Preference-based Health-related Quality Of Life Research Articles

Validation of China Health-Related Outcomes Measures-Cardiovascular Disease

ObjectivesChina Health-Related Outcomes Measures (CHROME) was an initiative aimed at developing a system of preference-based health-related quality of life instruments for China. CHROME-cardiovascular disease (CVD) is a CVD-specific instrument with 14 items developed under this initiative. This study aimed to test the psychometric properties of CHROME-CVD. MethodsThis validation study was conducted using cross-sectional questionnaire survey in China. Eligible patients with CVD were recruited and asked to complete the CHROME-CVD, the EQ-5D-5L, and a CVD-specific nonpreference-based health-related quality of life instrument selected according to the confirmed diagnosis of the patients. Item evaluation, internal consistency, measurement invariance, test-retest reliability, structural validity, and construct validity were tested using classic test theory. Item response theory was used to evaluate item-level performance. ResultsA total of 444 patients with CVD (coronary artery disease, n = 276, heart failure, n = 104, angina, n = 33, and atrial fibrillation, n = 16) from 6 provinces in China were enrolled for the validation. Exploratory factor analysis identified 4 factors: chest pain, other symptoms, physical health, and mental and social health. Cronbach’s alpha and intraclass correlation coefficient were >0.8. A total of 20 of 26 (76.9%), and 90 of 95 (94.7%) predefined hypotheses were met for convergent and discriminant validities, respectively. No important difference was identified between subgroups of gender and residency. Response options of 10 items were found overlapped based on categorical response curves, which led to modification to 4-level response options. Wording of 3 items were modified by referring wordings of reference instruments. ConclusionThe validation of the CHROME-CVD demonstrated generally good psychometric properties. Further validation on the modified CHROME-CVD is needed.

Health state utility and health-related quality of life measures in patients with advanced ovarian cancer

PurposeMeasuring health-related quality of life (HRQoL) in ovarian cancer patients is critical to understand the impact of disease and treatment. Preference-based HRQoL measures, called health state utilities, are used specifically in health economic evaluations. Real-world patient-reported data on HRQoL and health state utilities over the long-term course of ovarian cancer are limited. This study aims to determine HRQoL and health state utilities in different health states of ovarian cancer. MethodsThis cross-sectional, multicenter study included patients with stage III-IV ovarian cancer in six health states: at diagnosis, during chemotherapy, after cytoreductive surgery (CRS), after chemotherapy, in remission, and at first recurrence. HRQoL was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30, and the ovarian cancer-specific module OV28. Health state utilities were assessed using the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire. Descriptive analyses were performed for each health state. ResultsTwo hundred thirty-two patients participated, resulting in 319 questionnaires. Median age was 66 years. The lowest HRQoL was observed during chemotherapy and shortly after CRS. Physical and role functioning were most affected and the highest symptom prevalence was observed in the fatigue, nausea, pain, dyspnea, gastrointestinal, neuropathy, attitude, and sexuality domains. Patients in remission had the best HRQoL. Mean utility values ranged from 0.709 (±0.253) at diagnosis to 0.804 (±0.185) after chemotherapy. ConclusionsThis study provides clinicians with a valuable resource to aid in patient counseling and clinical decision-making. The utilities, in particular, are crucial for researchers conducting economic analyses to inform policy decisions.

The Quality of Life of Seniors with Eye Diseases during COVID-19

Purpose. To assess health-related quality of life (HRQoL), vision-related quality of life (VRQoL), depression and anxiety symptoms, and social support and community integration of seniors with eye diseases and to identify important predictor variables of the outcomes. Methods. A cross-sectional survey was performed in seniors with eye diseases (n = 90). Demographic characteristics and questionnaire scores were summarized. Linear regression analysis with backward stepwise selection was used to predict the value of the outcomes of eye disease. Results. Preference-based HRQoL of the study patients with eye diseases during the pandemic was likely good with a mean utility value of 0.88. VRQoL and sleep quality appeared to be good as well. Depression and anxiety symptoms appeared to be low, while community integration and social support were moderate. Furthermore, the presence of retinal disease, number of nonocular comorbidities, and education appeared to have significant negative effects on social support and community integration. The presence of retinal disease and the number of nonocular comorbidities both appeared to negatively impact VRQoL. The use of a mobility aid appeared to negatively affect depressive symptoms and sleep quality. Conclusions. Overall quality of life and wellness among seniors with eye diseases appeared to be good during the COVID-19 pandemic. However, the presence of retinal disease and the number of nonocular comorbidities both appeared to negatively impact VRQoL and social support and community integration. Education appeared to impact social support and community integration negatively. The use of a mobility aid appeared to negatively affect depressive symptoms and sleep quality.

