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Fexuprazan, a novel potassium-competitive acid blocker, is expected to be used for the prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) induced ulcer. This study aimed to evaluate pharmacokinetic (PK) interactions between fexuprazan and NSAIDs in healthy subjects. A randomized, open-label, multicenter, six-sequence, one-way crossover study was conducted in healthy male subjects. Subjects randomly received one of the study drugs (fexuprazan 40 mg BID, celecoxib 200 mg BID, naproxen 500 mg BID, or meloxicam 15 mg QD) for 5 or 7 days in the first period followed by the combination of fexuprazan and one of NSAIDs for the same days and the perpetrator additionally administered for 1-2 days in the second period. Serial blood samples for PK analysis were collected until 48- or 72-h post-dose at steady state. PK parameters including maximum plasma concentration at steady state (Cmax,ss) and area under plasma concentration-time curve over dosing interval at steady state (AUCτ,ss) were compared between monotherapy and combination therapy. The PKs of NSAIDs were not significantly altered by fexuprazan. For fexuprazan, differences in PK parameters (22% in Cmax, 19% in AUCτ,ss) were observed when co-administered with naproxen, but not clinically significant. The geometric mean ratio (90% confidence interval) of combination therapy to monotherapy for Cmax,ss and AUCτ,ss was 1.22 (1.02-1.46) and 1.19 (1.00-1.43), respectively. There were no significant changes in the systemic exposure of fexuprazan by celecoxib and meloxicam. Fexuprazan and NSAIDs did not show clinically meaningful PK interactions.
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Antiinflamatorios no Esteroideos , Estudios Cruzados , Interacciones Farmacológicas , Humanos , Masculino , Antiinflamatorios no Esteroideos/farmacocinética , Antiinflamatorios no Esteroideos/administración & dosificación , Adulto , Adulto Joven , Voluntarios Sanos , Área Bajo la Curva , Meloxicam/farmacocinética , Meloxicam/administración & dosificación , Naproxeno/farmacocinética , Naproxeno/administración & dosificación , Celecoxib/farmacocinética , Celecoxib/administración & dosificación , Persona de Mediana EdadRESUMEN
BACKGROUND: Childhood obesity has emerged as a major health issue due to the rapid growth in the prevalence of obesity among young children worldwide. Establishing healthy eating habits and lifestyles in early childhood may help children gain appropriate weight and further improve their health outcomes later in life. OBJECTIVE: This study aims to classify clusters of young children according to their eating habits and identify the features of each cluster as they relate to childhood obesity. METHODS: A total of 1280 children were selected from the Panel Study on Korean Children. Data on their eating habits (eating speed, mealtime regularity, consistency of food amount, and balanced eating), sleep hours per day, outdoor activity hours per day, and BMI were obtained. We performed a cluster analysis on the children's eating habits using k-means methods. We conducted ANOVA and chi-square analyses to identify differences in the children's BMI, sleep hours, physical activity, and the characteristics of their parents and family by cluster. RESULTS: At both ages (ages 5 and 6 years), we identified 4 clusters based on the children's eating habits. Cluster 1 was characterized by a fast eating speed (fast eaters); cluster 2 by a slow eating speed (slow eaters); cluster 3 by irregular eating habits (poor eaters); and cluster 4 by a balanced diet, regular mealtimes, and consistent food amounts (healthy eaters). Slow eaters tended to have the lowest BMI (P<.001), and a low proportion had overweight and obesity at the age of 5 years (P=.03) and 1 year later (P=.005). There was a significant difference in sleep time (P=.01) and mother's education level (P=.03) at the age of 5 years. Moreover, there was a significant difference in sleep time (P=.03) and the father's education level (P=.02) at the age of 6 years. CONCLUSIONS: Efforts to establish healthy eating habits in early childhood may contribute to the prevention of obesity in children. Specifically, providing dietary guidance on a child's eating speed can help prevent childhood obesity. This research suggests that lifestyle modification could be a viable target to decrease the risk of childhood obesity and promote the development of healthy children. Additionally, we propose that future studies examine long-term changes in obesity resulting from lifestyle modifications in children from families with low educational levels.
