bluuebunny/crossref_metadata_2025_split huggingface dataset:
Does problem-based learning improve patient empowerment and cardiac risk factors in patients with coronary heart disease in a Swedish primary care setting? A long-term prospective, randomised, parallel single randomised trial (COR-PRIM)
Authors: Andreae Christina , Tingström Pia , Nilsson Staffan , Jaarsma Tiny , Karlsson Nadine , Kärner Köhler Anita 
Published: February 2023

ObjectivesTo investigate long-term effects of a 1-year problem-based learning (PBL) on self-management and cardiac risk factors in patients with coronary heart disease (CHD).DesignA prospective, randomised, parallel single centre trial.SettingsPrimary care settings in Sweden.Participants157 patients with stable CHD completed the study. Subjects with reading and writing impairments, mental illness or expected survival less than 1 year were excluded.InterventionParticipants were randomised and assigned to receive either PBL (intervention) or home-sent patient information (control group). In this study, participants were followed up at baseline, 1, 3 and 5 years.Primary and secondary outcomesPrimary outcome was patient empowerment (Swedish Coronary Empowerment Scale, SWE-CES) and secondary outcomes General Self-Efficacy Scale (GSES), self-rated health status (EQ-VAS), high-density lipoprotein cholesterol (HDL-C), body mass index (BMI), weight and smoking. Outcomes were adjusted for sociodemographic factors.ResultsThe PBL intervention group resulted in a significant improved change in SWE-CES over the 5-year period (mean (M), 39.39; 95% CI 37.88 to 40.89) compared with the baseline (M 36.54; 95% CI 35.40 to 37.66). PBL intervention group increased HDL-C level (M 1.39; 95% CI 1.28 to 1.50) compared with baseline (M 1.24; 95% CI 1.15 to 1.33) and for EQ-VAS (M 77.33; 95% CI 73.21 to 81.45) compared with baseline (M 68.13; 95% CI 63.66 to 72.59) while these outcomes remained unchanged in the control group. There were no significant differences in BMI, weight or scores on GSES, neither between nor within groups over time. The overall proportion of smokers was significantly higher in the control group than in the experimental group.ConclusionOne-year PBL intervention had positive effect on patient empowerment, health status and HDL-C at a 5-year follow-up compared with the control group. PBL education aiming to improve patient empowerment in cardiac rehabilitation should account for sociodemographic factors.Trial registration numberNCT01462799.
Development and validation of a prediction model for intrapartum cesarean delivery based on the artificial neural networks approach: a protocol for a prospective nested case–control study
Authors: Huang Chuanya , Luo Biru , Wang Guoyu , Chen Peng , Ren Jianhua 
Published: February 2023

IntroductionAlthough intrapartum caesarean delivery can resolve dystocia, it would still lead to several adverse outcomes for mothers and children. The obstetric care professionals need effective tools that can help them to identify the possibility and risk factors of intrapartum caesarean delivery, and further implement interventions to avoid unnecessary caesarean birth. This study aims to develop a prediction model for intrapartum caesarean delivery with real-life data based on the artificial neural networks approach.Methods and analysisThis study is a prospective nested case–control design. Pregnant women who plan to deliver vaginally will be recruited in a tertiary hospital in Southwest China from March 2022 to March 2024. The clinical data of prelabour, intrapartum period and psychosocial information will be collected. The case group will be the women who finally have a baby with intrapartum caesarean deliveries, and the control group will be those who deliver a baby vaginally. An artificial neural networks approach with the backpropagation algorithm multilayer perceptron topology will be performed to construct the prediction model.Ethics and disseminationEthical approval for data collection was granted by the Ethics Committee of West China Second University Hospital, Sichuan University, and the ethical number is 2021 (204). Written informed consent will be obtained from all participants and they can withdraw from the study at any time. The results of this study will be published in peer-review journal.
What should the standard be for passing and mastery on the Critical Thinking about Health Test? A consensus study
Authors: Nsangi Allen , Aranza Diana , Asimwe Roger , Munaabi-Babigumira Susan Kyomuhendo , Nantongo Judith , Nordheim Lena Victoria , Ochieng Robert , Oyuga Cyril , Uwimana Innocent , Dahlgren Astrid , Oxman Andrew 
Published: February 2023

