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Background and objective The EuroQol 5 dimensions 5 levels (EQ-5D-5L) is the new version of EQ-5D, developed to improve its discriminatory capacity. This study aims to evaluate the construct validity of the Spanish version and provide index and dimension population-based reference norms for the new EQ-5D-5L. Methods Data were obtained from the 2011/2012 Spanish National Health Survey, with a representative sample (n = 20,587) of non-institutionalized Spanish adults (≥ 18 years). The EQ-5D-5L index was calculated by using the Spanish value set. Construct validity was evaluated by comparing known groups with estimators obtained through regression models, adjusted by age and gender. Sampling weights were applied to restore the representativeness of the sample and to calculate the norms stratified by gender and age groups. We calculated the percentages and standard errors of dimensions, and the deciles, percentiles 5 and 95, means, and 95% confidence intervals of the health index. Results All the hypotheses established a priori for known groups were confirmed (P< 0.001). The EQ-5D-5L index indicated worse health in groups with lower education level (from 0.94 to 0.87), higher number of chronic conditions (0.96-0.79), probable psychiatric disorder (0.94 vs 0.80), strong limitations (0.96-0.46), higher number of days of restriction (0.93-0.64) or confinement to bed (0.92-0.49), and hospitalized in the previous 12 months (0.92 vs 0.81). Conclusions The EQ-5D-5L is a valid instrument to measure perceived health in the Spanish-speaking population. The representative population-based norms provided here will help improve the interpretation of results obtained with the new EQ-5D-5L.

Background The WHODAS-2 is a disability assessment instrument based on the conceptual framework of the International Classification of Functioning, Disability, and Health (ICF). It provides a global measure of disability and 7 domain-specific scores. The aim of this study was to assess WHODAS-2 conceptual model and metric properties in a set of chronic and prevalent clinical conditions accounting for a wide scope of disability in Europe. Methods 1,119 patients with one of 13 chronic conditions were recruited in 7 European centres. Participants were clinically evaluated and administered the WHODAS-2 and the SF-36 at baseline, 6 weeks and 3 months of follow-up. The latent structure was explored and confirmed by factor analysis (FA). Reliability was assessed in terms of internal consistency (Cronbach's alpha) and reproducibility (intra-class correlation coefficients, ICC). Construct validity was evaluated by correlating the WHODAS-2 and SF-36 domains, and comparing known groups based on the clinical-severity and work status. Effect size (ES) coefficient was used to assess responsiveness. To assess reproducibility and responsiveness, subsamples of stable (at 6 weeks) and improved (after 3 moths) patients were defined, respectively, according to changes in their clinical-severity. Results The satisfactory FA goodness of fit indexes confirmed a second order factor structure with 7 dimensions, and a global score for the WHODAS-2. Cronbach's alpha ranged from 0.77 (self care) to 0.98 (life activities: work or school), and the ICC was lower, but achieved the recommended standard of 0.7 for four domains. Correlations between global WHODAS-2 score and the different domains of the SF-36 ranged from -0.29 to -0.65. Most of the WHODAS-2 scores showed statistically significant differences among clinical-severity groups for all pathologies, and between working patients and those not working due to ill health (p < 0.001). Among the subsample of patients who had improved, responsiveness coefficients were small to moderate (ES = 0.3-0.7), but higher than those of the SF-36. Conclusions The latent structure originally designed by WHODAS-2 developers has been confirmed for the first time, and it has shown good metric properties in clinic and rehabilitation samples. Therefore, considerable support is provided to the WHODAS-2 utilization as an international instrument to measure disability based on the ICF model.

