title: Reporting clinical trial results to inform providers, payers, and consumers.
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.
authors.affiliation: Department of Veterans Affairs (VA) Center for Practice Management and Outcomes Research, VA Ann Arbor Healthcare System, University of Michigan, USA. rhayward@umich.edu
authors.forename: Rodney A
authors.initials: RA
authors.lastname: Hayward
authors.forename: David M
authors.initials: DM
authors.lastname: Kent
authors.forename: Sandeep
authors.initials: S
authors.lastname: Vijan
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Hofer
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D019300:Medical Errors / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D014481:United States