ObjectiveMost health literacy measures rely on subjective self-assessment. The Critical Thinking about Health Test is an objective measure that includes two multiple-choice questions (MCQs) for each of the nine Informed Health Choices Key Concepts included in the educational resources for secondary schools. The objective of this study was to determine cut-off scores for passing (the border between having and not having a basic understanding and the ability to apply the nine concepts) and mastery (the border between having mastered and not having mastered them).DesignUsing a combination of two widely used methods: Angoff’s and Nedelsky’s, a panel judged the likelihood that an individual on the border of passing and another on the border of having mastered the concepts would answer each MCQ correctly. The cut-off scores were determined by summing up the probability of answering each MCQ correctly. Their independent assessments were summarised and discussed. A nominal group technique was used to reach a consensus.SettingThe study was conducted in secondary schools in East Africa.ParticipantsThe panel included eight individuals with 5 or more years’ experience in the following areas: evaluation of critical thinking interventions, curriculum development, teaching of lower secondary school and evidence-informed decision-making.ResultsThe panel agreed that for a passing score, students had to answer 9 of the 18 questions and for a mastery score, 14 out of 18 questions correctly.ConclusionThere was wide variation in the judgements made by individual panel members for many of the questions, but they quickly reached a consensus on the cut-off scores after discussions.
Study protocol for PREPARE: a phase II feasibility/safety randomised controlled trial on PeRiopErative Penicillin AlleRgy TEsting
Authors: De Luca Joseph F , James Fiona , Vogrin Sara , Chua Kyra , Fletcher Luke , Nazareth Justin , Guha Ranjan , Hardidge Andrew , Douglas Ned , Carruthers John , Stewardson Andrew , Cheng Allen C , Johnson Douglas , Douglass Jo , Peel Trisha , Trubiano Jason 
Published: February 2023

IntroductionPatient-reported antibiotic allergy labels (AALs) are common. These labels have been demonstrated to have a negative impact on use of appropriate antibiotics and patient-related health outcomes. These patients are more likely to receive suboptimal antibiotics, have increased rates of surgical site infections and are more likely to be colonised with multidrug-resistant organisms. Increasing recognition that antibiotic allergy forms a key part of good antimicrobial stewardship has led to calls for greater access to antibiotic allergy assessment.PREPARE is a pilot randomised controlled trial of beta-lactam allergy assessment and point of care delabelling in perioperative patients utilising a validated antibiotic allergy assessment tool that has been repurposed into a smartphone application. The aim of the study is to assess the feasibility and safety of this approach in the perioperative outpatient setting.Methods and analysisAdult participants requiring elective surgery and are likely to require prophylactic intravenous antibiotics will be recruited. During the intervention phase, participants will be randomised to the intervention or control arm, with control patients receiving usual standard of care. Those randomised to intervention undertake a risk assessment via the smartphone application, with those deemed low risk proceeding to direct oral provocation with either a penicillin or cephalosporin. Study outcomes will be evaluated in the postintervention phase, 30 and 90 days after surgery.Feasibility of intervention delivery and recruitment will be reported as proportions with respective 95% CIs. Participants who experience an antibiotic adverse event will be reported by group with respective 95% CIs and compared using modified Poisson regression model with robust SE estimation.Ethics and disseminationThis protocol has received approval from the Austin Health human research and ethics committee, Heidelberg, Victoria, Australia (HREC/17/Austin/575). Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences.Trial registration numberACTRN12620001295932.
Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community–RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol
Authors: Furukawa Toshi A , Tajika Aran , Sakata Masatsugu , Luo Yan , Toyomoto Rie , Horikoshi Masaru , Akechi Tatsuo , Kawakami Norito , Nakayama Takeo , Kondo Naoki , Fukuma Shingo , Noma Hisashi , Christensen Helen , Kessler Ronald C , Cuijpers Pim , Wason James M S 
Published: February 2023

IntroductionThe health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive–behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies.Methods and analysisBased on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants’ characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50.Ethics and disseminationThe trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556).Trial registration numberUMIN000047124.
Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial
Authors: Shah Tayyab , McCarthy Marianne , Nasir Irem , Archer Herb , Ragheb Elio , Kluger Jonathan , Kashyap Nitu , Paredes Carlos , Patel Prashant , Lu Jing , Kandel Prakash , Song Christopher , Khan Mustafa , Huang Haocheng , Ul Haq Faheem , Ahmad Rami , Howes Christopher , Cambi Brian , Lancaster Gilead , Cleman Michael , Dela Cruz Charles , Parise Helen , Lansky Alexandra 
Published: February 2023

