Nudging interventions to improve children's sleep, physical activity and sedentary behavior: A scoping review.

In recent years, nudges to improve health behaviors have generated growing public health interest, as a promising and inexpensive intervention approach. Most nudging intervention reviews have examined nudges targeting adults, with few focusing on children. We aimed to review the literature on nudges designed to improve children's sedentary behaviors, physical activity, and sleep, and to identify existing gaps in scientific knowledge. We screened the literature for experimental and quasi-experimental studies written in French or English reporting on nudging interventions designed to improve physical activity, sedentary or sleep behavior in children aged 2-12. No setting restrictions were applied. Data extracted included setting, population, health behavior and method of measurement (reported vs measured or observed). The search was performed in June 2021 and yielded 3768 results, of which 17 articles met inclusion criteria. Most included studies aimed to improve physical activity, seven targeted sedentary behavior and only one was directed at sleep. Home or school settings were the most common. Most studies were RCTs, reported a positive effect and presented multicomponent interventions, including both nudges and non-nudge aspects. Interventions targeting the decision structure were the least represented type of nudges among our sample. Our results show a paucity of research investigating nudges aimed at improving pediatric physical activity, sedentary behavior, and sleep. Interventions using nudges alone were even fewer, highlighting the need to study this promising type of intervention to improve lifestyle behaviors of children.

Simplification and Multidimensional Adaptation of the Stratification Tool for Pharmaceutical Care in People Living With HIV.

BACKGROUND: People living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary approach that focuses on patient needs, it is too complex and presents room for improvement. OBJECTIVE: The aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients. METHODS: The new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients. RESULTS: Thirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined. CONCLUSIONS AND RELEVANCE: We created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.

L'adhérence au traitement de maladies chroniques chez les jeunes - Rôle du niveau d'actualisation et de la tolérance au risque.

Adolescents with chronic diseases must adhere to medication regimens to control their symptoms and avoid long-term complications. Despite its importance, medication adherence is low among adolescents. This commentary briefly covers the challenges described in the literature associated with measuring and addressing low medication adherence in adolescents. Next, it presents the evidence for the link between medication adherence and two prevalent psychological characteristics that have not been properly assessed so far: delay discounting (i.e., the relative value assigned to the future compared to the present), and risk tolerance. These psychological traits deserve further studies and are potentially amenable to interventions to improve medication adherence in adolescents with chronic conditions.

Les adolescents atteints d'une maladie chronique doivent adhérer à un régime médicamenteux pour contrôler leurs symptômes et éviter des complications à long terme. Malgré son importance, l'adhérence aux médicaments est faible chez les adolescents.Le présent commentaire décrit brièvement les défis associés à la mesure de l'adhérence médicamenteuse et les facteurs qui les influencent, rapportés dans la littérature scientifique. Il présente ensuite les données probantes démontrant le lien entre l'adhérence aux médicaments et deux caractéristiques psychologiques communes, mais qui ont été peu évaluées jusqu'à maintenant: le taux d'actualisation (la valeur relative que l'on attribue au futur comparativement au présent) et la tolérance au risque.Ces caractéristiques psychologiques méritent d'être approfondies, et pourraient être propices à des interventions pour améliorer l'adhérence au médicament chez les adolescents ayant une maladie chronique.

Soluble ST2 is a sensitive clinical marker of ulcerative colitis evolution.

BACKGROUND: The ST2/IL-33 pathway has been related to ulcerative colitis (UC), and soluble ST2 (sST2), to disease severity. We tested the potential usefulness of sST2 as a predictive marker of treatment response and patients' outcome. METHODS: Twenty-six patients with active UC were prospectively recruited and grouped according to an endoscopic score and therapy response. Colonoscopic biopsies were collected at baseline and 6 months or when patients showed clinical activity. The protocol was reinitiated in patients requiring rescue therapy. Blood and stool were collected at baseline, 1, 3, 6 and 12 months. Serum and mucosal ST2, and fecal calprotectin (FC) content were determined by ELISA and correlated to Mayo clinical and endoscopic subscore. Intestinal ST2 was evaluated by immunofluorescence. Wilcoxon signed rank test and Spearman correlations (Rs) were applied (p <0.05). RESULTS: Follow-up was completed in 24 patients. sST2 levels (median and range) varied from 173.5 [136.6-274.0] to 86.5 [54.6-133.2] in responders (p < 0.05), and 336.3 [211.0-403.2] to 385.3 pg/mL [283.4-517.3] in non-responders at baseline and 6 months, respectively. sST2 levels correlated with Mayo clinical and endoscopic subscore, mucosal ST2 and FC (Rs = 0.57, 0.66, 0.74 and 0.42, respectively; p < 0.0001) and showed a trend similar to that of FC in responders. Non-responders revealed an increased ST2 content, restricted to the lamina propria's cellular infiltrate. CONCLUSIONS: Consecutive sST2 measurement to follow changes in inflammatory activity of UC patients who respond or not to treatment identifies sST2, like FC, as a useful biomarker in predicting clinical outcome of UC patients.