Translation and Cultural Adaptation of Multi-Attribute Utility Instrument (MAUI) Indonesian Version of the 15D Questionnaire

Background: Diabetes mellitus is a chronic metabolic disorder that cannot be cured and progressively develop into a complication affecting the patient's health-related quality of life (HRQoL). The utility is a measure of preference-based HRQoL. Indirect utility measurements can be measured using the Multi-Attribute Utility Instrument (MAUI) instrument, one of which is the 15D questionnaire that has never been translated and adapted culturally in Indonesian. Objective: Translating and culturally adapting the 15D questionnaire to Indonesian diabetes mellitus patients. Methods: The translation process was carried out through the stages of forward translation, reconciliation, and backward translation involving two qualified translators and three experts in their field. The pilot test stage involved eight respondents consisting of 6 diabetes mellitus patients and two healthy individuals. Results: Problems in the linguistic validation process led to more conformity of word equivalents from the original to the target language. The agreement found was in the area of semantic equivalence, idiomatic equivalence, and experiential equivalence. The problem was resolved by reconciliation during the Focus Group Discussion, which translators and experts in their field attended and discussed with the original author to get equality of meaning in terms of language and culture. The Indonesian version of the 15D questionnaire tested on eight respondents showed results that were easy to understand and straightforward. Conclusion: The Indonesian version of the 15D questionnaire is valid from the linguistic and cultural adaptation stage. Further research is needed relating to the validation and reliability of the questionnaire.

China Health Related Outcomes Measures (CHROME): development of a descriptive system to support cardiovascular disease specific preference-based measure for the Chinese population.

Preference-based measures have been increasingly recommended to measure health outcomes for economic evaluation. However, none of existing cardiovascular disease (CVD)-specific health-related quality of life (HRQoL) instruments are preference-based. This study aimed to develop the descriptive system of preference-based HRQoL instrument for Chinese patients with CVDs under the Initiative of China Health Related Outcomes Measures (CHROME). Qualitative face-to-face interviews were conducted with Chinese patients with CVDs. Content analysis was employed to generate candidate items for the instrument. Then expert consultation and cognitive debriefing interviews were conducted to guide further selection and revision of the items. We interviewed 127 CVD patients with 67.7% being male and 63.8% living in the urban area. A hierarchical code book comprised of four themes, 20 categories, 62 sub-categories, and 207 codes, was developed. Candidate items were selected based on the criteria set by the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology and ISPOR PRO guidance. An online survey and meeting with an expert advisory panel (n = 15) followed by cognitive debriefing interviews with 20 patients and 13 physicians were conducted to further select and revise the candidate items. The descriptive system of CHROME-CVD consists of 14 items, namely frequency and severity of chest pain, chest tightness, palpitation, shortness of breath, dizziness, fatigue, appetite, sleeping, mobility, daily activities, depression, worry, and social relationship. Four or five level responses were selected based on cognitive debriefing results to each item. The current study developed the descriptive system (items and response options) of CHROME-CVD, the future CVD-specific preference-based HRQoL instrument for Chinese CVD patients.

Comparative evaluation of the health utilities index mark 3 and the short form 6D: evidence from an individual participant data meta-analysis of very preterm and very low birthweight adults

