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Validation of the World Health Organization quality of life instrument

in patients with HIV infection

q

C.-T. Fang1, P.-C. Hsiung2, C.-F. Yu3, M.-Y. Chen1& J.-D. Wang1,3

1

Department of Internal Medicine, National Taiwan University Hospital (E-mail:

jdwang@ha.mc.ntu.edu.tw);2School of Nursing, College of Medicine;3Institute of Occupation Medicine and Industrial Hygiene, College of Public Health, National Taiwan University, Taipei, Taiwan, ROC

Accepted in revised form 27 April 2002

Abstract

We studied the reliability and validity of the World Health Organization quality of life (WHOQOL) assessment instrument in patients with human immunodeficiency virus (HIV) infection. WHOQOL-BREF was used to assess 136 HIV-infected outpatients. The results were analyzed and compared with data from 213 healthy persons. The Cronbach’s a for internal consistency ranged from 0.74 to 0.85 across domains in HIV-infected patients. The test–retest reliability ranged from 0.64 to 0.79 across domains at average 4-week retest interval. Factor analysis identified four major factors: social, psychological, environment, and physical, consistent with the four domains of the instrument. The scores of all four domains correlated positively with self-evaluated health status and happiness (r range: 0.52–0.60 and 0.55–0.73 across domains, respectively), and correlated negatively with the number and severity of symptoms (r range:0.40 to 0.47 and0.41 to 0.52, respectively). The scores of physical, psychological and social domains, but not the environment domain, discriminated between healthy persons and HIV-infected patients (all p < 0:01). We conclude that the WHOQOL-BREF can be a useful quality-of-life instrument in patients with HIV in-fection.

Key words: Human immunodeficiency virus infection, Quality of life, WHOQOL

Introduction

Improvements in life expectancy of patients with human immunodeficiency virus (HIV) infection in recent years [1], due to advances in highly active antiretroviral therapy, have led to greater empha-sis of quality of life among these patients [2–10]. Measurement of quality of life is now an essential component in both clinical trials and cost-effec-tiveness analysis for HIV disease [11–15]. A wide variety of quality-of-life instruments have been applied in the evaluation of HIV-infected patients,

including the multiple versions of the Medical Outcome Study (MOS) [16–19], the Quality of Well-Being Scale [19, 20], the HIV-QL31 [21], the HAT-QoL [22], the AIDS-HAQ [23], the HOPES [24], the MQoL-HIV [25], and the FAHI [26]. However, because these instruments were devel-oped in the context of western culture, they may not be readily applicable to patients from societies with different cultural background, although sev-eral of these instruments have been used with success in some Asian countries [27].

In 1991, the World Health Organization (WHO) initiated a project to develop a generic quality-of-life instrument in 15 countries simultaneously, which led to the WHO quality of life (WHOQOL) assessment [28–31]. The WHOQOL has two

q

The preliminary abstract of this paper was presented at Pan-Pacific Conference of the International Society for Quality of Life Research, Tokyo, April 2001.

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unique features. First, it is based on a well-clarified definition of quality of life and encompasses physical, psychological, social and environment domains comprehensively [28], and is not just a functional assessment. Second, it is a cross-culture instrument developed for use across patient groups in various countries [29]. Despite these advantages, the reliability and validity of WHOQOL have not yet been well studied in HIV-infected patients. It is also unclear whether disease-specific modifications are needed. This study sought to determine the reliability and validity of the WHOQOL when used for the evaluation of patients with HIV in-fection.

Methods

Subjects

A total of 138 consecutive HIV-infected patients treated and followed up regularly at the outpatient clinics at the National Taiwan University Hospi-tal (NTUH) (Taipei, Taiwan) and the Taipei Municipal Venereal Disease Control Institute (TMVDC) (Taipei, Taiwan) were enrolled. To evaluate the test–retest reliability, 44 of the 138 patients were retested after an average interval of 4.6 weeks (range: 1–8 weeks). NTUH and TMVDC have the largest cohort of patients with HIV infection in Taiwan. The two institutes co-operate closely to provide these patients the best integrative medical service in Taiwan, including pharmacological therapy, medical and surgical services, counseling for both patients and family, and social support network. Inpatients were not enrolled because most of them were too ill to re-spond adequately to the questionnaire. The diag-nosis of HIV infection was confirmed by Western blot in all of the enrolled patients. Informed con-sent was obtained for all of the participants.

