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Updated: Aug 14, 2026

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
Reporting clinical trial results to inform providers, payers, and consumers
Rodney A Hayward1, David M Kent, Sandeep Vijan
1Department of Veterans Affairs (VA) Center for Practice Management and Outcomes Research, VA Ann Arbor Healthcare System, University of Michigan, USA. rhayward@umich.edu
Abstract:
Results of randomized clinical trials are the preferred "evidence" for establishing the benefits and safety of medical treatments. We present evidence suggesting that the conventional approach to reporting clinical trials has fundamental flaws that can result in overlooking identifiable subgroups harmed by a treatment while underestimating benefits to others. A risk-stratified approach can dramatically reduce the chances of such errors. Since professional and economic incentives reward advocating treatments for as broad a patient population as possible, we suggest that payers and regulatory bodies might need to act to motivate prompt, routine adoption of risk-stratified assessments of medical treatments' safety and benefits.
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