Strategies to improve retention in randomised trials
- PMID: 33675536
- PMCID: PMC8092429
- DOI: 10.1002/14651858.MR000032.pub3
Strategies to improve retention in randomised trials
Abstract
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.
Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
Two of the review authors (ST and GR) are authors on two of the eligible studies (Bailey 2013; Treweek 2020a). There are no other conflicts to declare.
Figures
Comment in
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Cochrane in CORR: Strategies to Improve Retention in Randomised Trials.Clin Orthop Relat Res. 2022 Jan 1;480(1):23-28. doi: 10.1097/CORR.0000000000002028. Clin Orthop Relat Res. 2022. PMID: 34699387 Free PMC article. No abstract available.
References
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Poling 2006 {published data only}
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- Poling J, Oliveto A, Petry N, Sofuoglu M, Gonsai K, Gonzalez G, et al. Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained population. Archives of General Psychiatry 2006;63:219-28. - PubMed
Price 2019 {published data only}
Puffer 2004 {published data only}
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- Puffer S, Porthouse J, Birks Y, Morton V, Torgerson D. Increasing response rates to postal questionnaires: a randomised trial of variations in design. Journal of Health Services Research and Policy 2004;9(4):213?7. - PubMed
Rhoades 1998 {published data only}
Roberts 2000 {published data only}
Rodgers 2019a {published data only}
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- Rodgers S, Sbizzera I, Cockayne S, Fairhurst C, Lamb SE, Vernon W, et al. A study update newsletter or Post-it® note did not increase postal questionnaire response rates in a falls prevention trial: an embedded randomised factorial trial. F1000Research 2019;7:1083. [DOI: 10.12688/f1000research.14591.2] - DOI - PMC - PubMed
Rodgers 2019b {published data only}
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- Rodgers M, Meisel Z, Wiebe D, Crits-Christoph P, Rhodes KV. Wireless participant incentives using reloadable bank cards to increase clinical trial retention with abused women drinkers: a natural experiment. Journal of Interpersonal Violence 2019;34(13):2774-96. [DOI: 10.1177/0886260516662849] - DOI - PMC - PubMed
Rolfson 2011 {published data only}
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- Rolfson O, Salomonsson R, Dahlberg LE, Garellick G. Internet-based follow-up questionnaire for measuring patient-reported outcome after total hip replacement surgery?reliability and response rate. Value in Health 2011;14(2):316-21. [DOI: 10.1016/j.jval.2010.08.004 ] - PubMed
Sano 2013 {published data only}
Schmitz 2005 {published data only}
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- Schmitz J, Sayre S, Stotts A, Rothfleisch J, Mooney M. Medication compliance during a smoking cessation clinical trial: a brief intervention using MEMS feedback. Journal of Behavioral Medicine 2005;28(2):139-47. - PubMed
Shulman 2019 {published data only}
Smeeth 2001ab {published data only}
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- Smeeth L, Fletcher AE, Stirling S, Nunes M, Breeze E, Ng E, et al. Randomised comparison of three methods of administering a screening questionnaire to elderly people: findings from the MRC trial of the assessment and management of older people in the community. BMJ 2001;323(7326):1403. - PMC - PubMed
Smith 2015 {published data only}
Stoner 1998 {published data only}
Svoboda 2001 {published and unpublished data}
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- Svoboda P. A comparison of two questionnaires for assessing outcome after head injury. Personal email communication from P Edwards in April 2010.
Tariq 2019 {published data only}
Tassopoulos 2007 {published data only}
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- Tassopoulos C. The challenges of follow-up in a multi-centre randomised controlled trial. Clinical Trials 2007;4:371-455.
Trevena 2006 {published data only}
von Allmen 2019 {published data only}
Wagstaff 2019 {published data only}
Wensing 2005 {published data only}
Weston 2017 {published data only}
Wood 2015 {published data only}
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- Wood J, Bruhn H, Cook JA, McDonald A, Norrie J, Watson AJ. PTU-225 Strategies to improve response rates to patient reported outcome measures in a surgical rct. Gut 2015;64:A161-2. [DOI: 10.1136/gutjnl-2015-309861.340] - DOI
Wood 2017 {published data only}
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- Wood J, Cook JA, Hudson J, McDonald A, Bruhn H, Watson AJ. Do higher monetary incentives improve response rates part-way through a randomised control trial? Trials 2017;18(Suppl 1):P65. [DOI: 10.1186/1745-6215-16-S2-P123 ]
Wu 1997 {published and unpublished data}
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- Wu AW, Jacobson DL, Berzon RA, Revicki DA, Horst C, Fichtenbaum CJ, et al. The effect of mode of administration on medical outcomes study health ratings and EuroQol scores in AIDS. Quality of Life Research 1997;6(1):3-10. - PubMed
References to studies awaiting assessment
Letley 2000 {published data only}
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- Letley L, Garratt A. Questionnaire length and internal reliability: a randomised study. In: Society for Social Medicine 43rd Annual Scientific Meeting; 2000 6-8 Sept; Norwich. 2000.
