Generic Measure Of Health-related Quality Research Articles

Estimating an EQ-5D-Y-3L Value Set for Brazil.

The EQ-5D-Y-3L is a generic measure of health-related quality of life in children and adolescents. Although the Brazilian-Portuguese EQ-5D-Y-3L version is available, there is no value set for it, hampering its use in economic evaluations. This study aimed to elicit a Brazilian EQ-5D-Y-3L value set based on preferences of the general adult population. Two independent samples of adults participated in an online discrete choice experiment (DCE) survey and a composite time trade-off (cTTO) face-to-face interview. The framing was "considering your views for a 10-year-old child". DCE data were analyzed using a mixed-logit model. The 243 DCE predicted values were mapped into the observed 28 cTTO values using linear and non-linear mapping approaches with and without intercept. Mapping approaches' performance was assessed to estimate the most valid method to rescale DCE predicted values using the model fit (R2), Akaike Information Criteria (AIC), root mean squared error (RMSE), and mean absolute error (MAE). A representative sample of 1376 Brazilian adults participated (DCE, 1152; cTTO, 211). The linear mapping without intercept (R2 = 96%; AIC, - 44; RMSE, 0.0803; MAE, - 0.0479) outperformed the non-linear without intercept (R2 = 98%; AIC, - 63; RMSE, 0.1385; MAE, - 0.1320). Utilities ranged from 1 (full health) to - 0.0059 (the worst health state). Highest weights were assigned to having pain or discomfort (pain/discomfort), followed by walking about (mobility), looking after myself (self-care), doing usual activities (usual activities), and feeling worried, sad, or unhappy (anxiety/depression). This study elicited the Brazilian EQ-5D-Y-3L value set using a mixed-logit DCE model with a power parameter based on a linear mapping without intercept, which can be used to estimate the quality-adjusted life-years for economic evaluations of health technologies targeting the Brazilian youth population.

Reliability and validity of the PROMIS-29 health profile in Ankylosing Spondylitis patients: A cross-sectional study.

The Patient-Reported Outcomes Measurement Information System 29-Item Health Profile (PROMIS-29) is a generic measure of health-related quality of life that is not well-studied in Ankylosing Spondylitis (AS) patients. Our objective was to investigate the reliability and validity of the PROMIS-29 in AS. About 169 consecutive AS patients were enrolled from 2017 to 2022 with 167/169 patients fully completing the PROMIS-29 in this cross-sectional study. Test-retest reliability and internal consistency was assessed using intraclass correlation coefficients (ICC) and Cronbach alpha, respectively. We studied structural validity with confirmatory factor analysis (CFA) of our hypothesized and general population models. We evaluated model fit by Chi-squared goodness-of-fit-test (χ2), comparative fit index, and root mean square error of approximation. A χ2 test was used to compare nested models. PROMIS-29 convergent validity was studied by Spearman correlation coefficients with AS-legacy measures. PROMIS-29 domains showed good test-retest reliability (intraclass correlation coefficients (ICC) > 0.7) and excellent internal consistency with Cronbach alpha > 0.9 in all subscales. CFA of only the general population model met our model fit cutoffs (χ2 goodness-of-fit P-value of 0.21, comparative fit index of 0.99, and root mean square error of approximation of 0.05). Furthermore, a nested χ2 test was not significantly different between our hypothesized (full) and general (reduced) model [χ2 (1) = 0.754, P > .38]. AS legacy measures showed a strong correlation (rho > |0.7|) with the extracted physical health factor. The PROMIS-29 demonstrated good reliability and construct validity in AS patients with the general population model. Further study is required to determine its clinical and research utility in AS patients.

Societal Utilities for Cognitive Impairment in Schizophrenia: Developing a Preference-Based Scoring Algorithm Based on the Schizophrenia Cognition Rating Scale.

