Background
Method
Search strategy
HIV | Quality of Life | Measurea
| Review |
Human Immunodeficiency Virus | QoL | Inventora
| |
PROM | Scalea
| ||
Antiretrovirala
| Patient Reported Outcome | Questionnairea
| |
Self-reporta
| |||
Assessmenta
| |||
Surveya
| |||
Toola
| |||
Indicatora
| |||
Instrumenta
|
Inclusion and exclusion criteria
Inclusion criteria
Exclusion criteria
Analysis
Inclusion of HRQoL measures for the review
-
Content: Coverage of at least three core domains of HRQoL: physical function, social/role function and mental/emotional health. In addition patient input was required in the development of HIV-specific measures, in order to reflect patients’ experience of disease.
-
Practicality: Measures needed to be self-administered and typically completed within 10 min. Where completion time data were not available, we included measures with less than 40 items. This cut-off was based on an estimation of completion rates drawing on the data available in the reviews, indicating approximately four items per minute.
-
Normative data: For generic measures, normative data needed to be available to allow comparison between people with HIV and the general population.
Results
Overview of the published systematic reviews
Paper | Aim of the review | Dates of search | Databases and other sources | Search terms | Language restriction? | No. papers reviewed | No. HRQoL measures identified | No. generic HRQoL measures | No. HIV-specific measures |
---|---|---|---|---|---|---|---|---|---|
Carabin et al. (2008) [17] | To assist clinicians in choosing the most appropriate instrument to measure health related quality of life among people living with HIV. | Not stated | OVID, Pubmed and ERIC English language | Not stated | English and Spanish | Not stated | 17 | 6 | 11 |
Clayson et al. (2006) [4] | To review existing HR-QOL measures reported in the HIV/AIDS literature since 1990 and identify those most worthy of consideration for use in clinical trials. | 1990-not stated | General abstract databases such as MEDLINE, PsycINFO, INSPEC, EMBASE, CINAHL PRO instrument databases such as the On-Line Guide to Quality of Life Assessment (OLGA) and the Quality of Life Instruments Database (QOLID) | Not stated | Not stated | Not stated | 34 | 17 | 17 |
Cochrane Library Database International Society for Quality of Life Research and the International Society for Pharmacoeconomics and Outcomes Research abstracts and conference proceedings Specific HIV-related journals, including AIDS, AIDS Care, International Journal of STD & AIDS and Journal of Acquired Immune Deficiency Syndrome. | |||||||||
Colautti et al. (2006) [18] | To review validated questionnaires to assess health related quality of life in HIV/AIDS patients | Not stated | PubMed, Medline and Medscape | “HRQL”, “questionnaire” and “HIV” | None | Not stated | 20 | 9 | 11 |
Davis & Pathak (2001) [19] | To provide a comparative evaluation of psychometric properties of four HIV disease–specific quality-of-life (QoL) instruments. | Not stated | MEDLINE, Health Star, International Pharmacy Abstracts, Social Sciences Citation Index, Current Contents Manual reference list search | Not stated | Not stated | Not stated | 4 | 0 | 4 |
Drewes et al. (2013) [3] | To provide a comprehensive summary of the methodological approaches used to study the QOL of people with HIV and AIDS based on published research. | To early 2011 | PubMed and PsycINFO | “HIV/AIDS,” “quality of life,” and related concepts, like “well-being,” “life satisfaction,” and the names of established QOL instruments. | English abstract | 852 | >40 (but only report on the 14 most commonly used QOL measures) | 8 | 6 |
Gakhar et al. (2013) [12] | To provide an overview of the Health Related Quality of Life tools available, the methods used for validation, the impact that ART has had on the HRQOL of HIV-infected people, as well as looking at some of the most important adverse effects of ARVs and co-morbidities. | Not stated | PubMed, Web of Science, Cochrane, MEDLINE and Scopus. Manual reference list search Internet databases to look for other HRQOL tools (http://www.proqolid.org). | Included “HIV,” “HRQOL Measures,” “quality of life” and “health status.” | English | Not stated | 41 | 23 | 18 |
