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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

BACKGROUND: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with pat...

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Autores principales: Scantlebury, Arabella, McDaid, Catriona, Brealey, Stephen, Cook, Elizabeth, Sharma, Hemant, Ranganathan, Arun, Adamson, Joy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285860/
https://www.ncbi.nlm.nih.gov/pubmed/34274006
http://dx.doi.org/10.1186/s13063-021-05420-4
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author Scantlebury, Arabella
McDaid, Catriona
Brealey, Stephen
Cook, Elizabeth
Sharma, Hemant
Ranganathan, Arun
Adamson, Joy
author_facet Scantlebury, Arabella
McDaid, Catriona
Brealey, Stephen
Cook, Elizabeth
Sharma, Hemant
Ranganathan, Arun
Adamson, Joy
author_sort Scantlebury, Arabella
collection PubMed
description BACKGROUND: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. DESIGN: Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. SETTING: NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. PARTICIPANTS: Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. RESULTS: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. CONCLUSIONS: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. TRIAL REGISTRATION: ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018, SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05420-4.
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spelling pubmed-82858602021-07-19 Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials Scantlebury, Arabella McDaid, Catriona Brealey, Stephen Cook, Elizabeth Sharma, Hemant Ranganathan, Arun Adamson, Joy Trials Research BACKGROUND: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. DESIGN: Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. SETTING: NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. PARTICIPANTS: Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. RESULTS: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. CONCLUSIONS: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. TRIAL REGISTRATION: ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018, SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05420-4. BioMed Central 2021-07-17 /pmc/articles/PMC8285860/ /pubmed/34274006 http://dx.doi.org/10.1186/s13063-021-05420-4 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Scantlebury, Arabella
McDaid, Catriona
Brealey, Stephen
Cook, Elizabeth
Sharma, Hemant
Ranganathan, Arun
Adamson, Joy
Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
title Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
title_full Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
title_fullStr Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
title_full_unstemmed Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
title_short Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
title_sort embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285860/
https://www.ncbi.nlm.nih.gov/pubmed/34274006
http://dx.doi.org/10.1186/s13063-021-05420-4
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