Health Equity: What is PCORI’s unique role or contribution?
To solicit and fund studies across the health research spectrum
Achieve Health Equity: What does success look like?
To improve health outcomes for all individuals regardless of background.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
To foster place-based transformative improvements in patient-centered experiences and improve health outcomes.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
The lack of doctors, nurses, and medical staff available in the U.S. is a major issue and one that rural locations only complicates.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
To facilitate the collaboration of required partnerships and monitoring of success or failure.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
To fund and maintain multi sector interventions that focus on the whole-person with personalized medicine.
For the full set of National Priorities: What other comments do you have?
Since there is a lack of doctors, nurses, and medical staff in the U.S., would standards for licensing doctors from other countries be lowered (meaning are they required to complete medical school again within the U.S.)? If they can pass competency exams, is four or more years of med school still required? What about state vs. federal mandates, how are these issues reconciled?
Name and/or Organization
American Chronic Pain Association
Community
Patient
Patient Group
Patient/Caregiver Advocate or Advocacy Organization
Submitted
8/12/21 21:02
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
One of the main challenges in "Communicate research findings effectively and in ways tailored to diverse audiences" is in combatting misinformation.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Given there is limited funding for health communication studies from NIH unless they focus on cancer or other specific topics, PCORI can play an important role in providing funding to explore communication strategies for health issues and outcomes that aren't typically funded by NIH. Developing patient advisory boards to guide messaging is critical.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Success would include creating toolkits for best practices for different channels of communication and target audiences for disseminating research findings and related recommendations.
Name and/or Organization
Jennifer Manganello
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/11/21 13:38
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
I urge you to consider prioritizing the needs of pediatric patients across all of the new research priorities listed. Or adding that as another focus. The COVID pandemic has been a reminder of how we do not prioritize our children enough, as we've protected adults at the expense of child health, emotional well-being, and immune tolerance to variants that were harmless to them before being subjected to more harmful mutations with no access to vaccine. Unique challenges of pediatric clinical research are also evident ni the fact that no vaccine has been approved for children younger than 12. Diversity is important and I encourage you to include age diversity in that mix, with priority given to the youngest among us. They are our future.
Name and/or Organization
Mike Siegel
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/10/21 18:45
Achieve Health Equity: What are the opportunities?
-Development and application of methods to guide operationalization of health equity and evaluation of outcomes in existing and future PCORI-funded CER -Stakeholder engagement in prioritizing health equity targets in PCORI-funded research -Research that integrates implementation science frameworks with health equity frameworks to guide and evaluate health equity in CER
Achieve Health Equity: What is PCORI’s unique role or contribution?
-Support development and testing of methods in this area
Achieve Health Equity: What does success look like?
-Reaching health disparity groups and decreasing inequities in care with evidence-based interventions
Name and/or Organization
Kelly Aschbrenner
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/10/21 10:59
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
We say we want: "...people have better information when making health decisions." The opportunity here is to first understand the patient within his or her real world context at ground level. Understanding will lead to better interventions and outcomes.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
I believe we are missing an opportunity when we do not fully understand the human component at ground level. I have recently reviewed a couple of PCORI abstracts, and am saddened that there was little or no positive impact on patient/caregiver behavior or outcomes. I believe one of the challenges that we face as public health and healthcare researchers is that we must strive to gain a deeper understanding of the lived experiences of patients and communities—humans do the things we do for a reason, and if we seek to move behavior and empower patients to play an active role in their own health and wellbeing, we must understand the realities that exist at ground level (beyond the clinical diagnosis or area of focus). We say we want to "...(Fill) these gaps for both current and emerging approaches..." in order to "...improve health care, health outcomes, and health equity." I believe there is a tremendous gap in actual understanding of the patient realities that inform so much of the why behind the what in terms of health state, healthcare behavior, and health outcomes.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI is in an important seat... if we were to make human understanding compulsory to research, then we would have a better view of the social, cultural, and emotional determinants of health.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
We say we want to: "Strengthen and expand ongoing comparative clinical effectiveness..." Success must include stakeholder understanding. Without it, we are missing a crucial component of true patient empowerment.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Make ethnography or some form of qualitative insights and understanding compulsory to CER studies.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
We invest in research, and often times see little material impact... and I believe this may have something to do with understanding the deeper dynamics driving patient behavior and engagement (competency). When we have the opportunity, we should take the step to delve into the lived experiences of patients and caregivers at ground level. This context and understanding will inform successful outcomes.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Again, consider encouraging research teams to look beyond the clinic and to understand the cultural, emotional, and behavioral aspects of patient behavior.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Patient and stakeholder understanding—truly understanding the realities and burdens at ground level. Better CER study outcomes. Healthier more engaged communities. Better healthcare economics.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
We say we want to: "...accelerate the movement of comparative clinical effectiveness research results into practice." This is not possible at scale without cultural and behavioral context and understanding.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
People are complicated and the human condition is dense. Understanding these complications and the nuances of what makes them tick will only inform better methods for engaging and empowering behavior.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Compel researchers to dig a little deeper and look beyond clinical realities. Require ethnography or empirical components to studies—it will pay dividends. Again, patients (and related stakeholders) do the things they do for a reason. Understanding those reasons will facilitate better engagement, education, empowerment, and competency—leading to a more engaged and successful patient reality.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Better research study outcomes visa vis patient understanding and empowerment. Success at scale.
Achieve Health Equity: What are the opportunities?
There is so much that goes unsaid—but that is explicitly felt and understood by the patient. Through the lens of equity, we have an opportunity, if not an obligation, to connect with and understand the realities of the communities we seek to empower. Not just clinical presentations of symptoms, but the cultural and behavioral nuances that lay just beneath the surface, if we just took the time to ask, observe, listen, and understand.
Achieve Health Equity: What are the challenges?
Again, the human condition is so dense and complicated—and if we truly want to impact equity, we must invest in understanding. It's a tall order, perhaps (although I do not see it as so), but the reality is what it is and only by engaging with and exploring the realities that drive health behavior and wellbeing will we be able to move the needle on equity and inclusion.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Again, compel researchers to seek understanding first.
Achieve Health Equity: What does success look like?
Communities and stakeholders who feel understood. Advocacy who truly "gets it" and who uses that understanding to facilitate access and wellbeing.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
I love LHS. We are working on an LHS-based study now. We say we want to "...serves the needs and preferences of individuals." The first step is truly engaging with them and understanding them not only in the clinical context, but outside the four walls of the clinical space.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Again, the density of the human condition—on both sides of the healthcare transactions. In this case, understanding not only patients but HCPs, clinicians, site managers and so on...
