The study protocol was approved by the National AIDS Control Program of Pakistan (NACP) and Research Ethics Committee (REC) of ART center of Pakistan Institute of Medical Sciences (PIMS) (Approval No; 1827). Written informed consent from patients was taken after providing them with the written information as well as a verbal explanation of the study. Participants were told that study participation was voluntary and can be terminated at any time. All the information collected in this research will be confidential and only available to the research team that manages the data; Upon completion of the analysis, the contact details of the participants will be removed. All the study procedures were handled following the Helsinki Declaration ethical principles (33).
Study Design and Study Setting
For data collection, we adopted a cross-sectional study design. The study was carried out at the ART center at PIMS hospital, which is a 947-bed hospital located in Islamabad Capital Territory (ICT), Pakistan. PIMS hospital is a teaching and referral center catering to the needs of more than 1.5 million population. ART center PIMS is the biggest center of HIV care in Pakistan having more than 4000 registered PLWH who are getting free of charge HIV treatment. Almost 15 to 20 PLWH visit the ART center daily for their medical needs. This center was selected because of the geographic location, and it is the biggest referral center where patients from different ethnic groups and regions of Pakistan receive their ART.
For psychometric evaluation of questionnaires or instruments, a minimum of 5 subjects should be selected for each question (34). Therefore, 155 PLWH was recruited in the current study for the validation of the 31-item instrument in the present study. Considering a dropout rate of 20% (such high rate was considered due to stigma among PLWH), 190 subjects were approached. Participants who did not fill the questionnaire and patients with missing information (viral load, CD4 T cell count) were excluded; therefore, 182 (95.8%) subjects were included in the final analysis.
Subjects aged more than 18 years, diagnosed with HIV (more than six months), have a new CD-4 T cells count and viral load tests (not more than four weeks older from the date of interview) were included in the study. Furthermore, participants who follow up ART regularly and able to communicate in Urdu language were also included. Moreover, terminally ill patients, visually impaired, subjects with hearing impairment, multiple comorbid, cognitively impaired and patients unable to complete the interviews were excluded.
The questionnaire consisted of three parts, including sociodemographic information, HIV related characteristics, and the WHOQOL HIV Bref. The sociodemographic part consisted of gender, age, education, marital status, and work status. HIV related components included HIV since diagnosed, viral load, CD-4 lymphocytes count, HIV serostatus, total time on ART and mode of HIV transmission. HIV serostatus was divided into three stages Asymptomatic, symptomatic and AIDS converted similarly CD-4 T lymphocytes count were also divided into three groups.
The WHOQOL HIV Bref instrument consisted of a total of 31 questions, including two general questions and 29 specific questions explaining six areas of quality of life. The first domain; physical wellbeing, consisting of four questions, i.e. 3, 4, 14, 21; the second domain; psychological health, consisting of five questions 6, 11, 15, 24, 31; the third domain is the degree of freedom, consisting of four questions 5, 20, 22, 23; the fourth domain is social relations, consisting of four questions 17, 25, 26, 27; the fifth domain is environmental health, consisting of eight questions 12, 13, 16, 18, 19, 28, 29, 30; Sixth domain is spiritual wellness comprised of 4 questions 7, 8, 9, 10 (16).
Respondents were asked to rate 31 statements of quality of life instrument describing specific behaviors related to HIV care during the past two weeks. Five-point Likert scale is used to develop the ratings ranging from 1, Very poor/Not at all/Very dissatisfied/Never to 5, Very good/Extremely/Completely/Very satisfied/Always. Out of the 31 items, 7 are negative statements, for which responses were reversely coded to ensure higher scores representing better quality of life. Each item in a facet contributes equally to the domain score, however, since each aspect comprised of a different number of questions, therefore, to calculate each domain score, the average score of the facet was multiplied by four. The total facet score ranged from 4 as the lowest score to 20 represents the most effective score (35). WHOQOL HIV Bref user manual also provides the sociodemographic and current health characteristics of the participants like age, gender, marital status and HIV transmission route (36).
