Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis
| Autor: | Andrew J. F. Bing, Michael Karski, Stephen A Milner, Malik Siddique, James Blackstone, Alba Realpe, Damian R. Griffin, Andy Goldberg |
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| Rok vydání: | 2021 |
| Předmět: |
Patient experience
Ankle fusion randomized clinical trials arthrodesis medicine.medical_specialty medicine.medical_treatment Arthrodesis ankle arthrodesis Ankle arthritis Ankle osteoarthritis law.invention Randomized controlled trial law clinicians medicine Orthopedic surgery clinical trials patient experience business.industry ankle arthritis Ankle arthroplasty General Engineering Orthopaedic orthopaedic surgeons Surgical procedures Ankle arthrodesis Arthroplasty physiotherapists orthopaedic Clinical trial recruitment ankle osteoarthritis randomized controlled trials Physical therapy arthroplasty Randomized clinical trials Recruitment ankle arthroplasty business ankle fusion orthopaedic surgical trials RD701-811 Qualitative research |
| Zdroj: | Bone & Joint Open, Vol 2, Iss 8, Pp 631-637 (2021) Realpe, A X, Blackstone, J, Griffin, D R, Bing, A J F, Karski, M, Milner, S A, Siddique, M & Goldberg, A 2021, ' Barriers to recruitment to an orthopaedic randomized controlled trial comparing two surgical procedures for ankle arthritis : a qualitative study ', Bone & joint open, vol. 2, no. 8, pp. 631-637 . https://doi.org/10.1302/2633-1462.28.BJO-2021-0074.R1 |
| ISSN: | 2633-1462 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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