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Past Opportunities to Provide Input
- Patient-Centered Economic Outcomes Landscape (2023-2024)
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- 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)
- Past Opportunities to Provide Input
Diabetes is a chronic condition that, while treatable and manageable with proper care, can have serious negative effects on quality and length of life if left unaddressed. More than half of Hispanic and Latino adults in the United States will develop type 2 diabetes in their lifetime.
Even so, most research on telehealth programs to treat type 2 diabetes has not tailored technologies and interventions specifically to fit the needs of the most affected or underserved groups, such as Hispanic or Latino adults. By studying the use of diabetes telemanagement, which allows patients to track their vital signs and share information with their healthcare team through a smart device, a PCORI-funded study is aiming to fill in some of the gaps in attention and care for Hispanic and Latino adults living with type 2 diabetes.
Research Done Differently®
As the leading funder of patient-centered comparative clinical effectiveness research (CER) in the United States, PCORI is dedicated to producing and promoting evidence-based information through the research it funds so patients and those who care for them can make the best-informed healthcare decisions that reflect their desired health outcomes. Our process of Research Done Differently® ensures that all relevant and interested patients and caregivers are active participants and have a seat at the table throughout the research process, rather than being consulted briefly to check a box. Patients are part of the teams designing and executing and then sharing results from each patient-centered CER study or related project PCORI funds.
Such is the case with the PCORI-funded Culturally Congruent Latino-Adapted Telemonitoring in Underrepresented Adults with Type 2 Diabetes (CULTURA-DM2) trial, underway from researchers at The Feinstein Institutes for Medical Research along with the American Diabetes Association (ADA), studying the use of diabetes telemanagement in this community. The project team includes a Community Advisory Board and Patient Advisory and Provider Panel Committee. Over the course of eight months of planning, interested and involved participants engaged in focus groups and structured interviews and discussions on how best to use telemanagement to serve Hispanic and Latino adults with type 2 diabetes. Additionally, a one-month pilot program was conducted with 12 patients whose feedback was used to further adapt and refine the program. Insights from this feasibility period informed major decisions in study design, from handling recruitment and informed consent for maximized participation, to ensuring intervention components were useable and acceptable to the community. Through its community-based participatory approach, the study has involved patients and other interested parties who may not have been considered as participants before.
Preliminary results indicate that patients who are telemanaged by a program that has been adapted for cultural congruence tend to have very high adherence, have significantly lower HbA1c and systolic and diastolic blood pressure, and are more likely to meet ADA guidelines.
“These results are incredibly exciting; this is the first time cultural tailoring of a telemonitoring intervention has been studied exclusively in Hispanic and Latino patients with type 2 diabetes,” said Renee Pekmezaris, Ph.D., professor at The Feinstein Institutes for Medical Research, senior vice president of strategic grant acquisition at Northwell Health and principal investigator of the study. “Our qualitative data indicate that patients love the program. As one patient put it: ‘La diabetes no me controla a mi, sino que yo tengo que controlar la diabetes (diabetes does not control me; in fact, I have to control diabetes).'"
“These results are incredibly exciting; this is the first time cultural tailoring of a telemonitoring intervention has been studied exclusively in Hispanic and Latino patients with type 2 diabetes.”Renee Pekmezaris, Ph.D. Principal investigator; Professor, Feinstein Institutes for Medical Research; Senior vice president of Strategic Grant Acquisition, Northwell Health
Robert Gabbay, M.D., Ph.D., chief scientific and medical officer for the ADA, adds: “Hispanic and Latino adults are both more likely to be diagnosed with diabetes than non-Hispanic White adults and more likely to face diabetes complications. Studies like these provide models of care that can bridge the gap in the health inequities that exist for some people living with diabetes. The reported changes in A1c and blood pressure are clinically significant and have the potential to decrease the risk of diabetes complications over time.”
Indeed, the CULTURA-DM2 trial shows promise in providing support in determining which treatment option might work best for Hispanic and Latino adults living with diabetes, as a strong, patient-centered base has now been laid.
Diabetes is just one of many health concerns in the United States that disproportionality affects some populations over others. Health inequities like this cannot be truly addressed or prevented if there is not equitable representation and authority from members of the affected populations in research striving for solutions. Patient-centered CER study designs ensure an investment in more patient-centered research results – and, ultimately, in more patient-centered health care.