摘要：Background: Numerous health-related issues continue to undermine the health and health-related quality of life (HRQoL) of people living with HIV (PLHIV). We developed a clinic screening tool (CST-HIV) for the purpose of identifying these issues in routine specialist clinical care in Spain. Methods: We used the following established instrument development procedures: (1) a literature review; (2) four focus group discussions (FGDs), two that convened 16 expert HIV care providers, and two that convened 15 PLHIV; (3) prioritisation, selection and definition of constructs (health-related issues) to include in the CST-HIV and drafting of initial item pool; and (4) a pilot study to analyse psychometric properties and validity of items and to determine which to retain in the final CST-HIV. The FGD interview scripts incorporated an exercise to prioritise the health-related issues perceived to have the greatest negative effect on HRQoL. The online questionnaire used for the pilot study included the pool of CST-HIV items and validated measures of each construct. Results: We identified 68 articles that reported on factors associated with the HRQoL of PLHIV. The most burdensome health-related issues identified in the FGDs related to stigma, socioeconomic vulnerability, sleep/fatigue, pain, body changes, emotional distress, and sexuality. Based on the literature review and FGD findings, we selected and defined the following constructs to include in the initial CST-HIV: anticipated stigma, emotional distress, sexuality, social support, material deprivation, sleep/fatigue, cognitive problems, and physical symptoms. Two researchers wrote six to eight items for each construct. Next, 18 experts rated 47 items based on their clarity, relevance, and representativeness. Pilot testing was carried out with 226 PLHIV in Spain. We retained 24 items based on empirical criteria that showed adequate psychometric properties. Confirmatory factor analysis confirmed the eight-factor structure with a good fit to the data (RMSEA=0.035, AGFI=0.97, CFI=0.99). We found strong positive correlations between the instrument’s eight dimensions and validated measures of the same constructs. Likewise, we found negative associations between the dimensions of the CST-HIV and HRQoL. Conclusions: The CST-HIV is a promising tool for use in routine clinical care to efficiently identify and address health-related issues undermining the HRQoL of PLHIV.
关键词：HIV; Patient-reported outcome measure (PROM); health-related quality of life; Symptom Assessment; health measurement instrument; Psychometrics; Spain
