Preference-based measures of health-related quality of life in Indigenous people: a systematic review.

PURPOSE: In many countries, there are calls to address health inequalities experienced by Indigenous people. Preference-based measures (PBMs) provide a measurement of health-related quality of life and can support resource allocation decisions. This review aimed to identify, summarize, and appraise the literature reporting the use and performance of PBMs with Indigenous people. METHODS: Eleven major databases were searched from inception to August 31, 2022. Records in English that (1) assessed any measurement property of PBMs, (2) directly elicited health preferences, (3) reported the development or translation of PBMs for Indigenous people, or (4) measured health-related quality of life (HRQL) using PBMs were included. Ethically engaged research with Indigenous people was considered as an element of methodological quality. Data was synthesized descriptively (PROSPERO ID: CRD42020205239). RESULTS: Of 3139 records identified, 81 were eligible, describing psychometric evaluation (n = 4), preference elicitation (n = 4), development (n = 4), translation (n = 2), and HRQL measurement (n = 71). 31 reported ethically engaged research. Reports originated primarily from Australia (n = 38), New Zealand (n = 20), USA (n = 9) and Canada (n = 6). Nearly all (n = 73) reported indirect, multi-attribute PBMs, the most common of which was the EQ-5D (n = 50). CONCLUSION: A large number of recent publications from diverse disciplines report the use of PBMs with Indigenous people, despite little evidence on measurement properties in these populations. Understanding the measurement properties of PBMs with Indigenous people is important to better understand how these measures might, or might not, be used in policy and resource decisions affecting Indigenous people. (Funding: EuroQoL Research Foundation).

The use of EQ-5D-5L as a patient-reported outcome measure in evaluating community rehabilitation services in Alberta, Canada.

BACKGROUND: The purpose of this study was to describe the characteristics and health-related quality of life (HRQL) of patients accessing community rehabilitation services in Alberta, Canada, using routinely collected EQ-5D-5L data, and explore factors associated with the impact of these services. METHODS: A retrospective, longitudinal, observational design was used. Patients completed the EQ-5D-5L and demographic questions at intake and end of rehabilitation care. Change in EQ-5D-5L dimensions from intake until end of rehabilitation was examined using the Pareto Classification of Health Change. Change scores were calculated for the EQ-5D-5L index, VAS, and total sum scores. Change groups in the EQ-5D-5L index and VAS scores, were defined by minimally important differences of 0.04 and 7.0, respectively. One level change was considered important for the total sum score. Effect size of the change in index, VAS, and total sum scores was also examined. Chi-squared tests were conducted to examine whether change in EQ-5D-5L varied by age, gender, region, and having anxiety/depression at intake. RESULTS: Three service programs were examined; pulmonary rehabilitation (n = 542), group-based community exercise (n = 463), and physiotherapy for bone and joint care (n = 391). At intake, HRQL in all programs was lower than that of the general Alberta population norms and improved by end of rehabilitation. The mean (SD) change in index, VAS, and total sum scores were 0.02 (0.13), 6.0 (18.3), and - 0.5 (2.4) in pulmonary rehabilitation, 0.06 (0.13), 6.6 (18.7), - 1.2 (2.4) in community exercise, and 0.13 (0.16), 1.2 (0.9), and - 2.8 (2.8) in physiotherapy, respectively. Based on change of the index score, 24% deteriorated, 38% improved, and 38% had no change in pulmonary rehabilitation; 17% deteriorated, 51% improved, and 32% had no change in community exercise; 5% deteriorated, 72% improved, and 23% had no change in physiotherapy. Similar trends were seen in the VAS and total sum scores. Older age, urban region, and having anxiety/depression at intake were associated with positive change in EQ-5D-5L. CONCLUSIONS: The results of this study are intended to inform program/service level decisions by describing the characteristics and HRQL of patients accessing community rehabilitation, as well as the predictors of change in health status, which will help direct future program growth and service changes.

