The development of PROQOL-HIV: an international instrument to assess the health-related quality of life of persons living with HIV/AIDS.
OBJECTIVE
Health-related quality of life (HRQL) is an important outcome in HIV/AIDS infection and treatment. However, most existing HIV-HRQL instruments miss important issues (eg, sleeping problems, lipodystrophy). They were developed before highly active antiretroviral therapy (pre-HAART), and in a single language. We sought to develop a contemporary HIV-HRQL instrument (PROQOL-HIV) in multiple languages that accounts for HAART treatment and side effects. This article details the 3-stage content validation phase of PROQOL-HIV.


METHODS
In stage 1, we developed a conceptual model of HIV-HRQL and questionnaire item bank from thematic analysis of 152 patient interviews conducted simultaneously across 9 countries. In stage 2, pilot items were selected by an expert panel to form the pilot instrument. Stage 3 involved linguistic validation and harmonization of selected items to form an equivalent instrument in 9 target languages.


RESULTS
Analysis of 3375 pages of interview text revealed 11 underlying themes: general health perception, social relationships, emotions, energy/fatigue, sleep, cognitive functioning, physical and daily activity, coping, future, symptoms, and treatment. Seven issues new to HIV-HRQL measurement were subsumed by these themes: infection fears, future concerns, satisfaction with care, self-esteem problems, sleep problems, work disruption, and treatment issues. Of the 442 theme-related items banked, 70 items met the retention criteria and formed the pilot PROQOL-HIV instrument.


CONCLUSIONS
HIV patients across 11 countries attributed a wide range of physical, mental, and social issues to their condition, many of which were not measured by existing HIV-HRQL instruments. The pilot PROQOL-HIV instrument captures these issues, is sensitive to sociocultural context, disease stage, and HAART.
AP-HP, Saint-Louis Hospital, Department of Clinical Research (Patient-Reported Outcomes Unit), Paris, France. martin.duracinsky@bct.aphp.fr
Martin
M
Duracinsky
Susan
S
Herrmann
Baiba
B
Berzins
Andrew R
AR
Armstrong
Rewa
R
Kohli
Sophie
S
Le Coeur
Assane
A
Diouf
Isabelle
I
Fournier
Mauro
M
Schechter
Olivier
O
Chassany
D000203:Activities of Daily Living; D000328:Adult; D005260:Female; D015658:HIV Infections / Q000523:psychology*; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires