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

Authors :
Mayo-Wilson E
Li T
Fusco N
Bertizzolo L
Canner JK
Cowley T
Doshi P
Ehmsen J
Gresham G
Guo N
Haythornthwaite JA
Heyward J
Hong H
Pham D
Payne JL
Rosman L
Stuart EA
Suarez-Cuervo C
Tolbert E
Twose C
Vedula S
Dickersin K
Source :
Journal of clinical epidemiology [J Clin Epidemiol] 2017 Nov; Vol. 91, pp. 95-110. Date of Electronic Publication: 2017 Aug 24.
Publication Year :
2017

Abstract

Objectives: The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs).<br />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]).<br />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).<br />Conclusions: Disagreements across data sources affect the effect size, statistical significance, and interpretation of trials and meta-analyses.<br /> (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1878-5921
Volume :
91
Database :
MEDLINE
Journal :
Journal of clinical epidemiology
Publication Type :
Academic Journal
Accession number :
28842290
Full Text :
https://doi.org/10.1016/j.jclinepi.2017.07.014