Loss of cognitive function is a common feature in schizophrenia. However, generic measures of health-related quality of life favored by decision-makers, such as the EQ-5D, are not designed to detect changes in cognitive function. We report the valuation of the Schizophrenia Cognition Rating Scale (SCoRS), a schizophrenia-specific measure of cognitive impairment. Expert opinion and psychometric analysis of the SCoRS from clinical trial data was undertaken to select 5 key items from the measure. These items were combined orthogonally to develop health-state vignettes. Vignettes were valued using composite time trade-off (cTTO) in one-on-one video calls. Several econometric models were fitted to the data to estimate disutilities. Performance of EQ-5D- and SCoRS-based utilities were compared in the trial data. The SCoRS items selected for the valuation study represented attention, learning, processing speed, social cognition and memory. Four hundred respondents participated in the valuation study. The best observed health state was valued at 0.855 [standard deviation (SD)=0.179] and the worst at 0.152 (SD=0.575). At the most severe levels, 'social cognition' received the largest disutility followed by 'learning' and 'memory'. The final model to estimate utilities had 15 parameters. SCoRS-based utilities were sensitive to change in cognition, but the EQ-5D was not. It is feasible to value different dimensions of cognition separately using a validated instrument for proxy assessment. The resulting utilities indicate loss of quality of life due to reduced cognitive functioning.

Measuring Quality of Life in Residential Aged Care Using the EQ-5D-5L: A Cross-Sectional Study on the Impact of Cognition Level and Proxy Perspective on Interrater Agreement

Quality of life (QoL) is an important outcome in aged care, but self-report is not always possible due to the high prevalence of cognitive impairment in older aged care residents. This study aims to assess the impact of family member proxy perspective (proxy-proxy or proxy-person) on interrater agreement with resident self-report by different cognition levels. The influence of proxy perspective and cognition level is a significant gap in the extant literature which this study seeks to address. A cross-sectional study was undertaken with residents classified into cognition subgroups according to the Mini Mental State Examination. Residents completed the self-report EQ-5D-5L, a well-established generic measure of health-related quality of life (HRQoL). Family member proxies completed EQ-5D-5L proxy version 1 (proxy-proxy perspective, where the proxy responds based on their own opinions) and proxy version 2 (proxy-person perspective, where the proxy responds as they believe the person would). Interrater agreement was assessed using the concordance correlation coefficient (CCC) for utility scores and the weighted kappa for dimension-level responses. Sixty-three residents (n = 22 no cognitive impairment, n = 27 mild impairment, and n = 14 moderate impairment) and proxies participated. EQ-5D-5L utility scores were lower for proxies compared with residents (self-report = 0.522, proxy-proxy = 0.299, and proxy-person = 0.408). Interrater agreement with self-report was higher for proxy-person (CCC = 0.691) than for proxy-proxy (CCC = 0.609). Agreement at the dimension level was higher for more easily observable dimensions, such as mobility, compared to less observable dimensions, such as anxiety/depression. Resident self-reported and proxy family member-reported HRQoL assessments, using the EQ-5D-5L, are different but may be more closely aligned when the proxy is specifically guided to respond from the person’s perspective. Further research is needed to address the impact of divergences in self-report and proxy-report ratings of HRQoL for quality assessment and economic evaluation in aged care.

Reliability and validity of using EQ-5D-5L among healthy and adolescents with major mental health disorders in Ethiopia.

The EQ-5D is a validated and widely used generic measure of health-related quality of life (HRQoL) in both healthy individuals and those with various medical conditions. The objective of this study was to test whether EQ-5D-5L is reliable and valid for use among school sample adolescents and those with major mental health disorders in Ethiopia. Participants were recruited fromten sub-districts comprising the Butajira Rural Health Programme (BRHP) and Butajira major mental health disorders center. Data were collected using an Amharic(Ethiopia) EQ-5D-5L self-complete-paper and the questionnaire was administered 10days after the first completion for test-retest procedures. Two-way mixed-effects models absolute intraclass correlation coefficient (ICC) was used to test reliability of the instrument while Kruskal-Wallis rank test with pairwise comparison was used to assess the known group validity of the instrument. There were 501 (201 school sample and 300 adolescents with major mental health disorders) participants recruited and 497 were included in the sample for analysis. The ICC was high (ICC > 0.7, p < 0.001) for all EQ-5D-5L dimensions, EQ-5D-5L utility index and EQ-VAS scores. The findings revealed that the Amharic EQ-5D-5L has significant known group validity as shown by the difference in scores among various disease group (depression, schizophrenia, and bipolar) and experience of chronic illness. The results shows that the Amharic EQ-5D-5L is reliable and valid instrument for the measurement of HRQoL among adolescent populations in Ethiopia.

