Impact of treatment adherence and inhalation technique on asthma outcomes of pediatric patients: a longitudinal study.

Introduction: We aimed to evaluate the longitudinal relationships, both at between- and within-person levels, that adherence to inhaled corticosteroid-based maintenance treatment and inhalation technique present with symptom control, exacerbations, and health-related quality of life (HRQoL) in children and adolescents with asthma. Methods: Participants (6-14 years old) from the ARCA (Asthma Research in Children and Adolescents) cohort-a prospective, multicenter, observational study (NCT04480242)-were followed for a period from 6 months to 5 years via computer-assisted telephone interviews and a smartphone application. The Medication Intake Survey-Asthma (MIS-A) was administered to assess the implementation stage of adherence, and the Inhalation Technique Questionnaire (InTeQ) was used to assess the five key steps when using an inhaler. Symptom control was measured with the Asthma Control Questionnaire (ACQ), and HRQL was measured with the EQ-5D and the Patient-Reported Outcomes Measurement Information System-Pediatric Asthma Impact Scale (PROMIS-PAIS). Multilevel longitudinal mixed models were constructed separately with symptom control, exacerbation occurrence, EQ-5D, and PROMIS-PAIS as the dependent variables. Results: Of the 360 participants enrolled, 303 (1,203 interviews) were included in the symptom control and exacerbation analyses, 265 (732) in the EQ-5D, and 215 (617) in the PROMIS-PAIS. Around 60% of participants were male subjects, and most of them underwent maintenance treatment with inhaled corticosteroids plus long-acting ß-agonists in a fixed dose (73.3%). Within-person variability was 83.6% for asthma control, 98.6% for exacerbations, 36.4% for EQ-5D, and 49.1% for PROMIS-PAIS. At the within-person level, patients with higher adherence had better symptom control (p = 0.002) and HRQoL over time (p = 0.016). Patients with a better inhalation technique reported worse HRQoL simultaneously (p = 0.012), but they showed better HRQoL in future assessments (p = 0.012). The frequency of reliever use was associated with symptom control (p < 0.001), exacerbation occurrence (p < 0.001), and HRQoL (p = 0.042); and boys were more likely to present better symptom control and HRQoL than girls. Conclusion: Our results confirm longitudinal associations at the within-person level of the two indicators of quality use of inhalers: for adherence to maintenance treatment with symptom control and HRQoL, and for the inhalation technique with HRQoL. Although treatment adherence was shown to be excellent, a third of the participants reported a suboptimal inhalation technique, highlighting the need for actions for improving asthma management of the pediatric population.

Evaluating conceptual model measurement and psychometric properties of Oral health-related quality of life instruments available for older adults: a systematic review.

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.

Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26.

PURPOSE: To assess the validity, reliability, and responsiveness of the Spanish version of the Expanded Prostate cancer Index Composite (EPIC) with 26 items. METHODS: Multicentric longitudinal study of patients diagnosed with localized or locally advanced prostate cancer (any T, any N, M0) treated with active surveillance, surgery, external radiotherapy, or brachytherapy. The EPIC-50 was administered initially to the cohort (n = 324 patients), until it was replaced in November 2019 by the EPIC-26 (n = 543), in both groups before treatment and 12 months after. We assessed confirmatory factor analysis (CFA), reliability with Cronbach's alpha coefficient, criterion validity with the intraclass correlation coefficient (ICC), and responsiveness by testing a priori hypotheses on deterioration effect size (ES). RESULTS: The CFA confirmed the five-domain structure of the EPIC-26 proposed by the original instrument (comparative fit index = 0.95). The agreement between EPIC-50 (gold standard) and EPIC-26 domains was excellent (ICC > 0.90). Cronbach's alpha was > 0.7 in almost all domains, and the floor effect was near zero, although ceiling effect was higher than 50% in urinary incontinence and bowel domains. Hypothesized changes between before and 12 months after treatment were confirmed: ES > 0.8 in both urinary incontinence and sexual domains among patients who underwent surgery; and ES ranging 0.44-0.48 for bowel and sexual domains in patients treated with external radiotherapy. CONCLUSION: The Spanish version of the EPIC-26 has demonstrated adequate metric properties, similar to those of the original version, with acceptable goodness-of-fit indices, good criterion validity, reliability, and responsiveness to detect changes after radical prostatectomy or external radiotherapy.

