| Background:Though HIV can greatly be decreased by highly effect anti-virus medicine, there have not medicine that can deracinate HIV completely from the body. HIV and AIDS will exist for a long term, and bring big disadvantage to the patients and society. Since immunity of the patients will dicrease with the time, patients will arise easily different kinds of opportunistic infection, tumor,and deformity(or disability).Most of terminal patients will die of AIDS inescapability. Moreover, patients must suffer from poverty, medical side effect, discrimination that HIV/AIDS result and so on. It is very important to improve HIV/AIDS patient's quality of life when they are still alive.Many study have suggested that Chinese traditional medicine can improve immunity, decrease symptoms, and impove quality of life patients with the HIV/AIDS patients. Acupuncture even can improve psychology well-being.But it is a pity that there have not a Chinese measurement to rightly evaluate the effect of Chinese traditional medicine.There are several HIV/AIDS measurements have been developed to measure the quality of life with HIV/AIDS. Since the current questionnaire is based on modern medical theory, and foreign culture. It cannot enbody the real meaning of quality of life of the patients with HIV/AIDS in china, especially when it come to evaluate the effect of Chinese traditional medicine.So it is very important to develop a new measurement in china.The aim of the study is to develop a new measurements base on Chinese culture backgroud and chinses traditional medicine theory.Design: Cross-sectional survey.Setting:DIBA Hospital in GuangZhou city, part of place that therapy and manage HIV/AIDS patients in HeNan province, Centre of disease control and prevention.Participants:From oct. 2003 to Nov.2004, 353patients were recruited in 5different places. 77 of them were asked to complete the SF-36 at the same time, which were randomly delivered to them. 81 of them were interviewed again after 2-7days. 50 normal persons, 50 chronic hepatitis B patients, 50 hypertension elder-patients were asked to compelete A scale.Part of HIV/A settings.The selected cases were those meeting the inclusive criteria as follows: (1) be over 18 years old; (2) be able to speak Mandarin. And those who unwilling or unable to cooperate would meet the exclusive criteria. Those who didn' t finish the survey would be drop out.Main Outcome Measures:(1) The primary item pool was developed, based on a series of steps,for example, inquirying literature and expert, clinical consultation, et al.Then part of HIV/AIDS patients, doctors and nurses who therapy and care HIV/AIDS patients,and experts who study HIV/AIDS disease, experts whoes specialty is studying HIV/AIDS administer the primary scale in order to learn the importance of the items. (2)A rank test was performed in order to find appropriate scale. (3) All the participants were asked to complete the 65-item version of primary A scale, and problems on some social economic characteristics. HIV/A IDS patients were taking HAAT, capsule of herb medicine, and herb medicine sepatately. 18 patients were inquired at base 0 and 6 months after they take S30, S30+ChuanKeZhi,ChuanKeZhi separately. (4) By a series of statistic analyse, Item were deleted according to some criteria, validity, responsibility, reliability were counted in evaluating psychologic characteristic of modified A scale. (5)We compare reliability, responsibility of the A scale with MOS-HIV and so on .Results: (1) 353 HIV/AIDS patients (100%) responded by returning the questionnaire. The response rate of the A scale (upper than 90%) was 93. 7%. The completion of the 65-item version of A scale took 16. 42±6.85 minutes; (2) 55 items met the criteria, and 10 items were removed;(3) As a result of factor analysis and basis on our hypothesis, the 55-item version of A scale was proposed to be composed of 3 dimensions and 13 sub-dimensions. The 3 dimensions were physical health, spirit psychology, and social dimensions. The 13 sub-dimensions were physical functioning, psychological functioning, daily activity, social functioning, health perception, therapy affection, cognizing function, social intercourse, symptom, sleeping, pain,econimical state, worries of being disclosed(4) The split-half reliability was 0.7905. The internal reliability for each dimensions and sub-dimensions was good(dimensions:0. 8753-0. 9388; subdimensions:0. 8425-0.8868). 2-7 days interval test-retest reliability was found among the 81 patients who completed the questionnaire by themselves. The intraclass correlation coefficient (ICC) was 0.9318, the 95% confidence interval (CI) was 0.8923-0.9568, and ICC of the demension and sub-dimensions was good (dimensions: 0.8753-0. 9388; subdimensions:0.62-0. 