1 Utilization of Quality of Life Research in Decision-Making and Policy  Prof. Dr. Jan J.V. Busschbach  Erasmus MC, Rotterdam, The Netherlands  Section Medical Psychology and Psychotherapy Department of Psychiatry  Conflict of Interest  Member of the EuroQol Group  Chair of the EuroQol Research Foundation

2 Health Economics  Comparing different allocations  Should we spent our money on Wheel chairs Screening for cancer  Comparing costs  Comparing outcome  Outcomes must be comparable  Make a generic outcome measure 2

3 Outcomes in health economics  Specific outcome are incompatible  Allow only for comparisons within the specific field Clinical successes: successful operation, total cure Clinical failures: “events” “Hart failure” versus “second psychosis”  Generic outcome are compatible  Allow for comparisons between fields Life years Quality of life  Most generic outcome  Quality adjusted life year (QALY) 3

4  Example  Blindness  Quality of life value = 0.5  Life span = 80 years  0.5 x 80 = 40 QALYs Quality Adjusted Life Years: QALYs X Life years x 80 = 40 QALYs

QALY = Area under the curve

6 Which health care program is the most cost-effective?  A new wheelchair for elderly (iBOT)  Special post natal care 6

7 Which health care program is the most cost-effective?  A new wheelchair for elderly (iBOT)  Increases quality of life = 0.1  10 years benefit  QALY = Y x V(Q) = 10 x 0.1 = 1 QALY  Extra costs: $ 3,000 per life year  Costs are 10 x $ 3,000 = $30,000  Cost/QALY = 30,000/QALY  Special post natal care  Quality of life = 0.8  35 year  QALY = 35 x 0.8 = 28 QALY  Costs are $ 250,000  Cost/QALY = 8,929/QALY 7

QALYs are truly cross-disciplinary / holistic  A holistic view on Healthcare  Include both survival and quality of live  Generic  Include main and side effects  Cross-disciplinary  Health Economics  Clinical Decision making  Epidemiology 8

QALYs in clinical decision making  Haynes, Sackett, Guyatt and Tugwell  How to Do Clinical Practice Research…. 9

10 Burden of disease: QALY lost = DALY (Disability adjusted life year) DALY QALY

Fatal and non fatal burden 11

QALY publications

13  Example  Blindness  Quality of life value = 0.5  Life span = 80 years  0.5 x 80 = 40 QALYs Quality Adjusted Life Years: QALYs X Life years x 80 = 40 QALYs Most debate

14 Uni-dimensional value  QALYs need a uni-dimensional value  Like the IQ-test measures intelligence  QALYs need a ratio or interval scale  Difference 0.00 and 0.80 must be 8 time higher than 0.10  Five popular methods have these pretensions  Visual analog scale  Time trade-off  Standard gamble  Person Trade-off  Discrete Choice

15 Visual Analogue Scale  From psychological research  Also called “category scaling”  Rescale from 0.00 to 1.00  Main critique  No guarantee ratio scale  Lower value then face value

16 Time Trade-Off (TTO)  Wheelchair  With a life expectancy: 50 years  How many years would you trade-off for a cure?  Max. trade-off is 10 years  QALY(wheel) = QALY(healthy)  Y * V(wheel) = Y * V(healthy)  50 V(wheel) = 40 * 1  V(wheel) =.80  Main critique  Discounting effect  More complicated than VAS

Problems  Patients values tent to be too high  We rather have values from the general public  Time Trade-off is cumbersome 17

18 Patients values tend to be too high  Stensman  Scan J Rehab Med 1985;17:  Scores on a visual analogue scale  36 subjects in a wheelchair  36 normal matched controls  Mean score  Wheelchair: 8.0  Health controls: 8.3 Healthy Death

Coping  Medicine: Coping  Quality of life: Response shift  Psychology: Cognitive dissonance reduction  Economics: Preference drift  Is a good thing for patients…  ….but it not handy in measurement  You rather ask the general public 19

Societal values  Patient  Consumer  The patient does not pay  …. In a (social) health insurance system  Consumer = General public  Potential patients are paying  Those who feel solidarity with patients  We need the values of the general public  In health economics 20