Montelukast in paediatric asthma and allergic rhinitis: a systematic review and meta-analysis.

BACKGROUND: We aim to assess the impact of montelukast on paediatric patients with asthma/allergic rhinitis, measured using patient-reported outcome measures, compared with other treatments or placebo. METHODS: Protocol registration CRD42020216098 (www.crd.york.ac.uk/PROSPERO). MEDLINE and Embase databases were used to conduct the search. Two authors independently selected studies and extracted data, and a third reviewer resolved discrepancies. Meta-analyses were constructed to estimate the standardised mean difference (SMD) using a random-effects model. RESULTS: Out of 3937 articles identified, 49 studies met the inclusion criteria, mostly randomised clinical trials (sample sizes: 21-689 patients). The SMD of change pooled estimators for the global, mental and physical domains of health-related quality of life were not statistically significant. For daytime and night-time symptoms scores, the SMD (95% CI) was in favour of inhaled corticosteroids (-0.12, -0.20- -0.05 and -0.23, -0.41- -0.06, respectively). The pooled estimator for global asthma symptoms was better for montelukast when compared with placebo (0.90, 0.44-1.36). CONCLUSIONS: The synthesis of the available evidence suggests that, in children and adolescents, montelukast was effective in controlling asthma symptoms when compared with placebo, but inhaled corticosteroids were superior in controlling symptoms, especially at night-time. These findings of our systematic review concur with current guidelines for asthma treatment.

Validation of the Spanish electronic version of the BREAST-Q questionnaire.

BACKGROUND: Patient-reported outcome measures (PROMs) have gained considerable interest in health care moving beyond traditional outcome measures of morbidity and mortality. In breast cancer surgery, women's' perceptions of appearance, function and quality of life have become increasingly important. The BREAST-Q questionnaire is a validated PROM for use in cosmetic and reconstructive breast surgery in clinical practice. The objective of this study was to validate the Spanish electronic version of the BREAST-Q questionnaire, to verify the measurement equivalence of digital and paper versions and to identify the possible disadvantages and advantages of implementing this new tool. METHODS: The study population included 113 patients undergoing breast cancer survey at a single hospital in Barcelona (Spain) who were able to complete both the electronic and paper versions of the preoperative module of the BREAST-Q questionnaire. RESULTS: The intraclass correlation coefficient (ICC) in the four domains of the questionnaire between the two versions of the questionnaire was >0.9, with a weighted kappa of >0.74 at item level. The reliability of the internal consistency was also excellent, with Cronbach's alpha coefficient of >0.70 in all domains. Age was a limiting factor for the delivery of the electronic version of BREAST-Q, with 69 years of age as the cut-off point to obtain reliable results. CONCLUSIONS: The interchangeability of the electronic and paper versions of the BREAST-Q questionnaire facilitates implementation of this instrument in routine surgical oncological practice.

Health Inequalities by Sexual Orientation: Results from the 2016-2017 Barcelona Health Survey.

