bluuebunny/crossref_metadata_2025_split huggingface dataset:
Preventive effect of prenatal maternal oral probiotic supplementation on neonatal jaundice (POPS Study): A protocol for the randomised double-blind placebo-controlled clinical trial
Authors: Alemu Bekalu Kassie , Lee May Wing , Leung Maran Bo Wah , Lee Wing Fong , Wang Yao , wang Chi Chiu , Lau So Ling 
Published: June 2024

IntroductionNeonatal jaundice is a common and life-threatening health problem in neonates due to overaccumulation of circulating unconjugated bilirubin. Gut flora has a potential influence on bilirubin metabolism. The infant gut microbiome is commonly copied from the maternal gut. During pregnancy, due to changes in dietary habits, hormones and body weight, maternal gut dysbiosis is common, which can be stabilised by probiotics supplementation. However, whether probiotic supplements can reach the baby through the mother and reduce the incidence of neonatal jaundice has not been studied yet. Therefore, we aim to evaluate the effect of prenatal maternal probiotic supplementation on the incidence of neonatal jaundice.Methods and analysisThis is a randomised double-blind placebo-controlled clinical trial among 94 pregnant women (47 in each group) in a tertiary hospital in Hong Kong. Voluntary eligible participants will be recruited between 28 and 35 weeks of gestation. Computer-generated randomisation and allocation to either the intervention or control group will be carried out. Participants will take either one sachet of Vivomixx (450 billion colony-forming units per sachet) or a placebo per day until 1 week post partum. Neither the study participants nor researchers will know the randomisation and allocation. The intervention will be initiated at 36 weeks of gestation. Neonatal bilirubin level will be measured to determine the primary outcome (hyperbilirubinaemia) while the metagenomic microbiome profile of breast milk and maternal and infant stool samples as well as pregnancy outcomes will be secondary outcomes. Binary logistic and linear regressions will be carried out to assess the association of the microbiome data with different clinical outcomes.Ethics and disseminationEthics approval is obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee, Hong Kong (CREC Ref: 2023.100-T). Findings will be published in peer-reviewed journals and presented at international conferences.Trial registration numberNCT06087874.
Evaluation of the passive mast cell activation test for identifying allergens in perioperative anaphylaxis: a study protocol for a prospective diagnostic accuracy study
Authors: Li Zhe , Cai Huamei , Liu Zhen , Liu Xiaowen , Zhao Jing 
Published: June 2024

IntroductionPerioperative anaphylaxis (POA) can lead to significant complications. Therefore, accurate identification of allergens for POA patients is critical to ensure the safety of future surgical and anaesthetic procedures. Existing perioperative allergen detection methods face challenges in sensitivity and specificity. The passive mast cell activation test (pMAT) has recently emerged as a potential diagnostic tool. Our study aims to evaluate the diagnostic efficacy of pMAT for identifying perioperative allergens, with a focus on non-depolarising neuromuscular blocking agents, the most common culprits of POA.Methods and analysisThis prospective diagnostic accuracy study will measure the diagnostic accuracy of pMAT in POA patients. Participants will undergo skin testing (ST), basophil activation testing (BAT) and pMAT. The diagnostic validity of pMAT will be assessed based on the results of ST and BAT. The assessment of diagnostic accuracy will include sensitivity, specificity, likelihood ratios, and false-positive and false-negative rates while measurement of the consistency rate will assess reliability.Ethics and disseminationThis study has been approved by the Institutional Review Board of China-Japan Friendship Hospital (2023-KY-247). Results will be disseminated through academic presentations and peer-reviewed journal publications and will provide valuable scientific data and some new insights into the diagnostic accuracy of pMAT.
Patient-reported outcomes of psychiatric and/or mental health nursing in hospitals: a systematic review protocol
Authors: Desmet Karel , Vrancken Bruce , Bergs Jochen , Van Hecke Ann , Deproost Eddy , Bracke Piet , Debyser Bart , Cools Olivia , De Fruyt Jürgen , Muylaert Sofie , Verhaeghe Sofie 
Published: June 2024

