Leysen Laurence, Marticic Giljevic Karla, Piccinin Claire, Shkodra Morena, Pe Madeline, Petersen Morten, Apolone Giovanni, Brunelli Cinzia, Lombardo Claudio, Velikova Galina, Gilbert Alexandra, Pravettoni Gabriella, Ciliberto Gennaro, Groenvold Mogens, Ferrer Montserrat, Bos Nanne, Pietrobon Ricardo, Couespel Norbert, Caraceni Augusto, Guren Marianne, Sirven Aude, Vachon Hugo
Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
BMJ Open. 2025 Mar 29;15(3):e088716. doi: 10.1136/bmjopen-2024-088716.
Over the past decades, there has been increasing recognition that assessing patients with cancer's health-related quality of life (HRQoL) is pivotal to delivering optimal patient-centred healthcare. However, with the increasing number of patient-reported outcome measures (PROMs) available, it becomes more and more challenging to identify the most appropriate PROM to capture HRQoL. Therefore, the aim of this systematic review is to (1) identify all available PROMs assessing HRQoL across the European cancer continuum and (2) critically appraise, compare and summarise the psychometric properties of the identified PROMs.
Bibliographic databases MEDLINE and PubMed Central (through PubMed) and EMBASE (through Scopus) will be comprehensively searched from database inception until March 2024. Studies reporting on the measurement properties of PROMs assessing HRQoL throughout the European cancer continuum will be included. The evaluation of the psychometric properties, data extraction and data synthesis will be conducted according to the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. Two reviewers will independently assess the methodological quality using the COSMIN risk of bias checklist and the COSMIN criteria for good measurement properties. Subsequently, findings will be qualitatively summarised. The Grading of Recommendations Assessment, Development and Evaluations (GRADE) guidelines will be used to grade and summarise the quality of the evidence.
Ethical clearance for this research is not required, as the systematic review will only use information from previously published research. The results of this review will be submitted for publication in a peer-reviewed journal and will be used to provide a set of evidence-based recommendations for a European project (EUonQOL), which aims at developing a new PROM (EUonQOL toolkit) to assess HRQoL across the European cancer continuum. Moreover, findings will be disseminated to a clinical audience and policymakers through conferences, supporting researchers and clinicians in choosing the best measure to evaluate HRQoL in patients with cancer and survivors in Europe.
CRD42023418616.
在过去几十年中，人们越来越认识到评估癌症患者的健康相关生活质量（HRQoL）对于提供以患者为中心的最佳医疗保健至关重要。然而，随着可用的患者报告结局测量工具（PROMs）数量不断增加，确定最适合用于评估HRQoL的PROM变得越来越具有挑战性。因此，本系统评价的目的是：（1）识别欧洲癌症全程中所有可用的评估HRQoL的PROM；（2）严格评估、比较和总结所识别PROM的心理测量特性。
将全面检索文献数据库MEDLINE和PubMed Central（通过PubMed）以及EMBASE（通过Scopus），检索时间从数据库建立至2024年3月。纳入报告欧洲癌症全程中评估HRQoL的PROM测量特性的研究。将根据基于共识的健康测量工具选择标准（COSMIN）方法进行心理测量特性评估、数据提取和数据合成。两名评价者将使用COSMIN偏倚风险清单和COSMIN良好测量特性标准独立评估方法学质量。随后，将对结果进行定性总结。将使用推荐分级评估、制定与评价（GRADE）指南对证据质量进行分级和总结。
本研究无需伦理批准，因为该系统评价仅使用先前发表研究中的信息。本评价结果将提交至同行评审期刊发表，并将用于为一个欧洲项目（EUonQOL）提供一套基于证据的建议，该项目旨在开发一种新的PROM（EUonQOL工具包）以评估欧洲癌症全程中的HRQoL。此外，研究结果将通过会议向临床受众和政策制定者传播，支持研究人员和临床医生选择最佳测量工具来评估欧洲癌症患者及其幸存者的HRQoL。
PROSPERO注册号：CRD42023418616。