Robberstad & Olsen (2010) [13] | To review the existing evidence on health related quality of life in HIV/AIDS patients in sub-Saharan Africa and consider how this information is used in the economic evaluation literature. | Not stated | PubMed, Embase and ISI Expert input | “HIV OR AIDS”, “Africa south of the Sahara” AND “health related quality of life” | Not stated | 29 | 24 | 6 | 18 (only describe 3) |
Simpson et al. (2013) [11] | To identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs. | March 2003–Feb 2013 | PubMed Manual reference list search | Included a combination of MeSH terms for HIV [HIV OR HIV infections], MeSH terms associated with PROs/instruments [questionnaires OR interviews as topic OR quality of life OR patient satisfaction OR self-evaluation programs], Substance Names of NNRTIs [efavirenz OR nevirapine OR delavirdine OR etravirine OR rilpivirine OR efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination], and clinical trial Publication Types [clinical trial OR clinical trial, phase IV OR clinical trial, phase III OR clinical trial, phase II OR controlled clinical trial OR randomized controlled trial] | English | 26 | 8 | 4 | 4 |
Skevington & O’Connell (2003) [20] | To address issues surrounding the measurement of quality of life of people living with HIV and AIDS and discuss the properties of suitable instruments | Jan 1995–May 2000 | EMBASE, MEDLINE, the Web of Science (Version 4.1), PubMed. And Psychlit | ‘quality of life’ with ‘HIV’ and/or ‘AIDS’ Names of particular QOL scales (e.g. Euroqol, SF-36) AND HIV/AIDS | Not stated | Not stated | 21 | 10 | 11 |
Wu et al. (2013) [10] | To examine the responsiveness of two health-related quality of life (HRQL) instruments used in clinical trials involving HIV-infected adults: the HIV-targeted Medical Outcomes Study HIV Health Survey (MOS-HIV), and a generic measure, the EuroQol-5D (EQ-5D). | 2001–2010 | PubMed Manual reference list search | Included a combination of MeSH terms for HIV [HIV OR HIV infections], instrument names [Euroqol, EQ-5D, MOS-HIV], and clinical trial Publication Types [clinical trial OR clinical trial, phase IV OR clinical trial, phase III OR clinical trial, phase II OR controlled clinical trial OR randomized controlled trial] | English | 17 | 2 | 1 | 1 |
Quality of the reviews
Paper | 1. Is the review based on a focused question that is adequately formulated and described? | 2. Were eligibility criteria for included and excluded studies predefined and specified? | 3. Did the literature search strategy use a comprehensive systematic approach? | 4. Were titles, abstracts, and full-text articles dually and independently reviewed for inclusion and exclusion to minimize bias? | 5. Was the quality of each included study rated independently by two or more reviewers using a standard method to appraise its internal validity? | 6. Were the included studies listed along with important characteristics and results of each study? | 7. Was publication bias assessed | 8. Was heterogeneity assessed? (this question only applies to meta-analyses) |
---|---|---|---|---|---|---|---|---|
Carabin et al. (2008) [17] | N | N | N | NR | N | N | N | NA |
Clayson et al. (2006) [4] | Y | N | NR | NR | N | N | N | NA |
Colautti et al. (2006) [18] | Y | N | N | NR | N | N | N | NA |
Davis & Pathak (2001) [19] | Y | N | NR | N | N | N | N | NA |
Drewes et al. (2013) [3] | Y | Y | N | N | N | N | N | NA |
Gakhar et al. (2013) [12] | Y | N | NR | NR | N | N | N | NA |
Robberstad & Olsen (2010) [13] | Y | Y | N | NR | N | N | N | NA |
Simpson et al. (2013) [11] | Y | Y | N | NR | N | Y | N | NA |
Skevington & O’Connell (2003) [20] | N | N | N | NR | N | N | N | NA |
Wu et al. (2013) [10] | Y | Y | N | NR | N | Y | N | NA |
Selection of measures for further scrutiny
Generic measures
HIV-specific measures
Overview of selected generic HRQoL measures
Scale | Domains addressed | Completion time/Number of items | Response format | Accessibility | Validity | Reliability | Responsiveness | Floor/ Ceiling effects | Conclusions/recommendations of the reviews |
---|---|---|---|---|---|---|---|---|---|
COOP/WONCA [21] | Physical fitness, feelings, daily activities, social activities, pain, change in health, overall health, social support and quality of life | <5 mins [58] 9 items (more recently reduced to 6) | Five options with pictorial depictions accompanying the text | Available in 20 languages [18] Acceptable and feasible [13] | HIV positive women had poorer scores than HIV negative women on six out of nine health dimensions (construct validity) [13] | not stated | not stated | not stated | not stated |