BackgroundThe most appropriate preference-based health-related quality of life (HRQoL) instruments for trials or research studies that ascertain the consequences of individuals born very preterm and/or low birthweight (VP/VLBW) are not known. Agreement between the HUI3 and SF-6D multi-attribute utility measures have not been previously investigated for VP/VLBW and normal birthweight or term-born controls. This study examined the agreement between the outputs of the HUI3 and SF-6D measures among adults born VP/VLBW and normal birthweight or term born controls.MethodsWe used two prospective cohorts of individuals born VP/VLBW and controls contributing to the ‘Research on European Children and Adults Born Preterm’ (RECAP) consortium which assessed HRQoL using two preference-based measures. The combined dataset of individual participant data (IPD) included 407 adult VP/VLBW survivors and 367 controls, ranging in age from 18 to 26 years. Bland–Altman plots, intra-class correlation coefficients, and generalized linear mixed models in a one-step approach were used to examine agreement between the measures.ResultsThere was significant discordance between the HUI3 and SF-6D multi-attribute utility measures in the VP/VLBW sample, controls, and in the combined samples. Agreement between the HUI3 and SF-6D multi-attribute utility measures was weaker in controls compared with VP/VLBW individuals.Conclusions and relevanceThe HUI3 and SF-6D each provide unique information on different aspects of health status across the groups. The HUI3 better captures preterm-related changes to HRQoL in adulthood compared to SF-6D. Studies focused on measuring physical or cognitive aspects of health will likely benefit from using the HUI3 instead of the SF-6D, regardless of gestational age at birth and birthweight status.

How do common conditions impact health-related quality of life for children? Providing guidance for validating pediatric preference-based measures

BackgroundThere is increasing interest in the validation of pediatric preference-based health-related quality of life measurement instruments. It is critical that children with various degrees of health-related quality of life (HRQoL) impact are included in validation studies. To inform patient sample selection for validation studies from a pragmatic perspective, this study explored HRQoL impairments between known-groups and HRQoL changes over time across 27 common chronic child health conditions and identified conditions with the largest impact on HRQoL.MethodsThe health dimensions of two common preference-based HRQoL measures, the EQ-5D-Y and CHU9D, were constructed using Pediatric Quality of Life Inventory items that overlap conceptually. Data was from the Longitudinal Study of Australian Children, a nationally representative sample with over 10,000 children at baseline. Seven waves of data were included for the analysis, with child age ranging from 2 to18 years. Impacts to specific health dimensions and overall HRQoL between those having a specific condition versus not were compared using linear mixed effects models. HRQoL changes over time were obtained by calculating the HRQoL differences between two consecutive time points, grouped by “Improved” and “Worsened” health status. Comparison among various health conditions and different age groups (2–4 years, 5–12 years and 13–18 years) were made.ResultsConditions with the largest statistically significant total HRQoL impairments of having a specific condition compared with not having the condition were recurrent chest pain, autism, epilepsy, anxiety/depression, irritable bowel, recurrent back pain, recurrent abdominal pain, and attention deficit hyperactivity disorder (ADHD) for the total sample (2–18 years). Conditions with largest HRQoL improvement over time were anxiety/depression, ADHD, autism, bone/joint/muscle problem, recurrent abdominal pain, recurrent pain in other part, frequent headache, diarrhea and day-wetting. The dimensions included in EQ-5D-Y and CHU9D can generally reflect HRQoL differences and changes. The HRQoL impacts to specific health dimensions differed by condition in the expected direction. The conditions with largest HRQoL impacts differed by age group.ConclusionsThe conditions with largest HRQoL impact were identified. This information is likely to be valuable for recruiting patient samples when validating pediatric preference-based HRQoL instruments pragmatically.

Global Mapping of Interventions to Improve Quality of Life of Patients with Cancer: A Protocol for Literature Mining and Meta-Analysis

Cancer led to nearly 10 million deaths in 2020, as reported by the World Health Organization (WHO). Consequently, both biomedical therapeutics and psychological interventions have been implemented to decrease the burden of this non-communicable disease. However, the research conducted so far has only described some aspects of these interventions, which may increase the health-related quality of life of cancer patients. Therefore, a systematic review is necessary to depict an overall picture of the cancer interventions globally. Then, the impact of these interventions on the preference-based health-related quality of life of cancer patients may be synthesized. The protocol is developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The Web of Science database is used to retrieve the literature using four keyword terms: quality of life (QoL), cancer, interventions, and health utility. Then, we draw the global mapping diagram and conduct the meta-analysis for this research. Additionally, longitudinal measurements are used to estimate the changes in the health utility of patients during the interventions. Thus, this systematic review can provide insight into the impact of interventions on increasing the health-related quality of life (HRQL) of cancer patients.

