Health-related quality of life (HRQoL) measures are a type of patient-reported outcome (PRO). Patients play a vital role in ensuring that their perspectives are reflected in the development, validation, and use of these instruments—especially in the early stages of clinical development. 

Specifically, patients can: 

📝 Contribute to the design of HRQoL instruments by helping to identify and formulate meaningful questions (items) addressing specific concepts and domains;

✅ Review and endorse HRQoL measures that meet quality standards and demonstrate meaningful inclusion of the patient voice;

🔍 Scrutinise the use of HRQoL measures and the magnitude of changes claimed in HTA submissions or marketing authorisation applications;

💬 Share personal experiences that illustrate and validate the key domains captured by HRQoL instruments.

 

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.