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ABSTRACT BACKGROUND Low health literacy is considered a potential barrier to improving health outcomes in people with diabetes and other chronic conditions, although the evidence has not been previously systematically reviewed. OBJECTIVE To identify, appraise, and synthesize research evidence on the relationships between health literacy (functional, interactive, and critical) or numeracy and health outcomes (i.e., knowledge, behavioral and clinical) in people with diabetes. METHODS English-language articles that addressed the relationship between health literacy or numeracy and at least one health outcome in people with diabetes were identified by two reviewers through searching six scientific databases, and hand-searching journals and reference lists. FINDINGS Seven hundred twenty-three citations were identified and screened, 196 were considered, and 34 publications reporting data from 24 studies met the inclusion criteria and were included in this review. Consistent and sufficient evidence showed a positive association between health literacy and diabetes knowledge (eight studies). There was a lack of consistent evidence on the relationship between health literacy or numeracy and clinical outcomes, e.g., A1C (13 studies), self-reported complications (two studies), and achievement of clinical goals (one study); behavioral outcomes, e.g., self-monitoring of blood glucose (one study), self-efficacy (five studies); or patient-provider interactions (i.e., patient-physician communication, information exchange, decision-making, and trust), and other outcomes. The majority of the studies were from US primary care setting (87.5 %), and there were no randomized or other trials to improve health literacy. CONCLUSIONS Low health literacy is consistently associated with poorer diabetes knowledge. However, there is little sufficient or consistent evidence suggesting that it is independently associated with processes or outcomes of diabetes-related care. Based on these findings, it may be premature to routinely screen for low health literacy as a means for improving diabetes-related health-related outcomes.

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.

Background Anxiety and depression disorders are associated with significantly lower health-related quality of life (HRQL). The EQ-5D is a commonly used generic measure of HRQL; it captures mental health through a single domain—the anxiety/depression dimension. Evidence on the responsiveness of this measure in assessing changes in mental health changes is limited. Objective To examine the performance of the anxiety/depression dimension (A/D) of the 3- and 5-level (3L and 5L) versions of the EQ-5D in assessing changes in mental health. Methods Data from two patient populations were used: 495 adults post-discharge from general internal medicine ward (EQ-5D-3L), and 225 type 2 diabetes patients who screened positive for depressive symptoms (EQ-5D-5L). Anchor-based approach along with effect sizes (ES) and ROC analysis was used. Anchors included patient health questionnaire 9-items \"PHQ9\" and generalized anxiety disorder 2-item questionnaire \"GAD2\" for EQ-5D-3L, and PHQ9 and SF-12 mental composite summary scores (MCS) for EQ-5D-5L. A/D change was quantified as the difference between follow-up and baseline levels. Results The A/D dimension of the EQ-5D-3L showed limited responsiveness to changes in depressive symptoms measured by PHQ9 and for anxiety symptoms measured by GAD2, whereby in those who improved or deteriorated in either symptom, more than half of the patients did not have an A/D change. In the ROC analysis, the A/D dimension of the EQ-5D-3L showed weak performance with C-indices ranging from 0.58 to 0.63 and probability of detection of depressive or anxiety symptoms ranging between 20 and 40%, which are all well below acceptable ranges. Similar results were observed for the A/D dimension of the EQ-5D-5L; although the performance was slightly better, it was still below acceptable range. In patients who improved or deteriorated based on the PHQ9 or MCS, around a third had no changes on the A/D dimension. The performance of the A/D dimension of the EQ-5D-5L was also very limited with C-indices ranging between 0.67 and 0.76, and probability of detection between 50 and 67%, slightly better than that of the 3L, yet unsatisfactory. Conclusions Although the A/D of both EQ-5D-3L and 5L was limited in capturing changes in mental health in these populations, the 5L was slightly more responsive than the 3L. While the performance was better for depressive than anxiety symptoms, it varied by the direction of change. Further research using other measures of mental health in other populations is warranted.

Purpose To examine the relationship of neighbourhood-level material and social deprivation with health-related quality of life, measured by the EQ-5D-5L, in the general adult population. Methods A sample of 11,835 adults living in Alberta, Canada was drawn from three combined annual Health Quality Council of Alberta Satisfaction and Experiences with Health Care Services surveys from 2012 to 2016. Neighbourhood-level material and social deprivation indices were derived using the Pampalon index and the 2006 Canadian census. The EQ-5D-5L dimensions, index and VAS scores were compared across the deprivation indices quintiles in the overall sample and by participants' sub-groups. Differences were tested using ANOVA or Chi-square test as appropriate. Multivariate linear regression models were conducted to examine the independent association of material and social deprivation with the EQ-5D-5L index and VAS scores, and multinomial logistic regression models with each of the EQ-5D-5L dimensions. Results Respondents in higher material or social deprivation categories had lower EQ-5D-5L index and VAS scores than those in the least deprived categories. Additionally, respondents with higher material deprivation were more likely to report problems on mobility, usual activities, and pain/discomfort; those with higher social deprivation were more likely to report problems on mobility, self-care, usual activities, and anxiety/depression. Conclusion Higher neighbourhood-level material and social deprivation is significantly associated with lower health-related quality of life in the general adult population. Examining the factors leading to this inequity in health between individuals living in the least and most deprived neighbourhoods is imperative to mitigating these inequities.