Purpose The objective of this study was to evaluate the psychometric properties of the Constant–Murley Score (CMS) in various shoulder pathologies, based on a systematic review and expert standardized evaluations. Methods A systematic review was performed in MEDLINE and EMBASE databases. Titles and abstracts were reviewed and finally the included articles were grouped according to patients' pathologies. Two expert evaluators independently assessed the CMS properties of reliability, validity, responsiveness to change, interpretability and burden score in each group, using the EMPRO (Evaluating Measures of Patient Reported Outcomes) tool. The CMS properties were assessed per attribute and overall for each considered group. Only the concept and measurement model was assessed globally. Results Five individual pathologies (i.e. subacromial, fractures, arthritis, instability and frozen shoulder) and two additional groups (i.e. various pathologies and healthy subjects) were considered. Overall EMPRO scores ranged from 58.6 for subacromial to 30.6 points for instability. Responsiveness to change was the only quality to obtain at least 50 points across all groups, but for frozen shoulder. Insufficient information was obtained in relation to the concept and measurement model and great variability was seen in the other evaluated attributes. Conclusions The current evidence does not support the CMS as a gold standard in shoulder evaluation. Its use is advisable for subacromial pathology; but data are inconclusive for other shoulder conditions. Prospective studies exploring the psychometric properties of the scale, particularly for fractures, arthritis, instability and frozen shoulder are needed. Level of evidence Systematic review.

We aimed to assess the changes in health-related quality of life (HRQL) in patients with confirmed diagnosis of influenza (H1N1)2009, and to estimate the individual and societal loss of quality-adjusted life years (QALYs) caused by the pandemic. Longitudinal study of patients recruited at major hospitals and primary care centers in Spain. Patients reported their HRQL (EQ-5D) during their influenza episode and seven days prior to it. A subsample was monitored to evaluate HRQL after recovery. HRQL loss was estimated as the difference between EQ-5D prior to the influenza episode and during it. Individual QALY loss (disutility multiplied by the duration of the influenza episode in days) for confirmed cases was calculated and used to estimate the societal loss in Spain (with the official estimations). A total of 432 inpatients and 563 outpatients were included, of whom 145 and 184, respectively, were followed up. Baseline mean HRQL loss was 0.58 (95% CI, 0.53-0.63) for inpatients and 0.43 (95% CI, 0.40-0.46) for outpatients. The majority of the 145 inpatients and 184 outpatients who were followed up regained initial HRQL levels, presenting a mean difference of 0.01 between the EQ-5D score prior to and after the influenza episode. Individual QALY losses for inpatients (0.031, 95% CI, 0.025-0.037) were higher than for outpatients (0.009, 95% CI, 0.007-0.011), while societal QALY losses were reversed: 94 years for inpatients and 6,778 years for outpatients. For fatal cases (an official number of 318), we estimated a QALY loss of 11,981. The influenza (H1N1)2009 pandemic had a significant but temporary impact on the HRQL of the majority of confirmed in- and outpatients. The societal impact of the influenza pandemic in Spain was estimated to be higher than other acute conditions. These results provide useful data for future cost-utility analyses.

Studies on health-related quality of life (HRQoL) inequalities according to sexual orientation are scarce. The aim of this study was to assess HRQoL inequalities between lesbian, gay, and bisexual (LGB) people and heterosexuals in the 2011 Barcelona population, to describe the extent to which sociodemographic characteristics, health-related behaviors, and chronic conditions could explain such inequalities, and to understand if they are sexual orientation inequities. In the 2011 Barcelona Health Interview Survey 3277 adults answered the EQ-5D, which measures five dimensions of HRQoL summarized into a single utility index (1 = perfect health, 0 = death). To assess HRQoL differences by sexual orientation we constructed Tobit models for the EQ-5D index, and Poisson regression models for the EQ-5D dimensions. In both cases, nested models were constructed to assess the mediator role of selected variables. After adjusting by socio-demographic variables, the LGB group presented a significantly lower EQ-5D index than heterosexuals, and higher prevalence ratios of problems in physical EQ-5D dimensions among both genders: adjusted prevalence ratio (aPR) = 1.70 for mobility (p = 0.046) and 2.11 for usual activities (p = 0.019). Differences in mental dimensions were only observed among men: aPR = 3.15 for pain/discomfort (p = 0.003) and 2.49 for anxiety/depression (p = 0.030). All these differences by sexual orientation disappeared after adding chronic conditions and health-related behaviors in the models. The LGB population presented worse HRQoL than heterosexuals in the EQ-5D index and most dimensions. Chronic conditions, health-related behaviors and gender play a major role in explaining HRQoL differences by sexual orientation. These findings support the need of including sexual orientation into the global agenda of health inequities.