Self-reported health-related quality of life of the general population in Alberta, Canada during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has impacted various aspects of people's life and wellbeing around the world. This study aimed to examine the impact of the COVID-19 pandemic on health-related quality of life (HRQL), measured by the EQ-5D-5L, amongst the general population in the province of Alberta, Canada, and explore whether the impact varied across population subgroups based on age, gender, and dwelling. METHODS: Data came from two waves of a repeated cross-sectional population-based survey, the COVID-19 Experiences and Impact Survey, administered by the Health Quality Council of Alberta. The first data collection (survey 1: n = 8790) was during May/June 2020 and the second (survey 2: n = 9263) during Oct 2020. We examined the comparability of weighted survey data and their representativeness to Alberta's general population. We then explored between-survey differences in EQ-5D-5L index, EQ-VAS and dimension responses, and differences across subgroups within each survey. We compared HRQL of the pooled sample (survey 1&2) with the Alberta population norms data from the pre-pandemic period. RESULTS: Mean EQ-5D-5L index and EQ-VAS scores were 0.81 (0.15) and 72.54 (18.57), and 0.82 (0.14) and 71.98 (18.96) in surveys 1 and 2, respectively. The anxiety/depression dimension had the most reported problems (survey 1: 69.5%, survey 2: 70.2%). Respondents aged 16-24 or 75 and older, who identified themselves as a woman, or residing in urban areas had significantly lower EQ-5D-5L index scores compared to their counterparts in both surveys. Between-survey differences were not substantially different. Comparing the pooled sample with the pre-pandemic Alberta population norms, EQ-5D-5L index scores (0.82 vs. 0.84) and EQ-VAS scores (72.26 vs. 77.40) were significantly lower, and respondents aged 16-44, women, or urban residents were more impacted. More problems were reported in the anxiety/depression (69.9% vs. 37.2%) and usual activities dimensions (40.5% vs. 26.0%) during the pandemic period, especially for respondents aged 16-44, women, and those residing in urban areas. CONCLUSIONS: Lower HRQL was reported during the COVID-19 pandemic compared to pre-pandemic HRQL in this population, with anxiety/depression and usual activities affected the most. People who were younger, women, and residing in urban areas were most impacted. The government responses to COVID-19 policies during population outbreaks should consider the needs of Albertans in these particular groups.

Comparative performance of the EuroQol EQ-5D-5L and the CDC healthy days measures in assessing population health.

OBJECTIVES: To examine the comparative performance of EuroQol EQ-5D-5L and Center for Disease Control Healthy Days measures in assessing population health. METHODS: Using data from 2014 Alberta Community Health Survey, a cross-sectional population-based survey (N = 7559), conducted in Alberta, Canada, we examined construct validity of the measures as indicators of population health. Differences in EQ-5D-5L index score, visual analogue scale (EQ-VAS), and CDC unhealthy days index across socio-demographic subgroups were tested by Mann-Whitney and Kruskal-Wallis tests using known-groups approach. RESULTS: EQ-5D-5L and CDC Healthy Days provided comparable assessments of population health in this sample. Both measures discriminated between subgroups defined by self-perceived health status, level of education, and material deprivation. The discriminative ability of CDC Healthy Days was limited in capturing variability in health among age groups compared to the EQ-5D-5L. Among participants who reported 0 unhealthy days, the proportion of those with level 3 problems in pain/discomfort varied from 1.1% for participants aged 18-24 to 19.2% for those over 75 years. CONCLUSIONS: EQ-5D-5L demonstrated better construct validity than CDC Healthy Days in assessing health in a population-based sample of adults.

Determinants of Health Preferences Using Data from the Egyptian EQ-5D-5L Valuation Study.

