Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Oct 15;20(1):593.
doi: 10.1186/s13063-019-3687-7.

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

Dan Brunsdon  1 , Linda Biesty  2 , Peter Brocklehurst  3 , Valerie Brueton  4 , Declan Devane  5 , Jim Elliott  6 , Sandra Galvin  5 , Carrol Gamble  7 , Heidi Gardner  1 , Patricia Healy  2 , Kerenza Hood  8 , Joan Jordan  9 , Doris Lanz  10 , Beccy Maeso  11 , Amanda Roberts  1 , Imogen Skene  12 , Irene Soulsby  1 , Derek Stewart  1 , David Torgerson  13 , Shaun Treweek  1 , Caroline Whiting  11 , Sharon Wren  14 , Andrew Worrall  1 , Katie Gillies  15
Affiliations

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

Dan Brunsdon et al. Trials. .

Abstract

Background: One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders.

Methods: This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative, to support key stakeholders (researchers, patients, and the public) in jointly identifying and agreeing on priority research questions. There were three stages. (1) First an initial online survey was conducted consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure that they had not been answered by existing research. (2) An interim stage involved a further online survey where stakeholders were asked to select questions of key importance from the longlist. (3) A face-to-face consensus meeting was held, where key stakeholder representatives agreed on an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials.

Results: A total of 456 respondents yielded 2431 answers to six open-ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the Steering Group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting in which key stakeholder representatives prioritised the order. The 'Top 10' of these are reported in this paper. The number one ranked question was 'What motivates a participant's decision to complete a clinical trial?' The entire list will be available at www.priorityresearch.ie .

Conclusion: The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.

Keywords: James Lind Alliance; Participant retention; Participation in randomised trials; Patient and public involvement; Priority Setting Partnership; Retention challenges; Trials methodology.

PubMed Disclaimer

Conflict of interest statement

Professor Shaun Treweek is an Editor-in-Chief for Trials.

Figures

Fig. 1
Fig. 1
PRioRiTy II priority setting partnership process
See this image and copyright information in PMC

References

    1. Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014;15:32. doi: 10.1186/1745-6215-15-32. - DOI - PMC - PubMed
    1. Walsh M, Sackett D, Deveraux PJ. When RCT participants are lost to follow up. Why even a few can matter. Clin Trials. 2015;12:537–539. doi: 10.1177/1740774515597702. - DOI - PubMed
    1. Gillies K, Bower P, Elliott J, MacLennan G, Newlands RSN, Ogden M, Treweek SP, Wells M, Witham MD, Young B, Francis JJ. Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol. Trials. 2018;19:197. doi: 10.1186/s13063-018-2572-0. - DOI - PMC - PubMed
    1. Brueton VC, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev. 2013;12:MR000032. doi: 10.1002/14651858.MR000032.pub2. - DOI - PMC - PubMed
    1. Brueton VC, Stevenson F, Vale C, Tierney J, Meredith S, Harding S, Stenning S, Nazareth I, Rait G. Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews. BMJ Open. 2014;4(1):e003835. doi: 10.1136/bmjopen-2013-003835. - DOI - PMC - PubMed

Publication types

LinkOut - more resources