Version of WHOQOL

The WHOQOL-BREF (Taiwan version) [31, 32] was used. The WHOQOL-BREF [31] consists of 26 items, including one item (G1) for general quality of life, one item (G4) for health-related quality of life, and 24 items belonged to four

do-mains (physical, psychological, social and envi-ronment). There are seven items in the physical domain, six items in the psychological domain, three items in the social domain, and eight items in the environment domain. The Taiwan version of the WHOQOL-BREF [32] contains the 26 original items, plus two national items of Taiwan; one item belonged to the social domain and another be-longed to the environment domain. The method of application, reference time point, and the scoring of items were performed as described for the original WHOQOL-BREF [31]. In brief, the questionnaire was self-administrated. The partici-pants were required to evaluate their quality of life in recent 2 weeks. The item scores ranged from 1 to 5, with a higher score indicating a better quality of life on the corresponding item. Because the number of items are different for each domain, the domain scores were calculated by multiplying the average of the scores of all items in the domain by the same factor of 4. Thus, the domain scores would have the same range from 4 to 20.

Qualitative research

The content validity of WHOQOL-BREF in pa-tients with HIV infection was studied through qualitative research. Eleven HIV-infected patients, of different age, gender, social background and disease stage, were enrolled to focus groups. Four medical professionals, experienced in the care of HIV-infected patients, were also invited to form an expert committee. Focus groups and the expert committee were interviewed separately to identify the determinants and major concerns of quality of life in HIV-infected patients. With the permission of participants, the content of the interview was tape-recorded and then transcribed for analysis. Factors influencing quality of life were then iden-tified and extracted. The results were compared with the content and definition of WHOQOL-BREF.

Health status measures

The convergent validity was studied through measuring the strength of correlation between WHOQOL-BREF domain scores and health sta-tus measures. The health stasta-tus measures used in study included: (1) the self-evaluated health status

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and self-evaluated happiness, both measured by a five-point response scales (Table 1); (2) the num-ber and severity of symptoms, measured by the University of California at San Francisco (UCSF) symptoms and signs checklist for persons living with HIV disease (SSC-HIV) [33].

We hypothesized that if WHOQOL-BREF ac-curately assessed quality of life in patients with HIV infection, then:

(1) WHOQOL-BREF domain scores should pos-itively correlate with self-evaluated health status and happiness in these patients. (2) WHOQOL-BREF domain scores should

in-versely correlate with number and severity of symptoms in these patients.

Severity of diseases

The discriminant validity was studied through comparing the WHOQOL-BREF domain scores between HIV-infected patients and healthy people, and between HIV-infected patients with different severity of diseases. The severity of HIV diseases were determined by (1) the number and severity of symptoms, measured by the UCSF symptoms and signs checklist for persons living with HIV disease (SSC-HIV) [33]; (2) the CD4 count, the plasma HIV RNA level, and the presence of acquired immunodeficiency syndrome (AIDS) assessed by the 1993 Centers for Disease Control and Pre-vention (CDC) criteria [34]. The data from 213 healthy persons, who were hospital volunteers or employees, or family members of non-HIV in-fected patients, were obtained for comparison.

We hypothesized that if WHOQOL-BREF ac-curately assessed quality of life in patients with HIV infection, then:

(1) Healthy persons should have better WHO-QOL-BREF domain scores than HIV-infected patients.

(2) HIV-infected patients with milder disease should have better WHOQOL-BREF domain scores than HIV-infected patients with more severe disease.

Statistical analysis

The internal consistency reliability was evaluated using Cronbach’s a. Test–retest reliability was evaluated using intraclass correlation coefficient (ICC). The construct validity was tested using ex-ploratory factor analysis. The factor analysis was conducted through extracting factors by principal axis factoring, followed by Promax rotation with Kaiser normalization. Kaiser’s ‘eigenvalues greater than 1’ rule was used to determine the number of

Table 1. Characteristics of 136 patients with HIV infection

Characteristics % (N = 136) Age (years) O30 34 31–40 42 >40 24 Male 96

Education of high school or more 82 HIV risk factor

Men have sex with men 84

Heterosexual 15

Intravenous drug abuser 1

Presence of AIDS 35

Current antiretroviral therapy

Nonea 10

PIs-based regimensb 80

NNRTIs-based regimensc 10

Self-evaluated health status

Very poor 4 Poor 16 Fair 52 Good 25 Excellent 3 Self-evaluated happiness Very unhappy 2 Unhappy 19 Moderately happy 49 Happy 26 Very happy 4

Number of body symptoms

None 4

1–10 34

11–20 40

21–30 22

Current CD4 cell count (/mm3)

O200 10

201–500 44

>500 46

Current plasma HIV RNA (copies/ml)

O5000 78

5001–20000 7

20001–100000 8

>100001 7

a

Including treatment-naive fresh cases and patients under structured treatment interruption.

b

PIs – protease inhibitors.

c

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factors to rotate. Since this rule tends to include too many factors, solutions containing less num-bers of factors were also sought. The significance of differences between domain scores was evalu-ated by Student’s t test. All data was analyzed using SPSS for Windows Version 10.0. Two-tailed p values of <0.05 were considered to be statisti-cally significant.