PP46 INEAS Guidelines For Pharmacoeconomic Evaluation: Focus On Health-Related Quality of Life Recommendations

IntroductionIn many low- and middle-income countries scarcity of local data on health outcomes and health-related quality of life (HRQoL) is a hindrance to conducting cost-effectiveness analyses. The Tunisian National Authority for Accreditation and Assessment in Healthcare (INEAS) developed a set of methodological guidelines to support pharmaceutical companies in the submission of health technology assessment (HTA) dossiers. The guidelines include INEAS’ methodological choices for pharmacoeconomic analysis, which take into consideration the specificities and constraints of the Tunisian context. We aimed to present the principal recommendations of the Tunisian guidelines for pharmacoeconomic studies, with a focus on patient-reported outcome and HRQoL measurement.MethodsThe INEAS pharmacoeconomic analysis guidelines were reviewed and the recommendations regarding outcome measurement and HRQoL were retrieved and reported.ResultsTo populate the economic model, INEAS recommends using the best available evidence. Health outcomes should be measured in terms of life-years gained and quality-adjusted life-years (QALYs); disability-adjusted life-years can be used but are not the preferred method. To estimate QALYs, INEAS favors the indirect measure of patient preferences with a validated measurement instrument. Alternatively, other measures of utility may be used, including those identified through a systematic review of the scientific literature and the publications of other HTA agencies. Justification and details of the source of the data must be provided. The utility values selected should be recent and representative of the Tunisian population, as far as possible. The guidelines refer to a set of generic preference-based HRQoL instruments, including the EuroQol five-dimensions (EQ5D), the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3), and the Short-Form Six-Dimension (SF-6D), but do not provide any explicit recommendations on their use.ConclusionsThe INEAS pharmacoeconomic analysis guidelines adhere to international best practices but provide more flexibility for overcoming the lack of local data. The INEAS economic guidelines constitutes a further milestone in the process of implementing HTA in Tunisia and in the Middle Eastern and African regions.

PMON260 Cost-Effectiveness of Testosterone Treatment for Men with Hypogonadism

Abstract Background Testosterone replacement therapy is the standard treatment for male hypogonadism (MH). Prescribing rates of testosterone in the UK have risen between 2001 and 2010 without an observable increase in the prevalence of hypogonadism, which may reflect increasing media awareness among men about hypogonadism. Currently, there is uncertainty about the safety and efficacy of testosterone treatment for MH, especially regarding its impact on cardiovascular risk, which has led to mandatory safety labelling in some countries. Aim We conducted an economic evaluation of testosterone therapy in men with hypogonadism, using individual patient data (IPD) of safety and efficacy outcomes in over 3000 participants as part of an international collaboration of investigators of 17 existing placebo-controlled RCTs assessing the safety and efficacy of testosterone treatment for MH (TestES Consortium). Methods A cost-utility analysis of the use of testosterone treatment for MH was conducted using a cohort Markov model developed following best practice. The model care pathway was informed by existing clinical guidelines, the results of the TestES Consortium individual patient data (IPD) meta-analysis, and discussions with clinical and methodological experts. Five Markov states were included: no complications, post-Cardiac pathology, post-Peripheral Vascular System Pathology, post-Cerebrovascular System Pathology, and Death. All-cause mortality, cardiovascular and cerebrovascular complications, and utility weights were obtained from the TestES IPD analyses. The UK NHS and personal and social services perspective was adopted for costs. Ten-year and lifetime time horizons were considered with costs and effects discounted annually at 3.5% rate. The model was run probabilistically using 10,000 Monte Carlo simulations. Three starting ages were defined (40, 60, and 75 years). Mean total cost, mean QALYs and incremental cost-effectiveness ratios were calculated. Results Cost-effectiveness of testosterone treatment appears to be dependent on the relative risk (RR) of all-cause mortality - favouring TRT - and the methods used to derive health state utility scores (i.e., SF-6D or a mapping between Beck Depression Inventory -BDI- score and EQ-5D score) for testosterone treatment versus standard care. When the RR of mortality and the BDI utilities were used, ICERs remained below the £20,000 ($27,400) UK conventional threshold, irrespective of the cohort starting age. However, ICERs increased above the £20,000 threshold when the difference in all-cause mortality was dropped, and the SF-6D utility scores were used. Conclusions We report the most in-depth economic analysis of male hypogonadism treatment to date. There remains limited data for generating preference-based health-related quality of life (HRQoL) weights for economic evaluation. Further clarity on the long-term cardiovascular safety of testosterone treatment in men with hypogonadism, and more in-depth mapping of clinical outcomes to generic preference-based measures of HRQoL will be crucial to inform robust estimates of the cost-effectiveness of testosterone treatment for MH. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.

