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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 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 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.

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.

Background Cancer treatment greatly impacts physical and psychological functioning of cancer patients, negatively affecting their quality of life (QoL). This Umbrella Review (UR) aims to systematically summarize psychological and social factors positively or negatively associated with QoL in cancer patients undergoing treatment. Method Four scientific databases (PubMed, Embase, Scopus, and PsycInfo) were searched to identify systematic reviews between 2012 and 2023 analyzing the relationship between QoL and psychosocial factors in cancer patients in treatment. The UR was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Joanna Briggs Institute (JBI) review guidelines. The methodological quality of the included studies was evaluated using Assessment of Multiple Systematic Reviews 2 (AMSTAR2). Results Eighteen systematic reviews were included. The major psychological factors influencing QoL are depression, coping strategies, anxiety, and distress. Results also demonstrate the significant impact of social factors on QoL: perceived social support has a positive influence on QoL of cancer patients, while lowered social support, impaired social functioning, interactions, and role limitations worsen their QoL and overall well-being. Conclusion This UR provides a comprehensive overview of the psychosocial factors impacting QoL of cancer patients and serves as a prominent base for developing questionnaires and policies aimed at measuring QoL in cancer patients undergoing treatment. Moreover, the findings of the study can guide future research or the development of personalized clinical interventions aimed at improving QoL for this cancer population group.

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.

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.

Background The Early Childhood Oral Health Impact Scale (ECOHIS) measures the impact of dental diseases on Oral Health-Related Quality of Life both in children and their families. The aim of this study was to develop a Chilean Spanish version of the ECOHIS that is conceptually equivalent to the original and to assess its acceptability, reliability and validity in the preschool population of Chile. Methods The Chilean version of the ECOHIS was obtained through a process including forward and back-translation, expert panel, and cognitive debriefing interviews. To assess metric properties, a cross-sectional study was carried out in Carahue, Southern Chile (April–October 2016). Children younger than six years old without systemic diseases, disabilities or chronic medication from eleven public preschools were included. Parents were invited to complete the Chilean version of the ECOHIS, PedsQL™4.0 Generic Core and PedsQL Oral Health scales, and to answer global questions about their children’s general and oral health. A subsample was administrated ECOHIS a second time 14–21 days after. A clinical examination was performed to assess dental caries, malocclusion, and traumatic dental injuries. Reliability was evaluated using measures of internal consistency (Cronbach’s alpha) and reproducibility (Intraclass correlation coefficient - ICC). Construct validity was assessed by testing hypotheses based on available evidence about known groups and relationships between different instruments. Results The content comparison of the back-translation with the original ECOHIS showed that all items except one were conceptually and linguistically equivalent. The cognitive debriefing showed a suitable understanding of the Chilean version by the parents. In the total sample ( n  = 302), the ECOHIS total score median was 1 (IQR 6), floor effect was 41.6%, and ceiling effect 0%. Cronbach’s alpha was 0.89 and the ICC was 0.84. The correlation between ECOHIS and PedsQL™4.0 Generic Core was weak ( r  = 0.21), while it was strong-moderate ( r  = 0.64) with the PedsQL Oral Health scale. In the known groups comparison, the ECOHIS total score was statistically higher in children with poor than excellent/very good oral health (median 11.6 vs 0, p  < 0.01), and in the high severity than in the caries-free group (median 8 vs 0.5, p  < 0.01). No differences were found according to malocclusion and traumatic dental injuries groups. Conclusions These results supported the feasibility, reliability and validity of the Chilean version of ECOHIS questionnaire for preschool children through proxy.

Background Self-harm presents a significant public health challenge. Emergency departments (EDs) are crucial healthcare settings in managing self-harm, but clinician uncertainty in risk assessment may contribute to ineffective care. Clinical Decision Support Systems (CDSSs) show promise in enhancing care processes, but their effective implementation in self-harm management remains unexplored. Methods PERMANENS comprises a combination of methodologies and study designs aimed at developing a CDSS prototype that assists clinicians in the personalized assessment and management of ED patients presenting with self-harm. Ensemble prediction models will be constructed by applying machine learning techniques on electronic registry data from four sites, i.e., Catalonia (Spain), Ireland, Norway, and Sweden. These models will predict key adverse outcomes including self-harm repetition, suicide, premature death, and lack of post-discharge care. Available registry data include routinely collected electronic health record data, mortality data, and administrative data, and will be harmonized using the OMOP Common Data Model, ensuring consistency in terminologies, vocabularies and coding schemes. A clinical knowledge base of effective suicide prevention interventions will be developed rooted in a systematic review of clinical practice guidelines, including quality assessment of guidelines using the AGREE II tool. The CDSS software prototype will include a backend that integrates the prediction models and the clinical knowledge base to enable accurate patient risk stratification and subsequent intervention allocation. The CDSS frontend will enable personalized risk assessment and will provide tailored treatment plans, following a tiered evidence-based approach. Implementation research will ensure the CDSS’ practical functionality and feasibility, and will include periodic meetings with user-advisory groups, mixed-methods research to identify currently unmet needs in self-harm risk assessment, and small-scale usability testing of the CDSS prototype software. Discussion Through the development of the proposed CDSS software prototype, PERMANENS aims to standardize care, enhance clinician confidence, improve patient satisfaction, and increase treatment compliance. The routine integration of CDSS for self-harm risk assessment within healthcare systems holds significant potential in effectively reducing suicide mortality rates by facilitating personalized and timely delivery of effective interventions on a large scale for individuals at risk of suicide.

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.