An Exploration on Attribute Non-attendance Using Discrete Choice Experiment Data from the Irish EQ-5D-5L National Valuation Study

BackgroundGeneric measures of health-related quality of life (HRQoL) permit comparisons of competing demands for healthcare resources using outcomes that reflect the preferences of tax payers. EQ-5D instruments are the most commonly used generic, preference-based measures of HRQoL. The EQ-5D-5L enables respondents to describe their health state using five dimensions of health, each with five response levels. The standardised protocol for the valuation of EQ-5D-5L health states comprises use of the composite time trade-off valuation technique, supplemented by a discrete choice experiment (DCE).ObjectiveThis paper presents the first exploration on attribute non-attendance (ANA) to the dimensions of the EQ-5D-5L using DCE data collected following the standardised protocol.MethodThis paper uses the equality constrained latent class model and the endogenous attribute attendance model to examine ANA to the dimensions of the EQ-5D-5L.ResultsThe results suggest that respondents are less likely to consider the physical dimensions of the EQ-5D-5L (such as self-care and usual activities) when evaluating the health states. The effects of ANA on utility scores depends on the interpretation of the underlying reasons for ANA.ConclusionsWe recommend that future value sets based in whole or in part on DCE data examine the impact of and reasons for non-attendance in national valuation studies.

A qualitative study exploring content validity and feasibility of frequently used generic health-related quality of life measures in older people with hip fracture: The patients’ perspective

ObjectiveTo evaluate hip fracture patients´ views on content validity and feasibility of four commonly used generic measures of health-related quality of life (HRQOL). MethodsWe interviewed 32 elderly hip fracture patients without relevant cognitive impairment (mean age=81 years). Using think-aloud and verbal probing techniques, patients completed the EQ-5D descriptive system, Nottingham Health Profile (NHP), Short-Form 12 Health Questionnaire (SF-12) and WHO Quality of Life-BREF (WHOQOL-BREF). ResultsPatients were mostly not able to self-complete the questionnaires. Content validity was most constrained by problems in comprehensibility (e.g. vaguely phrased). Some items, for instance, were considered irrelevant if the example was inappropriate. Patients named e.g. problems with vision as important for their HRQOL, but none of the instruments included related items. ConclusionAlthough patients reported problems with all instruments, we suggest the EQ-5D or SF-12, as these appear to have the fewest limitations in content validity and feasibility from the patient´s perspective.

Improved RIDIT statistic approach provides more intuitive and informative interpretation of EQ-5D data

