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“PASIBO”的研究设计——与炎症性肠病患者共同创建和开发一项体育活动干预措施。

Study design of 'PASIBO' - co-creation and development of a physical activity intervention to patients with inflammatory bowel disease.

作者信息

Thomsen Tanja, Villumsen Marie, Poulsen Anja, Hansen Anders B G, Esbensen Bente A, Jess Tine, Aadahl Mette

机构信息

Center for Clinical Research and Prevention, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.

Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark.

出版信息

BMC Health Serv Res. 2025 Aug 7;25(1):1036. doi: 10.1186/s12913-025-13120-x.

DOI:10.1186/s12913-025-13120-x
PMID:40770633
Abstract

BACKGROUND

Patients with inflammatory bowel disease (IBD) tend to be physically inactive, i.e., not meeting the recommend daily physical activity levels, which may lead to poorer health outcomes and lower quality of life. Despite growing evidence on the benefits of physical activity, few interventions are tailored to the needs and preferences of this population. This study describes the systematic development of a co-created physical activity intervention for patients with IBD.

METHODS

The intervention development process was guided by the Medical Research Council (MRC) framework for developing and evaluating complex interventions and informed by principles of co-creation and participatory system-oriented approaches. The process encompassed three stages, including (1) a preparation phase with e.g., literature review, stakeholder consultations and a system mapping workshop, (2) two co-creation workshops with multiple stakeholders to collaboratively design intervention components, and (3) prototyping the intervention, including reviews and feedback from health professionals and other researchers to refine content and delivery model.

RESULTS

Stakeholders identified five focus areas as central to the intervention: individualization, community-fostering, mental health, sustainability, and enhancing knowledge about IBD and physical activity. The focus areas were then translated into concrete intervention elements. These included group-based educational sessions and nurse-led individual motivational counselling sessions, supplemented by optional intervention elements, consisting of one-on-one sessions with a physiotherapist, links to short videos featuring physiotherapists demonstrating specific exercises, and peer-support opportunities. During the final stage of the intervention development, feedback from a multidisciplinary team of health professionals and a researcher specializing in physical activity and IBD played a crucial role in refining and finalizing the manual's content and practicality.

CONCLUSIONS

The development process resulted in a multicomponent physical activity intervention tailored to the needs and preferences of patients with IBD. The intervention integrates both individual and social components, with some optional. This intervention development highlights the value of combining evidence-based strategies with stakeholder involvement to create a contextually relevant and potentially sustainable physical activity intervention. A feasibility study currently underway will provide further insights into the feasibility and acceptability of the intervention, and the potential need for additional adjustments of intervention elements.

摘要

背景

炎症性肠病(IBD)患者往往身体活动不足,即未达到推荐的每日身体活动水平,这可能导致更差的健康结果和更低的生活质量。尽管越来越多的证据表明身体活动有益,但很少有干预措施是根据该人群的需求和偏好量身定制的。本研究描述了一种为IBD患者共同创建的身体活动干预措施的系统开发过程。

方法

干预措施的开发过程以医学研究理事会(MRC)开发和评估复杂干预措施的框架为指导,并以共同创造和面向参与式系统的方法为依据。该过程包括三个阶段,包括(1)准备阶段,例如文献综述、利益相关者咨询和系统映射研讨会;(2)与多个利益相关者举行的两次共同创造研讨会,以协作设计干预措施的组成部分;(3)干预措施的原型设计,包括来自卫生专业人员和其他研究人员的审查和反馈,以完善内容和实施模式。

结果

利益相关者确定了五个重点领域作为干预措施的核心:个性化、社区培育、心理健康、可持续性以及增强关于IBD和身体活动的知识。然后将这些重点领域转化为具体的干预措施要素。这些措施包括基于小组的教育课程和由护士主导的个人动机咨询课程,并辅以可选的干预措施要素,包括与物理治疗师的一对一课程、链接到物理治疗师演示特定锻炼的短视频以及同伴支持机会。在干预措施开发的最后阶段,来自卫生专业人员多学科团队以及一位专门研究身体活动和IBD的研究人员的反馈在完善和最终确定手册的内容及实用性方面发挥了关键作用。

结论

该开发过程产生了一种针对IBD患者的需求和偏好量身定制的多成分身体活动干预措施。该干预措施整合了个人和社会成分,其中一些是可选的。这种干预措施的开发突出了将基于证据的策略与利益相关者参与相结合以创建与背景相关且可能可持续的身体活动干预措施的价值。目前正在进行的一项可行性研究将提供关于该干预措施的可行性和可接受性以及对干预措施要素进行额外调整的潜在需求的进一步见解。

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