OBJECTIVE: The aim of this study was to explore the impact of sociodemographic characteristics and illness experience on time trade-off (TTO)-based utility scores using data from the EQ-5D-5L Egyptian valuation study. METHODS: Data were from the Egyptian valuation study that was conducted using the adapted translated version of the EQ-VT to develop the Egyptian Tariff for the EQ-5D-5L based on preferences of the Egyptian population. Data were analysed using a series of univariate and multivariable censored linear regression models adjusted for severity of health states where the dependent variable was the TTO scores and the independent variables included age, sex, education, geographical region, dwelling, marital status, number of people in the household, employment status, having health insurance, number of chronic conditions, previous experience with illness, and self-rated health. RESULTS: Age, sex, education, marital status, dwelling, region of residence, health insurance and multimorbidity were significantly associated with health state valuations, while employment status, number of people in a household, religion, and previous experience with illness had non-significant associations. CONCLUSION: Age, sex and marital status are the main determinants of health state valuation in the Egyptian population, a finding consistent with those from other countries. Knowing these factors will help tailor health services provided and improve patient-centered care.

A Pilot Study of Valuation Methods of the EQ-5D and the Impact of Literacy, Cultural, and Religious Factors on Preferences.

OBJECTIVES: This study aimed to examine the feasibility of the 3-level-EQ-5D valuation methods and the impact of literacy, culture, and religion on the preferences of the Pakistani population. METHODS: Respondents aged 18 to 65 years were recruited using quota sampling. The EuroQol Portable Valuation Technology was used, and data collection was done in Urdu. Graphical presentations were used to elicit responses from illiterate respondents. All interviews were audio recorded and transcribed. Odds ratios associated with the choice impact were assessed. RESULTS: Usual activities showed highest impact on respondents' choice outcomes, followed by self-care and then anxiety/depression and mobility. Compared with "no problem," any problems in mobility had higher odds for a respondent to not to choose otherwise. The impact of health impairment on usual activities imposed the highest influences choices made. Most of the respondents reported that religion had no impact on their responses. Compared with literate respondents, illiterate respondents were more likely to be older, were unemployed, resided in rural, had lower self-reported health, had lower education/income, and had family members living in the same household with lower income. Although not significant, the number of nontraders was slightly higher in illiterate respondents. Literate respondents indicated cultural beliefs did not affects their responses whereas most of the illiterate respondents highlighted the impact of cultural norms on their responses, especially for self-care. CONCLUSIONS: Preference elicitation methods used in 3-level-EQ-5D valuation studies, namely, time trade-off and discrete choice experiments, are feasible in the Pakistani population. The use of graphical illustrations for illiterate respondents was successful.

Economic Evaluation of Sucrose Octasulfate Dressing for Treatment of Diabetic Foot Ulcers in Patients with Type 2 Diabetes.

OBJECTIVES: Patients with noninfected neuroischemic diabetic foot ulcers (DFUs) treated with sucrose octasulfate (SOS) dressing have been shown to have improved healing compared with patients wearing a similar type of dressing without SOS. In this study, we aimed to estimate the cost-effectiveness of SOS dressing compared with conventional dressings from a Canadian public payer's perspective. METHODS: We built a Markov model in a hypothetical cohort of 1,000 inpatients with type 2 diabetes with DFUs. The time horizon was 5 years, and the cycle length was 3 months. We incorporated effectiveness data from the Explorer trial and cohort studies, cost data (2020 Canadian dollars) from published Canadian studies and administrative databases, and utility parameters from the Alberta's Caring for Diabetes cohort. We used probabilistic analysis to calculate the incremental cost-effectiveness ratio of SOS dressing compared with conventional dressings. RESULTS: In the comparison with conventional dressings, use of SOS dressing resulted in an expected increase of 0.16 quality-adjusted life-year (QALY) and an expected $5,878 decrease in health-care costs over 5 years. Adding SOS dressing resulted in a cost savings of $37,061 for every QALY gained. The probability that adding SOS dressing is cost-saving and cost-effective compared with conventional dressings was 89% and 86%, respectively, at a $50,000/QALY willingness-to-pay threshold. CONCLUSIONS: SOS dressing accelerates ulcer healing and helps reduce the spending induced by persistent ulcer management and amputation. Therefore, SOS dressing is likely to be cost-effective and cost-saving, which is consistent with previous health technology assessments in other health-care systems.

