Centre for Research on Health and Social Care Management, SDA Bocconi, via Sarfatti 10, 20136, Milan, Italy; Evidence Synthesis and Modeling for Health Improvement, College of Medicine and Health, University of Exeter, EX1 2LU, Exeter, UK.
LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK; Care Policy and Evaluation Centre, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK.
J Clin Epidemiol. 2021 Aug;136:26-36. doi: 10.1016/j.jclinepi.2021.03.003. Epub 2021 Mar 6.
There is no comprehensive assessment of which patient-reported outcomes (PROs) are recommended in core outcome sets (COS), and how they should be measured. The aims of this study are to review COS that include patient-reported outcomes measures (PROMs), identify their target health domains, main characteristics, and their overlap within and across different disease areas.
We selected COS studies collected in a publicly available database that included at least one recommended PROM. We gathered information on study setting, disease area, and targeted outcome domains. Full-text of recommended instruments were obtained, and an analysis of their characteristics and content performed. We classified targeted domains according to a predefined 38-item taxonomy.
Overall, we identified 94 COS studies that recommended 323 unique instruments, of which: 87% were included in only one COS; 77% were disease-specific; 1.5% preference-based; and 61% corresponded to a full questionnaire. Most of the instruments covered broad health-related constructs, such as global quality of life (25%), physical functioning (22%), emotional functioning and wellbeing (7%).
The wealth of recommended instruments observed even within disease areas does not fit with a vision of systematic, harmonized collection of PROM data in COS within and across disease areas.
目前尚无综合评估哪些患者报告结局（PROs）被纳入核心结局测量集（COS），以及应如何对其进行测量。本研究旨在对包含患者报告结局测量（PROMs）的 COS 进行综述，确定其目标健康领域、主要特征以及在不同疾病领域内和跨疾病领域的重叠情况。
我们选择了在公开数据库中收集的 COS 研究，这些研究至少包含一种推荐的 PROM。我们收集了有关研究设置、疾病领域和目标结局领域的信息。获取了推荐仪器的全文，并对其特征和内容进行了分析。我们根据预定义的 38 项分类法对目标领域进行了分类。
总体而言，我们确定了 94 项 COS 研究，推荐了 323 种独特的仪器，其中：87%的仪器仅包含在一个 COS 中；77%为疾病特异性；1.5%基于偏好；61%对应完整问卷。大多数仪器涵盖了广泛的健康相关结构，如总体生活质量（25%）、身体功能（22%）、情感功能和幸福感（7%）。
即使在疾病领域内，观察到的推荐仪器数量之多也不符合在疾病领域内和跨疾病领域系统、协调地收集 COS 中的 PROM 数据的设想。
