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

Patricia Healy, Sandra Galvin, Paula R. Williamson, Shaun Treweek, Caroline Whiting, Beccy Maeso, Christopher Bray, Peter Brocklehurst, Mary Clarke Moloney, Abdel Douiri, Carrol Gamble, Heidi Rebecca Gardner, Derick Mitchell, Derek Stewart, Joan Jordan, Martin O'Donnell, Mike Clarke, Sue H. Pavitt, Eleanor Woodford Guegan, Amanda Blatch-Jones & 3 others Valerie Smith, Hannah Reay, Declan Devane

Research output: Contribution to journalArticle

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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.
Original languageEnglish
Article number147
Pages (from-to)1-12
Number of pages12
JournalTrials
Volume19
DOIs
Publication statusPublished - 1 Mar 2018

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Keywords

  • Recruitment challenges
  • Participation in randomised trials
  • Survey
  • Priority setting partnership
  • James Lind Alliance
  • Trial methodology

Cite this

Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy (Prioritising Recruitment in Randomised Trials) Study. / 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 Rebecca; Mitchell, Derick ; Stewart, Derek; Jordan, Joan; O'Donnell, Martin; Clarke, Mike; Pavitt, Sue H.; Guegan, Eleanor Woodford ; Blatch-Jones, Amanda ; Smith, Valerie ; Reay, Hannah ; Devane, Declan.

In: Trials, Vol. 19, 147, 01.03.2018, p. 1-12.

Research output: Contribution to journalArticle

Healy, P, Galvin, S, Williamson, PR, Treweek, S, Whiting, C, Maeso, B, Bray, C, Brocklehurst, P, Moloney, MC, Douiri, A, Gamble, C, Gardner, HR, Mitchell, D, Stewart, D, Jordan, J, O'Donnell, M, Clarke, M, Pavitt, SH, Guegan, EW, Blatch-Jones, A, Smith, V, Reay, H & Devane, D 2018, 'Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy (Prioritising Recruitment in Randomised Trials) Study', Trials, vol. 19, 147, pp. 1-12. https://doi.org/10.1186/s13063-018-2544-4
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 Rebecca ; Mitchell, Derick ; Stewart, Derek ; Jordan, Joan ; O'Donnell, Martin ; Clarke, Mike ; Pavitt, Sue H. ; Guegan, Eleanor Woodford ; Blatch-Jones, Amanda ; Smith, Valerie ; Reay, Hannah ; Devane, Declan. / Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy (Prioritising Recruitment in Randomised Trials) Study. In: Trials. 2018 ; Vol. 19. pp. 1-12.
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abstract = "BackgroundDespite 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.MethodsThis 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.ResultsA 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.ConclusionThe 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.",
keywords = "Recruitment challenges, Participation in randomised trials, Survey, Priority setting partnership, James Lind Alliance, Trial methodology",
author = "Patricia Healy and Sandra Galvin and Williamson, {Paula R.} and Shaun Treweek and Caroline Whiting and Beccy Maeso and Christopher Bray and Peter Brocklehurst and Moloney, {Mary Clarke} and Abdel Douiri and Carrol Gamble and Gardner, {Heidi Rebecca} and Derick Mitchell and Derek Stewart and Joan Jordan and Martin O'Donnell and Mike Clarke and Pavitt, {Sue H.} and Guegan, {Eleanor Woodford} and Amanda Blatch-Jones and Valerie Smith and Hannah Reay and Declan Devane",
note = "Acknowledgements The authors would like to thank all contributing individuals who completed the surveys and the people that participated in the final prioritisation workshop in Birmingham. Funding This research was funded under the Health Research Board Knowledge Exchange and Dissemination Scheme Awards 2015, through the Health Research Board -Trials Methodology Research Network (HRB-TMRN) and with the support of the James Lind Alliance throughout this PSP. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.",
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month = "3",
day = "1",
doi = "10.1186/s13063-018-2544-4",
language = "English",
volume = "19",
pages = "1--12",
journal = "Trials",
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TY - JOUR

T1 - Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - The PRioRiTy (Prioritising Recruitment in Randomised Trials) Study

AU - Healy, Patricia

AU - Galvin, Sandra

AU - Williamson, Paula R.

AU - Treweek, Shaun

AU - Whiting, Caroline

AU - Maeso, Beccy

AU - Bray, Christopher

AU - Brocklehurst, Peter

AU - Moloney, Mary Clarke

AU - Douiri, Abdel

AU - Gamble, Carrol

AU - Gardner, Heidi Rebecca

AU - Mitchell, Derick

AU - Stewart, Derek

AU - Jordan, Joan

AU - O'Donnell, Martin

AU - Clarke, Mike

AU - Pavitt, Sue H.

AU - Guegan, Eleanor Woodford

AU - Blatch-Jones, Amanda

AU - Smith, Valerie

AU - Reay, Hannah

AU - Devane, Declan

N1 - Acknowledgements The authors would like to thank all contributing individuals who completed the surveys and the people that participated in the final prioritisation workshop in Birmingham. Funding This research was funded under the Health Research Board Knowledge Exchange and Dissemination Scheme Awards 2015, through the Health Research Board -Trials Methodology Research Network (HRB-TMRN) and with the support of the James Lind Alliance throughout this PSP. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.

PY - 2018/3/1

Y1 - 2018/3/1

N2 - BackgroundDespite 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.MethodsThis 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.ResultsA 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.ConclusionThe 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.

AB - BackgroundDespite 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.MethodsThis 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.ResultsA 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.ConclusionThe 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.

KW - Recruitment challenges

KW - Participation in randomised trials

KW - Survey

KW - Priority setting partnership

KW - James Lind Alliance

KW - Trial methodology

U2 - 10.1186/s13063-018-2544-4

DO - 10.1186/s13063-018-2544-4

M3 - Article

VL - 19

SP - 1

EP - 12

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 147

ER -