Comparing the psychometric properties of EQ-5D-3L and EQ-5D-5L proxy ratings by informal caregivers and a health professional for people with dementia

BackgroundAssessing health-related quality of life (HRQoL) among persons with dementia poses several challenges due to cognitive decline and limited perception. As a result, proxy ratings by family members or health professionals are used. The EQ-5D is the most commonly used generic and preference-based HRQoL instrument. Methodological drawbacks of the three-level version (EQ-5D-3L) prompted the development of the five-level version (EQ-5D-5L) by expanding the range in the domains. However, no comparison of the psychometric properties of both versions and different proxy ratings exist so far. Therefore, the objective of this study was to compare the psychometric properties of the EQ-5D-5L and EQ-5D-3L by application of different proxy ratings in dementia.MethodsThe EQ-5D-3L and -5L were completed by n = 52 family caregivers and one care manager at baseline and three and six months later. In total, 106 caregiver and 133 care manager proxy ratings were completed. The EQ-5D-3L and 5L were evaluated in terms of acceptability (missing values), agreement, ceiling effects, redistribution properties and inconsistency, and informativity (Shannon, H', and Shannon Evenness, J', indices) as well as convergent and discriminative validity.ResultsMean proxy index scores were higher for the 5L than the 3L. Missing values occurred less frequently in both proxy ratings and versions (< 1%). Agreement between both measures was high but higher in caregiver than care-manager ratings (ICC 0.885 vs. 0.840). The relative ceiling effect decreased from the 3L to the 5L, more intensively in the care-manager (75%) than the caregiver rating (56%). Inconsistency between both versions was low. Informativity increased from the 3L to the 5L version, nearly equally in both proxy ratings. The 5L also demonstrated a better discriminative ability and convergent validity than the 3L, especially in the caregiver rating.ConclusionCompared to the EQ-5D-3L, the EQ-5D-5L had higher feasibility and acceptability and was slightly superior by a reduction of ceiling effects and an improvement in informativity, discriminative ability and convergent validity. Proxy ratings by informal caregivers overall demonstrated better psychometric properties than professional care-manager ratings.

Psychometric properties of the PROMIS Preference score (PROPr) in patients with rheumatological and psychosomatic conditions

BackgroundThe PROMIS Preference score (PROPr) is a new generic preference-based health-related quality of life (HRQoL) score that can be used as a health state utility (HSU) score for quality-adjusted life years (QALYs) in cost-utility analyses (CUAs). It is the first HSU score based on item response theory (IRT) and has demonstrated favorable psychometric properties in first analyses. The PROPr combines the seven PROMIS domains: cognition, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. It was developed based on preferences of the US general population. The aim of this study was to validate the PROPr in a German inpatient sample and to compare it to the EQ-5D.MethodsWe collected PROPr and EQ-5D-5L data from 141 patients undergoing inpatient treatment in the rheumatology and psychosomatic departments. We evaluated the criterion and convergent validity, and ceiling and floor effects of the PROPr and compared those characteristics to those of the EQ-5D.ResultsThe mean PROPr (0.26, 95% CI: 0.23; 0.29) and the mean EQ-5D (0.44, 95% CI: 0.38; 0.51) scores differed significantly (d = 0.18, p < 0.001). Compared to the EQ-5D, the PROPr scores were less scattered across the measurement range which has resulted in smaller confidence intervals of the mean scores. The Pearson correlation coefficient between the two scores was r = 0.72 (p < 0.001). Both scores showed fair agreement with an Intraclass Correlation Coefficient (ICC) of 0.48 (p < 0.05). The PROPr and EQ-5D demonstrated similar discrimination power across sex, age, and conditions. While the PROPr showed a floor effect, the EQ-5D showed a ceiling effect.ConclusionThe PROPr measures HSU considerably lower than the EQ-5D as a result of different construction, anchors and measurement ranges. Because QALYs derived with the EQ-5D are widely considered state-of-the-art, application of the PROPr for QALY measurements would be problematic.

