This paper is in the following e-collection/theme issue:

HIV/AIDS/STI Prevention and Care (873) Digital Health Reviews (1289) Patient-Reported Outcome Measures (PROMs) (288)

Published on in Vol 8, No 12 (2022): December

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/39015, first published .
HIV-Specific Reported Outcome Measures: Systematic Review of Psychometric Properties

HIV-Specific Reported Outcome Measures: Systematic Review of Psychometric Properties

HIV-Specific Reported Outcome Measures: Systematic Review of Psychometric Properties

Authors of this article:

Ziqi Wang1 Author Orcid Image ;   Yaxin Zhu1 Author Orcid Image ;   Xiyu Duan1 Author Orcid Image ;   Hao Kang2 Author Orcid Image ;   Bo Qu1, 3 Author Orcid Image
Article Authors Cited by (8) Tweetations (2) Metrics

    Review

    1Institute for International Health Professions Education and Research, China Medical University, Shenyang, China

    2Administration Department of Nosocomial Infection, Southwest Hospital, Third Military Medical University, Chongqing, China

    3School of Public Health, China Medical University, Shenyang, China

    *these authors contributed equally

    Corresponding Author:

    Bo Qu, PhD

    School of Public Health

    China Medical University

    No.77 Puhe Road

    Shenyang North New Area

    Shenyang, 110122

    China

    Phone: 86 18900910198

    Email: qubo6666@163.com


    Background: The management of people living with HIV and AIDS is multidimensional and complex. Using patient-reported outcome measures (PROMs) has been increasingly recognized to be the key factor for providing patient-centered health care to meet the lifelong needs of people living with HIV and AIDS from diagnosis to death. However, there is currently no consensus on a PROM recommended for health care providers and researchers to assess health outcomes in people living with HIV and AIDS.

    Objective: The purpose of this systematic review was to summarize and categorize the available validated HIV-specific PROMs in adults living with HIV and AIDS and to assess these PROMs using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology.

    Methods: This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A literature search of 3 recommended databases (PubMed, Embase, and PsychINFO) was conducted on January 15, 2021. Studies were included if they assessed any psychometric property of HIV-specific PROMs in adults living with HIV and AIDS and met the eligibility criteria. The PROMs were assessed for 9 psychometric properties, evaluated in each included study following the COSMIN methodology by assessing the following: the methodological quality assessed using the COSMIN risk of bias checklist; overall rating of results; level of evidence assessed using the modified Grading of Recommendations, Assessment, Development, and Evaluation approach; and level of recommendation.

    Results: A total of 88 PROMs classified into 8 categories, assessing the psychometric properties of PROMs for adults living with HIV and AIDS, were identified in 152 studies including 79,213 people living with HIV and AIDS. The psychometric properties of most included PROMs were rated with insufficient evidence. The PROMs that received class A recommendation were the Poz Quality of Life, HIV Symptom Index or Symptoms Distress Module of the Adult AIDS Clinical Trial Group, and People Living with HIV Resilience Scale. In addition, because of a lack of evidence, recommendations regarding use could not be made for most of the remaining assessed PROMs (received class B recommendation).

    Conclusions: This systematic review recommends 3 PROMs to assess health outcomes in adults living with HIV and AIDS. However, all these PROMs have some shortcomings. In addition, most of the included PROMs do not have sufficient evidence for assessing their psychometric properties and require a more comprehensive validation of the psychometric properties in the future to provide more scientific evidence. Thus, our findings may provide a reference for the selection of high-quality HIV-specific PROMs by health care providers and researchers for clinical practice and research.

    JMIR Public Health Surveill 2022;8(12):e39015

    doi:10.2196/39015

    Keywords

    HIV; AIDS; people living with HIV and AIDS; patient-reported outcome measures; psychometric properties 


    Background

    According to the statistics from the Joint United Nations Program on HIV/AIDS, 28.2 million individuals were accessing antiretroviral therapy (ART) as of mid-2021 [1]. Although effective treatment via ART has improved the life expectancy of people living with HIV and AIDS [2], this population still faces substantial challenges brought by HIV [3-6]. Therefore, Lazarus et al [7] proposed the Fourth 90 target to ensure that 90% of people living with HIV and AIDS with viral suppression have a good health-related quality of life (HRQoL) after the World Health Organization proposed the 90-90-90 targets. They proposed that HRQoL in people living with HIV and AIDS should be considered as important as viral suppression [8]. For people living with HIV and AIDS, the focus should be shifted toward improving HIV-related care [9].

    The management of people living with HIV and AIDS is multidimensional and complex. To overcome the obstacles to achieving the Fourth 90 [10], patient-centered care that can meet the lifelong needs of people living with HIV and AIDS from diagnosis to death is the key requirement [9]. The collection and use of patient-reported outcome (PRO) data is one of the most effective approaches for ensuring that the care reflects the needs and priorities of people living with HIV and AIDS [9]. Compared with clinician-reported outcomes, PROs present a more comprehensive method for assessing the subjective perceptions of people living with HIV and AIDS of their own health that cannot be observed or are not easily observed directly and have been shown to accurately predict health outcomes among this population [11,12]. Furthermore, there is sufficient evidence that PROs can be used to improve the care quality and health outcomes in people living with HIV and AIDS, such as by improving patient-physician communication [13], clinical decision-making [14], and symptom recognition [15].

    Why Did This Systematic Review Only Include HIV-Specific PRO Measures?

    Patient-reported outcome measures (PROMs) are the actual tool developed for collecting PRO data. There are 2 types of PROMs: generic (designed for use in any population and cover general aspects of outcome measures) and disease specific (designed for use in people with a condition and measure specific aspects of an outcome of importance). Many generic and HIV-specific PROMs have been validated in people living with HIV and AIDS. The advantage of a generic PROM is that it enables researchers to compare the health outcomes of people living with HIV and AIDS with those of other populations based on the same measurements [16]. However, unlike generic PROMs, HIV-specific PROMs do not have a significant ceiling and floor effect and do not overestimate health outcomes in people living with HIV and AIDS [17,18]. Furthermore, HIV-specific PROMs are more closely associated with HIV than are generic PROMs. In addition, they have the sensitivity for detecting and quantifying minor changes and specificity needed for HIV-specific domains, such as HIV-related stigma, comorbidities, and ART-related treatment [19]. Some related reviews have recommended a strategy to combine generic and HIV-specific PROMs to supplement HIV-specific health care outcomes that cannot be obtained with generic PROMs alone [20,21]. Clayson et al [20] suggested that the right combination of generic and HIV-specific PROMs can improve the comprehensiveness of assessment content, such that it includes not only the 3 core domains that generic PROMs focus on, that is, physical function, social or role function, and mental health or emotional well-being, but also the items or domains addressing issues relevant to HIV or AIDS and its treatment. Considering that many HIV-specific PROMs were developed before the widespread use of ART, they may not be able to detect the impact of current treatment on people living with HIV and AIDS and serve as an assessment tool for the long-term management of people living with HIV and AIDS [9]. In addition, many poorly designed PROMs lack a standardized development process. Therefore, it is necessary to summarize the existing HIV-specific PROMs and assess their psychometric properties.

    Previous Studies

    With the rapid development of this field, many HIV-specific PROMs have been developed. After a preliminary literature search in MEDLINE using a comprehensive search strategy (Table S1 in Multimedia Appendix 1), we found some relevant reviews. Wen et al [19] recently conducted a systematic review on a similar topic; however, they only aimed at identifying and assessing the psychometric properties of HRQoL in people living with HIV and AIDS. Engler et al [22] identified 117 different HIV-specific PROMs in 2016; however, they did not quantitatively assess the psychometric properties of these PROMs. Cooper [16] reported an overview of the available reviews and summarized the PROMs with <40 items for measuring HRQoL in people living with HIV and AIDS in 2017. Earlier, several researchers conducted nonsystematic reviews of some PROMs in specific contexts [20,23,24]. Although many previous reviews have summarized the content of some existing HIV-specific PROMs, few have comprehensively reported the psychometric properties of these PROMs and given recommendations for the use of these PROMs.

    As accurate and reliable PROMs are a precondition for obtaining robust results, PROMs with good psychometric properties are indispensable for research [25]. Lancet HIV also suggested in the special issue of “HIV outcomes beyond viral suppression” that the psychometric properties of the existing PROMs should be assessed in line with the existing guidelines, such as the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines [9]. The COSMIN guidelines provide a consecutive procedure to help health care providers and researchers improve the selection of the most suitable PROMs in research and clinical practice [26]. Therefore, we conducted a systematic review to identify studies assessing the psychometric properties of HIV-specific PROMs validated in a population of adults living with HIV and AIDS and categorized these PROMs based on the type of outcome measure. We further assessed the methodological quality and level of evidence of these PROMs in association with their psychometric properties.

    Objective

    The purpose of this systematic review was to summarize and categorize the available and validated HIV-specific PROMs for adults living with HIV and AIDS. This systematic review also aimed to use the COSMIN methodology to assess the psychometric properties of these PROMs and make an evidence-based and completely transparent recommendation for the use of these PROMs.


    Overview

    This systematic review was conducted and reported according to the COSMIN guidelines [27] and the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement [28]. It included only a secondary data analysis of publicly available content not involving human participants. Therefore, ethics approval was not required for this review.

    Search Strategy

    Three literature databases (MEDLINE, Embase, and PsycINFO) were searched on January 15, 2021. Two important web databases, PROQOLID and PROMIS, which contain a large number of PROMs and cover a wide range of populations and therapeutic areas, were also searched for PROMs. These 2 databases were developed by the Mapi Research Trust in France and the National Institutes of Health in the United States to facilitate the selection process of PROMs and are now used by many clinical investigators. The reference lists of relevant reviews in the preliminary literature search and the included studies were further examined for relevant publications. The search strategy used three COSMIN-guided search terms in reference to the search for constructs developed by Terwee et al [29]: (1) construct of interest, (2) condition of interest, and (3) psychometric properties (Table S2 in Multimedia Appendix 1). A comprehensive search strategy was developed under the guidance of a senior health research librarian.

    Study Selection

    The eligibility criteria of the studies were as follows: (1) the study validated HIV-specific PROMs for adults living with HIV or AIDS and assessed at least one of the 9 psychometric properties defined by the COSMIN guidelines: content validity, structural validity, internal consistency, cross-cultural validity or measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness [30]; (2) the study was published in English in a peer-reviewed journal; and (3) the study applied self-administered PROMs for patients.

    Studies were excluded if (1) they used the PROM mainly for outcome measures rather than for assessing the 9 psychometric properties; (2) they developed and used PROMs for screening or diagnostic purposes only; (3) they were not an original investigation, such as reviews, letters, and editorials; (4) they included generic PROMs or other disease-specific PROMs not related to or only partially related to HIV (such as the 36-Item Short-Form Health Survey Questionnaire); and (5) they provided indirect evidence of psychometric properties (such as studies using a PROM in a validation study of another instrument [30]).

    The retrieved literature was imported into the EndNote software (version X9; Clarivate Plc), and duplications were automatically removed. A 2-stage screening process was used to select eligible studies. First, the titles and abstracts were screened based on the predetermined selection criteria (stage I). Subsequently, the full texts of articles deemed relevant or possibly relevant were obtained and further assessed for eligibility (stage II). Two independent researchers (ZW and YZ) determined study eligibility, and any disagreement was settled by consensus or discussion with a third researcher (BQ).

    Data Exclusion

    For the eligible studies, data were independently extracted by the same 2 researchers (ZW and YZ) using a standardized form, and completeness and correctness were confirmed. Any discrepancy was resolved via a discussion with the third researcher (BQ). The extracted data included the characteristics of PROMs (name of the PROM[abbreviation], year of PROM development, targeted concept, recall period, number of items, each domain and the number of items in each domain, response options and score range, and original language), characteristics of the included studies (first author [year of publication], the total number of patients [N], age, gender, patient description, years diagnosis, severity of disease, recruitment context, country of research, and effective response rate of the questionnaire), and results of the included studies (COSMIN risk of bias information, evidence of the 9 psychometric properties, and COSMIN summary and rating).

    Data Analysis

    According to the suggestions mentioned in the COSMIN guidelines, each PROM was assessed via a 4-step process [27]. First, the methodological quality for every psychometric property in each study was assessed using the COSMIN risk of bias checklist based on a four-point response, “very good,” “adequate,” “doubtful,” or “inadequate,” and an overall rating of the psychometric property was determined based on the item with the worst rating [30]. Second, the results for every psychometric property in each study were rated based on the updated criteria for good psychometric properties [27], and each result was graded as positive (+), negative (–), or indeterminate (?). Third, the overall results for each psychometric property of a PROM were rated as sufficient (+), insufficient (–), inconsistent (±), or indeterminate (?), and the level of evidence for each psychometric property of a PROM was rated as “high,” “moderate,” “low,” or “very low” by following the Grading of Recommendations, Assessment, Development, and Evaluation approach, which considered the initial level of evidence to be high, with subsequent downgrading based on the score for 4 criteria: risk of bias, inconsistencies, imprecision, and indirectness. Finally, a table summarizing the findings was constructed and used to make recommendations for the selection of the most suitable PROMs.

    All assessments were conducted independently by 3 researchers (ZW, HK, and XD), and any disagreement was settled via consensus or discussion with a fourth researcher (YZ). The Cohen κ coefficient was calculated using the SPSS software (version 24.0; IBM) to evaluate the interrater agreement for title and abstract screening, study selection, and data extraction.


    Search Results

    A total of 11,361 articles were identified in the literature search, and another 27 articles were identified through reference and citation searches. Of these, 2090 were excluded because of duplication. After screening the titles and abstracts, 535 articles were found to be potentially relevant, and their full text was reviewed for further assessment. Of these, 152 articles were finally included [31-182]. The PRISMA flow diagram and the reasons for exclusion are presented in Figure 1. The average Cohen κ coefficients for the title and abstract screening, study selection, and data extraction were 0.85, 0.82, and 0.89, respectively, indicating that the 2 researchers reached a “substantial agreement” as defined by Landis and Koch [183] in 1991.

    ‎
    Figure 1. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. PROM: patient-reported outcome measure. aThese studies were identified through further research of the reference lists of relevant reviews in the preliminary literature search and the included studies.
    View this figure

    Characteristics of the Included PROMs

    Table 1 lists the characteristics of the included PROMs, with details of the subscales provided in Table S3 in Multimedia Appendix 1. A total of 88 PROMs were reported in the 152 included studies, and these PROMs can be divided into 8 categories (improved based on the initial taxonomy developed by Engler et al [22]): HRQoL (24/88, 27% of PROMs) [31-102], symptoms (10/88, 11% of PROMs) [103-120], stigma (15/88, 17% of PROMs) [121-142], psychological (8/88, 9% of PROMs) [143-151], body and facial appearance (5/88, 6% of PROMs) [152-156], treatment (17/88, 19% of PROMs) [153-173], social support (3/88, 3% of PROMs) [174-176], and self-management and self-care (6/88, 7% of PROMs) [177-182]. All the included PROMs were tools self-administered by people living with HIV and AIDS either in a clinical or research context. Of these 88 PROMs, 22 (25%) PROMs were developed before 2000, 31 (35%) between 2000 and 2009, and 35 (40%) after 2010. The recall period for PROMs ranged from “past 7 days” to “last 12 months.” The number of items varied between 4 and 165. The original language for most PROMs was English, and the response option format for most PROMs was the 5-point Likert scale.

