Exhaled Volatile Organic Compounds for Asthma Control Classification in Children with Moderate to Severe Asthma: Results from the SysPharmPediA Study.

RATIONALE: Early identification of children with poorly controlled asthma is imperative for optimizing treatment strategies. The analysis of exhaled volatile organic compounds (VOCs) is an emerging approach to identify prognostic and diagnostic biomarkers in pediatric asthma. OBJECTIVES: To assess the accuracy of gas chromatography-mass spectrometry based exhaled metabolite analysis to differentiate between controlled and uncontrolled pediatric asthma. METHODS: This study encompassed a discovery (SysPharmPediA) and validation phase (U-BIOPRED, PANDA). Firstly, exhaled VOCs that discriminated asthma control levels were identified. Subsequently, outcomes were validated in two independent cohorts. Patients were classified as controlled or uncontrolled, based on asthma control test scores and number of severe attacks in the past year. Additionally, potential of VOCs in predicting two or more future severe asthma attacks in SysPharmPediA was evaluated. MEASUREMENTS AND MAIN RESULTS: Complete data were available for 196 children (SysPharmPediA=100, U-BIOPRED=49, PANDA=47). In SysPharmPediA, after randomly splitting the population into training (n=51) and test sets (n=49), three compounds (acetophenone, ethylbenzene, and styrene) distinguished between uncontrolled and controlled asthmatics. The area under the receiver operating characteristic curve (AUROCC) for training and test sets were respectively: 0.83 (95% CI: 0.65-1.00) and 0.77 (95% CI: 0.58-0.96). Combinations of these VOCs resulted in AUROCCs of 0.74 ±0.06 (UBIOPRED) and 0.68 ±0.05 (PANDA). Attacks prediction tests, resulted in AUROCCs of 0.71 (95% CI 0.51-0.91) and 0.71 (95% CI 0.52-0.90) for training and test sets. CONCLUSIONS: Exhaled metabolites analysis might enable asthma control classification in children. This should stimulate further development of exhaled metabolites-based point-of-care tests in asthma.

Health Literacy in Pediatric Consultations on Allergy Prevention.

BACKGROUND: The first 3 years of life offer an opportunity to prevent allergic diseases. Pediatricians are an important source of health information for parents. However, a certain degree of health literacy is necessary to understand, appraise, and apply preventive behavior, which can be supported by health literacy (HL) sensitive consultations and a HL friendly environment. OBJECTIVE: In this study, we want to shed light on how pediatricians in outpatient care in Germany advise on early childhood allergy prevention (ECAP) and how they consider parental HL. METHODS: We conducted 19 semi-standardized telephone interviews with pediatricians from North-Rhine-Westphalia and Bavaria. The interviews were audio-recorded, transcribed, pseudonymized, and subjected to content analysis. KEY RESULTS: Current ECAP recommendations were well known among our sample. Despite the shift of evidence from avoidance of allergens toward early exposure, providing advice on ECAP was considered non-controversial and it was widely assumed that recommendations were easy to understand and apply for parents. However, ECAP was treated as an implicit topic resonating among others like infant nutrition and hygiene. Regarding HL, our interview partners were not aware of HL as a concept. However, they deemed it necessary to somehow assess parental information level and ability to understand provided information. Formal HL screening was not applied, but implicit strategies based on intuition and experience. Concerning effective HL-sensitive communication techniques, interviewees named the adaptation of language and visual support of explanations. More advanced techniques like Teach Back were considered too time-consuming. Medical assistants were considered important in providing an HL-sensitive environment. Time constraints and the high amount of information were considered major barriers regarding HL-sensitive ECAP counseling. CONCLUSION: It seems warranted to enhance professional education and training for pediatricians in HL and HL-sensitive communication, to reach all parents with HL-sensitive ECAP counseling. [HLRP: Health Literacy Research and Practice. 2024;8(2):e47-e61.].

PLAIN LANGUAGE SUMMARY: We asked pediatricians how they advise parents on prevention of allergy in children. We found that pediatricians were well aware of the recommendations on allergy prevention, but they did not pass on all the information to parents. The HL of parents (that is the ability to find, understand, appraise, and apply health information) was not an important issue for the doctors.

Directed acyclic graph for epidemiological studies in childhood food allergy: Construction, user's guide, and application.

