Department of Obstetrics and Gynaecology, Epsom & St Helier University Hospitals NHS Trust, London KT18 7EG, UK; St George's University of London, Crammer Terrace, London SW17 0RE, UK.
Department of Obstetrics and Gynaecology, Epsom & St Helier University Hospitals NHS Trust, London KT18 7EG, UK.
J Clin Epidemiol. 2022 Sep;149:1-11. doi: 10.1016/j.jclinepi.2022.04.016. Epub 2022 Apr 19.
To evaluate the content validity of 19 patient-reported outcome measures (PROMs) used to measure quality of life (QoL) in women with chronic pelvic pain (CPP).
We searched Embase, MEDLINE, PsycINFO databases and Google Scholar from inception to August 2020. We included records describing the development or studies assessing content validity of PROMs. Two reviewers independently assessed the methodological quality of PROMs using the Consensus-based Standards for the Selection of Health Measurement Instruments checklist. Evidence was synthesized for relevance, comprehensiveness, and comprehensibility. Quality of evidence was rated using a modified Grading of Recommendations, Assessment, Development, and Evaluations approach.
PROM development was inadequate for all instruments included in this review. No high-quality evidence ratings were found for relevance, comprehensiveness, and comprehensibility. QoL was measured using generic instruments (68.42%, 13/19) rather than those specific to chronic pain (21.04%, 4/19) or pelvic pain (10.53%, 2/19). Quality of concept elicitation was inadequate for 90% of PROMs. Half of PROMs did not include patients in their development and only 40% were devised using a sample representative of the target population for which the PROM was developed. Cognitive interviews were conducted in one-fifth of PROMs and were mostly of inadequate/doubtful quality.
There is poor quality of evidence for content validity of PROMs used to measure QoL in women with CPP.
评估 19 种用于测量慢性盆腔痛（CPP）女性生活质量（QoL）的患者报告结局测量（PROM）的内容效度。
我们检索了 Embase、MEDLINE、PsycINFO 数据库和 Google Scholar，检索时间从建库至 2020 年 8 月。我们纳入了描述 PROM 开发或评估其内容效度的研究记录。两名审查员使用共识基础的健康测量仪器选择标准清单独立评估 PROM 的方法学质量。采用相关性、全面性和可理解性综合证据。使用改良的推荐评估、开发和评估方法对证据质量进行评级。
本综述纳入的所有工具的 PROM 开发均不充分。在相关性、全面性和可理解性方面，均未发现高质量证据评级。QoL 测量使用通用工具（68.42%，13/19）而非慢性疼痛（21.04%，4/19）或盆腔疼痛专用工具（10.53%，2/19）。90%的 PROM 概念提取质量不充分。一半的 PROM 未纳入患者参与开发，只有 40%是根据目标人群样本设计的。五分之一的 PROM 进行了认知访谈，且大多质量不足/可疑。
用于测量 CPP 女性 QoL 的 PROM 的内容效度证据质量较差。