BackgroundEQ-5D is generic measure of health-related quality of life. Studies using EQ-5D generate ordinal data that are interpreted as categories ordered by severity. New analytic approaches taking into account the ordinal nature of the health dimension severity and leading to a better interpretation of EQ-5D data are needed to better elucidate differences in health-related quality of life. We propose utilizing the Improved RIDIT statistical method to analyze EQ-5D outcomes.Methods556 Moroccan participants aged over 18 years representing four chronic diseases: back pain (n = 158), renal insufficiency (n = 56), diabetes (n = 82) or hypertension (n = 80) and healthy subjects (n = 180). All participants received the two EQ-5D versions. Two other published data sets were included. The first was extracted from a diabetic Spain study and the second was extracted from a clinical trial study. The Improved RIDIT analyses were carried out using an R statistic program we developed.ResultsApplying the Improved RIDIT on the EQ-5D data allowed estimating for the first time the ordinal odds, the Absolute Risk Reduction (ARR) or the Absolute Risk Increase (ARI) and the Number Needed to Treat. The ARI values estimated for Moroccan patients showed that (i) hypertension increased anxiety/depression by 66% and reduced mobility by 65%; (ii) back pain increased pain/discomfort by 69%; (iii) renal insufficiency impacts mobility (ARI = 57%, oddsordinal = 9.95) and usual activities (ARI = 44%, oddsordinal = 6.41) and (iv) diabetes acts only on anxiety/depression (ARI = 50%, oddsordinal = 4.8). Also, we demonstrated that the approach works well in clinical trials.ConclusionsImproved RIDIT provides more intuitive and informative interpretation of the EQ-5D data by (1) taking into account the level severity; estimating (2) the odds ordinal, (3) the ARR/ARI and the NNT; (4) analyzing the five dimensions of the EQ-5D separately, which gives clinical teams more precision in understanding the treatment/pathology impacts on the health status and completes the EQ-5D data analysis based on score utilities.

Increased risk of mortality and readmission associated with lower SF-12 scores in cardiac patients: Results from the national DenHeart study.

The SF-12v2 health survey (SF-12) is widely used as a generic measure of health-related quality of life. However, interpretation of score differences can be difficult. To estimate benchmarks for interpretation of score differences on the SF-12 for readmission and all-cause mortality in cardiac patients. Data from the DenHeart study, a national cross-sectional survey including one year follow-up register data, were used. Patients with ischaemic heart disease, arrhythmia, heart failure and heart valve disease answered the survey at hospital discharge. Cox proportional hazards models were used to regress readmission and all-cause mortality. A total of 10,813 cardiac patients completed the SF-12. For patients with ischaemic heart disease and arrhythmia, a one point lower physical component summary score was associated with a 2% increase in risk in readmission (hazard ratio (HR) 1.022 (95% confidence interval 1.017;1.027) and HR 1.024 (1.018; 1.029), respectively) and a 3% increase in risk for patients with heart failure (HR 1.027 (1.015; 1.038)). A one point lower mental component summary score was associated with a 2% increase in the risk of readmission (HR 1.017 (1.013; 1.022)) across diagnoses. For both the physical and mental component summary score, a one point lower score meant a 5% increase in the risk of all-cause mortality (HR 1.046 (1.031; 1.060) and HR 1.046 (1.029; 1.065), respectively) across diagnoses. In a large group of cardiac patients, a one point lower physical or mental component summary score was associated with an up to 3% increased risk of readmission and a 5% increased risk of mortality in the first year after discharge.

Screening for health-related quality of life in children and adolescents: Optimal cut points for the KIDSCREEN-10 for epidemiological studies.

Generic measures of health-related quality of life are important in pediatrics. Here, we try to establish optimal cut points for the self-report and parental-report versions of the KIDSCREEN-10. We re-analyzed data from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) study. In total, data from 2566 children, 2136 younger adolescents, and 2740 older adolescents were used. The KIDSCREEN-10 was contrasted to three different anchors: the strength and difficulties questionnaire, self-rated general health, and chronic diseases. A kernel-based method and bootstrapping were used to determine the optimal cut points and their variability. We found large differences in HRQoL between children with vs. without mental health problems but there is only medium-to-small differences in HRQoL between children with vs. without chronic diseases and children with self-rated good vs. poor physical health. Acceptable levels of classification accuracy were found in relation to mental health problems for all versions (AUCs between 0.77 and 0.79), but only for the parental-report version in relation to general health and for no version in relation to chronic diseases. Cut points identified as optimal differed systematically between parental-report versions (cut point = 41.13) and self-report for younger (cut point = 42.52) and older adolescents (cut point = 40.29). The results aid the interpretation of KIDSCREEN-10 in epidemiological studies. Specifically, we suggest a cut point of 41 should be used to interpret the parental-report version of the KIDSCREEN and 40 and 42, respectively, for young and older adolescents.

