Element card for assessment element D0013 in HTA Core Model Application for Medical and Surgical Interventions (2.0) application

D. Clinical Effectiveness

Health-related Quality of life

What is the effect of the technology on disease specific quality of life?


Health related quality of life (HRQL) is typically measured with self- or interviewer-administered questionnaires to measure cross-sectional differences in quality of life between patients at a point in time (discriminative instruments) or longitudinal changes in HRQL within patients during a period of time (evaluative instruments). Two basic approaches to quality-of-life measurement are available: generic instruments that provide a summary of HRQL; and specific instruments that focus on problems associated with single disease states, patient groups, or areas of function. Each approach has its strengths and weaknesses and may be suitable for different circumstances.See also •Methodological guideline for REA of pharmaceuticals: Health-related quality of life. http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Health-related%20quality%20of%20life.pdf

Trials, observational and qualitative studies




EMEA 2005, FDA 2009, Chassany 2002, Terwee 2007, Revicki 2008, Puhan 2006