IntroductionThere is a lack of distinct and measurable outcomes in psychiatric and/or mental health nursing which negatively impacts guiding clinical practice, assessing evidence-based nursing interventions, ensuring future-proof nursing education and establishing visibility as a profession and discipline. Psychiatric and/or mental health nursing struggle to demonstrate patient-reported outcomes to assess the effectiveness of their practice. A systematic review that summarising patient-reported outcomes, associated factors, measured nursing care/interventions and used measurement scales of psychiatric and/or mental health nursing in the adult population in acute, intensive and forensic psychiatric wards in hospitals will capture important information on how care can be improved by better understanding what matters and what is important to patients themselves. This review can contribute to the design, planning, delivery and assessment of the quality of current and future nursing careMethods and analysisThis protocol follows the Cochrane methodological guidance on systematic reviews of interventions and The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol. The search strategy will be identified by consultations with clinical and methodological experts and by exploring the literature. The databases Ovid MEDLINE, CINAHL, EMBASE, APA PsychARTICLES, Web of Science and Scopus will be searched for all published studies. Studies will be screened and selected with criteria described in the population, intervention, control and outcomes format after a pilot test by two researchers. Studies will be screened in two stages: (1) title and abstract screening and (2) full-text screening. Data extraction and the quality assessment based on the Johanna Briggs Institute guidelines will be conducted by two researchers. Data will be presented in a narrative synthesis.Ethics and disseminationNo ethical approval is needed since all data are already publicly accessible. The results of this work will be published in a peer-reviewed scientific journal.PROSPERO registration numberCRD42023363806.
Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review
Authors: Suzumura Erica Aranha , de Oliveira Ascef Bruna , Maia Fernando Henrique de Albuquerque , Bortoluzzi Aline Frossard Ribeiro , Domingues Sidney Marcel , Farias Natalia Santos , Gabriel Franciele Cordeiro , Jahn Beate , Siebert Uwe , de Soarez Patricia Coelho 
Published: June 2024

ObjectivesTo map the available methodological guidelines and documents for conducting and reporting benefit–risk assessment (BRA) during health technologies’ life cycle; and to identify methodological guidelines for BRA that could serve as the basis for the development of a BRA guideline for the context of health technology assessment (HTA) in Brazil.DesignScoping review.MethodsSearches were conducted in three main sources up to March 2023: (1) electronic databases; (2) grey literature (48 HTA and regulatory organisations) and (3) manual search and contacting experts. We included methodological guidelines or publications presenting methods for conducting or reporting BRA of any type of health technologies in any context of the technology’s life cycle. Selection process and data charting were conducted by independent reviewers. We provided a structured narrative synthesis of the findings.ResultsFrom the 83 eligible documents, six were produced in the HTA context, 30 in the regulatory and 35 involved guidance for BRA throughout the technology’s life cycle. We identified 129 methodological approaches for BRA in the documents. The most commonly referred to descriptive frameworks were the Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk and Linked decisions and the Benefit–Risk Action Team. Multicriteria decision analysis was the most commonly cited quantitative framework. We also identified the most cited metric indices, estimation and utility survey techniques that could be used for BRA.ConclusionsMethods for BRA in HTA are less established. The findings of this review, however, will support and inform the elaboration of the Brazilian methodological guideline on BRA for HTA.Trial registration numberhttps://doi.org/10.17605/OSF.IO/69T3V.
Dermatological changes in a prospective cohort of acutely ill, hospitalised Malawian children, stratified according to nutritional status
Authors: van den Brink Deborah , Mponda Kelvin , Thompson Debbie , van Hees Colette , Ngong'a Fletchter , Segula Emma , Mbale Emmie , Boele van Hensbroek Michael , Bandsma Robert H J , Walson Judd L , Brals Daniella , Berkely James , Voskuijl Wieger 
Published: June 2024

