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. 2021 Aug;2(8):631-637.
doi: 10.1302/2633-1462.28.BJO-2021-0074.R1.

Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study

Alba X Realpe  1 , James Blackstone  2 , Damian R Griffin  3 , Andrew J F Bing  4 , Michael Karski  5 , Stephen A Milner  6 , Malik Siddique  7 , Andrew Goldberg  8   9   10
Affiliations

Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study

Alba X Realpe et al. Bone Jt Open. 2021 Aug.

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. Cite this article: Bone Jt Open 2021;2(8):631-637.

Keywords: Ankle arthrodesis; Ankle arthroplasty; Ankle fusion; Ankle osteoarthritis; Orthopaedic; Orthopaedic surgeons; Patient experience; Randomized clinical trials; Recruitment; ankle arthritis; ankle arthroplasty; arthrodesis; arthroplasty; clinical trials; clinicians; orthopaedic surgical trials; physiotherapists; randomized controlled trials.

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Conflict of interest statement

ICMJE COI statement: D. R. Griffin reports grants from the National Institute of Health Research (NIHR) during the conduct of the study, and personal fees from Stryker UK, outside the submitted work; he is also a board member of the International Society of Hip Arthroscopy and is a consultant surgeon who routinely performs hip arthroscopy. A. Goldberg reports grants from the National Institute of Health Research (NIHR) during the conduct of the study, and personal fees from Wright Medical, outside of the submitted work. A. J. F. Bing receives personal fees from Wright Medical & MattOrtho outside of the submitted work. S. A. Milner receives personal fees from EIDO Healthcare, outside of the submitted work. M. Karski receives personal fees from DePuy Synthes and Wright Medical outside of the submitted work. All other authors declare no competing interests.

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