Results

Characteristics of subjects

Among the 138 enrolled patients, only two pa-tients declined to participate. The response rate was 99% (136/138). The majority (114 of 136) of these patients were homosexual men. AIDS had been diagnosed in 47 patients (35%). Most (90%) of the patients were receiving highly active anti-retroviral therapy, with current CD4 cell count >200/mm3 and plasma HIV RNA <5000 copies/ ml. A high percentage (62%) of patients reported more than 10 symptoms listed on SSC-HIV. The characteristics of the 136 HIV-infected patients are summarized in Table 1. The 213 healthy subjects included 97 men and 116 women, with age and education level distribution similar to that of 136 HIV-infected patients.

Descriptive statistics

Among the respondents (n¼ 136), the scores of items ranged from 1 to 5 in all but two items. The mean ± standard deviation (range) of the domain scores was 13.73 ± 2.24 (8.00–18.86) for the physical domain, 12.49 ± 2.75 (6.67–18.67) for the psychological domain, 12.85 ± 2.70 (6.00– 20.00) for the social domain, and 13.14 ± 2.36 (7.50–19.11) for the environment domain.

Internal consistency and test–retest reliability

The Cronbach a values (n¼ 136) ranged from 0.74 to 0.85 across domains (Table 2). The a value of the entire questionnaire was as high as 0.93. All of the 44 patients tested twice were in apparently clinical stable condition, but there were variations in number of symptoms and SSC-HIV scores between the first and the second test (r¼ 0:82 and 0.78,

re-spectively). Only eight patients showed no change in number of symptoms and signs on the checklist of SSC-HIV and only two patients showed no change in average SSC-HIV scores after an interval averaging 4 weeks (range 1–8 weeks). The majority of items had test–retest reliability ranging from 0.51 to 0.78 (p < 0:01, n¼ 44). In four of the items (pain, dependence on medical service, being spected by others, healthy environment), the re-sponse was less reproducible, probably because these items may not be stable during the 4 weeks. The test–retest reliability of domain scores was 0.72 (physical domain), 0.79 (psychological domain), 0.64 (social domain) and 0.71 (environment do-main) (all p < 0:01, n¼ 44), respectively.

Content validity

All of the focus groups and the expert committee gave the similar message. The early stage of HIV infection is often asymptomatic, but in the later stage, intractable fatigue and wasting syndrome can be disturbing. Loss of interpersonal relation-ships, particularly the relationship with family members, can be a painful experience. Potential discrimination in employment and medical service often forces patients to hide their HIV-positive status. A lot of varieties of symptoms, including nausea, vomiting, abdominal fullness, diarrhea, numbness, headache, insomnia, weakness, dry mouth, thirsty, shooting pain, flank pain, hemat-uria, skin rash, dizziness, insomnia, difficult to concentrate, loss of hair, and various kinds of lipodystrophy, etc. were experienced sooner or later under antiretroviral therapy. The types of symptoms were clearly associated with the types of medication prescribed. The complexity of some antiretroviral regimens was also troublesome. While fatigue, pain, body image, sleep, ability to

Table 2. Internal consistency of the WHOQOL-BREF in HIV-infected patients (n = 136) Cronbach’s a Physical domain 0.74 Psychological domain 0.81 Social domain 0.76 Environment domain 0.85 26 items 0.92

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concentrate and personal relationships have been addressed in the WHOQOL-BREF, other symp-toms due to adverse drug effects and the discrim-ination in workplace and medical service were not covered.

