- •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.
Study design and setting
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Conflict of interest: The authors do not declare any conflict of interest in relation to the present study.
Authors’ contributions: O.C., M.S.K., M.M. contributed to the conceptualization and methodology. O.C., M.S.K., M.M., K.S., S.G., S.D. performed the analyses. O.C., M.S.K., M.M. wrote the original draft. K.S., S.G., S.D., P.W., G.F. reviewed and edited the draft. G.F. acquired financial support for the project.
Funding: This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116055 (Big Data for Better Outcomes DO-IT). This Joint Undertaking receives support from the European Union's Horizon 2020 Research and Innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). This work was also supported by a National Institute for Health Research (NIHR) Senior Investigator Award ( NF-SI_0513-10025 ) and the MRC Trials Methodology Research Partnership (grant reference MR/S014357/1 ).