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Obesidad Infantil , Humanos , Niño , Preescolar , Obesidad Infantil/epidemiología , Estilo de Vida , Conducta Alimentaria , Análisis por Conglomerados , República de Corea/epidemiologíaRESUMEN
Observational data (e.g. electronic health records) has become increasingly important in evidence-based research on dynamic treatment regimes, which tailor treatments over time to patients based on their characteristics and evolving clinical history. It is of great interest for clinicians and statisticians to identify an optimal dynamic treatment regime that can produce the best expected clinical outcome for each individual and thus maximize the treatment benefit over the population. Observational data impose various challenges for using statistical tools to estimate optimal dynamic treatment regimes. Notably, the task becomes more sophisticated when the clinical outcome of primary interest is time-to-event. Here, we propose a matching-based machine learning method to identify the optimal dynamic treatment regime with time-to-event outcomes subject to right-censoring using electronic health record data. In contrast to the established inverse probability weighting-based dynamic treatment regime methods, our proposed approach provides better protection against model misspecification and extreme weights in the context of treatment sequences, effectively addressing a prevalent challenge in the longitudinal analysis of electronic health record data. In simulations, the proposed method demonstrates robust performance across a range of scenarios. In addition, we illustrate the method with an application to estimate optimal dynamic treatment regimes for patients with advanced non-small cell lung cancer using a real-world, nationwide electronic health record database from Flatiron Health.
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Registros Electrónicos de Salud , Aprendizaje Automático , Humanos , Registros Electrónicos de Salud/estadística & datos numéricos , Modelos Estadísticos , Neoplasias Pulmonares/tratamiento farmacológico , Resultado del Tratamiento , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológicoRESUMEN
PURPOSE: Diffuse gliomas are managed with radiation and temozolomide; however, this therapy often results in hematologic toxicities. Patients undergoing chemoradiation also risk contracting Pneumocystis jirovecii pneumonia (PJP), and frequently receive prophylaxis against PJP during treatment. Independent of chemoradiation, some PJP prophylaxis drugs have the potential to cause myelosuppression, which could require cessation of chemotherapy. Here, we evaluate differences in the frequency of hematologic toxicities during chemoradiation when patients receive PJP prophylaxis. METHODS: This retrospective chart review evaluated patients with primary brain tumors treated with radiation and concurrent temozolomide. Analyses were performed to assess the effect of the type of PJP prophylaxis on risk for neutropenia, lymphopenia, or thrombocytopenia and the severity of these adverse effects as defined using the Common Terminology Criteria for Adverse Events. RESULTS: Of the 217 patients included in this analysis, 144 received trimethoprim-sulfamethoxazole (TMP/SMX) and 69 received pentamidine. Of the patients who received TMP/SMX, 15.3% developed an absolute neutrophil count < 1500 cells/µL compared with 7.2% of patients receiving pentamidine (p = 0.10). Platelet count < 100,000/µL occurred in 18.1% of patients who received TMP/SMX and 20.3% of patients who received pentamidine (p = 0.70). No significant differences in lymphocyte counts between therapies were seen. Severity of hematologic toxicities were similar between PJP prophylaxis groups. CONCLUSION: These findings suggest that the type of PJP prophylaxis does not significantly affect the risk for hematologic toxicity in brain tumor patients receiving radiation and temozolomide. Additional studies are merited to evaluate the higher rate of neutropenia in patients on TMP/SMX observed in this study.
