bluuebunny/crossref_metadata_2025_split huggingface dataset:
A biosocial analysis of perinatal and late neonatal mortality among Indigenous Maya Kaqchikel communities in Tecpán, Guatemala: a mixed-methods study
Authors: Venzor Strader Anahí , Sotz Magda , Gilbert Hannah N , Miller Ann C , Lee Anne CC , Rohloff Peter 
Published: April 2024

IntroductionNeonatal mortality is a global public health challenge. Guatemala has the fifth highest neonatal mortality rate in Latin America, and Indigenous communities are particularly impacted. This study aims to understand factors driving neonatal mortality rates among Maya Kaqchikel communities.MethodsWe used sequential explanatory mixed methods. The quantitative phase was a secondary analysis of 2014–2016 data from the Global Maternal and Newborn Health Registry from Chimaltenango, Guatemala. Multivariate logistic regression models identified factors associated with perinatal and late neonatal mortality. A number of 33 in-depth interviews were conducted with mothers, traditional Maya midwives and local healthcare professionals to explain quantitative findings.ResultsOf 33 759 observations, 351 were lost to follow-up. There were 32 559 live births, 670 stillbirths (20/1000 births), 1265 (38/1000 births) perinatal deaths and 409 (12/1000 live births) late neonatal deaths. Factors identified to have statistically significant associations with a higher risk of perinatal or late neonatal mortality include lack of maternal education, maternal height <140 cm, maternal age under 20 or above 35, attending less than four antenatal visits, delivering without a skilled attendant, delivering at a health facility, preterm birth, congenital anomalies and presence of other obstetrical complications. Qualitative participants linked severe mental and emotional distress and inadequate maternal nutrition to heightened neonatal vulnerability. They also highlighted that mistrust in the healthcare system—fueled by language barriers and healthcare workers’ use of coercive authority—delayed hospital presentations. They provided examples of cooperative relationships between traditional midwives and healthcare staff that resulted in positive outcomes.ConclusionStructural social forces influence neonatal vulnerability in rural Guatemala. When coupled with healthcare system shortcomings, these forces increase mistrust and mortality. Collaborative relationships among healthcare staff, traditional midwives and families may disrupt this cycle.
Estimated health benefits, costs and cost-effectiveness of eliminating industrial trans-fatty acids in Nigeria: cost-effectiveness analysis
Authors: Marklund Matti , Aminde Leopold N , Wanjau Mary Njeri , Ale Boni M , Ojo Adedayo E , Okoro Clementina E , Adegboye Abimbola , Huang Liping , Veerman J Lennert , Wu Jason HY , Huffman Mark D , Ojji Dike B 
Published: April 2024

IntroductionNigeria is committed to reducing industrialtrans-fatty acids (iTFA) from the food supply, but the potential health gains, costs and cost-effectiveness are unknown.MethodsThe effect on ischaemic heart disease (IHD) burden, costs and cost-effectiveness of a mandatory iTFA limit (≤2% of all fats) for foods in Nigeria were estimated using Markov cohort models. Data on demographics, IHD epidemiology andtrans-fatty acid intake were derived from the 2019 Global Burden of Disease Study. Avoided IHD events and deaths; health-adjusted life years (HALYs) gained; and healthcare, policy implementation and net costs were estimated over 10 years and the population’s lifetime. Incremental cost-effectiveness ratios using net costs and HALYs gained (both discounted at 3%) were used to assess cost-effectiveness.ResultsOver the first 10 years, a mandatory iTFA limit (assumed to eliminate iTFA intake) was estimated to prevent 9996 (95% uncertainty interval: 8870 to 11 118) IHD deaths and 66 569 (58 862 to 74 083) IHD events, and to save US$90 million (78 to 102) in healthcare costs. The corresponding lifetime estimates were 259 934 (228 736 to 290 191), 479 308 (95% UI 420 472 to 538 177) and 518 (450 to 587). Policy implementation costs were estimated at US$17 million (11 to 23) over the first 10 years, and US$26 million USD (19 to 33) over the population’s lifetime. The intervention was estimated to be cost-saving, and findings were robust across several deterministic sensitivity analyses.ConclusionOur findings support mandating a limit of iTFAs as a cost-saving strategy to reduce the IHD burden in Nigeria.
Colchicine for the treatment of patients with COVID-19: an updated systematic review and meta-analysis of randomised controlled trials
Authors: Cheema Huzaifa Ahmad , Jafar Uzair , Shahid Abia , Masood Waniyah , Usman Muhammad , Hermis Alaa Hamza , Naseem Muhammad Arsal , Sahra Syeda , Sah Ranjit , Lee Ka Yiu 
Published: April 2024