Purpose: The aim of this study was to assess health inequalities by sexual attraction in the 2016-2017 Barcelona population, stratifying by sex. Methods: Data came from the 2016-2017 Barcelona Health Survey, where 3362 adults answered among other instruments the EuroQol-5 dimensions-5 levels (EQ-5D-5L), which measures five dimensions and summarizes health-related quality of life into a single utility index score. To assess health differences by sexual attraction, we constructed Tobit models for the EQ-5D index score and Poisson regression models for the EQ-5D dimensions. Nested models were constructed to examine the mediating role of discrimination and health-related variables. Results: After adjusting for sociodemographic variables, women feeling attraction to more than one sex showed a lower EQ-5D index score (worse health) than those with only other sex attraction (-0.042, p = 0.012), and higher prevalence of problems with mobility, usual activities, and anxiety/depression with the following adjusted prevalence ratios (aPR) and confidence intervals (CIs): 1.79 (95% CI 1.05-3.05), 1.84 (95% CI 1.05-3.21), and 1.76 (95% CI 1.27-2.43). Women feeling attraction only to their same sex also presented higher prevalence of anxiety/depression (aPR = 1.46, CI 95% 1.10-1.92). In contrast, differences were not observed for men. Conclusion: Women, but not men, feeling attraction to more than one sex and only same-sex attraction in Barcelona in 2016-2017 presented worse health than those feeling only other sex attraction, with discrimination playing a mediating role in explaining such inequalities. These results among women indicate the need to develop public health strategies in Barcelona addressed to lesbian and bisexual women, considering the intersection of gender and sexual orientation.

Mortality and biochemical recurrence after surgery, brachytherapy, or external radiotherapy for localized prostate cancer: a 10-year follow-up cohort study.

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 125I 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.

The Inhaler Technique Questionnaire (InTeQ): Development and Validation of a Brief Patient-Reported Measure.

There is a need for instruments designed for patients with asthma to self-report their performance of inhaling steps. We aimed to develop an accessible and easy-to-use patient-reported tool for inhaler technique assessment, which could also serve as a training and monitoring resource for any type of inhaler device, and to evaluate its feasibility, validity, and reliability in adults with asthma. The development was based on literature review and pilot testing with clinicians and patients. The Inhaler Technique Questionnaire (InTeQ) asks about the frequency of performing five steps when using inhalers (on a five-point Likert scale). We analyzed data from adults with persistent asthma (n = 361). We examined the measurement model using Mokken scaling analysis, construct validity by assessing hypotheses on expected discrimination among known groups, and reliability based on internal consistency and reproducibility. Means of the InTeQ items were in the range of 0.23-1.61, and coefficients of homogeneity were above the cutoff point, demonstrating the unidimensionality of the scale. Known groups' global score differences were statistically significant between patients reporting having "Discussed in detail" or having "Not discussed/Only in general" the inhaler technique with their healthcare providers (p = 0.023). The Cronbach's alpha coefficient was 0.716, and the intraclass correlation coefficient was 0.775. The InTeQ is a feasible, valid, and reliable instrument for self-reporting inhaler technique on any type of device.

Measurement properties of the EQ-5D-Y administered through a smartphone app in children with asthma: a longitudinal questionnaire study.

BACKGROUND: Asthma impacts children's physical, emotional, and psychosocial Health-Related Quality of Life (HRQL). The EQ-5D-Y is a generic econometric instrument developed to measure HRQL in children. OBJECTIVE: Evaluation of feasibility, validity, reliability, and responsiveness of EQ-5D-Y descriptive system and utility index to allow the assessment of HRQL in children with asthma, aged 8-11 years (self-response version) or under 8 years old (proxy-response version). METHODS: We used data from baseline to 10 months of follow-up of an observational, prospective study of children with persistent asthma recruited by pediatricians in Spain (2018-2020). HRQL instruments were administered through a smartphone application: ARCA app. The EQ-5D-Y is composed of a 5-dimension descriptive system, a utility index ranging from 1 to - 0.5392, and a general health visual analogue scale (EQ-VAS). The Pediatric Asthma Impact Scale (PROMIS-PAIS) includes 8 items, providing a raw score. Construct validity hypotheses were stated a priori, and evaluated following two approaches, multitrait-multimethod matrix and known groups' comparisons. Reliability and responsiveness subsamples were defined by stability or change in EQ-VAS and the Asthma Control Questionnaire (ACQ), to estimate the intraclass correlation coefficient (ICC) and the magnitude of change over time. RESULTS: The EQ-5D-Y was completed at baseline for 119 children (81 self-responded and 38 through proxy response), with a mean age of 9.1 (1.7) years. Mean (SD) of the EQ-5D-Y utility index was 0.93 (0.11), with ceiling and floor effects of 60.3% and 0%, respectively. Multitrait-multimethod matrix confirmed the associations previously hypothesized for the EQ-5D-Y utility index [moderate with PROMIS-PAIS (0.38) and weak with ACQ (0.28)], and for the EQ-5D-Y dimension "problems doing usual activities" [moderate with the ACQ item (0.35) and weak with the PROMIS-PAIS item (0.17)]. Statistically significant differences were found in the EQ-5D-Y between groups defined by asthma control, reliever inhalers use, and second-hand smoke exposure, with mostly moderate effect sizes (0.45-0.75). The ICC of the EQ-5D-Y utility index in the stable subsamples was high (0.81 and 0.79); and responsiveness subsamples presented a moderate to large magnitude of change (0.68 and 0.78), though without statistical significance. CONCLUSIONS: These results support the use of the EQ-5D-Y as a feasible, valid, and reliable instrument for evaluating HRQL in children with persistent asthma. Further studies are needed on the responsiveness of the EQ-5D-Y in this population.