Mobility; self-care, usual activities, pain/discomfort, anxiety/depression, self-reported health | 1 min [4] 6 items | 5 dimensions of quality of life are rated on either a 3 point scale (no problems/ some or moderate problems/ extreme problems – EQ-5D-3 L) or 5 point scale (no problems/ slight problems/ moderate problems/ severe problems/ extreme problems – EQ-5D-5 L). In addition, a visual analogue scale (0–100) is used to rate overall health. | Approximately 1 min to complete [4]. Can be administered electronically or over phone [12]. General population preference weights have been derived for many countries [4]. | Correlates with MOS-HIV subscales and discriminates between participants stratified by HIV/AIDS severity based on CD4 count/viral load (construct validity) [4, 12]. Lower EQ-5D scores among people with HIV not receiving ART than general population (construct validity) [13]. | not stated | Clayson et al. recommend using the EQ-5D alongside a disease-targeted measure, however because of ceiling effects in general population samples they would not recommend the EQ-5D for studies including individuals with early, asymptomatic HIV infection. [4] Wu et al. recommend use alongside the MOS-HIV to obtain HIV-specific HRQL and utility measures [10]. Performance equivalent to the MOS-HIV in clinical trials [20]. | |||
FLZM Questions on life satisfaction [24] | Satisfaction with life in general: friends’ free time, general health, financial security, work, life conditions, family life and relationships. Satisfaction with health: physical condition, ability to rest, energy, mobility, freedom from anxiety, freedom from pain, independence | “A few minutes” [24] 16 items | 5 point scales rating the importance of and satisfaction with each aspect of quality of life. | not stated | not stated | not stated | not stated | not stated | not stated |
Health Utilities Index (HUI) HUI2; HU13 [25] | Vision, ambulation, dexterity, emotion, cognition, hearing, speech and pain | 5–10 mins [59] 15 items | 4–6 response options for each question | Available in multiple languages [12]. Can be administered electronically [12]. | HUI2 and 3 have been associated with disease severity/AIDS related events and plasma viral load (construct validity). [4] | not stated | not stated | Despite less evidence for the HUI than EQ-5D and SF-36, emerging data were positive. [4] Potentially useful adjuvant to an HIV-specific measure in a trial. [4] | |
McGill Quality of life questionnaire (M-QOL) [26] | Physical, Psychological, Existential, Support. | 16 items | Two response options for each item (e.g. no problem vs tremendous problem) | not stated | Content/face validity: The existential dimension is particularly relevant to people with advanced disease (CD4 < 100) [20] Only scores for physical symptoms distinguished between people with HIV with low and high CD4 count (construct validity). [20] | Factor analysis indicated four reliable subscales plus a single item about physical wellbeing (internal consistency). [20] | not stated | not stated | not stated |
SF-12 [27] | Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health | 2–3 mins [60] 12 items | 2–6 response options per item | not stated | not stated | No internal consistency data reported [17]. | Mixed results in terms of responsiveness to change in treatment [12]. | Likely to have similar floor and ceiling effects to other MOS measures [17]. | Clayson et al. recommend the use of the SF-12 where the length of the SF-36 is a problem. [4] |
SF-20 [28] | not stated | 3–5 mins [61] 20 items | 3–6 response options per item | not stated | No construct validity data [17]. | Adequate cronbach’s alphas (internal consistency) [17]. | not stated | Floor and ceiling effects noted in some dimensions [17]. | not stated |
Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, reported health transition | 7–10 mins [4] 36 | 2–6 response options per item | Dominates generic HR-QOL measurement with normative scores for US, UK and many other countries [4, 20]. Takes 7–10 min to complete [4]. Can be administered electronically [18] | Correlates with disease severity, CD4 counts and other measures of QOL.(construct validity) [12] PLWL reported lower QOL on all dimensions, compared to healthy controls [12, 13, 20], with the biggest decline between Stages 1 and 2 of the disease (construct validity) [13, 20]. Scale scores were associated with treatment duration, less co-morbidity, and better social support improved physical functioning (construct validity) [13]. | Responsive to the initiation of ART and change in CD4 count, viral load and the number of symptoms. [4] Improvement in all HRQOL domains along with clinical indicators after starting ART. May not be sensitive to change of ART medication in people with HIV who are stable on ART [12]. | More evidence for the SF-36 in people with HIV than other recommended generic measures (EQ-5D or HUI) and the SF-12 is a viable alternative if the length is a problem. [4] Coluatti et al. recommend the SF-36 as the most appropriate generic measure for assessing HRQL in people with HIV [18]. Use alongside a disease-targeted measure (other than the MOS-HIV which shares items) is recommended. [4] Unclear whether there is an advantage to using the MOS-HIV over the SF-36. [4] This and other MOS measures were developed in US – although translated into other languages people from these countries had no input into development and these versions may have limited semantic equivalence [20]. Can be used in cost-utility analyses by deriving utility weights from the SF-36 [11]. | |||
Physical health, psychological health, social relationships and environment. | <5 mins [20] 26 items | 5-point scales | Available in 40 languages. Takes <5 min to complete [20]. Developed in 15 centres worldwide to increase cross-cultural validity [12]. | Correlates well with disease severity, patients who had lower CD4 counts had lower HRQOL (construct validity) [12]. | Cronbach’s alpha coefficients in the acceptable range (internal consistency) [12]. | not stated | not stated | Developed from the WHOQOL-100 measure, which was developed within an international collaboration of 15 countries using a spoke-wheel methodology to ensure conceptual and semantic equivalence [20]. |
COOP/WONCA [21]
EQ-5D [22, 23]
Health utilities Index [25]
The McGill quality of life questionnaire (M-QOL) [26]
SF-12 [27]
SF-36 [29‐31]
WHOQOL-BREF [32, 33]
Overview of selected HIV specific HRQoL measures
Scale | Domains addressed | Completion time/No. items | Response format | Accessibility | Validity | Reliability | Responsiveness | Floor/ Ceiling effects | Conclusions/recommendations of the reviews |
---|---|---|---|---|---|---|---|---|---|
ACTG SF-21 [34] | Physical functioning, energy/fatigue, social functioning, role functioning, cognition, pain, health perception and emotional well-being. | 4–5 mins [34] 21 items | 3–6 response options per item plus a visual analogue scale | Available in 2 languages [17]. | No validity data available [17]. | No internal consistency reported [17]. | not stated | Likely to have similar floor and ceiling effects to other MOS measures [17]. | not stated |
HIV-QL31 [35] | Sex life, pain, psychological aspects, relationships, limitations caused by HIV, symptoms, impact of treatment and care | 31 items | Yes/No | Available in English and French [18]. | Discriminates between groups with different severity levels (construct validity) [20]. | not stated | not stated | QL-31 is a relatively sound and useful instrument where attention has been paid to the breadth of the concept as a result of listening to the concerns of patients. However it is culture-specific in the ways it has been designed [20]. | |
MQOL-HIV [37] | Mental health, physical health, physical functioning, social functioning, social support, cognitive functioning, financial status, partner intimacy, sexual functioning, perceived access to medical care | 10 mins [4] 40 items | Likert scale (never – always) | In a study comparing the MQOL-HIV with the MOS-HIV there were more missing data/incomplete responses on the MQOL-HIV [12] | Discriminates between patients based on symptom severity, inpatient care and stage of illness [4]. MQOL-HIV scores distinguished between AIDS, symptomatic HIV, and asymptomatic cases, on 7 domains and overall QOL in one study however inadequate discrimination between disease stages was found in a Spanish study [20]. | Good internal consistency (Cronbach’s alpha >0.70) for 8 of the 