Discriminative validity of the EQ-5D-5\u2009L and SF-12 in older adults with arthritis

BackgroundThe EQ-5D-5 L and the SF-12 are the most commonly used generic measures of health-related quality of life among people with arthritis. However, there is little evidence on the extent to which the individual dimensions and domains of these instruments perform among this population. The objective was to examine the discriminative validity of the EQ-5D-5 L and the SF-12 version 2 (and SF-6D) in capturing the burden of arthritis on health-related quality of life in older adults.MethodsCross-sectional data from the Alberta Retired Teachers Association survey were used. A known-groups approach, with a-priori hypotheses, was used to examine the discriminative validity of the domain and summary scores of the EQ-5D-5 L and the SF-12 version 2 (and SF-6D). Groups were defined based on self-reported of arthritis, chronic pain level, presence and number of comorbidities, and self-reported health status.ResultsMean age of respondents (N = 2844) was 68.6 (standard deviation [SD] 5.9) years; 54.8% were female, with mean body mass index (BMI) of 27.2 kg/m2 (SD 4.8), and 36.6% reported having arthritis. The overall mean EQ-5D-5 L index score was 0.86 (SD 0.11) and that of SF-6D was 0.79 (SD 0.13). Participants with arthritis had lower EQ-5D-5 L index score (0.83, SD 0.13) and SF-6D index score (0.75, SD 0.13) compared to those without arthritis (0.88, SD 0.09 and 0.81, SD 0.12, respectively). EQ-5D-5 L and SF-6D index scores demonstrated moderate discriminative validity with a moderate effect size (0.5). Related dimensions and domains between the EQ-5D-5 L and SF-12 (e.g., mobility with physical functioning score, pain/discomfort with bodily pain and anxiety/depression with mental health) were moderately to strongly correlated (r = 0.6–0.7). Both instruments could not adequately discriminate between participants with moderate and severe chronic pain of 6-month duration.ConclusionOverall, the EQ-5D-5 L pain/discomfort and mobility dimensions, and the SF-12 bodily pain scale had moderate discriminative ability among older adults with arthritis. However, both instruments had limited discriminative ability for chronic pain. The importance and nature of chronic pain assessment in a given application need to be considered when choosing any of these instruments for measuring health-related quality of life in this patient population.

The EQ-5D-5L Is Superior to the -3L Version in Measuring Health-related Quality of Life in Patients Awaiting THA or TKA

