Oriana Ciani1, Maximilian Salcher-Konrad2, Michela Meregaglia3, Kathrine Smith4, Sarah L Gorst5, Susanna Dodd5, Paula R Williamson5, Giovanni Fattore6. 1. 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. Electronic address: oriana.ciani@unibocconi.it. 2. 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. 3. Centre for Research on Health and Social Care Management, SDA Bocconi, via Sarfatti 10, 20136, Milan, Italy. 4. Imperial College, London, UK. 5. MRC/NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool L69 3BX, UK. 6. Centre for Research on Health and Social Care Management, SDA Bocconi, via Sarfatti 10, 20136, Milan, Italy; Department of Social and Political Science, Bocconi University, via Sarfatti 36, 20136, Milan, Italy.
Abstract
OBJECTIVE: 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. STUDY DESIGN AND SETTING: 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. RESULTS: 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%). CONCLUSION: 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.
OBJECTIVE: 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. STUDY DESIGN AND SETTING: 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. RESULTS: 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%). CONCLUSION: 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.