Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review.

IF 3.4 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Health and Quality of Life Outcomes Pub Date : 2025-10-08 DOI:10.1186/s12955-025-02432-5

Hongqin Chen, Jian Meng, Qiao Li, Xin Luo, Yajing Wang, Yueyue Chen, Xiaoyu Niu, Dongmei Wei

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引用次数: 0

Abstract

Background: The heterogeneity of patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in published clinical studies on vaginal relaxation syndrome (VRS) hinders cross-study comparisons and integration of evidence-based findings, impeding the development of robust clinical evidence.

Objective: To comprehensively investigate the current use of PROs and PROMs in VRS research, compile a comprehensive catalog, and provide guidance for selecting outcome measures and tools VRS patients.

Methods: This study systematically searched clinical studies on VRS treatment published up to December 2024 in PUBMED, EMBASE, Web of Science, and Cochrane databases, focusing primarily on pelvic floor muscle training, physical energy therapies, and surgical interventions. PROs and PROMs were extracted, organized into a structured catalog, and categorized by thematic domains. The COSMIN checklist was applied to assess the measurement properties of commonly used PROMs.

Results: A total of 69 studies were included, comprising 14 randomized controlled trials (1193 patients) and 55 observational studies (3327 patients), totaling 4520 participants. These studies reported 68 PROs and 57 PROMs. The most commonly used PROMs were the Female Sexual Function Index (FSFI, 47.83%), Vaginal Laxity Questionnaire (VLQ), Visual Analog Scale (VAS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Sexual Satisfaction Questionnaire (SSQ). Notably, 42 PROMs (73.68%) appeared only once.

Conclusions: PROs for surgical and non-surgical VRS treatments are similar, but non-surgical interventions include additional outcomes, such as overall efficacy and patient's vaginal tightness satisfaction. The high proportion of unvalidated PROMs (81.09%) underscores the need for standardized, disease-specific measures. Future Delphi surveys and expert consensus are anticipated to facilitate the development of a comprehensive core outcome set (COS) and core outcome measurement set (COMS) for VRS.

查看原文本刊更多论文

患者报告的结果和阴道松弛综合征管理措施：系统回顾。

背景：在已发表的阴道松弛综合征（VRS）临床研究中，患者报告结果（pro）和患者报告结果测量（PROMs）的异质性阻碍了交叉研究比较和循证结果的整合，阻碍了强有力的临床证据的发展。目的：全面了解pro和PROMs在VRS研究中的应用现状，编制综合目录，为VRS患者选择结局指标和工具提供指导。方法：本研究系统检索了截至2024年12月在PUBMED、EMBASE、Web of Science和Cochrane数据库中发表的VRS治疗的临床研究，主要集中在盆底肌肉训练、物理能量疗法和手术干预方面。对PROs和prom进行提取，组织成一个结构化的目录，并按主题域进行分类。采用COSMIN检查表对常用prom的测量性能进行评估。结果：共纳入69项研究，包括14项随机对照试验（1193例）和55项观察性研究（3327例），共计4520名受试者。这些研究报告了68个PROs和57个prom。最常用的问卷是女性性功能指数（FSFI, 47.83%）、阴道松弛问卷（VLQ）、视觉模拟量表（VAS）、盆腔器官脱垂/尿失禁性问卷（PISQ-12）和性满意度问卷（SSQ）。值得注意的是，42个prom（73.68%）只出现过一次。结论：手术和非手术治疗VRS的优点相似，但非手术干预包括额外的结果，如总体疗效和患者阴道紧度满意度。未经验证的prom的高比例（81.09%）强调了标准化的疾病特异性措施的必要性。未来的德尔菲调查和专家共识有望促进VRS综合核心结果集（COS）和核心结果测量集（COMS）的发展。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health and Quality of Life Outcomes 医学-卫生保健

CiteScore

7.30

自引率

2.80%

发文量

154

审稿时长

3-8 weeks

期刊介绍： Health and Quality of Life Outcomes is an open access, peer-reviewed, journal offering high quality articles, rapid publication and wide diffusion in the public domain. Health and Quality of Life Outcomes considers original manuscripts on the Health-Related Quality of Life (HRQOL) assessment for evaluation of medical and psychosocial interventions. It also considers approaches and studies on psychometric properties of HRQOL and patient reported outcome measures, including cultural validation of instruments if they provide information about the impact of interventions. The journal publishes study protocols and reviews summarising the present state of knowledge concerning a particular aspect of HRQOL and patient reported outcome measures. Reviews should generally follow systematic review methodology. Comments on articles and letters to the editor are welcome.