    Table 1. Characteristics of the included patient-reported outcome measures (PROMs)a.
    PROM; year of developmentTargeted
    concept    		Recall periodTotal no. of itemsResponse optionsScore rangeOriginal language
    HRQoLb

    		MOS-HIVc [31-51]; 1996HRQoLPast 4 weeks35Multiple response
    options    		Raw scores for each scale were transformed to a scale of 0 to 100English

    		MOS-HIV-17 [53]; 2000HRQoLPast 4 weeks17Multiple response
    options    		Raw scores for each scale were transformed to a scale of 0 to 100English

    		MOS-HIV-29 [52]; 2012HRQoLPast 30 days29Multiple response
    options    		Raw scores for each scale were transformed to a scale of 0 to100Luganda

    		HIV Overview of Problems Evaluation System [54,55]; 1992HRQoL—d1655-point Likert scale (0-4)Summary of scales: physical scale, medical interaction, psychosocial scale, sexual scale, and significant others or partnersEnglish

    		HIV-Related Quality of Life Questions [56]; 1993HRQoLPast month34Multiple response
    options    		—English

    		AIDS Health Assessment Questionnaire [57]; 1997HRQoLDifferent recall periods per dimensions116Multiple response
    options    		Raw scores were transformed to a scale of 0 to 100English

    		HIV-PARSEe [58]; 1994HRQoLDifferent recall periods per dimensions30Multiple response
    options    		Perceived Health Index (25 items)English

    		HIV-PARSE-Brief [59]; 1995HRQoLDifferent recall periods per dimensions21Multiple response
    options    		Perceived Health Index (13 items)English

    		HRQoL [60]; 1995HRQoLPast 4 weeks64Multiple response
    options    		A physical health dimension and a Mental health dimensionEnglish

    		Functional Assessment of HIV Infection [61-65]; 1996HRQoLPast 7 days445-point Likert scale (0-4)Sum of all item scores (0-176)English

    		General Health Self-Assessment [66]; 1997HRQoLPast 4 weeks49Multiple response
    options    		The subscales are scored as summated and transformed on a scale of 0 to 100English

    		HIV Quality of Life 31-item scale [67]; 1997HRQoL—31Dichotomous: yes or noSimple summation of dichotomous response optionsFrench

    		HAT-QoLf-42 [68,69]; 1997HRQoLPast 4 weeks425-point Likert scale (1-5)All subscales are coded to range from 0 to 100English

    		HAT-QoL-30 [35]; 1999HRQoLPast 4 weeks305-point Likert scale (1-5)All subscales are coded to range from 0 to 100English

    		HAT-QoL-34 [42,70,71]; 2008HRQoLPast 4 weeks345-point Likert scale (1-5)All subscales are coded to range from 0 to 100English

    		MQoLg for patients with HIV or AIDS [34,72-75]; 1997HRQoL—407-point Likert scale (1-7)Each subscale ranged from 4 to 28; mental health score + (2 × physical functioning score) = overall index for MQoL (12-84)English

    		Living with HIV Scale [76]; 1998HRQoL—325-point Likert scale (0-4)Sum of all item scores: 0-128; subscale scores range: 0-24English

    		WHOQOL-HIVh [77-83]; 2004HRQoLThe last 2 weeks120 (30 facets)5-point Likert scale (1-5)Facet scores range: 4-20English

    		WHOQOL-HIV-BREFi [84-95]; 2012HRQoLThe last 2 weeks315-point Likert scale (1-5)Facet scores range: 4-20English

    		Instituto Superiore di Sanità Quality of Life [96]; 2006HRQoLPast 4 weeks625-point Likert scales (1-5)All subscales are coded to range from 0 to 100Italian

    		Symptom Quality of Life Adherence [97]; 2009HRQoLPast 4 weeks26HRQoL: 5-point Likert scales (1-5), symptoms: yes or no, and adherence: 10 cm VASjHRQoL: standardized sum (0-100), symptoms: summed, and adherence: score 0-10 VASFrench

    		PROQOL-HIVk-43 [98-100]; 2012HRQoLPast 2 weeks435-point Likert scale (0-4)Sum of the 8 subscales and coded as a total score range from 0 to 100English

    		PROQOL-HIV-38 [101]; 2016HRQoLPast 2 weeks385-point Likert scale (0-4)Four subscale scores are summed of item responses, coded to range from 0 to 100French

    		Poz Quality of Life [102]; 2018HRQoL—135-point Likert scale (1-5)Items were averaged to create the total score and scores for each subscaleEnglish
    Symptoms

    		Riverside Symptom Checklist [103]; 1993HIV-related symptomsPast 3 months285-point Likert scale (0-4)The subscales are scored as summated and transformed on a scale from 0 to 100English

    		HIV Symptom Index [104]; 1994HIV-related symptomsPast 2 weeks124-point Likert scales (0-3)Scores range: 0-24English

    		HIV Assessment Tool [105]; 1994HIV-related symptoms—34 in each exploratory factor analysis100-mm linear scaleItems were averaged to create the total score (0-100)English

    		SSC-HIVl [106,107]; 1999HIV-related symptoms—264-point Likert scales (0-3)The items within a factor are summed for a subscale scoreEnglish

    		SSC-HIV-rev [108]; 2001HIV-related symptoms—724-point Likert scales (0-3)The items within a factor are summed for a subscale scoreEnglish

    		HIV Cost and Services Utilization Study Symptom Measure [109]; 2000HIV-related symptomsPreceding 6 months13 for male and 14 for female respondents5-point Likert scale (1-5)The subscales are scored as summated and transformed on a scale of 0 to 100English

    		HIV Symptom Index or Symptoms Distress Module of the ACTGm [110-112]; 2001HIV-related symptomsPast 4 weeks205-point Likert scale (0-4)Score range: 0-80English

    		HIV-Related Fatigue Scale [113-115]; 2002HIV-related fatiguePast week56Multiple response
    options    		All subscales are coded to range from 1 to 10English

    		HIV Disability Questionnaire [116-119]; 2013HIV-related disabilityPast week69Disability presence scores: yes or no; disability severity scores: 5-point Likert scale (0-4); episodic scores: yes or no; 7-point Likert scale (0-6) [116]Each method of calculating scores was to sum the scores and transform them into scores out of 100English

    		Istituto Superiore di Sanità-HIV symptoms scale [120]; 2016HIV-related symptomsPast 4 weeks225-point Likert scale (no score for each option)—Italian
    Stigma

    		HSSn-40 [121,122]; 2001HIV-related stigma—404-point Likert scale (1-4)Score range: 40-160English

    		HSS-32 [123,124]; 2007HIV-related stigma—324-point Likert scale (1-4)Score range: 32-128English

    		HSS-12 [125-127]; 2010HIV-related stigma—124-point Likert scale (1-4)Score range: 12-48Swedish

    		HSS-39 [128]; 2014HIV-related stigma—394-point Likert scale (1-4)Score range: 39-156Swedish

    		HSS-30 [129]; 2015HIV-related stigma—304-point Likert scale (1-4)Score range: 30-120Spanish

    		HSS-10 [130]; 2020HIV-related stigma—105-point Likert scale (1-5)Score range: 10-50Japanese

    		HIV or AIDS stigma instrument–People living with AIDS [131,132]; 2007HIV-related stigmaTwo recall periods: past 3 months and ever since HIV diagnosis334-point Likert scale (0-3)Score range: 0-3English

    		Internalized HIV Stigma Measure [133]; 2008Internalized HIV-related stigma—28Transformed linearly to a range of 0 to 100The subscales are scored as summated and transformed on a scale of 0 to 100English

    		Internalized AIDS-Related Stigma Scale [134-136]; 2009Internalized HIV-related stigma—6Binary response: 1=agree and 0=disagreeTotal scores range of endorsed stigma items: 0-6English

    		Internalized Stigma in Those With HIV or AIDS [137]; 2011Internalized HIV-related stigmaEver since HIV diagnosis105-point Likert scale (1-5)Score range: 10-50English

    		HIV- and Abuse-Related Shame Inventory [138]; 2012HIV- and abuse-related shamePast month315-point Likert scale (0-4)Score range: 0-124English

    		Self, Experienced, and Perceived HIV or AIDS Stigma Scales [139]; 2012HIV-related stigma—224-point Likert scale (1-4)Score range: 22-88English

    		HIV Stigma Mechanisms [140]; 2013HIV stigma mechanisms—245-point Likert scales (1-5)Items were averaged to create composite scoresEnglish

    		HIV or AIDS Stigma Assessment for Latino Gay Men, Bisexual Men, and Transgender Women Living With HIV [141]; 2013HIV-related stigma—364-point Likert scale (1-4)Score range: 36-144English

    		Van Rie HIV or AIDS-Related Stigma Scale-Revised for use in the United States [142]; 2015HIV-related stigma—154-point Likert scale (0-3)Items were averaged to create composite scores and subscales scoresEnglish
    Psychological

    		The Mental Adjustment to HIV scale [143]; 1994Mental adjustment—404-point Likert scale (1-4)The subscales are scored as summatedEnglish

    		HIV or AIDS Stress Scale [144]; 2002Stress and copingPast month235-point Likert scale (0-4)Score range: 0-92English

    		Perceived Stress Scale Among People Living With HIV or AIDS [145]; 2008HIV-related stressPast month355-point Likert scale (1-5)Score range: 35-175Simplified Chinese

    		Screenphiv [146,147]; 2012Psychological issues related to HIV—63VAS (0-100 mm)Items were averaged to create composite scoresSpanish

    		Impact on Self-Concept Scale [148]; 2013Impact of HIV on self-concept—106-point Likert scale (1-6)Items were averaged to create composite scoresEnglish

    		Impact of HIV [149]; 2015Challenges of HIV survivorship—385-point Likert scale (1-5)Score range: 38-190English

    		HIV Meaningfulness Scale [150]; 2015HIV meaningfulness—47-point Likert scaleScore range: 1-28English

    		People Living with HIV Resilience Scale [151]; 2019ResiliencePast 12 months10Positively affected: “+1,” not affected: “0,” and negatively affected: “–1”Score range: (–10 to 10)English
    Body and facial appearance

    		Body Image in Patients With HIV or AIDS [152]; 2005Perceived body image—125-point VASScore range: 12-60English

    		Owen Clinic Lipodystrophy Scale [153]; 2006Body change—12Dichotomous: (yes or no)—English

    		ACTG-ABCDo [154]; 2006Body change and distressPart 3: past 4 weeks27Part 1: dichotomous: (yes or no); part 2 and part 3: 5-point Likert scale (1-5)Sum of all item scores in part 3 (20 items)English

    		ACTG-ABCD Short form [155]; 2014Body change and distressPast 4 weeks185-point Likert scale (1-5)Sum of all item scoresEnglish

    		Facial Appearance Inventory [156]; 2016AppearancePast 4 weeks107-point Likert scale (1-7)Score range: 24-168;
    final score is linearly transformed to 0-100    		English
    Treatment

    		Medication Attribution Scale [157]; 1998Attributions about ARTp (its limitations on functioning, etc)—1011-point Likert scale (0-10)Sum of all item scoresEnglish

    		HIVTSQq [158]; 2001Satisfaction with ARTPast 4 weeks97-point Likert scale (0-6)Total treatment satisfaction is the sum of the 9 item scoresEnglish

    		HIV Treatment Satisfaction Questionnaire status version [159]; 2006Satisfaction with ARTPast few weeks107-point Likert scale (0-6)Total treatment satisfaction is the sum of the 10 item scoresEnglish

    		Treatment-Related Empowerment Scale [160]; 2001Empowerment (involvement in treatment decision-making)—105-point Likert scale (1-5)Sum of all item scoresEnglish

    		Subcutaneous Injection Survey [161]; 2002Satisfaction with ART–subcutaneous injection—155-point Likert scale (1-5)Score range: 20-100English

    		Quality of care through the patient’s eyes [162]; 2003Quality of care—27Importance and performance were measured using a 4-point Likert scale (1-4)[Qij = Iij × Pij]rEnglish

    		Attitudes Toward HIV Health Care Provider scale [163]; 2004Attitudes toward health care providers—196-point Likert scale (1-6)Sum of all item scoresEnglish

    		Antiretroviral General Adherence Scale [164]; 2006Ease and ability to adhere to ARTPast 30 days56-point Likert scale (1-6)Sum of all item scores or a proportion (by dividing this score by the total possible score)English

    		Health Care Relationship Trust Scale [165]; 2006Trust toward health care providers—155-point Likert scale (0-4)Sum of item scores and the mean of item scoresEnglish

    		HIV Medication Readiness Scale [166]; 2007Readiness to adhere to ART—105-point Likert scale (0-4)Score range: 0-40English and French

    		SECope [167]; 2007Coping with the side effects of ART—205-point Likert scale (0-4)Score range: 0-80English

    		HIV Treatment Optimism Scale [168]; 2009Optimism about ART—197-point Likert scale (1-7)Score range: 19-133English

    		HIV Medication Taking Self-Efficacy Scale [169]; 2010Self-efficacy to adhere to ART—2611-point Likert scale (0-10)Sum of all item scoresEnglish

    		Brief Estimate of Health Knowledge and Action-HIV version [170]; 2010ART-related health literacy—8Part I: 4-point Likert scale (0-3); Part II: 6-point Likert scale (0-5)Sum of all item scoresEnglish

    		HIV Treatment Readiness Measure [171]; 2011Factors affecting the readiness for ARTAlcohol and drug use subscale in the past 3 months385-point Likert scale (1-5)Sum of all item scores and the mean of all item scoresEnglish

    		HIV Treatment Regimen Fatigue Scale [172]; 2015Regimen fatigue—22–3 to 3 (excluding 0)Sum of all item scoresEnglish

    		HIV Engagement in and Continuity of Care Scale [173]; 2017Engagement in care—265-point Likert scale—English
    Social support

    		Social Support Inventory [174]; 1999Received social support—14/17Satisfaction: 5-point Likert scale (1-5); want: yes or no; have: yes, no, or not applicableNine subscales: 0-5English

    		Unsupportive Social Interactions Inventory-HIV version [175]; 1999Unsupportive social interactions—244-point Likert scale (0-4)An overall score, the Unsupportive Social Interactions Inventory-18, is based on 3 of its subscalesEnglish

    		Perceived Social Support for HIV [176]; 2014Perceived social support—125-point Likert scale (1-5)Sum of all item scores; Score range: 12-60Spanish
    Self-management and self-care

    		HIV Treatment Adherence Self-Efficacy Scale [177]; 2007Self-efficacy to adhere to HIV carePast 1 month1211-point Likert scale (0-10)Item scores were averaged for each respondentEnglish

    		Perceived HIV Self-Management Scale [178]; 2011Self-efficacy for HIV self-management—86-point Likert scale (1-6)Sum of all item scoresEnglish

    		HIV Self-Management Scale (Women) [179]; 2012HIV Self-Management Scale (Women)—204-point Likert scale (0-3)Subscale score range: 0-3English

    		HIV Intention Measure [180]; 2012Intention to adhere to HIV care—146-point Likert scale (1-6)—English

    		HIV Exercise Stereotypes Scale [181]; 2016Stereotypes related to exercise in people living with HIV—146-point Likert scale (1-6)Three subscale scores are computed as the mean of item responsesFrench

    		HIV Symptom Management Self-Efficacy for Women Scale [182]; 2011Self-efficacy for HIV symptom management—911-point Likert scale (0-10)The final score is calculated as the mean of the 9 item scoresEnglish

    aEach version of a PROM is considered a separate PROM.

    bHRQoL: health-related quality of life.

    cMOS-HIV: Medical Outcomes Study-HIV Health Survey.

    d—: not reported.

    eHIV-PARSE: HIV Patient–Reported Status and Experience.

    fHAT-QoL: HIV or AIDS-Targeted Quality of Life Instrument.

    gMQoL: Multidimensional Quality of Life.

    hWHOQOL-HIV: World Health Organization Quality of Life-HIV.

    iWHOQOL-HIV-BREF: World Health Organization Quality of Life-HIV-Bref instrument.

    jVAS: visual analog scale.

    kPROQOL-HIV: Patient-Reported Outcome Quality of Life-HIV Questionnaire.

    lSSC-HIV: Sign and Symptom Checklist for HIV.

    mACTG: Adult AIDS Clinical Trial Group.

    nHSS: HIV Stigma Scale.

    oACTG-ABCD: Adult AIDS Clinical Trial Group’s Assessment of Body Change and Distress.

    pART: antiretroviral therapy.

    qHIVTSQ: HIV Treatment Satisfaction Questionnaire.

    rThe quality improvement score (Q) on a health service (j) by an individual patient (i) is equal to the importance score (I) multiplied by the (perceived) performance score (P).

