Assessing HIV and AIDS treatment safety and health-related quality of life among cohort of Malaysian patients: a discussion on methodological approach.

Background: Health-related quality of life (HRQoL) is increasingly recognized as an important outcome and as a complement to traditional biological end points of diseases such as mortality. Unless there is a complete cure available for HIV/AIDS, development and implementation of a reliable and valid cross cultural quality of life measure is necessary to assess not only the physical and medical needs of HIV/AIDS people, but their psychological, social, environmental, and spiritual areas of life.

Methods: A qualitative exploration of HIV/AIDS patients' understanding, perceptions and expectations will be carried out with the help of semi structured interview guide by in depth interviews, while quantitative assessment of patient reported adverse drug reactions and their impact on health related quality of life will be carried out by using data collection tool comprising patient demographics, SF-12, Naranjo scale, and a clinical data sheet.

Results/outcomes: The findings may serve as baseline QOL data of people living with HIV/AIDS in Malaysia and also a source data to aid construction of management plan to improve HIV/AIDS patients' QOL. It will also provide basic information about HIV/AIDS patients' perceptions, expectations and believes towards HIV/AIDS and its treatment which may help in designing strategies to enhance patients' awareness which in turn can help in addressing issues related to compliance and adherence.