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Cited by 1,049Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAdvanced Causal Inference Techniques

The DOI matches its Crossref record; 40 of the 41 references it cites were found in a registry or an index.

Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials

Savović, Jelena, Jones, Hayley E., Altman, Douglas G., Harris, Ross J., Jüni, Peter, Pildal, Julie, Als-Nielsen, Bodil, Balk, Ethan M., Gluud, Christian, Gluud, Lise Lotte, Ioannidis, John P.A., Schulz, Kenneth F., Beynon, Rebecca, Welton, Nicky J., Wood, Lesley, Moher, David, Deeks, Jonathan J., Sterne, Jonathan A.C.·2012·Annals of Internal Medicine
DOI 10.7326/0003-4819-157-6-201209180-00537
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Abstract

Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear (vs. adequate) random-sequence generation (ratio of odds ratios, 0.89 [95% credible interval {CrI}, 0.82 to 0.96]) and with inadequate or unclear (vs. adequate) allocation concealment (ratio of odds ratios, 0.93 [CrI, 0.87 to 0.99]). Lack of or unclear double-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 [CrI, 0.79 to 0.96]), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 [CrI, 0.02 to 0.30]). For each characteristic, average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes.

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Metadata

Authors
Savović, J., Jones, H. E., Altman, D. G., Harris, R. J., Jüni, P., Pildal, J., Als-Nielsen, B., Balk, E. M., Gluud, C., Gluud, L. L., Ioannidis, J. P. A., Schulz, K. F., Beynon, R., Welton, N. J., Wood, L., Moher, D., Deeks, J. J., & Sterne, J. A. C.
Affiliations
University of Bern (CH)
ORCID
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2012-09-18
Volume
157
Issue
6
Pages
429-438
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/0003-4819-157-6-201209180-00537
OpenAlex
W1964502734
Semantic Scholar
5667b851bbf788508a249be0a5243029fcf25bdd
Cited by
1,049
References
41
Citations by year
2026: 21 · 2025: 44 · 2024: 51 · 2023: 44 · 2022: 50 · 2021: 68 · 2020: 67 · 2019: 84 · 2018: 99 · 2017: 100 · 2016: 93 · 2015: 112 · 2014: 113 · 2013: 87 · 2012: 9
FWCI
115.35
Type
journal article
Language
en
Open access
closed
Licence
www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • BORIS (University Library Bern) (submittedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
  • Bristol Research (University of Bristol) (submittedVersion)
Funders
National Institute for Health and Care Research (NF-SI-0611-10168)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords
trial design bias, random sequence generation, allocation concealment, double blinding, between-trial heterogeneity, meta-epidemiology, subjective outcomes, mortality, trial reporting quality
MeSH terms
Bayes Theorem, Double-Blind Method, Humans, Research Design, Meta-Analysis as Topic, Bias, Odds Ratio, Randomized Controlled Trials as Topic

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