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A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality
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Diaz-Ordaz, Karla , Froud, Robert J., Sheehan, Bart and Eldridge, Sandra (2013) A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality. BMC Medical Research Methodology, Volume 13 (Number 1). Article number 127. doi:10.1186/1471-2288-13-127
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Official URL: http://dx.doi.org/10.1186/1471-2288-13-127
Abstract
Background
Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality.
Methods
We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites.
Results
73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality.
Conclusions
Despite international attempts to improve methods in cluster randomised trials, important quality limitations remain amongst these trials in residential facilities. Statistician involvement on trial teams may be more effective in promoting quality than further journal endorsement of the CONSORT statement. Funding bodies and journals should promote statistician involvement and co-authorship in addition to adherence to CONSORT guidelines.
| Item Type: | Journal Article | ||||||||
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| Subjects: | H Social Sciences > HN Social history and conditions. Social problems. Social reform H Social Sciences > HV Social pathology. Social and public welfare |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Older people -- Institutional care , Old age homes, Older people -- Housing, Clinical trials, Cluster analysis | ||||||||
| Journal or Publication Title: | BMC Medical Research Methodology | ||||||||
| Publisher: | BioMed Central Ltd. | ||||||||
| ISSN: | 1471-2288 | ||||||||
| Official Date: | 22 October 2013 | ||||||||
| Dates: |
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| Date of first compliant deposit: | 28 December 2015 | ||||||||
| Volume: | Volume 13 | ||||||||
| Number: | Number 1 | ||||||||
| Article Number: | Article number 127 | ||||||||
| DOI: | 10.1186/1471-2288-13-127 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access | ||||||||
| Funder: | National Institute for Health Research (Great Britain) (NIHR) |
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