Oral Health-Related Quality of Life Changes in Patients with Dentofacial Deformities Class II and III after Orthognathic Surgery: A Systematic Review and Meta-Analysis.

Our aim was to assess the impact of combined orthodontic-surgical treatment on patients' oral health-related quality of life (OHRQoL) according to type of dentofacial deformities, by synthesizing the available evidence. METHODS: Search was conducted in the PubMed, Embase/MEDLINE, Scopus, and Cochrane databases. The eligibility criteria were studies that measured OHRQoL before-after orthognathic surgery, with results disaggregated by Class II and III. Two researchers independently performed the selection process, data extraction, and methodological quality assessment. Meta-analysis of the standard mean differences (SMD) was performed using random effect models. RESULTS: The search identified 1047 references. Thirteen studies met the inclusion criteria, and four were included in the meta-analysis. The SMD of OHRQL global score showed large improvement 4-7 months after surgery in Class II and III patients (2.09, 95% CI 0.68 to 3.49 and 1.96, 95% CI 1.22 to 2.70, respectively). The sensitivity analyses, excluding studies with weak methodological quality, showed that Class III patients' improvement in functional limitation was significantly higher than in Class II patients (SMD 0.57, 95% CI 0.12-1.02). CONCLUSIONS: There is not enough evidence to support differences between Class II and III patients in the OHRQoL impact after orthognathic surgery, but findings suggest lower improvement of some domains in Class II patients.

Mapping the Patient-Oriented Prostate Utility Scale From the Expanded Prostate Cancer Index Composite and the Short-Form Health Surveys.

OBJECTIVES: This study aimed to develop mapping algorithms from the Expanded Prostate Cancer Index Composite (EPIC) and the Short-Form (SF) Health Surveys to the Patient-Oriented Prostate Utility Scale (PORPUS), an econometric instrument specifically developed for patients with prostate cancer. METHODS: Data were drawn from 2 cohorts concurrently administering PORPUS, EPIC-50, and SF-36v2. The development cohort included patients who had received a diagnosis of localized or locally advanced prostate cancer from 2017 to 2019. The validation cohort included men who had received a diagnosis of localized prostate cancer from 2014 to 2016. Linear regression models were constructed with ln(1 - PORPUS utility) as the dependent variable and scores from the original and brief versions of the EPIC and SF as independent variables. The predictive capacity of mapping models constructed with all possible combinations of these 2 instruments was assessed through the proportion of variance explained (R2) and the agreement between predicted and observed values. Validation was based on the comparison between estimated and observed utility values in the validation cohort. RESULTS: Models constructed with EPIC-50 with and without SF yielded the highest predictive capacity (R2 = 0.884, 0.871, and 0.842) in comparison with models constructed with EPIC-26 (R2 = 0.844, 0.827, and 0.776). The intraclass correlation coefficient was excellent in the 4 models (>0.9) with EPIC and SF. In the validation cohort, predicted PORPUS utilities were slightly higher than those observed, but differences were not statistically significant. CONCLUSIONS: Mapping algorithms from both the original and the abbreviated versions of the EPIC and the SF Health Surveys allow estimating PORPUS utilities for economic evaluations with cost-utility analyses in patients with prostate cancer.

