The Use and Reporting of the Cross-Over Study Design in Clinical Trials and Systematic Reviews: A Systematic Assessment

Nolan, Sarah Jane ORCID: 0000-0001-9988-2709, Hambleton, Ian and Dwan, Kerry (2016) The Use and Reporting of the Cross-Over Study Design in Clinical Trials and Systematic Reviews: A Systematic Assessment. PLOS ONE, 11 (7). e0159014-.

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Abstract

<h4>Background</h4>Systematic reviews of treatment interventions in stable or chronic conditions often require the synthesis of clinical trials with a cross-over design. Previous work has indicated that methodology for analysing cross-over data is inadequate in trial reports and in systematic reviews assessing trials with this design.<h4>Objective</h4>We assessed systematic review methodology for synthesising cross-over trials among Cochrane Cystic Fibrosis and Genetic Disorders Group reviews published to July 2015, and assessed the quality of reporting among the cross-over trials included in these reviews.<h4>Methodology</h4>We performed data extraction of methodology and reporting in reviews, trials identified and trials included within reviews.<h4>Principal findings</h4>We reviewed a total of 142 Cochrane systematic reviews including 53 reviews which synthesised evidence from 218 cross-over trials. Thirty-three (63%) Cochrane reviews described a clear and appropriate method for the inclusion of cross-over data, and of these 19 (56%) used the same method to analyse results. 145 cross-over trials were described narratively or treated as parallel trials in reviews but in 30 (21%) of these trials data existed in the trial reports to account for the cross-over design. At the trial level, the analysis and presentation of results were often inappropriate or unclear, with only 69 (32%) trials presenting results that could be included in meta-analysis.<h4>Conclusions</h4>Despite development of accessible, technical guidance and training for Cochrane systematic reviewers, statistical analysis and reporting of cross-over data is inadequate at both the systematic review and the trial level. Plain language and practical guidance for the inclusion of cross-over data in meta-analysis would benefit systematic reviewers, who come from a wide range of health specialties. Minimum reporting standards for cross-over trials are needed.

Item Type:	Article
Uncontrolled Keywords:	Humans, Cystic Fibrosis, Cross-Over Studies, Clinical Trials as Topic
Depositing User:	Symplectic Admin
Date Deposited:	27 Oct 2016 11:30
Last Modified:	19 Jan 2023 07:27
DOI:	10.1371/journal.pone.0159014
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3004006