RationaleSince the first documentation of skin changes in malnutrition in the early 18th century, various hair and skin changes have been reported in severely malnourished children globally. We aimed to describe the frequency and types of skin conditions in children admitted with acute illness to Queen Elizabeth Central Hospital, Blantyre, Malawi across a spectrum of nutritional status and validate an existing skin assessment tool.MethodsChildren between 1 week and 23 months of age with acute illness were enrolled and stratified by anthropometry. Standardised photographs were taken, and three dermatologists assessed skin changes and scored each child according to the SCORDoK tool.ResultsAmong 103 children, median age of 12 months, 31 (30%) had severe wasting, 11 (11%) kwashiorkor (nutritional oedema), 20 (19%) had moderate wasting, 41 (40%) had no nutritional wasting and 18 (17%) a positive HIV antibody test. Six (5.8%) of the included patients died. 51 (50%) of children presented with at least one skin change. Pigmentary changes were the most common, observed in 35 (34%), with hair loss and bullae, erosions and desquamation the second most prevalent skin condition. Common diagnoses were congenital dermal melanocytosis, diaper dermatitis, eczema and postinflammatory hyperpigmentation. Severe skin changes like flaky paint dermatosis were rarely identified. Inter-rater variability calculations showed only fair agreement (overall Fleiss’ kappa 0.25) while intrarater variability had a fair-moderate agreement (Cohen’s kappa score of 0.47–0.58).DiscussionSkin changes in hospitalised children with an acute illness and stratified according to nutritional status were not as prevalent as historically reported. Dermatological assessment by means of the SKORDoK tool using photographs is less reliable than expected.
Correlation of anthropometric measurements with body mass index and estimation of the proportion of metabolic syndrome among overweight and obese children: a hospital-based cross-sectional study
Authors: Ramesh Nithin , Kumar Pradeep , Sweta Sweta , Prasad Arun , Tiwari Lokesh Kumar 
Published: June 2024

BackgroundEarly identification of overweight and obesity with the help of simple anthropometric tests can prevent from development of metabolic complications in these children. Body mass index (BMI) is the most commonly used parameter but, measurements such as waist circumference (WC), waist-to-height ratio (WHtR) and wrist circumference (WrC) have also been studied and found to have a better correlation with visceral fat.ObjectiveTo correlate WC, WHtR and WrC with BMI among overweight and obese children. The secondary objective was to estimate the proportion of metabolic syndrome among obese and overweight children.MethodsA single-centre, cross-sectional study involving 80 overweight and obese children aged 3–15 years. Anthropometric measures such as WC, WHtR and WrC of the study subjects were correlated with BMI and investigated for metabolic syndrome.ResultsStatistically significant and moderate positive correlation was found between BMI and WC, r (80)=0.45 and p<0.001 with WC explaining 20% of the variation of BMI. There was a statistically significant, moderate positive correlation between WHtR and BMI r (80)=0.34 and p<0.001 with 11% of the variation in BMI. There was a statistically significant strong positive correlation between WC and WrC (80)=0.61 and p<0.001, and WrC explains 37.2% of the variation in WC. However, there was no statistically significant correlation between BMI and WrC. Metabolic syndrome was found in 13 (16.25%) children.ConclusionAlternative anthropometric measurements such as WC and WHtR have a significant correlation with BMI and may be of help in defining overweight and obesity in children. There was a statistically significant strong positive correlation between WC and WrC among obese children. Metabolic syndrome is common in these children.
Sex differences in the association of pretransfusion haemoglobin and cognition in preterm infants
Authors: Mostek Amanda M Benavides , Bell Edward F , Feldman Henry A , Josephson Cassandra D , Georgieff Michael K , Nopoulos Peg , Patel Ravi Mangal , Stowell Sean R , Sola-Visner Martha , Conrad Amy L 
Published: June 2024