    Characteristics of the Included Records

    As 3 studies [34,35,42] included the assessment of 2 PROMs, 155 records were included. Table S4 in Multimedia Appendix 1 shows the characteristics of the 155 included records. Of these 155 records, 31 (20%) records were reported before 2000, 46 (29.7%) records were reported between 2000 and 2009, and 78 (50.3%) records were reported after 2010. The total sample size of these records was 79,213 (range 20-5521). There were more men than women in 83.2% (129/155) of the records, and 1.3% (2/155) of records did not indicate gender data. Most records gave the mean (SD) or median (IQR) age data for samples (range 16-84 years), and 8.4% (13/155) of records indicated no age data. There were 70.3% (109/155) records from high-income countries (64/155, 41.3% records from the United States), 20.6% (32/155) records from low- and medium-income countries (9/155, 5.8% records from China), and 9% (14/155) of records from multiple countries. Table S4 in Multimedia Appendix 1 also summarizes the years since diagnosis, the severity of the disease, recruitment context, and effective response rate.

    Methodological Quality Assessment

    The methodological quality for each psychometric property of every record is summarized in Table S5 in Multimedia Appendix 1 based on the COSMIN risk of bias checklist. As there is no generally accepted “golden standard” for assessing health outcomes in adults living with HIV and AIDS, the criterion validity of all studies was not considered. Most records assessed internal consistency (146/155, 94.2% of records) and structural validity (96/155, 61.9% of records), and most of them were rated as “very good” or “adequate.” Although 79.4% (123/155) of records assessed the hypotheses testing for construct validity, most were rated as “doubtful” or “inadequate.” As for the remaining psychometric properties, only a few records assessed them, and most of them were rated as “doubtful” or “inadequate.”

    Overall Results and the Level of Evidence

    Table S6 in Multimedia Appendix 1 shows the results of each psychometric property of each record. The overall results and the level of evidence are presented in Table S7 in Multimedia Appendix 1. There are only few studies on PROMs, except for some well-known PROMs; accordingly, there is little evidence for psychometric properties.

    Of the 88 PROMs, PROM development was assessed in 18% (16/88) PROMs, and original content validity was assessed in 3% (3/88) PROMs. However, no PROM exhibited “sufficient” high-quality evidence for content validity. Subsequently, we found that 16% (14/88) of the PROMs had “sufficient” high-quality evidence of structural validity; however, most others had “indeterminate” moderate-quality evidence. The internal consistency for a PROM can be assessed only if it has at least low-quality evidence for “sufficient” structural validity; otherwise, the internal consistency will be considered “indeterminate” [30]. Therefore, although 83% (73/88) of PROMs presented high-quality evidence for internal consistency, only 16% (14/88) demonstrated “sufficient” results. Evidence supporting hypotheses testing for construct validity was available for 81% (71/88) of the PROMs. Furthermore, reliability was assessed in 30% (26/88) PROMs, but no PROM presented “sufficient” high-quality evidence. The responsiveness of 8% (7/88) of PROMs was evaluated as “sufficient,” but only 2% (2/88) PROMs (Functional Assessment of HIV Infection [61-66] and HIV Medication Readiness Scale [166]) showed high-quality evidence. Cross-cultural validity or measurement invariance was assessed in only 6% (5/88) of PROMs with low or very low quality [82,111,122,124,127]. Finally, only 1% (1/88) of PROMs assessed measurement error with “indeterminate” low-quality evidence [118].

    Recommendations

    The following recommendations are presented according to the COSMIN guidelines (Table 2):

    • Class A: The PROMs with evidence for “sufficient” content validity (any level) and at least low-quality evidence for “sufficient” internal consistency included the following: Poz Quality of Life (PozQoL) [102], HIV Symptom Index or Symptoms Distress Module of the Adult AIDS Clinical Trial Group (HIV-SI or SDM) [110-112], and People Living with HIV Resilience Scale (PLHIV-RS) [151]. These may be recommended for use, and the results obtained may be credible.
    • Class B: The remaining PROMs have the potential to be recommended for use; however, further research is required to assess their quality (PROMs not included in class A or C).
    • Class C: The PROMs with high-quality evidence for an “insufficient” psychometric property included the following: Multidimensional Quality of Life for patients With HIV and AIDS [72-75], Patient-Reported Outcome Quality of Life-HIV Questionnaire-38 [101], HIV-Related Fatigue Scale [113-115], HIV Stigma Scale-10 [130], HIV or AIDS Stress Scale [144], Screenphiv [146,147], SECope [167], and HIV Exercise Stereotypes Scale [181]. They may not be recommended for use.

    Although 3 PROMs have been recommended, they all have some shortcomings, reducing the strength of the recommendation for their routine use. Furthermore, although PozQoL [102] and PLHIV-RS [151] achieved class A, they were developed and assessed based on a single validation study. In addition, some items in HIV-SI or SDM have significant differential item functioning between different cultural groups [111], indicating low-quality evidence for “insufficient” cross-cultural validity.

    Table 2. Summary of findingsa.
    PROMbContent validityStructural validityInternal consistencycCCV or MIdReliabilityMeasurement errorHTCVe,fResponsivenessClassg

    		ResultsLoEhResultsLoEResultsLoEResultsLoEResultsLoEResultsLoEResultsLoEResultsLoE
    MOS-HIVi [31-51]+M±M±M+HB
    MOS-HIV-17 [53]?H–LB
    MOS-HIV-29 [52]?M?M+L+LB
    HOPESj [54,55]?H+VL+VLB
    HIV-QoLk [56]?HB
    AIDS-HAQl [57]?H+H+LB
    HIV-PARSEm [58]?HB
    HIV-PARSE-Brief [59]?HB
    HRQOLn [60]–VL?H+LB
    FAHIo [61-65]±M–M?H+H+HB
    GHSAp [66]?M?H+LB
    HIV-QL31q [67]?VL–M?H–LB
    HAT-QoLr-42 [68,69]?H–MB
    HAT-QoL-30 [35]?H+LB
    HAT-QoL-34 [42,70,71]?M?H–M+HB
    MQoL-HIVs [34,72-75]?M?M?H–H+H+MC
    LWHIVSt [76]±VL?M?H–LB
    WHOQOL-HIVu [77-83]+M?L?VL+M+HB
    WHOQOL-HIV-BREF [84-95]±L?H?M+LB
    ISSQoLv [96]+L?H+LB
    HIV-SQUADw [97]?M?H+LB
    PROQOLx-HIV-43 [98-100]+VL?M?H+L+LB
    PROQOL-HIV-38 [101]–H?H+VLC
    PozQoly [102]+L+H+H+M+MA
    RSCz [103]?H+HB
    HSIaa [104]?H+L–L+VLB
    HATab [105]?VL?VL+LB
    SSC-HIVac [106,107]+M+HB
    SSC-HIV-rev [108]?M?H–LB
    HCSUS-SMad [109]?HB
    HIV-SI or SDMae [110-112]+L+H+H–L+LA
    HRFSaf [113-115]?VL?H–H+MC
    HDQag [116-119]+M+H+M?L±MB
    ISS-HIV-SSah [120]?M?H+HB
    HSSai-40 [121,122]?M?H–L+M+HB
    HSS-32 [123,124]±M?H–VL+LB
    HSS-12 [125-127]+H+H–L–MB
    HSS-39 [128]?VL?H+VLB
    HSS-30 [129]?M+H+H+HB
    HSS-10 [130]+H–H+LC
    HASIaj-P [131,132]?H?H+HB
    IHSMak [133]?M?H–LB
    IA-RSSal [134-136]+H+H–M±MB
    ISATam [137]?M?H+HB
    HARSIan [138]?M?H–VLB
    SEP-HASSao [139]?H+VLB
    HIV-SMap [140]?M–VLB
    HA-SAL-GBTaq [141]?VL?H–LB
    VR-HARSSRar [142]?L?M+MB
    MAHas [143]?VL?HB
    SS-HIVat [144]–H?H+M+LC
    PSSHIVau [145]±VL?M?H+L+LB
    Screenphiv [146,147]?L+H–H+HC
    ISCSav [148]?M?H+LB
    IHIVaw [149]+H+HB
    HIVMSax [150]?M?H+L+VLB
    PLHIV-RSay [151]+L+H+H+LA
    BISaz [152]?M?L+VLB
    OCLSba [153]?M?VLB
    ACTG-ABCDbb [154]?H–LB
    ACTG-ABCD-SFbc [155]?M?H+LB
    FAIbd [156]?L?VL+VLB
    MASbe [157]?M–MB
    HIVTSQbf [158]?M?H–LB
    HIVTSQ status version [159]+H+H–LB
    TESbg [160]?L–VLB
    SISbh [161]?M?H–LB
    QUOTE-HIVbi [162]?LB
    AHHCPbj [163]?M?H+HB
    AGASbk [164]?M?H+LB
    HCRbl [165]±VL?L?M–VL–VLB
    HMRSbm [166]?M?H+VL+L+HB
    SECope [167]±VL+H–H–M–LC
    HTOSbn [168]?M?HB
    HIV-MT-SESbo [169]+H+H–L+LB
    BEHKA-HIVbp [170]?M?HB
    HTRMbq [171]?M?H–MB
    HTRFSbr [172]?L?M+VLB
    HECCSbs [173]+M+H+HB
    SSIbt [174]±VL?M?H+VLB
    USII-HIVbu [175]?M?H–LB
    PSS-HIVbv [176]?L+VLB
    HIV-ASESbw [177]+H+H?L+LB
    PHIVSMSbx [178]?H+LB
    HIV-SMS-Wby [179]+VL+H+H?VLB
    HIV-IMbz [180]±L?L?H+LB
    HIVESSca [181]–H?H+VLC
    HSM-SEWScb [182]?L?M?VLB

    aAs there is no generally accepted “golden standard” for assessing health outcomes in adults living with HIV and AIDS, the criterion validity of all studies was not considered. Overall results of PROMs are rated as +: sufficient; ?: indeterminate; ±: inconsistent; and –: insufficient. LoE is rated as H: high, M: moderate, L: low; VL: very low. Blank cells indicate that the data are not available.

    bPROM: patient-reported outcome measure.

    cInternal consistency can be rated as “sufficient” if there is at least low evidence for “sufficient” structural validity, and Cronbach α values≥.70 for each unidimensional scale or subscale; the evidence for “sufficient” structural validity may come from different studies, and the “at least low evidence” was defined by grading the evidence according to the Grading of Recommendations, Assessment, Development, and Evaluation approach.

    dCCV or MI: cross-cultural validity or measurement invariance.

    eHTCV: hypotheses testing for construct validity.

    fThe results of all included records should be taken together, and it should then be decided if 75% of the results are in accordance with the hypotheses. Only assessed measurement properties are shown.

    gClass A represents evidence for sufficient content validity (any level) and at least low-quality evidence for sufficient internal consistency (PROMs can be recommended for use); class B, PROMs categorized not in class A or C; and class C, high-quality evidence for an insufficient measurement property; PROMs with class B recommendation require further evaluation to assess their quality before recommendation for use; PROMs with class C recommendation are not recommended for use.

    hLoE: level of evidence (using the Grading of Recommendations, Assessment, Development, and Evaluations assessment tool).

    iMOS-HIV: Medical Outcomes Study-HIV Health Survey.

    jHOPES: HIV Overview of Problems Evaluation System.

    kHIV-QoL: HIV-Related Quality of Life Questions.

    lAIDS-HAQ: AIDS Health Assessment Questionnaire.

    mHIV-PARSE: HIV Patient–Reported Status and Experience.

    nHRQoL: health-related quality of life.

    oFAHI: Functional Assessment of HIV Infection.

    pGHSA: General Health Self-Assessment.

    qHIV-QL31: HIV Quality of Life 31-item scale.

    rHAT-QoL: HIV or AIDS-Targeted QoL Instrument.

    sMQoL-HIV: Multidimensional QoL for patients with HIV or AIDS.

    tLWHIVS: Living with HIV Scale.

    uWHOQOL-HIV: World Health Organization Quality of Life-HIV.

    vISSQoL: Instituto Superiore di Sanità Quality of Life.

    wHIV-SQUAD: Symptom Quality of Life Adherence.

    xPROQOL-HIV: Patient-Reported Outcome Quality of Life-HIV Questionnaire.

    yPozQol: Poz Quality of Life.

    zRSC: Riverside Symptom Checklist.

    aaHSI: HIV Symptom Index.

    abHAT: HIV Assessment Tool.

    acSSC-HIV: Sign and Symptom Checklist for HIV.

    adHCSUS-SM: HIV Cost and Services Utilization Study Symptom Measure.

    aeHIV-SI or SDM: HIV Symptom Index or Symptoms Distress Module of the Adult AIDS Clinical Trial Group.

    afHRFS: HIV-Related Fatigue Scale.

    agHDQ: HIV Disability Questionnaire.

    ahISS-HIV-SS: Istituto Superiore di Sanità-HIV symptoms scale.

    aiHSS-40: HIV Stigma Scale.

    ajHASI-P: HIV or AIDS Stigma Instrument-PLWA.

    akIHSM: Internalized HIV Stigma Measure.

    alIA-RSS: Internalized AIDS-Related Stigma Scale.

    amISAT: Internalized Stigma in Those With HIV or AIDS.

    anHARSI: HIV- and Abuse-Related Shame Inventory.

    aoSEP-HASS: Self, Experienced, and Perceived HIV or AIDS Stigma Scales.

    apHIV-SM: HIV stigma mechanisms.

    aqHA-SAL-GBT: HIV or AIDS Stigma Assessment for Latino Gay Men, Bisexual Men and Transgender Women Living With HIV.

    arVR-HARSSR: Van Rie HIV or AIDS-Related Stigma Scale-Revised for use in the United States.

    asMAH: Mental Adjustment to HIV scale.

    atSS-HIV: HIV or AIDS Stress Scale.

    auPSSHIV: Perceived Stress Scale Among People Living With HIV and AIDS.

    avISCS: Impact on Self-Concept Scale.

    awIHIV: Impact of HIV.

    axHIVMS: HIV Meaningfulness Scale.

    ayPLHIV-RS: People Living with HIV Resilience Scale.

    azBIS: Body Image in Patients With HIV or AIDS.

    baOCLS: Owen Clinic Lipodystrophy Scale.

    bbACTG-ABCD: Adult AIDS Clinical Trial Group’s Assessment of Body Change and Distress.

    bcACTG-ABCD-SF: ACTG-ABCD Short Form.

    bdFAI: Facial Appearance Inventory.

    beMAS: Medication Attribution Scale.

    bfHIVTSQ: HIV Treatment Satisfaction Questionnaire.

    bgTES: Treatment-Related Empowerment Scale.

    bhSIS: Subcutaneous Injection Survey.

    biQUOTE-HIV: quality of care through the patient’s eyes.

    bjAHHCP: Attitudes Toward HIV Health Care Provider scale.

    bkAGAS: Antiretroviral General Adherence Scale.

    blHCR: Health Care Relationship Trust Scale.

    bmHMRS: HIV Medication Readiness Scale.

    bnHTOS: HIV Treatment Optimism Scale.

    boHIV-MT-SES: HIV Medication Taking Self-Efficacy Scale.

    bpBEHKA-HIV: Brief Estimate of Health Knowledge and Action-HIV version.

    bqHTRM: HIV Treatment Readiness Measure.

    brHTRFS: HIV Treatment Regimen Fatigue Scale.

    bsHECCS: HIV Engagement in and Continuity of Care Scale.

    btSSI: Social Support Inventory.

    buUSII-HIV: Unsupportive Social Interactions Inventory-HIV version.

    bvPSS-HIV: Perceived Social Support for HIV.

    bwHIV-ASES: HIV Treatment Adherence Self-Efficacy Scale.

    bxPHIVSMS: Perceived HIV Self-Management Scale.

    byHIV-SMS-W: HIV Self-Management Scale (Women).

    bzHIV-IM: HIV Intention Measure.

    caHIVESS: HIV Exercise Stereotypes Scale.

    cbHSM-SEWS: HIV Symptom Management Self-Efficacy for Women Scale.


