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.

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.

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.

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.

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.

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.

Prospective study of shoulder strength, shoulder range of motion, and lymphedema in breast cancer patients from pre-surgery to 5 years after ALND or SLNB.

OBJECTIVE: Determine the changes in shoulder strength, shoulder range of motion, and arm volume in breast cancer patients treated with sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) METHOD: Sixty-eight SLNB and 44 ALND patients were followed up from pre-surgery to 5 years after surgery. Primary outcomes were the differences between affected and non-affected sides for the following: shoulder strength measured by dynamometry, shoulder range of motion measured by goniometry, and lymphedema measured by volume. As a secondary outcome, health-related quality of life (HRQL) was assessed by the Short Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy for breast cancer (FACT-B+4) questionnaires. Changes over time were tested for SLNB and ALND using univariate repeated measures analysis of variance. Generalized estimating equation models were constructed to assess the effect of SLNB and ALND over time. RESULTS: After 5 years, the ALND group had significant loss of strength for internal rotators (1.39 kg, p = 0.001) and significant arm volume increase (132.45 mL, p = 0.031). The ALND group had a greater number of patients with clinically relevant internal rotator strength loss (38.7 vs. 13.6%, p = 0.012) and a greater number of lymphedema requiring treatment (33.3 vs. 3.4%, p < 0.001) than the SLNB group. A loss of strength for shoulder external rotators, shoulder range of motion, and HRQL in physical and arm domains persisted at 5 years in both SLNB and ALND groups. CONCLUSION: These results could help understand and plan the prevention, needs, and long-term care of breast cancer patients.

Validity of the EQ-5D-5L and reference norms for the Spanish population.

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.

Shoulder Strength Changes One Year After Axillary Lymph Node Dissection or Sentinel Lymph Node Biopsy in Patients With Breast Cancer.

OBJECTIVES: To assess the changes in shoulder strength of patients with breast cancer during the first year after surgery; and to compare the effect of sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND) on shoulder strength. DESIGN: Prospective longitudinal observational study from presurgery to 1 year after. SETTING: Tertiary hospital. PARTICIPANTS: Of 129 consecutive patients examined for eligibility, a sample of women (N=112) with breast cancer were included (44 underwent ALND, and 68 underwent SLNB). INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: Difference between the affected and unaffected arm in strength of shoulder external rotators, internal rotators, abductors, and serratus anterior, measured by dynamometry. Evaluations were performed prior to surgery and at 1, 6, and 12 months after surgery. RESULTS: After breast cancer ALND surgery, strength decreased significantly at the first month for internal rotators, without having recovered presurgery values after 1 year of follow-up, with a mean difference of 2.26kg (P=.011). There was no significant loss of strength for patients treated with SLNB. The loss of shoulder range of motion was only significant the first month for the ALND group. The factors identified as associated with strength loss in the general estimating equation models were the ALND surgery and having received physical/occupational therapy during follow-up. CONCLUSIONS: One year after breast cancer surgery, patients treated with ALND had not recovered their previous shoulder internal rotators strength, whereas those who underwent SLNB presented no significant loss of strength. This provides important information for designing rehabilitation programs targeted specifically at the affected muscle group after nodal surgical approach.

Economic evaluation of treatments for patients with localized prostate cancer in Europe: a systematic review.

BACKGROUND: Our objective was to assess the efficiency of treatments in patients with localized prostate cancer, by synthesizing available evidence from European economic evaluations through systematic review. METHODS: Articles published 2000-2015 were searched in MEDLINE, EMBASE and NHS EED (Prospero protocol CRD42015022063). Two authors independently selected studies for inclusion and extracted the data. A third reviewer resolved discrepancies. We included European economic evaluations or cost comparison studies, of any modality of surgery or radiotherapy treatments, regardless the comparator/s. Drummond's Checklist was used for quality assessment. RESULTS: After reviewing 8,789 titles, 13 European eligible studies were included: eight cost-utility, two cost-effectiveness, one cost-minimization, and two cost-comparison analyses. Of them, five compared interventions with expectant management, four contrasted robotic with non robotic-assisted surgery, three assessed new modalities of radiotherapy, and three compared radical prostatectomy with brachytherapy. All but two studies scored ≥8 in the quality checklist. Considering scenario and comparator, three interventions were qualified as dominant strategies (active surveillance, robotic-assisted surgery and IMRT), and six were cost-effective (radical prostatectomy, robotic-assisted surgery, IMRT, proton therapy, brachytherapy, and 3DCRT). However, QALY gains in most of them were small. For interventions considered as dominant strategies, QALY gain was 0.013 for active surveillance over radical prostatectomy; and 0.007 for robotic-assisted over non-robotic techniques. The highest QALY gains were 0.57-0.86 for radical prostatectomy vs watchful waiting, and 0.72 for brachytherapy vs conventional radiotherapy. CONCLUSIONS: Currently, relevant treatment alternatives for localized prostate cancer are scarcely evaluated in Europe. Very limited available evidence supports the cost-effectiveness of radical prostatectomy over watchful waiting, brachytherapy over radical prostatectomy, and new treatment modalities over traditional procedures. Relevant disparities were detected among studies, mainly based on effectiveness. These apparently contradictory results may be reflecting the difficulty of interpreting small differences between treatments regarding QALY gains.