The impact of COVID-19 pandemic on health-related quality of life of adults visiting emergency departments and primary care settings in Alberta.

OBJECTIVES: To examine the impact of COVID-19 pandemic on health-related quality of life (HRQL) of adults visiting emergency departments (ED) and primary care (PC) settings in Alberta, Canada, and explore whether this impact varies across demographic subgroups. METHODS: Data from two repeated cross-sectional surveys that measured HRQL using EQ-5D-5L were used; "pre-COVID" Sept 2019-Feb 2020 (ED, N=5927; PC, N=317), "Wave-1" Mar 2020-Aug 2020 (ED, N=4781; PC, N=375), and "Wave-2" Sept 2020-Jan 2021 (ED, N=4443; PC, N=327). RESULTS: In the ED sample, there were decrements in mild-extreme problems of 3.7% in mobility and 4.1% in usual activities from pre-COVID to wave 2. There were very minor changes in mild-extreme problems in self-care (decrement=1.3%), pain/discomfort (decrement=2.6%), and anxiety/depression (decrement=0.9%). In the PC sample, there were increases of 4.8% in mild-extreme pain/discomfort and 10.7% in anxiety/depression from pre-COVID to wave 2. Despite these changes, HRQL of both samples pre-COVID and during waves 1 and 2 was worse than that of the general Alberta population. There were no significant variations in the impact of COVID-19 pandemic on HRQL across age, sex, and income subgroups in the ED survey; however, such variations were observed in the PC survey whereby younger adults, females, and those with high income had the largest HRQL deteriorations. CONCLUSION: The impact of COVID-19 pandemic on HRQL was minimal in adults seeking ED care, but more pronounced in those seen in PC, especially in terms of mental health. Policies around COVID-19 should take into account the needs of certain groups of the population, especially women and young people.

RéSUMé: OBJECTIFS: Examiner l'impact de la pandémie de COVID-19 sur la qualité de vie liée à la santé (QVLS) des adultes visitant les services d'urgence (SU) et les établissements de soins primaires (SP) en Alberta, au Canada, et déterminer si cet impact varie selon les sous-groupes démographiques. MéTHODES: Les données de deux enquêtes transversales répétées qui ont mesuré la QVL à l'aide de l'EQ-5D-5L ont été utilisées; « pré-COVID ¼ septembre 2019-février 2020 (SU, N=5 927; SP, N=317), « Vague-1 ¼ mars 2020-août 2020 (SU, N=4 781; SP, N=375) et « Vague-2 ¼ septembre 2020-janvier 2021 (SU, N=4 443; SP, N=327). RéSULTATS: Dans l'échantillon du SU, il y a eu des diminutions des problèmes légers à extrêmes de 3,7 % dans la mobilité et de 4,1 % dans les activités habituelles de la période pré-COVID à la vague 2. Il y a eu des changements très mineurs dans les problèmes légers à extrêmes dans les soins personnels (diminution = 1,3 %), douleur/gêne (diminution=2,6 %) et anxiété/dépression (diminution=0,9 %). Dans l'échantillon SP, il y a eu des augmentations de 4,8 % de la douleur/gêne légère à extrême et de 10,7 % de l'anxiété/de la dépression de la période pré-COVID à la vague 2. Malgré ces changements, la QVLS des deux échantillons avant la COVID et pendant les vagues 1 et 2 était pire que celle de la population générale de l'Alberta. Il n'y avait pas de variations significatives de l'impact de la pandémie de COVID-19 sur la QVLS selon l'âge, le sexe et les sous-groupes de revenu dans l'enquête SU; cependant, de telles variations ont été observées dans l'enquête SP, où les jeunes adultes, les femmes et les personnes à revenu élevé présentaient les plus fortes détériorations de la QVLS. CONCLUSION: L'impact de la pandémie de COVID-19 sur la QVLS était minime chez les adultes cherchant des SU, mais plus prononcé chez ceux observés dans le SP, en particulier en termes de santé mentale. Les politiques autour de COVID-19 devraient prendre en compte les besoins de certains groupes de la population, en particulier les femmes et les jeunes.

