bluuebunny/crossref_metadata_2025_split huggingface dataset:
Confronting ‘chaos’: a qualitative study assessing public health officials’ perceptions of the factors affecting Tanzania’s COVID-19 vaccine rollout
Authors: Yamanis Thespina , Carlitz Ruth , Gonyea Olivia , Skaff Sophia , Kisanga Nelson , Mollel Henry 
Published: January 2023

ObjectivesMass COVID-19 vaccination in Africa is required to end the pandemic. In low-income settings, street-level bureaucrats (SLBs), or public officials who interact directly with citizens, are typically responsible for carrying out vaccination plans and earning community confidence in vaccines. The study interviewed SLBs to assess their perceptions of the factors affecting COVID-19 vaccination rollout in Tanzania.MethodsWe interviewed 50 SLBs (19 rural; 31 urban) responsible for implementing COVID-19 vaccination microplans across four diverse regions and districts of Tanzania in September 2021. Moreover, we conducted six in-depth interviews with non-governmental organisation representatives and seven focus group discussions with health facility governing committees. We asked for their perceptions of factors facilitating and challenging vaccine rollout according to three preidentified domains: political, health system and community. We analysed translated transcripts using a thematic analysis approach.ResultsPolitical factors facilitating mass vaccination included the executive leadership change from a denialist president to a president who accepted vaccines and promoted transparency. Global integration, commercially and politically, also motivated vaccine acceptance. Political challenges included community confusion that emerged from the consecutive presidents’ divergent communications and messaging by prominent religious antivaccination leaders. Health system factors facilitating vaccination included scaling up of immunisation sites and campaigns. Urban district officials reported greater access to vaccination sites, compared with rural officials. Limited financial resources for paying healthcare workers and for transport fuel and a lack of COVID-19 testing compromised mass vaccination. Furthermore, SLBs reported being inadequately trained on COVID-19 vaccine benefits and side effects. Having community sources of accurate information was critical to mass vaccination. Challenges at the community level included patriarchal gender dynamics, low risk perception, disinformation that the vaccine has satanic elements, and lack of trust in coronavirus vaccines.ConclusionMass COVID-19 vaccination in Tanzania will require greater resources and investment in training SLBs to mitigate mistrust, overcome misinformation, and engage communities.
Capacity and quality of maternal and child health services delivery at the subnational primary healthcare level in relation to intermediate health outputs: a cross-sectional study of 12 low-income and middle-income countries
Authors: Ramadan Marwa , Gutierrez Jose Carlos , Feil Cameron , Bolongaita Sarah , Bernal Oscar , Villar Uribe Manuela 
Published: January 2023

ObjectivesTo examine the capacity and quality of maternal and child health (MCH) services at the subnational primary healthcare (PHC) level in 12 low-income and middle-income countries (LMICs) and its association with intermediate health outputs such as coverage and access to care.DesignObservational cross-sectional study using matched subnational data from service provision assessment surveys and demographic health surveys from 2007 to 2019.Settings138 subnational areas with available survey data in 12 LMICs (Afghanistan, Bangladesh, Democratic Republic of Congo, Haiti, Kenya, Malawi, Namibia, Nepal, Rwanda, Senegal, Tanzania and Uganda).OutcomesEight intermediate MCH outcomes/outputs were explored: (1) met need for family planning by modern methods; (2) attendance of four or more antenatal care visits; (3) perceived financial barriers to care; (4) perceived geographical barriers to care; (5) diphtheria-pertussis-tetanus (DPT) third dose coverage; (6) DPT dropout-rate; (7) care-seeking for pneumonia; and (8) oral rehydration solutions coverage.ResultsOverall, moderate-to-poor PHC performance was observed across the 12 countries, with substantial heterogeneity between the different subnational areas in the same country as well as within the same subnational area across both capacity and quality subdomains. The analysis of the relationship between PHC service delivery and child health outcomes revealed that recent supervision (b=0.34, p<0.01) and supervisors’ feedback (b=0.28, p<0.05) were each associated with increased care-seeking for pneumonia. We also observed the associations of several measures of capacity and quality with DPT immunisation. The analysis of maternal health outcomes yielded only a few statistically significant results at p<0.05 level, however, none remained significant after adjusting for other covariates.ConclusionThe results of this analysis illustrate the heterogeneity in the capacity and quality of PHC service delivery within LMICs. Countries seeking to strengthen their PHC systems could improve PHC monitoring at the subnational level to better understand subnational bottlenecks in service delivery.
Factors associated with COVID-19 vaccine uptake in people with kidney disease: an OpenSAFELY cohort study
Authors:   The OpenSAFELY Collaborative, Parker Edward PK , Tazare John , Hulme William J , Bates Christopher , Carr Edward J , Cockburn Jonathan , Curtis Helen J , Fisher Louis , Green Amelia CA , Harper Sam , Hester Frank , Horne Elsie MF , Loud Fiona , Lyon Susan , Mahalingasivam Viyaasan , Mehrkar Amir , Nab Linda , Parry John , Santhakumaran Shalini , Steenkamp Retha , Sterne Jonathan AC , Walker Alex J , Williamson Elizabeth J , Willicombe Michelle , Zheng Bang , Goldacre Ben , Nitsch Dorothea , Tomlinson Laurie A 
Published: January 2023