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Again, I hate to beat an old drum... but encouraging research teams to engage with and understand the human, cultural, emotional, and behavioral drivers of health.
For the full set of National Priorities: What other comments do you have?
After being involved in PCORI for three years now, I just feel like we are missing a tremendous opportunity. I soulfully believe that if we are to impact healthcare and health outcomes at scale, we must must must seek to understand the humans at the center of the transaction. I know it seems like a heavy lift... and it actually is—but we will do well to nurture competency and support behavior. PCORI has the resources and the vision, but is missing (in my humble opinion) an important piece of the puzzle by not leveraging studies qualitative practices into studies.
Name and/or Organization
David McDonald, Healthcare Anthropologist
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/9/21 8:56
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Opportunity to model and test completely different ways to deliver health care and support patient wellness. Freedom to work outside the limitations of payors and health system politics. Unbiased curiosity for how things could be done in a new, more effective way.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Applying these new concepts into real world practice. Providing ROI, sustainability, scalability and positive outcomes to stakeholders to secure buy-in from the financial, administrative and clinical perspectives. Convincing key parties that the benefits of change will outweigh the significant time and resources required.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Unbiased information. Solutions that approach the problems of access, quality, equity and engagement outside payor or political restrictions. Providing holistic solutions that address current problems in an agile way. Providing compelling evidence for uptake of the whole solution. Reinforcement that the sum of the solution’s parts will have a larger impact than each solution in isolation.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Real actionable frameworks for communities and health systems to use to shape policy. Clear ROI and demonstrated outcomes to build confidence and interest from all stakeholders. Uptake and execution by a few well respected parties to spur interest and trust.
For the full set of National Priorities: What other comments do you have?
Exciting work!
Name and/or Organization
Sarah Davis
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/8/21 23:19
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Opprotunities for better care in surgical decision making and treatment of oral cavity cancers
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Lack of support for oral cavity and head and neck cancer research
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Studies to explore improving head and neck cancer care are unlikely to be funded through traditional research mechanisms.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Improved decision making which is evidence based for head and neck cancer.
Name and/or Organization
Sid Puram
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/7/21 13:07
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Looking toward the basics of lifestyle - the etiology of so many of the chronic diseases within our population, and recognizing that therapeutic lifestyle changes need to be front and center to halt and in many cases reverse non-communicable chronic diseases.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Lifestyle interventions can be very inexpensive. Yet these are not readily billable within medicine. This presents an incredibly difficult challenge of awarding providers to write prescriptions or order procedures even though the first intervention in chronic disease guidelines is lifestyle changes.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI could compare the clinical effectiveness of lifestyle interventions and common medical care (procedures, surgeries, prescriptions). For example - the clinical effectiveness of intensive cardiac rehabilitation programs (ICRPs) versus CABG, stents. Or diabetes reversal programs versus standard medical care.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Outcomes that lead not only to symptom relief for non-communicable chronic diseases, but also the ability to "rectangularize the curve" of disability as the population ages through lifestyle interventions that have multifaceted benefits (weight loss, decreased inflammation, increased activity, improved nutrition, more socialization) versus procedure, surgeries, and prescriptions that may be of shorter-term benefit and with risks.
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/5/21 17:50
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Telehealth is here to stay, whether by phone, video, text or an app. We need to understand where the technology adds value for patients and when it is a barrier.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Implementation has been variable and the sites best able to do research may also be the most successful at using the new technology.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Funding studies of the patient experience of telehealth
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Clear guidelines on when telehealth is appropriate and when it is not.
Name and/or Organization
Theodore Levin
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/5/21 15:34
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Advancing the science of authentic patient partners in implementation studies: seems like ImpSci focuses mostly on engaging providers and more grass tops engagment than patient and patient partners. What is the unique contribution of patients in the adaptation and implementation of EBI. Another area: studies assessing the core and adaptable components of EBI for implementation.
Name and/or Organization
Duke University School of Medicine
Community
Patient
Patient Group
Patient
Submitted
8/5/21 14:45
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Provide guidance to investigators on how to implement resources like social media to identify and recruit participants outside of major medical centers and how to recruit participants with rare disease. Provide recruitment infrastructure for investigators who are not at a major medical institution (e.g., those at academic universities).
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Participant recruitment. There are several regulatory barriers that interfere with recruitment. It is almost impossible outside of major medical centers (and the approvals to implement effective strategies there are lengthy). Participants at these major medical centers are not always representative of the broader population (higher SES, more urban, etc.)
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
PCORI has excellent guidelines and training resources for how to conduct quality research. These were particularly useful to me as a young investigator. Guidelines on the pragmatics like recruitment, use of technology, etc., and state of the art methodological guidelines for implementation/dissemination work would also be helpful.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
PCORI could establish relationships with payer organizations that investigators can leverage in their projects. This would help payers keep up with the science and investigators have greater impact with their projects.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Difficulty connecting with payor organizations. When you can get them to engage at all, they are typically very busy and it is hard to get the depth of engagement that is desirable. There is a general resistance for them to implement/cover new interventions and the "burden of proof" that they require for reimbursement is often higher than what can feasibly be achieved, especially for populations of people that are hard to recruit for studies (e.g., rare conditions, people with disabilities).
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/5/21 12:06
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
I believe it would be important to increase existing evidence for the surgical management of oral cancer
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Prospective multi-institutional investigations
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Support development of new multi-institutional collaborations
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
8/5/21 11:21
For the full set of National Priorities: What other comments do you have?
From the disappointing compliance and implementation of vaccination with COVID, while this can fall under No. 3 (Advance the Science of Dissemination, Implementation, and Health Communication), I think one specific priority should be Policy and Implementation of Vaccination (and other Protective Health care measures) to reach >95% compliance. Personal freedoms should not be the freedom to place others at risk of disease and death.
Name and/or Organization
David Kaufman
Community
Patient
Submitted
8/5/21 11:06
For the full set of National Priorities: What other comments do you have?
I am fully supportive of the proposed five priorities!!