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Neoplasias Encefálicas , Neutropenia , Pneumocystis carinii , Neumonía por Pneumocystis , Humanos , Neumonía por Pneumocystis/etiología , Neumonía por Pneumocystis/prevención & control , Combinación Trimetoprim y Sulfametoxazol/efectos adversos , Pentamidina/farmacología , Pentamidina/uso terapéutico , Estudios Retrospectivos , Temozolomida/efectos adversos , Neutropenia/inducido químicamente , Neutropenia/prevención & control , Neoplasias Encefálicas/radioterapiaRESUMEN
INTRODUCTION: Cystometry is essential for evaluating bladder function. However, children may react negatively to the physical pain of urethral catheterization or anxiety and fear of an unfamiliar environment. These pain responses during the cystometry procedure may interfere with the cystometry procedure and make it difficult to interpret the cystometry result. In this regard, the International Children's Continence Society has advised performing cystometry while holding infants as an effective nonpharmacological pain management method, but there is insufficient evidence to support this. PURPOSE: This study aimed to analyze the effect of parental holding on reducing pain in children during cystometry. METHODS: This was an experimental study in a randomized controlled pre-post test design. A total of 64 participants aged 6-18 months were recruited. During cystometry, the participants in the experimental group were placed on the parent's laps and held in the parents' arms. The participants in the control group were laid down on the examination table. During the procedure, both groups of parents were allowed to touch their children in all ways except holding them and to use the pacifier if they wished. The behavioral (face, leg, activity, cry, consolability scale) and physiological (oxygen saturation and heart rate) pain responses were measured at three-time points (immediately, 3, and 10 min after urethral catheter insertion). RESULTS: Comparing the two groups, in the experimental group, the behavioral pain response at 3 min after urethral catheter insertion (t = -2.165, p = 0.034) and 10 min after (t = -3.155, p = 0.002) was decreased compared with that immediately after urethral catheter insertion. In addition, oxygen saturation increased more (t = 2.021, p = 0.048), and the heart rate decreased more (t = -2.033, p = 0.047) at 10 min than at 3 min after urethral catheter insertion in the experimental group. CONCLUSIONS: This study revealed that parental holding could reduce pain responses during cystometry in children. Further research is required to confirm the applicability and usefulness of parental holding during cystometry.
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Dolor , Cateterismo Urinario , Lactante , Niño , Humanos , Preescolar , Dolor/etiología , Frecuencia Cardíaca , Ansiedad/etiología , PadresRESUMEN
This scoping review aimed to explore the characteristics of neonatal palliative care in the neonatal intensive care unit, including the features, contents, and experiences of infants, parents, and nurses during palliative care. Five databases (PubMed, Cochrane, CINAHL, Research Information Sharing Service, and Korean Studies Information Service System) were searched to identify relevant articles published between 2011 and 2020. From the systematic search and review process, 13 studies that met the eligibility criteria were selected for the analysis. From the literature review, 2 key principles were found to facilitate neonatal palliative care: family-centered care and integrative care in the neonatal intensive care unit. In addition, the themes found in this review included (1) providing comfortable care to dying infants with respect to infants and offering parents choices, (2) therapeutic communication, (3) support with respect, and (4) bereavement care for parents of dying infants in the neonatal intensive care unit. Caregivers require effective communication, manpower support, emotional support, educational programs, and well-defined protocols. The evidence mapped and synthesized in this review indicates the need to facilitate the provision of palliative care in the neonatal intensive care unit in line with the unique needs of infants, parents, and nurses.
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Cuidados Paliativos al Final de la Vida , Atención de Enfermería , Humanos , Lactante , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Cuidados Paliativos/psicología , Padres/psicologíaRESUMEN
Fexuprazan is a potassium-competitive acid blocker approved for treating gastric-acid-related diseases. Although the effectiveness of the recent formulation fexuprazan 10 mg has been demonstrated in Phase 3 clinical trials, data on the pharmacokinetics (PKs) of administering fexuprazan 10 mg twice daily at a 12 h interval are lacking. Moreover, it is imperative to ensure the bioequivalence of the new formulation with the previously approved 40 mg formulation. This study evaluated the pharmacokinetics (PKs) of the single- and multiple-dose oral administration of fexuprazan 10 mg tablets in healthy participants (Part 1) and investigated their bioequivalence with 40 mg tablets (Part 2). Part 1 comprised a single- and multiple-dose, one-sequence, two-period design and eight participants, while Part 2 comprised a single-dose, 2 × 2 crossover design and 24 participants. In Part 1, in Periods 1 and 2, participants received single and multiple doses (twice daily) of fexuprazan 10 mg, respectively. The maximum plasma concentration (Cmax) area under the concentration-time curve from 0 to 12 h (AUC0-12h) of the multiple-dose participants was approximately double that of the single-dose participants. In Part 2, the geometric mean ratios (90% confidence intervals) for Cmax and AUC from zero to the time of the last quantifiable concentration (AUClast) of the use of four fexuprazan 10 mg tablets to those of one fexuprazan 40 mg tablet were 1.0290 (0.9352-1.1321) and 1.0290 (0.9476-1.1174), respectively, meeting the bioequivalence criteria. Favorable PKs were observed after single and multiple administrations of one fexuprazan 10 mg tablet, and four fexuprazan 10 mg tablets were pharmacokinetically equivalent to one fexuprazan 40 mg tablet.
