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J Clin Epidemiol. 2016 Sep;77:24-37. doi: 10.1016/j.jclinepi.2016.04.005. Epub 2016 Apr 29.

Empirical evaluation of which trial characteristics are associated with treatment effect estimates.

Author information

1
Centre de Recherche Epidémiologie et Statistique, INSERM U1153, Team METHODS, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France; Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, 1 place du parvis Notre Dame, 75004 Paris, France; Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, 15 rue de l'école de médecine, 75006 Paris, France; Cochrane France, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France. Electronic address: agnes.dechartres@htd.aphp.fr.
2
Centre de Recherche Epidémiologie et Statistique, INSERM U1153, Team METHODS, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France; Cochrane France, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France; Department of Epidemiology, Mailman School of Public Health, Columbia University, 722 West 168th Street, 10032 New York, NY, USA.
3
Centre de Recherche Epidémiologie et Statistique, INSERM U1153, Team METHODS, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France; Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, 1 place du parvis Notre Dame, 75004 Paris, France.
4
Centre de Recherche Epidémiologie et Statistique, INSERM U1153, Team METHODS, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France; Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, 1 place du parvis Notre Dame, 75004 Paris, France; Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, 15 rue de l'école de médecine, 75006 Paris, France; Cochrane France, Hôpital Hôtel-Dieu, 1 place du parvis Notre Dame, 75004 Paris, France; Department of Epidemiology, Mailman School of Public Health, Columbia University, 722 West 168th Street, 10032 New York, NY, USA.

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.

KEYWORDS:

Bias; Meta-analysis; Meta-epidemiology; Methods; Randomized controlled trial; Systematic review

PMID:
27140444
DOI:
10.1016/j.jclinepi.2016.04.005
[Indexed for MEDLINE]

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