Construct validity

The scores of 26 items were all correlated with the scores of the corresponding domains (r range: 0.42–0.82 across items, all p < 0:01, n¼ 136). The scores of four domains were also all correlated with the scores for general quality of life (item G1)

(r range: 0.49–0.64 across domains, all p < 0:01, n¼ 136) and the scores for health-related quality of life (item G4) (r range: 0.52–0.62 across do-mains, all p < 0:01, n¼ 136). Exploratory factor analysis of data from the 136 patients showed six factors with eigenvalues greater than 1, which ex-plained 53% of total variance. However, the meanings of these six factors were fragmented, suggesting too many factors were used. Instead, a four-factor solution, which explained 47% of total variance, allowed meaningful interpretation for all four factors that were essentially corresponding to the four WHOQOL-BREF domains (Table 3).

Table 3. Exploratory factor analysis, principle axis factoring, Promax rotation with Kaiser normalization (n = 136)

Domains Facets Items Factor 1

(Social) Factor 2 (Psycho) Factor 3 (Environ) Factor 4 (Physical) Physical F1. Pain 3 0.200 0.177 0.018 0.754 Physical F11. Dependence on medical service 4 0.271 0.202 0.152 0.626 Physical F2. Energy 10 0.128 0.239 0.399 0.153 Physical F3. Sleep 16 0.184 0.405 0.450 0.082

Physical F9. Ability to get around 15 0.674 0.147 0.123 0.006

Physical F12. Working ability 18 0.347 0.275 0.199 0.047

Physical F10. Daily activity 17 0.265 0.382 0.268 0.064

Psycho F5. Ability to concentrate 7 0.002 0.585 0.175 0.078

Psycho F6. Satisfied with oneself 19 0.171 0.743 0.045 0.103

Psycho F8. Negative feelings 26 0.107 0.533 0.092 0.070

Psycho F24. Meaning of life 6 0.045 0.837 0.118 0.058

Psycho F4. Enjoy life 5 0.353 0.113 0.022 0.055

Psycho F7. Body image 11 0.470 0.444 0.232 0.103

Social F13. Personal relationship 20 0.547 0.010 0.082 0.076

Social F14. Social support 22 0.643 0.051 0.033 0.094

Social F25. Respected by others 27 0.594 0.052 0.228 0.065

Social F15. Sexual life 21 0.021 0.148 0.387 0.193

Environment F19. Accessibility to medical care 24 0.080 0.102 0.348 0.040

Environment F22. Healthy environment 9 0.075 0.176 0.732 0.093

Environment F23. Transportation 25 0.069 0.099 0.688 0.058

Environment F17. Living condition 23 0.103 0.075 0.602 0.062

Environment F16. Safety in daily life 8 0.389 0.378 0.030 0.045

Environment F18. Enough money 12 0.512 0.116 0.145 0.121

Environment F20. Accessibility to daily information

13 0.580 0.320 0.146 0.157

Environment F21. Leisure time 14 0.456 0.005 0.311 0.083

Environment F26. Get things like to eat 28 0.735 0.274 0.185 0.091

Correlation between four factors

Factor 1 Factor 2 Factor 3 Factor 4

Factor 1 1

Factor 2 0.687 1

Factor 3 0.624 0.604 1

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Convergent validity

The scores for the physical, psychological, social, and environment domains were all correlated positively with patients’ self-evaluated health sta-tus and self-evaluated happiness (Spearman’s r range: 0.52–0.60 and 0.55–0.73 across domains, respectively, all p < 0:01), and correlated nega-tively with the number and severity of symptoms (r range:0.40 to 0.47 and 0.41 to 0.52 across domains, respectively, all p < 0:01) (Table 4).

Discriminant validity

The scores for the physical, psychological and so-cial domains, but not the environment domain, discriminated between healthy persons and HIV-infected patients (all p < 0:01, Student’s t test) (Table 5). This result remains valid if the 97 healthy men, rather than the total 213 healthy persons, were used as the healthy group for the comparison. The scores for all domains also dis-criminated between HIV-infected patients with more severe symptoms with an SSC-HIV score higher than the average (mean) and those with scores lower than the average (all p < 0:01, Stu-dent’s t test), and between HIV-infected patients with a number of symptoms higher than the av-erage (mean) and those with a number of symp-toms lower than the average (all p < 0:01, Student’s t test) (Table 5).

Under highly active antiretroviral therapy, the majority (72%) of the 47 patients initially with AIDS had a favorable clinical response, with a sustained rise in CD4 counts and durable sup-pression of plasma HIV RNA level, and remained free from opportunistic infections. With this

im-Table 4. Correlation between WHOQOL domain scores and health status measures (n = 136)

Self-evaluated heath status Self-evalu-ated happiness Number of symptoms Severity of symptoms Domain scores Physical 0.53* 0.55* 0.46* 0.52* Psychological 0.60* 0.73* 0.47* 0.49* Social 0.52* 0.59* 0.40* 0.41* Environment 0.57* 0.55* 0.41* 0.43* * p < 0:01.

