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全科医疗团队及其患者参与临床研究的经历——巴伐利亚研究实践网络(BayFoNet)的混合方法过程评估

Experiences of general practice teams and their patients with clinical research-a mixed-methods process evaluation of the Bavarian Research Practice Network (BayFoNet).

作者信息

Sanftenberg Linda, Schnaidt Anna-Lena, Eck Stefanie, Schneider Antonius, Bucher Eva, Kurotschka Peter Konstantin, Gágyor Ildikó, Klanke Merle, Stark Stefanie, Kühlein Thomas, Walter Fabian, Roos Marco, Dreischulte Tobias, Gensichen Jochen

机构信息

Institute of General Practice and Family Medicine, LMU University Hospital, LMU Munich, Nußbaumstr. 5, 80336, Munich, Germany.

Institute of General Practice and Health Services Research, Department Clinical Medicine, TUM School of Medicine and Health, Technical University of Munich (TUM), Munich, Germany.

出版信息

BMC Prim Care. 2025 Feb 28;26(1):59. doi: 10.1186/s12875-025-02744-x.

Abstract

BACKGROUND

Practice-based research networks (PBRNs) have been implemented to support clinical research in German general practice since 2020. General practitioners (GPs) are often critical concerning the feasibility of clinical trials. Among others, high workload, lack of resources in GP teams and little acceptance of the trial requirements by the patients are assumed barriers. Therefore, the aim of this study was to evaluate the perspectives of the GP teams and their patients on the set up of BayFoNet during the implementation of the two pilot cluster-randomized trials to improve this collaboration on a sustainable basis.

METHODS

GPs and medical assistants (MAs) were interviewed using semi-structured interviews based on the Consolidated Framework for Implementation Research. Implementation research and verbatim transcripts were analyzed using qualitative content analysis. Patient attitudes were evaluated quantitatively with questionnaires based on the theoretical domains framework using descriptive statistics.

RESULTS

A total of 15 GPs and 15 MAs were interviewed, and 109 complete patient questionnaires were returned. Main facilitators for GPs' active participation in clinical research were networking as well as active participation of GP teams at different levels of the research process. Increased awareness concerning PBRNs might promote a lively network. From the GPs' perspective, lack of motivation among MAs and patients was a perceived barrier to support clinical research in general practice. MAs emphasized their own increase in knowledge and competence as well as the importance of clinical research for improved patient care. In contrast to the GPs, most MAs were not aware of BayFoNet as a network structure. The surveyed patients rated their own capabilities and opportunities to actively participate in the pilot studies as very good. Prior to the implementations of the interventions, some patients experienced some difficulty in defining clear goals for their own participation.

DISCUSSION

Increased awareness concerning PBRNs might promote a lively network. Target-group specific dissemination strategies as well as opportunities for GP teams and their patients to participate in clinical research should be elaborated. This might increase the feasibility of clinical trials and the motivation of all participants to conduct clinical trials in general practice.

TRIAL REGISTRATION

Pilot cluster-randomized trial 1 (MicUTI) was prospectively registered on December 19, 2022 at www.

CLINICALTRIALS

gov (NCT05667207); Pilot cluster-randomized trial 2 (IMONEDA) was prospectively registered on April 22, 2022 at www.bfarm.de (DRKS00028805).

摘要

背景

自2020年以来,德国已实施基于实践的研究网络(PBRN)以支持全科医疗中的临床研究。全科医生(GP)通常对临床试验的可行性持怀疑态度。除其他因素外,工作量大、全科医生团队资源匮乏以及患者对试验要求的接受度低被认为是障碍。因此,本研究的目的是在两项试点整群随机试验实施期间,评估全科医生团队及其患者对BayFoNet建立的看法,以便在可持续的基础上改善这种合作。

方法

采用基于实施研究综合框架的半结构化访谈对全科医生和医疗助理(MA)进行访谈。使用定性内容分析法对实施研究和逐字记录进行分析。基于理论领域框架,通过问卷调查并使用描述性统计对患者态度进行定量评估。

结果

共访谈了15名全科医生和15名医疗助理,共收回109份完整的患者问卷。全科医生积极参与临床研究的主要促进因素是建立网络以及全科医生团队在研究过程不同层面的积极参与。对基于实践的研究网络的认识提高可能会促进一个活跃的网络。从全科医生的角度来看,医疗助理和患者缺乏积极性被认为是全科医疗中支持临床研究的障碍。医疗助理强调了自身知识和能力的提升以及临床研究对改善患者护理的重要性。与全科医生不同,大多数医疗助理并未意识到BayFoNet是一种网络结构。接受调查的患者对自己积极参与试点研究的能力和机会评价很高。在实施干预措施之前,一些患者在为自己的参与确定明确目标方面遇到了一些困难。

讨论

对基于实践的研究网络的认识提高可能会促进一个活跃的网络。应制定针对目标群体的传播策略以及全科医生团队及其患者参与临床研究的机会。这可能会提高临床试验的可行性以及所有参与者在全科医疗中开展临床试验的积极性。

试验注册

试点整群随机试验1(MicUTI)于2022年12月19日在www.CLINICALTRIALS.gov(NCT05667207)上进行前瞻性注册;试点整群随机试验2(IMONEDA)于2022年4月22日在www.bfarm.de(DRKS00028805)上进行前瞻性注册。

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