ObjectivesWe conducted an updated systematic review and meta-analysis to investigate the effect of colchicine treatment on clinical outcomes in patients with COVID-19.DesignSystematic review and meta-analysis.Data sourcesWe searched PubMed, Embase, the Cochrane Library, medRxiv and ClinicalTrials.gov from inception to January 2023.Eligibility criteriaAll randomised controlled trials (RCTs) that investigated the efficacy of colchicine treatment in patients with COVID-19 as compared with placebo or standard of care were included. There were no language restrictions. Studies that used colchicine prophylactically were excluded.Data extraction and synthesisWe extracted all information relating to the study characteristics, such as author names, location, study population, details of intervention and comparator groups, and our outcomes of interest. We conducted our meta-analysis by using RevMan V.5.4 with risk ratio (RR) and mean difference as the effect measures.ResultsWe included 23 RCTs (28 249 participants) in this systematic review. Colchicine did not decrease the risk of mortality (RR 0.99; 95% CI 0.93 to 1.05; I2=0%; 20 RCTs, 25 824 participants), with the results being consistent among both hospitalised and non-hospitalised patients. There were no significant differences between the colchicine and control groups in other relevant clinical outcomes, including the incidence of mechanical ventilation (RR 0.75; 95% CI 0.48 to 1.18; p=0.22; I2=40%; 8 RCTs, 13 262 participants), intensive care unit admission (RR 0.77; 95% CI 0.49 to 1.22; p=0.27; I2=0%; 6 RCTs, 961 participants) and hospital admission (RR 0.74; 95% CI 0.48 to 1.16; p=0.19; I2=70%; 3 RCTs, 8572 participants).ConclusionsThe results of this meta-analysis do not support the use of colchicine as a treatment for reducing the risk of mortality or improving other relevant clinical outcomes in patients with COVID-19. However, RCTs investigating early treatment with colchicine (within 5 days of symptom onset or in patients with early-stage disease) are needed to fully elucidate the potential benefits of colchicine in this patient population.PROSPERO registration numberCRD42022369850.
Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms
Authors: Abe Hirofumi , Sako Tomoya , Yamamoto Yoshinobu , Ikeda Atsushi , Kawara Fumiaki , Ose Takayuki , Takao Toshitatsu , Kitamura Yasuaki , Ariyoshi Ryusuke , Morita Yoshinori , Ishida Tsukasa , Ikegawa Takuya , Ishida Ryosuke , Yoshizaki Tetsuya , Sakaguchi Hiroya , Toyonaga Takashi , Kodama Yuzo 
Published: April 2024

IntroductionEndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified.Methods and analysisThe G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%.Ethics and disseminationThis trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers.Trial registration numberjRCT1052220166.
Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study
Authors: Schmidt Kira Leandra , Kowalski Axel , Schweda Adam , Dörrie Nora , Skoda Eva Maria , Bäuerle Alexander , Teufel Martin 
Published: April 2024

IntroductionElectroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice.Methods and analysis30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring’s content analysis.Ethics and disseminationThe study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23–11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations.Trial registration numberProspectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.
Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study)
Authors: Lanzi Stefano , Pousaz Anina , Fresa Marco , Besson Cyril , Desgraz Benoit , Gremeaux-Bader Vincent , Mazzolai Lucia 
Published: April 2024

IntroductionSupervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.Methods and analysisThis study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15×60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.Ethics and disseminationThe Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.Trial registration numberNCT05612945.
COVID-19 vaccine acceptance in the general population and under-resourced communities from high-income countries: realist review
Authors: Gonzalez-Jaramillo Nathalia , Abbühl Dominik , Roa-Díaz Zayne Milena , Kobler-Betancourt Cristopher , Frahsa Annika 
Published: April 2024

ObjectiveTo compare vaccination willingness before rollout and 1 year post-rollout uptake among the general population and under-resourced communities in high-income countries.DesignA realist review.Data sourcesEmbase, PubMed, Dimensions ai and Google Scholar.SettingHigh-income countries.DefinitionsWe definedvaccination willingnessas the proportion of participants willing or intending to receive vaccines prior to availability. We defined vaccine uptake as the real proportion of the population with complete vaccination as reported by each country until November 2021.ResultsWe included data from 62 studies and 18 high-income countries. For studies conducted among general populations, the proportion of vaccination willingness was 67% (95% CI 62% to 72%). In real-world settings, the overall proportion of vaccine uptake among those countries was 73% (95% CI 69% to 76%). 17 studies reported pre-rollout willingness for under-resourced communities. The summary proportion of vaccination willingness from studies reporting results among people from under-resourced communities was 52% (95% CI 0.46% to 0.57%). Real-world evidence about vaccine uptake after rollout among under-resourced communities was limited.ConclusionOur review emphasises the importance of realist reviews for assessing vaccine acceptance. Limited real-world evidence about vaccine uptake among under-resourced communities in high-income countries is a call to context-specific actions and reporting.
Using active learning strategies during a quality improvement collaborative: exploring educational games to enhance learning among healthcare professionals
Authors: da Silva Marianilza Lopes , Franco Flavia Fernanda , Vieira Jessica Alves , da Silva Juliana Fernandes , Santos Guilherme Cesar Silva Dias , da Cunha Beatriz Marques , Pereira Fernando Enrique Arriel , Nardoni Natalia , Gomes Francielle Bendersky , Cocentino Brunno Cesar Batista , Marques Roberta Gonçalves , de Melo Natalia Souza , Petenate Ademir Jose , Hamada Andreza Pivato Susin , Cristalda Cristiane Maria Reis , Ue Luciana Yumi , de Barros Claudia Garcia , Vernal Sebastian 
Published: April 2024

BackgroundThe Breakthrough Series model uses learning sessions (LS) to promote education, professional development and quality improvement (QI) in healthcare. Staff divergences regarding prior knowledge, previous experience, preferences and motivations make selecting which pedagogic strategies to use in LS a challenge.AimWe aimed to assess new active-learning strategies: two educational games, a card game and an escape room-type game, for training in healthcare-associated infection prevention.MethodsThis descriptive case study evaluated the performance of educational strategies during a Collaborative to reduce healthcare-associated infections in Brazilian intensive care units (ICUs). A post-intervention survey was voluntarily offered to all participants in LS activities.ResultsSeven regional 2-day LS were held between October and December 2022 (six for adult ICUs and one for paediatric/neonatal ICUs). Of 194 institutions participating in a nationwide QI initiative, 193 (99.4%) participated in these activities, totalling 850 healthcare professionals. From these, 641 participants responded to the survey (75.4%). The post-intervention survey showed that the participants responded positively to the educational activities.ConclusionThe participants perceived the various pedagogical strategies positively, which shows the value of a broad and diverse educational approach, customised to local settings and including game-based activities, to enhance learning among healthcare professionals.
Locum doctor working and quality and safety: a qualitative study in English primary and secondary care
Authors: Ferguson Jane , Stringer Gemma , Walshe Kieran , Allen Thomas , Grigoroglou Christos , Ashcroft Darren M , Kontopantelis Evangelos 
Published: April 2024