Table 5. Comparison of the WHOQOL domain scores (mean ± SD)

Domains HIV-infected patients (N = 136) Healthy persons (N = 213) p-Value (a) Between HIV-infected patients and healthy persons

Physical 13.73 ± 2.24 15.39 ± 1.88 <0.01

Psychological 12.49 ± 2.75 13.74 ± 2.11 <0.01

Social 12.85 ± 2.70 14.00 ± 2.11 <0.01

Environment 13.14 ± 2.36 13.11 ± 2.21 0.124

(b) Between HIV-infected patients with different number of symptoms

Moreasymptoms (N = 73) Lessbsymptoms (N = 62)

Physical 12.94 ± 1.99 14.69 ± 2.18 <0.01

Psychological 11.54 ± 2.40 13.59 ± 2.75 <0.01

Social 12.06 ± 2.35 13.76 ± 2.81 <0.01

Environment 12.46 ± 2.20 13.92 ± 2.31 <0.01

(c) Between HIV-infected patients with different severity of symptoms

HighcSSC-HIV scores (N = 57) LowdSSC-HIV scores (N = 78)

Physical 12.56 ± 1.87 14.60 ± 2.13 <0.01

Psychological 10.92 ± 2.15 13.58 ± 2.59 <0.01

Social 11.70 ± 2.32 13.67 ± 2.68 <0.01

Environment 12.08 ± 1.97 13.88 ± 2.34 <0.01

aNumber of symptoms more than the average (mean). bNumber of symptoms less than the average (mean). cSSC-HIV scores higher than the average (mean). dSSC-HIV scores lower than the average (mean).

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provement of clinical status and none of our pa-tients were currently hospitalized, although the scores for all domains were still consistently worse in patients initially with AIDS than in those ini-tially without AIDS, the differences were not sta-tistically significant (data not shown).

Discussion

In the present study, we demonstrated that the WHOQOL-BREF, in its Taiwan national version, can be a useful generic quality-of-life instrument in patients with HIV infection. The internal con-sistency was good. The domain scores were well correlated with self-evaluated health status and self-evaluated happiness, and inversely correlated with number and severity of symptoms. The scores of physical, psychological, and social domains also discriminated between HIV-infected patients and healthy persons, and between HIV-infected pa-tients with different number and severity of symptoms. To provide further information about validity in this group of patients, a better design would have been to compare the generic WHO-QOL to an existing, previously tested, leading disease-specific instrument, such as MOS-HIV [18]. However, because up to the beginning of this study there was still no Taiwan version for such instruments, we were unable to use this strategy to corroborate the validity of WHOQOL in the pre-sent study.

Although a reliability level of 0.90 was advo-cated by Nunnally [35] as a minimum standard for measurement that is designed for individual as-sessment, in practice it may be too stringent and many highly regarded quality-of-life instruments fail to meet this standard [36]. Even the test–retest reliability (24 hour) for physiological measure-ment of blood pressure, 0.87 for systolic pressure and 0.67 for diastolic pressure [36, 37], did not meet this standard, either. Furthermore, real changes of status may occur during the retest in-terval. To minimize the effect of real changes, the ideal interval between the first and the second test for quality of life would have been 2 weeks or less. However, most participants in this study found it difficult to make an extra visit to the clinic before the scheduled monthly follow-up. Although all 44 patients tested twice were in apparently clinical

stable condition, there were variations in number of symptoms and SSC-HIV scores between the first and the second test (r¼ 0:82 and 0.78, re-spectively). Only eight patients showed no change in number of symptoms and signs on the checklist of SSC-HIV, and only two patients showed no change in average SSC-HIV scores. It indicated that minor but real changes of symptoms and subjective feelings might have occurred during the long interval (average 4.6 weeks) between the first and the second tests in our study. Thus, we ob-tained a test–retest reliability of 0.51–0.79 for items and domains, which was slightly less ade-quate compared with the reliability between 0.56 and 0.84 of the original WHOQOL-BREF [31].

