1. QUALITY OF LIFE ASSESSMENT IN PEOPLE LIVING WITH HIV/AIDS Antonieta Medina Lara HIV/AIDS and STI Knowledge Programme Liverpool School of Tropical Medicine

2. Why measure Quality of Life? It takes account of the individuals’ perceptions of the benefits of ART

3. Quality of Life measurement Multidimensional concept that focuses on the impact of disease and its treatment on the well- being of an individual

4. WHO definition of health “State of complete physical, mental and social well-being and not merely the absence of infirmity and disease”

5. Quality of life measures Specific This type of instrument evaluates a series of health dimensions specific to a disease. Generic These instruments can be used with any population. They generally cover perceptions on overall health and also questions on social, emotional and physical functioning, pain and self-care.

6. Specific QoL measures in HIV MOS-HIV MQoL-HIV WHOQOL-HIV

7. MOS-HIV & MQoL-HIV Assessment of domains that are relevant to HIV/AIDS Domains evaluated: Overall function, sexual function, disclosure worries, financial worries, HIV mastery, life satisfaction, medication concerns and provider trust  Are intended to capture changes in perceived health that may impact on the other measured dimensions of quality of life

8. WHOQOL-HIV “an individual’s perception of his/her position in life in the context of the culture and value systems in which he/she lives, and in relation to his/her goals, expectations, standards and concerns”…WHOQOL Group, 1995.

9. WHOQOL-HIV Skevington, S M, (2002). Advancing cross-cultural research on quality of life: observations drawn from the WHOQOL development. Quality of life Research; 11:135-144

10. Generic measures Framework for evaluating the trade off between the quality and the quantity of life Individual’s own valuation of hypothetical health states, measured in an index that reflects the value placed on a health state relative to perfect health or death

11. Health state valuation instruments Visual Analogue Scale (VAS) Standard Gamble (SG) Time Trade-Off (TTO)

12. Visual Analogue Scale (VAS)10060 50 40 30 20 10 0 70 80 90 Please draw a line at the point on the scale that summarises your current health status Your own health state today  It is easy to use and achieve high response rates  It is a choice-less assessment

13. Time Trade-Off Evaluates the desirability of living the remainder of one’s life in the current state of health vis-à-vis living less time in excellent health Healthy State i Alternative 2 Alternative 1 1.0 hihi 0 Time VALUE Dead

15. Standard Gamble 95% Alternative 1: certain outcome Alternative 2: uncertain outcome 100% 5% Complete health Death Limited health Involves weighing trade-offs Measures the preferences of individuals under risky situations

17. Context 3000 patients will be enrolled over one year and followed for 4 to 5 years in an open label randomised trial assessing two strategies for managing ARTs in Uganda and Zimbawe Strategies 1) Comparison of clinical monitoring with clinical monitoring plus laboratory testing 2) Comparison of continuous ART with structured treatment interruptions (12 weeks on and 12 weeks off ART)

18. Benefits from the trial Since the effectiveness measure (progression to a new WHO HIV stage 4 disease or death) of the trial will not reflect how the patient feels and functions in daily activities, nor will it give any information on the patient’s views of whether and how she or he has benefited from ART, QoL will be assessed alongside the trial

19. Quality of life sub-study aim To assess the effects of antiretroviral therapy on the patients’ health related quality of life in Uganda.

20. Sub-study Two sets of QoL instruments will be used to evaluate ART: 1)MOS-HIV or WHOQoL-HIV 2) Culturally adjusted utility instruments, i.e., Visual Analogue Scale (VAS), Time Trade-Off (TTO) and Standard Gamble (SG)

21. Sub-study Specific measures will allow focusing on changes relevant to HIV and its treatment (antiretroviral drugs) Health states evaluation will assess the net effect of the treatment on the patient health-related quality of life

22. Challenges of the sub-study Terms such as expressing preference, giving up time, gambling and uncertainty need to be understood by the patients Cultural and religious practices need to be addressed and understood Evaluation of reliability, construct and content validity

23. Conclusion QoL assessment is essential to understand the whole impact of ART Disease-target instrument should not be redundant with the generic instrument and both should not be so long as to be a burdensome for subjects to complete.