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Objective: We developed a new scale-the Social Adjustment Scale for Youth Cancer Survivors-and examined its psychometric properties. Methods: In the scale's development stage, preliminary items were constructed based on the results of a concept analysis of the hybrid model, literature review, and interviews. These items were then reviewed through content validity and cognitive interviews. In the validation stage, 136 survivors were recruited from two children's cancer centers in Seoul, South Korea. An exploratory factor analysis was performed to identify a set of constructs, and validity and reliability were tested. Results: Starting with 70 items constructed through literature review and interviews with youth survivors, the final scale comprised 32 items. The exploratory factor analysis identified four domains-namely, role achievement in one's present position, harmony in relationships, disclosure and acceptance of cancer history, and preparation and expectation for future roles. Correlations with quality of life indicated good convergent validity (r â= â0.82, P â< â0.001). The Cronbach's α of the overall scale was 0.95, indicating excellent internal consistency; and the intraclass correlation coefficient was 0.94 (P â< â0.001), suggesting high test-retest reliability. Conclusions: The Social Adjustment Scale for Youth Cancer Survivors exhibited acceptable psychometric properties in measuring the social adjustment of youth cancer survivors. It can be used to identify youths facing difficulty in adjusting to society after treatment and to investigate the effect of interventions implemented to promote social adjustment among youth cancer survivors. Future research is needed to examine the applicability of the scale in patients across diverse cultural backgrounds and healthcare systems.
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Young children are increasingly exposed to an obesogenic environment through increased intake of processed food and decreased physical activity. Mothers' perceptions of obesity and parenting styles influence children's abilities to maintain a healthy weight. This study developed a prediction model for childhood obesity in 10-year-olds, and identify relevant risk factors using a machine learning method. Data on 1185 children and their mothers were obtained from the Korean National Panel Study. A prediction model for obesity was developed based on ten factors related to children (gender, eating habits, activity, and previous body mass index) and their mothers (education level, self-esteem, and body mass index). These factors were selected based on the least absolute shrinkage and selection operator. The prediction model was validated with an Area Under the Receiver Operator Characteristic Curve of 0.82 and an accuracy of 76%. Other than body mass index for both children and mothers, significant risk factors for childhood obesity were less physical activity among children and higher self-esteem among mothers. This study adds new evidence demonstrating that maternal self-esteem is related to children's body mass index. Future studies are needed to develop effective strategies for screening young children at risk for obesity, along with their mothers.
