Background: Fidelity to the treatment protocol is key to successful trials but often problematic. This article reports the staff's views on delivering a complex rehabilitation intervention: patient-led therapy during inpatient stroke care. Methods: An exploratory qualitative study using focus groups with staff involved in a multicenter (n = 12) feasibility trial of patient-led therapy (the MAESTRO trial) was undertaken as part of the evaluation process. Purposive sampling ensured that participants represented all recruiting sites, relevant professions and levels of seniority. Data analysis used a Framework Approach. Results: Five focus groups were held involving 30 participants. Five main themes emerged: the effect of the interventions, practical problems, patient-related factors, professional dilemmas, and skills. Staff felt the main effect of the therapies was on patients' autonomy and occupation; the main practical problems were the patients' difficulties in achieving the correct position and a lack of space. Staff clearly identified characteristics that made patient-led therapy unsuitable for some patients. Most staff experienced dilemmas over how to prioritize the trial interventions compared to their usual therapy and other clinical demands. Staff also lacked confidence about how to deliver the interventions, particularly when adapting the interventions to individual needs. For each barrier to implementation, possible solutions were identified. Of these, involving other people and establishing a routine were the most common. Conclusions: Delivering rehabilitation interventions within a trial is complex. Staff require time and support to develop the skills, strategies and confidence to identify suitable patients, deliver new treatments, adapt the new treatments to individuals' needs and balance the demands of delivering the trial intervention according to the treatment protocol with other clinical and professional priorities. Trial registration: ISRCTN: ISRCTN29533052. October 2011.

Recruitment, Rehabilitation, Stroke, Trial,
Department of Rehabilitation Medicine

Horne, M, Thomas, N, Vail, A, Selles, R, McCabe, C, & Tyson, M. (2015). Staff's views on delivering patient-led therapy during inpatient stroke rehabilitation: A focus group study with lessons for trial fidelity. Trials, 16(1). doi:10.1186/s13063-015-0646-9