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. 2012 Sep 20;367(12):1119-27.
doi: 10.1056/NEJMsa1202397.

A Randomized Study of How Physicians Interpret Research Funding Disclosures

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Free PMC article

A Randomized Study of How Physicians Interpret Research Funding Disclosures

Aaron S Kesselheim et al. N Engl J Med. .
Free PMC article

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.

Figures

Figure 1
Figure 1. Association between Methodologic Rigor and Physicians’ Perceptions of Hypothetical New-Drug Trials
Panel A shows the physicians’ perception of a trial’s level of rigor, Panel B their confidence in the results, and Panel C their willingness to prescribe the drug being studied. For each survey question, using Likert-scale responses, we determined the likelihood that the physician would assign a higher score to trials randomly assigned to have low or high rigor, as compared with trials with medium rigor, with adjustment for the disclosure variable. Open circles designate the point estimates for the odds ratios, with the 95% confidence intervals (CI) indicated by the vertical lines.
Figure 2
Figure 2. Association between Disclosure Variable and Physicians’ Perceptions of Hypothetical New-Drug Trials
Panel A shows the physicians’ perception of a trial’s level of rigor, Panel B their confidence in the results, and Panel C their willingness to prescribe the drug being studied. For each survey question, using Likert-scale responses, we determined the likelihood that the physician would assign a higher score to trials randomly assigned to funding by a pharmaceutical company, as compared with trials having no funding source listed and trials described as being funded by the National Institutes of Health (NIH), adjusting for the methodologic rigor variable. Open circles designate the point estimates for the odds ratios, with the 95% confidence intervals indicated by the vertical lines.

Comment in

  • Believe the data.
    Drazen JM. Drazen JM. N Engl J Med. 2012 Sep 20;367(12):1152-3. doi: 10.1056/NEJMe1207121. N Engl J Med. 2012. PMID: 22992081 No abstract available.
  • How physicians interpret research funding disclosures.
    Fonseca R. Fonseca R. N Engl J Med. 2012 Dec 13;367(24):2358; author reply 2360. doi: 10.1056/NEJMc1212744. N Engl J Med. 2012. PMID: 23234526 No abstract available.
  • How physicians interpret research funding disclosures.
    Feuerstein JD, Leffler DA, Cheifetz AS. Feuerstein JD, et al. N Engl J Med. 2012 Dec 13;367(24):2358-9; author reply 2360. doi: 10.1056/NEJMc1212744. N Engl J Med. 2012. PMID: 23234527 No abstract available.
  • Do We Care? Should We?
    Reider B. Reider B. Am J Sports Med. 2016 Apr;44(4):835-7. doi: 10.1177/0363546516639299. Am J Sports Med. 2016. PMID: 27034330 No abstract available.

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