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Obesidad Infantil , Femenino , Humanos , Niño , Preescolar , Obesidad Infantil/diagnóstico , Obesidad Infantil/epidemiología , Obesidad Infantil/etiología , Conducta Alimentaria , Índice de Masa Corporal , Madres , República de Corea/epidemiología , Responsabilidad ParentalRESUMEN
BACKGROUND: Fetal echocardiography is widely available, but normative data are not robust. In this pilot study, the authors evaluated (1) the feasibility of prespecified measurements in a normal fetal echocardiogram to inform study design and (2) measurement variability to assign thresholds of clinical significance and guide analyses in larger fetal echocardiographic Z score initiatives. METHODS: Images from predefined gestational age groups (16-20, >20-24, >24-28, and >28-32 weeks) were retrospectively analyzed. Fetal echocardiography expert raters attended online group training and then independently analyzed 73 fetal studies (18 per age group) in a fully crossed design of 53 variables; each observer repeated measures for 12 fetuses. Kruskal-Wallis tests were used to compare measurements across centers and age groups. Coefficients of variation (CoVs) were calculated at the subject level for each measurement as the ratio of SD to mean. Intraclass correlation coefficients were used to show inter- and intrarater reliabilities. Cohen's d > 0.8 was used to define clinically important differences. Measurements were plotted against gestational age, biparietal diameter, and femur length. RESULTS: Expert raters completed each set of measurements in a mean of 23 ± 9 min/fetus. Missingness ranged from 0% to 29%. CoVs were similar across age groups for all variables (P < .05) except ductus arteriosus mean velocity and left ventricular ejection time, which were both higher at older gestational age. CoVs were >15% for right ventricular systolic and diastolic widths despite fair to good repeatability (intraclass correlation coefficient > 0.5); ductal velocities and two-dimensional measures, left ventricular short-axis dimensions, and isovolumic times all had high CoVs and high interobserver variability despite good to excellent intraobserver agreement (intraclass correlation coefficient > 0.6). CoVs did not improve when ratios (e.g., tricuspid/mitral annulus) were used instead of linear measurements. Overall, 27 variables had acceptable inter- and intraobserver repeatability, while 14 had excessive variability between readers despite good intraobserver agreement. CONCLUSIONS: There is considerable variability in fetal echocardiographic quantification in clinical practice that may affect the design of multicenter fetal echocardiographic Z score studies, and not all measurements may be feasible for standard normalization. As missingness was substantial, a prospective design will be needed. Data from this pilot study may aid in the calculation of sample sizes and inform thresholds for distinguishing clinically significant from statistically significant effects.
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Ecocardiografía , Ultrasonografía Prenatal , Embarazo , Femenino , Humanos , Lactante , Edad Gestacional , Reproducibilidad de los Resultados , Proyectos Piloto , Estudios Retrospectivos , Ultrasonografía Prenatal/métodos , Ecocardiografía/métodos , Variaciones Dependientes del ObservadorRESUMEN
PURPOSE: The diagnosis of cancer in children can negatively impact their parents, owing to the complex treatment processes. Families with high levels of resilience can overcome these difficulties and thus perform higher family functions. We aimed to develop an internet-based family resilience-promoting program for parents of children with cancer and evaluate its effect on the levels of family resilience, depression, and family function. METHODS: This prospective, parallel-group, randomized-controlled study that was conducted at Yonsei Cancer Center from June to October 2021 included 41 parents of children with cancer. In total, four sessions of the internet-based family resilience-promoting program, led by a nurse, were conducted individually for parents. Levels of family resilience, depression, and family function were measured before, immediately after, and 4 weeks after the program. The data were analyzed using the linear mixed-effect model, and program satisfaction was evaluated through an internet-based questionnaire and interview. RESULTS: The experimental group (the family resilience-promoting program participants) differed more significantly from the control group in the level of change in family resilience (ß = 13.214, p = 0.003, effect size = 0.374) and family function (ß = 1.256, p = 0.018, effect size = 0.394). However, there was no significant difference between the groups in the level of depression (ß = 2.133, p = 0.187, effect size = 0.416). All the program participants showed a high program satisfaction score of 4.75 out of 5.00 points overall. CONCLUSIONS: The applicability of the internet-based family resilience-promoting program as an appropriate nursing intervention was verified. Its application can help the families of children with cancer adapt to the stressful situation of their children's cancer diagnosis and treatment.
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Neoplasias , Resiliencia Psicológica , Niño , Humanos , Estudios Prospectivos , Salud de la Familia , Padres , Conducta Infantil , Neoplasias/diagnóstico , Neoplasias/terapiaRESUMEN
Fexuprazan (DWP14012), a potassium-competitive acid blocker, is a medical formulation prescribed to inhibit the secretion of gastric acid. The present study encompasses a comparative evaluation of pharmacokinetic (PK) analysis between the previous (reference) and size-reduced (test) formulation of fexuprazan 20 mg in healthy subjects. The study employed a randomized, open-label, single-dose, 2-sequence, 2-period, crossover design with a 7-day wash-out between periods. A total of 24 subjects were enrolled in this randomized study. During each period, the 21 subjects received either the test or reference formulation. Blood samples were collected at multiple time point ranging from 0 (pre-dose) to 48 hours post-dosing for PK analysis. The calculated PK parameters were considered bioequivalent when the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) were within the bioequivalence limit of 0.8-1.25. Safety and tolerability were included in the evaluation. A total of 20 subjects completed the study. Point estimates (90% CIs) of the GMRs were 1.1014 (0.9892-1.2265) for the maximum plasma concentration and 1.0530 (0.9611-1.1536) for the area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration, between the test and reference formulations. The reference and size-reduced test formulations of fexuprazan were well tolerated with no reports of serious adverse events. In conclusion, size-reduced and previous formulations of fexuprazan 20 mg were bioequivalent with regard to PKs, safety and tolerability.