    Principal Findings

    From the 152 included studies, we identified 88 PROMs in 8 categories for adults living with HIV, and the psychometric properties of the majority of the included PROMs were rated with insufficient evidence. The principal finding of this review was the lack of comprehensively validated HIV-specific PROMs for the assessment of health outcomes in adults living with HIV and AIDS. Although 3 available PROMs (PozQoL, HIV-SI or SDM, and PLHIV-RS) have been recommended based on the COSMIN guidelines, they all have some shortcomings. In addition, because of limited evidence, recommendations regarding the use of most of the remaining assessed PROMs (class B recommendation) cannot be made. These findings emphasize on the need for a more comprehensive validation of the psychometric properties of the existing PROMs. Furthermore, our findings indicate the need for a robust and rapid validation of PROMs through the use of electronic PROMs (ePROMs) and modern measurement theories (such as Item Response Theory).

    Taxonomy of HIV-Specific PROMs

    This systematic review updated the review reported by Engler [22] and provided improvisations on the inclusion and exclusion criteria, such that many unvalidated PROMs were excluded because if we include these PROMs, we cannot summarize the overall status of their psychometric properties. In addition, using the 12 categories reported by inductive content analysis in the review of Engler [22] as reference, this review reported 8 integrated categories (Table 1). The 2 categories of “ART and adherence-related views and experiences” and “healthcare-related views and experiences” in the study by Engler et al [22] were integrated into “treatment,” and “psychological challenges” and “psychological resources” were integrated into the category “psychological”; the PROMs in the “sexual and reproductive health” category were excluded because they did not meet the inclusion criteria for our study. Finally, the “Disability” category was integrated with “Symptoms.” The new taxonomy proposed in this review should be helpful for health care providers and researchers in selecting PROM.

    In addition, although some of the PROMs included cognitive function or symptoms to some extent (such as “cognitive functioning” of Medical Outcomes Study-HIV Health Survey and “cognitive symptoms” of HIV Disability Questionnaire), no PROM specifically designed to measure cognitive concerns was included in the analysis. However, considering the high prevalence of HIV-associated neurocognitive disorders and HIV-associated dementia in people living with HIV and AIDS, it is important to assess their cognition via PROMs [184]. Askari [185,186] conducted a series of studies to progressively simplify the item pool and developed a PROM (the Communicating Cognitive Concerns Questionnaire) aimed at assessing the cognitive abilities of people living with HIV and AIDS. The main cognitive dimensions measured by this PROM included memory, concentration, executive function, language, emotions, and motivation. Although the Communicating Cognitive Concerns Questionnaire did not correlate strongly with cognitive test performance in people living with HIV and AIDS, it reflected the real-life concerns of people living with HIV and AIDS in terms of their mood, work, and work productivity. Although the related PROMs were not included in this review, we will further explore these cognitive concerns as an independent PROM category in future studies.

    Psychometric Properties

    Overview

    A thorough validation process is important for ensuring the applicability of a PROM to individual patient care [187]. However, in this review, most included PROMs were short of evidence for many psychometric properties, such as content validity, measurement error, cross-cultural validity or measurement invariance, and responsiveness. Therefore, it was difficult to assess the quality of these PROMs.

    Content Validity

    On the basis of the most up-to-date COSMIN methodology [26], content validity is the most important psychometric property, and the current guidance suggests that it is very important for patients to participate in development and validation studies [25]. As suggested by Selby and Velikova [188], and public involvement should appear as a core feature in PROM design and application. In addition, Wilson [189] believed that the perception of patients was essential for providing better insights into how a disease affects HRQoL. However, they were short of evidence in terms of patient and public involvement in the development process of the included PROMs. To determine whether a PROM was well designed, it should be confirmed that the PROM is relevant, comprehensible, and comprehensive from a patient perspective and for their context of use [190]. In addition, PROMs should be able to record the experience of people living with HIV and AIDS and how HIV affects their lives so as to make a study more relevant and have better content validity [191].

    Internal Structure

    Internal consistency was the most frequently reported psychometric property. However, many studies used internal consistency as the only indicator of reliability, which was definitely not enough. Besides, structural validity is also one of the most important psychometric properties [192]. The premise for assessing internal consistency is at least “low” evidence for “sufficient” structural validity, and this evidence may come from different studies [27]. However, only exploratory factor analysis was conducted in many studies for the assessment of structural validity instead of confirmatory factor analysis. Accordingly, this property can only obtain the rating of “indeterminate,” further affecting the assessment of internal consistency. In addition, the assessment of structural validity in most studies included in this review was based on classical test theory. Only 2 studies used Rasch analysis to assess the extent of interval level measurement and implementation of unidimensionality in this review [62,67]. However, no guidance has been provided in the COSMIN guidelines with regard to relying on only Rasch analysis without classical test theory statistics to assess the structural validity of PROMs. Therefore, Recchioni [193] suggested that it is necessary to provide additional guidance for the study that only uses Rasch analysis, especially in the development of new PROMs.

    A PROM developed in one particular context may not be suitable for another. Therefore, it is necessary to use the same PROM for direct comparisons between different populations. No positive results for cross-cultural validity or measurement invariance were reported in this review [82,111,122,124,127], showing that the validity and transferability of the included PROMs between different geographies, cultural contexts, and risk populations were still unclear. Many researchers directly use the existing PROMs through simple translations and ignore cross-cultural adaptation [194]. However, there are great differences in the understanding of some concepts among people of different cultures, global regions, genders, ages, and socioeconomic strata [195]. The use of PROMs in different contexts is not simply dependent on translating items but should be processed based on a 7-key-step process for comprehensive cross-cultural adaptation [196].

    Remaining Psychometric Properties

    Measurement error was also important for interpreting PROs. Minimal important change is best calculated from multiple studies and using multiple anchors with an anchor-based longitudinal approach [197]. In this review, only 1 study reported the smallest detectable change ranging from 7.3 to 15.0 points without minimal important change. Therefore, measurement error was assessed as “indeterminate” [118]. Moreover, only few studies assessed responsiveness. However, responsiveness was vital to assess the effectiveness of a clinical intervention designed to improve the health outcomes of people living with HIV and AIDS. This identifies several gaps for future research in the area of HIV. Without such information, it is impossible to understand whether changes in the levels of health outcomes of people living with HIV and AIDS are meaningful and matter to health care providers and researchers.

    Clinical Implications

    Despite a 64% reduction in HIV-related deaths in 2020 compared with the peak reported in 2004, a total of 680,000 people living with HIV and AIDS still died from HIV-related illnesses in 2020. This was largely due to the unique physical and psychosocial symptoms [1]. These symptoms seriously affect the physical function and clinical outcomes of people living with HIV and AIDS [4,198-200]. PRO data can be used in a variety of ways to improve care and health outcomes at a patient, institution, and population level [201-204]. Considering the particularity of people living with HIV and AIDS on subjective and privacy issues, PROs should be the primary outcome or end point. Many regulatory agencies and guidelines also recommend the inclusion of PROMs as the primary or secondary end points in clinical trials [205,206]. In addition, the development of the current ART regimen aims at simplifying the form of administration to meet the needs of long-term ART and maintain viral suppression with minimal toxicity [207]. Therefore, PRO data are becoming increasingly important for determining which ART regimen to use [208]. Therefore, a reliable, valid, and sensitive PROM is invaluable to health care providers and researchers.

    In this systematic review, only 3 available PROMs (PozQoL, HIV-SI or SDM, and PLHIV-RS) were recommended based on the COSMIN guidelines, wherein PozQoL was used to assess HIV-related HRQoL, HIV-SI or SDM was used to assess HIV-related symptoms, and PLHIV-RS was used to assess HIV-related resilience. Health care providers can adopt these 3 PROMs for different application purposes. With regard to PROMs that received class B recommendation, although these PROMs are not recommended in this systematic review, researchers can select the PROMs with relatively good results for psychometric properties and use them according to the research purpose or further validate them for use in their context. For administrators, selecting validated PROMs can aid in the development of continuous quality improvement reports to understand health care providers’ performance against the measurement framework and standard key performance indicators [209]. On the basis of the data collected through validated PROMs, policy makers can further evaluate system performance by comparing outcomes over time and support health care policy decision-making [210]. In summary, this review will help health care providers, administrators, policy makers, and researchers to choose suitable PROMs in different contexts, which in turn will promote the systematic use of these PROMs, identify areas that need to be improved from a patient perspective, and improve the quality of assessment for intervention.

    Limitations

    Our study has some limitations. First, although this systematic review additionally searched 2 important web-based databases of PROMs (PROQOLID and PROMIS) that are considered to be an important source of gray literature, we did not search dissertations, non-English literature, and other gray literature. This may have caused some relevant studies to be left out of our analysis, and these studies may help provide some evidence to support or refute our findings. Furthermore, evidence on the validation of PROMs can be deduced from the results of some studies. However, it was not the primary purpose of these studies; therefore, these studies were not included. Furthermore, some other PROMs were not included because they are still under study. Moreover, this systematic review may have ignored PROMs that only assessed a certain domain related to specific comorbidities, such as PROMs specifically designed to measure cognitive concerns. Considering the importance of evaluating these comorbidities in people living with HIV and AIDS, we will conduct further research on these PROMs. Furthermore, because no generally accepted “golden standard” measure for adults living with HIV and AIDS currently exists, the criterion validity of the included PROMs was not assessed. In addition, an insufficient number of studies reporting PROM development and content validity were included in this systematic review. Although we excluded many qualitative studies during the title and abstract screening stage, none of these studies researched on content validity. However, this is the same as the other relevant reviews [16,19] that also searched for insufficient studies reporting on the content validity of HIV-related PROMs.

    One another limitation of this review is that the selection of studies, scoring of methodological quality, and grading of evidence were subjective in nature. However, this systematic review strictly followed the steps of the COSMIN guidelines, and the processes mentioned earlier involved multiple researchers. We believe that this could resolve discrepancies and reduce variability in interpretation, thereby minimizing the chance of errors. Furthermore, given that the negative results of many PROMs are less likely to be published, the possibility of publication bias cannot be eliminated. Moreover, some included studies may have reported on only some psychometric properties; accordingly, there may be a selective reporting bias. Finally, quantitative pooled summary or meta-analyses were not performed because of the possible large heterogeneity. These limitations may help to explain why concrete recommendations for the use of some PROMs were not made because there were few included studies for some PROMs, and not all psychometric properties were assessed in these studies.

    Future Work

    Although there are a large number of PROMs in each category, it would be necessary to validate the existing PROMs, or even develop new PROMs in some categories, because not enough validated PROMs are available. Considering the shortcomings of the 3 class A PROMs, efforts in future research should focus on validation as well as class B PROMs. It should be noted that multiple personnel such as patients themselves, their family members, health care providers, and researchers should participate in the development and validation of all PROMs [211]. In the future research on PROMs, researchers should follow the suggestions of the COSMIN guidelines to ensure the complete reporting of research details and accurate interpretation of results [27].

    For the existing PROMs, research should focus on the validation of content validity and measurement error to determine the suitability of a PROM for use in the care of people living with HIV and AIDS. Moreover, these PROMs should be applied to different regions or populations to assess their cross-cultural validity or measurement invariance and explore the comparability of the results. In addition, future research should use more longitudinal or experimental study designs to assess the responsiveness of PROMs [9].

    With the gradual aging of people living with HIV and AIDS, new and adjusted PROMs should focus on exploring the impact of aging on people living with HIV and AIDS, such as complex complications [212], polypharmacy [213], menopause in older women [214], low social support [215], cognitive impairment [216], and special symptoms of early exposure to HIV [9]. PROMs for children will be summarized in our future research.

    In the past decades, researchers have mainly used interviewer-administered surveys and self-administered paper questionnaires to collect data [217]. However, several limitations of these methods have been found in the actual application process. ePROMs are becoming increasingly popular in recent years, greatly saving labor and time costs, minimizing errors, and realizing complex survey management [9]. Despite the fact that ePROMs are rapidly developing, future research should pay attention to evaluating the equivalence between electronic questionnaires and paper questionnaires [218]. Some researchers have used the most advanced technologies to integrate ePROMs into electronic hospital records or routine HIV care, allowing health care providers to easily and conveniently assess the qualitative and quantitative health outcomes of people living with HIV and AIDS. In addition, there are independent apps and software used in clinical practice and research.

    Moreover, with the development of computer adaptive tests (CATs) in recent years, future research can develop and improve the item bank for people living with HIV and AIDS and use the CAT technology to dynamically select items for administration based on the respondent’s previous answers for finally assessing their PROs [219-221]. However, the item bank of the CAT instrument requires a large number of unidimensional scales, posing a great challenge to the content validity of each PROM and its subconstructs. At the same time, the development of a CAT item bank can promote the improvement of the existing HIV-specific PROMs and the development of new HIV-specific PROMs, further promoting the vigorous development of research in related fields in the future.

    Conclusions

    This systematic review provides a detailed assessment of the psychometric properties of the existing HIV-specific PROMs for adults living with HIV and AIDS. Class A rating of PROMs was achieved for PozQoL, HIV-SI or SDM, and PLHIV-RS. However, all of these have a few shortcomings. Therefore, this study believes that future studies should conduct a more comprehensive validation of the psychometric properties of the existing PROMs to provide sufficient assessment evidence. These findings may provide a reference for the selection of high-quality HIV-specific PROMs by health care providers and researchers for clinical practice and research.