Feasibility, reliability and validity of the health-related quality of life instrument Child Health Utility 9D (CHU9D) among school-aged children and adolescents in Sweden

BackgroundThis study was conducted in a general population of schoolchildren in Sweden, with the aim to assess the psychometric properties of a generic preference-based health related quality of life (HRQoL) instrument, the Swedish Child Health Utility 9D (CHU9D), among schoolchildren aged 7–15 years, and in subgroups aged 7–9, 10–12 and 13–15 years.MethodsIn total, 486 school aged children, aged 7–15 years, completed a questionnaire including the CHU9D, the Pediatric quality of life inventory 4.0 (PedsQL), KIDSCREEN-10, questions on general health, long-term illness, and sociodemographic characteristics. Psychometric testing was undertaken of feasibility, internal consistency reliability, test–retest reliability, construct validity, factorial validity, concurrent validity, convergent validity and divergent validity.ResultsThe CHU9D evidenced very few missing values, minimal ceiling, and no floor effects. The instrument achieved satisfactory internal consistency (Cronbach’s Alfa > 0.7) and strong test–retest reliability (r > 0.6). Confirmatory factor analyses supported the proposed one-factor structure of the CHU9D. For child algorithm, RMSEA = 0.05, CFI = 0.95, TLI = 0.94, and SRMR = 0.04. For adult algorithm RMSEA = 0.04, CFI = 0.96, TLI = 0.95, and SRMR = 0.04. The CHU9D utility value correlated moderately or strongly with KIDSCREEN-10 and PedsQL total scores (r > 0.5–0.7). The CHU9D discriminated as anticipated on health and on three of five sociodemographic characteristics (sex, age, and custody arrangement, but not socioeconomic status and ethnic origin).ConclusionsThis study provides evidence that the Swedish CHU9D is a feasible, reliable and valid measure of preference-based HRQoL in children. The study furthermore suggests that the CHU9D is appropriate for use among children 7–15 years of age in the general population, as well as among subgroups aged 7– 9, 10–12 and 13–15 years.

Health state utility values by cancer stage: a systematic literature review

ObjectivesCancer diagnoses at later stages are associated with a decrease in health-related quality of life (HRQOL). Health state utility values (HSUVs) reflect preference-based HRQOL and can vary based on cancer type, stage, treatment, and disease progression. Detecting and treating cancer at earlier stages may lead to improved HRQOL, which is important for value assessments. We describe published HSUVs by cancer type and stage.MethodsA systematic review was conducted using Embase, MEDLINE®, EconLit, and gray literature to identify studies published from January 1999 to September 2019 that reported HSUVs by cancer type and stage. Disutility values were calculated from differences in reported HSUVs across cancer stages.ResultsFrom 13,872 publications, 27 were eligible for evidence synthesis. The most frequent cancer types were breast (n = 9), lung (n = 5), colorectal (n = 4), and cervical cancer (n = 3). Mean HSUVs decreased with increased cancer stage, with consistently lower values seen in stage IV or later-stage cancer across studies (e.g., − 0.74, − 0.44, and − 0.51 for breast, colorectal, and cervical cancer, respectively). Disutility values were highest between later-stage (metastatic or stage IV) cancers compared to earlier-stage (localized or stage I–III) cancers.ConclusionsThis study provides a summary of HSUVs across different cancer types and stages that can inform economic evaluations. Despite the large variation in HSUVs overall, a consistent decline in HSUVs can be seen in the later stages, including stage IV. These findings indicate substantial impairment on individuals’ quality of life and suggest value in early detection and intervention.

Modifying the quality-adjusted life year calculation to account for meaningful change in health-related quality of life: insights from a pragmatic clinical trial.