Understanding modifiable prenatal and early life causal determinants of food allergy is important for the prevention of the disease. Randomized clinical trials studying environmental and dietary determinants of food allergy may not always be feasible. Identifying risk/protective factors for early-life food allergy often relies on observational studies, which may be affected by confounding bias. The directed acyclic graph (DAG) is a causal diagram useful to guide causal inference from observational epidemiological research. To date, research on food allergy has made little use of this promising method. We performed a literature review of existing evidence with a systematic search, synthesized 32 known risk/protective factors, and constructed a comprehensive DAG for early-life food allergy development. We present an easy-to-use online tool for researchers to re-construct, amend, and modify the DAG along with a user's guide to minimize confounding bias. We estimated that adjustment strategies in 57% of previous observational studies on modifiable factors of childhood food allergy could be improved if the researchers determined their adjustment sets by DAG. Future researchers who are interested in the causal inference of food allergy development in early life can apply the DAG to identify covariates that should and should not be controlled in observational studies.

M9657 Is a Bispecific Tumor-Targeted Anti-CD137 Agonist That Induces MSLN-Dependent Antitumor Immunity without Liver Inflammation.

The costimulatory receptor CD137 (also known as TNFRSF9 or 4-1BB) sustains effective cytotoxic T-cell responses. Agonistic anti-CD137 cancer immunotherapies are being investigated in clinical trials. Development of the first-generation CD137-agonist monotherapies utomilumab and urelumab was unsuccessful due to low antitumor efficacy mediated by the epitope recognized on CD137 or hepatotoxicity mediated by Fcγ receptors (FcγR) ligand-dependent CD137 activation, respectively. M9657 was engineered as a tetravalent bispecific antibody (mAb2) in a human IgG1 backbone with LALA mutations to reduce binding to FCγRs. Here, we report that M9657 selectively binds to mesothelin (MSLN) and CD137 with similar affinity in humans and cynomolgus monkeys. In a cellular functional assay, M9657 enhanced CD8+ T cell-mediated cytotoxicity and cytokine release in the presence of tumor cells, which was dependent on both MSLN expression and T-cell receptor/CD3 activation. Both FS122m, a murine surrogate with the same protein structure as M9657, and chimeric M9657, a modified M9657 antibody with the Fab portion replaced with an anti-murine MSLN motif, demonstrated in vivo antitumor efficacy against various tumors in wild-type and human CD137 knock-in mice, and this was accompanied by activated CD8+ T-cell infiltration in the tumor microenvironment. The antitumor immunity of M9657 and FS122m depended on MSLN expression density and the mAb2 structure. Compared with 3H3, a murine surrogate of urelumab, FS122m and chimeric M9657 displayed significantly lower on-target/off-tumor toxicity. Taken together, M9657 exhibits a promising profile for development as a tumor-targeting immune agonist with potent anticancer activity without systemic immune activation and associated hepatotoxicity.

[Frequency of Utilization of Medical and Paramedical Care in Infants with Excessive Crying: Cross- Sectional Analysis and Parent Survey]. / Inanspruchnahme medizinischer und paramedizinischer Versorgung bei Säuglingen mit exzessivem Schreien: Querschnittsanalyse und Eltern-Survey.

BACKGROUND: Infants can present in the first year of life with excessive, recurrent crying without an apparent illness or failure to thrive. The excessive crying results in a wide variety of problems for infants, parents and health care service. OBJECTIVES: This study aimed at evaluating how often parents of children with excessive crying seek help in the medical and paramedical health care system and which therapies are prescribed. MATERIALS AND METHODS: This study uses data collected within KUNO Kids health study. Families who participated completed questionnaires 4 weeks after birth and answered questions which screened for excessive crying. Families whose child was screened positive completed an additional questionnaire on symptoms, parental management and health care utilization. Data were analysed using descriptive statistics. RESULTS: We received 238 questionnaires from children with excessive crying, 105 fulfilled the modified Wessel criteria. Of these 37 children (36%) were seen by a pediatrician because of crying. 57 (55%) received medications by the pediatrician. 51 (49%) of the parents specified that they also used paramedical therapies due to crying or whining, most often osteopathy. 45 (43%) adapted their own nutrition or their child's nutrition. CONCLUSIONS: Our study shows that parents experience problems in dealing excessive crying. Frequent consultations with pediatricians or use of paramedical therapies are common, demanding additional resources. The parents received different diagnoses for excessive crying. Available drugs like Simeticon, homeopathy or manual therapy are recommended and applied despite largely missing evidence.