Name and/or Organization
Rubén Rosales
Community
Patient
Patient Group
Patient
Submitted
8/4/21 20:43
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
One of the major opportunities is to address needs of the incarcerated woman, who has unique health and wellness needs as compared to incarcerated men. One in 40 adult US residents are under an aspect of correctional supervision with ~1/3 of them women. 3/4 incarcerated women are childbearing age and 5% are pregnant on admission to prison.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Access to the prison system has been a challenge. In NJ, a Commission on Women's Reentry has been legislated to provide women in prison and upon reentry with more services.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
There is a lot of opportunity in this area with the infrastructure established by the state wide prison system.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Pre-incarceration trauma (PIT) and Incarceration-based trauma (IBT) would establish focused mental health care to these women to proactively deal with all health issues, but doing it with the focus of addressing mental health needs.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
The established reentry programs in NJ would be an opportunity to enhance delivery of overall preventive/interventive health care coupled with mental health care.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
would only be dealing with women upon discharge from prison
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
to establish a template for enhancing wellness of women who have been incarcerated (and their family)
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
as above
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
through many outlets established through the prison system.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
none
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
To do this in a patient centered way
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
employment, no recidivism, fewer hospitalizations
Achieve Health Equity: What are the opportunities?
Black women are incarcerated at a greater rate than all other women
Achieve Health Equity: What are the challenges?
would be intervening with release from prison and not during prison
Achieve Health Equity: What is PCORI’s unique role or contribution?
Give these women a better chance at successful reentry into their communities
Achieve Health Equity: What does success look like?
fewer black women being incarcerated.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Would like to establish PCORI program in NJ
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
None as Commission is established
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Be part of the initiative
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
dissemination to other states
For the full set of National Priorities: What other comments do you have?
none at this time.
Name and/or Organization
Gloria Bachmann Rutgers Robert Wood Johnson Medical School:Chair of the Health Committee of the reentry Commission
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
8/3/21 14:56
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Electronic communications between different healthcare systems couldearn to speak the same language in electronic records so patient I do doesn't land ibaack begkod question how. b
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Physicians do not get continuing education credits in many states for hard to diagnose conditions such as neuroendocrine cancer Communications among doctors in different specialties is not communicated timely and does not function line a team:con rest communications with Paris ta us not alt nor timely
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Good questionhow. An you address a I e leoems
Name and/or Organization
anonymous
Community
Patient
Submitted
8/2/21 21:54
Achieve Health Equity: What are the opportunities?
Identify additional reviewers of color to diversify the voices of underrepresented communities contributing to funding decisions.
Achieve Health Equity: What are the challenges?
Authentic engagement of diverse community members.
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI has the ability to buck the tradition of prioritizing academic medical voices over individuals who experience the results of their decisions. In a recent meeting, a scientific reviewer indicated that a proposal was not worthwhile because the applicant had no research experience and also had some typos in their application. It occurred to me that if we don't give individuals opportunities to learn or wholesale dismiss applications because proper English (in the academic sense) is not used, we run the risk of really biasing the types of research applications which get reviewed. In a sense, it's the same as radio stations - we only get to listen to a small proportion of the music that program managers deem worthy of listening to. PCORI has the opportunity to make a real statement on what proposals should be funded based on their substance, and not necessary what the academic world believes should be tied up in a pretty bow.
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
8/2/21 13:52
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Achieve Health Equity: What are the opportunities?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Achieve Health Equity: What are the challenges?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Achieve Health Equity: What is PCORI’s unique role or contribution?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Achieve Health Equity: What does success look like?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
For the full set of National Priorities: What other comments do you have?
I appreciate the time and thoughtfulness that went into these recommendations. What I don't see is a specific reference to oral health as integral to overall health. If history is any indication, we cannot leave this important identification to chance. Oral health (and behavioral health) is not option. It is an essential component of overall health. Please bring these important distinctions to the fore. Oral Health is integral to overall health.
Name and/or Organization
Steven P. Geiermann DDS
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
7/30/21 17:44
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
This priority area opens up the potential for PCORI to do more in pursuing *all* patient-centered outcomes (e.g., safety, side-effects [including not only biological, but also psychosocial, economic, & other side-effects] trustworthiness, equity, etc.), rather than limiting so much of its work strictly to comparative effectiveness research. Effectiveness is obviously a very important part of evidence-based decision-making on the part of patients and patient-clinician teams, but it is not the *only* consideration. While PCORI already funds some non-CER studies, the potential for a broader lens reflected by this priority could help answer important questions about the rest of that mosaic of concerns that factor into patient-centered care.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
The detailed language of this priority talks about outcomes beyond (and in many cases independent of) effectiveness, but the "blurb" that explains the priority still seems to focus strictly on CER. Whichever of these more accurately reflects PCORI's intent, lack of clarity here could undercut its pursuit of this priority.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
A focus on truly patient-centered outcomes and genuine integration of patients in priority setting and study design.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
The creation of better, broader, and more patient-centric evidence related to the new and existing interventions in health.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
To help build sustainable patient-clinician-researcher partnerships that extend beyond a specific research project.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Advancing patient-centered learning health systems vs. technology-driven learning health systems.
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
7/30/21 16:11
For the full set of National Priorities: What other comments do you have?
I am a 63 year old Disabled RN with MS and 35 years of Nursing Experience. Definitely you must involve patients in your planning. Follow @Markwebb on Twitter. He is part of a group doing similar studies in UK. All my blog posts where I mention Patient https://traveloguefortheuniverse.blogspot.com/search?q=Patient+ My recent posts show technology helping me monitor sleep with Oura Ring. Apollo Neuroscience wrist device to balance my sympathetic and parasympathetic nervous systems. https://traveloguefortheuniverse.blogspot.com/
Name and/or Organization
Mary Gerdt
Community
Patient
Patient Group
Patient
Submitted
7/29/21 18:56
Achieve Health Equity: What are the opportunities?
