Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review

Elizabeth L Turner; Alyssa C Platt; John A Gallis; Kaitlin Tetreault; Christina Easter; Joanne E McKenzie; Stephen Nash; Andrew B Forbes; Karla Hemming; CRT Binary Outcome Reporting Group

doi:10.1016/S2214-109X(21)00200-X

Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review

Elizabeth L Turner^* (Corresponding Author), Alyssa C Platt, John A Gallis, Kaitlin Tetreault, Christina Easter, Joanne E McKenzie, Stephen Nash, Andrew B Forbes, Karla Hemming, CRT Binary Outcome Reporting Group

^*Corresponding author for this work

Health Services Research Unit (HSRU)

Research output: Contribution to journal › Article › peer-review

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Abstract

Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.

Original language	English
Pages (from-to)	e1163-e1168
Number of pages	6
Journal	The Lancet Global Health
Volume	9
Issue number	8
Early online date	21 Jul 2021
DOIs	https://doi.org/10.1016/S2214-109X(21)00200-X
Publication status	Published - 31 Aug 2021

Bibliographical note

Acknowledgments

We received no funding specifically for this systematic review. ELT is funded in part by awards R01-AI141444 from the National Institute of Allergy and Infectious Diseases and R01-MH120649 from the US National Institute of Mental Health; both Institutes are part of the National Institutes of Health (NIH). JAG and ACP's support of this project was made possible (in part) by grant number UL1TR002553 from the National Center for Advancing Translational Sciences of the NIH, and the NIH Roadmap for Medical Research. JEM is supported by an Australian National Health and Medical Research Council Career Development Fellowship (APP1143429). SN was supported by an award that is jointly funded by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement, and part of the EDCTP2 programme supported by the European Union (grant reference MR/R010161/1). ABF acknowledges funding support from the National Health and Medical Research Council of Australia (grant ID 1183303). KH is funded by a National Institute for Health Research Senior Research Fellowship SRF-2017-10-002. The contents of the research included in this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of any of the funders. The research contributed by all authors of this manuscript are independent of their funders. Specifically, the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We wish to thank the three reviewers for their insightful comments and constructive feedback.

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© 2021 The Author(s). Published by Elsevier Ltd.Under a Creative Commons license. https://creativecommons.org/licenses/by-nc-nd/4.0/
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Turner, E. L., Platt, A. C., Gallis, J. A., Tetreault, K., Easter, C., McKenzie, J. E., Nash, S., Forbes, A. B., Hemming, K., & CRT Binary Outcome Reporting Group (2021). Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review. The Lancet Global Health, 9(8), e1163-e1168. https://doi.org/10.1016/S2214-109X(21)00200-X

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title = "Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review",

abstract = "Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.",

author = "Turner, {Elizabeth L} and Platt, {Alyssa C} and Gallis, {John A} and Kaitlin Tetreault and Christina Easter and McKenzie, {Joanne E} and Stephen Nash and Forbes, {Andrew B} and Karla Hemming and {CRT Binary Outcome Reporting Group} and Christine Adrion and Naseerah Akooji and Hannah Bensoussane and Aneel Bhangu and Jon Bishop and Bernadeta Bridgwood and Eric Budgell and Agn{\`e}s Caille and Michael Campbell and Shiwei Cao and Chan, {Claire Louise} and Versha Cheed and Michelle Collinson and Andrew Copas and Dixon, {Stephanie N} and Sandra Eldridge and Forster, {Alice S} and Alicia Gill and Bruno Giraudeau and Alan Girling and James Glasbey and Beatriz Goulao and Grantham, {Kelsey L} and Simon Hackett and Thomas Hamborg and Kelly Handley and Monica Harding and Pollyanna Hardy and Hewitt, {Catherine A} and Richard Hooper and Natalie Ives and Kirsty James and Jarvis, {Christopher I} and Ben Jones and Kahan, {Brennan C} and Mona Kanaan and Jessica Kasza and Lindsay Kendall and Caroline Kristunas and Kristie Kusibab and Hui-Jie Lee",

note = "Acknowledgments We received no funding specifically for this systematic review. ELT is funded in part by awards R01-AI141444 from the National Institute of Allergy and Infectious Diseases and R01-MH120649 from the US National Institute of Mental Health; both Institutes are part of the National Institutes of Health (NIH). JAG and ACP's support of this project was made possible (in part) by grant number UL1TR002553 from the National Center for Advancing Translational Sciences of the NIH, and the NIH Roadmap for Medical Research. JEM is supported by an Australian National Health and Medical Research Council Career Development Fellowship (APP1143429). SN was supported by an award that is jointly funded by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement, and part of the EDCTP2 programme supported by the European Union (grant reference MR/R010161/1). ABF acknowledges funding support from the National Health and Medical Research Council of Australia (grant ID 1183303). KH is funded by a National Institute for Health Research Senior Research Fellowship SRF-2017-10-002. The contents of the research included in this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of any of the funders. The research contributed by all authors of this manuscript are independent of their funders. Specifically, the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. We wish to thank the three reviewers for their insightful comments and constructive feedback. ",

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AU - Easter, Christina

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AU - Forbes, Andrew B

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AU - Kusibab, Kristie

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AB - Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.

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DO - 10.1016/S2214-109X(21)00200-X

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SP - e1163-e1168

JO - The Lancet Global Health

JF - The Lancet Global Health

IS - 8

ER -

Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review

Abstract

Bibliographical note

UN SDGs

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