Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany
Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany.
BMJ Open. 2023 Jul 12;13(7):e065947. doi: 10.1136/bmjopen-2022-065947.
General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order to enhance primary care research, the German government has funded six regional practice based research networks (PBRNs). Within the Bavarian PBRN (BayFoNet), two cluster-randomised pilot trials will be conducted. This paper presents the protocol of the process evaluation accompanying both trials, which aims to explore relevance, feasibility, acceptability and credibility of clinical research in primary care from the perspectives of BayFoNet researchers, general practitioners, and patients.
The BayFoNet will be established by recruiting general practices (GPs) as prospective research collaborators in two cluster randomised pilot trials. Research teams will provide training in good clinical practice, and support practices in patient recruitment, data collection and documentation. Our process evaluation explores barriers and facilitators in the set up of the BayFoNet PBRN and both cluster randomised pilot trials, under the application of the consolidated framework for implementation research and the theoretical domains framework. In a mixed-methods concept, we will use qualitative and quantitative approaches to evaluate both pilot cluster-randomised trials as well as the BayFoNet itself: focus groups with researchers, semi-structured interviews with general practitioners and questionnaires for patients participating in the pilot cluster-randomised trials at three different time points.
Research ethical approval for this study was granted by the Ethics Committee of the Medical Department, Ludwig-Maximilians-University Munich (AZ 21-1135). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as other PBRNs, GP teams and patients.
DRKS00028805, NCT05667207.
全科医生经常批评临床试验在基层医疗中的适用性差，这至少部分解释了他们参与基层医疗研究的积极性为何仍然有限。为了加强基层医疗研究，德国政府资助了六个基于实践的区域研究网络（PBRN）。在巴伐利亚 PBRN（BayFoNet）中，将进行两项集群随机对照试验。本文介绍了伴随这两项试验的过程评估方案，该方案旨在从 BayFoNet 研究人员、全科医生和患者的角度探索基层医疗中的临床研究的相关性、可行性、可接受性和可信度。
BayFoNet 将通过招募全科医生（GP）作为两个集群随机对照试验的前瞻性研究合作者来建立。研究团队将提供良好临床实践培训，并支持实践招募患者、收集和记录数据。我们的过程评估探索了 BayFoNet PBRN 和两项集群随机对照试验的实施障碍和促进因素，应用实施研究的综合框架和理论领域框架。在混合方法的概念下，我们将使用定性和定量方法评估两项试点集群随机对照试验以及 BayFoNet 本身：在三个不同时间点，对研究人员进行焦点小组讨论，对全科医生进行半结构化访谈，对参与试点集群随机对照试验的患者进行问卷调查。
这项研究的研究伦理获得了慕尼黑路德维希-马克西米利安大学医学系伦理委员会的批准（AZ 21-1135）。研究结果将发表在国际同行评议期刊上，并将向研究资助者以及其他 PBRN、全科医生团队和患者提供摘要。
DRKS00028805，NCT05667207。
