A Tufts Medical Center research team at the Institute for Clinical Research and Health Policy Studies (ICRHPS) has been approved for a funding award by the Patient-Centered Outcomes Research Institute (PCORI) to develop a method for patient-centered enrollment in comparative effectiveness trials called Mathematical Equipoise. The study is one of 82 proposals recently approved for PCORI funding to advance the field of patient-centered comparative effectiveness research and provide patients with information that will help them make better-informed decisions about their care.
Harry P. Selker, MD, MSPH, Executive Director of ICRHPS and Dean of Tufts Clinical and Translational Science Institute (CTSI) will lead the research project at Tufts Medical Center's ICRHPS. The project, which grew out of an exploration of how to improve clinical effectiveness trials methods done by Tufts CTSI, will also involve CTSI. It will use data in electronic health records to apply Mathematical Equipoise to an important treatment for which there are no previous randomized clinical trials: total knee replacement (over 600,000 done in US yearly) versus non-surgical treatment for knee osteoarthritis. When the predicted outcomes are similar, the patient would be identified as a potential candidate for a comparative effectiveness randomized clinical trial. This method should enhance the number, scope, and impact of patient-centered comparative effectiveness trials.
"In comparative effectiveness research, randomized clinical trials (RCTs) are the gold standard of evidence," said Dr. Selker. "Mathematical Equipoise will improve patient-centered enrollment into comparative effectiveness RCTs, and will inform researchers of the types of RCTs that should be conducted in the future."
"Tufts Medical Center appreciates PCORI's commitment to, and support for, cutting-edge comparative effectiveness research," said Michael Wagner, MD, FACP, Interim President and CEO of Tufts Medical Center. "The work of the ICRHPS and Tufts CTSI will lead to better-focused research, with better outcomes for patients."
"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options," said PCORI Executive Director Joe Selby, MD, MPH. "We look forward to following the study's progress and working with Tufts Medical Center to share the results."
Dr. Selker's study and the other projects approved for funding by PCORI's Board of Governors were selected from 624 applications submitted to PCORI's funding announcements. All were recently selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria.
All awards are approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
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