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Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis
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Realpe, Alba X., Blackstone, James, Griffin, Damian R., Bing, Andrew J. F., Karski, Michael, Milner, Stephen A., Siddique, Malik and Goldberg, Andrew (2021) Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis. Bone & Joint Open, 2 (8). pp. 631-637. doi:10.1302/2633-1462.28.BJO-2021-0074.R1
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WRAP-Barriers-to-recruitment-to-an-orthopaedic-randomized-controlled-trial-comparing-two-surgical-procedures-for-ankle-arthritis-Griffin-22.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution Non-commercial No Derivatives 4.0. Download (230Kb) | Preview |
Official URL: http://dx.doi.org/10.1302/2633-1462.28.BJO-2021-00...
Abstract
Aims
A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.
Methods
We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.
Results
Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm.
Conclusion
This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent.
| Item Type: | Journal Item | |||||||||
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| Subjects: | R Medicine > RC Internal medicine | |||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | |||||||||
| Library of Congress Subject Headings (LCSH): | Osteoarthritis -- Treatment, Osteoarthritis -- Diagnosis, Clinical trials, Clinical trials -- Statistical methods, Recruitment, Ankle -- Wounds and injuries -- Diagnosis, Patients | |||||||||
| Journal or Publication Title: | Bone & Joint Open | |||||||||
| Publisher: | British Editorial Society of Bone and Joint Surgery | |||||||||
| ISSN: | 2633-1462 | |||||||||
| Official Date: | 11 August 2021 | |||||||||
| Dates: |
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| Volume: | 2 | |||||||||
| Number: | 8 | |||||||||
| Page Range: | pp. 631-637 | |||||||||
| DOI: | 10.1302/2633-1462.28.BJO-2021-0074.R1 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 5 July 2022 | |||||||||
| Date of first compliant Open Access: | 6 July 2022 | |||||||||
| RIOXX Funder/Project Grant: |
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