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial.

BACKGROUND: ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. METHODS: This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. RESULTS: The pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median). CONCLUSION: The participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.

COVID-19 crisis management of German ICU clinicians in leadership - a metaphor analysis.

The COVID-19 pandemic coincided with an already long-standing crisis in health systems around the world characterized by economic pressure and increasing staff shortage. "Crisis" became a global metaphor to convey collective experiences of the COVID-19 threat. Little is known on how crisis metaphors influence thought and speech on crisis management and the challenging staff situation of intensive care unit (ICU) clinicians in leadership positions and how they act. Therefore, we were interested in (1) which metaphorical concepts ICU clinicians in leadership use to express experiences and strategies in dealing with coinciding crises, (2) how these change over time, and (3) how metaphors in speech reveal self-images of crisis management. We conducted a systematic metaphor analysis focusing on data from three participants of a qualitative interview study with twenty-four healthcare professionals in ICUs in Germany. The participants were interviewed at two time points between April 2020 and March 2021. We identified and reconstructed metaphorical concepts of three interviewees (ICU clinicians in leadership) with regard to the pandemic management, and developed a typology based on the dimensions of mood, modus operandi, location, and scope. The typology consists of eight self-images (protagonists) for the crisis management of ICU clinicians in leadership, such as the figure of the soldier ("to unite everyone behind this flag"), the distributor ("sometimes it is a crazy patchwork [wahnsinniges Gestückel]") or the critic ("we are the fool for everything"). They embody different qualities of a leader and refer to intra- and inter-role conflicts within multiple crisis conditions. Metaphor analysis reveals different self-images of ICU leadership clinicians in relation to crisis management. This illustrates that thinking and perceptions of crisis management may strongly differ between and within leaders and may change over the course of crises. Our findings highlight the need both to improve knowledge on challenges associated with leadership in crises and preparedness, and to support clinicians in their leadership by recognizing and addressing differences and changes in leaders' self-image.

Effect of QT interval-prolonging drugs taken in pregnancy on the neonatal QT interval.

Introduction: Acquired QT interval prolongations due to drug side effects can result in detrimental arrhythmia. Maternal use of placenta-permeable drugs may lead to fetal exposure, thus leading to an increased risk of neonatal QT prolongation and arrhythmia. Objectives: This study aimed to evaluate the influence of maternal QT-prolonging medication on the neonatal QT interval. Methods: In the prospective KUNO-Kids health study, an ongoing population-based birth cohort, we classified maternal medications according to the known risk of QT interval prolongation. Effects on the neonatal QT interval were tested by linear regression analyses, correcting for perinatal confounders (birth weight, gestational age, birth mode, and age at ECG recording). Subgroup analyses were performed for selective serotonin reuptake inhibitors, proton pump inhibitors, and antihistamine dimenhydrinate. Logistic regression analysis was performed using a QTc of 450 ms as the cut-off value. Results: A total of 2,550 pregnant women received a total of 3,990 medications, of which 315 were known to increase the risk of QT prolongation, resulting in 105 (4.1%) neonates exposed in the last month of pregnancy. Overall, the mean age of the neonates at ECG was 1.9 days and the mean QTc (Bazett) was 414 ms. Univariate (regression coefficient -2.62, p = 0.288) and multivariate (regression coefficient -3.55, p = 0.146) regression analyses showed no significant effect of fetal medication exposure on the neonatal QT interval, neither in the overall nor in the subgroup analysis. Logistic regression analysis showed no association of exposure to maternal medication with an increased risk of neonatal QT interval prolongation (OR (odds ratio) 0.34, p = 0.14). Conclusion: The currently used maternal medication results in a relevant number of fetuses exposed to QT interval-prolonging drugs. In our cohort, exposure was found to have no effect on the neonatal QT interval.

Trajectories of quality of life, return to work, psychopathology, and disability in survivors of the acute respiratory distress syndrome (ARDS): A three-year prospective cohort study (DACAPO).