We propose a modified quality-adjusted life year (QALY) calculation that aims to be consistent with guidance for interpreting change in patient-reported outcomes. This calculation incorporates the minimally important difference (MID) in generic preference-based health-related quality of life (HRQL) change scores to reflect what might be considered meaningful HRQL improvement/deterioration. In doing so, we review common issues in QALY calculations such as adjustment for baseline scores and standardizing for between-group differences. Using EQ-5D-5L outcome data from the Alberta TEAMCare-Primary Care Network trial in the management of depression for patients with type 2 diabetes (n = 98), this study compared results from different QALY calculation methods to investigate the impact of (i) adjusting for baseline HRQL score, (ii) standardizing between-group differences at baseline, and (iii) adjusting for 'meaningful' HRQL changes. The following QALY calculation methods are examined: area under curve (QALY-AUC), change from baseline (QALY-CFB), regression modelling (QALY-R), and incorporating an MID for HRQL changes from baseline (QALY-MID). The incremental QALY-AUC estimate favoured the Collaborative Care group (0.031) while the incremental QALY-CFB (-0.028) estimate favoured Enhanced Care. Adjusting for meaningful HRQL changes resulted in a crude incremental QALY-MID of -0.023; however, after adjusting for between-group differences at baseline, QALY-R and adjusted incremental QALY-MID estimates were -0.007 and -0.001, respectively. In addition, recursive regression analyses showed that very low baseline HRQL scores impact incremental QALY estimates. Uncertainty in incremental QALY estimates reflects uncertainty in the value of small within-individual change as well as the impact of small differences between groups at baseline. Applying a responder-definition approach yielded crude and adjusted QALY-MID estimates that were more in favour of Collaborative Care than QALY-CFB and QALY-R estimates, respectively, suggesting that ambiguous small changes in HRQL scores have the potential to influence QALY outcomes used in economic or non-economic applications.

PIH33 How Do Different Health Conditions IMPACT Dimensions of Pediatric Preference-Based Health-Related Quality of Life Measures?

The Child Health Utility instrument (CHU9D) and EQ-5D-Y are popular pediatric preference-based health-related quality of life (HRQOL) measures. This study aimed to investigate how health conditions influence dimensions of these measures by age and across time using Pediatric Quality of Life Inventory (PedsQL) data.

Burden and preference-based quality of life associated with bullying in children.

The objectives of this study are to assess the association between childhood bullying and preference-based health-related quality of life (QoL) in Australian school children and their parents and estimate quality-adjusted life years (QALYs) associated with bullying chronicity. Children aged 8-10years completed the child health utilities (CHU-9D), while parents completed the Australian quality of life (AQoL-8D). Children were grouped into four categories of bullying involvement (no bullying, victim, perpetrator, or both perpetrator and victim) based on the Revised Olweus Bully/Victim Questionnaire. Parental data were compared across two bullying involvement groups (bullying vs. no bullying). QALYs were calculated for children over two years and comparisons made based on the number of assessments where bullying was reported(baseline, 1- and 2-year follow up). Children who were involved in bullying (victims and/or perpetrators) reported statistically significantly lower mean utility scores compared to children who were not involved in bullying. Parents whose child was involved in bullying had significantly lower mean utility scores compared to parents of children not involved with bullying. There appeared to be a dose-response relationship, with higher QALY losses associated with increasing frequency of reported bullying. Bullying among Australian school children was associated with significantly lower preference-based QoL for themselves and their parents. This study also confirmed the significant burden of disease for bullying among children measured by an incremental decrease in QALY with an increasing chronicity of bullying over time.

A Systematic Literature Review of Preference-Based Health-Related Quality-of-Life Measures Applied and Validated for Use in Childhood and Adolescent Populations in Sub-Saharan Africa