Long-acting beta-agonists plus inhaled corticosteroids safety: a systematic review and meta-analysis of non-randomized studies.

BACKGROUND: Although several systematic reviews investigated the safety of long-acting beta-agonists (LABAs) in asthma, they mainly addressed randomized clinical trials while evidence from non-randomized studies has been mostly neglected. We aim to assess the risk of serious adverse events in adults and children with asthma treated with LABAs and Inhaled Corticosteroids (ICs), compared to patients treated only with ICs, from published non-randomized studies. METHODS: The protocol registration number was CRD42012003387 (http://www.crd.york.ac.uk/Prospero). Literature search for articles published since 1990 was performed in MEDLINE and EMBASE. Two authors selected studies independently for inclusion and extracted the data. A third reviewer resolved discrepancies. To assess the risk of serious adverse events, meta-analyses were performed calculating odds ratio summary estimators using random effect models when heterogeneity was found, and fixed effect models otherwise. RESULTS: Of 4,415 candidate articles, 1,759 abstracts were reviewed and 220 articles were fully read. Finally, 19 studies met the inclusion criteria. Most of them were retrospective observational cohorts. Sample sizes varied from 50 to 514,216. The meta-analyses performed (69,939-624,303 participants according to the outcome considered) showed that odds ratio of the LABAs and ICs combined treatment when compared with ICs alone was: 0.88 (95% CI 0.69-1.12) for asthma-related hospitalization; 0.75 (95% CI 0.66-0.84) for asthma-related emergency visits; 1.02 (95% CI 0.94-1.10) for systemic corticosteroids; and 0.95 (95% CI 0.9-1.0) for the combined outcome. CONCLUSIONS: Evidence from observational studies shows that the combined treatment of LABAs and ICs is not associated with a higher risk of serious adverse events, compared to ICs alone. Major gaps identified were prospective design, paediatric population and inclusion of mortality as a primary outcome.

Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS).

OBJECTIVE: The Patient-Oriented Prostate Utility Scale (PORPUS) is a combined profile and utility-based quality of life measure for prostate cancer patients. Our objectives were to adapt the PORPUS into Spanish and to assess its acceptability, reliability, and validity. METHODS: The PORPUS was adapted into Spanish using forward and back translations and cognitive debriefing. PORPUS was administered jointly with the SF-36 and the Expanded Prostate Index Composite (EPIC) to 480 Spanish prostate cancer patients treated with radical prostatectomy or radiotherapy. The Spanish PORPUS scores' distribution and reliability were examined and compared with the original instrument. To evaluate construct validity, relationships were assessed between PORPUS and other instruments (testing hypotheses of the original PORPUS study), and among known groups defined by side effect severity. RESULTS: Reliability coefficient was 0.76 (similar to the original PORPUS' 0.81). Spanish PORPUS items presented correlations ranging 0.57-0.88 with the corresponding EPIC domains, as in the original PORPUS study (0.60-0.83). Both PORPUS-P and PORPUS-U showed significant differences and large effect sizes (0.94-1.90) when comparing severe versus no problem groups on urinary, bowel, sexual and hormonal side effects defined by EPIC. CONCLUSIONS: A conceptually equivalent Spanish version was obtained, with high reliability and good construct validity, similar to the original Canadian PORPUS version. It can therefore be used to measure health-related quality of life and utilities in Spanish prostate cancer patients.

The EORTC QLQ43 and FACT H&N questionnaires of quality of life at 1 and 5 years after treatment and dental care in head and neck cancer patients: a pilot study.

