Browsing by Subject "HRQoL"

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    Open Access
    How does the EQ-5D-Y Proxy version 1 perform in 3, 4 and 5-year-old children?
    (2020-05-24) Verstraete, Janine; Lloyd, Andrew; Scott, Des; Jelsma, Jennifer
    Background The EQ-5D-Y Proxy is currently recommended for Health Related Quality of Life (HRQoL) measurement in children aged 4–8 years of age. However, it has only been validated in children over six years of age. The aim of this study was to investigate the performance of the EQ-5D-Y proxy version 1 in children between the ages of 3–6 years. Methods A sample of 328 children between 3 and 6 years of age were recruited which included children who were either acutely-ill (AI), chronically-ill (CI) or from the general school going population (GP). The EQ-5D-Y Proxy Version 1 and the PedsQL questionnaires were administered at baseline. The EQ-5D-Y Proxy was administered telephonically 24 h later to children with chronic illnesses to establish test-retest reliability. The distribution of dimensions and summary scores, Cohen’s kappa, the intraclass correlation coefficient, Pearson’s correlation and Analysis of variance were used to explore the reliability, and validity of the EQ-5D-Y for each age group. A single index score was estimated using Latent scores and Adult EQ-5D-3 L values (Dolan). Results The groups included 3-year olds (n = 105), 4-year olds (n = 98) and 5-years olds (n = 118). The dimension Looking after Myself had the greatest variability between age groups and had the highest rate of problems reported. Worried, Sad or Unhappy and Pain or Discomfort were not stable across time in test-retest analysis. The Visual Analogue Scale (VAS), and single index scores estimated using the latent values and Dolan tariff had good test retest (except for the latent value scores in a small number of 4-year olds). EQ-5D-Y scores for all ages had small to moderate correlations with PedsQL total score. The EQ-5D-Y discriminated well between children with a health condition and the general population for all age groups. Caregivers reported difficulty completing the Looking after Myself dimension due to age-related difficulties with washing and dressing. Conclusion The dimension of Looking after Myself is problematic for these young children but most notably so in the 3 year old group. If one considers the summary scores of the EQ-5D-Y Proxy version 1 it appears to work well. Known group validity was demonstrated. Concurrent validity was demonstrated on a composite level but not for individual dimensions of Usual Activities or Worried, Sad or Unhappy.. The observable dimensions demonstrated stability over time, with the inferred dimensions (Pain or Discomfort and Worried, Sad or Unhappy) less so, which is to be expected. Further work is needed in exploring either the adaptation of the dimensions in the younger age groups.
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    Open Access
    Influence of the child’s perceived general health on the primary caregiver’s health status
    (BioMed Central, 2018-01-10) Verstraete, Janine; Ramma, Lebogang; Jelsma, Jennifer
    Background: In estimating the impact of an intervention, ignoring the effect of improving the health of one member of the caregiver/child dyad on the Health Related Quality of Life (HRQoL) of the other member may lead to an underestimation of the utility gained. This may be particularly true for infants/young children and their caregivers. The aim of this study was to quantify the interaction between the child’s perceived general health as assessed by the newly developed Toddler and Infant Questionnaire (TANDI) on the reporting of the caregiver’s own HRQoL as assessed by the EQ-5D-3 L. Methods: A sample of 187 caregivers participated. A total of 60 caregivers of acutely-ill (AI) and 60 caregivers of chronically-ill (CI) children were recruited from a children’s hospital. The 67 caregivers of general population (GP) children were recruited at a pre-school. Each caregiver completed the proxy rating of their child’s HRQoL on the TANDI (The TANDI is an experimental HRQoL instrument, modelled on the EQ-5D-Y proxy, for children aged 1-36 months), which comprises of six dimensions of health and a rating of general health on a Visual Analogue Scale (VAS). The caregiver completed the EQ-5D-3 L, a self-report measure of their own HRQoL. Forward stepwise regression models were developed with 1) the VAS score of the caregiver and 2) the VAS score of the child as dependent variables. The independent variables for the caregiver included dummy variables for the presence or absence of problems on the EQ-5D-3 L and the VAS score of the child. The independent variables for the child included dummy variables for each TANDI dimension and the VAS of the caregiver. Results: The TANDI results indicated that in five of the six dimensions AI children had more problems than the other two groups and the GP children were reported to have a significantly higher VAS than the other two groups. The child’s VAS was significantly correlated with the caregiver’s VAS in all groups, but most strongly in the AI group. The preference based scores (using the UK TTO tariff) were only correlated in the AI group. The inclusion of the child’s VAS increased the variance accounted for 11% of the VAS score of the caregiver. Anxiety and depression was the only dimension which accounted for more variance (18%). Similarly the perceived health state, VAS of the caregiver accounted for 14% of the variance in the child’s VAS, second only to problems with play (25%). Conclusion: There does indeed appear to be a strong relationship between the VAS scores of the children and their caregivers. The perceived general health of the child influences the caregivers reporting of their general health, more than their own report of experiencing pain or discomfort or problems with mobility. Thus, improving the HRQoL of the very young child may improve the caregiver’s HRQoL as well. Conversely, if the caregiver has a lower perceived HRQoL this may result in a decrement in the reported VAS of the child, independent of the presence or absence of problems in the different dimensions. This improvement is not currently captured by Cost Utility Analysis (CUA). It is recommended that future research investigates this effect with regards to CUA calculations.