WHOQOL HIV Bref Instrument Translation
WHO was contacted regarding permission to conduct cross-cultural validation of WHOQOL HIV Bref in the Urdu language (the national language of Pakistan); the English version of the WHOQOL HIV Bref instrument was translated to Urdu by standardized forward-backwards translation procedure (Figure 1) explained in 5 steps by Beaton’s guidelines (37). Expert committee (Comprised of health professionals, language professionals, methodologists and translators) was responsible for the consolidation of original questionnaire and all versions of translation (T1, T2, T12, BT1, BT2). The original English version was independently forward translated into Urdu by a bilingual physician (T1) and a non-medical linguist (T2). Later, the authors reconciled the two translations in order to produce a single version of the forward translation (T12). Later the Urdu version (T12) was sent to native expert bilingual physician (BT1) and an independent bilingual liguist (BT2) for backward translation. Translators were asked to report any sort of difficulty during translation. After that authors compared the forward backwards translations and amended the questionnaire to produce preliminary translated Urdu version. Upon ensuring consistency in the translated version and the original English version, the preliminary version of Urdu was pre-tested for cognitive debriefing on 30 conveniently chosen PLWHAs at the PIMS hospital. Data were analyzed and Cronbach's alpha for each domain was shown to be between 0.78 and 0.92. Relevant changes to a few items have been made Based on the feedback of the respondents to submit the final version of WHOQOL HIV Bref in Urdu. Expert committee ensured the semantic, idiomatic, experiential and conceptual equivalence of translated version to the original questionnaire.
Data collection procedure
A simple random sampling technique was used to collect data from PLWHA. Data were collected from July to Sep 2019. In PIMS ART center, PLWHA regularly visits for ART follow up (All medicines provided to patients were free of cost from the Government of Pakistan) in a separate counseling room. After describing the objectives of the study and nature of research study participants were interviewed face-to-face. They were asked to fill the questionnaire for the collection of sociodemographic information, HIV characteristics and quality of life data. Eligible patients participated in the study after written consent under the guidance of a trained investigator. The completed questionnaires were checked by the study investigator and soring were performed. Furthermore, incomplete questionnaires were excluded from the study. 54 participants were asked to complete the WHOQOL HIV Bref questionnaire again after the gap of two weeks for test retest reliability analysis.
Statistical analysis was performed using Statistical Package for Social Sciences version 24® (SPSS v24, SPSS Inc., Chicago, IL, USA). Categorical parameters were calculated as frequencies and percentages, while numerical variables were reported as means and standard deviations. The reliability of the WHOQOL HIV Bref was measured by Cronbach’s α coefficient. Cronbach’s α > 0.70 indicates a good consistency (38). For test-retest analysis, an Independent Correlation Coefficient (ICC) was used with an ICC > 0.70; demonstrating high test-retest reliability (39).
Known group analysis was used to assess how well the Urdu version of the WHOQOL HIV Bref instrument differentiates between patients living with HIV concerning their HIV stages and CD-4 T cell count. One-way Analysis of Variance (ANOVA) was performed to assess known-group validity. Post hoc tests were conducted to look at critical contrasts in domain scores among the three CD-4 T-cell count /mm3 (good CD-4 T cell count (≥ 500), medium CD-4 T cell count (200-499) and poor CD-4 T cell count (≤ 200). It was hypothesized that HIV-symptomatic members and PLWHA with lower CD4 T Cell counts would have lower HRQoL scores mostly. Convergent validity was determined by measuring average variance extract (AVE), and composite reliability (CR) for all facets with minimal acceptable value of 0.5 and value > 0.7 indicates excellent validity (40). Statistical examinations of all HRQoL items were conducted by utilizing inverted item scores, and a p-value of < .05 (two-tailed test) was considered as a basis of measurable centrality for all analyses (41). The independent associations between the domains and CD-4 T-cell count were assessed using multivariable linear regression (42). The construct validity was evaluated by Exploratory Factor Analysis (EFA) by considering Kaiser-Meyer Olkin and Bartlett’s test of sphericity. The EFA validity was tried by extracting components via principal component analysis, taken after Varimax rotation with Kaisers’ normalization (43).