OBJECTIVES:

Patient-reported outcomes (PROs) constitute an integral part of health outcome measurement and are an essential component in the implementation of value-based care. However, no widely agreed consensus exists on patient-reported outcomes that could be measured across diseases, thus allowing for better comparability of outcome states between diseases and across the life course of individuals. Generic outcomes could also be applicable throughout the life cycle of medical interventions and reduce a potential overburdening of multimorbid patients with too many questionnaires.

Aim: To develop an international, multistakeholder consensus on generic, patient-reported outcome measurement and assess potential latent underlying factors.

METHODS:

We first reviewed existing generic outcome sets. Secondly, we performed a Delphi exercise to weigh the domains which we extracted from the existing sets. We then investigated the generic overlaps between outcome domains that were defined in parallel disease-specific workstreams in three chronic diseases (cancer, diabetes, and inflammatory bowel disease). Finally, we held a virtual consensus meeting with representatives from all stakeholder groups, including patients, regulators, clinical experts and researchers from both private and public organisations.

RESULTS:

Results of the Delphi study produced twelve distinct outcome domains with generic PRO potential. Five of the domains include manifest constructs bringing the total number of measures reviewed to twenty-four. A scale was identified for each measure and were assessed for appropriateness across the three diseases. An investigation into the relevance of each domain by disease type found five domains achieved a one-hundred percent agreement rate across stakeholders, including: mental wellbeing, physical functioning, sleep quality, and disease management.

CONCLUSIONS:

An exploration of the holistic importance of the domains identified and their broad relevance to numerous diseases was discussed. The generic perspective ensures that outcome domains listed in the three disease-specific streams are comprehensive in coverage and relevance.