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    Open Access
    Item generation for a proxy health related quality of life measure in very young children
    (2020-01-14) Verstraete, Janine; Ramma, Lebogang; Jelsma, Jennifer
    Abstract Background and aims Very young children have a relatively high prevalence of morbidity and mortality. Health care and supportive technology has improved but may require difficult choices and decisions regarding the allocation of these resources in this age group. Cost-effective analysis (CEA) can inform these decisions and thus measurement of Health-Related Quality of Life (HRQoL) is becoming increasingly important. However, the components of HRQoL are likely to be specific to infants and young children. This study aimed to develop a bank of items to inform the possible development of a new proxy report instrument. Methods A review of the literature was done to define the concepts, generate items and identify measures that might be an appropriate starting point of reference. The items generated from the cognitive interviews and systematic review were subsequently pruned by experts in the field of HRQoL and paediatrics over two rounds of a Delphi study. Results Based on the input from the different sources, the greatest need for a new HRQoL measure was in the 0–3-year age group. The item pool identified from the literature consisted of 36 items which was increased to 53 items after the cognitive interviews. The ranking of items from the first round of the Delphi study pruned this pool to 28 items for consideration. The experts further reduced this pool to 15 items for consideration in the second round. The experts also recommended that items could be merged due to their similar nature or construct. This process allowed for further reduction of items to 11 items which showed content validity and no redundancy. Conclusion The need for an instrument to measure appropriate aspects of HRQoL in infants and young children became apparent as items included in existing measures did not cover the required spectrum. The identification of the final items was based on a sound conceptual model, acceptability to stakeholders and consideration of the observability of the item selected. The pruned item bank of 11 items needs to be subject to further testing with the target population to ensure validity and reliability before a new measure can be developed.
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    A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy
    (2022-06-07) Ochanda, Perez N; Lamorde, Mohammed; Kintu, Kenneth; Wang, Duolao; Chen, Tao; Malaba, Thokozile; Myer, Landon; Waitt, Catriona; Reynolds, Helen; Khoo, Saye
    Introduction Evidence on health-related quality of life (HRQoL) outcomes is limited for new antiretroviral therapies (ART). Dolutegravir-based treatment is being rolled out as the preferred first-line treatment for HIV in many low- and middle-income countries. We compared HRQoL between treatment-naïve pregnant women randomized to dolutegravir- or efavirenz-based ART in a clinical trial in Uganda and South Africa. Methods We gathered HRQoL data from 203 pregnant women of mean age 28 years, randomized to either dolutegravir- or efavirenz-based ART. We used the medical outcomes study-HIV health survey at baseline, 24 and 48 weeks between years 2018 and 2019. Physical health summary (PHS) and mental health summary (MHS) scores were the primary study outcomes, while the 11 MOS-HIV subscales were secondary outcomes. We applied mixed model analysis to estimate differences within and between-treatment groups. Multivariate regression analysis was included to identify associations between primary outcomes and selected variables. Results At 24 weeks postpartum, HRQoL scores increased from baseline in both treatment arms: PHS (10.40, 95% CI 9.24, 11.55) and MHS (9.23, 95% CI 7.35, 11.10) for dolutegravir-based ART; PHS (10.24, 95% CI 9.10, 11.38) and MHS (7.54, 95% CI 5.66, 9.42) for efavirenz-based ART. Increased scores for all secondary outcomes were significant at p < 0.0001. At 48 weeks, improvements remained significant for primary outcomes within group comparison. Estimated difference in PHS were higher in the dolutegravir-based arm, while increases in MHS were more for women in the efavirenz-based armat 24 and 48 weeks. No significant differences were noted for corresponding PHS scores at these time points compared between groups. Differences between arms were observed in two secondary outcomes: role function (1.11, 95% CI 0.08, 2.13), p = 0.034 and physical function outcomes (2.97, 95% CI 1.20, 4.73), p = 0.001. In the multivariate analysis, internet access was associated with higher PHS scores while owning a bank account, using the internet and longer treatment duration were associated with an increase in MHS scores. Conclusion We found no important differences in HRQoL outcomes among HIV-positive women started on dolutegravir relative to efavirenz in late pregnancy. Increases in HRQoL in the first year after delivery provide additional support for the initiation of ART in HIV-positive women presenting late in pregnancy. Trial Registration Clinical Trial Number: NCT03249181
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    Open Access
    The development of an English Health-Related Quality of Life (HRQoL) measure for very young children, to be completed by proxy
    (2018) Verstraete, Janine; Jelsma, Jennifer; Ramma, Lebogang