Sutherland 1996 {published data only}
References to ongoing studies
SWAT #100 {unpublished data only}
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- O'Neill L, Knapp P, Doyle S, Guinan E, Hussey J. SWAT 100: Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding of a randomised trial. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog.... - PMC - PubMed
SWAT #105 {unpublished data only}
-
- Hynes S, Dwyer C, Joyce R. SWAT 105: Effects of a patient-designed-and-informed participant information sheet versus a standard, researcher-designed information sheet on recruitment to a randomised trial. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #107 {unpublished data only}
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- Shiely F. SWAT 107: Effects of a multi-trial programmable animation platform on the efficiency and success of pre-screening and subsequent recruitment to a randomised trial. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #109 {unpublished data only}
-
- Parker A, Brealey S, Sharma HK, Welch C, Keding A, Flett L, Hunkins D, Witts J, McDaid C. SWAT 109: The effectiveness of a text message reminder which participants can respond to, compared with a?no reply? text message on questionnaire response rates. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT#110 {unpublished data only}
-
- Ooms A. SWAT 110: Printing the primary outcomE on Pink PapER versus standard paper to increase participant engagement to postal questionnaires (PEPPER). https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT#112 {unpublished data only}
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- Woodford J & von Essen L. SWAT 112: Effects on recruitment of a personalised compared with a standard study invitation letter. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #119 {unpublished data only}
-
- Arundel C, Chetter I, Fairhurst C, Joshi K, McCaffery J, Mott A, Wilkinson J. SWAT 119: Effects on retention of giving trial participants a thank you card following each study visit.. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #121 {unpublished data only}
-
- Dhanjal G. SWAT 121: What are the effects on retention and follow-up of courtesy telephone calls versus postcards to trial participants following enrolment? https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #51 {unpublished data only}
-
- Agus A. SWAT 51: Promoting group identity to improve questionnaire return rate. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #54 {unpublished data only}
-
- Anand R. SWAT 54: Giving trial participants a thank you note or card after each study visit. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #63 {unpublished data only}
-
- Azuara-Blanco A & Clarke M. SWAT 63: Does local radio and social media advertisement increase recruitment? https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #79 {unpublished data only}
-
- Backhouse M, Torgerson D, Parker A, Cockayne S. SWAT 79: Effect of birthday cards with or without nudge on retention and data completion rates in trials involving children. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #81 {unpublished data only}
-
- BenSaaud A, Tawfick W, Jordan F. SWAT 81: A Telephone Reminder to Enhance Adherence to Interventions in Randomised Trials. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog.... - PubMed
SWAT #82 {published data only}
-
- Treweek S, Gillies K, Innes K, MacLennan G. SWAT 82: Sending Christmas cards to trial participants to improve retention.. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog.... - PMC - PubMed
SWAT #86 {unpublished data only}
-
- Sutton C, Cotterill S, Forshaw, D Rhodes S, Hammond A. SWAT 86: Advance notification of trial participants before outcome data collection to improve retention. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #87 {unpublished data only}
-
- Hopewell S, Cureton L, Greenall G. SWAT 87: Do participants complete the original or the reminder postal follow up questionnaire? https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #89 {unpublished data only}
-
- Starr K, McRae D, Gillies K, Cooper C, Wolfe A. SWAT 89: Including a theoretically informed leaflet in a participant takehome pack of questionnaires to increase response rate. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #92 {unpublished data only}
-
- Tew G, Tilbrook H, Paul S, Howe L, Parker A, Bell K. SWAT 92: Pen incentive to enhance retention in a randomised trial. https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
SWAT #97 {unpublished data only}
-
- kKnapp P. SWAT 97: TRECA (TRials Engagement in Children and Adolescents). https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodolog....
Additional references
Bensaaud 2020
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- Bensaaud A, Gibson I, Jones J, Flaherty G, Sultan S, Tawfick W, Jordan F. A telephone reminder to enhance adherence to interventions in cardiovascular randomized trials: a protocol for a study within a trial (SWAT). Journal of Evidence-based Medicine 2020;13(1):81-4. [DOI: 10.1111/jebm.12375] - DOI - PubMed
Booker 2011
Brunsdon 2019
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- Brunsdon D, Biesty L, Brocklehurst P, Brueton V, Devane D, Elliott J, et al. What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study. Trials 2019;20(1):593. [DOI: 10.1186/s13063-019-3687-7] - DOI - PMC - PubMed
Chan 2013
Edwards 2009
Egger 1997
Fewtrell 2008
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Guyatt 2008
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Higgins 2008a
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Higgins 2008b
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- Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S, editors(s). Cochrane Handbook for Systematic Reviews of Interventions. Chichester: John Wiley & Sons, 2008:482-529.
Hoffman 2014
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Hollis 1999
Madurasinghe 2016
Moher 2010
Murray 2009
PROMETHEUS
RevMan 2012 [Computer program]
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- The Nordic Cochrane Centre, The Cochrane Collaboration Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
Robotham 2016
Santesso 2020
Schulz 2002
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Skea 2019
Sterne 2008
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SWAT
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- SWAT repository. www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearc... Accessed on 1 December 2020.
Treweek 2018
Treweek 2020b
Trial Forge
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- Trial Forge - A systematic way to improve trial efficiency. wwww.trialforge.org.
Walsh 2014
Walsh 2015
Walters 2016
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- Walters SJ, Bonacho Dos Anjos Henriques-Cadby I, Bortolami O, Flight L, Hind D, Jacques RM, et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open 2017;7:3. [DOI: 10.1136/bmjopen-2016-015276] - DOI - PMC - PubMed
References to other published versions of this review
Brueton 2011
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- Brueton VC, Rait G, Tierney J, Meredith S, Darbyshire J, Harding S, et al. Strategies to reduce attrition in randomised trials. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No: MR000032. [DOI: 10.1002/14651858.MR000032] - DOI
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