What difference does multiple imputation make in longitudinal modeling of EQ-5D-5L data? Empirical analyses of simulated and observed missing data patterns.

PURPOSE: Although multiple imputation is the state-of-the-art method for managing missing data, mixed models without multiple imputation may be equally valid for longitudinal data. Additionally, it is not clear whether missing values in multi-item instruments should be imputed at item or score-level. We therefore explored the differences in analyzing the scores of a health-related quality of life questionnaire (EQ-5D-5L) using four approaches in two empirical datasets. METHODS: We used simulated (GR dataset) and observed missingness patterns (ABCD dataset) in EQ-5D-5L scores to investigate the following approaches: approach-1) mixed models using respondents with complete cases, approach-2) mixed models using all available data, approach-3) mixed models after multiple imputation of the EQ-5D-5L scores, and approach-4) mixed models after multiple imputation of EQ-5D 5L items. RESULTS: Approach-1 yielded the highest estimates of all approaches (ABCD, GR), increasingly overestimating the EQ-5D-5L score with higher percentages of missing data (GR). Approach-4 produced the lowest scores at follow-up evaluations (ABCD, GR). Standard errors (0.006-0.008) and mean squared errors (0.032-0.035) increased with increasing percentages of simulated missing GR data. Approaches 2 and 3 showed similar results (both datasets). CONCLUSION: Complete cases analyses overestimated the scores and mixed models after multiple imputation by items yielded the lowest scores. As there was no loss of accuracy, mixed models without multiple imputation, when baseline covariates are complete, might be the most parsimonious choice to deal with missing data. However, multiple imputation may be needed when baseline covariates are missing and/or more than two timepoints are considered.

Mapping the Edmonton Symptom Assessment System-Revised: Renal to the EQ-5D-5L in patients with chronic kidney disease.

PURPOSE: The Edmonton Symptom Assessment System-Revised: Renal (ESAS-r: Renal) is a disease-specific patient-reported outcome measure (PROM) that assesses symptoms common in chronic kidney disease (CKD). There is no preference-based scoring system for the ESAS-r: Renal or a mapping algorithm to predict health utility values. We aimed to develop a mapping algorithm from the ESAS-r: Renal to the Canadian EQ-5D-5L index scores. METHODS: We used data from a multi-centre cluster randomized-controlled trial of the routine measurement and reporting of PROMs in hemodialysis units in Northern Alberta, Canada. In two arms of the trial, both the ESAS-r: Renal and the EQ-5D-5L were administered to CKD patients undergoing hemodialysis. We used data from one arm for model estimation, and data from the other for validation. We explored direct and indirect mapping models; model selection was based on statistical fit and predictive power. RESULTS: Complete data were available for 506 patient records in the estimation sample and 242 in the validation sample. All models tended to perform better in patients with good health, and worse in those with poor health. Generalized estimating equations (GEE) and generalized linear model (GLM) on selected ESAS-r: Renal items were selected as final models as they fitted the best in estimation and validation sample. CONCLUSION: When only ESAS-r: Renal data are available, one could use GEE and GLM to predict EQ-5D-5L index scores for use in economic evaluation. External validation on populations with different characteristics is warranted, especially where renal-specific symptoms are more prevalent.

Selection of patient-reported outcome measures (PROMs) for use in health systems.

