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.This study was sponsored by a government grant from: Instituto de Salud Carlos III FEDER (PI06/90070

Patient-reported outcomes before treatment for localized prostate cancer: are there differences among countries? Data from the True North Global Registry

Introduction: Similar Patient-Reported Outcomes (PROs) at diagnosis for localized prostate cancer among countries may indicate that different treatments are recommended to the same profile of patients, regardless the context characteristics (health systems, medical schools, culture, preferences…). The aim of this study was to assess such comparison. Methods: We analyzed the EPIC-26 results before the primary treatment of men diagnosed of localized prostate cancer from January 2017 onwards (revised data available up to September 2019), from a multicenter prospective international cohort including seven regions: Australia/New Zealand, Canada, Central Europe (Austria / Czech Republic / Germany), United Kingdom, Italy, Spain, and the United States. The EPIC-26 domain scores and pattern of three selected items were compared across regions (with Central Europe as reference). All comparisons were made stratifying by treatment: radical prostatectomy, external radiotherapy, brachytherapy, and active surveillance. Results: The sample included a total of 13,483 men with clinically localized or locally advanced prostate cancer. PROs showed different domain patterns before treatment across countries. The sexual domain was the most impaired, and the one with the highest dispersion within countries and with the greatest medians' differences across countries. The urinary incontinence domain, together with the bowel and hormonal domains, presented the highest scores (better outcomes) for all treatment groups, and homogeneity across regions. Conclusions: Patients with localized or locally advanced prostate cancer undergoing radical prostatectomy, EBRT, brachytherapy, or active surveillance presented mainly negligible or small differences in the EPIC-26 domains before treatment across countries. The results on urinary incontinence or bowel domains, in which almost all patients presented the best possible score, may downplay the baseline data role for evaluating treatments' effects. However, the heterogeneity within countries and the magnitude of the differences found across countries in other domains, especially sexual, support the need of implementing the PRO measurement from diagnosis

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.The research leading to these results has received funding from the European Community 7th Framework (FP7/2007–2013) under grant agreement number 282593, and the H2020 programme (MSCA-IF) under grant agreement number 706028 for A.L.D. during manuscript preparation. The following researchers have worked on this manuscript while funded by grants: C.L.-B. (University of Costa Rica OAICE-85-2019), K.M. (Instituto de Salud Carlos III FEDER: Fondo Europeo de Desarrollo Regional FI16/00071) and A.L.D. (IDEXLYON 16-IDEX-0005). The Health Services Research Group, IMIM, received funding from Generalitat de Catalunya (2017 SGR 452). Funding information for this article has been deposited with the Crossref Funder Registry. The funding agreements ensure the authors’ independence in designing the study, interpreting the data, and writing and publishing the report

Health-related quality of life inequalities by sexual orientation: results from the Barcelona health interview survey

Background: 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. Methods: 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. Results: 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. Conclusion: 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

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 webcite). 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.Financial support for this study was provided by the Health Research Fund (European Union FP7, ASTROLAB project EC HEALTH-F5-2011-282593); the Agency for Management of University and Research Grants AGAUR (2012FI_B1 00177); and a Fundación Carolina Fellowship

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: 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. 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

Health inequalities by sexual orientation: results from the 2016-2017 Barcelona health survey

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

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

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

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: 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. 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