BackgroundThe use of temporary doctors, known as locums, has been common practice for managing staffing shortages and maintaining service delivery internationally. However, there has been little empirical research on the implications of locum working for quality and safety. This study aimed to investigate the implications of locum working for quality and safety.MethodsQualitative semi-structured interviews and focus groups were conducted with 130 participants, including locums, patients, permanently employed doctors, nurses and other healthcare professionals with governance and recruitment responsibilities for locums across primary and secondary healthcare organisations in the English NHS. Data were collected between March 2021 and April 2022. Data were analysed using reflexive thematic analysis and abductive analysis.ResultsParticipants described the implications of locum working for quality and safety across five themes: (1) ‘familiarity’ with an organisation and its patients and staff was essential to delivering safe care; (2) ‘balance and stability’ of services reliant on locums were seen as at risk of destabilisation and lacking leadership for quality improvement; (3) ‘discrimination and exclusion’ experienced by locums had negative implications for morale, retention and patient outcomes; (4) ‘defensive practice’ by locums as a result of perceptions of increased vulnerability and decreased support; (5) clinical governance arrangements, which often did not adequately cover locum doctors.ConclusionLocum working and how locums were integrated into organisations posed some significant challenges and opportunities for patient safety and quality of care. Organisations should take stock of how they work with the locum workforce to improve not only quality and safety but also locum experience and retention.
Germline homozygosity and allelic imbalance of HLA-I are common in esophagogastric adenocarcinoma and impair the repertoire of immunogenic peptides
Authors: Garcia-Marquez Maria Alejandra , Thelen Martin , Bauer Eugen , Maas Lukas , Wennhold Kerstin , Lehmann Jonas , Keller Diandra , Nikolić Miloš , George Julie , Zander Thomas , Schröder Wolfgang , Müller Philipp , Yazbeck Ali M , Bruns Christiane , Thomas Roman , Gathof Birgit , Quaas Alexander , Peifer Martin , Hillmer Axel M , von Bergwelt-Baildon Michael , Schlößer Hans Anton 
Published: April 2024

BackgroundThe individual HLA-I genotype is associated with cancer, autoimmune diseases and infections. This study elucidates the role of germline homozygosity or allelic imbalance of HLA-I loci in esophago-gastric adenocarcinoma (EGA) and determines the resulting repertoires of potentially immunogenic peptides.MethodsHLA genotypes and sequences of either (1) 10 relevant tumor-associated antigens (TAAs) or (2) patient-specific mutation-associated neoantigens (MANAs) were used to predict good-affinity binders using an in silico approach for MHC-binding (www.iedb.org). Imbalanced or lost expression of HLA-I-A/B/C alleles was analyzed by transcriptome sequencing. FluoroSpot assays and TCR sequencing were used to determine peptide-specific T-cell responses.ResultsWe show that germline homozygosity of HLA-I genes is significantly enriched in EGA patients (n=80) compared with an HLA-matched reference cohort (n=7605). Whereas the overall mutational burden is similar, the repertoire of potentially immunogenic peptides derived from TAAs and MANAs was lower in homozygous patients. Promiscuity of peptides binding to different HLA-I molecules was low for most TAAs and MANAs and in silico modeling of the homozygous to a heterozygous HLA genotype revealed normalized peptide repertoires. Transcriptome sequencing showed imbalanced expression of HLA-I alleles in 75% of heterozygous patients. Out of these, 33% showed complete loss of heterozygosity, whereas 66% had altered expression of only one or two HLA-I molecules. In a FluoroSpot assay, we determined that peptide-specific T-cell responses against NY-ESO-1 are derived from multiple peptides, which often exclusively bind only one HLA-I allele.ConclusionThe high frequency of germline homozygosity in EGA patients suggests reduced cancer immunosurveillance leading to an increased cancer risk. Therapeutic targeting of allelic imbalance of HLA-I molecules should be considered in EGA.