92). (5) The face and content validity of the A scale were established on the basis of the reasonable method for develop the scale. The correlation between the A scale and the MOS-HIV, SF-36 was 0.94 and 0.51.The correlations between the A scale and investigator, kind of patients (outpatient or inpatient), interview date, questionnaire type, interview time were under 0. 4. The fact of above suggest that A scale have good convergent validity and discriminant validity . The loading coefficient of the items to dimensions and sub-dimensions are above 0.5, and correlation coefficient between item with it' s sub-dimensions, sub-dimensions with if s dimensions are above 0.5. Correlation coefficient between item with others sub-dimensions, sub-dimensions with others dimensions are low. Except correlation coefficient between physical functioning with daily activity, health perception, and between health perception with pain, symptom and daily activity, and between social functioning with social intercourse, worries of being disclosed is does to or above 0. 5., others correlation coefficients between sub-dimensions are below 0. 5. The fact of the above suggest that A scale have good construct validity. (6)The three group's CD4 Count improved after 6 months therapy, and CD4 count of the S30+ChuanKeZhi group improved significantly. Scores of quality of life of the S30+ChuanKeZhi improved higher than that of S30 or ChuanKeZhi separately, and scores of quality of life of S30 improved higher than that of ChuanKeZhi. On the other hand, Scores of quality of normal persons is higher significantly than that of HIV/AIDS, Scores of quality of life chronic hepatitis B is higher than that of HIV/AIDS, but scores of psychological functioning, daily activity, social functioning, cognizing function, syptom,pain, worries of being discoursed and sum is significantly higher. Scores of psychological functioning, social functioning, therapy affection, social intercourse, economical state, worries of being discoursed and sum of elder chronic hypertension patients is significantly higher than that of HIV/AIDS, Comparsion of other dimensions scores is not significant. (7) 26 items of the MOS-HIV are included in A scale. It come intobeing 6 dimension: physical functioning, psychological functioning, daily activity, heal th perception, cognizing function, pain. The total variance of the factors is 75.95%. The split-half reliability was 0.7767. The internal reliability for six dimensions was from 0. 7673 to 0. 9414, but A scale's internal reliability of relevant dimension is a little higher than that of MOS-HIV. The correlations between dimension of the A scale and MOS-HIV was from 0. 93 to 1. Scores of four sub-dimensions of the A scale is significantly correlate with the CD4 count, while scores of two dimensions of the MOS-HIV is significantly with CD4 count. When divide the patients into three groups as the CD4 count (group 1: CD4>500 cell/l;group2: CD4250-500cell/l;group3: CD4<250cel1/1), except cognizing function, social intercourse, sleeping, and economical state of A scale, scores of other dimensions of the two questionnaire decrease when the CD4 count decrease. From the ROC curve, area of all dimension of the two questionnaires is above 0. 5. 8 of 13 sub-dimensions of A scale can significantly change with the therapy, while 3 of 6 dimensions of the MOS-HIV can significantly change with the therapy.Conclusions: (1) The response rate of both the A scale and the SF-36 were very high. And the completion of the A scale took about 23 minutes. The feasibility of the A scale was fine; (2) As a result of factor analysis, the 55-item version of A scale was proposed to be composed of 3 dimensions and 13 sub-dimensions. Physical health dimensions include sub-dimensions of physical functioning, daily activity, health perception, therepy affection, syptom, sleeping, pain. Sprit phychology dimensions include sub-dimensions of psychological functioning,cognize function, worries of being disclosed.Social functioning dimensions include sub-dimensions of social functioning, social intercourse, econimical state (3) Good test-retest reliability, internal reliability and split reliability were found for the A scale and the (sub-)dimensions; (4) The A scale had good content and face validity. At the same, A scale have good convergent validity , discriminant validity and construct validity. The purpose of the A scale and the MOS-HIV was similar, and the comparability between A scale and SF-36 is relatively worse, According to the correlation between them, the A scale had good convergent validity. The low correlations between the A scale and investigator, kind of patients (outpatients or inpatients), interview date, questionnaire type, interview time implied that the A scale had good divergent construct validity. (5)A scale can discriminate HIV/AIDS patients from...
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