OBJECTIVETo develop a specific quality of life (QOL) instrument for Chinese patients living with HIV/AIDS and to assess its reliability and validity.

METHODSA primary questionnaire was developed with reference to existing instrument and information through discussion with experts, front-line professionals and patients living with HIV/AIDS. This questionnaire was applied in 443 patients living with HIV/AIDS. Some items were removed through the results of responsive rate, factor analysis, correlation matrix,internal consistency and so on. Reliability and validity were assessed after items reduction.

RESULTSThe developed instrument contained 44 items, including 10 scales and other 3 items used for the evaluation of curative effect and side effect of anti-virus drug. No substantial ceiling/floor effects existed. All scales' internal consistency coefficients were > or = 0.70 and the whole instrument was 0.90. The two week retest reliability coefficient of the whole instrument was 0.80, and there were 6 scales below 0.70 of this coefficient. Multitrait/multiitem assessment indicated scaling success rates were all 100% for all items. Spearman correlation coefficient of total score of this instrument with SF-36 was 0.69.

CONCLUSIONIt was the first time that the developed QOL-CPLWHA instrument introducing the scale of hostility regarding mentality trend as well as expressed its acceptable reliability and validity so could be used for the evaluation of Chinese patients living with HIV/AIDS.