Many healthcare systems around the world have been increasingly using patient-reported outcome measures (PROMs) in routine outcome measurement to enhance patient-centered care and incorporate the patient's perspective in health system performance evaluation. One of the key steps in using PROMs in health systems is selecting the appropriate measure(s) to serve the purpose and context of measurement. However, the availability of many PROMs makes this choice rather challenging. Our aim was to provide an integrated approach for PROM(s) selection for use by end-users in health systems.The proposed approach was based on relevant literature and existing guidebooks that addressed PROMs selection in various areas and for various purposes, as well as on our experience working with many health system users of PROMs in Canada. The proposed approach includes the following steps: (1) Establish PROMs selection committee; (2) Identify the focus, scope, and type of PROM measurement; (3) Identify potential PROM(s); (4) Review practical considerations for each of the identified PROMs; (5) Review measurement properties of shortlisted PROMs; (6) Review patient acceptance of shortlisted PROMs; (7) Recommend a PROM(s); and (8) Pilot the selected PROM(s). The selection of appropriate PROMs is one step in the successful implementation of PROMs within health systems, albeit, an essential step. We provide guidance for the selection of PROMs to satisfy all potential usages at the micro (patient-clinician), meso (organization), and macro (system) levels within the health system. Selecting PROMs that satisfy all these purposes is essential to ensure continuity and standardization of measurement over time. This is an iterative process and users should consider all the available information from all presented steps in selecting PROMs. Each of these considerations has a different weight in diverse clinical contexts and settings with various types of patients and resources.

Implementation of EQ-5D-5L as a routine outcome measure in Community Outpatient and Specialized Rehabilitation Services.

Rehabilitation is a person-centred approach that optimizes functioning to reduce impairments in individuals with illness, injury or disability. Patient-reported outcome measures (PROMs) have a role in rehabilitation to inform clinical practice, enhance patient-centered care, support health services programming, direct performance measurement, and contribute to quality improvement. A Canadian provincial health system implemented a Rehabilitation Model of Care that provides a real-world perspective on the adoption of a standardized PROM, the EuroQol EQ-5D-5L, in the community rehabilitation setting. This article will provide an overview of PROMs implementation in the community rehabilitation context, and discuss key facilitators and challenges to implementation within the 18 early adopter sites and with the spread and scale to 152 urban and rural sites. A change management approach, contextualized local coaching and strong leadership support were facilitators in the initial phases of implementation. Adequate resources and infrastructure from technological platforms for electronic data capture and visualization were assets in addition to clinical teams that had existing strong quality improvement cultures to collect PROMS in existing workflows. Challenges to implementation include the clinical relevance of the PROM, difficulty with contextualization to suit diverse clinical and programmatic teams, and the need for further knowledge sharing activities to build readiness for adoption. The implementation of PROMs in community rehabilitation has added value at the clinical (micro), programmatic (meso) and health system level (macro). Clinically, it has promoted the importance of incorporating the patients' voice into outcome measurement. At the program level, the cultivation of a data informed learning community was fostered as teams make improvements and use data to inform future program growth or service changes. Finally, at the health system level, data visualization promotes transparency and accountability with performance across the province and the standardized use of the EQ-5D-5L provides a consistent language to promote measurement throughout the health system.

The predictive ability of EQ-5D-3L compared to the LACE index and its association with 30-day post-hospitalization outcomes.

PURPOSE: To examine whether the EQ-5D-3L at the time of discharge from hospital provides additional prognostic information above the LACE index for 30-day post-discharge hospital readmission and to explore the association of EQ-5D-3L with readmissions, emergency department (ED) visits, and death within the same period. METHODS: Using data (n = 495; mean age 62.9 years (SD 18.6), 50.5% female) from a prospective cohort study of patients discharged from medical wards at two university hospitals, the prognostic ability of EQ-5D-3L was examined using C-statistic, Integrated Discrimination Improvement (IDI) Index, and Akaike's Information Criterion (AIC). The associations between EQ-5D-3L dimensions, total sum, index and VAS scores at the time of discharge and 30-day post-discharge ED visits, readmission, and readmission/death were examined using multivariate logistic regression. RESULTS: At the time of discharge, 58.6% of participants reported problems in mobility, 28.3% in self-care, 62.1% in usual activities, 62.7% in pain/discomfort, and 42.4% in anxiety/depression. Mean (SD) total sum score was 7.9 (2.0), index score was 0.69 (0.21), and VAS score was 63.7 (18.4). In adjusted analyses, mobility, self-care, usual activities, and the total sum score were significantly associated with 30-day readmission and readmission/death. Differences in C-statistic for LACE readmission prediction models with and without EQ-5D-3L were small. AIC analysis suggests that readmission prediction models containing EQ-5D-3L dimensions or scores were more often preferred to those with the LACE index only. IDI analysis indicates that the discrimination slope of readmission prediction models is significantly improved with the addition of mobility, self-care, or the total sum score of the EQ-5D-3L. CONCLUSION: The EQ-5D-3L, especially the mobility and self-care dimensions as well as the total sum score, improves 30-day readmission prediction of the LACE index and is associated with 30-day readmissions or readmissions/death.

