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Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study
Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study

Background: Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology. Methods: This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop. Results: A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was "How can randomised trials become part of routine care and best utilise current clinical care pathways?" The top 10 research questions can be viewed at www.priorityresearch.ie. Conclusion: The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

James Lind Alliance, Participation in randomised trials, Priority setting partnership, Recruitment challenges, Survey, Trial methodology
1745-6215
Healy, Patricia
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Galvin, Sandra
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Williamson, Paula R.
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Treweek, Shaun
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Whiting, Caroline
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Maeso, Beccy
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Bray, Christopher
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Brocklehurst, Peter
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Moloney, Mary Clarke
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Douiri, Abdel
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Gamble, Carrol
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Gardner, Heidi R.
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Mitchell, Derick
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Stewart, Derek
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Jordan, Joan
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O'Donnell, Martin
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Clarke, Mike
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Pavitt, Sue H.
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Guegan, Eleanor Woodford
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Blatch-Jones, Amanda
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Smith, Valerie
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Reay, Hannah
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Devane, Declan
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Healy, Patricia
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Galvin, Sandra
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Williamson, Paula R.
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Treweek, Shaun
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Whiting, Caroline
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Maeso, Beccy
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Bray, Christopher
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Brocklehurst, Peter
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Moloney, Mary Clarke
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Douiri, Abdel
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Gamble, Carrol
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Gardner, Heidi R.
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Mitchell, Derick
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Stewart, Derek
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Jordan, Joan
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O'Donnell, Martin
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Clarke, Mike
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Pavitt, Sue H.
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Guegan, Eleanor Woodford
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Blatch-Jones, Amanda
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Smith, Valerie
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Reay, Hannah
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Devane, Declan
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Healy, Patricia, Galvin, Sandra, Williamson, Paula R., Treweek, Shaun, Whiting, Caroline, Maeso, Beccy, Bray, Christopher, Brocklehurst, Peter, Moloney, Mary Clarke, Douiri, Abdel, Gamble, Carrol, Gardner, Heidi R., Mitchell, Derick, Stewart, Derek, Jordan, Joan, O'Donnell, Martin, Clarke, Mike, Pavitt, Sue H., Guegan, Eleanor Woodford, Blatch-Jones, Amanda, Smith, Valerie, Reay, Hannah and Devane, Declan (2018) Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. Trials, 19 (1). (doi:10.1186/s13063-018-2544-4).

Record type: Article

Abstract

Background: Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology. Methods: This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop. Results: A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was "How can randomised trials become part of routine care and best utilise current clinical care pathways?" The top 10 research questions can be viewed at www.priorityresearch.ie. Conclusion: The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

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Accepted/In Press date: 13 February 2018
e-pub ahead of print date: 1 March 2018
Keywords: James Lind Alliance, Participation in randomised trials, Priority setting partnership, Recruitment challenges, Survey, Trial methodology

Identifiers

Local EPrints ID: 418739
URI: https://eprints.soton.ac.uk/id/eprint/418739
ISSN: 1745-6215
PURE UUID: 6bdc3919-e24b-46b1-8074-12731fe66a4e
ORCID for Eleanor Woodford Guegan: ORCID iD orcid.org/0000-0001-7225-6249
ORCID for Amanda Blatch-Jones: ORCID iD orcid.org/0000-0002-1486-5561

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Date deposited: 21 Mar 2018 17:30
Last modified: 19 Nov 2019 01:49

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Contributors

Author: Patricia Healy
Author: Sandra Galvin
Author: Paula R. Williamson
Author: Shaun Treweek
Author: Caroline Whiting
Author: Beccy Maeso
Author: Christopher Bray
Author: Peter Brocklehurst
Author: Mary Clarke Moloney
Author: Abdel Douiri
Author: Carrol Gamble
Author: Heidi R. Gardner
Author: Derick Mitchell
Author: Derek Stewart
Author: Joan Jordan
Author: Martin O'Donnell
Author: Mike Clarke
Author: Sue H. Pavitt
Author: Eleanor Woodford Guegan ORCID iD
Author: Valerie Smith
Author: Hannah Reay
Author: Declan Devane

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