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.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
15 Oct 2019
Historique:
received: 20 02 2019
accepted: 29 08 2019
entrez: 17 10 2019
pubmed: 17 10 2019
medline: 16 4 2020
Statut: epublish

Résumé

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. 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. 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 . 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.

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 31615577
doi: 10.1186/s13063-019-3687-7
pii: 10.1186/s13063-019-3687-7
pmc: PMC6794792
doi:

Types de publication

Consensus Development Conference Journal Article Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

593

Subventions

Organisme : Medical Research Council Methodology Fellowship
ID : MR/L01193X/1
Organisme : Scottish Government Health and Social Care Directorate
ID : CGA/17/49
Organisme : Medical Research Council
ID : MR/L01193X/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/K024310/1
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : HSRU1
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : CGA/17/49
Pays : United Kingdom

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Auteurs

Dan Brunsdon (D)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Linda Biesty (L)

School of Nursing and Midwifery, Evidence Synthesis Ireland, NUI Galway, Galway, Ireland.

Peter Brocklehurst (P)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.

Valerie Brueton (V)

Department of Adult Nursing, Kings College London, London, UK.

Declan Devane (D)

Health Research Board-Trials Methodology Research Network, Galway, Ireland.

Jim Elliott (J)

Health Research Authority, National Health Service, London, UK.

Sandra Galvin (S)

Health Research Board-Trials Methodology Research Network, Galway, Ireland.

Carrol Gamble (C)

Department of Biostatistics, University of Liverpool, Liverpool, UK.

Heidi Gardner (H)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Patricia Healy (P)

School of Nursing and Midwifery, Evidence Synthesis Ireland, NUI Galway, Galway, Ireland.

Kerenza Hood (K)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Joan Jordan (J)

European Patients' Academy, London, UK.

Doris Lanz (D)

Women's Health Research Unit, Queen Mary University of London, London, UK.

Beccy Maeso (B)

James Lind Alliance, Wessex Institute, University of Southampton, Southampton, UK.

Amanda Roberts (A)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Imogen Skene (I)

Barts Health NHS Trust, London, UK.

Irene Soulsby (I)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Derek Stewart (D)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

David Torgerson (D)

York Trials Unit, University of York, York, UK.

Shaun Treweek (S)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Caroline Whiting (C)

James Lind Alliance, Wessex Institute, University of Southampton, Southampton, UK.

Sharon Wren (S)

Action on Hearing Loss, British Deaf Association, Deafscotland, Glasgow, UK.

Andrew Worrall (A)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Katie Gillies (K)

Health Services Research Unit, University of Aberdeen, Aberdeen, UK. k.gillies@abdn.ac.uk.

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Classifications MeSH