The aim was to evaluate the impact of asthma on patients' Health-Related Quality of Life (HRQoL) by comparing asthmatic women and men with reference norms, to examine the factors which contributed to an impaired HRQoL, and to identify groups at higher risk. Cross-sectional evaluation of 222 primary care patients with persistent asthma (18-40 years old). HRQoL impact was estimated with the EuroQol-5 Dimensions (EQ-5D), which allows calculating Quality-Adjusted Life-Years (QALYs) by applying society preferences. Participants self-completed the EQ-5D questionnaire online. Telephonic interviews collected information on medication and adherence, and administered the Asthma Control Questionnaire. Severity markers included asthma-related comorbidity, previous oral corticosteroids course prescription, and inhaled corticosteroids daily dose. After bivariate analyses, multiple linear regression models were constructed to examine the relations between HRQoL asthma impact and socio-demographic and clinical variables, using as dependent variable the deviation from general population-based EQ-5D reference norms. Deviation from the EQ-5D index norms was moderate in most age/gender groups (-0.1, which corresponds to 0.6 standard deviations), while it was large in women aged 18-24 years (-0.18, corresponding to 1.1 standard deviations). In regression models, a poor asthma control was the only factor independently associated to HRQoL impact in both women and men: β -0.18 (p<0.001) and -0.15 (p = 0.01) respectively. Translating these β coefficients to QALYs, they are interpretable as 66 fewer days of full health per year in women with uncontrolled asthma and 55 for men, compared with those with controlled asthma. Persistent asthma has a moderately negative HRQoL impact on patients of both genders, and the youngest women have been identified as a high risk group which merits further research. We identified asthma control as the major contributor to impaired HRQoL in patients, regardless of their gender, suggesting that asthma HRQoL impact could be alleviated by achieving a good control of symptoms.

Functional social support is one of the most established predictors of health, and the Duke-UNC Functional Social Support Questionnaire (DUFSS) is one of the most commonly used instruments to measure this parameter. The objective of this study is to systematically review the available evidence on the psychometric and administration characteristics of the different versions of the DUFSS and perform a standardized assessment though to a specifically designed tool. A systematic review was performed in the PubMed/MEDLINE, SCOPUS, WOS and SCIELO databases. All articles that contained information on the development process of the instrument, the psychometric properties and aspects related to its administration were included, without restrictions based on publication date, language, or the version of the questionnaire that was studied. The selection and extraction procedure were carried out by two researchers. The articles finally included were peer-reviewed through a standardised assessment using the Evaluating the Measurement of Patient-Reported Outcomes (EMPRO) tool. PROSPERO registration number: CRD42022342977. A total of 54 articles were identified. After eliminating duplicates and screening articles based on the selection criteria, 15 studies that examined the DUFSS questionnaire resulting in 4 different versions: 3 articles obtained the 8-item version; 11 the 11-item version; and a single article obtained two versions, the 14-item version and the 5-item version. At least 60% of them did so in a young adult population, predominantly female and with a medium-low socio-economic level or with characteristics of social vulnerability. The EMPRO evaluation showed that the 11-item version (54.01 total score) was the only one that had been studied on all recommended attributes and had higher total scores than the other versions: 8 items (36.31 total score), 14 items (27.48 total score) and 5 items (23.81 total score). This difference appears in all attributes studied, with the highest scores in \"reliability (internal consistency)\" and \"validity\". Of the 4 versions identified in the DUFSS questionnaire, the 11-item version was found to be optimal based on the EMPRO standardized tool. Although, a priori, we could prioritise its use in epidemiological studies over the other versions, it should be noted that this version should also be used with caution because there are attributes that have not been studied.

