Preprint: Please note that this article has not completed peer review.

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, Linda Biesty, Peter Brocklehurst, Valerie Brueton, Declan Devane, Jim Elliott, Sandra Galvin, Carrol Gamble, Heidi Gardner, Patricia Healy, Kerenza Hood, Joan Jordan, Doris Lanz, Beccy Maeso, Amanda Roberts, Imogen Skene, Irene Soulsby, Derek Stewart, David Torgerson, Shaun Treweek, Caroline Whiting, Sharon Wren, Andrew Worrall, Katie Gillies

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 public) in jointly identifying and agreeing priority research questions.

There were three stages

(i) An initial online survey 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 they had not been answered by existing research. (ii) An interim stage, which involved a further online survey where stakeholders were asked to select questions of key importance from the longlist.. (iii) A face-to-face consensus meeting, where key stakeholder representatives agreed an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials.

Results

456 respondents yielded 2,431 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 is 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
Trials methodology, Retention challenges, Participation in randomised trials, Participant retention, Priority setting partnership, James Lind Alliance, PPI

Figures

Background

Methods

Results

Discussion

Conclusions

Appendix

Declarations

List of Abbreviations

References

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Preprint: Please note that this article has not completed peer review.

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, Linda Biesty, Peter Brocklehurst, Valerie Brueton, Declan Devane, Jim Elliott, Sandra Galvin, Carrol Gamble, Heidi Gardner, Patricia Healy, Kerenza Hood, Joan Jordan, Doris Lanz, Beccy Maeso, Amanda Roberts, Imogen Skene, Irene Soulsby, Derek Stewart, David Torgerson, Shaun Treweek, Caroline Whiting, Sharon Wren, Andrew Worrall, Katie Gillies

STATUS: In Review

Comments: 0
PDF Downloads: 51
HTML Views: 504

Integrity Check:

  • Article

  • Peer Review Timeline

  • Related Articles

  • Comments

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 public) in jointly identifying and agreeing priority research questions.

There were three stages

(i) An initial online survey 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 they had not been answered by existing research. (ii) An interim stage, which involved a further online survey where stakeholders were asked to select questions of key importance from the longlist.. (iii) A face-to-face consensus meeting, where key stakeholder representatives agreed an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials.

Results

456 respondents yielded 2,431 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 is 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.

Figures

Background

Methods

Results

Discussion

Conclusions

Appendix

Declarations

List of Abbreviations

References

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