    Acknowledgments

    The authors would like to thank all the authors and research teams who developed all the PROMs included in this review. Furthermore, they would like to acknowledge the COSMIN group for their advice on the study design and application of the COSMIN tools. In addition, they thank the senior health research librarian (Liyuan Cui from the library of China Medical University) for her guidance on the search strategy for this review. Finally, they would like to thank MogoEdit for its English editing during the preparation of this manuscript. This work was supported by the National Natural Science Foundation of China (grant 71473269 and 71673301), the Distinguished Professor Program of Liaoning Province, and the “Bai-Qian-Wan” Talents program of Liaoning Province. The funding agencies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.

    Authors' Contributions

    ZW, YZ, and BQ conceptualized and designed the study. ZW and HK performed literature search, screening, and selection. ZW, HK, and XD extracted the data. ZW, HK, and YZ performed quality appraisal and statistical analysis. ZW, HK, XD, YZ, and BQ contributed to COSMIN evaluation. YZ and BQ supervised the study. ZW, YZ, and BQ drafted the manuscript. ZW, YZ, and BQ critically revised the manuscript for important intellectual content. ZW, YZ, and BQ provided administrative, technical, or material support. All the authors critically reviewed the manuscript and approved the final version before submission.

    Conflicts of Interest

    None declared.

    ‎
    Multimedia Appendix 1

    Literature search strategy for existing review, literature search strategy for HIV-specific patient-reported outcome measures, subscales of the included PROMs, characteristics of the included records, methodological quality assessment of the included records, results and ratings of each psychometric property of each record, the overall results and the level of evidence, PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 abstract checklist, and PRISMA 2020 main checklist.

