Incorporating quality of life measures in HIV clinical trials.
OBJECTIVE
To increase awareness regarding issues specific to health-related quality of life (HRQL) assessments for investigators designing clinical trials and for clinicians reading published reports on clinical trials. HQRL measures are becoming more prevalent, alongside conventional therapeutic and laboratory endpoints. However, they differ from these physiologic or biologic measurements because HRQL data are subjective. We discuss the criteria for selecting and implementing HRQL instruments to optimize the usefulness of HRQL assessments in clinical studies.


METHODS
We conducted a review of selected design and measurement issues that should be considered when planning for the use of HRQL instruments in HIV/AIDS clinical trials.


CONCLUSIONS
When used appropriately, HRQL measures can indicate the impact of HIV treatment on patient functioning and well-being and can help to inform clinicians about treatment effects.
Lin
Maria K
MK
Department of International Health, School of Medicine, Johns Hopkins University, Baltimore, Maryland 21205, USA.
Wu
Albert W
AW
Revicki
Dennis A
DA
D002986:Clinical Trials as Topic / Q000592:standards*; D015658:HIV Infections / Q000523:psychology*; D006801:Humans; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012107:Research Design