    Background and Aims: There is an increasing awareness that, in order to monitor health outcomes both mortality and morbidity need to be assessed. A common metric used to measure morbidity and functional limitation is the quality adjusted life year or QALY, which incorporates time spent in a health condition and Health-Related Quality of Life (HRQoL) into the measure. This is of increasing importance in Low Income Countries (LIC) where programmes have been adopted and implemented to address the high burden of child mortality. The ‘first 1000 days’ is one such initiative which has been adopted by the WHO to improve nutritional support, health care and social support for both the mother and child. One of the aims is to improve quality of life during this vulnerable period. As there is currently no appropriate measure of HRQoL in this age group, we set out to develop a valid and reliable, HRQoL instrument for children from 1 month to 3 years old, amenable to the elicitation of preference weights. Methods: The new HRQoL instrument, HRQoL-6D-IT, was based firstly on a mapping review of HRQoL measures for children. The next stage involved eliciting options through cognitive review from caregivers of very young children regarding HRQoL dimensions included in the EQ-5D-Y an existing validated HRQoL measure for older children. The care-givers were requested to identify items to be considered for inclusion, the wording and layout of the new measure. The item pool generated from the literature reviews and cognitive interviews were then assessed through a Delphi study with experts in the field. These items were further reduced through subsequent testing of items and retesting of a preliminary measure. The final items on the HRQoL-6D-IT included: movement, play, pain, relationships, communication and eating and, apart from pain, the descriptors referenced the behaviour of the child to age appropriate behaviour. The HRQoL-6D-IT was then tested for validity and reliability in a group of acutely-ill (AI), chronically-ill (CI) and typically developing (TD) children in two provinces in South Africa: Western and Eastern Cape. Results: The methodology used to identify candidate items was rigorous and yielded items which were developed to be observable with dimension descriptors referring to ‘age appropriate behaviour’. Caregivers were able to reliably report on HRQoL of their very young children from age 1-36 months. The content validity had been established during the development of the instrument. Concurrent validity of the different items (dimensions) was tested between the HRQoL-6D-IT and relevant items from the ASQ, FLACC and NIPS pain scale and Diet History.
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    Open Access
    The use of the EQ-5D-Y health related quality of life outcome measure in children in the Western Cape, South Africa: psychometric properties, feasibility and usefulness - a longitudinal, analytical study
    (BioMed Central, 2017-01-19) Scott, Des; Ferguson, Gillian D; Jelsma, Jennifer
    Background: The EQ-5D-Y, an outcome measure of Health Related Quality of Life (HRQoL) in children, was developed by an international task team in 2010. The multinational feasibility, reliability and validity study which followed was undertaken with mainly healthy children. The aim of this study was to investigate the psychometric properties of the EQ-5D-Y when used to assess the HRQoL of children with different health states. Method: A sample of 224 children between eight and twelve years were grouped according to their health state. The groups included 52 acutely ill children, 67 children with either a chronic health condition or disability and 105 mostly healthy, mainstream school children as a comparator. They were assessed at baseline, at three months and at six months. An analysis of the psychometric properties was performed to assess the reliability, validity and responsiveness of the EQ-5D-Y in the different groups of children. Cohen’s kappa, the intraclass correlation coefficient, Pearson Chi-square, Kruskal-Wallis ANOVA and effect size of Wilcoxon Signed-rank test were used to determine the reliability, validity and responsiveness of the instrument. Results: The EQ-5D-Y dimensions were found to be reliable on test-retest (kappa varying from 0.365 to 0.653), except for the Usual Activities dimension (kappa 0.199). The Visual Analogue Scale (VAS) was also reliable (ICC = 0.77). Post-hoc analysis indicated that dimensions were able to discriminate between acutely ill and healthy children (all differences p < 0.001). The acutely ill children had the lowest ranked VAS (median 50, range 0–100), indicating worst HRQoL and was the only group significantly different from the other three groups (p < 0.001 in all cases). Convergent validity between all similar EQ-5D-Y and PedsQL, WeeFIM and Faces Pain Scale dimensions was only evident in the acutely ill children. As expected the largest treatment effect was also observed in these children (Wilcoxon Signed-rank test for VAS was 0.43). Six of the nine therapists who took part in the study, found the measure quick and easy to apply, used the information in the management of the child and would continue to use it in future. Conclusions: The EQ-5D-Y could be used with confidence as an outcome measure for acutely-ill children, but demonstrated poorer psychometric properties in children with no health condition or chronic conditions. It appears to be feasible and useful to include the EQ-5D-Y in routine assessments of children.