    DOCX File , 258 KB
    1. Global HIV and AIDS statistics — Fact sheet. Joint United Nations Programme on HIV/AIDS. 2021 Dec 1.   URL: https://www.unaids.org/en/resources/fact-sheet [accessed 2021-12-18]
    2. Antiretroviral Therapy Cohort Collaboration. Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies. Lancet HIV 2017 Aug;4(8):e349-e356 [FREE Full text] [CrossRef] [Medline]
    3. Hemelaar J, Elangovan R, Yun J, Dickson-Tetteh L, Fleminger I, Kirtley S, WHO–UNAIDS Network for HIV Isolation Characterisation. Global and regional molecular epidemiology of HIV-1, 1990-2015: a systematic review, global survey, and trend analysis. Lancet Infect Dis 2019 Feb;19(2):143-155. [CrossRef] [Medline]
    4. Remien RH, Stirratt MJ, Nguyen N, Robbins RN, Pala AN, Mellins CA. Mental health and HIV/AIDS: the need for an integrated response. AIDS 2019 Jul 15;33(9):1411-1420 [FREE Full text] [CrossRef] [Medline]
    5. Sued O, Figueroa MI, Cahn P. Clinical challenges in HIV/AIDS: hints for advancing prevention and patient management strategies. Adv Drug Deliv Rev 2016 Aug 01;103:5-19. [CrossRef] [Medline]
    6. Back D, Marzolini C. The challenge of HIV treatment in an era of polypharmacy. J Int AIDS Soc 2020 Feb;23(2):e25449 [FREE Full text] [CrossRef] [Medline]
    7. Lazarus JV, Safreed-Harmon K, Barton SE, Costagliola D, Dedes N, Del Amo Valero J, et al. Beyond viral suppression of HIV - the new quality of life frontier. BMC Med 2016 Jun 22;14(1):94 [FREE Full text] [CrossRef] [Medline]
    8. Serwadda DM. Beyond HIV viral suppression: an African perspective. Lancet HIV 2019 Dec;6(12):e812-e814. [CrossRef] [Medline]
    9. Kall M, Marcellin F, Harding R, Lazarus JV, Carrieri P. Patient-reported outcomes to enhance person-centred HIV care. Lancet HIV 2020 Jan;7(1):e59-e68. [CrossRef] [Medline]
    10. Yang Z, Zhu Z, Wen H, Han S, Xing W, Dong T, et al. Psychometric properties of self-reported measures of health-related quality of life in people living with HIV: a systematic review protocol. JBI Evid Synth 2021 May 14;19(10):2829-2838. [CrossRef] [Medline]
    11. Jerant A, Tancredi DJ, Franks P. Mortality prediction by quality-adjusted life year compatible health measures: findings in a nationally representative US sample. Med Care 2011 May;49(5):443-450. [CrossRef] [Medline]
    12. DeSalvo KB, Jones TM, Peabody J, McDonald J, Fihn S, Fan V, et al. Health care expenditure prediction with a single item, self-rated health measure. Med Care 2009 Apr;47(4):440-447. [CrossRef] [Medline]
    13. Herrmann S, Power B, Rashidi A, Cypher M, Mastaglia F, Grace A, et al. Supporting patient-clinician interaction in chronic HIV care: design and development of a patient-reported outcomes software application. J Med Internet Res 2021 Jul 30;23(7):e27861 [FREE Full text] [CrossRef] [Medline]
    14. Boyce MB, Browne JP, Greenhalgh J. The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research. BMJ Qual Saf 2014 Jun;23(6):508-518. [CrossRef] [Medline]
    15. Etkind SN, Daveson BA, Kwok W, Witt J, Bausewein C, Higginson IJ, et al. Capture, transfer, and feedback of patient-centered outcomes data in palliative care populations: does it make a difference? A systematic review. J Pain Symptom Manage 2015 Mar;49(3):611-624 [FREE Full text] [CrossRef] [Medline]
    16. Cooper V, Clatworthy J, Harding R, Whetham J, Emerge Consortium. Measuring quality of life among people living with HIV: a systematic review of reviews. Health Qual Life Outcomes 2017 Nov 15;15(1):220 [FREE Full text] [CrossRef] [Medline]
    17. Huang IC, Frangakis C, Atkinson MJ, Willke RJ, Leite WL, Vogel WB, et al. Addressing ceiling effects in health status measures: a comparison of techniques applied to measures for people with HIV disease. Health Serv Res 2008 Feb;43(1 Pt 1):327-339 [FREE Full text] [CrossRef] [Medline]
    18. Seguiti C, Salvo PF, Di Stasio E, Lamonica S, Fedele AL, Manfrida S, et al. Health-related quality of life (HRQoL) from HIV patients' perspective: comparison of patient-reported outcome (PRO) measures among people living with HIV (PLWH) and other chronic clinical conditions. J Patient Rep Outcomes 2022 Mar 26;6(1):27 [FREE Full text] [CrossRef] [Medline]
    19. Wen H, Yang Z, Zhu Z, Han S, Zhang L, Hu Y. Psychometric properties of self-reported measures of health-related quality of life in people living with HIV: a systematic review. Health Qual Life Outcomes 2022 Jan 10;20(1):5 [FREE Full text] [CrossRef] [Medline]
    20. Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics 2006;24(8):751-765. [CrossRef] [Medline]
    21. Wu AW, Hanson KA, Harding G, Haider S, Tawadrous M, Khachatryan A, et al. Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies. Health Qual Life Outcomes 2013 Mar 12;11:42 [FREE Full text] [CrossRef] [Medline]
    22. Engler K, Lessard D, Lebouché B. A review of HIV-specific patient-reported outcome measures. Patient 2017 Apr;10(2):187-202. [CrossRef] [Medline]
    23. Gakhar H, Kamali A, Holodniy M. Health-related quality of life assessment after antiretroviral therapy: a review of the literature. Drugs 2013 May;73(7):651-672 [FREE Full text] [CrossRef] [Medline]
    24. Robberstad B, Olsen JA. The health related quality of life of people living with HIV/AIDS in sub-Saharan Africa - a literature review and focus group study. Cost Eff Resour Alloc 2010 Apr 16;8:5 [FREE Full text] [CrossRef] [Medline]
    25. Terwee CB, Prinsen CA, Chiarotto A, Westerman MJ, Patrick DL, Alonso J, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res 2018 May;27(5):1159-1170 [FREE Full text] [CrossRef] [Medline]
    26. Mokkink LB, de Vet HC, Prinsen CA, Patrick DL, Alonso J, Bouter LM, et al. COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Qual Life Res 2018 May;27(5):1171-1179 [FREE Full text] [CrossRef] [Medline]
    27. Prinsen CA, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HC, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res 2018 May;27(5):1147-1157 [FREE Full text] [CrossRef] [Medline]
    28. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. J Clin Epidemiol 2021 Jun;134:178-189 [FREE Full text] [CrossRef] [Medline]
    29. Terwee CB, Jansma EP, Riphagen II, de Vet HC. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res 2009 Oct;18(8):1115-1123 [FREE Full text] [CrossRef] [Medline]
    30. Mokkink LB, Prinsen CA, Patrick DL, Alonso J, Bouter LM, de Vet HC, et al. COSMIN methodology for systematic reviews of patient-reported outcome measures (PROMs) user manual. COSMIN. 2018 Feb.   URL: https://cosmin.nl/wp-content/uploads/COSMIN-syst-review-for-PROMs-manual_version-1_feb-2018.pdf [accessed 2021-03-07]
    31. Carretero MD, Burgess AP, Soler P, Soler M, Catalán J. Reliability and validity of an HIV-specific health-related quality-of-life measure for use with injecting drug users. AIDS 1996 Dec;10(14):1699-1705. [CrossRef] [Medline]
    32. Murri R, Ammassari A, Fantoni M, Scoppettuolo G, Cingolani A, De Luca A, et al. Disease-related factors associated with health-related quality of life in people with nonadvanced HIV disease assessed using an Italian version of the MOS-HIV Health Survey. J Acquir Immune Defic Syndr Hum Retrovirol 1997 Dec 15;16(5):350-356. [CrossRef] [Medline]
    33. Revicki DA, Sorensen S, Wu AW. Reliability and validity of physical and mental health summary scores from the Medical Outcomes Study HIV Health Survey. Med Care 1998 Feb;36(2):126-137. [CrossRef] [Medline]
    34. Badia X, Podzamczer D, Garcia M, López-Lavid C, Consiglio E. A randomized study comparing instruments for measuring health-related quality of life in HIV-infected patients. Spanish MOS-HIV and MQOL-HIV Validation Group. Medical Outcomes Study HIV Health Survey. AIDS 1999 Sep 10;13(13):1727-1735. [CrossRef] [Medline]
    35. Holmes WC, Shea JA. Two approaches to measuring quality of life in the HIV/AIDS population: HAT-QoL and MOS-HIV. Qual Life Res 1999 Sep;8(6):515-527. [CrossRef] [Medline]
    36. Scott-Lennox JA, Wu AW, Boyer JG, Ware JE. Reliability and validity of French, German, Italian, Dutch, and UK English translations of the Medical Outcomes Study HIV Health Survey. Med Care 1999 Sep;37(9):908-925. [CrossRef] [Medline]
    37. Delate T, Coons SJ. The use of 2 health-related quality-of-life measures in a sample of persons infected with human immunodeficiency virus. Clin Infect Dis 2001 Feb 01;32(3):E47-E52. [CrossRef] [Medline]
    38. Paton NI, Chapman CA, Chan S, Tan KM, Leo Y, Aboulhab J, et al. Validation of the Medical Outcomes Study HIV Health Survey as a measure of quality of life in HIV-infected patients in Singapore. Int J STD AIDS 2002 Jul;13(7):456-461. [CrossRef] [Medline]
    39. Schifano P, Borgia P, Wu AW, Spadea T, Milanese G, Perucci CA. Validity and reliability of the Italian translation of the MOS-HIV health survey in persons with AIDS. Qual Life Res 2003 Dec;12(8):1137-1146. [CrossRef] [Medline]
    40. Ichikawa M, Natpratan C. Quality of life among people living with HIV/AIDS in northern Thailand: MOS-HIV Health Survey. Qual Life Res 2004 Apr;13(3):601-610. [CrossRef] [Medline]
    41. Lau JT, Tsui HY, Patrick LC, Rita CW, Molassiotis A. Validation of a Chinese version of the Medical Outcomes Study HIV Health Survey (MOS-HIV) among Chinese people living with HIV/AIDS in Hong Kong. Qual Life Res 2006 Aug;15(6):1079-1089. [CrossRef] [Medline]
    42. Taylor TN, Dolezal C, Tross S, Holmes WC. Reliability and validity of two HIV/AIDS-specific quality of life instruments adapted for use in HIV-positive Zimbabweans. AIDS Care 2009 May;21(5):598-607 [FREE Full text] [CrossRef] [Medline]
    43. Henderson WA, Schlenk EA, Kim KH, Hadigan CM, Martino AC, Sereika SM, et al. Validation of the MOS-HIV as a measure of health-related quality of life in persons living with HIV and liver disease. AIDS Care 2010 Apr;22(4):483-490 [FREE Full text] [CrossRef] [Medline]
    44. Stasinopoulou PG, Tzavara C, Dimitrakaki C, Georgiou O, Baraboutis IG, Skoutelis A, et al. Reliability and validity of the Greek translation of the MOS-HIV health survey in HIV-infected individuals. Qual Life Res 2010 Mar;19(2):199-205. [CrossRef] [Medline]
    45. Chariyalertsak S, Wansom T, Kawichai S, Ruangyuttikarna C, Kemerer VF, Wu AW. Reliability and validity of Thai versions of the MOS-HIV and SF-12 quality of life questionnaires in people living with HIV/AIDS. Health Qual Life Outcomes 2011 Mar 15;9:15 [FREE Full text] [CrossRef] [Medline]
    46. Hsiung PC, Fang CT, Lee KL, Sheng WH, Wu CY, Wang JD, et al. Validation of the medical outcomes study HIV (MOS-HIV) health survey among HIV-infected patients in Taiwan. Qual Life Res 2011 Mar;20(2):281-286. [CrossRef] [Medline]
    47. Epino HM, Rich ML, Kaigamba F, Hakizamungu M, Socci AR, Bagiruwigize E, et al. Reliability and construct validity of three health-related self-report scales in HIV-positive adults in rural Rwanda. AIDS Care 2012;24(12):1576-1583. [CrossRef] [Medline]
    48. Huang ZJ, Tian M, Dai SY, Ye DQ. Feasibility, reliability and validity of the Chinese simplified version of the MOS-HIV health survey among AIDS patients in China. Qual Life Res 2013 Mar;22(2):403-407. [CrossRef] [Medline]
    49. Marzieh A, Peyman J, Seyyed Mohammad Taghi A, Parvin Afsar K. Reliability and validity of Persian version of medical outcome study-HIV health survey in Iranian people living with HIV. J Tradit Chin Med 2017 Oct;37(5):695-701 [FREE Full text] [Medline]
    50. Liu J, Zhu Y, Qu B. Reliability and validity of the Chinese version of the Medical Outcomes Study HIV Health Survey (MOS-HIV) in people living with HIV/AIDS (PLWHA) in China. PLoS One 2018 Jul 25;13(7):e0201177 [FREE Full text] [CrossRef] [Medline]
    51. Shim EJ, Ha H, Lee SH, Kim NJ, Kim ES, Bang JH, et al. Psychometric properties of the Korean version of the medical outcomes study HIV health survey: results from a multicenter survey in Korea. Health Qual Life Outcomes 2018 May 15;16(1):92 [FREE Full text] [CrossRef] [Medline]
    52. Stangl AL, Bunnell R, Wamai N, Masaba H, Mermin J. Measuring quality of life in rural Uganda: reliability and validity of summary scores from the medical outcomes study HIV health survey (MOS-HIV). Qual Life Res 2012 Nov;21(9):1655-1663. [CrossRef] [Medline]
    53. McDonnell KA, Gielen AC, Wu AW, O'Campo P, Faden R. Measuring health related quality of life among women living with HIV. Qual Life Res 2000;9(8):931-940. [CrossRef] [Medline]
    54. Schag CA, Ganz PA, Kahn B, Petersen L. Assessing the needs and quality of life of patients with HIV infection: development of the HIV Overview of Problems-Evaluation System (HOPES). Qual Life Res 1992 Dec;1(6):397-413. [CrossRef] [Medline]
    55. De Boer JB, Sprangers MA, Aaronson NK, Lange JM, van Dam FS. A study of the reliability, validity and responsiveness 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 Jun;5(3):339-347. [CrossRef] [Medline]
    56. Cleary PD, Fowler Jr FJ, Weissman J, Massagli MP, Wilson I, Seage 3rd GR, et al. Health-related quality of life in persons with acquired immune deficiency syndrome. Med Care 1993 Jul;31(7):569-580. [CrossRef] [Medline]
    57. 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 Aug;6(6):494-506. [CrossRef] [Medline]
    58. Bozzette SA, Hays RD, Berry SH, Kanouse DE. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care 1994 Jul;32(7):716-731. [CrossRef] [Medline]
    59. Bozzette SA, Hays RD, Berry SH, Kanouse DE, Wu AW. Derivation and properties of a brief health status assessment instrument for use in HIV disease. J Acquir Immune Defic Syndr Hum Retrovirol 1995 Mar 01;8(3):253-265. [CrossRef] [Medline]
    60. Hays RD, Cunningham WE, Ettl MK, Beck CK, Shapiro MF. Health related quality of life in HIV disease. Assessment 1995 Dec;2(4):363-380. [CrossRef]
    61. Cella DF, McCain NL, Peterman AH, Mo F, Wolen D. Development and validation of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Qual Life Res 1996 Aug;5(4):450-463. [CrossRef] [Medline]
    62. 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 Aug;6(6):572-584. [CrossRef] [Medline]
    63. Viala-Danten M, Dubois D, Gilet H, Martin S, Peeters K, Cella D. Psychometric evaluation of the functional assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials. Qual Life Res 2010 Oct;19(8):1215-1227. [CrossRef] [Medline]
    64. Byrne S, Petry NM. Reliability and validity of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) in patients with drug and alcohol use disorders. AIDS Care 2013;25(1):118-125 [FREE Full text] [CrossRef] [Medline]
    65. Nyongesa MK, Sigilai A, Hassan AS, Thoya J, Odhiambo R, Van de Vijver FJ, et al. A mixed methods approach to adapting and evaluating the functional assessment of HIV infection (FAHI), Swahili version, for use with low literacy populations. PLoS One 2017 Apr 5;12(4):e0175021 [FREE Full text] [CrossRef] [Medline]
    66. Lenderking WR, Testa MA, Katzenstein D, Hammer S. Measuring quality of life in early HIV disease: the modular approach. Qual Life Res 1997 Aug;6(6):515-530. [CrossRef] [Medline]
    67. Leplège 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 Aug;6(6):585-594. [CrossRef] [Medline]
    68. Holmes WC, Shea JA. Performance of a new, HIV/AIDS-targeted quality of life (HAT-QoL) instrument in asymptomatic seropositive individuals. Qual Life Res 1997 Aug;6(6):561-571. [CrossRef] [Medline]
    69. Holmes WC, Shea JA. A new HIV/AIDS-targeted quality of life (HAT-QoL) instrument: development, reliability, and validity. Med Care 1998 Feb;36(2):138-154. [CrossRef] [Medline]
    70. Holmes WC, Ruocco JE. Test-retest evaluation of HAT-QoL and SF-36 in an HIV-seropositive sample. AIDS Care 2008 Oct;20(9):1084-1092. [CrossRef] [Medline]
    71. Mafirakureva N, Dzingirai B, Postma MJ, van Hulst M, Khoza S. Health-related quality of life in HIV/AIDS patients on antiretroviral therapy at a tertiary care facility in Zimbabwe. AIDS Care 2016 Jul;28(7):904-912. [CrossRef] [Medline]
    72. Smith KW, Avis NE, Mayer KH, Swislow L. Use of the MQoL-HIV with asymptomatic HIV-positive patients. Qual Life Res 1997 Aug;6(6):555-560. [CrossRef] [Medline]
    73. Kemmler G, Schmied B, Shetty-Lee A, Zangerle R, Hinterhuber H, Schüssler G, et al. Quality of life of HIV-infected patients: psychometric properties and validation of the German version of the MQOL-HIV. Qual Life Res 2003 Dec;12(8):1037-1050. [CrossRef] [Medline]
    74. Remple VP, Hilton BA, Ratner PA, Burdge DR. Psychometric assessment of the Multidimensional Quality of Life Questionnaire for Persons with HIV/AIDS (MQOL-HIV) in a sample of HIV-infected women. Qual Life Res 2004 Jun;13(5):947-957. [CrossRef] [Medline]
    75. Watanabe M, Nishimura K, Inoue T, Kimura S, Oka S, QoL Research Group Of The AIDS Clinical Centre And Eight Regional AIDS Treatment Hospitals In Japan. A discriminative study of health-related quality of life assessment in HIV-1-infected persons living in Japan using the Multidimensional Quality of Life Questionnaire for persons with HIV/AIDS. Int J STD AIDS 2004 Feb;15(2):107-115. [CrossRef] [Medline]
    76. Holzemer WL, Gygax Spicer J, Skodol Wilson H, Kemppainen JK, Coleman C. Validation of the quality of life scale: living with HIV. J Adv Nurs 1998 Sep;28(3):622-630. [CrossRef] [Medline]