PURPOSE: Describe the long-term development of outcomes for survivors of the Acute Respiratory Distress Syndrome (ARDS). MATERIAL AND METHODS: A cohort study with N = 877 ARDS survivors was conducted. Health related quality of life (HRQoL, Physical and Mental Component Scale: PCS, MCS of the SF-12), return to work (RtW), panic disorder, depressive symptoms (PHQD), and post-traumatic-stress-disorder (PTSD, PTSS-14) were assessed at 3, 6, 12, 24, and 36 months after discharge from ICU. RESULTS: PCS, MCS, and RtW increased during the first 12 months [e.g. PCS: Md = 36 (IQR 31-43) at 3 months, Md = 42 (IQR 34-52) at 12 months; MCS: Md = 44 (IQR 32-54) at 3 months, Md = 47 (IQR 33-57) at 12 months, RtW = 23.2% at 3 months, 54.5% at 12 months], and remained relatively stable afterwards. Proportion of major depressive syndrome decreased from 3 (14.2%) to 36 months (8.9%). Proportions of panic disorder (5.3% to 7.4%) and PTSD (27.1% to 32.6%) varied only slightly. CONCLUSIONS: Most of recovery in HRQoL and RtW occur during the first 12 months, after which a plateau is reached, indicating a chronification for many patients. Contrary to this, however, psychopathological symptoms remain stable, except for depressive symptoms. [200 words].

Pediatricians' experiences of managing outpatient care during the COVID-19 pandemic: A qualitative study in Germany.

Background: Pediatricians are important sources of information for parents regarding their children's health. During the COVID-19 pandemic, pediatricians faced a variety of challenges regarding information uptake and transfer to patients, practice organization and consultations for families. This qualitative study aimed at shedding light on German pediatricians' experiences of providing outpatient care during the first year of the pandemic. Methods: We conducted 19 semi-structured, in-depth interviews with pediatricians in Germany from July 2020 to February 2021. All interviews were audio recorded, transcribed, pseudonymized, coded, and subjected to content analysis. Results: Pediatricians felt able to keep up to date regarding COVID-19 regulations. However, staying informed was time consuming and onerous. Informing the patients was perceived as strenuous, especially when political decisions had not been officially communicated to pediatricians or if the recommendations were not supported by the professional judgment of the interviewees. Some felt that they were not taken seriously or adequately involved in political decisions. Parents were reported to consider pediatric practices as sources of information also for non-medical inquiries. Answering these questions was time consuming for the practice personnel and involved non-billable hours. Practices had to adapt their set-up and organization immediately to the new circumstances of the pandemic, which proved costly and laborious as well. Some changes in the organization of routine care, such as the separation of appointments for patients with acute infection from preventive appointments, were perceived as positive and effective by some study participants. Telephone and online consultations were established at the beginning of the pandemic and considered helpful for some situations, whereas for others these methods were deemed insufficient (e.g. for examinations of sick children). All pediatricians reported reduced utilization mainly due to a decline in acute infections. However, preventive medical check-ups and immunization appointments were reported to be mostly attended. Conclusion: Positive experiences of reorganizing pediatric practice should be disseminated as "best practices" in order to improve future pediatric health services. Further research could show how some of these positive experiences in reorganizing care during the pandemic are to be maintained by pediatricians in the future.

Correction: The Evaluation of Health Care Services for Children and Adolescents With Post-COVID-19 Condition: Protocol for a Prospective Longitudinal Study.

[This corrects the article DOI: 10.2196/41010.].

Parents' and Health Care Professionals' Perspectives on Prevention and Prediction of Food Allergies in Children: Protocol for a Qualitative Study.

