ArticleTrials2021
Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.
- Can we ever have evidence-based decision making in orthopaedics? A qualitative evidence synthesis and conceptual framework.BMC medical informatics and decision making · 2025Pooled it
- Negotiating research in the Emergency Department: a qualitative study of staff experience of the Distal Radius Acute Fracture Trial CAst versus SPlint (DRAFT3-CASP) RCT for distal radius fractures.Bone & joint open · 2026Article
- Taxonomy of chronic illness research recruitment: a restricted scoping review.BMC health services research · 2025Article
- A Pilot Three Arm Randomised Controlled Trial and Qualitative Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing (SOLEFUL): A Study Protocol.International wound journal · 2025Article
- Inclusivity of the target population in orthopaedic surgical randomised trials: a review of high impact journals.NIHR open research · 2025Article
- Applying mixed methods to pilot feasibility studies to inform intervention trials.Pilot and feasibility studies · 2022Article
- Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundRecruitment 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.
designTwo 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.
settingNHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.
participantsThirty-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.
resultsWe 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.
conclusionsA 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 registrationACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.
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