ObjectivesTo assess sex-specific differences in the association between pre-transfusion haemoglobin values and early neurodevelopmental function.DesignObservational follow-up of infants with birth weights <1000 g and gestational ages 22–28 weeks who were enrolled in the NICHD Neonatal Research Network Transfusion of Prematures (TOP) Trial at 19 U.S. sites, 2012–2017.Main outcome measuresPretransfusion haemoglobin values were obtained longitudinally through 36 weeks’ postmenstrual age. The infant’s mean pretransfusion haemoglobin was used as a marker of degree of anaemia (n=1655 measures). Measures of brain function were obtained at 22–26 months’ corrected age using the Bayley Scales of Infant & Toddler Development, third edition (BSID-III) (n=1290 BSID-III scores). Sex-specific estimates for the linear relation between pretransfusion haemoglobin and BSID-III scores were obtained from repeated-measures regression analysis, adjusted for gestational age, birth weight, study site, clinical characteristics, and demographic covariates.ResultsThe relation of pretransfusion haemoglobin with 24-month BSID-III scores showed significant, independent interactions with both (1) sex (p=0.046) and (2) retinopathy of prematurity (ROP; p=0.004). In 614 males, BSID-III scores were higher by 1.07 points per g/dL (95% CI 1.58 to 4.33; p=0.008), not differing significantly among the three subscales (cognitive, language and motor; p=0.94). In 247 infants with ROP, BSID-III scores were higher by 2.95 points per g/dL (95% CI 0.28 to 1.87; p<0.0001), uniformly across subscales (p=0.73). These associations were non-significant in 676 females (p=0.96) and 1043 infants without ROP (p=0.81).ConclusionsThis study demonstrates sex-specific associations between mean pretransfusion haemoglobin (a marker of the severity of anaemia throughout the neonatal intensive care unit [NICU] hospitalisation) and early neurodevelopmental function at 22–26 months’ corrected age.
Multidisciplinary re-evaluation of neuropsychiatric events to confirm the neuropsychiatric lupus diagnosis at an Indonesian tertiary hospital
Authors: Estiasari Riwanti , Banu Syairah , Widhani Alvina , Octaviana Fitri , Maharani Kartika , Aninditha Tiara , Islami Muthia Huda , Imran Darma , Lastri Diatri Nari 
Published: June 2024

ObjectiveNeuropsychiatric SLE (NPSLE) has a broad spectrum and to date, there is no gold-standard biomarker. The diagnosis relies on clinical assessment, supporting examinations and exclusion of other possible aetiologies. One method that can be used to establish NPSLE is to conduct a re-evaluation by involving several fields of medical science. This study aims to reassess SLE cases with neuropsychiatric (NP) manifestations through multidisciplinary re-evaluation and determine the final diagnosis of NPSLE or non-NPSLE.MethodsThis retrospective cross-sectional study used medical record data from patients with SLE with NP manifestations. Inclusion criteria included patients diagnosed with SLE, who had clinical manifestations of NP and were >18 years old. Multidisciplinary re-evaluation was conducted and agreed upon the diagnosis of NPSLE or non-NPSLE.ResultsWe included 94 subjects with a total of 132 NP events consisting of 69 NPSLE and 63 non-NPSLE. After re-evaluating NPSLE events, 33.3% were still concluded to be NPSLE. Meanwhile, from the non-NPSLE group, 22.2% were then declared as NPSLE. There were no significant differences in demographic characteristics between the NPSLE and non-NPSLE groups. The proportion of NP events in both groups was almost the same except for cerebrovascular disease manifestations which were more common in the NPSLE group. Higher Mexican SLE Disease Activity Index scores with (p<0.001) or without NP (p=0.02) were observed in the NPSLE group compared with the non-NPSLE group, as well as higher proportion of active disease (p=0.03), higher anti-double-stranded DNA titres (p<0.001) and lower values of C3 (p=0.018) and C4 (p=0.001).ConclusionsMultidisciplinary re-evaluation can be used as a method to confirm the diagnosis of NPSLE. There is a tendency for overdiagnosis of NPSLE when clinicians are faced with NP events in patients with SLE. Complete clinical and supporting data are needed to determine the final diagnosis of NPSLE.
Population-based disease-group analysis of Spanish excess mortality in the early COVID-19 pandemic period
Authors: Reyes-Santias Francisco , Reboredo-Nogueira Juan Carlos , Garcia-Alvarez Rosa Maria , Cinza-Sanjurjo Sergio , Gonzalez Juanatey Jose Ramon 
Published: June 2024