"Social-justice equity" and activism is in the process of destroying millions of disabled elderly, injured vets, sickle cell, cancer, CRPS, fibromyalgia...the list of untreated painful conditions is long. Suffering, suicides, bigotry, and (ironically) overdoses increase every year, because of a countless number of harmful organizations like this one created under Obama. BOTH parties are now infected by D.C.-cesspool logic. The only collective goal should be ensuring the freedom to solve local problems after government approves medicine and ensures manufacturing safety for ALL INDIVIDUAL AMERICANS. THAT is equality. Overreach and "averaging" individuals enables a gigantic self-help scam involving "recovery" and fake research. Most people do NOT like using drugs - even medicine they need. There is no addiction or overdose crisis, and any problems must be solved locally - by individual human beings. The causes of addiction are unique to individual people. It's NOT a collective problem, NOT a brain disease; and NOT a crisis. "Equity" used by democrat-communists and many RINOs (state A.G.s, e.g.) means preferred treatment based on group identity, skin color, fake crises (like "opioids!"), etc. Substances do NOT *cause* addictive behavior, and even if they did fewer overdoses occurred when pill mills flourished. Utopianist prophecy doesn't save anybody. The D.C. cesspool and social-justice crusading (including behavior addicts treated like subhumans) is immoral. Dissolving Obama's corrupt PCORI would be a good first start. You repeat a bunch of "human resources" garbage intended to cover up and expand stigma and corruption. The federal bureaucracy, even the Justice Department, fraudulently influenced an election in 2020. Sadly, people are still too coddled to be bothered to fight for individual liberty. Yet.
Name and/or Organization
Lee H. Alderman
Community
Patient
Patient Group
Patient
Submitted
7/29/21 10:52
Name and/or Organization
Leo Lochard
Community
Stakeholder
Stakeholder Community
Health Researcher
File Upload
Submitted
7/28/21 22:02
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
One of PCORI's critical mandates, as presented in its authorizing legislation and articulated in the PCORI’s original National Priorities has disappeared. And, critically, it is the mandate and aspect of PCOR most central to defining and distinguishing what Patient-centered outcomes research actually is. This is the aim to distinguish “what works for whom”, elsewhere known as “heterogeneity of treatment effect.” This important aspect of research seems to have vanished entirely from the proposed priorities. This mandate was articulated clearly in the authorizing legislation both in the section describing PCORI's "Purpose" (Section (2) (C) - "through research and evidence synthesis that considers variations in patient subpopulations" and more specifically under PCORI's Duties (Section (2)(D) Taking Into Account Potential Differences): "Research shall be designed, as appropriate, to take into account the potential for differences in the effectiveness of health care treatments, services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, or quality of life preferences and include members of such subpopulations as subjects in the research as feasible and appropriate." This instruction was taken very seriously by PCORI's Board, Staff and MC in PCORI 1.0. The National Priorities mention it in its first priority: “…comparing the effectiveness and safety of alternative prevention, diagnosis, and treatment options to see which ones work best for different people with a particular health problem.” A section of the Methodology Standards deals with treatment heterogeneity. An instruction to applicants to describe their approach to looking for treatment heterogeneity was included in every PCORI funding announcement. A large body of research on this topic was funded in PCORI 1.0. PCORI just funded two new projects in this area at its July 2021 Board meeting under the Methods Initiative. PCORI sponsored an IOM meeting on this topic from which an IOM publication ensued. It’s pretty clear that PCORI continues to emphasize this important research strategy – and is distinguished in doing so. More to the point, a focus on individual differences in treatment response is at the center of patient-centered research. Engagement is NOT the single defining characteristic of the patient-centered approach. Rather, an effort to ensure that research findings support individual decision-making is the its centerpiece. The absence of any mention of treatment heterogeneity in the new national priorities would suggest a turning away from this approach (which I don't think has happened at PCORI). The need to bend research toward identification and validation of true treatment heterogeneity is closely linked to PCORI's emphases on larger more representative patient populations and on its policies regarding data sharing (also not mentioned in the priorities, despite PCORI’s leadership position in this area). The most important rationale for data sharing is to allow data pooling which provides the statistical power to took reliably at patient heterogenity. Typical clinical trials are not planned for this purpose, so pooling is necessary to look with precision at population subgroups. This approach to data synthesis and in fact any mention of systematic reviews or meta-analyses, an important PCORI role, has also escaped mention in the proposed priorities. Hopefully, the new priorities can be augmented to add an emphasis on the need for attention to treatment heterogeneity, and the concomitant needs for data sharing which allow for individual patient meta-analysis with its potential to support analyses of possible treatment heterogeneity.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Since PCORI is the unique funder of "Patient-centered Research", it seems fundamental to define what PCORI means by this - beyond patient and stakeholder engagement. I believe that PCORI's longstanding focus on looking for subgroup differences ("treatment heterogeneity") is a central feature of "patient-centered outcomes research" and that PCORI has realized and emphasized this from its earliest days.
Achieve Health Equity: What are the opportunities?
Again, attention to treatment heterogeneity has the potential to inform us all that some treatments or programs may not work as well in all of our diverse population subgroups.
Achieve Health Equity: What are the challenges?
Demonstrating "what works best for whom." PCORI has a wonderful research portfolio in diverse patient populations. The underlying rationale for much of the funded research is that there is a need to "tailor" treatments to specific population groups. This reflects the underlying assumption that one size does not fit all. It can be challenging to establish that treatments may work differently or not at all in some populations, but that has to remain a central concern of PCORI>
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
The biggest challenge I'm aware of is getting systems to share data for research purposes. PCORnet is a good start, but for it to fully succeed, health plans must share their data and all must work on data linkage. In the US., very few single entities hold the full data on large patient populations. Data sharing needs to become the norm. Overcoming faux concerns such as the HIPAA regulations and "data incompatibility" will be essential. Just as it has done for research data with its policies on data sharing, PCORI could look for ways to encourage systems (plans and delivery systems) to share their data for specified research purposes. The barriers are two-fold: proprietary concerns (not a true concern) and organizational inertia (which should be addressable by emphasizing the value of learning, although other incentives may be needed as well. .
For the full set of National Priorities: What other comments do you have?
These priorities represent an exciting refinement of PCORI's original priorities, incorporating much of what PCORI has learned during its first decade and much of what has changed in the US healthcare environment during the same period. Congratulations to PCORI for building on its experiences.
Name and/or Organization
Joe Selby
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
7/27/21 22:35
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
There must be more attention to integrated behavioral and physical care. It involves treating the whole person and not just one aspect.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Current funding and healthcare structural organization do not support integrated care. PCORI could move the field in this direction if they required a consideration for behavioral implications in all severe, chronic and rare diseases.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Could structure project applications to address behavioral health implications
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Integrated behavioral and mental health care
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Continue with requiring patient participation in all phases of application formulation
Achieve Health Equity: What are the challenges?
That Medicaid recipients are offered quality health care
Achieve Health Equity: What is PCORI’s unique role or contribution?