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Family caregivers of children with tracheostomies or home ventilators are more likely to experience poor sleep quality when undertaking the full responsibility of caring for fragile children. This scoping review aimed to identify the sleep quality, related factors, and their impact on the health of family caregivers of children with tracheostomies or home ventilators. The included studies (N = 16) were retrieved through PubMed, CINAHL, Cochrane Library, Embase, PsycINFO, and Web of Science. Family caregivers' sleep were low in quality, frequently disturbed, and insufficient. Their sleep quality was related to fatigue, anxiety, depression, family functioning, and health-related quality of life. The sleep disturbing factors were classified as child, caregiver, or environment-related, which were mutually interrelated. This review emphasizes the need to develop nursing interventions to both improve the sleep quality of family caregivers and the health of children with tracheostomies or home ventilators based on an in-depth understanding of the family's context.
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Cuidadores , Calidad de Vida , Niño , Humanos , Calidad del Sueño , Traqueostomía , Ventiladores MecánicosRESUMEN
BACKGROUND: Regulating meal timing may have efficacy for improving metabolic health for preventing or managing chronic disease. However, the reliability of measuring meal timing with commonly used dietary assessment tools needs characterization prior to investigating meal timing and health outcomes in epidemiologic studies. OBJECTIVES: To evaluate the reliability of estimating meal timing parameters, including overnight fasting duration, the midpoint of overnight fasting time, the number of daily eating episodes, the period with the largest percentage of daily caloric intake, and late last eating episode (> 09:00 pm) from repeated 24-h dietary recalls (24HRs). METHODS: Intraclass correlation coefficients (ICC), Light's Kappa estimates, and 95% CIs were calculated from repeated 24HR administered in 3 epidemiologic studies: The United States-based Interactive Diet and Activity Tracking in AARP (IDATA) study (n = 996, 6 24HR collected over 12-mo), German EPIC-Potsdam Validation Study (European Prospective Investigation into Cancer and Nutrition Potsdam Germany cohort) (n = 134, 12 24HR collected over 12-mo) and EPIC-Potsdam BMBF-II Study (Federal Ministry of Education and Research, "Bundesministerium für Bildung und Forschung") (n = 725, 4 24HR collected over 36 mo). RESULTS: Measurement reliability of overnight fasting duration based on a single 24HR was "poor" in all studies [ICC range: 0.27; 95% CI: 0.23, 0.32 - 0.46; 95% CI: 0.43, 0.50]. Reliability was "moderate" with 3 24HR (ICC range: 0.53; 95% CI: 0.47, 0.58 in IDATA, 0.62; 95% CI: 0.52, 0.69 in the EPIC-Potsdam Validation Study, and 0.72; 95% CI: 0.70-0.75 in the EPIC-Potsdam BMBF-II Study). Results were similar for the midpoint of overnight fasting time and the number of eating episodes. Reliability of measuring late eating was "fair" in IDATA (Light's Kappa: 0.30; 95% CI: 0.21, 0.39) and "slight" in the EPIC-Potsdam Validation study and the EPIC-Potsdam BMBF-II study (Light's Kappa: 0.19; 95% CI: 0.15, 0.25 and 0.09; 95% CI: 0.06, 0.12, respectively). Reliability estimates differed by sex, BMI, weekday, and season of 24HR administration in some studies. CONCLUSIONS: Our results show that ≥ 3 24HR over a 1-3-y period are required for reliable estimates of meal timing variables.
