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如何将这些牢记于心? 对辅助医疗专业人员而言,在研究中实施良好临床实践原则的障碍和促进因素是什么:一项定性探索。

"How do I keep this live in my mind?" Allied Health Professionals' perspectives of barriers and enablers to implementing good clinical practice principles in research: a qualitative exploration.

机构信息

School of Health Sciences and Social Work, Griffith University Gold Coast, Gold Coast, Australia.

Allied Health and Rehabilitation Services, Gold Coast Health Southport, Southport, Australia.

出版信息

BMC Health Serv Res. 2023 Mar 30;23(1):309. doi: 10.1186/s12913-023-09238-5.


DOI:10.1186/s12913-023-09238-5
PMID:36998032
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10064695/
Abstract

BACKGROUND: Allied health professionals (AHPs) engaged in research are expected to comply with Good Clinical Practice (GCP) principles to protect participant safety and wellbeing and enhance data integrity. Currently, few studies have explored health professionals' perceptions of implementing and adhering to GCP principles in research with none of these including AHPs. Such knowledge is vital to guide future interventions to increase adherence to GCP principles. This study aimed to identify the barriers and enablers AHPs experience when applying GCP principles to research conduct in a public hospital and health service, as well as their perceived support needs. METHODS: The study used a qualitative descriptive study approach guided by behaviour change theory. AHPs currently undertaking ethically approved research within a public health service in Queensland, Australia were interviewed to explore barriers and enablers to adherence to GCP principles and support needs, with interview questions guided by the Theoretical Domains Framework (TDF). The TDF was chosen as it allows for a systematic understanding of factors influencing implementation of a specific behaviour (i.e., GCP implementation) and can be used to inform tailored interventions. RESULTS: Ten AHPs across six professions were interviewed. Participants identified both enablers and barriers to implementing GCP across nine domains of the TDF and enablers across three additional domains. Examples of enablers included strong beliefs about the importance of GCP in increasing research rigour and participant safety (i.e. from TDF - beliefs about consequences); applying clinical skills and personal attributes when implementing GCP (i.e., skills), available training and support (i.e., environmental context and resources); and alignment with their moral sense to 'do the right thing' (i.e., professional identity). Barriers to GCP implementation were generally less commonly reported but included reduced time to implement GCP and a sense of 'red tape' (i.e., environmental context and resources), a lack of knowledge of GCP principles (i.e., knowledge) and a fear of making mistakes (i.e., emotions), and varying relevance to individual projects (i.e., knowledge). Suggestions for support were identified beyond training, such as physical resources (e.g., prescriptive checklists, templates and scripts), additional time, and regular one-on-one mentoring support. CONCLUSION: Findings suggest that while clinicians recognise the importance of GCP and want to implement it, they report barriers to its practical implementation. GCP training alone is unlikely to address these barriers to implementing GCP in daily practice. Findings suggest that GCP training may be more useful to AHPs when it is tailored to the allied heath context and supplemented with additional supports including check-ups from experienced researchers and access to prescriptive resources. Future research however is needed to investigate the effectiveness of such strategies.

摘要

背景:从事研究的辅助医疗专业人员(AHPs)预计将遵守良好临床实践(GCP)原则,以保护参与者的安全和健康,并增强数据完整性。目前,很少有研究探讨卫生专业人员在研究中实施和遵守 GCP 原则的看法,而这些研究中都没有包括辅助医疗专业人员。这些知识对于指导未来增加遵守 GCP 原则的干预措施至关重要。本研究旨在确定辅助医疗专业人员在昆士兰州一家公立医院和卫生服务机构开展研究时应用 GCP 原则所面临的障碍和促成因素,以及他们认为的支持需求。

方法:该研究采用了定性描述性研究方法,以行为改变理论为指导。采访了目前在澳大利亚昆士兰州的一家公共卫生服务机构进行伦理批准研究的辅助医疗专业人员,以探讨他们在遵守 GCP 原则方面的障碍和促成因素以及支持需求,采访问题由理论领域框架(TDF)指导。选择 TDF 是因为它允许对影响特定行为(即 GCP 实施)实施的因素进行系统理解,并可用于提供定制的干预措施。

结果:共采访了六个专业的 10 名辅助医疗专业人员。参与者确定了在 TDF 的九个领域中实施 GCP 的促成因素和障碍,以及在另外三个领域中实施 GCP 的促成因素。促成因素的例子包括坚信 GCP 对提高研究严谨性和参与者安全性的重要性(即来自 TDF-对后果的信念);在实施 GCP 时应用临床技能和个人属性(即技能)、可用的培训和支持(即环境背景和资源);以及与他们的道德感保持一致,即“做正确的事”(即专业身份)。实施 GCP 的障碍通常较少报告,但包括实施 GCP 的时间减少和“繁文缛节”的感觉(即环境背景和资源)、缺乏 GCP 原则的知识(即知识)以及害怕犯错(即情绪),以及对个别项目的相关性不同(即知识)。除了培训之外,还确定了对支持的建议,例如物理资源(例如,规定检查表、模板和脚本)、额外的时间和定期的一对一指导支持。

结论:研究结果表明,尽管临床医生认识到 GCP 的重要性并希望实施它,但他们报告了其实际实施的障碍。仅进行 GCP 培训不太可能解决在日常实践中实施 GCP 的这些障碍。研究结果表明,当 GCP 培训针对辅助医疗背景并辅以其他支持措施时,例如有经验的研究人员的定期检查和获得规定性资源,对辅助医疗专业人员可能更有用。然而,需要进一步研究来调查这些策略的有效性。

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Putting the "good" into Good Clinical Practice.

Med J Aust. 2021-2

[2]
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[3]
More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.

Contemp Clin Trials Commun. 2020-7-2

[4]
Operationalizing Good Clinical Practice Principles in Pediatric Clinical Research.

J Pediatr. 2020-6

[5]
Barriers and enablers to the use of venous leg ulcer clinical practice guidelines in Australian primary care: A qualitative study using the theoretical domains framework.

Int J Nurs Stud. 2019-12-10

[6]
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Contemp Clin Trials. 2020-2

[7]
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Aust J Rural Health. 2019-12

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Health Res Policy Syst. 2018-9-21

[9]
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Glob Qual Nurs Res. 2017-11-24

[10]
A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems.

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