ObjectivesConsideration of health status in children and adolescents now includes broader concepts such as health-related quality-of-life (HRQoL). Globally, there is a need for relevant preference-based HRQoL measures (PBMs) for use in children and adolescents, yet measurement of HRQoL in these groups presents particular challenges. This article systematically reviews the available generic childhood PBMs and their application and cross-cultural validation in sub-Saharan African (sSA). MethodsA systematic review of published literature from January 1, 1990, to February 8, 2017, was conducted using MEDLINE (through OvidSP), EMBASE (OvidSP), EconLit (EBSCOhost), PsycINFO, Web of Science, and PubMed. ResultsA total of 220 full-text articles were included in a qualitative synthesis. Ten generic childhood PBMs were identified, of which 9 were adapted from adult versions and only 1 was developed specifically for children. None of the measures were originally developed in sSA or other resource-constrained settings. The Health Utilities Index Mark 3 (HUI3) and the EQ-5D-Y were the only measures that had been applied in sSA settings. Further, the HUI3 and the EQ-5D-Y were the only generic childhood PBM that attempted to establish cross-cultural validation in sSA. Five of the 6 of these validation studies were conducted using the EQ-5D-Y in a single country, South Africa. ConclusionsThe findings show that application of generic childhood PBMs in sSA settings has hitherto been limited to the HUI3 and EQ-5D-Y. Most adaptations of existing measures take an absolutist approach, which assumes that measures can be used across cultures. Nevertheless, there is also need to ensure linguistic and conceptual equivalence and undertake validation across a range of sSA cultural contexts.

Empirical Validity of a Generic, Preference-Based Capability Wellbeing Instrument (ICECAP-A) in the Context of Spinal Cord Injury.

Assessing the validity of generic instruments across different clinical contexts is an important area of methodological research in economic evaluation and outcomes measurement. Our objective was to examine the empirical validity of a generic, preference-based capability wellbeing instrument (ICECAP-A) in the context of spinal cord injury. This study consisted of a secondary analysis of data collected using an online cross-sectional survey. The survey included questions regarding demographics, injury classifications and characteristics, secondary health conditions, quality of life and wellbeing, and functioning in activities of daily living. Analysis comprised thedescriptive assessment of Spearman's rank correlations between item-/dimension-level data for the ICECAP-A and four preference-based health-related quality of life (HRQoL) instruments, and discriminant and convergent validity approaches to examine 21 evidence-informed or theoretically derived constructs. Constructs were defined using participant and injury characteristics and responses to a range of health, wellbeing and functioning outcomes. Three hundred sixty-fourindividuals completed the survey. Mean index score for the ICECAP-A was 0.761; 12 (3%) individuals reported full capability (upper anchor; score = 1), and there were no reports of zero capabilities (lower anchor; score = 0). The strongest correlations were dominated by items and dimensions on the comparator (HRQoL) instruments that are non-health aspects of quality of life, such as happiness and control over one's life (including self-care). Of 21 hypothesised constructs, 19 were confirmed in statistical tests, the exceptions being the exploratory hypotheses regarding education and age at injury. The ICECAP-A is an empirically valid outcome measure for assessing capability wellbeing in people with spinal cord injury living in a community setting. The extent to which the ICECAP-A provides complementary information to preference-based HRQoL instruments is dependent on the comparator.

The relationship between preference-based health-related quality of life and lifestyle behavior: a cross-sectional study on a community sample of adults who had undergone a health check-up

BackgroundPreference-based Health-Related Quality of Life (HRQL) is one of the most important indicators for calculating QALY (Quality-Adjusted Life Years) in a cost-effectiveness analysis. This study aimed to collect data on healthy individuals’ HRQL based on the preferences of Japanese people who had undergone a comprehensive health check-up, and to examine the influence of relevant factors, such as blood biochemical data and lifestyle behavior.MethodsWe conducted a cross-sectional study targeting people who had undergone a comprehensive health check-up in 2015. Participants were asked to respond to a medical interview sheet. We then examined the utility value, as well as lifestyle habits such as alcohol intake, smoking, and exercise. HRQL was examined using EQ-5D-5L. Using a multiple regression analysis, we examined the influence of related factors, such as lifestyle and biochemical test data.ResultsWe collected 2037 responses (mean age = 54.98 years; 55.0% female). The average preference-based health-related HRQL was 0.936 ± 0.087. A total of 1167 people (57.2%) responded that they were completely healthy. The biochemical test data that were recognized to correlate with HRQL were hemoglobin, total cholesterol, creatinine, all of which were weak (r = − 0.045–0.113). The results of multiple regression analysis showed that significant facts were: being female, age (≧70 year-old), drinking alcohol (sometimes), activity (very often), and lack of sleep.ConclusionsThe HRQL of participants who had undergone a comprehensive health check-up was generally high, and only declined for those over 70 years of age. It is suggested that preference-based HRQL is related to physical activity, and that decrease of activity and lack of sleep leads to a decrease in HRQL.