Center for Research on Health and Social Care Management, SDA Bocconi School of Management, Milan, Italy.
Department of Oncology, University of Turin, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy; Italian Association of Medical Oncology (AIOM), Italy.
Eur J Cancer. 2024 Aug;207:114161. doi: 10.1016/j.ejca.2024.114161. Epub 2024 Jun 10.
Choosing the most adequate measure of patient-reported outcomes (PROs) for a specific medical condition is not straightforward. This study aimed to develop a comprehensive archive of patient-reported outcome measures (PROMs), observer-reported outcome measures (ObsROMs) and caregiver-reported outcome measures (CROMs) in oncology and identify their main characteristics and target outcome domains.
As part of the Italian PRO4All Project, we retrieved questionnaires through an extensive search of online databases. We developed a data extraction form to collect information on cancer type, questionnaire variant(s), recall period, and scoring system. We performed a content analysis of the questionnaires to assign each item a specific outcome domain according to a predefined 38-item taxonomy.
A total of 386 PROMs (n = 356), ObsROMs (n = 13) and CROMs (n = 17) were identified and described; of these, 358 were also analyzed in their content. 47.3 % of the instruments were cancer type-specific, 45.1 % were generic for cancer and 7.9 % were developed for the general population but also recommended in oncology. The great majority (92.2 %) were patient-reported. In 50.3 % the recall period was "last week". The mean number of items per questionnaire was 22.0 (range: 1-130). 7794 items were assigned an outcome domain, the most frequent being emotional functioning/wellbeing (22 %), physical functioning (15.7 %), general outcomes (10.1 %) and delivery of care (8.9 %).
There are a variety of patient and caregiver-reported measures in oncology. This archive can guide researchers and practitioners in selecting the most suitable measures and fostering a patient-centered approach in clinical trials, clinical practice, and regulatory activities.
为特定的医疗状况选择最合适的患者报告结局（PROs）测量方法并非易事。本研究旨在建立一个全面的肿瘤患者报告结局测量（PROM）、观察者报告结局测量（ObsROM）和照顾者报告结局测量（CROM）档案，并确定其主要特征和目标结局领域。
作为意大利 PRO4All 项目的一部分，我们通过广泛搜索在线数据库检索问卷。我们制定了数据提取表格，以收集有关癌症类型、问卷变体、回忆期和评分系统的信息。我们对问卷进行了内容分析，根据预先设定的 38 项分类法，为每个条目分配一个特定的结局领域。
共确定并描述了 386 个 PROM（n=356）、ObsROM（n=13）和 CROM（n=17）；其中 358 个也进行了内容分析。47.3%的工具是针对特定癌症类型的，45.1%是通用的癌症工具，7.9%是为一般人群开发的，但也推荐用于肿瘤学。绝大多数（92.2%）是患者报告的。在 50.3%的情况下，回忆期为“上周”。每个问卷的平均条目数为 22.0（范围：1-130）。7794 个条目被分配到一个结局领域，最常见的是情绪功能/幸福感（22%）、身体功能（15.7%）、总体结局（10.1%）和护理提供（8.9%）。
肿瘤学中有多种患者和照顾者报告的测量方法。该档案可以为研究人员和从业者提供指导，帮助他们选择最合适的测量方法，并在临床试验、临床实践和监管活动中促进以患者为中心的方法。