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Dieta , Ingestión de Energía , Humanos , Estudios Prospectivos , Reproducibilidad de los Resultados , Ingestión de Energía/fisiología , ComidasRESUMEN
Acid-reducing agents are commonly used for the prevention of aspirin-induced gastrointestinal complications such as peptic ulcers. As a novel potassium-competitive acid blocker, fexuprazan is expected to prevent aspirin-induced gastrointestinal complications. This randomized, open-label study aimed to evaluate the pharmacodynamic and pharmacokinetic interactions between aspirin and fexuprazan in healthy Koreans. Subjects randomized to the aspirin group received 500 mg aspirin in combination with 80 mg fexuprazan. For the fexuprazan group, fexuprazan 80 mg was administered alone and then in combination with aspirin 500 mg. Platelet aggregation inhibited by aspirin and the pharmacokinetic parameters of aspirin and fexuprazan were compared between monotherapy and combination therapy. A total of 22 subjects completed the study. The platelet aggregation-inhibitory activity and systemic exposure to aspirin were not significantly affected by fexuprazan coadministration. The systemic exposure of fexuprazan was decreased up to 20% by aspirin coadministration, which was not regarded as clinically meaningful considering the previously reported exposure-response relationship. In conclusion, there were no clinically relevant pharmacodynamic or pharmacokinetic interactions between aspirin and fexuprazan. This finding suggests the potential of fexuprazan for the prevention of aspirin-induced gastrointestinal complications, serving as a baseline for optimizing its therapeutic application with aspirin.
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PURPOSE: The purpose of this study was to investigate the effect of family-centered interventions on improving health outcomes in children and adolescents with type 1 diabetes mellitus (T1DM). METHODS: A literature search was conducted according to the PRISMA guidelines, using six electronic databases: EMBASE, CINAHL, Medline, CENTRAL, Scopus, and Web of Science. The inclusion criteria encompassed studies with populations of children and adolescents (age <18 years) and at least one parent/caregiver, or only parents/caregivers if the children were very young, and studies that investigated the health outcomes of children and parents/caregivers diagnosed with T1DM. RESULTS: From 2,746 published studies, only nine studies met the inclusion criteria. The key interventions were non-technology-based interventions (n=4), technology-based interventions (n=2), and combined technology- and non-technologybased interventions (n=3). The interventions had effects on glycated hemoglobin, adherence to diabetes management, diabetes self-management behaviors, and parentchild teamwork in diabetes management. Other essential effects were children's quality of life, children's problem-solving skills, parents' quality of life, and parents' coping and depression. CONCLUSION: Family-centered interventions can effectively improve health outcomes in children and adolescents with T1DM. In the future, family-centered interventions integrated with other approaches, theories, and models should be developed to achieve the best possible outcomes.
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BACKGROUND: Despite the significant advances in neonatal treatment and care over the past 30 years, palliative care in the neonatal intensive care unit has not been fully provided in South Korea. Neonatal nurses are essential professionals in palliative care as they are directly involved in the care, but there is little information on their palliative care competency because no assessment instrument is available in Korea. OBJECTIVES: The aim of this study was to develop and test the validity and reliability of the Korean version of the Palliative Care Nursing Self-Competence scale for neonatal palliative care. METHODS: This scale for infant care was developed through parallel translation techniques and revised based on cognitive interviews. Survey data were then collected from 220 neonatal nurses who worked in 13 neonatal intensive care units in Korea. Internal consistency reliability, construct validity based on exploratory factor analysis, and criterion-related validity were tested. RESULTS: The final version of the scale included 40 items in five domains that explained 53.4% of the variance. Criterion-related validity was confirmed based on a positive correlation with the Korean version of the attitudes towards neonatal palliative care measurement tool. The Cronbach's alpha for the scale was 0.95. CONCLUSIONS: The Korean version of the Palliative Care Nursing Self-Competence scale for infant care has satisfactory construct validity and reliability to measure palliative care self-competence of neonatal nurses in Korea and evaluate an education program in future studies.
