Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Universiti Malaya, Kuala Lumpur, Malaysia.
Department of Obstetrics and Gynecology, University Hospital Sharjah, Sharjah, United Arab Emirates.
Int J Gynaecol Obstet. 2024 Feb;164(2):613-623. doi: 10.1002/ijgo.15106. Epub 2023 Sep 13.
To develop and validate an electronic, patient-reported outcomes measure (PROM) specific for genitourinary syndrome of menopause (GSM) patients. The PROM aimed to accurately assess the burden of GSM symptoms, their impact on health-related and sexual quality of life, and the acceptability of vaginal treatments.
The study encompassed a comprehensive three-stage approach to the development and validation of the PROM. Initially, during the preliminary design stage, the necessity for a new PROM was recognized, an expert panel was formed, and semi-structured qualitative interviews were carried out with GSM patients. In the second stage, the study used the five-step pre-validation methodology established by Prior et al. to generate and refine the PROM items. The third and final stage encompassed the determination of scale and item content validity indexes to ensure validity. Additionally, the reliability of each construct was evaluated using Cronbach's α.
The resulting PROM was named GSM-SVTAQ (GSM-symptoms and vaginal treatments acceptability questionnaire). It demonstrated excellent validity in assessing symptoms burden, health-related and sexual quality of life, and vaginal treatment acceptability, with high content validity indices and strong internal consistency. The scale content validity indices and Cronbach's α coefficients for the three domains were (0.926, 0.939), (0.875, 0.947), and (0.824, 0.855), respectively.
The GSM-SVTAQ stands as the first GSM-specific, valid, and reliable PROM capable of comprehensively measuring the three components of GSM and the acceptability of vaginal treatments. Its implementation has the potential to significantly enhance patient care and outcomes in GSM management.
开发和验证一种专门针对女性生殖泌尿系统绝经综合征(GSM)患者的电子患者报告结局测量工具(PROM)。该 PROM 旨在准确评估 GSM 症状的负担、其对健康相关和性生活质量的影响,以及阴道治疗的可接受性。
该研究采用了综合的三阶段方法来开发和验证 PROM。最初,在初步设计阶段,认识到需要开发一种新的 PROM,成立了一个专家小组,并对 GSM 患者进行了半结构化定性访谈。在第二阶段,研究采用了 Prior 等人提出的五步预验证方法来生成和精炼 PROM 项目。第三阶段也是最后阶段包括确定量表和项目内容有效性指标以确保有效性。此外,还使用 Cronbach's α 评估每个构建的可靠性。
由此产生的 PROM 被命名为 GSM-SVTAQ(GSM-症状和阴道治疗可接受性问卷)。它在评估症状负担、健康相关和性生活质量以及阴道治疗可接受性方面表现出优异的有效性,具有较高的内容有效性指标和较强的内部一致性。三个领域的量表内容有效性指标和 Cronbach's α 系数分别为(0.926、0.939)、(0.875、0.947)和(0.824、0.855)。
GSM-SVTAQ 是第一个专门针对 GSM 的有效且可靠的 PROM,能够全面测量 GSM 的三个组成部分和阴道治疗的可接受性。它的实施有可能显著改善 GSM 管理中患者的护理和结果。