ObjectiveTo evaluate the effect of colchicine and high-intensity rosuvastatin in addition to standard of care on the progression of COVID-19 disease in hospitalised patients.DesignA pragmatic, open-label, multicentre, randomised controlled trial conducted from October 2020 to September 2021. Follow-up was conducted at 30 and 60 days. The electronic medical record was used at all stages of the trial including screening, enrolment, randomisation, event ascertainment and follow-up.SettingFour centres in the Yale New Haven Health System.ParticipantsNon-critically ill hospitalised patients with COVID-19.InterventionsPatients were randomised 1:1 to either colchicine plus high-intensity rosuvastatin in addition to standard of care versus standard of care alone. Assigned treatment was continued for the duration of index hospitalisation or 30 days, whichever was shorter.Primary and secondary outcome measuresThe prespecified primary endpoint was progression to severe COVID-19 disease (new high-flow or non-invasive ventilation, mechanical ventilation, need for vasopressors, renal replacement therapy or extracorporeal membrane oxygenation, or death) or arterial/venous thromboembolic events (ischaemic stroke, myocardial infarction, deep venous thrombosis or pulmonary embolism) evaluated at 30 days.ResultsAmong the 250 patients randomised in this trial (125 to each arm), the median age was 61 years, 44% were women, 15% were Black and 26% were Hispanic/Latino. As part of the standard of care, patients received remdesivir (87%), dexamethasone (92%), tocilizumab (18%), baricitinib (2%), prophylactic/therapeutic anticoagulation (98%) and aspirin (91%). The trial was terminated early by the data and safety monitoring board for futility. No patients were lost to follow-up due to electronic medical record follow-up. There was no significant difference in the primary endpoint at 30 days between the active arm and standard of care arm (15.2% vs 8.8%, respectively, p=0.17).ConclusionsIn this small, open-label, randomised trial of non-critically ill hospitalised patients with COVID-19, the combination of colchicine and rosuvastatin in addition to standard of care did not appear to reduce the risk of progression of COVID-19 disease or thromboembolic events, although the trial was underpowered due to a lower-than-expected event rate. The trial leveraged the power of electronic medical records for efficiency and improved follow-up and demonstrates the utility of incorporating electronic medical records into future trials.Trial registrationNCT04472611.
Maternal and child outcomes for pregnant women with pre-existing multiple long-term conditions: protocol for an observational study in the UK
Authors: Lee Siang Ing , Hope Holly , O’Reilly Dermot , Kent Lisa , Santorelli Gillian , Subramanian Anuradhaa , Moss Ngawai , Azcoaga-Lorenzo Amaya , Fagbamigbe Adeniyi Francis , Nelson-Piercy Catherine , Yau Christopher , McCowan Colin , Kennedy Jonathan Ian , Phillips Katherine , Singh Megha , Mhereeg Mohamed , Cockburn Neil , Brocklehurst Peter , Plachcinski Rachel , Riley Richard D , Thangaratinam Shakila , Brophy Sinead , Hemali Sudasinghe Sudasing Pathirannehelage Buddhika , Agrawal Utkarsh , Vowles Zoe , Abel Kathryn Mary , Nirantharakumar Krishnarajah , Black Mairead , Eastwood Kelly-Ann 
Published: February 2023

IntroductionOne in five pregnant women has multiple pre-existing long-term conditions in the UK. Studies have shown that maternal multiple long-term conditions are associated with adverse outcomes. This observational study aims to compare maternal and child outcomes for pregnant women with multiple long-term conditions to those without multiple long-term conditions (0 or 1 long-term conditions).Methods and analysisPregnant women aged 15–49 years old with a conception date between 2000 and 2019 in the UK will be included with follow-up till 2019. The data source will be routine health records from all four UK nations (Clinical Practice Research Datalink (England), Secure Anonymised Information Linkage (Wales), Scotland routine health records and Northern Ireland Maternity System) and the Born in Bradford birth cohort. The exposure of two or more pre-existing, long-term physical or mental health conditions will be defined from a list of health conditions predetermined by women and clinicians. The association of maternal multiple long-term conditions with (a) antenatal, (b) peripartum, (c) postnatal and long-term and (d) mental health outcomes, for both women and their children will be examined. Outcomes of interest will be guided by a core outcome set. Comparisons will be made between pregnant women with and without multiple long-term conditions using modified Poisson and Cox regression. Generalised estimating equation will account for the clustering effect of women who had more than one pregnancy episode. Where appropriate, multiple imputation with chained equation will be used for missing data. Federated analysis will be conducted for each dataset and results will be pooled using random-effects meta-analyses.Ethics and disseminationApproval has been obtained from the respective data sources in each UK nation. Study findings will be submitted for publications in peer-reviewed journals and presented at key conferences.
Availability of refractive error correction services in selected Zambian hospitals: a cross-sectional quantitative study
Authors: Kapatamoyo Esnart , Sialubanje Cephas , Muma Kangwa I M , Syakantu Gardner , Minnies Deon 
Published: February 2023

