Literature DB >> 16284031

Reporting clinical trial results to inform providers, payers, and consumers.

Rodney A Hayward1, David M Kent, Sandeep Vijan, Timothy P Hofer.   

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.

Entities:  

Keywords:  Biomedical and Behavioral Research

Mesh:

Year:  2005        PMID: 16284031     DOI: 10.1377/hlthaff.24.6.1571

Source DB:  PubMed          Journal:  Health Aff (Millwood)        ISSN: 0278-2715            Impact factor:   6.301


  32 in total

1.  Facility-level variation in potentially inappropriate prescribing for older veterans.

Authors:  Walid F Gellad; Chester B Good; Megan E Amuan; Zachary A Marcum; Joseph T Hanlon; Mary Jo V Pugh
Journal:  J Am Geriatr Soc       Date:  2012-06-21       Impact factor: 5.562

Review 2.  Making performance indicators work: experiences of US Veterans Health Administration.

Authors:  Eve A Kerr; Barbara Fleming
Journal:  BMJ       Date:  2007-11-10

3.  The relative merits of population-based and targeted prevention strategies.

Authors:  Donna M Zulman; Sandeep Vijan; Gilbert S Omenn; Rodney A Hayward
Journal:  Milbank Q       Date:  2008-12       Impact factor: 4.911

4.  Who can respond to treatment? Identifying patient characteristics related to heterogeneity of treatment effects.

Authors:  Sherrie H Kaplan; John Billimek; Dara H Sorkin; Quyen Ngo-Metzger; Sheldon Greenfield
Journal:  Med Care       Date:  2010-06       Impact factor: 2.983

Review 5.  Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects.

Authors:  David M Kent; Ewout Steyerberg; David van Klaveren
Journal:  BMJ       Date:  2018-12-10

6.  Does medication adherence following a copayment increase differ by disease burden?

Authors:  Virginia Wang; Chuan-Fen Liu; Christopher L Bryson; Nancy D Sharp; Matthew L Maciejewski
Journal:  Health Serv Res       Date:  2011-06-20       Impact factor: 3.402

7.  A Systematic Assessment of the Surviving Sepsis Campaign's Evidence Supporting the Care of Patients with Severe Sepsis on the Wards.

Authors:  Andrew J Odden; Sushant Govindan; Jamie Sheth; Theodore J Iwashyna
Journal:  Ann Am Thorac Soc       Date:  2015-06

8.  Implications of Heterogeneity of Treatment Effect for Reporting and Analysis of Randomized Trials in Critical Care.

Authors:  Theodore J Iwashyna; James F Burke; Jeremy B Sussman; Hallie C Prescott; Rodney A Hayward; Derek C Angus
Journal:  Am J Respir Crit Care Med       Date:  2015-11-01       Impact factor: 21.405

9.  The effect of prone positioning in acute respiratory distress syndrome or acute lung injury: a meta-analysis. Areas of uncertainty and recommendations for research.

Authors:  Fekri Abroug; Lamia Ouanes-Besbes; Souheil Elatrous; Laurent Brochard
Journal:  Intensive Care Med       Date:  2008-03-19       Impact factor: 17.440

10.  Dealing with heterogeneity of treatment effects: is the literature up to the challenge?

Authors:  Nicole B Gabler; Naihua Duan; Diana Liao; Joann G Elmore; Theodore G Ganiats; Richard L Kravitz
Journal:  Trials       Date:  2009-06-19       Impact factor: 2.279

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