BI-RADS update for breast cancer caregivers.

This review will discuss changes relevant to breast cancer caregivers in the fifth edition of the Breast Imaging Reporting and Data System.

Correction: Evaluating the Clinical Feasibility of an Artificial Intelligence-Powered, Web-Based Clinical Decision Support System for the Treatment of Depression in Adults: Longitudinal Feasibility Study.

[This corrects the article DOI: 10.2196/31862.].

Does formal instruction about the BI-RADS ultrasound lexicon result in improved appropriate use of the lexicon?

OBJECTIVE: The purpose of this article is to determine whether formal instruction regarding the BI-RADS ultrasound lexicon results in improved appropriate use of the lexicon. MATERIALS AND METHODS: Ninety test questions depicting the features outlined by the 2003 BI-RADS lexicon were identified in our PACS. Informed consent was obtained from 34 radiology residents. The participants took the preinstruction test and then had 1 hour of formal instruction regarding the BI-RADS ultrasound lexicon, which included images depicting the different sonographic features and final assessment (including subcategories 4a, 4b, and 4c). The participants then completed the postinstruction test, which examined the same content. Test scores were calculated for both the pre- and postinstruction tests and then were compared by a linear mixed model and Wilcoxon signed rank tests. RESULTS: The participants' postinstruction test scores showed significant improvement in the overall use of the BI-RADS ultrasound lexicon (p < 0.0001). There was also significant improvement in the following specific areas: final assessment (p = 0.0005), margin (p = 0.0003), orientation (p = 0.0104), and lesion boundary (p = 0.0050). The categories for which test scores did not show significant improvement were echo pattern (p = 0.07), posterior acoustic features (p = 0.50), shape (p = 0.98), and subset of the final assessment (p = 0.24). CONCLUSION: Formal instruction regarding the BI-RADS ultrasound lexicon results in improved lesion characterization and final assessment.

[Highlights 56th SEPAR Congress]. / Highlights del 56° Congreso SEPAR.

The Spanish Society of Pneumology and Thoracic Surgery (SEPAR) has held its 56th congress in Granada from 8 to 10 June 2023. The SEPAR congress has established itself as the leading scientific meeting for specialists in medicine and respiratory care, reaching a record of participation this year with 2600 attendees. Our society thus demonstrates its leadership in the management of respiratory diseases, as well as its growth and progress in order to achieve excellence. In this review, we offer a summary of some notable issues addressed in six selected areas of interest: chronic obstructive pulmonary disease (COPD), asthma, interstitial lung diseases (ILDs), tuberculosis and respiratory infections, pulmonary circulation, and respiratory nursing.

A Brief Digital Screening and Intervention Tool for Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care in Canada: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Though rates of tobacco smoking have decreased consistently over the past 3 decades, cigarette use remains the top preventable cause of premature death in North America. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) is a medical clinic-based intervention that systematically screens parents for tobacco use and offers them direct access to evidence-based smoking cessation services. While the effectiveness of CEASE for parents who smoke has already been demonstrated in the United States, the CEASE model has not yet been tested in Canada, among parents who use e-cigarettes, or among adolescents who use cigarettes and e-cigarettes. OBJECTIVE: We aim to demonstrate the feasibility and evaluate the preliminary effectiveness of the CEASE program for parental smoking cessation and its adapted version for adolescent smoking cessation and adolescent and parental vaping cessation. METHODS: We will approach parents or guardians of children aged between 0 and 17 years, as well as adolescent patients aged between 14 and 17 years, from a tertiary care pediatric hospital in Montreal, Quebec, Canada, for participation in this single-blinded, pilot randomized controlled trial. Eligible participants are those who report using tobacco cigarettes or e-cigarettes at least once in the last 7 days and present to an outpatient pediatric clinic for a scheduled appointment. Our recruitment target is 100 participants: 50 parents or guardians of children aged 17 years or younger, and 50 adolescents aged between 14 and 17 years. The feasibility of implementation of the CEASE model will be measured by recruitment and retention rates for all 4 participant groups (stratified as follows: parents who use cigarettes, parents who use e-cigarettes exclusively, adolescents who use cigarettes, and adolescents who use e-cigarettes exclusively). Parent and adolescent participants within each group are randomized to the intervention and control groups using a 1:1 ratio through a computer-generated randomization list. Preliminary effectiveness outcomes include self-reported smoking and e-cigarette cessation, use of cessation resources, changes in smoking and e-cigarette use, motivation to quit, and quit attempts among participants. Participants complete electronic questionnaires on a tablet in the clinic at baseline as well as electronic follow-up questionnaires at 1, 3, and 6 months. Individuals reporting successful quit attempts are invited to provide a urine sample for cotinine testing to biochemically confirm quit. Analyses include descriptive statistics as well as exploratory trajectory analyses of smoking, e-cigarette use, and motivation to quit. RESULTS: Research activities began in June 2022. Participant enrollment and data collection began in February 2023 and are expected to be completed in 15 months. CONCLUSIONS: There is a strong need for effective and cost-effective smoking and vaping cessation interventions for parents and adolescents. If successful, this study will help inform the preparation of a fully powered randomized controlled trial of CEASE in Canada in these populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT05366790; https://www.clinicaltrials.gov/study/NCT05366790. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47978.

