Barriers and facilitators to conducting randomised controlled trials within routine care of neurorehabilitation centres: a qualitative study.

IF 3.9 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES BMC Medical Research Methodology Pub Date : 2024-10-30 DOI:10.1186/s12874-024-02386-0
Isabella Hotz, Nathalie Ernst, Christian Brenneis, Gudrun Diermayr, Barbara Seebacher
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Trial registration: This study was prospectively registered with the German Clinical Trials Register (08.04.2021 DRKSID DRKS00024982).

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在神经康复中心的常规护理中开展随机对照试验的障碍和促进因素:一项定性研究。
背景:随机对照试验(RCT)被认为是产生临床证据的黄金标准。随机对照试验注重高度的内部有效性,这就对研究结果的外部有效性和可推广性提出了挑战,可能会阻碍其在常规护理中的应用。在神经康复领域,有关可行、高效地开展 RCT 的文献十分有限。我们从德国和奥地利神经康复领域利益相关者的角度出发,调查了在神经康复中心常规护理中开展 RCT 的障碍和促进因素:我们以理论领域框架(TDF)和能力、机会、动机和行为模型(COM-B)为依据,对德国和奥地利四个神经康复中心的利益相关者进行了半结构化访谈。访谈分析采用混合方法,既有基于 TDF 领域和 COM-B 模型的演绎式理论驱动分析,也有归纳式反思主题分析:12 位相关人员(4 位医生、4 位治疗经理、4 位治疗师;5 位女性、7 位男性;研究经验跨度为 0-40 年)接受了访谈。在神经康复中心开展 RCT 的主要障碍包括财力、人力和时间资源有限,临床工作量大,以及一些治疗师缺乏兴趣。领导不力、缺乏研究专长和沟通问题也是主要障碍。缺乏雇主支持和培训机会不足等社会影响因素进一步加剧了这些挑战。此外,障碍还包括研究基础设施不足、空间有限、内部权力斗争以及僵化的成本承担规格。主要的促进因素包括医生和治疗师推动该领域发展、贡献知识以及优先考虑患者健康的积极性。上司的支持、共同决策和高效的组织是重要的促进因素。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,加强专业发展和理解,同时提供充足的财力、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,可能有助于提高积极性,并促进神经康复中心开展 RCT:本研究已在德国临床试验登记处进行了前瞻性登记(2021 年 4 月 8 日 DRKSID DRKS00024982)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Medical Research Methodology
BMC Medical Research Methodology 医学-卫生保健
CiteScore
6.50
自引率
2.50%
发文量
298
审稿时长
3-8 weeks
期刊介绍: BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
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