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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
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- Peer-Review Process Comments (2014)
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- Past Opportunities to Provide Input
WASHINGTON, DC—The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved an award slate with $32.7 million for a large, multi-phase comparative clinical effectiveness research (CER) study to compare how well colonoscopy versus stool-based testing works for monitoring patients ages 70 and older at low risk of developing colorectal cancer.
The Board also approved $61.3 million for a slate of several infrastructure projects that will support the activities of eight Clinical Research Networks (CRNs) to implement the next phase of PCORnet®, the National Patient-Centered Clinical Research Network. In addition, the Board approved funding for an award slate containing a $2.1 million project to support the implementation of a combined online weight management and population health management support program shown to be effective in a PCORI-funded study.
“People make critical health decisions every day, decisions that ultimately are better informed with the evidence produced by research and projects PCORI funds across the U.S.,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “The awards announced today exemplify the range of activities PCORI supports to help patients, caregivers, clinicians and stakeholders make these decisions in support of better health and health care.”
$32.7 Million for Colorectal Cancer Screening Study
Regular follow-up colonoscopies are commonly recommended for people who have had colon polyps identified. However, adults over 70 with a history of small, low-risk polyps may benefit little from repeated colonoscopies due to increased risks of complications from the procedure associated with age, co-morbidities and potentially limited life expectancy.
With PCORI funding, a research team at Dartmouth Institute for Health Policy & Clinical Practice and Kaiser Permanente Northern California Division of Research will recruit up to 15,310 English- and Spanish-speaking patients ages 70-82 across a network of sites in the U.S. Patients will be randomly assigned to surveillance with either colonoscopy or annual fecal immunochemical test, a widely used, noninvasive screening option for those at average risk for colorectal cancer. Researchers will monitor patients’ outcomes for five years during the study.
This funding award was made under a new PCORI funding opportunity that supports large, multiphase CER studies designed to fill critical gaps in evidence. Under this funding opportunity, PCORI awarded $135 million in July for a slate of five studies focused on suicide prevention methods, anesthesia, blood pressure control, diabetes medications and palliative care for cancer patients.
$61.3 Million to Implement Phase 3 of PCORnet
The Board’s approval of $61.3 million will enable eight PCORnet CRNs to optimize their infrastructure resources and capacities to support PCORnet in its third phase as a national resource for conducting rapid, efficient, patient-centered research.
A “network of networks” funded by PCORI, PCORnet involves many major health systems across the nation and provides access to health data, research expertise and patient insights to foster more efficient patient-centered clinical research. PCORnet has been critical to supporting COVID-19 research funded by the National Institutes of Health and surveillance funded by the Centers for Disease Control and Prevention.
The CRNs will work to ensure the continuity and maximization of resources and operations developed in prior phases of this national network. Key activities include increasing the diversity of patient populations and care settings within PCORnet, efficiently implementing studies addressing PCORI’s strategic research priorities, strengthening patient and stakeholder engagement, and providing high-quality data to power studies.
The CRNs awarded funding are:
- Accelerating Data Value Across a National Community Health Center (ADVANCE) Collaborative
- Greater Plains Collaborative (GPC)
- INSIGHT Clinical Research Network
- OneFlorida+ Clinical Research Consortium
- PaTH Network
- Research Action for Health Network (REACHnet)
- The Stakeholders, Technology and Researchers (STAR) Clinical Research Network
$2.1 Million Supports Implementing Weight Loss Study Results
With the approval of $2.1 million in funding for implementation, researchers at Brigham and Women’s Hospital will adapt an online weight loss intervention, shown in PCORI-funded research to help patients achieve significant weight loss, to support a broader population of patients with overweight or obesity in a variety of care settings.
Details of these and other studies approved for funding by PCORI’s Board today are on the website. All funding awards were approved pending a business and programmatic review by PCORI staff and the issuance of formal award contracts. With these latest awards, PCORI has invested about $3.3 billion to fund patient-centered CER and support other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.
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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.