Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy

被引:77
作者
Mayo-Wilson, Evan [1 ]
Li, Tianjing [1 ]
Fusco, Nicole [1 ]
Bertizzolo, Lorenzo [1 ]
Canner, Joseph K. [2 ]
Cowley, Terrie [3 ]
Doshi, Peter [4 ]
Ehmsen, Jeffrey [5 ]
Gresham, Gillian [1 ]
Guo, Nan [1 ]
Haythomthwaite, Jennifer A. [6 ]
Heyward, James [1 ]
Hong, Hwanhee [7 ]
Pham, Diana [8 ]
Payne, Jennifer L. [9 ]
Rosman, Lori [10 ]
Stuart, Elizabeth A. [7 ]
Suarez-Cuervo, Catalina [8 ]
Tolbert, Elizabeth [11 ]
Twose, Claire [10 ]
Vedula, Swaroop [12 ]
Dickersin, Kay [1 ]
机构
[1] Johns Hopkins Univ, Dept Epidemiol, Bloomberg Sch Publ Hlth, 615 North Wolfe St, Baltimore, MD 21205 USA
[2] Johns Hopkins Univ, Sch Med, Dept Surg, 600 North Wolfe St, Baltimore, MD 21205 USA
[3] TMJ Assoc Ltd, POB 26770, Milwaukee, WI 53226 USA
[4] Univ Maryland, Pharmaceut Hlth Serv Res, Sch Pharm, 20 North Pine St, Baltimore, MD 21201 USA
[5] Johns Hopkins Univ, Sch Med, Dept Neurol Neuromuscular Med, 733 North Broadway, Baltimore, MD 21205 USA
[6] Johns Hopkins Univ, Sch Med, Dept Psychiat & Behav Sci, 5510 Nathan Shock Dr,Suite 100, Baltimore, MD 21224 USA
[7] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Mental Hlth, 624 N Broadway, Baltimore, MD 21205 USA
[8] Johns Hopkins Bloomberg Sch Publ Hlth, Dept Hlth Policy & Management, 624 North Broadway, Baltimore, MD 21205 USA
[9] Johns Hopkins Univ Hosp, Womens Mood Disorders Ctr, Dept Psychiat & Behav Sci, 550 North Broadway, Baltimore, MD 21205 USA
[10] Johns Hopkins Univ, Sch Med, Welch Med Lib, 2024 Bldg 1-213, Baltimore, MD 21287 USA
[11] Johns Hopkins Univ, Peabody Inst, 1 East Mt Vernon Pl, Baltimore, MD 21202 USA
[12] Johns Hopkins Univ, Whiting Sch Engn, Malone Ctr Engn Healthcare, Malone Hall,3400 N Charles St, Baltimore, MD 21218 USA
关键词
Systematic reviews; Meta-analysis; Clinical trials; Reporting bias; Selective outcome reporting; Risk of bias assessment; BONE MORPHOGENETIC PROTEIN-2; CENTERED OUTCOMES RESEARCH; CLINICAL-TRIALS; PUBLICATION BIAS; DATA-COLLECTION; METAANALYSIS; REGISTRATION; MANAGEMENT; PROTOCOL; UPDATE;
D O I
10.1016/j.jclinepi.2017.07.014
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objectives: The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs). Study Design and Setting: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and nonpublic sources (clinical study reports [CSRs] and individual participant data [IPD]). Results: We found 21 gabapentin RCTs (74 reports, 6 IPD) and 7 quetiapine RCTs (50 reports, 1 IPD); most were reported in journal articles (18/21 [86%] and 6/7 [86%], respectively). When available, CSRs contained the most trial design and risk of bias information. CSRs and IPD contained the most results. For the outcome domains "pain intensity" (gabapentin) and "depression" (quetiapine), we found single trials with 68 and 98 different meta-analyzable results, respectively; by purposefully selecting one meta-analyzable result for each RCT, we could change the overall result for pain intensity from effective (standardized mean difference [SMD] = -0.45; 95% confidence interval [CI]: -0.63 to -0.27) to ineffective (SMD = -0.06; 95% CI: -0.24 to 0.12). We could change the effect for depression from a medium effect (SMD = -0.55; 95% CI: -0.85 to -0.25) to a small effect (SMD = -0.26; 95% CI: -0.41 to -0.1). Conclusions: Disagreements across data sources affect the effect size, statistical significance, and interpretation of trials and meta:analyses. (C) 2017 The Authors. Published by Elsevier Inc.
引用
收藏
页码:95 / 110
页数:16
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