Browsing by Author "Verstraete, Janine"
Now showing 1 - 8 of 8
Results Per Page
Sort Options
- ItemOpen AccessClinical and Experimental Determination of Protection Afforded by BCG Vaccination against Infection with Non-Tuberculous Mycobacteria: A Role in Cystic Fibrosis?(Multidisciplinary Digital Publishing Institute, 2023-08-01) Warner, Sherridan; Blaxland, Anneliese; Counoupas, Claudio; Verstraete, Janine; Zampoli, Marco; Marais, Ben J.; Fitzgerald, Dominic A.; Robinson, Paul D.; Triccas, James A.Mycobacterium abscessus is a nontuberculous mycobacterium (NTM) of particular concern in individuals with obstructive lung diseases such as cystic fibrosis (CF). Treatment requires multiple drugs and is characterised by high rates of relapse; thus, new strategies to limit infection are urgently required. This study sought to determine how Bacille Calmette-Guérin (BCG) vaccination may impact NTM infection, using a murine model of Mycobacterium abscessus infection and observational data from a non-BCG vaccinated CF cohort in Sydney, Australia and a BCG-vaccinated CF cohort in Cape Town, South Africa. In mice, BCG vaccination induced multifunctional antigen-specific CD up sup T cells circulating in the blood and was protective against dissemination of bacteria to the spleen. Prior infection with M. abscessus afforded the highest level of protection against M. abscessus challenge in the lung, and immunity was characterised by a greater frequency of pulmonary cytokine-secreting CD4 T cells compared to BCG vaccination. In the clinical CF cohorts, the overall rates of NTM sampling during a three-year period were equivalent; however, rates of NTM colonisation were significantly lower in the BCG-vaccinated (Cape Town) cohort, which was most apparent for M. abscessus. This study provides evidence that routine BCG vaccination may reduce M. abscessus colonisation in individuals with CF, which correlates with the ability of BCG to induce multifunctional CD4T cells recognising M. abscessus in a murine model. Further research is needed to determine the optimal strategies for limiting NTM infections in individuals with CF.
- ItemOpen AccessHow 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, JenniferBackground 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.
- ItemOpen AccessInfluence of the child’s perceived general health on the primary caregiver’s health status(BioMed Central, 2018-01-10) Verstraete, Janine; Ramma, Lebogang; Jelsma, JenniferBackground: 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.
- ItemOpen AccessItem generation for a proxy health related quality of life measure in very young children(2020-01-14) Verstraete, Janine; Ramma, Lebogang; Jelsma, JenniferAbstract 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.
- ItemOpen AccessPerformance of the EQ-5D-Y Interviewer Administered Version in Young Children(Multidisciplinary Digital Publishing Institute, 2022-01-10) Amien, Razia; Scott, Desiree; Verstraete, Janine(1) Background: An estimated 78% of South African children aged 9–10 years have not mastered basic reading, therefore potentially excluding them from self-reporting on health-related outcome measures. Thus, the aim of this study was to compare the performance of the EQ-5D-Y-3L self-complete to the newly developed interviewer-administered version in children 8–10 years. (2) Methods: Children (n = 207) with chronic respiratory illnesses, functional disabilities, orthopaedic conditions and from the general population completed the EQ-5D-Y-3L self-complete and interviewer-administered versions, Moods and Feelings Questionnaire (MFQ) and Faces Pain Scale-Revised (FPS-R). A functional independence measure (WeeFIM) was completed by the researcher. (3) Results: The 8-year-olds had significantly higher missing responses (x2 = 14.23, p < 0.001) on the self-complete version. Known-group and concurrent validity were comparable across dimensions, utility and VAS scores for the two versions. The dimensions showed low to moderate convergent validity with similar items on the MFQ, FPS-R and WeeFIM with significantly higher correlations between the interviewer-administered dimensions of Mobility and WeeFIM mobility total (z = 1.91, p = 0.028) and Looking After Myself and WeeFIM self-care total (z = 3.24, p = 0.001). Children preferred the interviewer-administered version (60%) (x2 = 21.87, p < 0.001) with 22% of the reasons attributed to literacy level. (4) Conclusions: The EQ-5D-Y-3L interviewer-administered version is valid and reliable in children aged 8–10 years. The results were comparable to the self-complete version indicating that versions can be used interchangeably.