[Highlights of the 55th SEPAR Congress]. / Highlights del 55.° Congreso SEPAR.

The 55th SEPAR Congress was held in Pamplona from 2 to 4 of June 2022. Once again, it was the referral scientific meeting for specialists in pulmonology, thoracic surgery, nursing, physiotherapy, paediatric respiratory diseases and other disciplines involved in respiratory care. The Spanish Society of Pulmonology and Thoracic Surgery showed its national and international leadership in the management of respiratory diseases, which was reflected in a program with an excellent content and a high scientific level. In this review, we offer a summary of some notable aspects covered in six selected areas of interest: pulmonary vascular diseases, non-invasive mechanical ventilation and sleep disorders, asthma, chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), and interventional pulmonolgy and lung transplant.

Impact of Unmet Social Needs, Scarcity, and Future Discounting on Adherence to Treatment in Children With Asthma: Protocol for a Prospective Cohort Study.

BACKGROUND: Asthma is one of the most prevalent chronic diseases of childhood and disproportionately affects children with lower socioeconomic status. Controller medications such as inhaled corticosteroids significantly reduce asthma exacerbations and improve symptoms. However, a large proportion of children still have poor asthma control, in part owing to suboptimal adherence. Financial barriers contribute to hindering adherence, as do behavioral factors related to low income. For example, unmet social needs for food, lodging, and childcare may create stress and worry in parents, negatively influencing medication adherence. These needs are also cognitively taxing and force families to focus on immediate needs, leading to scarcity and heightening future discounting; thus, there is the tendency to attribute greater value to the present than to the future in making decisions. OBJECTIVE: In this project, we will investigate the relationship between unmet social needs, scarcity, and future discounting as well as their predictive power over time on medication adherence in children with asthma. METHODS: This 12-month prospective observational cohort study will recruit 200 families of children aged 2 to 17 years at the Asthma Clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary care pediatric hospital in Montreal, Canada. The primary outcome will be adherence to controller medication, measured using the proportion of prescribed days covered during follow-up. Exploratory outcomes will include health care use. The main independent variables will be unmet social needs, scarcity, and future discounting, measured using validated instruments. These variables will be measured at recruitment as well as at 6- and 12-month follow-ups. Covariates will include sociodemographics, disease and treatment characteristics, and parental stress. Primary analysis will compare adherence to controller medication, measured using the proportion of prescribed days covered, between families with versus those without unmet social needs during the study period using multivariate linear regression. RESULTS: The research activities of this study began in December 2021. Participant enrollment and data collection began in August 2022 and are expected to continue until September 2024. CONCLUSIONS: This project will allow the documentation of the impact of unmet social needs, scarcity, and future discounting on adherence in children with asthma using robust metrics of adherence and validated measures of scarcity and future discounting. If the relationship between unmet social needs, behavioral factors, and adherence is supported by our findings, this will suggest the potential for novel targets for integrated social care interventions to improve adherence to controller medication and reduce risk across the life course for vulnerable children with asthma. TRIAL REGISTRATION: ClinicalTrials.gov NCT05278000; https://clinicaltrials.gov/ct2/show/NCT05278000. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37318.