As a generic measure of health-related quality of life among patients awaiting THA or TKA, the three-level version of the EQ-5D (EQ-5D-3L), which has three response levels of severity (no problems, some problems, and extreme problems/unable) to five questions, is widely used. Previous studies indicated that the ceiling effect of the EQ-5D-3L limits its application. The five-level version of the EQ-5D (EQ-5D-5L) was developed to enhance the measurement properties of the tool by adding two levels: slight problems and severe problems. However, only a few small studies have compared the EQ-5D-3L and EQ-5D-5L in patients awaiting THA and TKA. The purpose of this study was to examine the performance of the EQ-5D-3L and EQ-5D-5L among patients awaiting THA or TKA in terms of (1) response patterns, (2) convergent construct validity, (3) known-group validity, and (4) informativity and discriminatory power. This is a retrospective analysis of the Alberta Bone and Joint Health Data Repository, which recorded information on all patients receiving hip or knee arthroplasties between April 2010 and March 2017 in Alberta, Canada (n = 37,377). Patients receiving THA or TKA and who completed the EQ-5D and WOMAC at baseline (presurgery) were included in this study (n = 24,766). The EQ-5D-3L was administered to all patients in 2010, and was gradually replaced by the EQ-5D-5L between 2013 and 2016; the EQ-5D-5L reached full application in all clinics by 2017.A propensity score was used to match patients 1:1 who completed either the EQ-5D-3L or EQ-5D-5L before surgery. Response patterns have been explored using ceiling and floor effects and distribution across severity levels of each dimension. Convergent construct validity was examined using Spearman's correlation (rho) against the WOMAC. Known-group validity was examined by gender, preoperative risk factors, mental health, obesity, and WOMAC physical function score. Informativity and discriminatory power were examined using the Shannon (H') and Shannon evenness (J') indices. A total of 3446 pairs of patients awaiting THA (55% women; mean age, 66 years) and 5428 pairs of patients awaiting TKA (59% women; mean age 67 years) were included in this analysis; the study group included all patients who were kept in the propensity score matching. Ceiling and floor effects were comparable and small (less than 0.5%) for both versions; the responses across severity levels for each dimension were more evenly distributed for the EQ-5D-5L. Convergent construct validity was stronger for the EQ-5D-5L as it consistently had stronger correlations with the WOMAC overall and domain scores than the EQ-5D-3L (rho(3L-THA), -0.77 to -0.31; rho(3L-TKA), -0.71 to -0.24; rho(5L-THA), -0.71 to -0.17; rho(5L-TKA), -0.64 to -0.17; all p values < 0.001). The hypotheses of known-group analyses were confirmed for both versions. The EQ-5D-5L demonstrated stronger informativity and discriminatory power than the EQ-5D-3L, particularly for the mobility dimension (THA, H'(5L/3L)=1.66/0.37, J'(5L/3L)=0.72/0.23; TKA, H'(5L/3L)=1.66/0.41, J'(5L/3L)=0.71/0.26). This study demonstrates the superior construct validity, and informativity and discriminatory power of the EQ-5D-5L compared with the EQ-5D-3L among patients awaiting THA or TKA. Compared with the three-level version, the five-level version of the EQ-5D differentiates between patients awaiting THA and TKA much better based on their mobility, which is a key health aspect or outcome in these patients. Our findings suggest that the EQ-5D-5L is more appropriate for this population.

English translation and validation of the Zurich chronic middle ear inventory (ZCMEI-21-E) assessing quality of life in chronic otitis media: A prospective international multicentre study.

To translate and validate the Zurich Chronic Middle Ear Inventory (ZCMEI-21) for the English language in order to provide an English instrument to assess health-related quality of life in chronic otitis media (COM). Pilot translation study including cognitive debriefings, prospective multicentre cross-sectional psychometric validation study. Four tertiary referral centres in three different English-speaking countries (UK, USA and Australia). Adult patients suffering from COM. The English translation of the ZCMEI-21 (ZCMEI-21-E) and the five-level version of the EQ-5D questionnaire. The EQ-5D, which constitutes a generic measure of health-related quality of life, consists of a descriptive system score and a visual analogue scale. Statistical outcomes included single-item descriptive statistics, internal consistency (Cronbach's α) as an indicator of reliability, as well as construct validity. A total of 124 patients suffering from COM were included. The mean age was 50.1years (SD 16.9years), and 72 (58.1%) were males. The Cronbach's α of the ZCMEI-21-E was 0.91, suggesting an excellent internal consistency. The Spearman's correlation coefficient of the ZCMEI-21-E total score was 0.55 (P<0.0001) for convergent construct validity with EQ-5D descriptive system score and 0.57 (P<0.0001) with the EQ-5D visual analogue scale. The ZCMEI-21-E is a new validated questionnaire that provides clinicians with a short, comprehensive and reliable instrument to quantify health-related quality of life in patients suffering from COM. The ZCMEI-21-E may be of use in clinical routine as well as in outcome research and monitoring.