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    Open Access
    The use of the EQ-5D-Y health related quality of life outcome measure in children in the Western Cape, South Africa: psychometric properties, feasibility and usefulness - a longitudinal, analytical study
    (2017) Scott, Des; Ferguson, Gillian D; Jelsma, Jennifer
    Abstract Background The EQ-5D-Y, an outcome measure of Health Related Quality of Life (HRQoL) in children, was developed by an international task team in 2010. The multinational feasibility, reliability and validity study which followed was undertaken with mainly healthy children. The aim of this study was to investigate the psychometric properties of the EQ-5D-Y when used to assess the HRQoL of children with different health states. Method A sample of 224 children between eight and twelve years were grouped according to their health state. The groups included 52 acutely ill children, 67 children with either a chronic health condition or disability and 105 mostly healthy, mainstream school children as a comparator. They were assessed at baseline, at three months and at six months. An analysis of the psychometric properties was performed to assess the reliability, validity and responsiveness of the EQ-5D-Y in the different groups of children. Cohen’s kappa, the intraclass correlation coefficient, Pearson Chi-square, Kruskal-Wallis ANOVA and effect size of Wilcoxon Signed-rank test were used to determine the reliability, validity and responsiveness of the instrument. Results The EQ-5D-Y dimensions were found to be reliable on test-retest (kappa varying from 0.365 to 0.653), except for the Usual Activities dimension (kappa 0.199). The Visual Analogue Scale (VAS) was also reliable (ICC = 0.77). Post-hoc analysis indicated that dimensions were able to discriminate between acutely ill and healthy children (all differences p < 0.001). The acutely ill children had the lowest ranked VAS (median 50, range 0–100), indicating worst HRQoL and was the only group significantly different from the other three groups (p < 0.001 in all cases). Convergent validity between all similar EQ-5D-Y and PedsQL, WeeFIM and Faces Pain Scale dimensions was only evident in the acutely ill children. As expected the largest treatment effect was also observed in these children (Wilcoxon Signed-rank test for VAS was 0.43). Six of the nine therapists who took part in the study, found the measure quick and easy to apply, used the information in the management of the child and would continue to use it in future. Conclusions The EQ-5D-Y could be used with confidence as an outcome measure for acutely-ill children, but demonstrated poorer psychometric properties in children with no health condition or chronic conditions. It appears to be feasible and useful to include the EQ-5D-Y in routine assessments of children.
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    Open Access
    Valuing EQ-5D-Y: the current state of play
    (2022-07-06) Devlin, N; Pan, T; Kreimeier, S; Verstraete, J; Stolk, E; Rand, K; Herdman, M
    Background For nearly a decade, value sets for the EQ-5D-Y were not available, reflecting challenges in valuing child HRQoL. A methodological research programme led to publication of a valuation protocol in 2020, which was rapidly taken up by local study teams. By the end of 2022, between 11 and 17 EQ-5D-Y value sets will be available, more than for any other child HRQoL measure. It is timely to review the experience of those using the protocol to identify early learnings and remaining issues where more research is needed. Methods In June 2021, the EuroQol Group organised a three-day workshop, bringing together all those involved in EQ-5D-Y value set studies and related methodological research concerning EQ-5D-Y and valuation. Workshop discussions were captured by note taking and recording all sessions and online chat. A narrative summary of all sessions was produced and synthesised to identify points of agreement and aspects of methods where uncertainty remains. Results There was broad agreement that DCE is working well as the principal valuation method. However, the most appropriate means of anchoring the latent scale values produced by DCE remains unclear. Some studies have deviated from the protocol by extending the number of states included in TTO tasks, to better support modelling of DCE and TTO. There is ongoing discussion about the relative merits of alternative variants of TTO and other methods for anchoring. Very few studies have consulted with local end-users to gauge the acceptability of methods used to value EQ-5D-Y. Conclusions Priority areas for research include testing alternative methods for anchoring DCE data; exploring the preferences of adolescents; and scale differences in values for EQ-5D-Y and adult EQ-5D states, and implications of such differences for the use of EQ-5D-Y values in HTA. Given the normative elements of the protocol, engaging with HTA bodies and other local users should be the first step for all future value set studies. Value sets undertaken to date are for the three-level EQ-5D-Y. However, the issues discussed in this paper are equally relevant to valuation of the five-level version of EQ-5D-Y; indeed, similar challenges are encountered valuing any measure of child HRQoL.