Background Older adults present a variety of oral diseases and conditions, in addition to co-morbidities and limited access to dental care, which significantly impact their oral health-related quality of life (OHRQoL). There are many instruments published to measure OHRQoL. However, it is challenging for clinicians and researchers to choose the best instrument for a given purpose. Purpose To identify OHRQoL instruments available for older adults and summarize the evidence on the conceptual and measurement model, psychometric properties, interpretability, and administration issues of OHRQoL instruments available for older adults through a systematic review. Methods A systematic search was conducted in MEDLINE, EMBASE, LILACS, and CENTRAL up to February 2023. Articles reporting information on the concept model measurement, psychometric properties, and administration issues of an instrument measuring OHRQoL in older adults were included. Two researchers independently evaluated each instrument using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. The overall score and seven attribute-specific scores were calculated (range 0–100): Conceptual and measurement model, Reliability, Validity, Responsiveness, Interpretability, Burden, and Alternative forms. Results We identified 14 instruments evaluated in 97 articles. The overall score varied between 73.7 and 8.9, with only six questionnaires over the threshold score 50.0. EORTC QLQ OH-15 (cancer-specific questionnaire) achieved the highest score (73.7), followed by OHIP (generic OHRQoL questionnaire) (66.9), GOHAI (generic OHRQoL questionnaire) (65.5), and OHIDL (generic OHRQoL questionnaire) (65.2). Overall, the Conceptual and measurement model and Validity showed the best performance, while Responsiveness and Interpretability showed the worst. Insufficient information was presented for an overall evaluation of DSQ and OHAI. Conclusion The evidence supports using EORTC QLQ-OH15 as a specific instrument to assess OHRQoL in cancer patients and the OHIP-49, GOHAI, or OHIDL as generic instruments to assess OHRQoL either for cross-sectional or longitudinal studies in older adults.

Background Implementation of patient-reported measures (PRMs) is an integral element for patient-centered models; however, there is still hardly any quantitative evidence regarding its impact in routine care settings. The objective of this study was to codesign two concise tools that allow for a standardized and longitudinal assessment of the implementation of PRMs in routine care in terms of acceptability and perceived value from the perspective of both patients and healthcare professionals. Methods A list of constructs and items to be presented, separately, to patients and healthcare professionals was created from evidence gathered through a narrative literature review. Focus groups, composed of either patients or healthcare professionals from different chronic conditions, were conducted for the co-design of independent assessments. Once agreement was reached, the content validity was examined in separate consensus meetings. Results A total of 10 patients and 10 healthcare professionals participated in the focus groups. After 7 focus groups, the PRMs Implementation Assessment Tool for patients (PRMIAT-P) was developed with 33 items in 9 constructs, and the tool for healthcare professionals (PRMIAT-HP) had 33 items in 16 constructs. Content validity was confirmed for both tools. Conclusions The perspective of patients and healthcare professionals regarding the implementation of PRMs in routine care can be evaluated quantitively with the PRMIAT tools. These tools are understandable, concise and comprehensive, and can be used in multiple settings and for different chronic conditions. They have been codesigned as a standard set to facilitate both longitudinal assessments and performing benchmarking among different initiatives.

To compare the effectiveness at ten years of follow-up of radical prostatectomy, brachytherapy and external radiotherapy, in terms of overall survival, prostate cancer-specific mortality and biochemical recurrence. Cohort of men diagnosed with localized prostate cancer (T1/T2 and low/intermediate risk) from ten Spanish hospitals, followed for 10 years. The treatment selection was decided jointly by patients and physicians. Of 704 participants, 192 were treated with open radical retropubic prostatectomy, 317 with 125 I brachytherapy alone, and 195 with 3D external beam radiation. We evaluated overall survival, prostate cancer-specific mortality, and biochemical recurrence. Kaplan–Meier estimators were plotted, and Cox proportional-hazards regression models were constructed to estimate hazard ratios (HR), adjusted by propensity scores. Of the 704 participants, 542 patients were alive ten years after treatment, and a total of 13 patients have been lost during follow-up. After adjusting by propensity score and Gleason score, brachytherapy and external radiotherapy were not associated with decreased 10-year overall survival (aHR = 1.36, p = 0.292 and aHR = 1.44, p = 0.222), but presented higher biochemical recurrence (aHR = 1.93, p = 0.004 and aHR = 2.56, p < 0.001) than radical prostatectomy at ten years of follow-up. Higher prostate cancer-specific mortality was also observed in external radiotherapy (aHR = 9.37, p = 0.015). Novel long-term results are provided on the effectiveness of brachytherapy to control localized prostate cancer ten years after treatment, compared to radical prostatectomy and external radiotherapy, presenting high overall survival, similarly to radical prostatectomy, but higher risk of biochemical progression. These findings provide valuable information to facilitate shared clinical decision-making. Study identifier at ClinicalTrials.gov : NCT01492751.