PURPOSE: This study aimed to examine health-related quality of life (HRQoL) in head and neck cancer patients at 1 and 5 years after successful treatment of their tumors, and to explore the usefulness of 2 instruments for assessing the need of dental care services. METHODS: This cross-sectional pilot study included 20 adult patients with head and neck cancer who completed the Functional Assessment of Cancer Therapy-Head and Neck (FACT H&N) Symptom Index and the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-H&N43) after 1 and 5 years of treatment. RESULTS: Mean (standard deviation, SD) scores of the FACT H&N Symptom Index were higher (better HRQoL) at 5 years than at 1 year (24.1 [4.4] vs. 21.1 [6.4]; p = 0.236). Only three of the ten items of FACT H&N (swallow, pain in mouth/throat or neck, and solid foods) evaluated oral health. In the EORTC QLQ-H&N43 questionnaire, scores were lower at 5 years (better HRQoL) in almost all multi- and single-item symptoms. This questionnaire includes four multi-item scales (pain in the mouth, social eating, swallowing, and problems with teeth) measuring dental and orthodontic needs. CONCLUSION: HRQoL in patients with head and neck cancer improved with the length of follow-up. The EORTC QLQ-H&N43 has more items addressing oral health compared to the FACT H&N Symptom Index and may be more adequate to assess the need of dental therapy in clinical practice.

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.

Evidence on the global measurement model of the Minnesota Living with Heart Failure Questionnaire.

PURPOSE: The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the most widely used health-related quality of life measure in both clinical and research settings. Nevertheless, its measurement model has never been confirmed. This study aims to fill that gap with a large international sample. METHODS: Data from eight studies (3,847 patients with heart failure) from 21 countries were merged and analysed. Common variables included MLHFQ scores, functional capacity, cardiovascular risk factors and the socio-demographic characteristics of the patient. The measurement model of the MLHFQ was assessed by means of exploratory and confirmatory factor analyses (EFA-CFA). The reliability of MLHFQ scores was evaluated using Cronbach's alpha coefficient and the MLHFQ's ability to differentiate among known groups was assessed through severity levels. RESULTS: Findings from the EFA and CFA suggest that the MLHFQ total and domain-specific scores fall within a bifactor model. The physical and emotional scores were supported within the sample, as was the original total score. Furthermore, a third factor was revealed regarding social environment. The reliability coefficient reached 0.9 for almost all physical and total scores. All the MLHFQ mean scores showed the ability to differentiate among functional capacity groups, with most of the effect size coefficients reaching 0.8. CONCLUSIONS: Beyond the suitable degree of reliability and validity displayed by the MLHFQ scores in the different country-specific versions, our results confirmed for the first time the unidimensionality of the most commonly used score in HF patients: the total MLHFQ score. Moreover, the social environment domain identified in this study can now be considered when assessing these patients' HRQL, especially as a relevant outcome with regard to disease management.

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.

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.

Quality-of-life impact of sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer patients.

OBJECTIVES: Controversy about quality-of-life (QOL) benefits of sentinel lymph node biopsy (SLNB) versus axillary lymph node dissection (ALND) in patients with breast cancer remains. Our aim was to compare the impact of SLNB and ALND on QOL and arm symptoms of patients with early breast cancer, using generic (short form 36 health survey) and tumor site-specific (FACT-B+4) instruments. METHODS: This was a prospective longitudinal observational study of 93 patients (64 SLNB, 29 ALND). Patients were evaluated presurgery and 1, 6, and 12 months postsurgery. Generalized estimation equation models were constructed to assess the effect of treatment on QOL. The relative risks of edema, dysesthesia, and heaviness were calculated comparing ALND to SLND. RESULTS: Most patients presented T1 (67.7%) and underwent breast-conserving surgery (92.5%). At 12 months, the SLNB group presented deterioration on the FACT-B+4 Arm Scale (beta coefficient estimated a change of -1.6 score points; P < 0.01) while, compared with SLNB, the deterioration in the ALND group was almost 2 additional score points higher (P = 0.009). FACT-B+4 global summary and short form 36 health survey did not show statistically significant differences between groups. Relative risk of dysesthesia and subjective edema was higher for the ALND group than for the SLNB group (1.97 and 2.11 at month 12; P < 0.01). CONCLUSION: These results confirm the benefit of SLNB due to its lower arm morbidity impact on QOL, compared with ALND. There are clinically relevant between-treatment differences in the Arm Scale of FACT-B+4, while there were no relevant differences in general well-being, measured with the disease-specific FACT-B+4 and the generic short form 36 health survey.