The performance of the EQ-5D-3L in screening for anxiety and depressive symptoms in hospital and community settings.

BACKGROUND: To examine the performance of the EQ-5D-3L in screening for anxiety and depressive symptoms in hospital and community settings compared to other patient-reported screening tools. METHODS: Data from a prospective cohort of patients discharged from general internal medicine wards from two hospitals in Edmonton, Alberta were used in this study. Two waves of measurements (discharge and 90-days post-discharge) were analyzed. The performance of the EQ-5D-3L was compared to other self-report screening tools: Generalized Anxiety Disorder 2-item questionnaire was used to categorize anxiety symptoms into absent (< 3) and present (≥ 3), and the Patient Health Questionnaire 9-items was used to categorize depressive symptoms by two severity cut-points: no (< 10) vs. mild (≥ 10), and no (< 15) vs. moderate-severe (≥ 15). Performance of EQ-5D-3L in screening for anxiety and depressive symptoms was evaluated using receiver operating curve (ROC) analysis. RESULTS: Average age of participants (n = 493) was 62.9 years (SD 18.6); 51% were female. At discharge, 30.0% screened positive for mild and 12.8% for moderate-severe depressive symptoms, while 27.6% screened positive for anxiety symptoms. For co-morbid symptoms, 17.1% screened positive for anxiety and any depressive symptoms, while 10.8% for anxiety and moderate-severe depressive symptoms. While the EQ-5D-3L had limited screening ability in hospital, the anxiety/depression dimension performed well in the community setting (90-days post-discharge) in screening for anxiety (area under ROC 0.79), depressive symptoms (any: 0.78, moderate-severe: 0.84), and a combination of both (any: 0.86; moderate-severe: 0.91). CONCLUSIONS: The EQ-5D-3L anxiety/depression dimension could be a useful tool in screening for anxiety and depressive symptoms in community settings compared to other self-report screening tools. The usefulness of the EQ-5D-3L as a screening tool in other settings and populations is warranted.

Valuing health-related quality of life using a hybrid approach: Tunisian value set for the EQ-5D-3L.

OBJECTIVE: To develop a value set for EQ-5D-3L based on the societal preferences of the Tunisian population. METHODS: A representative sample of the Tunisian general population was obtained through multistage quota sampling involving age, gender and region. Participants (n = 327), aged above 20 years, were interviewed using the EuroQol Portable Valuation Technology in face-to-face computer-assisted interviews. Participants completed 10 composite time trade-off (cTTO) and 10 discrete choice experiments (DCE) tasks. Utility values for the EQ-5D-3L health states were estimated using regression modeling. The cTTO and DCE data were analyzed using linear and conditional logistic regression modeling, respectively. Multiple hybrid models were computed to analyze the combined data and were compared on goodness of fit measured by the Akaike information criterion (AIC). RESULTS: A total of 300 participants with complete data that met quality criteria were included. All regression models showed both logical consistency and significance with respect to the parameter estimates. A hybrid model accounting for heteroscedasticity presented the lowest value for the AIC among the hybrid models. Hence, it was used to construct the Tunisian EQ-5D-3L valuation set with a range of predicted values from - 0.796 to 1.0. CONCLUSION: This study provides utility values for EQ-5D-3L health states for the Tunisian population. This value set will be used in economic evaluations of health technologies and for Tunisian health policy decision-making.

A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol.

BACKGROUND: Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients' health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. METHODS: The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. DISCUSSION: While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. TRIAL REGISTRATION: Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.