Include Medicaid population as part of future funding
Name and/or Organization
Charlotte Kauffman
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
7/26/21 12:18
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
The evidence has been clear- early and cumulative traumas impact the health and well being of adults. Individual, interpersonal and cumulative traumas are disproportionately impacted by communities of color and that became very clear this past year in the context of the COVID-19 pandemic. Implementing and evaluating trauma-informed approached offers an opportunity to improve the patient experience, improve patient engagement, health outcomes, and lower health care costs.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
The main challenge is that trauma-informed approaches : 1) is quite variable; 2) evidence is sparse; 3) will require a paradigm shift in health delivery- from 'What's wrong with you?' to 'What's happen to you and how has that impacted your well being?'
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORI offers the opportunity to build this body of research. Trauma-informed care is grounded in a partnership with patient's that centers their voice, choices and aknowldgement of their cultural and historical backgrounds.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
1) patients are more engaged in their care 2) providers feel less compassion fatigue 3) advancement of health equity 4) improved health outcomes 5) lower health care costs 6) less fragmented care
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Understanding the impact that trauma-informed approaches can have not only on patients, but on staff and an organization. A major opportunity is the realization and recognition that past and acute traumas impacts the health and wellness of people- and that trauma-informed approaches rather than medical approaches offer significant opportunities.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
This will require a paradigm shift however having evidence that supports the shift offers a significant return on investment.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Philosophically PCORI aligns well with Trauma-Informed care (TIC)- as TIC centers the patient, identifies their strengths, acknowledges their race, ethnicity and gender identities.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
stated above
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Partnering with patients and communities to advance health equity and racial justice in ways that can be realized.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Building trust and partnerships with those that will benefit as trust is fundamental to success.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
stated above
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
stated above
Achieve Health Equity: What are the opportunities?
Using the 6 principles of TIC during every step of the research process.
Achieve Health Equity: What are the challenges?
Building trust and partnerships within communities. CHANGE- while many are aware that the system as is have flaws- many with resist new ways.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Respected funding source, large network, collaboration and again philosophically aligns the theoretical underpinnings of TIC.
Achieve Health Equity: What does success look like?
Patients: experience less stigma, less bias, easier access, engagement, improved health outcomes, decrease health costs, Staff: decrease compassion fatigue, increase job satisfaction,
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
outcomes would inform other systems. Perhaps JC would be interested in its application and outcomes within systems. Healthier work environment.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Novel work!
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
see above
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
see above
For the full set of National Priorities: What other comments do you have?
In between patients filling this out, so apologies for brevity. Trauma ( personal, interpersonal and collective) impact the health and well being of patients and also of those caring for them (health care professionals). Current approach (medical model) does not meet the needs of these patients, rather can often re-traumatize them. If we are to promote healing and improved health, then other frameworks of health delivery must be learned and applied.
Name and/or Organization
Brigham & Women's Hospital
Community
Stakeholder
Stakeholder Community
Hospitals and Health Systems
Submitted
7/10/21 15:38
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
(see attached document. I will leave it to PCORI staff to figure out where to place it with regard to these questions)
Name and/or Organization
Joel L. Nitzkin; JLN-MD Associates, LLC
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
File Upload
https://www.pcori.org/sites/default/files/webform/19726/NitzkinPCORIcomment20210710.pdf
Submitted
7/10/21 13:30
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
I sent you a note about the opportunities. Optimal medical therapy (OMT) for cardiometabolic and related conditions has been proven to prolong life and delay cardiovascular events. Primary care teams focused on cardiometabolic conditions can dramatically improve results compared with usual care. The main barrier is perverse financial incentives. We should move much more forcefully to value-based reimbursement. Pay primary care to produce optimal medical therapy. Most quality improvement programs fail because they don't deploy a comprehensive solution. Success requires OMT protocols for high risk patients. Population health tools to identify patients who have not been seen, have not had a visit or a test within a certain window, or are not at goal are necessary. Value-based payment rates should support the extra time and resources required for success. When all these factors are deployed clinical outcomes improve and net costs are lower, in some cases much lower.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Apply the principles learned in the optimal medical therapy trials to large populations. Collect the big data and compare the results to usual care, the care that most patients receive. OMT can be industrialized and scaled.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Population health tools that support providers in delivering care and measuring care outcomes are essential. Most costs are coming from chronic conditions. The great opportunity to apply optimal medical treatment is in outpatient primary care. Larger organizations can support rural providers with this expensive technology. The HIE system needs to be much more robust to provide access to essential data. Success requires population health tools and data on problems lists, medications, and measure like BP and A1c.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
In every case, the main barrier to progress is perverse financial incentives.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Singapore has healthcare coverage for all citizens. They have hypertension, diabetes, and lipid clinic teams in one stop primary care polyclinics. They live longer for one fourth the impact on GDP.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Certify Primary Care teams that focus on patients with cardiometabolic conditions based on their clinical and economic outcomes. It is not that hard. Patients should be able to receive best practice care from Sarasota to Seattle.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Perverse financial incentives.
Achieve Health Equity: What are the opportunities?
We could provide health equity, cover everyone, and save money if we provided OMT using proven generic medications that are inexpensive.
Achieve Health Equity: What are the challenges?
Perverse financial incentives.. Payment model does not support the needed level of change.
Achieve Health Equity: What does success look like?
Access to special operations primary care teams skilled in delivering OMT supported by the appropriate resources and payment models.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
close the 17 year gap between knowledge and practice in chronic diseases
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
We do not have a systematic approach to chronic diseases. Primary care providers who are on these teams should be comfortable practicing with other health care professionals as equals. They must use protocols and regularly update them.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Changes in policy are critical for all these advances.
For the full set of National Priorities: What other comments do you have?
Most costs come from chronic conditions. Cardiometabolic diseases are all related and they are the low hanging fruit. If we approached these diseases with teams, protocols, pop health tools, and payment models that support the work we could very quickly move to better outcomes at lower cost.