21 Time Trade-off is cumbersome  Can we not find a more simple way?

22 TTO validated questionnaires MOBILITY  I have no problems in walking about  I have some problems in walking about  I am confined to bed SELF-CARE  I have no problems with self-care  I have some problems washing or dressing myself  I am unable to wash or dress myself USUAL ACTIVITIES (e.g. work, study, housework family or leisure activities)  I have no problems with performing my usual activities  I have some problems with performing my usual activities  I am unable to perform my usual activities PAIN/DISCOMFORT  I have no pain or discomfort  I have moderate pain or discomfort  I have extreme pain or discomfort ANXIETY/DEPRESSION  I am not anxious or depressed  I am moderately anxious or depressed  I am extremely anxious or depressed X X X X X 22221

Solvings problems  Problems  Patients values tent to be too high  We rather have values from the general public  Time Trade-off is cumbersome  Solutions: Validated TTO questionnaires  No patient values involved  Given values from the general public  Easy to administer 23

Validated Questionnaires  Most used at this moment  SF-6D  HUI Mark 2 & 3  EuroQol EQ-5D-3L & EQ-5D-5L  AQoL  Typical validation study  Involved a representative sample of the general population  N = [300…5.000]  Done per country 24

National valuations  Because translations differs…  Values must follow translations  Because culture differ  Values must follow culture  National value sets EQ-5D  EQ-5D-3L Belgium, Denmark, Europe, Finland, France, Germany, Japan, New Zealand, Netherlands, Singapore, Slovenia, Spain, UK, USA, Zimbabwe  EQ-5D-5L England, Japan, Canada, Uruguay, Netherlands, China, Korea, Singapore, Indonesia 25

The EQ-5D-5L questionnaire Versi Bahasa Melayu untuk Malaysia

Valuation study Malaysia  Prof Dr Asrul Akmal Shafie  Universiti Sains Malaysia  Prof Dr Nan Lou  National University of Singapore  The EuroQol Group 27

Typical EuroQol Study  EQ-5D-5L  1000 respondents general population  4 Regions  Representative for age, gender, etnisity  Using advanced quality control  Computer guided time trade-off interview  Specific training of interviewers  Online quality checks during research by the EuroQol office 28

Can we use EQ-5D?  Non commercial research  Free  Registration: get the right version!  Pharmaceutical industry  Most large companies have a subscription  Hospitals for routine outcome monitoring  Small fee 29

EQ-5D Products  EQ-5D-3L Translations  More than 171 languages in Self-complete paper format  Also available in; Telephone, Face-to-face, Proxy, IVR, Web and Tablet format  EQ-5D-5L Translations  More than 138 languages in self-complete paper format  Also available in Web and Tablet format  EQ-5D-Y Translations  Available in more than 41 languages  Youth between 7-12 years

NICE  National Institute of Clinical Excellence  UK health economics  New pharmaceutical products are evaluated  3% of pharmaceutical budget worldwide  Influence = 25%  Mandatory  NICE methods guide 2008  QALY analysis  EQ-5D mandatory: reference case

Reference case  In the UK, EQ-5D is the reference case  Demanded by NICE in health economic evaluation  Deviations are allowed  Must be motivated  But….  ….EQ-5D should be included anyways … as it is the reference case  Reference case in other countries as well  Has propelled the EQ-5D  Most used in questionnaire in health economics 32

Why EuroQol?  UK strong tradition in health economics  York University  York involved in the EuroQol Group  Massive grant to develop TTO values  1994  NHS  N =

Other reasons  The EQ-5D is short  Can be done beside other questionnaires  Was develop as a reference case….  To make European research efforts comparable  ‘a basic common core of QoL Characteristics’  ‘for use alongside more detailed condition specific […] measures’  The European Common Core Group 34

EuroQol is noncommercial  Is not owned by some one….  No stocks  EuroQol Research Foundation  Money is put back in research  Malaysian validation study  In part financed by EuroQol  Part of the academic society  Can effort the questionnaire  Are allowed to help to develop the questionnaire  High acceptance 35

Most studied questionnaire  EQ-5D is not necessary the best  But we know in detail:  The good things  The bad things 36

Evidence on EQ-5D: some examples Hearing Prostate Erectile dysfunction Schizophrenia Bipolar disorder Vision Breast reconstruction Depression and anxiety Some cancers Skin Personality disorder

Use new Malaysian EQ-5D if…  In need of QALYs  Health economics  WHO DALYs  Clinical decision analysis  In need of valid quality of life instrument  High quality valuation study  Cross-disciplinary / holistic  Cheap  Simple 38

Conclusion  In health economics the primary outcome is cost per QALY  Clinical epidemiology  WHO DALYs  One need a specific type of validated quality of life questionnaire for QALYs  One need national validation research  Malaysia will there own EQ-5D in 2018  Prof Dr Asrul Akmal Shafie Universiti Sains Malaysia 39