The document discusses using patient-reported outcome measures like health-related quality of life (HRQoL) to evaluate the benefits of drug therapy from the patient's perspective. While traditionally outcomes were measured clinically, there is a shift towards considering how patients feel treatment impacts their daily lives. The document outlines challenges in defining what constitutes a clinically significant change in HRQoL and proposes further refining measures and educating clinicians on appropriate HRQoL data use.

1. ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG THERAPY? Professor Sam Salek Centre for Socioeconomic Research Welsh School of Pharmacy Cardiff University

4. Definitions of HRQoL Quality of life in clinical medicine represents the functional effect of an illness and its consequent therapy upon a patient, as perceived by the patient. (Schipper, et al 1996)

9. Linking Clinical and HRQoL Variables Source of Data    Overall QoL    General Health     Functional Status     Symptom Status  Biological/Physiological Patient Carer Physiological Clinician

14. Example Overall QoL General Health Inability to walk stairs Inability to sleep Functional Status Hip pain Itching Symptom Status Biological/Physiological

15. Example Depression, anxiety Inability to handle stressful situations “ in general, how would you rate your health?” “ overall, how would you rate your quality of life?” Overall QoL General Health Functional Status Symptom Status Biological/Physiological

16. Association of Clinical & HRQoL Variables Cystic Fibrosis 0.75 Patient-Reported MRC Dyspnea Scale Satisfaction HRQoL (QWB, SIP) Carer Proxy family carer 0.57 Clinician-Reported Maximal capacity- Exercise QoL 0.40 0.33 Satisfaction MRC Carer EX FEV 1 0.84 SaO 2 CT Physiological HR CT SaO 2 FEV 1

18. Association of Clinical & HRQoL Variables Atopic Dermatitis 0.65 0.82 0.72 0.70 0.75 0.80 0.70 0.67 Patient-Reported Sleep Itch Tolerability Efficacy EDI 0.38 0.19 0.57 0.67 UK-SIP 0.18 0.01 0.50 0.65 Clinician-Reported Disease activity Extent of disease Tolerability Efficacy

33. What is the Basic Problem with Quality of Life? How are you? I’m a little different and relatively young