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Enfermería de Cuidados Paliativos al Final de la Vida , Recién Nacido , Humanos , Lactante , Psicometría/métodos , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , República de CoreaRESUMEN
BACKGROUND: Painful procedures are unavoidable when providing critical care to infants in intensive care units. These adverse experiences during infancy can lead to later hyperalgesia and poor neurodevelopmental outcomes. Thus, appropriate interventions are required to relieve infant pain during these procedures. OBJECTIVES: This study evaluated the effectiveness of sensorial saturation in reducing pain for infants during jugular central venous catheter removal procedures in intensive care units. METHODS: This study involved a quasi-experimental, repeated-measures design. Data were collected from participants sequentially recruited from April to June 2019 (control period) and July to September 2019 (experimental period). Participants included 78 infants younger than 1 year with congenital heart disease. The control group (n = 38) received a general nursing intervention using swaddling, a common child-care practice that consists of wrapping infants to restrict movements, whereas the experimental group (n = 40) received sensorial saturation using oral sugar, body massage, and verbal interaction. Infants' physiological reactions to procedural pain were measured by changes in heart rate, oxygen saturation, and respiratory rate. Infants' procedural pain and behavioural indicators were measured using the Modified Behavioural Pain Scale. Data were analysed using descriptive statistics, independent t-tests, χ2 tests, and repeated-measures analysis of variance. RESULTS: Compared with the control group, the experimental group had lower heart rates (F = 53.15, p < .001), respiratory rates (F = 15.19, p < .001), and behavioural pain scores (F = 45.21, p < .001), both during and after the procedure. CONCLUSIONS: Sensorial saturation can be used as a nursing intervention in infants. Given the many invasive procedures that are part of infant clinical care, sensorial saturation may be a safe analgesic alternative. The findings of this study could lead to the development of evidence-based clinical practice guidelines for the nonpharmacological management of acute pain in infants.
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Recien Nacido Prematuro , Dolor Asociado a Procedimientos Médicos , Recién Nacido , Lactante , Humanos , Manejo del Dolor/métodos , Dolor , Unidades de Cuidados IntensivosRESUMEN
Innovative teaching and learning strategies in pediatric clinical education are needed to ensure that learning outcomes are achieved efficiently and to improve students' satisfaction with the learning process. We developed a mobile application to enhance the clinical learning of nursing students during pediatric clinical practice and explored the participants' perceptions of the learning method. A mixed-method design and an online survey were used to assess participants' perceived achievement of learning objectives and satisfaction with the clinical practicum. Focus groups explored the participants' experience of using the application. The overall achievement of learning outcomes was 4.1 out of 5, and participants reported high satisfaction with the clinical practicum using the mobile application. Qualitative analysis of the transcripts revealed four major themes: (1) facilitation of collaborative learning through real-time interactions and communication; (2) engagement in active learning through an application; (3) a useful tool for enhancing critical thinking; and (4) the "curate's egg" nature of the application. The mobile application can be incorporated into the clinical education of nursing students to promote self-regulated learning and collaboration with faculty. Clear guidance on how to use the application in a clinical environment should be provided to students and preceptors to achieve better learning outcomes.
Asunto(s)
Bachillerato en Enfermería , Prácticas Interdisciplinarias , Aplicaciones Móviles , Estudiantes de Enfermería , Humanos , Niño , Bachillerato en Enfermería/métodos , Aprendizaje Basado en ProblemasRESUMEN
The aim of this study was to identify the prevalence of media addiction and its associated factors in elementary school children based on the problem behavior theory. This cross-sectional study was a secondary data analysis using national data from the 10th Panel Study on Korean Children 2017, which included 1,078 families of third-grade students (8-9 years of age). Descriptive statistics were used to examine the prevalence of media addiction, and logistic regression analysis was conducted to identify factors associated with media addiction. Prevalence of media addiction was 22.91% in this sample. Media addiction was significantly associated with general characteristics (gender, education level of mother, and time spent without parents), socialization (media use time), factors in the personal system (happiness), and factors in the perceived-environment system (parenting style). More comprehensive, tailored education may prevent elementary school children's media addiction. In addition, parents should participate in media addiction education with their children.