PMU89 - EUROPEAN UNION 5 (EU5) NORMS FOR THE 3-LEVEL EQ-5D (EQ-5D-3L) QUESTIONNAIRE

. The EQ-5D is a generic measure of health-related quality of life that is widely applied for health economic and non-economic purposes. Population norms can be used to facilitate the interpretation of EQ-5D data. The objective of this study was to develop normative 3-level EQ-5D (EQ-5D-3L) values for the European Union 5 (EU5) countries. . EQ-5D-3L index values based on the time trade-off (TTO) were available for all EU5 countries (France, Germany, Italy, Spain, and United Kingdom) (n=21,425). Country-specific data sets were aggregated and weighted equally to facilitate the derivation of norms for gender and age groups. Sensitivity analyses included weighting by population and economy size. Norms were also calculated using the European visual analog scale-based value set (EurVAS). . Pooled mean (SD) TTO values for males/females were 0.969 (0.119)/0.962 (0.117) for ages 18-24; 0.965 (0.100)/0.955 (0.128) for ages 25-34; 0.942 (0.180)/0.935 (0.191) for ages 35-44; 0.931 (0.174)/0.918 (0.184) for ages 45-54; 0.895 (0.211)/0.874 (0.221) for ages 55-64; 0.901 (0.179)/0.838 (0.244) for ages 65-74; and 0.827 (0.246)/0.750 (0.299) for ages 75 and older. Mean values decreased and variance increased with age; females had slightly lower mean values than males across all age bands. The unequal weighting approaches produced similar point estimates with smaller variances. The means derived using these approaches most closely reflected values for Germany, which has a larger population and economy than other EU5 countries. Mean values for the EurVAS were slightly lower than those for the TTO-based index, though a similar pattern of means across demographic strata was observed. . Normative EQ-5D-3L values can be used to benchmark the outcomes of treated patients against the health of the general population. EU5 norms may be useful in research applications inferring to the EU as a whole, particularly when sample size precludes analysis at the country level.

The burden of amyloid light chain amyloidosis on health-related quality of life

BackgroundLight chain (AL) amyloidosis is a rare disease characterized by misfolded amyloid protein deposits in tissues and vital organs, and little is known about the burden of AL amyloidosis on health-related quality of life. This study aimed to quantify the burden of AL amyloidosis in terms of health-related quality of life in a diverse, community-based sample of AL amyloidosis patients.ResultsThe SF-36v2® Health Survey (SF-36v2), a widely used generic measure of health-related quality of life (using physical and mental summary scales and subscales assessing eight aspects of functioning and well-being), was administered as an online survey of AL amyloidosis patients with AL amyloidosis (ClinicalTrials.gov, NCT02574676; n = 341). Compared with adjusted general population sample norms, health-related quality of life of AL amyloidosis patients was significantly worse across all SF-36v2 scales and summary measures based on analysis of variance (p < 0.05 for all). The largest decrement in AL amyloidosis patients was related to General Health (Δ = 9.7; p < 0.001). With the exception of Bodily Pain and Mental Health, differences were also clinically meaningful based on established clinically minimal important differences. The burden of AL amyloidosis overall and in key subgroups tended to be greater on physical health than on mental health. Stratified analyses indicated additional burden among patients with recently diagnosed disease and those with cardiac involvement than among their respective counterparts.ConclusionUnderstanding the burden of AL amyloidosis highlights the unmet need for treatment, helps physicians identify ancillary treatments and services geared towards improving patients’ functioning, well-being, and overall health-related quality of life. These findings also help to support the use of health-related quality of life end points as important outcome measures in current and future treatment studies.Trial registrationClinicalTrials.gov, NCT02574676. Registered October 5, 2015.

Development of the Teen Oral Health-Related Quality of Life Instrument.

The aim of this study was to develop the Teen Oral Health-Related Quality of Life instrument (TOQOL) and demonstrate its validity and reliability in a diverse sample of 13-18-year-old adolescents. A total of 363 adolescents aged 13-18 years participated in this cross sectional study. Oral screening examinations were conducted to collect oral health status data. Adolescents completed the TOQOL and a generic measure of health-related quality of life, the PedsQL. The psychometric properties of the TOQOL were evaluated in terms of face, content, convergent, concurrent and discriminant validity in addition to internal reliability. The 16-item TOQOL covers five domains: Physical functioning, Role functioning, Social functioning, Oral problems, and Emotional functioning. The total scale and subscales showed satisfactory reliability with Cronbach alpha ranging from 0.75 to 0.92. TOQOL scores showed significant associations with perceived oral health status and the PedsQL (convergent validity) and discriminated well between adolescents with caries and adolescents who were caries free (discriminate validity). The TOQOL is a valid and reliable oral health-related quality of life measurement that can be recommended for self-report in adolescents aged 13-18 years.

