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Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study

BACKGROUND: Cluster randomized trials (CRTs) and individually randomized trials (IRTs) are often pooled together in meta-analyses (MAs) of randomized trials. However, the potential systematic differences in intervention effect estimates between these two trial types has never been investigated. Ther...

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Autores principales: Leyrat, Clémence, Caille, Agnès, Eldridge, Sandra, Kerry, Sally, Dechartres, Agnès, Giraudeau, Bruno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469309/
https://www.ncbi.nlm.nih.gov/pubmed/30418549
http://dx.doi.org/10.1093/ije/dyy229
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author Leyrat, Clémence
Caille, Agnès
Eldridge, Sandra
Kerry, Sally
Dechartres, Agnès
Giraudeau, Bruno
author_facet Leyrat, Clémence
Caille, Agnès
Eldridge, Sandra
Kerry, Sally
Dechartres, Agnès
Giraudeau, Bruno
author_sort Leyrat, Clémence
collection PubMed
description BACKGROUND: Cluster randomized trials (CRTs) and individually randomized trials (IRTs) are often pooled together in meta-analyses (MAs) of randomized trials. However, the potential systematic differences in intervention effect estimates between these two trial types has never been investigated. Therefore, we conducted a meta-epidemiological study comparing intervention effect estimates between CRTs and IRTs. METHODS: All Cochrane MAs including at least one CRT and one IRT, published between 1 January 2010 and 31 December 2014, were included. For each MA, we estimated a ratio of odds ratios (ROR) for binary outcomes or a difference of standardized differences (DSMD) for continuous outcomes, where less than 1 (or 0, respectively) indicated a greater intervention effect estimate with CRTs. RESULTS: Among 1301 screened reviews, we selected 121 MAs, of which 76 had a binary outcome and 45 had a continuous outcome. For binary outcomes, intervention effect estimates did not differ between CRTs and IRTs [ROR 1.00, 95% confidence interval (0.93 to 1.08)]. Subgroup and adjusted analyses led to consistent results. For continuous outcomes, the DSMD was 0.13 (0.06 to 0.19). It was lower for MAs with a pharmacological intervention [-0.03, (-0.12 to 0.07)], an objective outcome [0.05, (-0.08 to 0.17)] or after adjusting for trial size [0.06, (-0.01 to 0.15)]. CONCLUSION: For binary outcomes, CRTs and IRTs can safely be pooled in MAs because of an absence of systematic differences between effect estimates. For continuous outcomes, the results were less clear although accounting for trial sample sizes led to a non-significant difference. More research is needed for continuous outcomes and, meanwhile, MAs should be completed with subgroup analyses (CRTs vs IRTs).
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spelling pubmed-64693092019-04-22 Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study Leyrat, Clémence Caille, Agnès Eldridge, Sandra Kerry, Sally Dechartres, Agnès Giraudeau, Bruno Int J Epidemiol Miscellaneous BACKGROUND: Cluster randomized trials (CRTs) and individually randomized trials (IRTs) are often pooled together in meta-analyses (MAs) of randomized trials. However, the potential systematic differences in intervention effect estimates between these two trial types has never been investigated. Therefore, we conducted a meta-epidemiological study comparing intervention effect estimates between CRTs and IRTs. METHODS: All Cochrane MAs including at least one CRT and one IRT, published between 1 January 2010 and 31 December 2014, were included. For each MA, we estimated a ratio of odds ratios (ROR) for binary outcomes or a difference of standardized differences (DSMD) for continuous outcomes, where less than 1 (or 0, respectively) indicated a greater intervention effect estimate with CRTs. RESULTS: Among 1301 screened reviews, we selected 121 MAs, of which 76 had a binary outcome and 45 had a continuous outcome. For binary outcomes, intervention effect estimates did not differ between CRTs and IRTs [ROR 1.00, 95% confidence interval (0.93 to 1.08)]. Subgroup and adjusted analyses led to consistent results. For continuous outcomes, the DSMD was 0.13 (0.06 to 0.19). It was lower for MAs with a pharmacological intervention [-0.03, (-0.12 to 0.07)], an objective outcome [0.05, (-0.08 to 0.17)] or after adjusting for trial size [0.06, (-0.01 to 0.15)]. CONCLUSION: For binary outcomes, CRTs and IRTs can safely be pooled in MAs because of an absence of systematic differences between effect estimates. For continuous outcomes, the results were less clear although accounting for trial sample sizes led to a non-significant difference. More research is needed for continuous outcomes and, meanwhile, MAs should be completed with subgroup analyses (CRTs vs IRTs). Oxford University Press 2019-04 2018-11-09 /pmc/articles/PMC6469309/ /pubmed/30418549 http://dx.doi.org/10.1093/ije/dyy229 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of the International Epidemiological Association. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Miscellaneous
Leyrat, Clémence
Caille, Agnès
Eldridge, Sandra
Kerry, Sally
Dechartres, Agnès
Giraudeau, Bruno
Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
title Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
title_full Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
title_fullStr Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
title_full_unstemmed Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
title_short Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
title_sort intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study
topic Miscellaneous
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469309/
https://www.ncbi.nlm.nih.gov/pubmed/30418549
http://dx.doi.org/10.1093/ije/dyy229
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