BACKGROUND: Food allergy in children is increasing in prevalence in the western world and appears to become an important health problem. Parents of children at risk of food allergy live with the fear of allergic reaction, especially when the children are very young. The paradigm shift in allergy prevention in the last decade-away from allergen avoidance toward a tolerance induction approach-challenges both parents and health care professionals, as they have to deal with changing information and new evidence that often contradicts previous assumptions. Yet, research on health information-seeking behavior and needs of parents on primary prevention of food allergy in children as well as on prediction and prevention strategies of German health care professionals is lacking. OBJECTIVE: The aim of the study is to explore and understand parents' and health care professionals' perspectives on the prediction and prevention of food allergies. We are particularly interested in information needs, information seeking, and health care usage and place a special focus on families' experiences when their child is at risk or diagnosed with food allergies. Furthermore, food allergy prediction and prevention strategies of health care professionals will be explored. METHODS: This study is part of the NAMIBIO (food allergy biomarker) app consortium, which aims to identify early predictors for the development of food allergy in children and develop apps to guide health care professionals and parents of children with a high risk of food allergy toward prevention and timely tolerance induction. The study uses a qualitative approach with topic-guided interviews and focus groups with parents of children (0-3 years) and health care professionals. Data collection will continue until theoretical saturation is reached. The qualitative content analysis will be used according to Kuckartz to identify overarching themes toward information needs and seeking behavior as well as usage of health care and health care professionals' predictive and preventive strategies. In addition, a constructivist grounded theory approach will be used to explore and understand parents' experiences, interactions, and social processes in families in daily life. RESULTS: Recruitment and data collection started in February 2022 and is still ongoing. CONCLUSIONS: The qualitative study will provide insight into parents' information-seeking behavior and needs regarding the prevention of food allergy in children, parents' use of pediatric primary care, and health care professionals strategies for the prediction and prevention of food allergies in children. We assume that our results will highlight the challenges associated with the paradigm shift in allergy prevention for both parents and health care professionals. The results will be used to make practical recommendations from the user's perspective and inform the development of the NAMIBIO apps. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41436.

Epigenome-Wide Association Studies of the Fractional Exhaled Nitric Oxide and Bronchodilator Drug Response in Moderate-to-Severe Pediatric Asthma.

Asthma is the most prevalent pediatric chronic disease. Bronchodilator drug response (BDR) and fractional exhaled nitric oxide (FeNO) are clinical biomarkers of asthma. Although DNA methylation (DNAm) contributes to asthma pathogenesis, the influence of DNAm on BDR and FeNO is scarcely investigated. This study aims to identify DNAm markers in whole blood associated either with BDR or FeNO in pediatric asthma. We analyzed 121 samples from children with moderate-to-severe asthma. The association of genome-wide DNAm with BDR and FeNO has been assessed using regression models, adjusting for age, sex, ancestry, and tissue heterogeneity. Cross-tissue validation was assessed in 50 nasal samples. Differentially methylated regions (DMRs) and enrichment in traits and biological pathways were assessed. A false discovery rate (FDR) < 0.1 and a genome-wide significance threshold of p < 9 × 10-8 were used to control for false-positive results. The CpG cg12835256 (PLA2G12A) was genome-wide associated with FeNO in blood samples (coefficient= -0.015, p = 2.53 × 10-9) and nominally associated in nasal samples (coefficient = -0.015, p = 0.045). Additionally, three CpGs were suggestively associated with BDR (FDR < 0.1). We identified 12 and four DMRs associated with FeNO and BDR (FDR < 0.05), respectively. An enrichment in allergic and inflammatory processes, smoking, and aging was observed. We reported novel associations of DNAm markers associated with BDR and FeNO enriched in asthma-related processes.

The Evaluation of Health Care Services for Children and Adolescents With Post-COVID-19 Condition: Protocol for a Prospective Longitudinal Study.

BACKGROUND: Some children and adolescents suffer from late effects of a SARS-CoV-2 infection despite a frequently mild course of the disease. Nevertheless, extensive care for post-COVID-19 condition, also known as post-COVID-19 syndrome, in children and young people is not yet available. A comprehensive care network, Post-COVID Kids Bavaria (PoCo), for children and adolescents with post-COVID-19 condition has been set up as a model project in Bavaria, Germany. OBJECTIVE: The aim of this study is to evaluate the health care services provided within this network structure of care for children and adolescents with post-COVID-19 condition in a pre-post study design. METHODS: We have already recruited 117 children and adolescents aged up to 17 years with post-COVID-19 condition who were diagnosed and treated in 16 participating outpatient clinics. Health care use, treatment satisfaction, patient-reported outcomes related to health-related quality of life (the primary endpoint), fatigue, postexertional malaise, and mental health are being assessed at different time points (at baseline and after 4 weeks, 3 months, and 6 months) using routine data, interviews, and self-report questionnaires. RESULTS: The study recruitment process ran from April 2022 until December 2022. Interim analyses will be carried out. A full analysis of the data will be conducted after follow-up assessment is completed, and the results will be published. CONCLUSIONS: The results will contribute to the evaluation of therapeutic services provided for post-COVID-19 condition in children and adolescents, and avenues for optimizing care may be identified. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41010.