10 domains [4]. Poor internal consistency for physical and mental health, physical and sexual functioning [20]. Good test-retest reliability for all domains except cognitive functioning [4]. Poor test-retest reliability [20]. | Somewhat responsive to change in the number of symptoms, viral load and CD4 count over a 3-month period [4]. Responsive to perceived changes in quality of life over 6 months in one study however only five dimensions were sensitive to clinical changes during ART [20]. Less sensitive than the MOS-HIV for detecting changes after starting or switching ART. MOS-HIV detected change on a greater number of subscales [12]. | Floor and/or ceiling effects were reported in some dimensions [17]. Fewer problems with floor ceiling effects when compared to the MOS-20 [20]. | The MQoL-HIV was not one of the reviewed measures recommended by Clayson et al. [4] A relatively sound and useful measure where attention has been paid to patient input and the breadth of the concept however the instrument is culture-specific [20]. |
8 scored domains: Physical health and symptoms, treatment impact, emotional distress, health concerns, body change, intimate relationships, social relationships, stigma and 4 additional items addressing religious beliefs, finance, having children and satisfaction with care. | 7 mins [51] 43 items | Rated on a 5-point scale ranging from 0 = ‘never’ to 4 = “always” | not stated | not stated | not stated | not stated | not stated | No information reported in the reviews | |
MOS-HIV [36] | Two summary scores—the physical health score and mental health score and 10 domains: physical functioning, pain, social functioning, role functioning, emotional well-being, energy/fatigue, cognitive functioning, health distress, health transition, general health and overall quality of life | 35 items | 2–6 response options per item | Translated into at least 14 languages, largely designed for industrialised world [20]. English version takes approx. 5–10 min [4, 12, 20] but twice as long has been reported for the use of some translations, e.g. Spanish, where more words are needed to express the concepts [20]. Less missing data than MQOL-HIV [12]. | Responsiveness has been established in a wide variety of contexts including adverse events, increased symptoms, opportunistic infections and AIDS-defining events, initiation of ART [4, 10, 12, 18]. Negligible effects in treatment experienced adults changing therapy [10]. Studies have found the MOS-HIV is more responsive than EQ-5D, HUI3 and MQOL-HIV [12]. | Well established reliability/validity and widely used but concerns that as one of the earliest HIV-specific measures to be developed it may not have continued relevance for PLWH. They question whether there is a true advantage to using the MOS-HIV over the SF-36. Would be unwise to administer alongside another MOS measure such as the SF-36 because of shared items [4]. May have limited value in cross-cultural research because although the scale has been translated into many languages, it may not have sematic and conceptual equivalence outside the USA [20]. More information is needed about performance of the scale in women, low income and other socially disadvantaged groups [20]. Can be administered individually or together with the EQ-5D to measure changes in HRQOL [10]. There is a lack of items addressing sexual function and body image [18]. Validation data draws on a range of patient groups from asymptomatic to those with advanced HIV [4]. | |||
WHOQOL-HIV BREF [39] | Physical, psychological, level of independence, social, environmental, and spiritual QoL | 31 items | 5 point likert scale | not stated | not stated | not stated | not stated | not stated | not stated |
Symptom Quality of Life Adherence (HIV-SQUAD) [40] | HRQOL items include physical and psychological domains. The measure also includes symptoms and a visual analogue scale for adherence | 24 items | 5 point likert scales, dichotomous items and a visual analogue scale | not stated | The measure discriminated between patients at different CD4 counts and with/without hepatitis co-infection (construct validity) [12]. | Cronbach’s alpha was acceptable for the physical component but <0.7 for the psychological component (internal consistency) [12] | Responsive to change in HIV viral load [12]. | not stated | not stated |