An educational review of the statistical issues in analysing utility data for cost-utility analysis.

The aim of cost-utility analysis is to support decision making in healthcare by providing a standardised mechanism for comparing resource use and health outcomes across programmes of work. The focus of this paper is the denominator of the cost-utility analysis, specifically the methodology and statistical challenges associated with calculating QALYs from patient-level data collected as part of a trial. We provide a brief description of the most common questionnaire used to calculate patient level utility scores, the EQ-5D, followed by a discussion of other ways to calculate patient level utility scores alongside a trial including other generic measures of health-related quality of life and condition- and population-specific questionnaires. Detail is provided on how to calculate the mean QALYs per patient, including discounting, adjusting for baseline differences in utility scores and a discussion of the implications of different methods for handling missing data. The methods are demonstrated using data from a trial. As the methods chosen can systematically change the results of the analysis, it is important that standardised methods such as patient-level analysis are adhered to as best as possible. Regardless, researchers need to ensure that they are sufficiently transparent about the methods they use so as to provide the best possible information to aid in healthcare decision making.

The Quality of Life Scale for Children (QoL-C)

Purpose – There is a lack of valid and reliable generic measures of Health-Related Quality of Life (HRQoL) for children under eight. The purpose of this paper is to assess the psychometric properties of the newly formulated Quality of Life Scale for Children (QoL-C), which uses a pictorial response format. Design/methodology/approach – In total, 335 primary school children completed the QoL-C on two occasions, two weeks apart. Children aged four to seven were interviewed one-to-one while children aged eight to nine completed the measure as a class activity. Test-re-test reliability, convergent validity and child-parent concordance were assessed. Findings – Only one child refused to complete the QoL-C, which suggests the measure is user-friendly. Test-re-test reliability was moderate for the measure's total score (intraclass correlation coefficient =0.48, 95 percent CI 0.39, 0.57) but low to fair for individual items (K from 0.13 to 0.37). Internal consistency was moderate (α=0.42 time one, 0.53 time two). A small significant correlation was found between the QoL-C and Child Health Meter in the expected direction (r=−0.32), suggesting convergent validity. There was low concordance between the children's QoL-C responses and parent's responses (r=0.19) to a parallel measure. Research limitations/implications – The results suggest that further development of this measure is needed. However, the findings indicate that one-to-one support increases the reliability of very young children's responses. The use of pictures, emoticons and minimal text used in the QoL-C should be investigated further. Originality/value – Low parent-child concordance underscores the importance of younger children getting the opportunity to share their views about their HRQoL.

Post-thrombotic syndrome is an independent determinant of health-related quality of life following both first proximal and distal deep vein thrombosis

Post-thrombotic syndrome (PTS) is a common complication of deep vein thrombosis (DVT), affecting between 20 and 50%.[1][1] DVT and PTS have been demonstrated to adversely impact on disease-specific and generic measures of health-related quality of life (QOL).[2][2],[3][3] We sought to establish

Comparison of howRU and EQ-5D measures of health-related quality of life in an outpatient clinic

This paper reports on a head-to-head study of howRU and EQ-5D on patients with cardiovascular disease. howRU is a short generic measure of health-related quality of life comprising 39 words, designed for routine use, which we compare with EQ-5D (230 words). Patients attending a clinic completed both instruments. Completed data were available for 116 patients, 51% female, mean age 56 and SD 20. howRU is shorter, has better readability statistics, a higher completion rate, a wider range of states used and a smaller ceiling effect than EQ-5D. The correlations of howRU with EQ-5D are similar to those of EQ-5D with other validated instruments.