    77. Starace F, Cafaro L, Abrescia N, Chirianni A, Izzo C, Rucci P, et al. Quality of life assessment in HIV-positive persons: application and validation of the WHOQOL-HIV, Italian version. AIDS Care 2002 Jun;14(3):405-415. [CrossRef] [Medline]
    78. WHOQOL HIV Group. WHOQOL-HIV for quality of life assessment among people living with HIV and AIDS: results from the field test. AIDS Care 2004 Oct;16(7):882-889. [CrossRef] [Medline]
    79. Zimpel RR, Fleck MP. Quality of life in HIV-positive Brazilians: application and validation of the WHOQOL-HIV, Brazilian version. AIDS Care 2007 Aug;19(7):923-930. [CrossRef] [Medline]
    80. Canavarro MC, Pereira M, Simoes MR, Pintassilgo AL. Quality of life assessment in HIV-infection: validation of the European Portuguese version of WHOQOL-HIV. AIDS Care 2011 Feb;23(2):187-194. [CrossRef] [Medline]
    81. Mweemba P, Zeller R, Ludwick R, Gosnell D, Michelo C. Validation of the World Health Organization Quality of Life HIV instrument in a Zambian sample. J Assoc Nurses AIDS Care 2011;22(1):53-66. [CrossRef] [Medline]
    82. Olsen M, Jensen NK, Tesfaye M, Holm L. Conceptual equivalence of WHOQOL-HIV among people living with HIV in Ethiopia. Qual Life Res 2013 Mar;22(2):361-367. [CrossRef] [Medline]
    83. Reychler G, Caty G, Vincent A, Billo S, Yombi J. Validation of the French version of the World Health Organization quality of life HIV instrument. PLoS One 2013 Sep 3;8(9):e73180 [FREE Full text] [CrossRef] [Medline]
    84. Saddki N, Noor MM, Norbanee TH, Rusli MA, Norzila Z, Zaharah S, et al. Validity and reliability of the Malay version of WHOQOL-HIV BREF in patients with HIV infection. AIDS Care 2009 Oct;21(10):1271-1278. [CrossRef] [Medline]
    85. Hsiung PC, Fang CT, Wu CH, Sheng WH, Chen SC, Wang JD, et al. Validation of the WHOQOL-HIV BREF among HIV-infected patients in Taiwan. AIDS Care 2011 Aug;23(8):1035-1042. [CrossRef] [Medline]
    86. O'Connell KA, Skevington SM. An international quality of life instrument to assess wellbeing in adults who are HIV-positive: a short form of the WHOQOL-HIV (31 items). AIDS Behav 2012 Feb 23;16(2):452-460. [CrossRef] [Medline]
    87. Tran BX. Quality of life outcomes of antiretroviral treatment for HIV/AIDS patients in Vietnam. PLoS One 2012 Jul 20;7(7):e41062 [FREE Full text] [CrossRef] [Medline]
    88. Canavarro MC, Pereira M. Factor structure and psychometric properties of the European Portuguese version of a questionnaire to assess quality of life in HIV-infected adults: the WHOQOL-HIV-Bref. AIDS Care 2012 Nov 22;24(6):799-807. [CrossRef] [Medline]
    89. Pereira M, Martins A, Alves S, Canavarro MC. Assessing quality of life in middle-aged and older adults with HIV: psychometric testing of the WHOQOL-HIV-Bref. Qual Life Res 2014 Nov;23(9):2473-2479. [CrossRef] [Medline]
    90. Meemon N, Paek SC, Yenchai D, Wan TT. Application of the WHOQOL-HIV-BREF questionnaire in HIV-infected Thai patients: reliability and validity of the instrument. J Assoc Nurses AIDS Care 2016;27(5):698-708. [CrossRef] [Medline]
    91. Salehi M, Niroumand S, Erfanian MR, Sajjadi RB, Dadgarmoghaddam M. Validation of Persian version of WHOQOL-HIV BREF questionnaire in Islamic Republic of Iran. East Mediterr Health J 2016 Dec 12;22(9):647-653 [FREE Full text] [CrossRef] [Medline]
    92. Tesfaye M, Olsen MF, Medhin G, Friis H, Hanlon C, Holm L. Adaptation and validation of the short version WHOQOL-HIV in Ethiopia. Int J Ment Health Syst 2016;10:29 [FREE Full text] [CrossRef] [Medline]
    93. Zhu Y, Liu J, Qu B. Psychometric properties of the Chinese version of the WHOQOL-HIV BREF to assess quality of life among people living with HIV/AIDS: a cross-sectional study. BMJ Open 2017 Aug 21;7(8):e016382 [FREE Full text] [CrossRef] [Medline]
    94. Fuster-RuizdeApodaca MJ, Laguía A, Safreed-Harmon K, Lazarus JV, Cenoz S, Del Amo J. Assessing quality of life in people with HIV in Spain: psychometric testing of the Spanish version of WHOQOL-HIV-BREF. Health Qual Life Outcomes 2019 Aug 19;17(1):144 [FREE Full text] [CrossRef] [Medline]
    95. Barger D, Hessamfar M, Neau D, Vareil MO, Lazaro E, Duffau P, et al. Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study. Health Qual Life Outcomes 2020 Jul 10;18(1):220 [FREE Full text] [CrossRef] [Medline]
    96. Bucciardini R, Murri R, Guarinieri M, Starace F, Martini M, Vatrella A, et al. ISSQoL: a new questionnaire for evaluating the quality of life of people living with HIV in the HAART era. Qual Life Res 2006 Apr;15(3):377-390. [CrossRef] [Medline]
    97. Spire B, Arnould B, Barbier F, Durant J, Gilquin J, Landman R, et al. Simplification and first validation of a short battery of patient questionnaires for clinical management of HIV-infected patients: the HIV-SQUAD (Symptom Quality of life Adherence) Questionnaire. HIV Clin Trials 2009 Jan 6;10(4):215-232. [CrossRef] [Medline]
    98. Duracinsky M, Herrmann S, Berzins B, Armstrong AR, Kohli R, Le Coeur S, et al. The development of PROQOL-HIV: an international instrument to assess the health-related quality of life of persons living with HIV/AIDS. J Acquir Immune Defic Syndr 2012 Apr 15;59(5):498-505. [CrossRef] [Medline]
    99. Duracinsky M, Lalanne C, Le Coeur S, Herrmann S, Berzins B, Armstrong AR, et al. Psychometric validation of the PROQOL-HIV questionnaire, a new health-related quality of life instrument-specific to HIV disease. J Acquir Immune Defic Syndr 2012 Apr 15;59(5):506-515. [CrossRef] [Medline]
    100. Duracinsky M, Lalanne C, Goujard C, Herrmann S, Cheung-Lung C, Brosseau JP, et al. Electronic versus paper-based assessment of health-related quality of life specific to HIV disease: reliability study of the PROQOL-HIV questionnaire. J Med Internet Res 2014 Apr 25;16(4):e115 [FREE Full text] [CrossRef] [Medline]
    101. Lalanne C, Chassany O, Carrieri P, Marcellin F, Armstrong AR, Lert F, et al. A reduced factor structure for the PROQOL-HIV questionnaire provided reliable indicators of health-related quality of life. J Clin Epidemiol 2016 Apr;72:116-125. [CrossRef] [Medline]
    102. Brown G, Mikołajczak G, Lyons A, Power J, Drummond F, Cogle A, et al. Development and validation of PozQoL: a scale to assess quality of life of PLHIV. BMC Public Health 2018 Apr 20;18(1):527 [FREE Full text] [CrossRef] [Medline]
    103. Burgess AP, Irving G, Riccio M. The reliability and validity of a symptom checklist for use in HIV infection: a preliminary analysis. Int J STD AIDS 1993 Jun 25;4(6):333-338. [CrossRef] [Medline]
    104. Whalen CC, Antani M, Carey J, Landefeld CS. An index of symptoms for infection with human immunodeficiency virus: reliability and validity. J Clin Epidemiol 1994 May;47(5):537-546. [CrossRef] [Medline]
    105. Nokes KM, Wheeler K, Kendrew J. Development of an HIV assessment tool. Image J Nurs Sch 1994;26(2):133-138. [CrossRef] [Medline]
    106. Sousa KH, Tann SS, Kwok OM. Reconsidering the assessment of symptom status in HIV/AIDS care. J Assoc Nurses AIDS Care 2006;17(2):36-46. [CrossRef] [Medline]
    107. Holzemer WL, Henry SB, Nokes KM, Corless IB, Brown MA, Powell-Cope GM, et al. Validation of the sign and symptom check-list for persons with HIV disease (SSC-HIV). J Adv Nurs 1999 Nov;30(5):1041-1049. [CrossRef] [Medline]
    108. Holzemer WL, Hudson A, Kirksey KM, Hamilton MJ, Bakken S. The revised sign and symptom check-list for HIV (SSC-HIVrev). J Assoc Nurses AIDS Care 2001;12(5):60-70. [CrossRef] [Medline]
    109. Mathews WC, McCutchan JA, Asch S, Turner BJ, Gifford AL, Kuromiya K, et al. National estimates of HIV-related symptom prevalence from the HIV cost and services utilization study. Med Care 2000 Jul;38(7):750-762. [CrossRef] [Medline]
    110. Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Adult AIDS Clinical Trials Unit Outcomes Committee. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol 2001 Dec;54 Suppl 1:S77-S90. [CrossRef] [Medline]
    111. Regnault A, Marfatia S, Louie M, Mear I, Meunier J, Viala-Danten M. Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients. Clin Trials 2009 Dec;6(6):574-584. [CrossRef] [Medline]
    112. Marc LG, Wang MM, Testa MA. Psychometric evaluation of the HIV symptom distress scale. AIDS Care 2012 Mar 12;24(11):1432-1441 [FREE Full text] [CrossRef] [Medline]
    113. Barroso J, Lynn MR. Psychometric properties of the HIV-Related Fatigue Scale. J Assoc Nurses AIDS Care 2002;13(1):66-75. [CrossRef] [Medline]
    114. Pence BW, Barroso J, Leserman J, Harmon JL, Salahuddin N. Measuring fatigue in people living with HIV/AIDS: psychometric characteristics of the HIV-related fatigue scale. AIDS Care 2008 Aug;20(7):829-837 [FREE Full text] [CrossRef] [Medline]
    115. Li SY, Wu HS, Barroso J. The development and psychometric analysis of the Chinese HIV-Related Fatigue Scale. J Clin Nurs 2016 Apr;25(7-8):1025-1034. [CrossRef] [Medline]
    116. O'Brien KK, Solomon P, Bayoumi AM. Measuring disability experienced by adults living with HIV: assessing construct validity of the HIV Disability Questionnaire using confirmatory factor analysis. BMJ Open 2014 Sep 01;4(8):e005456 [FREE Full text] [CrossRef] [Medline]
    117. O'Brien KK, Solomon P, Bergin C, O'Dea S, Stratford P, Iku N, et al. Reliability and validity of a new HIV-specific questionnaire with adults living with HIV in Canada and Ireland: the HIV Disability Questionnaire (HDQ). Health Qual Life Outcomes 2015 Aug 12;13:124 [FREE Full text] [CrossRef] [Medline]
    118. Brown DA, Simmons B, Boffito M, Aubry R, Nwokolo N, Harding R, et al. Evaluation of the psychometric properties of the HIV Disability Questionnaire among adults living with HIV in the United Kingdom: a cross-sectional self-report measurement study. PLoS One 2019 Jul 10;14(7):e0213222 [FREE Full text] [CrossRef] [Medline]
    119. O'Brien KK, Kietrys D, Galantino ML, Parrott JS, Davis T, Tran Q, et al. Reliability and validity of the HIV disability questionnaire (HDQ) with adults living with HIV in the United States. J Int Assoc Provid AIDS Care 2019;18:2325958219888461 [FREE Full text] [CrossRef] [Medline]
    120. Bucciardini R, Pugliese K, Francisci D, Costantini A, Schiaroli E, Cognigni M, et al. Validation of a self-reported HIV symptoms list: the ISS-HIV symptoms scale. AIDS Res Ther 2016 Apr 9;13:18 [FREE Full text] [CrossRef] [Medline]
    121. Berger BE, Ferrans CE, Lashley FR. Measuring stigma in people with HIV: psychometric assessment of the HIV stigma scale. Res Nurs Health 2001 Dec;24(6):518-529. [CrossRef] [Medline]
    122. Rao D, Pryor JB, Gaddist BW, Mayer R. Stigma, secrecy, and discrimination: ethnic/racial differences in the concerns of people living with HIV/AIDS. AIDS Behav 2008 Mar;12(2):265-271. [CrossRef] [Medline]
    123. Bunn JY, Solomon SE, Miller C, Forehand R. Measurement of stigma in people with HIV: a reexamination of the HIV Stigma Scale. AIDS Educ Prev 2007 Jun;19(3):198-208. [CrossRef] [Medline]
    124. Reinius M, Rao D, Manhart LE, Wiklander M, Svedhem V, Pryor J, et al. Differential item functioning for items in Berger's HIV Stigma Scale: an analysis of cohorts from the Indian, Swedish, and US contexts. Qual Life Res 2018 Jun;27(6):1647-1659 [FREE Full text] [CrossRef] [Medline]
    125. Rongkavilit C, Wright K, Chen X, Naar-King S, Chuenyam T, Phanuphak P. HIV stigma, disclosure and psychosocial distress among Thai youth living with HIV. Int J STD AIDS 2010 Feb;21(2):126-132. [CrossRef] [Medline]
    126. Reinius M, Wettergren L, Wiklander M, Svedhem V, Ekström AM, Eriksson LE. Development of a 12-item short version of the HIV stigma scale. Health Qual Life Outcomes 2017 May 30;15(1):115 [FREE Full text] [CrossRef] [Medline]
    127. Luz PM, Torres TS, Almeida-Brasil CC, Marins LM, Bezerra DR, Veloso VG, et al. Translation and validation of the Short HIV Stigma scale in Brazilian Portuguese. Health Qual Life Outcomes 2020 Oct 02;18(1):322 [FREE Full text] [CrossRef] [Medline]
    128. Lindberg MH, Wettergren L, Wiklander M, Svedhem-Johansson V, Eriksson LE. Psychometric evaluation of the HIV stigma scale in a Swedish context. PLoS One 2014 Dec 18;9(12):e114867 [FREE Full text] [CrossRef] [Medline]
    129. Fuster-RuizdeApodaca MJ, Molero F, Holgado FP, Ubillos S. Adaptation of the HIV stigma scale in Spaniards with HIV. Span J Psychol 2015 Sep 15;18:E66. [CrossRef] [Medline]
    130. Kagiura F, Fujii T, Kihana N, Maruyama E, Shimoji Y, Kakehashi M. Brief HIV stigma scale for Japanese people living with HIV: validation and restructuring using questionnaire survey data. AIDS Care 2020;32(sup1):1-9. [CrossRef] [Medline]
    131. Holzemer WL, Uys LR, Chirwa ML, Greeff M, Makoae LN, Kohi TW, et al. Validation of the HIV/AIDS stigma instrument - PLWA (HASI-P). AIDS Care 2007 Sep;19(8):1002-1012. [CrossRef] [Medline]
    132. Maluccio JA, Wu F, Rokon RB, Rawat R, Kadiyala S. Assessing the impact of food assistance on stigma among people living with HIV in Uganda using the HIV/AIDS stigma instrument-PLWA (HASI-P). AIDS Behav 2017 Mar;21(3):766-782. [CrossRef] [Medline]
    133. Sayles JN, Hays RD, Sarkisian CA, Mahajan AP, Spritzer KL, Cunningham WE. Development and psychometric assessment of a multidimensional measure of internalized HIV stigma in a sample of HIV-positive adults. AIDS Behav 2008 Sep;12(5):748-758 [FREE Full text] [CrossRef] [Medline]
    134. Kalichman SC, Simbayi LC, Cloete A, Mthembu PP, Mkhonta RN, Ginindza T. Measuring AIDS stigmas in people living with HIV/AIDS: the Internalized AIDS-Related Stigma Scale. AIDS Care 2009 Jan;21(1):87-93. [CrossRef] [Medline]
    135. Tsai AC, Weiser SD, Steward WT, Mukiibi NF, Kawuma A, Kembabazi A, et al. Evidence for the reliability and validity of the internalized AIDS-related stigma scale in rural Uganda. AIDS Behav 2013 Jan;17(1):427-433 [FREE Full text] [CrossRef] [Medline]
    136. Geibel S, Gottert A, Friedland BA, Jeremiah K, McClair TL, Mallouris C, PLHIV Stigma Index 2.0 Study Group in Cambodia‚ the Dominican Republic‚ and Uganda. Internalized stigma among people living with HIV: assessing the Internalized AIDS-Related Stigma Scale in four countries. AIDS 2020 Sep 01;34 Suppl 1:S33-S41. [CrossRef] [Medline]
    137. Phillips KD, Moneyham L, Tavakoli A. Development of an instrument to measure internalized stigma in those with HIV/AIDS. Issues Ment Health Nurs 2011;32(6):359-366. [CrossRef] [Medline]
    138. Neufeld SA, Sikkema KJ, Lee RS, Kochman A, Hansen NB. The development and psychometric properties of the HIV and Abuse Related Shame Inventory (HARSI). AIDS Behav 2012 May;16(4):1063-1074 [FREE Full text] [CrossRef] [Medline]
    139. Zelaya CE, Sivaram S, Johnson SC, Srikrishnan AK, Suniti S, Celentano DD. Measurement of self, experienced, and perceived HIV/AIDS stigma using parallel scales in Chennai, India. AIDS Care 2012;24(7):846-855. [CrossRef] [Medline]
    140. Earnshaw VA, Smith LR, Chaudoir SR, Amico KR, Copenhaver MM. HIV stigma mechanisms and well-being among PLWH: a test of the HIV stigma framework. AIDS Behav 2013 Jun;17(5):1785-1795 [FREE Full text] [CrossRef] [Medline]
    141. Molina Y, Ramirez-Valles J. HIV/AIDS stigma: measurement and relationships to psycho-behavioral factors in Latino gay/bisexual men and transgender women. AIDS Care 2013;25(12):1559-1568 [FREE Full text] [CrossRef] [Medline]
    142. Kipp AM, Audet CM, Earnshaw VA, Owens J, McGowan CC, Wallston KA. Re-validation of the Van Rie HIV/AIDS-related stigma scale for use with people living with HIV in the United States. PLoS One 2015 Mar 4;10(3):e0118836 [FREE Full text] [CrossRef] [Medline]
    143. Ross MW, Hunter CE, Condon J, Collins P, Begley K. The Mental Adjustment to HIV scale: measurement and dimensions of response to AIDS/HIV disease. AIDS Care 1994;6(4):407-411. [CrossRef] [Medline]
    144. Niu L, Qiu Y, Luo D, Chen X, Wang M, Pakenham KI, et al. Cross-culture validation of the HIV/AIDS stress scale: the development of a revised Chinese version. PLoS One 2016 Apr 4;11(4):e0152990 [FREE Full text] [CrossRef] [Medline]
    145. Su X, Lau JT, Mak WW, Chen L, Feng T, Chen X, et al. Development of the perceived stress scale for people living with HIV/AIDS in China. AIDS Patient Care STDS 2008 Dec;22(12):989-998. [CrossRef] [Medline]
    146. Remor E, Fuster MJ, Ballester-Arnal R, Gómez-Martínez S, Fumaz CR, González-Garcia M, et al. Development of a new instrument for the assessment of psychological predictors of well-being and quality of life in people with HIV or AIDS. AIDS Behav 2012 Nov;16(8):2414-2423. [CrossRef] [Medline]
    147. Remor E, Fuster-RuizdeApodaca MJ, Ballester-Arnal R, Gómez-Martínez S, Fumaz CR, González-Garcia M, et al. Field psychometric testing of the instrument for assessment of psychological predictors of well-being and quality of life in people with HIV or AIDS. AIDS Behav 2016 Jun;20(6):1360-1369. [CrossRef] [Medline]
    148. Golub SA, Rendina HJ, Gamarel KE. Identity-related growth and loss in a sample of HIV-positive gay and bisexual men: initial scale development and psychometric evaluation. AIDS Behav 2013 Feb;17(2):748-759 [FREE Full text] [CrossRef] [Medline]
    149. Buscher AL, Kallen MA, Suarez-Almazor ME, Giordano TP. Development of an "Impact of HIV" instrument for HIV survivors. J Assoc Nurses AIDS Care 2015;26(6):720-731 [FREE Full text] [CrossRef] [Medline]
    150. Audet CM, Wagner LJ, Wallston KA. Finding meaning in life while living with HIV: validation of a novel HIV meaningfulness scale among HIV-infected participants living in Tennessee. BMC Psychol 2015 May 2;3(1):15 [FREE Full text] [CrossRef] [Medline]
