Clinic for Rehabilitation Münster, Department of Rehabilitation Science, Münster, Austria.
School of Therapeutic Sciences, SRH Hochschule Heidelberg, Heidelberg, Germany.
BMC Med Res Methodol. 2024 Oct 30;24(1):258. doi: 10.1186/s12874-024-02386-0.
Randomised controlled trials (RCTs) are considered the gold standard for generating clinical evidence. The focus on high internal validity in RCTs challenges the external validity and generalisability of findings, potentially hindering their application in routine care. In neurorehabilitation, limited literature addresses conducting RCTs feasibly and efficiently. We investigated barriers and facilitators to conducting RCTs within routine care of neurorehabilitation centres from the perspective of stakeholders in neurorehabilitation in Germany and Austria.
We conducted semi-structured interviews with stakeholders in neurorehabilitation from four centres in Germany and Austria, informed by the Theoretical Domains Framework (TDF) and the Capability, Opportunity, Motivation and Behaviour model (COM-B). Employing a hybrid approach, the interview analysis integrated both deductive, theory-driven analysis based on the TDF domains and COM-B model and inductive, reflexive thematic analysis.
Twelve stakeholders (4 physicians, 4 therapy managers, 4 therapists; 5 females, 7 males; with research experience spanning 0-40 years) were interviewed. Key barriers to conducting RCTs in neurological rehabilitation centres include limited financial, human, and time resources, high clinical workloads, and a lack of interest of some therapists. Ineffective leadership, perceived lack of research expertise, and communication issues were also significant barriers. Social influence factors such as lack of employer support and inadequate training access further contributed to the challenges. Additionally, barriers included insufficient research infrastructure, limited space, internal power struggles, and rigid cost bearer specifications. Key facilitators included physicians' and therapists' motivation to advance the field, contribute to knowledge, and to prioritise patient health. Support from supervisors, joint decision-making, and efficient organisation were crucial facilitators. Flexible therapy planning, mutual support, and interdisciplinary collaboration also played important roles.
Our results suggest that increasing professional development and understanding, along with providing adequate financial, human, time, and spatial resources to support research endeavours, implementing effective communication strategies to enhance interdisciplinary collaboration and coordination among team members may contribute to increased motivation and facilitate RCTs within the setting of neurorehabilitation centres.
This study was prospectively registered with the German Clinical Trials Register (08.04.2021 DRKSID DRKS00024982).
随机对照试验（RCT）被认为是产生临床证据的金标准。RCT 对内在有效性的关注挑战了研究结果的外在有效性和普遍性，可能会阻碍其在常规护理中的应用。在神经康复领域，关于如何在神经康复中心的常规护理中进行 RCT 的文献有限。本研究旨在从德国和奥地利神经康复领域利益相关者的角度，探讨在神经康复中心常规护理中进行 RCT 的障碍和促进因素。
我们对德国和奥地利的四个中心的神经康复利益相关者进行了半结构化访谈，访谈内容基于理论领域框架（TDF）和能力、机会、动机和行为模型（COM-B）。采用混合方法，访谈分析综合了基于 TDF 领域和 COM-B 模型的演绎、理论驱动分析和归纳、反思性主题分析。
共对 12 名利益相关者（4 名医生、4 名治疗师经理、4 名治疗师；5 名女性，7 名男性；研究经验 0-40 年不等）进行了访谈。在神经康复中心进行 RCT 的主要障碍包括有限的财务、人力和时间资源、高临床工作量以及一些治疗师缺乏兴趣。无效的领导力、感知缺乏研究专业知识以及沟通问题也是重大障碍。社会影响因素，如缺乏雇主支持和培训机会不足，也进一步加剧了挑战。此外，障碍还包括研究基础设施不足、空间有限、内部权力斗争和僵化的成本承担者规范。主要促进因素包括医生和治疗师推进该领域、为知识做出贡献以及优先考虑患者健康的动机。主管的支持、联合决策和有效的组织是至关重要的促进因素。灵活的治疗计划、相互支持和跨学科合作也发挥了重要作用。
我们的研究结果表明，增加专业发展和理解，提供足够的财务、人力、时间和空间资源以支持研究工作，实施有效的沟通策略以加强跨学科合作和团队成员之间的协调，可能有助于提高动机并促进神经康复中心内的 RCT。
本研究在德国临床试验注册处（2021 年 4 月 8 日 DRKSID DRKS00024982）进行了前瞻性注册。
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