The results of qualitative research suggested that the content of WHOQOL-BREF might not cover some important issues for HIV-infected patients who were under regular highly active antiviral treatment. For example, pain (or discomfort) and fatigue are the only body symptoms listed in the WHOQOL-BREF physical domain. Other dis-turbing symptoms, such as gastrointestinal upset, hematuria, dry mouth, thirsty, dizziness, and skin rash, are not specifically listed. Similarly, dis-crimination to HIV-infected persons in workplace and medical service are not particularly mentioned in the content of WHOQOL-BREF. It is inter-esting to note that, although the content of WHOQOL-BREF may not be comprehensive for HIV-infected patients, there was a consistently good correlation between domain scores and symptoms (inverse correlation), and between do-main scores and self-evaluated health status mea-sures. The strength of correlation with validation variables was comparable to that reported in pre-vious WHOQOL literature [32]. During the initial validation of WHOQOL Taiwan version in gen-eral population, the magnitude of correlations between WHOQOL domain scores and the vali-dation variables ranged from 0.33 to 0.63 [32]. In the present study, the correlation between WHO-QOL domain scores and symptoms ranged from 0.40 to 0.47 (number of symptoms) and from 0.41 to 0.52 (SSC-HIV scores of symptoms severity). And the correlation between WHOQOL domain scores and self-evaluated health status measures ranged from 0.52 to 0.60 (self-evaluated health status) and from 0.55 to 0.73 (self-evaluated happiness).

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The results of factor analysis in this study showed that some items were not best correlated with their related domains. This is most likely due to the overlapping of constructs between the do-mains, especially when perceived from the view-points of HIV-infected patients. For example, to persons without fixed sexual partners, sexual life may be more suitably classified in the environment domain rather than the social domain. The grouping of money, accessibility to daily infor-mation, leisure time, and getting thing one like to eat into factor 1 (social) may reflect the perception that economic security, information and leisure activity are an integral part of social life.

Previous studies have consistently shown that the presence, number, and severity of symptoms are the major determinants of quality of life in HIV-in-fected patients [3–6]. Clinical stage has only a weak association with quality of life after adjusting for the number of symptoms [3]. Using number and severity of symptoms as the disease severity mark-ers, we found that the WHOQOL-BREF has good discriminant validity among patients with different severity of HIV disease. The magnitude of differ-ence in domain scores was comparable to that re-ported between sick and healthy persons in the original validation of WHOQOL [29]. We did not use current CD4 count as the marker in the testing of discriminative validity because only a very small proportion (<10%) of our patients had a low CD4 count (O200/mm3) when the questionnaire was applied (Table 1).

Although this study showed WHOQOL-BREF scores generally correlated well with validation variables in patients with HIV infection, it also showed some unique aspects of quality of life in HIV-infected patients were not covered. As a re-sult, WHOQOL-BREF may be insensitive to the change of status in these aspects. It is thus worthwhile to formally develop a disease-specific module to enhance its sensitivity and responsive-ness to clinical status [38]. This modular approach, initially proposed by Aaronson and coworker for cancer patients [39, 40], is a promising way to satisfy both the demand for cross-disease com-parison for the purpose of resource allocation and the need for assessing the status of a particular disease in clinical trials. There are still no official guidelines for the development of a disease-specific module of the WHOQOL. To ensure

cross-cul-tural validity, the official guidelines of The Euro-pean Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 instrument mandates that the development of disease-specific modules should involve a number of countries, each rep-resenting a broadly defined geographic and culture category [41]. We suggest that if an HIV-specific module of the WHOQOL is to be formally devel-oped, both the general guidelines for disease-spe-cific instruments [38] and the guidelines to ensure cross-cultural validity [39–41] should be followed. We conclude that the WHOQOL-BREF, in its national version, can be a useful generic quality-of-life instrument in patients with HIV infection. To further enhance the sensitivity and respon-siveness to clinical status, it is worthwhile to for-mally develop an HIV-specific module for WHOQOL.

Acknowledgements

This work was supported by grants NSC 89-2314-B-002-433-M56 and DOH91-DC-1056. We are in-debted to Dr Kai-Ping Yao for constructive com-ments. We would like to thank Dr Shou-Chien Chen, Dr Shiow-Ing Wu, and the Taipei Municipal Venereal Disease Control Institute for allowing us to recruit their patients for participation in this study. We also thank Miss Yu-Yin Chang for her help in statistical analysis. Dr Mao-Yen Chen and Dr Jung-Der Wang contributed equally to this work.

References

1. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998; 338: 853–860.

2. Wu AW. Quality of life assessment comes of age in the era of highly active antiretroviral therapy. AIDS 2000; 14: 1449–1451.