Name and/or Organization
Epigenex Health, Inc./William Bestermann
Community
Stakeholder
Submitted
7/10/21 8:56
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
There is strong evidence that optimal medical therapy for cardiometabolic conditions is superior to usual care. OMT for patients with a history of heart attack or a coronary artery stent reduces mortality by up to 90% and reduces costs by about $20,000 per patient per year. (Kaiser Permanente Collaborative Coronary Care Service) Similarly the Steno 2 Study showed patients with high-risk type 2 diabetes who receive OMT have one fourth as many heart attacks and one fifth as many strokes as patients in usual care. OMT alone is as effective as OMT plus a stent in stable angina patients. We cannot claim we have patient-centered care until all American have access to OMT. It should be a new standard of care according to WE Boden and David Maron. Expand these programs nationally and promote creation of the special operations primary care teams and value based payments to support them. [email protected]
Name and/or Organization
William Bestermann Congruity Health
Community
Stakeholder
Submitted
7/7/21 19:34
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
To help people who are suffering with chronic pain especially poor people with poor insurance that won't even pay for pain management
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
The challenge is the biased opinions of the doctors and the politicians that don't have to suffer from debilitating physical and mental trauma from injuries that have left them with chronic physical and mental and emotional pain that is not helped because they are poor and can't afford good care. Don't have to deal with doctors that won't prescribe pain relief because the doctor is in fear of losing his license if he prescribes pain medicine to a patient who might or might not be an addict. So they do nothing and let so many people suffer to the point they either turn to illegal methods street drugs or alcohol to relieve their pain or they just Kill themselves.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Why not legalize all drugs and allow people to judge for themselves what they need and quit locking up people for victimless crimes there are plenty of violent offenders that need to be in jail rather than punishment for minor infractions that ruin people's lives and make it impossible to have a life get a job or even rent somewhere.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
People no longer have to suffer on a daily basis and have relief from their pain and the injustice system has more resources to lock up the real criminals child molesters and rapists. Less people become addicted because it's not tabboo and now there are more resources to help people rather than lock them up and violent offenders don't get released early because of jail overcrowding.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
People that are in severe pain don't suffer so much and have more time to live rather than chasing pain relief.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Doctors can stop treating people worse than our animals are treated.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
To have more humanity and democracy and to allow people to get the help they need. If pain killers were sold over counter like so many other countries and people can treat themselves and save a lot of doctor visits and money.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
The whole system saves money and lives like all countries that have legalized all drugs. Less addicts less crime less death and more resources to help people rather than lock them up like animals.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Why does our democracy make sense. Why do a few wealthy people have the right to tell all of humanity what they can and can't do. It makes no sense. They pass laws to protect their money and power not the people.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
I know my body better than anyone else and I know what works for me and what doesn't I've been a victim of this system my entire life.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Look at college biggest scam of all go into debt taking a bunch of classes to learn a bunch of lies about history Sacagawea was kidnapped and raped she wasn't a willing participant and I never have used quadratic equations ever in any job I have ever done or will do. Take loans from the government to take all these classes which unless you are lucky you will be paying back with major interest rates that fluctuate depending on economy the sad thing is many never get a good job and pay it all back.
Achieve Health Equity: What are the opportunities?
The whole system is designed to keep the majority down in the dumps with no way to get out.
Achieve Health Equity: What are the challenges?
The challenge is if your not born wealthy you have slim to no chance of getting out of poverty.
Achieve Health Equity: What is PCORI’s unique role or contribution?
I have no idea but this injustice system has really done a number on those who have nothing why do we have to pay to exist
Achieve Health Equity: What does success look like?
When everyone has the right to the same health care a don't have to suffer in pain and prison because they were injured when they were young and we're put on oxycodone get a habit but still have pain get cut off the pain pills and now have to steal to get relief and ruin their whole life
Name and/or Organization
Tree a person who survived trauma and abuse all her life
Community
Patient
Submitted
7/6/21 14:13
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Overcoming false information propagated by those with malicious and non-malicious intent
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Creating non-political health communication sources that are more trusted than those of government agencies by a large segment of the U.S. population. Perhaps it is important that they include celebrity co-sponsors from a broad range of entertainment and sports fields, since many are trusted when they propagate false information. Ways of summarizing and presenting valid health data that are less likely to be ignored.
Name and/or Organization
UPMC Hillman Cancer Center
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
7/6/21 12:31
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Comments attached below in PDF
Name and/or Organization
Mitchell Berger
Community
Stakeholder
Stakeholder Community
Policymaker
File Upload
https://www.pcori.org/sites/default/files/webform/19726/pcoricomment.pdf
Submitted
7/5/21 12:47
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Fund research projects that are able to close some of the disparities gaps in health services and system research today. Often existing interventions and emerging innovations are more readily available for individuals with more financial resources than in under-resourced populations. To create a more equitable research strategy and agenda, development of fair or just methodologies that incorporate innovative interventions and evaluation opportunities need to be researched for use and accepted validation. PCORIs future portfolio strategy needs to embrace the individuals and communities who better understand the needs of their communities and should be directly involved in all levels of research processes.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
To acquire reliable scientific evidence, this requires good quality research as a foundation. Having patient, public, community and caregiver stakeholders work in collaboration with research teams that may also include statisticians, economists, pharmacists, OT and PT practitioners, social workers would benefit clinical comparative effectiveness patient centered research projects overall. Multi disciplinary stakeholder teams could also bring in experts from their respective subject matter expert fields to effectively inform research projects so that outcomes better reflect real world implementation feasible opportunities that can lead to beneficial health impacts that could be scaled. There needs to be space for emerging innovations to be analyzed and evaluated so that institutions, clinicians, and populations are able to benefit from said effective innovations.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
PCORIs portfolio is very large now and creating opportunities to better disseminate findings in an understandable format could benefit many. Funding short term multi stakeholder scoping work groups could benefit both PCORI overall and future research opportunities.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Having the opportunity to find existing PCORI evidence in an easy readable format is important and should be a priority. Different stakeholders most likely have different reasons for viewing evidence and the evidence should have summary tables that share this information for each project as well as for PCORI portfolio collectively .