Purpose To explore the comparative performance including discriminative and longitudinal validity of EQ-5D-5L and SF-6D index scores in adults with type 2 diabetes. Methods Data from an on-going cohort study of adults with type 2 diabetes in Alberta, Canada, were used. Known-groups approach was used to examine discriminative validity. Correlation and agreement indices and scatter and land-Airman plots were used to examine the relationship between the two measures. Longitudinal validity was explored using Wilcoxon signed-rank test, effect size, and standardized response mean. Results In 1832 participants at baseline (age 64.3, standard deviation 10.6 years; 45% female), median EQ-5D-5L score was 0.85 [interquartile range (IQR) 0.17], and floor and ceiling effects of 0.1 and 16.1%, respectively; median SF-6D score was 0.72 (IQR 0.24), and floor and ceiling effects of 0.1 and 3.2%, respectively. EQ-5D-5L and SF-6D index scores were significantly correlated with an overall Spearman correlation coefficient of 0.73, and an ICC of 0.62 (95% CI 0.42-0.74). Both EQ-5D-5L and SF-6D scores demonstrated statistically significant differences in self-reported chronic conditions, depressive symptoms, and diabetes-related distress, and were able to detect changes in depressive symptoms and diabetes distress across all change groups. Conclusions Both EQ-5D-5L and SF-6D index scores provide valid measurement in this patient population. Considerable overlap between the measures means it is not necessary to include both in surveys, however, the advantages and disadvantages of each should be considered.

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.

Purpose To examine the association of health literacy (HL) with changes in health-related quality of life (HRQL) among patients with type 2 diabetes. Methods Data from a cohort study of type 2 diabetes patients were used. HL was assessed using 3 previously validated screening questions and HRQL using the EQ-5D-5L and SF-12 [physical and mental composite summary scores (PCS, MCS)]. The associations of baseline HL with changes in EQ-5D, PCS, and MCS scores over 1 year and with directions of changes (no change; declined; improved) were examined. Missing data were handled with multiple imputation and sensitivity analyses. Results Average age of participants (N = 1948) was 64.6 ± 10.9 years, 45 % were female, and 12.6 % had inadequate HL. Participants had mean decrements of 0.01 in EQ-5D, 1.0 in PCS, and 1.2 in MCS over 1 year. In adjusted analysis, HL was not associated with changes in EQ-5D over 1 year (β = 0.01, P = 0.146); however, patients with adequate HL had 2.1 points greater increase in PCS (P < 0.001) and 3.1 points in MCS (P < 0.001) compared to those with inadequate HL. Patients with adequate HL were less likely to have a decline in EQ-5D (RR 0.66; 95 % CI 0.44, 0.98), PCS (RR 0.51; 95 % CI 0.34, 0.76), and MCS (RR 0.49; 95 % CI 0.33, 0.72) compared to those with inadequate HL. Patients with adequate HL were more likely to have an improvement in MCS compared to those with inadequate HL (RR 1.78; 95 % CI 1.04, 3.04); such associations were not observed for PCS or EQ-5D. All results were robust in sensitivity analyses. Conclusions Inadequate HL was independently associated with worsening HRQL in adults with type 2 diabetes, particularly in the mental health domain.

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.

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.

Purpose This systematic review was conducted to identify generic health related quality of life (HRQL) measures translated into Arabic, and evaluate their cross-cultural adaptation and measurement properties. Methods Six databases were searched, relevant journals were hand searched, and reference lists of included studies were reviewed. Previously established criteria were used to evaluate the cross-cultural adaptation of the identified instruments and their measurement properties. Results Twenty studies that reported the Arabic translations and adaptations of HRQL measures and/or their measurement properties were included in this review. The identified instruments were SF-36, RAND-36, WHOQOL-Bref, COOP/WONCA charts, EQ-5D, and QLI. Cross-cultural adaptations of all measures were of moderate to good quality, and evaluation of measurement properties was limited due to insufficiency of evidence. Based on cross-cultural adaptation evaluation, each instrument is more applicable to the population for whom it was adapted, and to other Arabic populations of similar culture and language specific idioms. Conclusion This review facilitates the selection among existing Arabic versions of generic HRQL for use in particular Arabic countries. However, each of the translated versions requires further investigation of measurement properties before more concrete recommendations could be made.