3. Hays RD, Cunningham WE, Sherbourne CD, et al. Health-related quality of life in patients with human im-munodeficiency virus infection in the United States: Results from the HIV Cost and Services Utilization Study. Am J Med 2000; 108: 714–722.

4. Cunningham WE, Shapiro MF, Hays RD, et al. Consti-tutional symptoms and health-related quality of life in pa-tients with symptomatic HIV disease. Am J Med 1998; 104: 129–136.

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5. Lorenz KA, Shapiro MF, Asch SM, Bozzette SA, Hays RD. Associations of symptoms and health-related quality of life: Findings from a national study of persons with HIV infection. Ann Intern Med 2001; 134: 854–860.

6. Bing EG, Hays RD, Jacobson LP, et al. Health-related quality of life among people with HIV disease: Results from the Multicenter AIDS Cohort Study. Qual Life Res 2000; 9: 55–63.

7. Low-Beer S, Chan K, Wood E, et al. Health-related quality of life among persons with HIV after the use of protease inhibitors. Qual Life Res 2000; 9: 941–949.

8. Osowiecki DM, Cohen RA, Morrow KM, et al. Neuro-cognitive and psychological contributions to quality of life in HIV-1-infected women. AIDS 2000; 14: 1327–1332. 9. Weinfurt KP, Willke RJ, Glick HA, Freimuth WW,

Schulman KA. Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients. Med Care 2000; 38: 404–410.

10. Call SA, Klapow JC, Stewart KE, et al. Health-related quality of life and virologic outcomes in an HIV clinic. Qual Life Res 2000; 9: 977–985.

11. Nieuwkerk PT, Gisolf EH, Colebunders R, Wu AW, Danner SA, Sprangers MA. Quality of life in asymptomatic and symptomatic HIV-infected patients in a trial of riton-avir/saquinavir therapy. The Prometheus Study Group. AIDS 2000; 14: 181–187.

12. Nieuwkerk PT, Gisolf EH, Reijers MH, Lange JM, Danner SA, Sprangers MA. Long-term quality of life outcomes in three antiretroviral treatment strategies for HIV-1 infec-tion. AIDS 2001; 15: 1985–1991.

13. Bucciardini R, Wu AW, Floridia M, et al. Quality of life outcomes of combination zidovudine-didanosine-nevira-pine and zidovudine-didanosine for antiretroviral-naive advanced HIV-infected patients. AIDS 2000; 14: 2567– 2574.

14. Freedberg KA, Losina E, Weinstein MC, et al. The cost effectiveness of combination antiretroviral therapy for HIV disease. N Engl J Med 2001; 344: 824–831.

15. Schackman BR, Goldie SJ, Weinstein MC, Losina E, Zhang H, Freedberg KA. Cost-effectiveness of earlier ini-tiation of antiretroviral therapy for uninsured HIV-infected adults. Am J Public Health 2001; 91: 1456–1463. 16. Smith MY, Feldman J, Kelly P, DeHovitz JA, Chirgwin K,

Minkoff H. Health-related quality of life of HIV-infected women: Evidence for the reliability, validity and respon-siveness of the Medical Outcomes Study Short-Form 20. Qual Life Res 1996; 5: 47–55.

17. Wachtel T, Piette J, Mor V, Stein M, Fleishman J, Car-penter C. Quality of life in persons with human immuno-deficiency virus infection: Measurement by the Medical Outcomes Study instrument. Ann Intern Med 1992; 116: 129–137.

18. Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Out-comes Study HIV Health Survey (MOS-HIV). Qual Life Res 1997; 6: 481–493.

19. Anderson JP, Kaplan RM, Coons SJ, Schneiderman LJ. Comparison of the Quality of Well-being Scale and the SF-36 results among two samples of ill adults: AIDS and other illnesses. J Clin Epidemiol 1998; 51: 755–762.

20. Kaplan RM, Anderson JP, Patterson TL, et al. Validity of the Quality of Well-Being Scale for persons with human immunodeficiency virus infection. Psychosom Med 1995; 57: 138–147.

21. Leplege A, Rude N, Ecosse E, Ceinos R, Dohin E, Pouchot J. Measuring quality of life from the point of view of HIV-positive subjects: The HIV-QL31. Qual Life Res 1997; 6: 585–594.

22. Holmes WC, Shea JA. A new HIV/AIDS-targeted quality of life (HAT-QoL) instrument: Development, reliability, and validity. Med Care 1998; 36: 138–154.

