A Randomized Study of How Physicians Interpret Research Funding Disclosures

被引:139
作者
Kesselheim, Aaron S. [1 ,2 ,3 ]
Robertson, Christopher T. [3 ,5 ]
Myers, Jessica A. [1 ,2 ]
Rose, Susannah L. [3 ,6 ]
Gillet, Victoria [1 ,2 ]
Ross, Kathryn M. [7 ]
Glynn, Robert J. [1 ,2 ]
Joffe, Steven [4 ]
Avorn, Jerry [1 ,2 ]
机构
[1] Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, Dept Med, Boston, MA 02120 USA
[2] Harvard Univ, Sch Med, Boston, MA USA
[3] Harvard Univ, Edmond J Safra Ctr Eth, Cambridge, MA 02138 USA
[4] Dana Farber Canc Inst, Boston, MA 02115 USA
[5] Univ Arizona, James E Rogers Coll Law, Tucson, AZ USA
[6] Cleveland Clin, Dept Bioeth, Cleveland, OH USA
[7] Amer Board Internal Med, Philadelphia, PA USA
基金
美国医疗保健研究与质量局;
关键词
CONFLICTS-OF-INTEREST; BIOMEDICAL-RESEARCH; CLINICAL-TRIALS; VENOUS THROMBOEMBOLISM; INDUSTRY RELATIONSHIPS; ROFECOXIB LITIGATION; FINANCIAL TIES; DOCUMENTS; CLINICALTRIALS.GOV; ROSUVASTATIN;
D O I
10.1056/NEJMsa1202397
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1119 / 1127
页数:9
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