Identification of M4205─A Highly Selective Inhibitor of KIT Mutations for Treatment of Unresectable Metastatic or Recurrent Gastrointestinal Stromal Tumors.

The treatment of gastrointestinal stromal tumors (GISTs) driven by activating mutations in the KIT gene is a prime example of targeted therapy for treatment of cancer. The approval of the tyrosine kinase inhibitor imatinib has significantly improved patient survival, but emerging resistance under treatment and relapse is observed. Several additional KIT inhibitors have been approved; still, there is a high unmet need for KIT inhibitors with high selectivity and broad coverage of all clinically relevant KIT mutants. An imidazopyridine hit featuring excellent kinase selectivity was identified in a high-throughput screen (HTS) and optimized to the clinical candidate M4205 (IDRX-42). This molecule has a superior profile compared to approved drugs, suggesting a best-in-class potential for recurrent and metastatic GISTs driven by KIT mutations.

Development of Mothers' Health Literacy: Findings From the KUNO-Kids Study.

BACKGROUND AND OBJECTIVE: The aim of this study was to analyze the longitudinal development of health literacy (HL) in a large cohort of new mothers in Germany and to investigate which determinants are associated with the initial HL level and with change over time. METHODS: Longitudinal data from 1,363 mothers participating with their child in the KUNO-Kids Health Study was used; data were collected at birth of the child (baseline), after 6 and 12 months, using interviews and self-report questionnaires. The HL of mothers was assessed with the health care scale of the European Health Literacy Survey Questionnaire, which has 16 items on accessing, understanding, appraising, and applying health information in the health care setting. Latent growth curve models were used to analyze average trajectories and predictors of HL in the total sample and in the subgroup of first-time mothers. KEY RESULTS: HL values increased from baseline (M = 35.46, standard deviation [SD] = 7.34) over 6 months (M = 37.31, SD = 7.31) to 12 months (M = 38.01, SD = 7.41). The increase was statistically significant in the total sample (1.188, standard error [SE] = 0.087, p < .001) and in the subgroup of first-time mothers (1.357, SE = 0.113, p <. 001), with a steeper trajectory for mothers with lower HL at baseline. Several personal and situational variables were associated with HL at baseline (e.g., education, child health) and with its development (e.g., number of children). CONCLUSION: Overall, new mothers became slightly more health literate during their child's first year of life. However, some groups of mothers could benefit from support in developing HL skills even before childbirth. [HLRP: Health Literacy Research and Practice. 2023;7(1):e39-e51.] Plain Language Summary: We investigated how health literacy (that is the ability to find, understand, and apply health information) develops in new mothers in Germany. Mothers told us that this ability slightly improved during the child's first year of life. Some mothers still have difficulties in dealing with health information; these mothers should be supported even before childbirth.

Classifying asthma control using salivary and fecal bacterial microbiome in children with moderate-to-severe asthma.

BACKGROUND: Uncontrolled asthma can lead to severe exacerbations and reduced quality of life. Research has shown that the microbiome may be linked with asthma characteristics; however, its association with asthma control has not been explored. We aimed to investigate whether the gastrointestinal microbiome can be used to discriminate between uncontrolled and controlled asthma in children. METHODS: 143 and 103 feces samples were obtained from 143 children with moderate-to-severe asthma aged 6 to 17 years from the SysPharmPediA study. Patients were classified as controlled or uncontrolled asthmatics, and their microbiome at species level was compared using global (alpha/beta) diversity, conventional differential abundance analysis (DAA, analysis of compositions of microbiomes with bias correction), and machine learning [Recursive Ensemble Feature Selection (REFS)]. RESULTS: Global diversity and DAA did not find significant differences between controlled and uncontrolled pediatric asthmatics. REFS detected a set of taxa, including Haemophilus and Veillonella, differentiating uncontrolled and controlled asthma with an average classification accuracy of 81% (saliva) and 86% (feces). These taxa showed enrichment in taxa previously associated with inflammatory diseases for both sampling compartments, and with COPD for the saliva samples. CONCLUSION: Controlled and uncontrolled children with asthma can be differentiated based on their gastrointestinal microbiome using machine learning, specifically REFS. Our results show an association between asthma control and the gastrointestinal microbiome. This suggests that the gastrointestinal microbiome may be a potential biomarker for treatment responsiveness and thereby help to improve asthma control in children.