Horne Maria, Thomas Nessa, Vail Andy, Selles Rudd, McCabe Candy, Tyson Sarah
School of Health, University of Bradford, Horton A Building, Richmond Rd, Bradford, BD7 1DP, England.
Stroke Research Centre, Manchester Academic Health Sciences Centre, University of Manchester, Jean McFarlane Building, Oxford Rd, Manchester, M13 9PL, England.
Trials. 2015 Apr 7;16:137. doi: 10.1186/s13063-015-0646-9.
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.
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.
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.
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.
ISRCTN29533052 . October 2011.
严格遵循治疗方案是试验成功的关键，但往往存在问题。本文报告了工作人员对实施一项复杂康复干预措施的看法：住院脑卒中护理期间的患者主导治疗。
作为评估过程的一部分，开展了一项探索性定性研究，采用焦点小组访谈法，访谈参与患者主导治疗多中心（n = 12）可行性试验（MAESTRO试验）的工作人员。目的抽样确保参与者代表所有招募地点、相关专业和不同资历水平。数据分析采用框架法。
共举行了5次焦点小组访谈，涉及30名参与者。出现了5个主要主题：干预措施的效果、实际问题、患者相关因素、专业困境和技能。工作人员认为这些治疗的主要效果在于患者的自主性和职业能力；主要实际问题是患者难以保持正确体位以及空间不足。工作人员明确指出了一些使患者主导治疗不适用于某些患者的特征。与常规治疗和其他临床需求相比，大多数工作人员在如何优先安排试验干预措施方面面临困境。工作人员对于如何实施干预措施也缺乏信心，尤其是在根据个体需求调整干预措施时。针对每个实施障碍，都确定了可能的解决方案。其中，让其他人参与和建立常规是最常见的。
在试验中实施康复干预措施很复杂。工作人员需要时间和支持来培养技能、策略和信心，以识别合适的患者、提供新治疗、根据个体需求调整新治疗，并在按照治疗方案提供试验干预措施的需求与其他临床和专业重点之间取得平衡。
ISRCTN29533052。2011年10月。