Background and aimIncreased mortality during the COVID-19 pandemic is not explained exclusively by COVID-19 infection and its complications. We analysed non-COVID-19 causes of mortality in a population analysis based on data from the Spanish National Institute of Statistics.MethodsUsing monthly mortality data in Spain (January 2010–December 2020), we analysed deaths associated with cancer, blood, endocrine, mental, nervous, cardiovascular, respiratory and digestive diseases and explored the COVID-19 impact using a difference-in-difference strategy. We calculated monthly interannual variations in mortality and computed percentage change in terms of the log of deaths in monthhof yeartminus the log of deaths in monthhin the previous yeart−1.ResultsIn 2020 in Spain, mortality increased 17.9% compared with 2019. COVID-19 was the leading cause of death (n=60 358), followed by ischaemic heart disease (n=29 654). Throughout 2020, monthly interannual variations in cardiovascular mortality showed an average upward trend of 1.7%, while digestive, cancer and blood diseases showed a downward trend.ConclusionsDuring the COVID-19 pandemic in Spain in 2020, excess mortality was primarily related to cardiovascular mortality while mortality associated with digestive, cancer and blood diseases was reduced.
International Map of Axial Spondyloarthritis (IMAS): results from the perspective of 5557 patients from 27 countries around the globe
Authors: Garrido-Cumbrera Marco , Poddubnyy Denis , Sommerfleck Fernando , Bundy Christine , Makri Souzi , Correa-Fernández José , Akerkar Shashank , Lowe Jo , Karam Elie , Christen Laura , Navarro-Compan Victoria 
Published: June 2024

BackgroundThe International Map of Axial Spondyloarthritis (IMAS) is a global initiative aimed to assess the impact and burden of axial spondyloarthritis (axSpA) and identify the unmet needs from the patient’s perspective.MethodIMAS is a collaboration between the Axial Spondyloarthritis International Federation (ASIF), the University of Seville, Novartis Pharma AG and steered by a scientific committee. IMAS collected information through an online cross-sectional survey (2017–2022) from unselected patients with axSpA from Europe, Asia, North America, Latin America and Africa who completed a comprehensive questionnaire containing over 120 items.Results5557 patients with axSpA participated in IMAS. Mean age was 43.9 ±12.8 years, 55.4% were female, 46.2% had a university education and 51.0% were employed. The mean diagnostic delay was 7.4 ±9.0 years (median: 4.0), and the mean symptom duration was 17.1 ±13.3 years. 75.0% of patients had active disease (Bath Ankylosing Spondylitis Disease Activity Index ≥4), and 59.4% reported poor mental health (12-item General Health Questionnaire ≥3). In the year before the survey, patients had visited primary care physicians 4.6 times and the rheumatologist 3.6 times. 78.6% had taken non-steroidal anti-inflammatory drug ever, 48.8% biological disease-modifying antirheumatic drugs and 43.6% conventional synthetic disease-modifying antirheumatic drugs. Patients’s greatest fear was disease progression (55.9%), while the greatest hope was to be able to relieve pain (54.2%).ConclusionsIMAS shows the global profile of patients with axSpA, highlighting unmet needs, lengthy delays in diagnosis and high burden of disease in patients with axSpA worldwide. This global information will enable more detailed investigations to obtain evidence on the critical issues that matter to patients around the world to improve their care and quality of life.
Care training and family caregiver anxiety: prospective cohort study
Authors: Uzun Uğur , Sarıtaş Aykut , Kökçe Sevda , Togay Bilge 
Published: June 2024

ObjectivesThe study aimed to improve family caregivers’ skills and evaluate the effect on their anxiety levels.MethodIn our study, family caregivers of patients unable to perform daily activities were provided with care training. Their anxiety levels were examined before and after the training.ResultsCare training increased the family caregivers’ sense of self-efficacy but caused no significant difference in their anxiety levels. Factors such as gender, education level and employment status influenced anxiety levels. Higher education and income were associated with lower trait anxiety while employment status was linked to higher anxiety levels.ConclusionCare training increased the family caregivers’ sense of self-efficacy while causing no difference in their anxiety levels. In order to reduce anxiety, other negative factors affecting the caregiver should be discovered and corrected.