Strategies to improve retention in randomised trials.


Journal

The Cochrane database of systematic reviews
ISSN: 1469-493X
Titre abrégé: Cochrane Database Syst Rev
Pays: England
ID NLM: 100909747

Informations de publication

Date de publication:
06 03 2021
Historique:
entrez: 6 3 2021
pubmed: 7 3 2021
medline: 22 4 2021
Statut: epublish

Résumé

Poor retention of participants in randomised trials can lead to missing outcome data which can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to improve retention but few have been formally evaluated. To quantify the effect of strategies to improve retention of participants in randomised trials and to investigate if the effect varied by trial setting. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Scopus, PsycINFO, CINAHL, Web of Science Core Collection (SCI-expanded, SSCI, CPSI-S, CPCI-SSH and ESCI) either directly with a specified search strategy or indirectly through the ORRCA database. We also searched the SWAT repository to identify ongoing or recently completed retention trials. We did our most recent searches in January 2020. We included eligible randomised or quasi-randomised trials of evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. We extracted data on: the retention strategy being evaluated; location of study; host trial setting; method of randomisation; numbers and proportions in each intervention and comparator group. We used a risk difference (RD) and 95% confidence interval (CI) to estimate the effectiveness of the strategies to improve retention. We assessed heterogeneity between trials. We applied GRADE to determine the certainty of the evidence within each comparison. We identified 70 eligible papers that reported data from 81 retention trials. We included 69 studies with more than 100,000 participants in the final meta-analyses, of which 67 studies evaluated interventions aimed at trial participants and two evaluated interventions aimed at trial staff involved in retention. All studies were in health care and most aimed to improve postal questionnaire response. Interventions were categorised into broad comparison groups: Data collection; Participants; Sites and site staff; Central study management; and Study design. These intervention groups consisted of 52 comparisons, none of which were supported by high-certainty evidence as determined by GRADE assessment. There were four comparisons presenting moderate-certainty evidence, three supporting retention (self-sampling kits, monetary reward together with reminder or prenotification and giving a pen at recruitment) and one reducing retention (inclusion of a diary with usual follow-up compared to usual follow-up alone). Of the remaining studies, 20 presented GRADE low-certainty evidence and 28 presented very low-certainty evidence. Our findings do provide a priority list for future replication studies, especially with regard to comparisons that currently rely on a single study. Most of the interventions we identified aimed to improve retention in the form of postal questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. None of the comparisons are supported by high-certainty evidence. Comparisons in the review where the evidence certainty could be improved with the addition of well-done studies should be the focus for future evaluations.

Sections du résumé

BACKGROUND
Poor retention of participants in randomised trials can lead to missing outcome data which can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to improve retention but few have been formally evaluated.
OBJECTIVES
To quantify the effect of strategies to improve retention of participants in randomised trials and to investigate if the effect varied by trial setting.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Scopus, PsycINFO, CINAHL, Web of Science Core Collection (SCI-expanded, SSCI, CPSI-S, CPCI-SSH and ESCI) either directly with a specified search strategy or indirectly through the ORRCA database. We also searched the SWAT repository to identify ongoing or recently completed retention trials. We did our most recent searches in January 2020.
SELECTION CRITERIA
We included eligible randomised or quasi-randomised trials of evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance.
DATA COLLECTION AND ANALYSIS
We extracted data on: the retention strategy being evaluated; location of study; host trial setting; method of randomisation; numbers and proportions in each intervention and comparator group. We used a risk difference (RD) and 95% confidence interval (CI) to estimate the effectiveness of the strategies to improve retention. We assessed heterogeneity between trials. We applied GRADE to determine the certainty of the evidence within each comparison.
MAIN RESULTS
We identified 70 eligible papers that reported data from 81 retention trials. We included 69 studies with more than 100,000 participants in the final meta-analyses, of which 67 studies evaluated interventions aimed at trial participants and two evaluated interventions aimed at trial staff involved in retention. All studies were in health care and most aimed to improve postal questionnaire response. Interventions were categorised into broad comparison groups: Data collection; Participants; Sites and site staff; Central study management; and Study design. These intervention groups consisted of 52 comparisons, none of which were supported by high-certainty evidence as determined by GRADE assessment. There were four comparisons presenting moderate-certainty evidence, three supporting retention (self-sampling kits, monetary reward together with reminder or prenotification and giving a pen at recruitment) and one reducing retention (inclusion of a diary with usual follow-up compared to usual follow-up alone). Of the remaining studies, 20 presented GRADE low-certainty evidence and 28 presented very low-certainty evidence. Our findings do provide a priority list for future replication studies, especially with regard to comparisons that currently rely on a single study.
AUTHORS' CONCLUSIONS
Most of the interventions we identified aimed to improve retention in the form of postal questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. None of the comparisons are supported by high-certainty evidence. Comparisons in the review where the evidence certainty could be improved with the addition of well-done studies should be the focus for future evaluations.

Identifiants

pubmed: 33675536
doi: 10.1002/14651858.MR000032.pub3
pmc: PMC8092429
doi:

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

MR000032

Subventions

Organisme : Chief Scientist Office
ID : HSRU1
Pays : United Kingdom

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Auteurs

Katie Gillies (K)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Anna Kearney (A)

Dept. of Health Data Science, University of Liverpool, Liverpool, UK.

Ciara Keenan (C)

Campbell UK & Ireland, Centre for Evidence and Social Innovation, Queen's University, Belfast, UK.

Shaun Treweek (S)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Jemma Hudson (J)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Valerie C Brueton (VC)

Department of Adult Nursing, Florence Nightingale Faculty of Nursing Midwifery and Palliative Care, King's College, London, UK.

Thomas Conway (T)

Clinical Research Facility Galway, National University of Ireland Galway, Galway, Ireland.

Andrew Hunter (A)

School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.

Louise Murphy (L)

School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.

Peter J Carr (PJ)

School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.

Greta Rait (G)

Research Department of Primary Care and Population Health, University College London, London, UK.

Paul Manson (P)

Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.

Magaly Aceves-Martins (M)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

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