Five-year quality of life in patients with high-risk localized prostate cancer treated with external beam radiotherapy alone versus external beam radiotherapy with high-dose-rate brachytherapy boost: a prospective multicenter study.

PURPOSE: Brachytherapy (BT) and external beam radiation therapy (EBRT) are effective treatments for high-risk prostate cancer (PCa). However, the impact of these treatments on health-related quality of life (HRQL) remains unclear. In this study, we compared EBRT alone with EBRT plus a boost with high-dose rate (HDR)-BT to determine the impact on HRQL in patients with high-risk PCa. MATERIAL AND METHODS: Prospective, multicenter study comparing patients with high-risk PCa treated with EBRT alone or EBRT + HDR-BT from 2004 to 2006. HRQL was assessed at baseline (pre-treatment) and periodically over the 5-year follow-up, using the SF-36 (v.2), EPIC, and FACT-G and FACT-P questionnaires. RESULTS: A total of 129 patients were included in the study, of these, 41 received EBRT alone and 88 EBRT + HDR-BT. All patients received hormonotherapy. Baseline clinical characteristics were similar, except for a slightly higher mean number of comorbidities in the EBRT group. During follow-up, the only significant between-group difference was a greater worsening on EPIC hormonal domain in the EBRT alone group (p = 0.028). There were no significant differences in time and interaction of treatment in SF-36, and FACT-G and FACT-P questionnaires or EPIC urinary incontinence, urinary irritative-obstructive, and bowel and sexual domains over the 5-year follow-up. Oncological outcomes were similar in both groups. CONCLUSIONS: After five years of follow-up, EBRT alone or combined with HDR-BT boost had a similar impact on HRQL in patients with high-risk localized PCa. However, patients in the EBRT alone group experienced greater worsening of hormonal domain according to EPIC questionnaire.

Comparative Effectiveness Research in Localized Prostate Cancer: A 10-Year Follow-up Cohort Study.

PURPOSE: Long-term comparative effectiveness research on localized prostate cancer treatments is scarce, and evidence is lacking especially for brachytherapy. The aim of this study was to assess the long-term impact of the side effects of radical prostatectomy, brachytherapy, and external radiation therapy on patients with localized prostate cancer at 10 years, using propensity score analyses. METHODS AND MATERIALS: This was a prospective observational study of a cohort of men who received a diagnosis of clinically localized prostate cancer (clinical stage T1 or T2, low and intermediate risk group) and were treated with radical prostatectomy (n = 139), brachytherapy (n = 317), or external radiation therapy (n = 194). Treatment decisions were jointly made by patients and physicians. Patient-reported outcome (PRO) evaluation included the Expanded Prostate Cancer Index Composite and Short Form-36, administered centrally by telephone interviews before and annually after treatment. The Expanded Prostate Cancer Index Composite covers urinary, bowel, sexual, and hormonal domains. To assess PRO changes over time, while accounting for correlation among repeated measures, generalized estimating equation models adjusted by propensity scores were constructed. RESULTS: The PRO completion rate at 10 years was 85.8%. Generalized estimating equation models showed that the pattern of radical prostatectomy side effects, with substantial urinary incontinence and sexual dysfunction, remained until 10 years after treatment (standard deviation [SD], -1.1 and -1.3, respectively). Brachytherapy produced late deterioration in urinary continence (SD, -0.4) and sexual function (SD, -0.9) that appeared midterm, but the differences from radical prostatectomy remained statistically significant at 10 years (P < .001 after adjusting by propensity score). External radiation therapy showed similar results to brachytherapy, but with bowel bother (SD, -0.3). CONCLUSIONS: Although late deterioration in radiation therapy groups attenuated differences from radical prostatectomy, relevant PRO differences still remained after 10 years. Our findings support that brachytherapy is the treatment option that causes the least impact on PROs; it is therefore an alternative to be considered when making evidence-based decisions on localized prostate cancer treatment.

