| Title: |
Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials |
| Authors: |
Arabella Scantlebury; Catriona McDaid; Stephen Brealey; Elizabeth Cook; Hemant Sharma; Arun Ranganathan; Joy Adamson; on behalf of the ACTIVE and PRESTO study teams |
| Source: |
Trials, Vol 22, Iss 1, Pp 1-13 (2021) |
| Publisher Information: |
BMC |
| Publication Year: |
2021 |
| Collection: |
Directory of Open Access Journals: DOAJ Articles |
| Subject Terms: |
Process evaluation; Recruitment; Retention; Randomised controlled trial; Orthopaedic; Surgery; Medicine (General); R5-920 |
| 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://doi.org/10.1186/s13063-021-05420-4; https://doaj.org/toc/1745-6215; https://doaj.org/article/4bdcace568514873886ede3d97d8ce3d |
| DOI: |
10.1186/s13063-021-05420-4 |
| Availability: |
https://doi.org/10.1186/s13063-021-05420-4; https://doaj.org/article/4bdcace568514873886ede3d97d8ce3d |
| Accession Number: |
edsbas.188089C0 |
| Database: |
BASE |