- ItemOpen AccessPerformance of the EQ-5D-Y Interviewer Administered Version in young children(2022) Amien, Razia; Verstraete, Janine; Scott, DesireeIntroduction The interest in Health-Related Quality of Life (HRQoL) in the paediatric population has grown over the last decade as it allows for a more holistic approach which has the potential to positively influence treatment outcomes (1–4). With an increase in interest, the need for alternative modes of administration of HRQoL instruments has become more important to allow for self-report in younger age-groups. Despite their age and/or literacy levels, their ability to understand the concept of HRQoL would allow for accurate self-report if the correct instrument is used (5). Proxy-report is used often as a default in these younger age-groups as only two interviewer-administered instruments are currently available (6,7), neither of which have been validated for African populations. The newly developed EQ-5D-Y-3L Interviewer Administered (IA) instrument would allow for self-report in younger paediatric populations, therefore limiting the reliance on proxy-report which does not account for the subjectivity of HRQoL or allow for the inclusion of the child's view (2,8–10). Aim The first aim of this study was to determine the performance and preference of the EQ-5D-Y-3L-IA and self-complete (SC), in children aged 8-10-years. The second aim was to determine the psychometric performance of the EQ-5D-Y-3L-IA version in children aged 5-7-years compared to those aged 8-10- years. Methods A cross-sectional, descriptive observational, analytical design was used. Children were recruited in two age-groups, 5-7-years (n=177, 46%) and 8-10-years (n=211, 54%). Participants were drawn from the General Population (GenPop) attending a Mainstream School (n=109, 28%), Special Schools for learners with special educational needs (n=55, 14%) and healthcare facilities caring for children with orthopaedic conditions (n=161, 41%) or chronic respiratory illnesses (n=63, 16%). All children completed the EQ-5D-Y-3L-IA, Faces Pain Scale-Revised (FPS-R), Moods and Feelings Questionnaire (MFQ). The researcher completed the observational Functional Independence Measure (WeeFIM). In addition, children in the 8-10-year group completed the EQ-5D-Y-3L-SC. Dimension responses of the EQ-5D-Y-3L-IA and SC were analysed for floor and ceiling effects, inconsistent responses, missing responses and differences in health states between age-groups and versions. Differences in reporting were determined by chi-square statistic (x2 ). Known-group validity across age (years), sex and health conditions were analysed using Spearman's rank order coefficients (rs) in addition to the median utility and Visual Analogue Scale (VAS) scores using Kruskal Wallis and Mann-Whitney U-test. Pearson's correlation was used to assess concurrent validity by comparing the utility and VAS scores between versions. Spearman's Rank Correlation was computed to assess the convergent validity of the EQ-5DY-3L-IA and SC compared to the FPS-R, MFQ and WeeFIM. Responses from structured cognitive debriefing interviews were grouped and coded by the researcher according to similar responses provided by participants. Cognitive debriefing was used to determine the acceptability, comprehensibility and where applicable, participants' preference between versions and the reasons for their preference. The researcher was aware of reflexivity and did not allow personal opinions to impact on participants' responses, nor the grouping and coding of responses. The EQ-5D-Y-3L-IA was retested 48 hours later only in children with a stable health condition, recruited from schools and analysed using weighted Cohen's kappa statistic (k) for dimension scores and the Intraclass Correlation Coefficient (ICC) for utility and VAS scores. Results There were no concerning differences in EQ-5D-Y-3L dimension responses, known-group validity, concurrent validity or correlation of VAS and utility scores between the IA and SC versions. The IA version had the advantage of no missing values and was preferred over the SC version by 8-10-yearolds (60%). When comparing the IA version between age-groups, the performance was similar. However, children aged 5-7-years reported significantly more problems with the Looking After Myself dimension (x2 =31.021; p<. 0001) by which cognitive debriefing revealed developmental difficulty with advanced dressing tasks such as laces and buttons. Conclusion Validity and test-retest reliability of the EQ-5D-Y-3L-IA version was successfully assessed in children aged 5-10-years. As the results were comparable to the SC version in children aged 8-10-years, it therefore indicates that versions can be used interchangeably. In settings with low literacy levels, such as South Africa, the IA version is recommended for young children, most notably those 8-years of age. The performance of the IA version across age-groups showed that younger children can reliably report on their HRQoL therefore also proved useful in younger age-groups, however, adaptations to the dimension of Looking after myself is suggested for improved developmental appropriateness. Therefore, it is recommended that EQ-5D-Y-3L-IA be included in children from 5-years in routine clinical practice and clinical trials.
- ItemOpen AccessPerformance of the Toddler and Infant (TANDI) Health-Related Quality of Life Instrument in 3–4-Year-Old Children(2021-10-15) Verstraete, Janine; Lloyd, Andrew J; Jelsma, JenniferThe Toddler and Infant (TANDI) dimensions of Health-Related Quality of Life assess ‘age appropriate’ behaviour and measurement could be extended to older children. A sample of 203 children 3–4 years of age was recruited, and their caregivers completed the TANDI, Pediatric Quality of Life Inventory (PedsQL) and EQ-5D-Y Proxy. Spearman and Pearson’s correlation coefficients, and Kruskal–Wallis H-test were used to explore the feasibility, known-group validity, discriminate validity and concurrent validity of the TANDI. Children with a health condition (n = 142) had a lower ceiling effect (p = 0.010) and more unique health profiles (p < 0.001) than the healthy group (n = 61). The TANDI discriminated between those with and without a health condition. In children with a health condition, the TANDI discriminated between clinician rated severity of the health condition. The TANDI had moderate to strong correlations with similar PedsQL and EQ-5D-Y items and scores. The TANDI is valid for children aged 3–4 years and is recommended for children with a health condition, whereas the PedsQL may be better for healthy children. The TANDI is recommended for studies with young children whereas the EQ-5D-Y Proxy is recommended for a sample including older children or for longitudinal studies with preschoolers. Further work on the TANDI is recommended to establish test-retest reliability and responsiveness.
- ItemOpen AccessThe 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, LebogangBackground 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.