Yang Shuhao, Yan Qing, Liu Fei, Yan Wei, Yuan Suzhen, Zhang Minli, Xiang Tao, Wang Shixuan, Li Ya, Wang Wenwen
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
BMJ Open. 2025 Jul 28;15(7):e087443. doi: 10.1136/bmjopen-2024-087443.
To systematically evaluate the psychometric measurement properties of existing patient-reported outcome measures (PROMs) for uterine fibroids using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and to provide recommendations for the most appropriate tools in clinical and research settings.
Systematic review using the COSMIN guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
The Medline, CINAHL, Embase and Web of Science databases were searched for relevant studies published up to 28 February 2025. Eligibility criteria were studies that targeted patients with uterine fibroids using a PROM instrument and were published as full-text, English-language articles in peer-reviewed journals. Studies that used only a portion or an unvalidated short form of the PROMs, non-English publication or non-peer-reviewed formats were excluded.
Two independent reviewers extracted the data using EndNote V.X9 (Clarivate, London, UK). The PROM quality assessment adhered to the COSMIN guidelines. The level of evidence for the psychometric properties of each PROM was determined using a modified GRADE approach.
Of 678 records retrieved in the literature search, 11 were included. Six uterine fibroid-specific PROMs were identified and evaluated according to the COSMIN guidelines. The Uterine Fibroid Symptom and Quality of Life (UFS-QoL) and the Bleeding and Pelvic Discomfort Scale (BPD) received class A recommendations (recommended) for sufficient content and structural and internal consistency. However, four other PROMs, namely the Perioperative Anxiety Scale for Uterine Fibroids, Fibroid Symptom Diary, Uterine Fibroid Daily Bleeding Diary and Menstrual Pictogram Superabsorbent Polymer-containing Version 3, received class B recommendations (further research required) due to poor measurement properties, including inadequate reliability and unquantified measurement error.
The results of the present study fill a knowledge gap in the systematic and comprehensive evaluation of uterine fibroid-related PROMs. These findings provide valuable insights and recommendations for clinicians and researchers seeking reliable PROMs for this patient population. The UFS-QoL and BPD were classified as 'A' and were recommended, demonstrating the potential to promote outcome measurements in future studies.
CRD42023474806.
使用基于共识的健康测量工具选择标准（COSMIN）指南，系统评估现有子宫肌瘤患者报告结局测量工具（PROMs）的心理测量特性，并为临床和研究环境中最合适的工具提供建议。
采用COSMIN指南和推荐分级评估、制定与评价（GRADE）方法进行系统评价。
检索Medline、CINAHL、Embase和科学网数据库，查找截至2025年2月28日发表的相关研究。纳入标准为使用PROM工具针对子宫肌瘤患者的研究，且以全文、英文发表在同行评审期刊上。仅使用PROMs一部分或未经验证的简短形式、非英文出版物或非同行评审格式的研究被排除。
两名独立评审记录检索，两名独立评审员使用EndNote V.X9（英国伦敦Clarivate公司）提取数据。PROM质量评估遵循COSMIN指南。使用改良的GRADE方法确定每个PROM心理测量特性的证据水平。
在文献检索中检索到的678条记录中，纳入了11条。根据COSMIN指南确定并评估了六种子宫肌瘤特异性PROMs。子宫肌瘤症状与生活质量（UFS-QoL）和出血与盆腔不适量表（BPD）因内容充分、结构和内部一致性良好而获得A级推荐（推荐）。然而，其他四种PROMs，即子宫肌瘤围手术期焦虑量表、肌瘤症状日记、子宫肌瘤每日出血日记和含超吸收性聚合物的月经象形图第3版，由于测量特性较差，包括可靠性不足和测量误差未量化，获得B级推荐（需要进一步研究）。
本研究结果填补了子宫肌瘤相关PROMs系统全面评价方面的知识空白。这些发现为寻求针对该患者群体可靠PROMs的临床医生和研究人员提供了有价值的见解和建议。UFS-QoL和BPD被归类为“A”级并被推荐，显示出在未来研究中促进结局测量的潜力。
PROSPERO注册号：CRD42023474806。