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
PCORnet and other registries working together on priority projects. Data informing storied communications are important. Modify the PCORI framework to incorporate medical societies identified prioritized conditions, prevention or treatment questions or strategies.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Create a working group comprised of individuals who have various challenges to accessing PCOR results who can help PCORI develop research priorities that can really reach and benefit underserved or under-resourced communities. (Deaf, Blind, TBI, Low-income, non high degreed, English second language, mobility challenged etc)
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Utilizing PEAP and other Advisory Boards to determine opportunities for sharing and accelerating PCOR is one way. Funding projects that are more open sourced based similar to Ludwig Boltzman in Austria is one other idea where social media crowd sourcing the public has brought some important research ideas to light, where research agenda setting was prioritized
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
Easier grant application and submission processes. Reviewers results might be peer reviewed before sending back to project teams. Understandable PCOR results available across sectors where one pagers with more graphics on one side than words can share what PCORI does and why one should apply to be involved or submit a proposal
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Sky is the limit. Thinking more broadly, holding quarterly town halls of sorts where D&I and Communications questions could be more easily be brought forward where an inclusive process is ensured, Mentoring young scientists and including lesser known entities in studies is important where disparities can be discussed and opportunities can be made.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
D & I is a newer science though has really taken off. The practical aspects of implementation science or research project interventions that 'work' should be highlighted and shared more broadly. Health Communication: When are funders going to fund opportunities for translators to participate in study design, interventions and implementation efforts- oh yes and multi language communicated PCOR results opportunities! Thank you
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI who has embraced and promoted multi stakeholder involvement since the inception is a major contributor to opening doors to inclusive research where patients and stakeholders had been knocking on previously. As PCORI has grown we now are seeing more research to impact stories that could definitely be communicated more effectively to individuals who are not aware of PCORI,
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
Understandable accessible results that are communicated with graphics of findings, short videos and more to touch communities where they have not had the results before. Representative community members participating along each portion of D&I and Communications.
Achieve Health Equity: What are the opportunities?
Sky is the limit. There are many leaders in the field of equity at PCORI and other known and not so well known entities who can inform the BOG and research projects as they develop new goals and strategies for more effective research. Encouraging all projects and advisory entities to bring in outside experts will help to inform PCORI's research agendas going forward.
Achieve Health Equity: What are the challenges?
Dis-trust in health Research and Health care more generally. There is a lot of work to be done. Flexibility in funding will open opportunities working towards achieving health equity, developing relationships with communities and other stakeholders takes time and therefore money to ensure everyone is compensated for their time. Reaching out to persons who distrust health research and are adverse to accepting some of the current climate equity goals are important for better understanding possible road blocks for future funding and or implementation efforts
Achieve Health Equity: What is PCORI’s unique role or contribution?
PCORI has a step or two ahead of most research funders with having patient centered care at the center. Continuation and refinement of funding projects that address disparities and equity will keep PCORI at the forefront. Open discussions on health equity and identifying limitations are important to going forward
Achieve Health Equity: What does success look like?
Fairness in access to care, opportunities for better informed care where patient preferences values and goals are taken into account, where understandable timely information is available for all patients. Representative workforces that reflect the population served. Fair and Just care for all.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
The sky is the limit. Different points of care could be identified and replicable successful projects where for each type of point of care could be made available where individual clinics, institutions and facilities could collaboratively equitably chose from options what they feel would be best to implement LHS in their space. Collaborative stakeholder engagement including community to determine what is a priority for their area
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
So much knowledge though how to best inform clinics and facilities and institutions and patients around the ecosystem? Identify some best practices that have compared interventions that assist front line and or ER staff to capture necessary data to identify gaps in an individual patients environment that could stymie health care interventions, prevention and treatments. Data informed interoperable systems are necessary where informed shared decision making could benefit all parties. $$ are needed.
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Funding of digital knowledge ecosystems that could help to accelerate PCORnet registries that would also allow for qualitative information to be captured in some form. *AHRQ ACTS and the human readable interoperable coding tools that are currently being developed to support this data informed evidence to action knowledge generation ecosystem framework is one example.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Being able to replicate successful interventions that incorporate physical and emotional care and social needs addressed effectively.
For the full set of National Priorities: What other comments do you have?
Thank you for this opportunity I am looking forward to learning what public comments bring to light and forefront for PCOR and PCORI.
Name and/or Organization
Janice Tufte DBA Hassanah Consulting
Community
Patient
Patient Group
Patient- Other
Submitted
7/1/21 22:00
Achieve Health Equity: What are the opportunities?
One opportunity here may be to leverage machine learning and other novel statistical methodologies to better understand social determinants of health. Large numbers of features can be compared and evaluated in this way.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Making sense of the complexity of information here.
Achieve Health Equity: What does success look like?
Everyone has access across all geographic regions.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Leverage AI to monitor and evaluate incoming information in real time. For example, using Natural Language Processing and reinforcement learning alongside qualitative analysis may help evaluate progress and check for bias.
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
6/30/21 13:17
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Case control studies among matched patients among different treating practitioners. Comparison of outcomes when a tissue diagnosis is provided vs. A diagnosis of “non-specific back pain”
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
Study design, recruitment and follow through will require a dedicated effort by practitioners.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Education of the public of their valuable role in establishing patient centre Ed outcomes.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Abundant contribution from patients on self selected outcomes, robust results from clinical studies.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Development of tools for practitioners that are easy and efficient. Multiple language options for patients to overcome language barriers.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
Uptake by profession and patient populations. Incentivisation May play a role.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What is PCORI’s unique role or contribution?
Development of clinical tools.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What does success look like?
New options for addressing patient centered outcomes that are widely adopted.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the opportunities?
Practice guidelines widely distributed through multiple channels and opinion leaders.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
Uptake by the profession, there are pockets of the profession that do not want to change or try something new.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
Broad dispersion of findings through multiple media channels including social media and direct email blasts.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
A wide adoption of PCO measures in the profession.
Achieve Health Equity: What are the opportunities?
Unbiased access to care by all members of society.
Achieve Health Equity: What are the challenges?
Systemically ingrained bias in health care, financial barriers, access for remote and rural populations.
Achieve Health Equity: What is PCORI’s unique role or contribution?
Education, funding (potentially), outreach.
Achieve Health Equity: What does success look like?
An increase in service provision to 2 or 3 times the current levels.
Accelerate Progress Toward an Integrated Learning Health System: What are the opportunities?
Inter professional education and research. Collaborative care. Agnostic delivery with the right service for the right patient at the right time.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
Old ruts and habits
Accelerate Progress Toward an Integrated Learning Health System: What is PCORI’s unique role or contribution?
Keep the educational material clear, concise and relevant. Devise incentive based uptake.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
Full integration of multidisciplinary care and research.
For the full set of National Priorities: What other comments do you have?
If patient-centered care is not our priority then what are we really doing but serving ourselves?
Name and/or Organization
David Gryfe CMCC
Community
Stakeholder
Stakeholder Community
Clinician
Submitted
6/30/21 7:44
For the full set of National Priorities: What other comments do you have?
PLEASE - try to be a beacon for integration in a research and health care world beset by fragmentation. Fragmented knowledge leads to fragmented depersonalized care. Fragmentation kills. Please make integrating care for whole people a priority. PCORI could be an antidote to the siloed NIH approach. The current priorities do not address this, and will unintentionally feed into the problem of fragmented, depersonalized care. Please add an additional priority on integrating care for whole people.
