Empirical evaluation of which trial characteristics are associated with treatment effect estimates
Abstract
Objective Meta-epidemiological studies provide empirical evidence of trial characteristics associated with treatment effects. We aimed to evaluate methods used and characteristics associated with treatment effect in these studies.Study design and setting For this systematic review, we searched MEDLINE, Embase, Cochrane Methodology Register, Web of Science, and PROSPERO up to April 2015. We particularly assessed four key methodological components: constitution of the collection, clustering of trials within meta-analyses, heterogeneity assessment, and adjustment on meta-confounders. We also assessed trial characteristics evaluated and their association with treatment effect.Results We included 56 meta-epidemiological studies with data from 3,199 meta-analyses, 32 networks, and 21,468 trials. Thirty-two (58%) were published since 2010. Only 13 (23%) included all key methodological components. Overall, 58 trial characteristics were assessed. Allocation concealment and sequence generation were assessed in 22 (39%) and 17 (30%) meta-epidemiological studies, respectively, and trial size in 9 (16%). These characteristics were consistently associated with treatment effect estimates with larger effects in trials with inadequate sequence generation or allocation concealment or smaller trials.Conclusions Key methodological components (e.g., constitution of the collection) were frequently missing. Concerning trial characteristics evaluated, there was consistent evidence that allocation concealment, sequence generation, and trial size were associated with treatment effect.
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Trials without proper RCT design, that is, with inadequate concealment of treatment allocation or inadequate randomisation, tend to report higher effect sizes.
“Meta-epidemiological studies have shown that trials without proper RCT design, that is, with inadequate concealment of treatment allocation or inadequate randomisation, tend to report higher effect sizes.76”
Meta-epidemiological studies found little to no effect of blinding on treatment results among randomised trials, including a review of oral health trials.
“based on meta-epidemiological studies [22][23][24][25] that found little to no effect of blinding on treatment results among randomised trials (including a review of oral health trials 26 )”
From Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials (2023) · cites this paper as [24]
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Flagged first, then by citations
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Self-citationConsidering bias and conflicts of interest among the included studies
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Sources of Bias in Randomised Controlled Trials
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- Authors
- Dechartres, A., Trinquart, L., Faber, T., & Ravaud, P.
- Affiliations
- Inserm (FR)
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2016-09
- Volume
- 77
- Pages
- 24-37
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2344229133
- Cited by
- 85
- References
- 106
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 11 · 2023: 12 · 2022: 25 · 2021: 6 · 2020: 13 · 2019: 5 · 2018: 5 · 2017: 3 · 2016: 2
- FWCI
- 1.72
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- 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
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- meta-epidemiology, trial characteristics, treatment effect estimates, allocation concealment, sequence generation, trial size, meta-analysis, heterogeneity assessment
- MeSH terms
- Humans, Research Design, Epidemiologic Studies
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