Association of Enacted Stigma with Depressive Symptoms Among Gay and Bisexual Men Who Have Sex with Men: Baltimore, 2011 and 2014.

Purpose: We assessed differences between gay and bisexual men in enacted stigma, and how the association between stigma and depressive symptoms may vary according to sexual orientation identity. Methods: Participants (671 gay and 331 bisexual men who have sex with men) in Baltimore's 2011 and 2014 National HIV Behavioral Surveillance completed an anonymous survey, including 3 enacted stigma dimensions and the Center for Epidemiologic Studies Depression Scale. Adjusted prevalence ratios were calculated through Generalized Estimating Equation models adjusting for theorized confounders (demographic, socioeconomic, and relational factors). Results: Bisexual men reported stigma experiences less frequently than did gay men (verbal harassment 22.7% vs. 32.3%, and discrimination 15.7% vs. 23.0%). Relevant depressive symptoms were reported by 43.1% of bisexual men and 34.2% of gay men (p < 0.001). Statistically significant differences in depressive symptoms between bisexual and gay men disappeared after adjusting for socioeconomic factors. The three enacted stigma dimensions were significantly associated with depressive symptoms, but their interaction with sexual orientation identity was not. Conclusion: This study confirms the association between enacted stigma and depressive symptoms among gay and bisexual men. However, sexual orientation identity did not modify this association as hypothesized. The bisexual men presented other psychosocial stressors that may explain their higher prevalence of depressive symptoms. The high levels of verbal harassment, discrimination, and physical assault reported by gay and bisexual men and their negative effect on mental health indicate the need to develop new effective public health strategies to avoid these consequences of homophobic and biphobic culture.

Measurement Properties of the Online EuroQol-5D-Youth Instrument in Children and Adolescents With Type 1 Diabetes Mellitus: Questionnaire Study.

BACKGROUND: The lack of continuity between health-related quality of life (HRQoL) instruments designed for children and adults hinders change analysis with a life course approach. To resolve this gap, EuroQol (EQ) developed the EQ-5D-Youth (EQ-5D-Y), derived from the EQ-5D for adults. Few studies have assessed the metric properties of EQ-5D-Y in children with specific chronic conditions, and none have done so for children with type I diabetes mellitus (T1DM). OBJECTIVE: This study aimed to evaluate the acceptability, validity, reliability, and responsiveness of the EQ-5D-Y in children and adolescents with T1DM, when administered online. METHODS: Participants with T1DM were consecutively recruited from July to December 2014, from a list of potential candidates aged 8-19 years, who attended outpatient pediatric endocrinology units. Before every quarterly routine visit, participants received an email/telephone reminder to complete the online version of two generic HRQoL questionnaires: EQ-5D-Y and KIDSCREEN-27. The EQ-5D-Y measures five dimensions, from which an equally weighted summary score was constructed (range: 0-100). Completion rate and distribution statistics were calculated. Construct validity was evaluated through known group comparisons based on general health, acute diabetic decompensations, mental health, family function, and a multitrait, multimethod matrix between EQ-5D-Y and KIDSCREEN by using Spearman correlations. Construct validity hypotheses were stated a priori. Reliability was assessed with the intraclass correlation coefficient and responsiveness by testing changes over time and calculating the effect size. Reliability and responsiveness were tested among the stable and improved subsamples defined by a KIDSCREEN-10 index change of <4.5 points or ≥4.5 points, respectively, from the first to the fourth visit. RESULTS: Of the 136 participants, 119 (87.5%) responded to the EQ-5D-Y at the last visit. The dimensions that showed higher percentages of participants with problems were "having pain/discomfort" (34.6%) and "worried/sad/unhappy" (28.7%). The mean (SD) of the EQ-5D-Y summary score was 8.5 (10.9), with ceiling and floor effects of 50.7% and 0%, respectively. Statistically significant HRQoL differences between groups defined by their general health (excellent/very good and good/regular/bad) and mental health (Strengths and Difficulties Questionnaire score ≤15 and >16, respectively) were found in three EQ-5D-Y dimensions ("doing usual activities," "having pain/discomfort," and "feeling worried/sad/unhappy"), summary score (effect size for general health and mental health groups=0.7 and 1.5, respectively), and KIDSCREEN-10 index (effect size for general health and mental health groups=0.6 and 0.9, respectively). Significant differences in the EQ-5D-Y dimensions were also found according to acute diabetic decompensations in "looking after myself" (P=.005) and according to family function in "having pain/discomfort" (P=.03). Results of the multitrait, multimethod matrix confirmed three of the four relationships hypothesized as substantial (0.21, 0.58, 0.50, and 0.46). The EQ-5D-Y summary score presented an intraclass correlation coefficient of 0.83. Statistically significant change between visits was observed in the improved subsample, with an effect size of 0.7 (P<.001). CONCLUSIONS: These results support the use of the EQ-5D-Y administered online as an acceptable, valid, reliable, and responsive instrument for evaluating HRQoL in children and adolescents with T1DM.

EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life in Adults With Asthma: Cross-Sectional Study.

BACKGROUND: The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure the health-related quality of life (HRQoL) and considered suitable for patients with asthma. In 2009, the EuroQol Group developed a new EQ-5D version to overcome limitations related to its consistently reported high ceiling effect. To enhance the sensitivity for assessing the HRQoL in further patient populations, the number of responses of EQ-5D was increased from 3 to 5 levels (EQ-5D-5L). Moreover, the availability of well-defined requirements for its Web-based administration allows EQ-5D-5L use to monitor the HRQoL in electronic health (eHealth) programs. No study has evaluated the metric properties of the new EQ-5D-5L in patients with asthma yet. OBJECTIVE: This study aims to examine the distribution, construct validity, and reliability of the new EQ-5D-5L questionnaire administered online to adults with asthma. METHODS: We evaluated patients with asthma (age: 18-40 years) from a primary care setting in France and England, who self-completed the EQ-5D-5L questionnaire online. The inclusion criteria were persistent asthma defined as >6 months of prescribed inhaled corticosteroids and long-acting beta-agonists or inhaled corticosteroids alone during the 12 months prior to inclusion. The EQ-5D index was obtained by applying the English preference value set for the new EQ-5D-5L and the French 3L-5L crosswalk value set. Both value sets produced single preference-based indices ranging from 1 (best health state) to negative values (health states valued as worse than death), where 0=death, allowing the calculation of quality-adjusted life years. Responses to dimensions and index distribution, including ceiling and floor effects, were examined. The construct validity was assessed by comparing the means of known groups by analyses of variance and calculation of effect sizes. RESULTS: Of 312 patients answering the baseline Web-based survey, 290 completed the EQ-5D-5L (93%). The floor effect was null, and the ceiling effect was 26.5% (74/279). The mean EQ-5D-5L index was 0.88 (SD 0.14) with the English value set and 0.83 (SD 0.19) with the French 3L-5L crosswalk value set. In both indices, large effect sizes were observed for known groups defined by the Asthma Control Questionnaire (1.06 and 1.04, P<.001). Differences between extreme groups defined by chronic conditions (P=.002 and P=.003 for the English value set and French 3L-5L crosswalk value set, respectively), short-acting beta-agonists (SABAs) canisters in the last 12 months (P=.02 and P=.03), or SABA use during the previous 4 weeks (P=.03 and P=.01) were of moderate magnitude with effect sizes around 0.5. CONCLUSIONS: The new EQ-5D-5L questionnaire has an acceptable ceiling effect, a good construct validity based on the discriminant ability for distinguishing among health-related known groups, and high reliability, supporting its adequacy for assessing the HRQoL in patients with asthma. EQ-5D-5L completion by most Web-based respondents supports the feasibility of this administration form.

