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The role of patients
HRQoL measures are a type of patient reported outcome (PRO). Patients have opportunities to ensure that their perspective is considered in the development and design of these measures in the early stages of clinical development. They can also actively review and endorse HRQoL measures that meet quality standards and have included patients in their design and development, notably by giving input to formulating appropriate questions (items) in instruments addressing specific concepts and domains.
Patients can also:
- scrutinise HRQoL measures and the magnitude of claimed changes in HRQoL used in HTA submissions and submissions for marketing authorisation to regulatory authorities,
- endorse certain HRQoL measures, and
- relate patient experiences in a way that reflects the key conceptual domains of HRQoL.
Patient involvement in developing HRQoL instruments follows the same principles as for any other PROM. Please visit Lesson 3 section 3.3 for guidance on patient involvement in PROMs.