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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
Background  ,[object Object],[object Object],[object Object]
Definitions of Quality of Life ,[object Object]
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)
Outcomes ,[object Object],[object Object],[object Object],Decision should not be made on two dimensional basis
Patient Outcomes Model (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Patient Outcomes Model (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Consultations should address patient’s needs during and after treatment
Linking Clinical & HRQoL Variables Measures of Patient Outcomes ,[object Object],[object Object],[object Object],[object Object],[object Object]
Linking Clinical and HRQoL Variables Source of Data    Overall QoL    General Health     Functional Status     Symptom Status  Biological/Physiological Patient Carer Physiological Clinician
Biological/Physiological ,[object Object],[object Object],[object Object],[object Object],[object Object]
Symptom Status ,[object Object]
Functional Status ,[object Object]
General Health Perceptions ,[object Object],[object Object],[object Object]
Example Overall QoL General Health Inability to walk stairs Inability to sleep Functional Status Hip pain Itching Symptom Status Biological/Physiological
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
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
Association of Clinical &  HRQoL Variables Acne ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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
Why Care About Error? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How to do it? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Guidelines for Instrument Reliability/Precision ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reliability of Common  Clinical Measures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Low Moderate High
Reliability of Common  Clinical Measures ,[object Object],[object Object],[object Object],[object Object],[object Object],Low Moderate High
Reliability of Common  Clinical Measures ,[object Object],[object Object],[object Object],[object Object],[object Object],Low Moderate High
Reliability of Common  Clinical Measures Oncology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Low Moderate High
Reliability of HRQoL Data  SF-36 (McHorney & Tarlov, Qual Life Res, 1995) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Low Moderate High
Reliability of HRQoL Data  NHP (McHorney & Tarlov, Qual Life Res, 1995) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Low Moderate High
Clinical Significance Problems and Solutions ,[object Object],[object Object]
Why is it Difficult to Define  “Clinical Significance” for QOL? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Usefulness of QOL Measures for Clinicians ,[object Object],[object Object],[object Object],[object Object]
Take Home Message (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Take Home Message (2) ,[object Object],[object Object],[object Object],[object Object]
What is the Basic Problem with Quality of Life? How are you? I’m a little different and relatively young

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ARE WE USING THE RIGHT OUTCOME MEASURE TO ASCERTAIN PATIENT BENEFIT FROM DRUG THERAPY?

  • 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
  • 2.
  • 3.
  • 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)
  • 5.
  • 6.
  • 7.
  • 8.
  • 9. Linking Clinical and HRQoL Variables Source of Data    Overall QoL    General Health     Functional Status     Symptom Status  Biological/Physiological Patient Carer Physiological Clinician
  • 10.
  • 11.
  • 12.
  • 13.
  • 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
  • 17.
  • 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
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33. What is the Basic Problem with Quality of Life? How are you? I’m a little different and relatively young