Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.
Pharmacy Policy and Strategic Planning Division, Pharmaceutical Services Programme, Ministry of Health Malaysia, 46200, Petaling Jaya, Selangor, Malaysia.
Osteoporos Int. 2024 May;35(5):745-757. doi: 10.1007/s00198-023-07005-0. Epub 2024 Jan 9.
The 41-item Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) is a widely used and freely available patient-reported outcome measure (PROM). However, data on its reliability, validity, and responsiveness remain unclear. Therefore, this study aimed to systematically review the measurement properties of the QUALEFFO-41. A systematic search of MEDLINE, EBSCOhost, and Cochrane Library from their inception up to December 2022 was performed. Data were extracted, and the methodological quality of each measurement property was evaluated according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. The evidence of the measurement properties was rated against the updated criteria for good measurement properties, and the quality of evidence was graded using the modified GRADE approach. A total of 99 articles were identified, of which eight studies were included in the review. The QUALEFFO-41 is categorized as B as it demonstrated moderate quality evidence for sufficient content validity, moderate-to-high quality evidence for sufficient hypothesis testing for construct validity (except for the social function domain for convergent validity), and very low-quality evidence for sufficient responsiveness. For structural validity and internal consistency, only the domains of pain and general health perception were sufficient with low-quality evidence. For reliability, only the domain of physical function was sufficient with low-quality evidence. None of the studies reported measurement error, cross-cultural validity, and criterion validity. The QUALEFFO-41 may be a promising, valid, and reliable PROM to assess HRQoL in osteoporosis patients with vertebral fractures. However, future studies must focus on good methodological quality to strengthen the evidence of measurement properties, especially on structural validity, reliability, responsiveness, and cross-cultural validity. The systematic review evaluated the measurement properties of the QUALEFFO-41 questionnaire for assessing Health-Related Quality of Life (HRQoL) in osteoporosis patients. The review found moderate-to-high-quality evidence for construct validity but limited evidence for responsiveness and other properties. Future studies should focus on strengthening the evidence, particularly for structural validity, reliability, responsiveness, and cross-cultural validity. The QUALEFFO-41 shows promise as a valid and reliable PROM for HRQoL assessment in osteoporosis patients.
欧洲骨质疏松症基金会的 41 项生活质量问卷（QUALEFFO-41）是一种广泛使用且免费的患者报告结局测量工具（PROM）。然而，其可靠性、有效性和反应度的数据仍不清楚。因此，本研究旨在系统地回顾 QUALEFFO-41 的测量特性。从成立到 2022 年 12 月，对 MEDLINE、EBSCOhost 和 Cochrane Library 进行了系统搜索。提取数据，并根据共识基础选择健康测量工具（COSMIN）指南评估每个测量特性的方法学质量。根据更新的良好测量特性标准对测量特性的证据进行评级，并使用改良的 GRADE 方法对证据质量进行分级。共确定了 99 篇文章，其中 8 篇研究被纳入综述。QUALEFFO-41 被归类为 B，因为它在内容有效性方面具有中等质量的证据，在结构有效性和内部一致性方面，仅物理功能领域具有足够的低质量证据。在可靠性方面，仅物理功能领域具有足够的低质量证据。没有研究报告测量误差、跨文化有效性和标准有效性。QUALEFFO-41 可能是一种有前途的、有效的和可靠的 PROM，可用于评估骨质疏松症伴椎体骨折患者的健康相关生活质量（HRQoL）。然而，未来的研究必须注重良好的方法学质量，以加强测量特性的证据，特别是结构有效性、可靠性、反应度和跨文化有效性。系统评价评估了 QUALEFFO-41 问卷用于评估骨质疏松症患者健康相关生活质量（HRQoL）的测量特性。该综述发现，结构有效性具有中等至高度的证据，但反应度和其他特性的证据有限。未来的研究应重点加强证据，特别是结构有效性、可靠性、反应度和跨文化有效性。QUALEFFO-41 作为一种有效的骨质疏松症患者 HRQoL 评估的可靠 PROM 具有潜力。