    151. Gottert A, Friedland B, Geibel S, Nyblade L, Baral SD, Kentutsi S, et al. The people living with HIV (PLHIV) resilience scale: development and validation in three countries in the context of the PLHIV stigma index. AIDS Behav 2019 Sep;23(Suppl 2):172-182 [FREE Full text] [CrossRef] [Medline]
    152. Martinez SM, Kemper CA, Diamond C, Wagner G, California Collaborative Treatment Group. Body image in patients with HIV/AIDS: assessment of a new psychometric measure and its medical correlates. AIDS Patient Care STDS 2005 Mar;19(3):150-156. [CrossRef] [Medline]
    153. Lee D, Patel P, Sachs J, Basinger S, Mathews WC, Barber RE. Psychometric properties of a lipodystrophy scale. AIDS Patient Care STDS 2006 Jan;20(1):30-35. [CrossRef] [Medline]
    154. Guaraldi G, Orlando G, Murri R, Vandelli M, De Paola M, Beghetto B, Esposito, et al. Quality of life and body image in the assessment of psychological impact of lipodystrophy: validation of the Italian version of assessment of body change and distress questionnaire. Qual Life Res 2006 Feb;15(1):173-178. [CrossRef] [Medline]
    155. Blashill AJ, Wilson JM, Baker JS, Mayer KH, Safren SA. Assessing appearance-related disturbances in HIV-infected men who have sex with men (MSM): psychometrics of the body change and distress questionnaire-short form (ABCD-SF). AIDS Behav 2014 Jun;18(6):1075-1084 [FREE Full text] [CrossRef] [Medline]
    156. Wu AW, Wansom T, Huang IC, CoFrancesco Jr J, Conant MA, Sarwer DB. The facial appearance inventory: development and preliminary evidence for reliability and validity in people with HIV and lipoatrophy. Aesthet Surg J 2016 Jul;36(7):842-851. [CrossRef] [Medline]
    157. Aversa S, Kimberlin C, Segal R. The Medication Attribution Scale: perceived effects of antiretrovirals and quality of life. Qual Life Res 1998 Apr;7(3):205-214. [CrossRef] [Medline]
    158. Woodcock A, Bradley C. Validation of the HIV treatment satisfaction questionnaire (HIVTSQ). Qual Life Res 2001;10(6):517-531. [CrossRef] [Medline]
    159. Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health 2006;9(5):320-333 [FREE Full text] [CrossRef] [Medline]
    160. Webb DG, Horne R, Pinching AJ. Treatment-related empowerment: preliminary evaluation of a new measure in patients with advanced HIV disease. Int J STD AIDS 2001 Feb;12(2):103-107. [CrossRef] [Medline]
    161. Green J, Kleinman L, Ciesla G, Huang J, Wintfeld N, Revicki D. Subcutaneous injection survey: psychometric evaluation of a treatment satisfaction instrument associated with a novel HIV medication. HIV Clin Trials 2002;3(5):387-395. [CrossRef] [Medline]
    162. Hekkink CF, Sixma HJ, Wigersma L, Yzermans CJ, Van Der Meer JT, Bindels PJ, et al. QUOTE-HIV: an instrument for assessing quality of HIV care from the patients' perspective. Qual Saf Health Care 2003 Jun;12(3):188-193 [FREE Full text] [CrossRef] [Medline]
    163. Bodenlos JS, Grothe KB, Kendra K, Whitehead D, Copeland AL, Brantley PJ. Attitudes toward HIV Health Care Providers scale: development and validation. AIDS Patient Care STDS 2004 Dec;18(12):714-720. [CrossRef] [Medline]
    164. Holstad MM, Foster V, Diiorio C, McCarty F, Teplinskiy I. An examination of the psychometric properties of the Antiretroviral General Adherence Scale (AGAS) in two samples of HIV-infected individuals. J Assoc Nurses AIDS Care 2010;21(2):162-172 [FREE Full text] [CrossRef] [Medline]
    165. Bova C, Fennie KP, Watrous E, Dieckhaus K, Williams AB. The health care relationship (HCR) trust scale: development and psychometric evaluation. Res Nurs Health 2006 Oct;29(5):477-488. [CrossRef] [Medline]
    166. Balfour L, Tasca GA, Kowal J, Corace K, Cooper CL, Angel JB, et al. Development and validation of the HIV Medication Readiness Scale. Assessment 2007 Dec;14(4):408-416. [CrossRef] [Medline]
    167. Johnson MO, Neilands TB. Coping with HIV treatment side effects: conceptualization, measurement, and linkages. AIDS Behav 2007 Jul;11(4):575-585 [FREE Full text] [CrossRef] [Medline]
    168. Brennan DJ, Welles SL, Miner MH, Ross MW, Mayer KH, Rosser BR, Positive Connections Team. Development of a treatment optimism scale for HIV-positive gay and bisexual men. AIDS Care 2009 Sep;21(9):1090-1097 [FREE Full text] [CrossRef] [Medline]
    169. Erlen JA, Cha ES, Kim KH, Caruthers D, Sereika SM. The HIV Medication Taking Self-efficacy Scale: psychometric evaluation. J Adv Nurs 2010 Nov;66(11):2560-2572 [FREE Full text] [CrossRef] [Medline]
    170. Osborn CY, Davis TC, Bailey SC, Wolf MS. Health literacy in the context of HIV treatment: introducing the Brief Estimate of Health Knowledge and Action (BEHKA)-HIV version. AIDS Behav 2010 Feb;14(1):181-188. [CrossRef] [Medline]
    171. Fernández MI, Hosek S, Warren JC, Jacobs RJ, Hernandez N, Martinez J, Adolescent Medicine Trials Network (ATN). Development of an easy to use tool to assess HIV treatment readiness in adolescent clinical care settings. AIDS Care 2011 Nov;23(11):1492-1499 [FREE Full text] [CrossRef] [Medline]
    172. Claborn KR, Miller MB, Meier E. Initial validation of the HIV treatment regimen fatigue scale for adults prescribed antiretroviral therapy. J Assoc Nurses AIDS Care 2015;26(4):308-315 [FREE Full text] [CrossRef] [Medline]
    173. Logie CH, Kennedy VL, Tharao W, Ahmed U, Loutfy MR. Engagement in and continuity of HIV care among African and Caribbean Black women living with HIV in Ontario, Canada. Int J STD AIDS 2017 Sep;28(10):969-974. [CrossRef] [Medline]
    174. Renwick R, Halpen T, Rudman D, Friedland J. Description and validation of a measure of received support specific to HIV. Psychol Rep 1999 Apr;84(2):663-673. [CrossRef] [Medline]
    175. Ingram KM, Jones DA, Fass RJ, Neidig JL, Song YS. Social support and unsupportive social interactions: their association with depression among people living with HIV. AIDS Care 1999 Jun;11(3):313-329. [CrossRef] [Medline]
    176. Cortes A, Hunt N, McHale S. Development of the scale of perceived social support in HIV (PSS-HIV). AIDS Behav 2014 Dec;18(12):2274-2284. [CrossRef] [Medline]
    177. Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). J Behav Med 2007 Oct;30(5):359-370 [FREE Full text] [CrossRef] [Medline]
    178. Wallston KA, Osborn CY, Wagner LJ, Hilker KA. The Perceived Medical Condition Self-Management Scale applied to persons with HIV/AIDS. J Health Psychol 2011 Jan;16(1):109-115 [FREE Full text] [CrossRef] [Medline]
    179. Webel AR, Asher A, Cuca Y, Okonsky JG, Kaihura A, Dawson Rose C, et al. Measuring HIV self-management in women living with HIV/AIDS: a psychometric evaluation study of the HIV Self-management Scale. J Acquir Immune Defic Syndr 2012 Jul 01;60(3):e72-e81 [FREE Full text] [CrossRef] [Medline]
    180. Nelsen A, Trautner BW, Petersen NJ, Gupta S, Rodriguez-Barradas M, Giordano TP, et al. Development and validation of a measure for intention to adhere to HIV treatment. AIDS Patient Care STDS 2012 Jun;26(6):329-334 [FREE Full text] [CrossRef] [Medline]
    181. Gray L, Falzon C, Bergamaschi A, Schuft L, Durant J, Rosenthal E, et al. Exercise stereotypes and health-related outcomes in French people living with HIV: development and validation of an HIV Exercise Stereotypes Scale (HIVESS). Health Qual Life Outcomes 2016 Nov 14;14(1):157 [FREE Full text] [CrossRef] [Medline]
    182. Webel AR, Okonsky J. Psychometric properties of a Symptom Management Self-Efficacy Scale for women living with HIV/AIDS. J Pain Symptom Manage 2011 Mar;41(3):549-557 [FREE Full text] [CrossRef] [Medline]
    183. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977 Mar;33(1):159-174. [Medline]
    184. Rosca EC, Tadger P, Cornea A, Tudor R, Oancea C, Simu M. International HIV dementia scale for HIV-associated neurocognitive disorders: a systematic review and meta-analysis. Diagnostics (Basel) 2021 Jun 20;11(6):1124 [FREE Full text] [CrossRef] [Medline]
    185. Askari S, Fellows L, Brouillette MJ, Moriello C, Duracinsky M, Mayo NE. Development of an item pool reflecting cognitive concerns expressed by people with HIV. Am J Occup Ther 2018;72(2):7202205070p1-7202205070p9. [CrossRef] [Medline]
    186. Askari S, Fellows LK, Brouillette MJ, Mayo NE. Development and validation of a voice-of-the-patient measure of cognitive concerns experienced by people living with HIV. Qual Life Res 2021 Mar;30(3):921-930. [CrossRef] [Medline]
    187. Nobels-Janssen E, van der Wees PJ, Verhagen WI, Westert GP, Bartels RH, Boogaarts JD. Patient-reported outcome measures in subarachnoid hemorrhage: a systematic review. Neurology 2019 Jun 04;92(23):1096-1112 [FREE Full text] [CrossRef] [Medline]
    188. Selby P, Velikova G. Taking patient reported outcomes centre stage in cancer research - why has it taken so long? Res Involv Engagem 2018 Jul 19;4:25 [FREE Full text] [CrossRef] [Medline]
    189. Wilson R. Patient led PROMs must take centre stage in cancer research. Res Involv Engagem 2018 Feb 26;4(1):7. [CrossRef]
    190. Venda Nova C, Zakrzewska JM, Baker SR, Ni Riordain R. Patient reported outcome measures in trigeminal neuralgia - a systematic review of psychometric performance. Eur J Pain 2021 Aug;25(7):1449-1461. [CrossRef] [Medline]
    191. Delvin NJ, Appleby J. Getting the most out of PROMs: Putting health outcomes at the heart of NHS decision-making. The King's Fund. 2010 Mar 11.   URL: http://www.kingsfund.org.uk/publications/proms.html [accessed 2021-12-18]
    192. Gutiérrez-Sánchez D, Gómez-García R, Cuesta-Vargas AI, Pérez-Cruzado D. The suffering measurement instruments in palliative care: a systematic review of psychometric properties. Int J Nurs Stud 2020 Oct;110:103704. [CrossRef] [Medline]
    193. Recchioni A, Aiyegbusi OL, Cruz-Rivera S, Rauz S, Slade A. A systematic review assessing the quality of patient reported outcomes measures in dry eye diseases. PLoS One 2021 Aug 9;16(8):e0253857 [FREE Full text] [CrossRef] [Medline]
    194. Prakash V, Shah S, Hariohm K. Cross-cultural adaptation of patient-reported outcome measures: a solution or a problem? Ann Phys Rehabil Med 2019 May;62(3):174-177 [FREE Full text] [CrossRef] [Medline]
    195. Lawrence V, Murray J, Banerjee S, Turner S, Sangha K, Byng R, et al. Concepts and causation of depression: a cross-cultural study of the beliefs of older adults. Gerontologist 2006 Feb;46(1):23-32. [CrossRef] [Medline]
    196. Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract 2011 Apr;17(2):268-274. [CrossRef] [Medline]
    197. de Vet HC, Terwee CB. The minimal detectable change should not replace the minimal important difference. J Clin Epidemiol 2010 Jul;63(7):804-806. [CrossRef] [Medline]
    198. Currier JS, Havlir DV. CROI 2019: complications and coinfections in HIV infection. Top Antivir Med 2019 Apr;27(1):34-40 [FREE Full text] [Medline]
    199. Srinivasa S, Grinspoon SK. Metabolic and body composition effects of newer antiretrovirals in HIV-infected patients. Eur J Endocrinol 2014 May;170(5):R185-R202. [CrossRef] [Medline]
    200. Lampe FC, Harding R, Smith CJ, Phillips AN, Johnson M, Sherr L. Physical and psychological symptoms and risk of virologic rebound among patients with virologic suppression on antiretroviral therapy. J Acquir Immune Defic Syndr 2010 Aug;54(5):500-505. [CrossRef] [Medline]
    201. Kjær AS, Rasmussen TA, Hjollund NH, Rodkjaer LO, Storgaard M. Patient-reported outcomes in daily clinical practise in HIV outpatient care. Int J Infect Dis 2018 Apr;69:108-114 [FREE Full text] [CrossRef] [Medline]
    202. Monroe AK, Jabour SM, Peña S, Keruly JC, Moore RD, Chander G, et al. A qualitative study examining the benefits and challenges of incorporating patient-reported outcome substance use and mental health questionnaires into clinical practice to improve outcomes on the HIV care continuum. BMC Health Serv Res 2018 Jun 07;18(1):419 [FREE Full text] [CrossRef] [Medline]
    203. Rosen S, Maskew M, Brennan AT, Fox MP, Vezi L, Ehrenkranz PD, et al. Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation. Trials 2018 Oct 11;19(1):548 [FREE Full text] [CrossRef] [Medline]
    204. Lowther K, Selman L, Simms V, Gikaara N, Ahmed A, Ali Z, et al. Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial. Lancet HIV 2015 Aug;2(8):e328-e334. [CrossRef] [Medline]
    205. Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007;10 Suppl 2:S125-S137 [FREE Full text] [CrossRef] [Medline]
    206. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013 Feb 27;309(8):814-822. [CrossRef] [Medline]
    207. Vitoria M, Rangaraj A, Ford N, Doherty M. Current and future priorities for the development of optimal HIV drugs. Curr Opin HIV AIDS 2019 Mar;14(2):143-149. [CrossRef] [Medline]
    208. Simpson KN, Hanson KA, Harding G, Haider S, Tawadrous M, Khachatryan A, et al. Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review. Health Qual Life Outcomes 2013 Oct 03;11:164 [FREE Full text] [CrossRef] [Medline]
    209. Marshall DA, Jin X, Pittman LB, Smith CJ. The use of patient-reported outcome measures in hip and knee arthroplasty in Alberta. J Patient Rep Outcomes 2021 Oct 12;5(Suppl 2):87 [FREE Full text] [CrossRef] [Medline]
    210. Sawatzky R, Kwon JY, Barclay R, Chauhan C, Frank L, van den Hout WB, Response Shift – in Sync Working Group. Implications of response shift for micro-, meso-, and macro-level healthcare decision-making using results of patient-reported outcome measures. Qual Life Res 2021 Dec;30(12):3343-3357 [FREE Full text] [CrossRef] [Medline]
    211. Weldring T, Smith SM. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs). Health Serv Insights 2013 Aug 4;6:61-68 [FREE Full text] [CrossRef] [Medline]
    212. Antela A, Rivero A, Llibre JM, Moreno S, RET Group. Redefining therapeutic success in HIV patients: an expert view. J Antimicrob Chemother 2021 Sep 15;76(10):2501-2518 [FREE Full text] [CrossRef] [Medline]
    213. Althoff KN, Smit M, Reiss P, Justice AC. HIV and ageing: improving quantity and quality of life. Curr Opin HIV AIDS 2016 Sep;11(5):527-536 [FREE Full text] [CrossRef] [Medline]
    214. King EM, Prior JC, Pick N, van Schalkwyk J, Kestler M, Tkachuk S, et al. Menopausal hormone therapy for women living with HIV. Lancet HIV 2021 Sep;8(9):e591-e598. [CrossRef] [Medline]
    215. Brown MJ, Adeagbo O. HIV and aging: double stigma. Curr Epidemiol Rep 2021;8(2):72-78 [FREE Full text] [CrossRef] [Medline]
    216. Cabrera DM, Diaz MM, Grimshaw A, Salvatierra J, Garcia PJ, Hsieh E. Aging with HIV in Latin America and the Caribbean: a systematic review. Curr HIV/AIDS Rep 2021 Feb;18(1):1-47 [FREE Full text] [CrossRef] [Medline]
    217. Muehlhausen W, Doll H, Quadri N, Fordham B, O'Donohoe P, Dogar N, et al. Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013. Health Qual Life Outcomes 2015 Oct 07;13:167 [FREE Full text] [CrossRef] [Medline]
    218. Byrom B, Doll H, Muehlhausen W, Flood E, Cassedy C, McDowell B, et al. Measurement equivalence of patient-reported outcome measure response scale types collected using bring your own device compared to paper and a provisioned device: results of a randomized equivalence trial. Value Health 2018 May;21(5):581-589 [FREE Full text] [CrossRef] [Medline]
    219. Edwards TC, Fredericksen RJ, Crane HM, Crane PK, Kitahata MM, Mathews WC, et al. Content validity of patient-reported outcomes measurement information system (PROMIS) items in the context of HIV clinical care. Qual Life Res 2016 Feb;25(2):293-302 [FREE Full text] [CrossRef] [Medline]
    220. Gibbons LE, Fredericksen R, Merrill JO, McCaul ME, Chander G, Hutton H, et al. Suitability of the PROMIS alcohol use short form for screening in a HIV clinical care setting. Drug Alcohol Depend 2016 Jul 01;164:113-119 [FREE Full text] [CrossRef] [Medline]
    221. Gibbons LE, Fredericksen R, Batey DS, Dant L, Edwards TC, Mayer KH, Centers for AIDS Research Network of Integrated Clinical Systems (CNICS). Validity assessment of the PROMIS fatigue domain among people living with HIV. AIDS Res Ther 2017 Apr 11;14:21 [FREE Full text] [CrossRef] [Medline]

    ‎
    ART: antiretroviral therapy
    CAT: computer adaptive test
    COSMIN: Consensus-Based Standards for the Selection of Health Measurement Instruments
    ePROM: electronic patient-reported outcome measure
    HIV-SI or SDM: HIV Symptom Index or Symptoms Distress Module of the Adult AIDS Clinical Trial Group
    HRQoL: health-related quality of life
    PLHIV-RS: People Living with HIV Resilience Scale
    PozQoL: Poz Quality of Life
    PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
    PRO: patient-reported outcome
    PROM: patient-reported outcome measure

    Edited by H Bradley; submitted 25.04.22; peer-reviewed by D Finitsis, MJ Brouillette, A Olekalns; comments to author 26.06.22; revised version received 03.08.22; accepted 11.10.22; published 08.12.22

    Copyright

    ©Ziqi Wang, Yaxin Zhu, Xiyu Duan, Hao Kang, Bo Qu. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 08.12.2022.

    This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Public Health and Surveillance, is properly cited. The complete bibliographic information, a link to the original publication on https://publichealth.jmir.org, as well as this copyright and license information must be included.