Trends of COPD in Spain: Changes Between Cross Sectional Surveys 1997, 2007 and 2017.

INTRODUCTION: We aim to describe the changes in prevalence and risk factors associated to chronic obstructive pulmonary disease (COPD) in Spain, comparing three population-based studies conducted in three timepoints. METHODS: We compared participants from IBERPOC conducted in 1997, EPISCAN conducted in 2007 and EPISCAN II in 2017. COPD was defined as a postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) ratio <0.70, according to GOLD criteria; subsequently, also as the FEV1/FVC below the lower limit of normal (LLN). RESULTS: COPD prevalence in the population between 40 and 69 years decreased from 21.6% (95% CI 20.7%-23.2%) in 1997 to 8.8% (95% CI 8.2%-9.5%) in 2017, a 59.2% decline (p<0.001). In 2007, the prevalence was 7.7% (95% CI 6.8%-8.7%) with an upward trend of 1.1 percentage points in 2017 (p=0.073). Overall COPD prevalence decreased in men and women, although a significant increase was observed in the last decade in females (p<0.05). Current smokers significantly increased in the last decades (25.4% in 1997, 29.1% in 2007 and 23.4% in 2017; p<0.001). Regrettably, COPD underdiagnosis was constantly high, 77.6% in 1997, 78.4% in 2007, and to 78.2% in 2017 (p=0.95), higher in younger ages (40-49 yrs and 50-59 yrs) and also higher in women than in men in all three studies (p<0.05). CONCLUSIONS: We report a significant reduction of 59.2% in the prevalence of COPD in Spain from 1997 to 2017 in subjects aged 40-69 years. Our study highlights the significant underdiagnosis of COPD, particularly sustained in women and younger populations.

Mercury bioaccumulation patterns in fish from the Iténez river basin, Bolivian Amazon.

The bioaccumulation mechanism expresses an increment of mercury concentration along the lifetime of each individual. It is generally investigated along the age or size range of organisms from a same population. Water chemistry and trophic position are important factors that may influence the emergence of bioaccumulation patterns. In order to detect the influence of these parameters on fish mercury bioaccumulation patterns, we explored the relations between mercury concentration, size and isotopic trophic position of fish populations of six species (three non piscivorous and three piscivorous) in three rivers of the Iténez basin (Bolivia) with different sediment load in water and anthropogenic impact. Fishes of the Iténez basin showed fairly lower mercury contamination in relation to the regional context. They presented lower total mercury concentrations in unperturbed clear water river (average of 0.051 µg g(-1) for non piscivores; 0.088 µg g(-1) for piscivores), intermediate values (average of 0.05 and 0.104 µg g(-1)) in unperturbed white water river, whereas the highest values (average of 0.062 and 0.194 µg g(-1)) were found in the perturbed clear water river. Piscivore and invertivore species showed significant positive bioaccumulation patterns in the perturbed river and in the unperturbed white water river. No positive pattern was detected in the unperturbed clear water river. Positive patterns could not be attributed to differences in trophic condition and mean fish mercury concentration between populations. Bioaccumulation seems not to be the main factor to explain increased mercury concentrations in fish from the perturbed river.

[Chronic Obstructive Pulmonary Disease]. / Enfermedad pulmonar obstructiva crónica.

Chronic Obstructive Pulmonary Disease (COPD) is related to smoking as the main etiological agent although there are other risk factors that can interact influencing the development of the disease. The definition of COPD is based on three points: the presence of persistent respiratory symptoms, exposure to risk agents, and a non-reversible obstructive spirometric ratio. Forced spirometry with a bronchodilator test is necessary to confirm the diagnosis of COPD, however, attempts are being made to develop alternative methods for screening given the current significant underdiagnosis of this pathology.In order to advance in a more personalized medicine for the patient, classification tools have been adopted such as clinical phenotypes and treatable traits, allowing treatments to be adapted according to the characteristics of the patients. Non-pharmacological treatment (smoking cessation, vaccination, physical exercise...) are essential for the management of the disease, as well as pharmacological treatment based on clinical phenotypes. Eosinophils have become a key marker when establishing treatment with inhaled glucocorticoids.In the follow-up of the disease, it is very relevant to evaluate the degree of control being a fundamental element the absence of exacerbations given their implications in mortality, morbidity and quality of life of patients. More studies are needed to better define the phenotypes of exacerbations and their biomarkers.

Prevalence of Chronic Obstructive Pulmonary Disease in an Urban Area. Changes in COPD Ten Years on.