ObjectiveTo assess the availability of refractive error correction services (RECS) in selected Zambian hospitals.MethodsBetween October 2021 and March 2022, we conducted a cross-sectional study design among 20 eye health service providers selected from 20 public health facilities offering RECS in 20 districts from 8 provinces of Zambia. A stratified random sampling technique was used to select study participants. A questionnaire was developed based on the access to healthcare services framework and distributed via email to respondents to collect their perspectives on the availability of RECS.ResultsAll 20 respondents returned the completed questionnaires. Most facilities met the Ministry of Health recommended equipment requirement, though tonometers were lacking in some facilities. Out of the 20 facilities, 75% reported having optometry technologists as the main staff offering eye health services; 10% had an ophthalmologist; no facility had an optometrist; none conducted school-based programmes and only 1 facility (5%) was able to dispense spectacles soon after refraction because it had a spectacle manufacturing workshop.ConclusionThese findings show limited availability of RECS in the 20 health facilities. They also confirm that challenges in staffing levels, insufficient equipment and low rate of spectacle dispensing negatively affect availability of these services. Furthermore, insufficient infrastructure undermines service delivery. Addressing these challenges is cardinal to improving RECS delivery and enhancing universal eye healthcare coverage in Zambia.
Clinical characteristics, diagnosis, outcomes and lung microbiome analysis of invasive pulmonary aspergillosis in the community-acquired pneumonia patients
Authors: Ao Zhi , Xu Huan , Li Mengqi , Liu Huifang , Deng Min , Liu Yuliang 
Published: February 2023

BackgroundInvasive pulmonary aspergillosis (IPA) remains underestimated in patients with community-acquired pneumonia (CAP). This study aims to describe clinical features and outcomes of IPA in CAP patients, assess diagnostic performance of metagenomic next-generation sequencing (mNGS) for IPA and analyse lung microbiome via mNGS data.MethodsThis retrospective cohort study included CAP patients from 22 April 2019 to 30 September 2021. Clinical and microbiological data were analysed. Diagnostic performance of mNGS was compared with traditional detection methods. The lung microbiome detected by mNGS was characterised and its association with clinical features was evaluated.Main resultsIPA was diagnosed in 26 (23.4%) of 111 CAP patients. Patients with IPA displayed depressed immunity, higher hospital mortality (30.8% vs 11.8%) and intensive care unit mortality (42.1% vs 17.5%) compared with patients without IPA. The galactomannan (GM) antigen test had the highest sensitivity (57.7%) in detecting theAspergillusspp, followed by mNGS (42.3%), culture (30.8%) and smear (7.7%). The mNGS, culture and smear had 100% specificity, while GM test had 92.9% specificity. The microbial structure of IPA significantly differed from non-IPA patients (p<0.001; Wilcoxon test). Nineteen different species were significantly correlated with clinical outcomes and laboratory biomarkers, particularly forStreptococcus salivarius,Prevotella timonensisandHuman betaherpesvirus 5.ConclusionsOur results reveal that patients withAspergillusinfection tend to have a higher early mortality rate. The mNGS may be suggested as a complement to routine microbiological test in diagnosis of patients at risk ofAspergillusinfection. The lung microbiota is associated with inflammatory, immune and metabolic conditions of IPA, and thus influences clinical outcomes.
Energy expenditure, dietary intake and energy availability in female professional football players
Authors: Dasa Marcus Smavik , Friborg Oddgeir , Kristoffersen Morten , Pettersen Gunn , Plasqui Guy , Sundgot-Borgen Jorunn Kaiander , Rosenvinge Jan H 
Published: February 2023

ObjectivesTo quantify energy expenditure and intake in professional female footballers playing on a national and/or international level. Second, to determine the prevalence of low energy availability among these players, defined as <30 kcal/kg fat-free mass (FFM)/day.MethodsFifty-one players completed a 14-day prospective observational study during the 2021/2022 football season. Energy expenditure was determined using the doubly labelled water method. Energy intake was assessed using dietary recalls, while global positioning system determined the external physiological load. Descriptive statistics, stratification and the correlation between explainable variables and outcomes were conducted to quantify the energetic demands.ResultsThe mean energy expenditure for all players (22±4 years) was 2918±322 kcal. Mean energy intake was 2274±450 kcal, resulting in a discrepancy of ~22%. Carbohydrate intake was below the recommended guidelines on match day at 4.5±1.9 g/kg. The mean energy availability was 36.7±17.7 kcal/kg FFM/day on matchday and 37.9±11.7 kcal/kg FFM/day on training days, resulting in a prevalence of 36% and 23% for low energy availability during the observational period, respectively.ConclusionThese elite female football players displayed moderate energy expenditure levels and failed to meet the recommended levels of carbohydrate intake. In conjunction with inadequate nutritional periodisation, this will likely hamper performance through inadequate muscle glycogen resynthesis. In addition, we found a considerable prevalence of low energy availability on match and training days.