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TOPSY 自我管理干预在阴道子宫脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂脱垂的女性中的理论和实际发展。

Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse.

机构信息

The Warrell Unit, St. Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.

Health Sciences & Sport, University of Stirling, Stirling, UK.

出版信息

Trials. 2022 Sep 5;23(1):742. doi: 10.1186/s13063-022-06681-3.

Abstract

BACKGROUND

Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention.

METHODS

The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition.

RESULTS

The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team.

CONCLUSIONS

The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management.

TRIAL REGISTRATION

ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

摘要

背景

盆腔器官脱垂(POP)是女性常见的病症,盆腔器官向下进入阴道会导致出现症状,影响生活质量。阴道子宫托为 POP 的治疗提供了一种有效的手术替代方案。然而,定期随访可能会给女性带来负担,并且需要大量的医疗资源。TOPSY 研究是一项随机对照试验,旨在确定阴道子宫托自我管理的临床和成本效益。本文描述了自我管理干预措施的理论和实际发展。

方法

该干预措施是使用 MRC 复杂干预框架、正常化进程理论(NPT)和自我管理理论开发的。干预措施旨在根据班杜拉的社会认知理论增强自我效能感,并且由 Lorig 和霍夫曼描述的自我管理健康状况所需的任务和技能指导。

结果

TOPSY 干预措施旨在支持女性对子宫托进行医疗管理、角色管理和情感管理。Lorig 和霍夫曼描述的六个自我管理技能:解决问题、决策、资源利用、形成医患伙伴角色、行动计划和自我调整,都进行了详细讨论,包括如何在子宫托自我管理的背景下支持女性完成每项任务。TOPSY 干预措施包括由接受过干预措施提供培训的子宫托从业者进行的自我管理支持会议、2 周后进行的随访电话以及根据女性的需求发起的与研究团队成员联系的电话或面对面的持续支持。

结论

TOPSY 研究干预措施是利用先前的服务开发项目、干预措施开发和自我效能理论、相关文献、临床医生经验以及使用子宫托的女性和公众的反馈得出的。2022 年,TOPSY 研究的结果将提供进一步的证据,为子宫托管理的这一重要方面提供信息。

试验注册

ISRCTN 注册处 ISRCTN62510577。于 2017 年 6 月 10 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6da2/9446823/2516fb7f7c01/13063_2022_6681_Fig1_HTML.jpg

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