Messner Donna A, Moloney Rachael, Warriner Amy H, Wright Nicole C, Foster Phillip J, Saag Kenneth G
Center for Medical Technology Policy, Baltimore, MD, USA.
Division of Endocrinology, Diabetes and Metabolism, University of Alabama at Birmingham, USA.
Contemp Clin Trials Commun. 2016 Aug 23;4:136-140. doi: 10.1016/j.conctc.2016.08.003. eCollection 2016 Dec 15.
BACKGROUND/AIMS: Pragmatic clinical trials (PCTs) represent an increasingly used strategy for "real-world" trials. Successful PCTs typically require participation of community-based practices. However, community clinicians often have limited interest or experience in clinical research. Many barriers to practice-based research have been described, but possible motivations to participate among community practices not active in research have not been well explored. The tendency is for researchers to assume similar motivations and priorities across all candidate practices. This is not necessarily the case. A better understanding of the range of reasons clinicians might see for participating in pragmatic trials could be key to promoting this type of practice-based research.
Semi-structured interviews were conducted with 30 clinicians and staff members. Half of the interviewees had experience doing practice-based clinical trials and half did not. Individuals in these two groups were also diversified in terms of their practice size and location. Participants were asked about motivations and barriers to doing practice-based research in the context of a planned osteoporosis pragmatic clinical trial. Interviews were transcribed, coded, and analyzed.
Barriers identified for both experienced and not-experienced clinicians and staff members included: a lack of time, increased paperwork, disruption to work flows, and concern over practice finances. Similar findings have been reported in the US, UK, Europe, and Australia. However, regarding positive motivations of practices to participate, we found systematic differences in attitude between research-engaged and research-naïve practices that have not been previously reported. The research-experienced group offered a greater number and variety of reasons to take part than the not-experienced group. While both groups expressed motivations related to patient care, clinicians and staff members experienced in practice-based clinical trials were much more likely to cite intellectual, professional, and societal benefits not envisioned by the other group.
We conclude that clinicians not already participating in practice-based trials may have a narrower range of motivations than those already participating. The lack of a broader view of possible benefits to participation may also translate into more obdurate recruiting challenges. These results point to the need for recruitment, engagement, and messaging approaches differentially tailored to the needs and interests of non-participating practices.
背景/目的:实用临床试验(PCTs)是一种越来越多地用于“真实世界”试验的策略。成功的实用临床试验通常需要社区医疗机构的参与。然而,社区临床医生对临床研究的兴趣和经验往往有限。虽然已经描述了许多基于实践的研究障碍,但对于未积极参与研究的社区医疗机构来说,参与研究的潜在动机尚未得到充分探讨。研究人员倾向于认为所有候选医疗机构的动机和优先事项都相似。但实际情况未必如此。更好地理解临床医生参与实用试验可能的各种原因,可能是推动这类基于实践的研究的关键。
对30名临床医生和工作人员进行了半结构化访谈。一半受访者有基于实践的临床试验经验,另一半则没有。这两组人员在医疗机构规模和地点方面也各不相同。在一项计划中的骨质疏松症实用临床试验背景下,询问了参与者进行基于实践的研究的动机和障碍。访谈内容被转录、编码和分析。
有经验和无经验的临床医生及工作人员所确定的障碍包括:时间不足、文书工作增加、工作流程中断以及对医疗机构财务状况的担忧。在美国、英国、欧洲和澳大利亚也有类似的研究结果报道。然而,关于医疗机构参与研究的积极动机,我们发现参与研究和未参与研究的医疗机构在态度上存在系统性差异,这在以前的研究中未曾报道过。有研究经验的组给出的参与理由在数量和种类上都多于无经验的组。虽然两组都表达了与患者护理相关的动机,但有基于实践的临床试验经验的临床医生和工作人员更有可能提及另一组未想到的知识、专业和社会层面的益处。
我们得出结论,尚未参与基于实践试验的临床医生的动机范围可能比已参与的医生更窄。对参与研究可能带来的益处缺乏更广泛的认识,也可能导致招募面临更顽固的挑战。这些结果表明,需要根据未参与研究的医疗机构的需求和兴趣,制定有差异的招募、参与和宣传策略。