23. Lubeck DP, Fries JF. Assessment of quality of life in early stage HIV-infected persons: Data from the AIDS Time-oriented Health Outcome Study (ATHOS). Qual Life Res 1997; 6: 494–506.

24. De Boer JB, Sprangers MA, Aaronson NK, Lange JM, van Dam FS. A study of the reliability, validity and respon-siveness of the HIV overview of problems evaluation system (HOPES) in assessing the quality of life of patients with AIDS and symptomatic HIV infection. Qual Life Res 1996; 5: 339–347.

25. Smith KW, Avis NE, Mayer KH, Swislow L. Use of the MQoL-HIV with asymptomatic HIV-positive patients. Qual Life Res 1997; 6: 555–560.

26. Peterman AH, Cella D, Mo F, McCain N. Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Qual Life Res 1997; 6: 572–584.

27. Thumboo J, Fong KY, Ng TP, et al. Validation of the MOS SF-36 for quality of life assessment of patients with systemic lupus erythematosus in Singapore. J Rheumatol 1999; 26: 97–102.

28. WHOQOL Group. The development of the World Health Organization Quality of Life Assessment Instrument (the WHOQOL). In: Orley J, Kuyken W (eds), Quality of Life Assessment: International Perspectives. New York: Springer-Verlag, 1994.

29. WHOQOL Group. The World Health Organization quality of life assessment (WHOQOL): Development and general psychometric properties. Soc Sci Med 1998; 46: 1569– 1585.

30. Bonomi AE, Patrick DL, Bushnell DM, Martin M. Vali-dation of the United States’ version of the World Health Organization Quality of Life (WHOQOL) instrument. J Clin Epidemiol 2000; 53: 1–12.

31. WHOQOL Group. Development of the World Health Or-ganization WHOQOL-BREF quality of life assessment. Psychol Med 1998; 28: 551–558.

32. The WHOQOL-Taiwan Group. The User’s Manual of the Development of the WHOQOL-BREF Taiwan Version. 1st edn., Taiwan, Taipei, 2000.

33. Holzemer WL, Henry SB, Nokes KM, et al. Validation of the sign and symptom check-list for persons living with HIV disease (SSC-HIV). J AdvNurs 1999; 30: 1041–1049. 34. Centers for Disease Control and Prevention. 1993 Revised classification system for HIV infection and expanded sur-veillance case definition for AIDS among adolescents and adults. MMWR 1992; 41(RR-17): 1–19.

35. Nunnally JC. Psychometric Theory. New York: McGraw-Hill, 1967: 226.

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36. Hays RD, Anderson RT, Revicki D. Assessing reliability and validity of measurement in clinical trials. In: Staquet MJ, Hays RD, Fayers PM (eds), Quality of Life Assessment in Clinical Trials: Methods and Practice. New York: Oxford University Press, 1998: 174–175.

37. Prisant LM, Carr AA, Bottini PB, Thompson WO, Rho-ades RB. Repeatability of automatic ambulatory blood pressure measurements. J Family Practice 1992; 34: 569– 574.

38. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993; 118: 622–629. 39. Aaronson NK, Bullinger M, Ahmedzai S. A modular ap-proach to quality-of-life assessment in cancer clinical trials. Recent Results Cancer Res 1988; 111: 231–249.

40. Aaronson NK, Ahmedzai S, Bergman B, et al. The Euro-pean Organization for Research and Treatment of Cancer

QLQ-C30: A quality-of-life instrument for use in interna-tional clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–376.

41. Sprangers MA, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK. The European Organization for Research and Treatment of Cancer approach to developing ques-tionnaire modules: An update and overview. EORTC Quality of Life Study Group. Qual Life Res 1998; 7: 291– 300.

Address for correspondence: Jung-Der Wang, Institute of Oc-cupation Medicine and Industrial Hygiene, College of Public Health, National Taiwan University, Taipei 100, Taiwan, ROC Phone: +886-2-23123456 ext. 2224; Fax: +886-2-23224660 E-mail: jdwang@ha.mc.ntu.edu.tw

數據

Table 1. Characteristics of 136 patients with HIV infection
Table 2. Internal consistency of the WHOQOL-BREF in HIV- HIV-infected patients (n = 136) Cronbach’s a Physical domain 0.74 Psychological domain 0.81 Social domain 0.76 Environment domain 0.85 26 items 0.92
Table 3. Exploratory factor analysis, principle axis factoring, Promax rotation with Kaiser normalization (n = 136)
Table 5. Comparison of the WHOQOL domain scores (mean ± SD)

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