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Patient-reported outcome measures in core outcome sets targeted overlapping domains but through different instruments

      Highlights

      • A total of 323 unique patient-reported outcomes measures (PROMs) were recommended for use across 94 core outcome sets (COS) and 26 disease areas.
      • Eighty-seven percent of instruments were recommended in only one COS, and each COS included a median of 4.5 instruments.
      • Overall, global quality of life (25%) and physical functioning (22%) were the most frequently targeted health outcome domains.
      • A fragmented landscape of recommended PROMs in COS calls for better harmonization of PRO selection and measurement.

      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.

      Keywords

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