Purpose: The prevalence of Chronic obstructive pulmonary disease (COPD) in Spain has been evaluated in the last ten years by EPISCAN in 2007 and EPISCAN II in 2017. This study describes changes in the prevalence of COPD in an urban region of Spain in the last 10 years, its risk factors and underdiagnosis. Patients and Methods: Participants from the Autonomous Community of Madrid (Spain) were selected from both studies up to the age of 80 years. A descriptive analysis of their sociodemographic and clinical characteristics, as well as by gender, was conducted. COPD was defined by a post-bronchodilator ratio <0.70. Results: The prevalence of COPD in the Autonomous Community of Madrid increased non-significantly from 11.0% (95% CI: 8.9-13.5%) to 12.1% (95% CI: 9.6-15.1, p=0.612). However, the prevalence by gender showed an increase in women (5.6% to 14.7%, p<0.001) and a decrease in men (17.6% to 9.8%, p=0.08). Underdiagnosis was reduced from 81.0% to 67.9% (p=0.006), although with greater underdiagnosis in women (86.4% in EPISCAN and 100% in EPISCAN II). Smoking was higher in men than in women in EPISCAN (31.2% vs 23.0%, p<0.01) but with no differences by gender in EPISCAN II (25.5% men vs 26.0% women, p=0.146). Age, smoking, low BMI, and a sedentary lifestyle were consistently associated with COPD. Conclusion: In 10 years in Madrid, there have been no changes in the global prevalence of COPD, but there have been important changes in women, with an increase in its prevalence, smoking habit and underdiagnosis.

A systematic meta-review of patient-level predictors of psychological therapy outcome in major depressive disorder.

BACKGROUND: Psychological therapies are effective for treating major depressive disorder, but current clinical guidelines do not provide guidance on the personalization of treatment choice. Established predictors of psychotherapy treatment response could help inform machine learning models aimed at predicting individual patient responses to different therapy options. Here we sought to comprehensively identify known predictors. METHODS: EMBASE, Medline, PubMed, PsycINFO were searched for systematic reviews with or without meta-analysis published until June 2020 to identify individual patient-level predictors of response to psychological treatments. 3113 abstracts were identified and 300 articles assessed. We qualitatively synthesized our findings by predictor category (sociodemographic; symptom profile; social support; personality features; affective, cognitive, and behavioural; comorbidities; neuroimaging; genetics) and treatment type. We used the AMSTAR 2 to evaluate the quality of included reviews. RESULTS: Following screening and full-text assessment, 27 systematic reviews including 12 meta-analyses were eligible for inclusion. 74 predictors emerged for various psychological treatments, primarily cognitive behavioural therapy, interpersonal therapy, and mindfulness-based cognitive therapy. LIMITATIONS: A paucity of studies examining predictors of psychological treatment outcome, as well as methodological heterogeneities and publication biases limit the strength of the identified predictors. CONCLUSIONS: The synthesized predictors could be used to supplement clinical decision-making in selecting psychological therapies based on individual patient characteristics. These predictors could also be used as a priori input features for machine learning models aimed at predicting a given patient's likelihood of response to different treatment options for depression, and may contribute toward the development of patient-specific treatment recommendations in clinical guidelines.

Evaluating the perceived utility of an artificial intelligence-powered clinical decision support system for depression treatment using a simulation center.

Aifred is a clinical decision support system (CDSS) that uses artificial intelligence to assist physicians in selecting treatments for major depressive disorder (MDD) by providing probabilities of remission for different treatment options based on patient characteristics. We evaluated the utility of the CDSS as perceived by physicians participating in simulated clinical interactions. Twenty physicians who were either staff or residents in psychiatry or family medicine completed a study in which they had three 10-minute clinical interactions with standardized patients portraying mild, moderate, and severe episodes of MDD. During these scenarios, physicians were given access to the CDSS, which they could use in their treatment decisions. The perceived utility of the CDSS was assessed through self-report questionnaires, scenario observations, and interviews. 60% of physicians perceived the CDSS to be a useful tool in their treatment-selection process, with family physicians perceiving the greatest utility. Moreover, 50% of physicians would use the tool for all patients with depression, with an additional 35% noting that they would reserve the tool for more severe or treatment-resistant patients. Furthermore, clinicians found the tool to be useful in discussing treatment options with patients. The efficacy of this CDSS and its potential to improve treatment outcomes must be further evaluated in clinical trials.

Preventing nipple pain/trauma in breastfeeding women: a best practice implementation project at the Marqués de Valdecilla University Hospital (Spain).

