Patient-Centered Outcomes Research Institute-funded study will focus on older adults with low-risk polyps
By Sue Rochman
Researchers from the Kaiser Permanente Northern California Division of Research and The Dartmouth Institute for Health Policy & Clinical Practice have received a $32.7 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) for a large study that will compare the risks and benefits of an annual fecal immunochemical test (FIT) to colonoscopy for colorectal cancer screening in adults over 70 who have previously been diagnosed with small, low-risk polyps.
TR Levin, MD, research scientist, Division of Research, gastroenterologist, TPMG.
“Over time, we’ve come to understand that people with only 1-2 small polyps are really at very similar risk for colorectal cancer as people with no polyps,” said study co-leader Theodore R. Levin, MD, a research scientist at the Division of Research and a gastroenterologist with The Permanente Medical Group. “In addition, as people age, their risk of problems associated with colonoscopy increases. With this study, we hope to understand whether older people with small, low-risk polyps can safely opt to use the non-invasive FIT for surveillance.”
Colon polyps are lumps that develop in the lining of the colon. Most are harmless; but some may, over time, became cancers. Regular follow-up colonoscopies are recommended for people who have been diagnosed with a colon polyp. But some older adults may skip this follow-up because of the inconvenience and potential risks of the procedure. If this newly funded study shows follow-up FIT tests, which can be done at home, are similarly effective for cancer detection, it could create a new screening option for these older adults.
Levin will co-lead the 5-year study with Audrey Calderwood, MD, MS, a gastroenterologist at The Dartmouth Institute for Health Policy & Clinical Practice. The researchers will use a network of sites to enroll more than 15,000 English- and Spanish-speaking adults ages 70 to 82 throughout the country. Participants will be randomly assigned to receive either an annual FIT or colonoscopy.
Yi-Fen Irene Chen, MD, associate executive director, The Permanente Medical Group.
“We have an excellent colorectal cancer screening program, and the findings from this research will help us tailor it to more closely meet the needs of older adults with small, low-risk polyps —and help save lives,” said Yi-Fen Irene Chen, MD, associate executive director of The Permanente Medical Group.
The research was selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate proposals for funding. This process was carried out through a PCORI initiative to support large-scale, high-impact comparative effectiveness research trials in a multi-phase format allowing for testing and refinement of the study approach. The award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
“This study was selected based on its scientific merit and commitment to engaging patients in conducting a major research effort on colorectal cancer screening,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “The study has the potential to fill an important evidence gap relevant to a range of healthcare decision makers and help them better assess their care options. We look forward to following the study’s progress and working with this research team to share its results.”
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About the Kaiser Permanente Division of Research
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being, and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 600-plus staff is working on more than 450 epidemiological and health services research projects. For more information, visit divisionofresearch.kaiserpermanente.org or follow us @KPDOR.
About 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. For more information about PCORI’s funding, visit www.pcori.org.