A Longitudinal Study on the Association Between Diabetic Foot Disease and Health-Related Quality of Life in Adults With Type 2 Diabetes.

OBJECTIVES: The aim of this study was to assess the association between diabetic foot disease and health-related quality of life (HRQOL) during a 2-year follow up among people with type 2 diabetes in Alberta. METHODS: A type 2 diabetes cohort was established (2011‒2013); those with self-reported diabetic foot disease were identified. HRQOL was assessed at baseline and 1 and 2 years. Scores from the 12-item Short Form Physical Component Summary (PCS) and Mental Component Summary (MCS) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument were collected. The association between diabetic foot disease and changes in HRQOL was assessed using the general linear mixed model after adjustment for sociodemographics, previous health-care use, Elixhauser comorbidities index, baseline health status and diabetes-specific behaviours. RESULTS: Among the cohort (n=969), average age was 64.3 (standard deviation, 10.0) years and 55% were male. Overall, 265 (27.4%) participants reported having diabetic foot disease. Those with diabetic foot disease reported lower HRQOL in comparison to those without diabetic foot disease at baseline: PCS, 8.44 (95% confidence interval [CI], 7.06 to 9.82); MCS, 4.33 (95% CI, 2.99 to 5.67) and EQ-5D-5L index score, 0.12 (95% CI, 0.09 to 0.14). After adjustment, no differences were observed in the score changes at year 2 (PCS, 0.16 [95% CI, -0.88 to 1.21]; MCS, 0.36 [95% CI, -0.77 to 1.50]; EQ-5D-5L index score, 0.004 [95% CI, -0.01 to 0.02]). CONCLUSIONS: Although participants with diabetic foot disease reported lower HRQOL at baseline, they had similar changes compared to those without diabetic foot disease during the 2-year follow up. Efforts to maintain general health and early intervention to prevent diabetic foot disease may help to avoid initial deterioration of physical health and HRQOL.

The relationship between individual-level deprivation and health-related quality of life.

OBJECTIVE: To examine the association between individual-level deprivation and health-related quality of life (HRQL) in the general population. METHODS: Data from a population-based survey in the Canadian province of Alberta were used. Individual-level deprivation was assessed using the Canadian Deprivation Index (CDI) and the Ontario Deprivation Index (ODI). HRQL was assessed using the EQ-5D-5 L. Differences in problems in the EQ-5D-5 L dimensions, index and visual analogue scale (VAS) scores across levels of deprivation were examined. Multivariate logistic and linear regression models adjusted for socio-demographic and other characteristics were used to examine the independent association between deprivation and HRQL. RESULTS: Of the 6314 respondents, 39% were aged between 18 and 44 years and 38% between 45 and 64 years; 60% were female. Mean EQ-5D-5 L index and VAS scores were 0.85 (standard deviation [SD] 0.14) and 79.6 (SD 17.7), respectively. Almost one-third (30.6%) of respondents reported no problems on all EQ-5D-5 L dimensions. Few participants reported some problems with mobility (23.8%), self-care (6.2%) and usual activities (25.2%), while 59.3 and 35.5% reported some levels of pain/discomfort and anxiety/depression, respectively. Differences between the most and least deprived in reporting problems in EQ-5D-5 L dimensions, index and VAS scores were statistically significant and clinically important. In adjusted regression models for both deprivation indices, the least well-off, compared to the most well-off, had higher likelihood of reporting problems in all EQ-5D-5 L dimensions. Compared to the most well-off, the least well-off had an EQ-5D-5 L index score decrement of 0.18 (p < 0.01) and 0.17 (p < 0.01) for the CDI and ODI, respectively. Similarly, an inverse association was found between the VAS score and the CDI (ß = - 17.3, p < 0.01) as well as the ODI (ß = - 13.3, p < 0.01). CONCLUSION: Individual-level deprivation is associated with worse HRQL. Poverty reduction strategies should consider the effects of not only neighbourhood-level deprivation, but also that of individual-level deprivation to improve overall health.