Literature DB >> 22992075

A randomized study of how physicians interpret research funding disclosures.

Aaron S Kesselheim1, Christopher T Robertson, Jessica A Myers, Susannah L Rose, Victoria Gillet, Kathryn M Ross, Robert J Glynn, Steven Joffe, Jerry Avorn.   

Abstract

BACKGROUND: The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians' reactions to trials with a high, medium, or low level of methodologic rigor.
METHODS: We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had high, medium, or low methodologic rigor, and each report included one of three support disclosures: funding from a pharmaceutical company, NIH funding, or none. For both factors studied (rigor and funding), one of the three possible variations was randomly selected for inclusion in the abstracts. Follow-up questions assessed the physicians' impressions of the trials' rigor, their confidence in the results, and their willingness to prescribe the drugs.
RESULTS: The 269 respondents (53.5% response rate) perceived the level of study rigor accurately. Physicians reported that they would be less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio, 0.64; 95% confidence interval [CI], 0.46 to 0.89; P=0.008) and would be more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (odds ratio, 3.07; 95% CI, 2.18 to 4.32; P<0.001). Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (odds ratio, 0.63; 95% CI, 0.46 to 0.87; P=0.006), their confidence in the results (odds ratio, 0.71; 95% CI, 0.51 to 0.98; P=0.04), and their willingness to prescribe the hypothetical drugs (odds ratio, 0.68; 95% CI, 0.49 to 0.94; P=0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (odds ratio, 0.52; 95% CI, 0.37 to 0.71; P<0.001). These effects were consistent across all levels of methodologic rigor.
CONCLUSIONS: Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial's quality. These effects may influence the translation of clinical research into practice.

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Year:  2012        PMID: 22992075      PMCID: PMC3538846          DOI: 10.1056/NEJMsa1202397

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


  44 in total

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Authors:  Justin E Bekelman; Yan Li; Cary P Gross
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2.  Patient-Centered Outcomes Research Institute: the intersection of science and health care.

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3.  Toward more uniform conflict disclosures--the updated ICMJE conflict of interest reporting form.

Authors:  Jeffrey M Drazen; Peter W de Leeuw; Christine Laine; Cynthia Mulrow; Catherine D DeAngelis; Frank A Frizelle; Fiona Godlee; Charlotte Haug; Paul C Hébert; Astrid James; Sheldon Kotzin; Ana Marusic; Humberto Reyes; Jacob Rosenberg; Peush Sahni; Martin B Van der Weyden; Getu Zhaori
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4.  Industry-sponsored clinical research: a broken system.

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5.  The money blind: how to stop industry bias in biomedical science, without violating the First Amendment.

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6.  Failure to discount for conflict of interest when evaluating medical literature: a randomised trial of physicians.

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7.  The ClinicalTrials.gov results database--update and key issues.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Robert M Califf; Nicholas C Ide
Journal:  N Engl J Med       Date:  2011-03-03       Impact factor: 91.245

8.  Funding of US biomedical research, 2003-2008.

Authors:  E Ray Dorsey; Jason de Roulet; Joel P Thompson; Jason I Reminick; Ashley Thai; Zachary White-Stellato; Christopher A Beck; Benjamin P George; Hamilton Moses
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9.  Selective publication of antidepressant trials and its influence on apparent efficacy.

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10.  Do self- reported intentions predict clinicians' behaviour: a systematic review.

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  47 in total

Review 1.  Quality of reporting of randomized controlled trials published in Intensive Care Medicine from 2001 to 2010.

Authors:  Nicola Latronico; Marta Metelli; Maddalena Turin; Simone Piva; Frank A Rasulo; Cosetta Minelli
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2.  Conflicts of interest in research: looking out for number one means keeping the primary interest front and center.

Authors:  Paul L Romain
Journal:  Curr Rev Musculoskelet Med       Date:  2015-06

3.  Declaration and Handling of Conflicts of Interest in Guidelines: A Study of S1 Guidelines From German Specialist Societies From 2010-2013.

Authors:  Gisela Schott; Klaus Lieb; Jochem König; Bernd Mühlbauer; Wilhelm Niebling; Henry Pachl; Stephan Schmutz; Wolf-Dieter Ludwig
Journal:  Dtsch Arztebl Int       Date:  2015-06-26       Impact factor: 5.594

4.  Confirmation Bias as a Factor in Pharmacy Student Assessment of Research Study Quality.

Authors:  Donald R Miller; Stefanie J Jangula
Journal:  Am J Pharm Educ       Date:  2019-06       Impact factor: 2.047

5.  White paper: statement on conflicts of interest.

Authors:  Julian Bion; Massimo Antonelli; LLuis Blanch; J Randall Curtis; Christiane Druml; Bin Du; Flavia R Machado; Charles Gomersall; Christiane Hartog; Mitchell Levy; John Myburgh; Gordon Rubenfeld; Charles Sprung
Journal:  Intensive Care Med       Date:  2018-09-06       Impact factor: 17.440

6.  Judge the science, not the funding source.

Authors:  M Binks
Journal:  Int J Obes (Lond)       Date:  2014-03-18       Impact factor: 5.095

7.  Association Between Financial Conflicts of Interests and Supportive Opinions for Erectile Dysfunction Treatment.

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8.  Effect of physician disclosure of specialty bias on patient trust and treatment choice.

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Journal:  Account Res       Date:  2013       Impact factor: 2.622

Review 10.  Assessing cardiovascular drug safety for clinical decision-making.

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