Name and/or Organization
Kurt Stange
Community
Stakeholder
Stakeholder Community
Stakeholder - Other
Submitted
6/29/21 15:21
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
We do not collect enough evidence about the safety and effectiveness of cancer treatments, especially off-label uses. I recommend oncologists report patient outcomes of off label uses, including the stage of the cancer treated, the survival outcome, and other relevant parameters to help us understand the benefit and risks of off-la bel cancer drugs. FDA reports about the toxic effects of drugs, including cancer drugs, should be easy to discover on the FDA web site.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What is PCORI’s unique role or contribution?
Facilitate improvements in data collection about the safety and effectiveness of drugs and devices that can be used by patients and patient advocates, including primary care physicians. Examples include metal on metal hip implants and artificial implantable intervertebral discs.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
Encourage CMS to require data submission about the new biologic drug for Alzheimer's disease to help verify whether or not it works, how much, and for what stage of the disease.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the opportunities?
Improve the ability of various health plans to share a patient's medical record across plans when permitted by the patient, such as when a patient changes primary care providers, or medical care delivery systems.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
The terms "health care" and "medical care" are not the same. Define each.
Name and/or Organization
Rogan consulting
Community
Patient
Patient Group
Patient
Submitted
6/29/21 14:51
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the opportunities?
Best available estimates indicate that only 15-20% of "accepted" practices have been validated by RCTs, raising urgent questions about actual effectiveness and safety. Historical evidence indicates that half of such unproven practices will, when tested rigorously, be found to be ineffective or harmful. The highest priority for clinical research must be identifying inadequately validated procedures and subjecting them to properly designed and run RCTs. This strategy can both minimize/avoid waste of resources AND improve outcomes. Mark W. Ketterer, PhD, ABPP Herrera-Perez D, Haslam A, Crain T, Gill J, Livingston C, Kaestner V, Hayes M, Morgan D, Cifu AS & Prasad V. (2019). A comprehensive review of randomized clinical trials in three medical journals reveals 396 medical reversals. eLife doi:https://doi.org/10.7554/eLife.45183. Evans HT, Chalmers I & Gasziou J. (2011). Testing Treatments: Better Research for Better Healthcare, Second Edition. London: Pinter & Martin. Fuchs VR. (2014). Critiquing U.S. Healthcare. JAMA doi:10.1001/jama.2014.14114. Ioannidis JPA. (2005). Contradicted and initially stronger effects in highly cited clinical research. Journal of the American Medical Association 294:218-228. Lenzer J. (2017). The Danger Within Us. NYC: Little, Brown. Ketterer MW. (2019). Cochrane’s Brake: Randomized Controlled Trials and the Doctor’s Pen. Researchgate. doi:10.13140/RG.2.2.20553.90723. Mulcahy AW, Merrell K & Mehotra A. (2020). Payment for services rendered – updating Medicare’s valuation of procedures. NEJM 382(4):303-305. Prasad V et al. (2012). Reversals of established medical practices: evidence to abandon ship. JAMA 307(1):37-38. Prasad V. (2013). Why randomized controlled trials are necessary to accept new practices: 2 world views. Mayo Clin Proceedings 88(10):1046-1050. Prasad VK & Cifu AS. (2015). Ending Medical Reversal: Improving Outcomes, Saving Lives. Baltimore: Johns Hopkins University Press. Prasad V, Cifu A & Ioanniddis JPA. (2012). Reversals of established medical practices: evidence to abandon ship. JAMA 307(1):37-38. Prasad VK, Gall V & Cifu AS. (2011). The frequency of medical reversal. Arch Int Med 171(18):1675-1676. Prasad VK, Vandross A, Toomey C et al. (2013). A decade of reversal: an analysis of 146 contradicted medical practices. Mayo Clin Proceedings 88(8): 790-798. Rettig RA, Jacobson PD, Fahrquahr CM & Aubry WM. (2007). False Hope: Bone Marrow Transplantation for Breast Cancer. NYC: Oxford University Press. Wennberg JE. (2010). Tracking Medicine: A Researcher’s Quest to Understand Health Care. Oxford: Oxford University Press
Name and/or Organization
Mark W. Ketterer, PhD
Community
Stakeholder
Stakeholder Community
Health Researcher
Submitted
6/28/21 21:37
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What are the challenges?
CER is not an appropriate methodology for increasing evidence for existing interventions and emerging innovations in health.
Increase Evidence for Existing Interventions and Emerging Innovations in Health: What does success look like?
There is no CER framework to evaluate emerging innovations in health. There are frameworks in implementation science but they are generic and would need to be highly tailored for PCOR evaluation. CER is not an appropriate methodology to develop an evaluation framework for PCOR.
Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research: What are the challenges?
CER is not an appropriate methodology to evaluate enhancements to infrastructure.
Advance the Science of Dissemination, Implementation, and Health Communication: What are the challenges?
CER is not an appropriate methodology for implementation and dissemination studies. There is a very rich methods literature in implementation science with standard methods and evaluation models that are not compatible with CER.
Advance the Science of Dissemination, Implementation, and Health Communication: What is PCORI’s unique role or contribution?
PCORI will need to expand considerably beyond CER methods if they truly want to advance implementation for PCOR. Consider convening a panel of experts in implementation science to learn what our methods are.
Advance the Science of Dissemination, Implementation, and Health Communication: What does success look like?
CER is not an appropriate methodology for many of these studies. In fact, dissemination and implementation are two different fields with different methods. Health communication has its own literature and methods and typically do not use CER.
Achieve Health Equity: What does success look like?
CER is not an appropriate methodology for many of these studies.
Accelerate Progress Toward an Integrated Learning Health System: What are the challenges?
CER is not an appropriate methodology for many of these studies.
Accelerate Progress Toward an Integrated Learning Health System: What does success look like?
CER is not an appropriate methodology for many of these studies.
For the full set of National Priorities: What other comments do you have?
CER is not an appropriate methodology for many of these studies. PCORI will need to expand its methods repertoire considerably to do adequate justice to the questions in the national priorities. Consider convening expert advisory panels in each area to advise on appropriate research methods to solicit in applications.
Name and/or Organization
Anonymous
Community
Stakeholder
Stakeholder Community
Health Researcher
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.
Image
