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Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics

Walker, Kate F.; Turzanski, Julie; Whitham, Diane; Montgomery, Alan; Duley, Lelia

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Authors

KATE WALKER Kate.Walker@nottingham.ac.uk
Clinical Professor

Julie Turzanski

Diane Whitham

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

Lelia Duley



Abstract

© 2018 The Author(s). Background: Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collecting high-quality, complete data in a timely manner. Collecting and monitoring easily accessible data relevant to performance of sites has the potential to improve trial management efficiency. The aim of this systematic review was to identify metrics that have either been proposed or used for monitoring site performance in multicentre trials. Methods: We searched the Cochrane Library, five biomedical bibliographic databases (CINAHL, EMBASE, Medline, PsychINFO and SCOPUS) and Google Scholar for studies describing ways of monitoring or measuring individual site performance in multicentre randomised trials. Records identified were screened for eligibility. For included studies, data on study content were extracted independently by two reviewers, and disagreements resolved by discussion. Results: After removing duplicate citations, we identified 3188 records. Of these, 21 were eligible for inclusion and yielded 117 performance metrics. The median number of metrics reported per paper was 8, range 1-16. Metrics broadly fell into six categories: site potential; recruitment; retention; data collection; trial conduct and trial safety. Conclusions: This review identifies a list of metrics to monitor site performance within multicentre randomised trials. Those that would be easy to collect, and for which monitoring might trigger actions to mitigate problems at site level, merit further evaluation.

Citation

Walker, K. F., Turzanski, J., Whitham, D., Montgomery, A., & Duley, L. (2018). Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics. Trials, 19, Article 562. https://doi.org/10.1186/s13063-018-2941-8

Journal Article Type Article
Acceptance Date Sep 26, 2018
Online Publication Date Oct 16, 2018
Publication Date Oct 16, 2018
Deposit Date Jan 30, 2019
Publicly Available Date Jan 30, 2019
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 19
Article Number 562
DOI https://doi.org/10.1186/s13063-018-2941-8
Keywords Medicine (miscellaneous); Pharmacology (medical)
Public URL https://nottingham-repository.worktribe.com/output/1506814
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2941-8

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