OBJECTIVES: To assess compliance with recommendations to alleviate nipple pain and/or trauma (NPT) and to reduce the rate of breastfeeding abandonment for this reason. INTRODUCTION: As a fundamental priority, health programmes encourage mothers to breastfeed exclusively for the first 6 months of the baby's life and to supplement breast milk with other foods up to the age of 2 years. However, the presence of NPT can reduce or prevent compliance with this recommendation. METHODS: The project was designed and carried out using a framework based on the JBI Practical Application of Clinical Evidence System (JBI-PACES). Six audit criteria were used in preaudits and postaudits to observe any changes in compliance with the recommendations. Between audits, the Getting Research into Practice (GRiP) tool was used to identify stakeholders, barriers and facilitators of the project. RESULTS: Two hundred and sixty-seven breastfeeding women were studied in the baseline phase and 275 during follow-up. Compliance in four criteria improved, and the rates of NPT decreased (pain: from 63.3 to 53.5%; P  = 0.02; trauma: from 37.8 to 24.7%; P  = 0.01). The proportion of women advised by qualified personnel increased from 63 to 88% whereas those who cited pain as the reason for abandoning exclusive breastfeeding decreased from 1.5 to 1.1%. CONCLUSION: This evidence-based implementation project achieved significantly improved compliance rates in most of the evidence-based criteria considered. In consequence, the prevalence of NPT fell significantly. Nevertheless, there was no significant impact on the proportion of mothers abandoning breastfeeding for this reason.

Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial.

Background: The use of IL-6 blockers in COVID-19 hospitalized patients has been associated with a reduction in mortality compared to standard care. However, many uncertainties remain pertaining to optimal intervention time, administration schedule, and predictors of response. To date, data on the use of subcutaneous sarilumab is limited and no randomized trial results are available. Methods: Open label randomized controlled trial at a single center in Spain. We included adult patients admitted with microbiology documented COVID-19 infection, imaging confirmed pneumonia, fever and/or laboratory evidence of inflammatory phenotype, and no need for invasive ventilation. Participants were randomly assigned to receive sarilumab, a single 400 mg dose in two 200 mg subcutaneous injections, added to standard care or standard care, in a 2:1 proportion. Primary endpoints included 30-day mortality, mean change in clinical status at day 7 scored in a 7-category ordinal scale ranging from death (category 1) to discharge (category 7), and duration of hospitalization. The primary efficacy analysis was conducted on the intention-to-treat population. Results: A total of 30 patients underwent randomization: 20 to sarilumab and 10 to standard care. Most patients were male (20/30, 67%) with a median (interquartile range) age of 61.5 years (56-72). At day 30, 2/20 (10%) patients died in the sarilumab arm vs. none (0/10) in standard care (Log HR 15.11, SE 22.64; p = 0.54). At day 7, no significant differences were observed in the median change in clinical status (2 [0-3]) vs. 3 [0-3], p = 0.32). Median time to discharge (days) was similar (7 [6-11] vs. 6 [4-12]; HR 0.65, SE 0.26; p = 0.27). No significant differences were detected in the rate of progression to invasive and noninvasive mechanical ventilation. Conclusions and Relevance: Our pragmatic pilot study has failed to demonstrate the benefit of adding subcutaneous sarilumab to standard care for mortality by 30 days, functional status at day 7, or hospital stay. Findings herein do not exclude a potential effect of sarilumab in severe COVID-19 but adequately powered blinded randomized phase III trials are warranted to assess the impact of the subcutaneous route and a more selected target population. Trial Registration: www.ClinicalTrials.gov, Identifier: NCT04357808.

Single-embryo transfer: a key strategy to reduce the risk for multiple pregnancy in assisted human reproduction.

In the early days of assisted reproductive technology (ART), the main target was achieving gestation. Success rates were low, and multiple embryo transfers became common practice, with multiple pregnancies being 20 times higher than in natural conception. Multiple pregnancy is associated with a higher risk of complications for the mother and the baby than a singleton pregnancy. Added to healthcare costs, multiple pregnancy also involves other costs and psychosocial risks, with a high social and health costs. At present, success rates of assisted human reproduction (AHR) have improved dramatically, partially due to advances in laboratory techniques such as culture of blastocyst-stage embryos and vitrification. Additionally, there is a wide range of counseling, health and economic policies that have demonstrated being effective in increasing single-embryo transfer (SET) practices and reducing multiple pregnancies, which ensures satisfactory success rates. Therefore, single-embryo transfer emerges as the approach of choice for AHR to result in a full-term healthy newborn.