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

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...

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Autores principales: Walker, Kate F., Turzanski, Julie, Whitham, Diane, Montgomery, Alan, Duley, Lelia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192157/
https://www.ncbi.nlm.nih.gov/pubmed/30326948
http://dx.doi.org/10.1186/s13063-018-2941-8
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author Walker, Kate F.
Turzanski, Julie
Whitham, Diane
Montgomery, Alan
Duley, Lelia
author_facet Walker, Kate F.
Turzanski, Julie
Whitham, Diane
Montgomery, Alan
Duley, Lelia
author_sort Walker, Kate F.
collection PubMed
description 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.
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spelling pubmed-61921572018-10-22 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 Trials Research 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. BioMed Central 2018-10-16 /pmc/articles/PMC6192157/ /pubmed/30326948 http://dx.doi.org/10.1186/s13063-018-2941-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Walker, Kate F.
Turzanski, Julie
Whitham, Diane
Montgomery, Alan
Duley, Lelia
Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
title Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
title_full Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
title_fullStr Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
title_full_unstemmed Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
title_short Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
title_sort monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192157/
https://www.ncbi.nlm.nih.gov/pubmed/30326948
http://dx.doi.org/10.1186/s13063-018-2941-8
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