Assessing oral health-related quality of life in children and adolescents: a systematic review and standardized comparison of available instruments.

OBJECTIVES: To obtain a systematic and standardized evaluation of the current evidence on development process, metric properties, and administration issues of oral health-related quality of life instruments available for children and adolescents. MATERIALS AND METHODS: A systematic search until October 2016 was conducted in PubMed, Embase, Lilacs, SciELO, and Cochrane databases. Articles with information regarding the development process, metric properties, and administration issues of pediatric instruments measuring oral health-related quality of life were eligible for inclusion. Two researchers independently evaluated each instrument applying the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden, and alternative forms. RESULTS: We identified 18 instruments evaluated in 132 articles. From five instruments designed for preschoolers, the Early Childhood Oral Health Impact Scale (ECOHIS) obtained the highest overall EMPRO score (82.2). Of nine identified for schoolchildren and adolescents, the best rated instrument was the Child Perceptions Questionnaire 11-14 (82.1). Among the four instruments developed for any age, the Family Impact Scale (FIS) obtained the highest scores (80.3). CONCLUSION: The evidence supports the use of the ECOHIS for preschoolers, while the age is a key factor when choosing among the four recommended instruments for schoolchildren and adolescents. Instruments for specific conditions, symptoms, or treatments need further research on metric properties. CLINICAL RELEVANCE: Our results facilitate decision-making on the correct oral health-related quality of life instrument selection for any certain study purpose and population during the childhood and adolescence life cycle.

Head-to-head comparison between the EQ-5D-5L and the EQ-5D-3L in general population health surveys.

BACKGROUND: The EQ-5D has been frequently used in national health surveys. This study is a head-to-head comparison to assess how expanding the number of levels from three (EQ-5D-3L) to five in the new EQ-5D-5L version has improved its distribution, discriminatory power, and validity in the general population. METHODS: A representative sample (N = 7554) from the Catalan Health Interview Survey 2011-2012, aged ≥18, answered both EQ-5D versions, and we evaluated the response redistribution and inconsistencies between them. To assess validity of this redistribution, we calculated the mean of the Visual Analogue Scale (VAS), which measures perceived health. The discriminatory power was examined with Shannon Indices, calculated for each dimension separately. Spanish preference value sets were applied to obtain utility indices, examining their distribution with statistics of central tendency and dispersion. We estimated the proportion of individuals reporting the best health state in EQ-5D-5L and EQ-5D-3L within groups of specific chronic conditions and their VAS mean. RESULTS: A very small reduction in the percentage of individuals with the best health state was observed, from 61.8% in EQ-5D-3L to 60.8% in EQ-5D-5L. In contrast, a large proportion of individuals reporting extreme problems in the 3 L version moved to severe problems (level 4) in the 5 L version, particularly for pain/discomfort (75.5%) and anxiety/depression (66.4%). The average proportion of inconsistencies was 0.9%. The pattern of the perceived health VAS mean confirmed the hypothesis established a priori, supporting the validity of the observed redistribution. Shannon index showed that absolute informativity was higher in the 5 L version for all dimensions. The means (SD) of the Spanish EQ-5D-3L and EQ-5D-5L indices were 0.87 (0.25) and 0.89 (0.22). The proportion of individuals with the best health state within each specific chronic condition was very similar, regardless of the EQ-5D version (≤ 30% in half of the 28 chronic conditions). CONCLUSION: Although the proportion of individuals with the best possible health state is still very high, our findings support that the increase of levels provided by the EQ-5D-5L contributed to the validity and discriminatory power of this new version to measure health in general population, as in the national health surveys.

Impact of asthma on women and men: Comparison with the general population using the EQ-5D-5L questionnaire.

BACKGROUND: 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. METHODS: 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. RESULTS: 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: ß -0.18 (p<0.001) and -0.15 (p = 0.01) respectively. Translating these ß 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. CONCLUSION: 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.