Wangler Julian, Jansky Michael
Centre for General Medicine and Geriatrics, University Medical Center of the Johannes Gutenberg, University Mainz, Am Pulverturm 13, Mainz, 55131, Germany.
Arch Public Health. 2024 Mar 20;82(1):41. doi: 10.1186/s13690-024-01272-x.
Long-term reinforcement in the role of primary care and improvement the healthcare system as a whole requires the involvement of GPs in clinical research processes. However, many clinical studies fail due to failure to achieve sample population targets amongst GPs and their patients. This issue has been identified and discussed, but effective strategies to overcome it are still lacking. One of the reasons is that the positions, requirements, and experiences of GPs on participating in clinical research have hardly been examined up to now.
The years 2021 and 2022 saw three quantitative and qualitative surveys amongst GPs in Germany with the aim of shedding light on the attitudes, experiences, and potential issues regarding the involvement of primary care in clinical research projects and participation in cluster-randomised controlled trials (cRCTs) in a general sense. This overview summarises and abstracts conclusions gained from the exploratory series of studies and compares the results with the current research situation. From here, this contribution will then develop an approach towards optimising the integration of GPs into clinical research.
Most of the GPs asked associated clinical research with opportunities and potential such as closing gaps in healthcare, using evidence-based instruments, optimising diagnostic and therapeutic management, and reinforcement of multiprofessional healthcare. Even so, many GPs unsure as to how far primary care in particular would stand to benefit from studies of this type in the long term. Respondents were also divided on willingness to participate in clinical research. GPs having already participated in Innovation Fund projects generally saw a benefit regarding intervention and cost-benefit relationship. However, some also reported major hurdles and stress factors such as excessive documentation and enrolment requirements, greater interference in practice routines, and sometimes poor integration into project processes such as in communication and opportunities to play an active role in the project.
Results from the studies presented provide indications as to how GPs perceive clinical research projects and cRCTs as a whole and from their existing project experience, and on the requirements that studies would have to meet for GPs to be willing to participate. In particular, making sure that clinical studies fully conform with GPs would play a major role; this especially applies to freedom to make medical decisions, limitation of documentation obligations, interference in regular practice routine, greater involvement in research planning, and long-term reinforcement in the role of primary care. Clinical research projects and cRCTs should be planned, designed, and communicated for clear and visible relevance to everyday primary care.
长期强化初级保健的作用并改善整个医疗体系需要全科医生参与临床研究过程。然而，许多临床研究由于未能达到全科医生及其患者的样本量目标而失败。这个问题已被识别和讨论，但仍缺乏有效的解决策略。原因之一是，到目前为止，全科医生参与临床研究的立场、要求和经验几乎未被研究过。
2021年和2022年，在德国的全科医生中进行了三项定量和定性调查，旨在阐明初级保健参与临床研究项目以及总体参与整群随机对照试验（cRCT）的态度、经验和潜在问题。本综述总结并提炼了从一系列探索性研究中得出的结论，并将结果与当前的研究状况进行比较。在此基础上，本论文将制定一种方法，以优化全科医生融入临床研究的过程。
大多数受访全科医生将临床研究与各种机会和潜力联系起来，比如填补医疗保健空白、使用循证工具、优化诊断和治疗管理以及加强多专业医疗保健。即便如此，许多全科医生不确定初级保健从长远来看究竟能在多大程度上从这类研究中受益。受访者对于参与临床研究的意愿也存在分歧。已经参与创新基金项目的全科医生普遍认为在干预和成本效益关系方面有好处。然而，一些人也报告了主要障碍和压力因素，如过多的文件记录和入组要求、对日常工作的更大干扰，以及有时在项目沟通和积极参与项目的机会方面融入项目过程不佳。
所呈现的研究结果表明了全科医生如何从他们现有的项目经验出发整体看待临床研究项目和cRCT，以及研究为了让全科医生愿意参与而必须满足的要求。特别是，确保临床研究完全符合全科医生情况将起到主要作用；这尤其适用于医疗决策自由、文件记录义务的限制、对日常工作的干扰、更多地参与研究规划以及长期强化初级保健的作用。临床研究项目和cRCT的规划、设计和沟通应使其与日常初级保健具有明确且可见的相关性。
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