ObjectiveTo characterise factors associated with COVID-19 vaccine uptake among people with kidney disease in England.DesignRetrospective cohort study using the OpenSAFELY-TPP platform, performed with the approval of NHS England.SettingIndividual-level routine clinical data from 24 million people across GPs in England using TPP software. Primary care data were linked directly with COVID-19 vaccine records up to 31 August 2022 and with renal replacement therapy (RRT) status via the UK Renal Registry (UKRR).ParticipantsA cohort of adults with stage 3–5 chronic kidney disease (CKD) or receiving RRT at the start of the COVID-19 vaccine roll-out was identified based on evidence of reduced estimated glomerular filtration rate (eGFR) or inclusion in the UKRR.Main outcome measuresDose-specific vaccine coverage over time was determined from 1 December 2020 to 31 August 2022. Individual-level factors associated with receipt of a 3-dose or 4-dose vaccine series were explored via Cox proportional hazards models.Results992 205 people with stage 3–5 CKD or receiving RRT were included. Cumulative vaccine coverage as of 31 August 2022 was 97.5%, 97.0% and 93.9% for doses 1, 2 and 3, respectively, and 81.9% for dose 4 among individuals with one or more indications for eligibility. Delayed 3-dose vaccine uptake was associated with younger age, minority ethnicity, social deprivation and severe mental illness—associations that were consistent across CKD severity subgroups, dialysis patients and kidney transplant recipients. Similar associations were observed for 4-dose uptake.ConclusionAlthough high primary vaccine and booster dose coverage has been achieved among people with kidney disease in England, key disparities in vaccine uptake remain across clinical and demographic groups and 4-dose coverage is suboptimal. Targeted interventions are needed to identify barriers to vaccine uptake among under-vaccinated subgroups identified in the present study.
Practitioner-led, peer-group sports intervention combined with a context-focused intervention for children with cerebral palsy: a protocol of a feasibility randomised clinical trial
Authors: Souto Deisiane Oliveira , da Silva Luana Cristina , de Sousa Junior Ricardo Rodrigues , Clutterbuck Georgina , Anaby Dana , Longo Egmar , Magalhães Rafael Coelho , Camargos Ana Cristina Resende , Leite Hércules Ribeiro 
Published: January 2023

BackgroundThere is a need to investigate relevant, acceptable and feasible approaches that promote participation in leisure-time physical activity for children with cerebral palsy (CP). The aim of this study is to assess the feasibility of a randomised controlled trial comparing a peer-group intervention focused on improving physical literacy (Sports Stars) with the combination of Sports Stars and a context-focused intervention (Pathways and Resources for Engagement and Participation, PREP) for ambulant children with CP in Brazil.MethodsIn this feasibility trial, 18 ambulant children (aged 6–12 years) with CP will be randomised into two groups (nine per group): (1) Sports Stars and (2) Sports Stars plus PREP. The Sports Stars group will receive 8 weekly group sessions, focusing on developing the physical, social, cognitive and psychological skills required to participate in popular Brazilian sports. The combined Sports Stars and PREP group will receive Sports Stars in addition to eight individual PREP sessions focused on overcoming environmental barriers to participation. The primary outcome will include feasibility measures: willingness to participate in an RCT, eligibility and recruitment rates, maintenance of evaluator blinding, acceptability of screening procedures and random allocation, feasibility of evaluating outcomes, contamination between the groups, intervention adherence, treatment satisfaction, understanding of the intervention and implementation resources. Additional instruments will be applied to obtain data related to leisure-time physical activity participation goals, overall participation (home, school and community), physical literacy, level of physical activity and family empowerment. Outcomes will be assessed before, after and 12 weeks after intervention.Ethics and disseminationThis feasibility trial has been approved by ethical Federal University of Minas Gerais’ Ethics Review Committee (CAAE: 33238520.5.0000.5149). All potential subjects will provide written informed consent. The results of this study will be published in peer-reviewed journals and be presented at academic conferences.Trial registration numbersRBR-4m3b4b6, U1111-1256-4998.
Effect of the GLP-1 receptor agonist semaglutide on metabolic disturbances in clozapine-treated or olanzapine-treated patients with a schizophrenia spectrum disorder: study protocol of a placebo-controlled, randomised clinical trial (SemaPsychiatry)
Authors: Sass Marie Reeberg , Danielsen Andreas Aalkjær , Köhler-Forsberg Ole , Storgaard Heidi , Knop Filip K , Nielsen Mette Ødegaard , Sjödin Anders Mikael , Mors Ole , Correll Christoph U , Ekstrøm Claus , Vinberg Maj , Nielsen Jimmi , Vilsbøll Tina , Fink-Jensen Anders 
Published: January 2023

IntroductionClozapine and olanzapine are some of the most effective antipsychotics, but both are associated with weight gain and relevant metabolic disturbances, including pre-diabetes and diabetes. Non-pharmacological/behavioural interventions have had limited effects counteracting these adverse effects. Semaglutide, a glucagon-like peptide 1 receptor agonist, is approved for the treatment of type 2 diabetes and obesity. We will investigate the long-term effects of add-on treatment with semaglutide once a week versus placebo once a week on the metabolic status in pre-diabetic (glycated haemoglobin A1c (HbA1c) 35–47 mmol/mol (5.4%–6.4%) and diabetic (HbA1c 48–57 mmol/mol (6.5%–7.4%)) patients diagnosed with a schizophrenia spectrum disorder who initiated clozapine or olanzapine treatment within the last 60 months.Methods and analysisThis is a 26-week, double-blinded, randomised, placebo-controlled trial. Altogether, 104 patients diagnosed with a schizophrenia spectrum disorder, aged 18–65 years, with pre-diabetes or diabetes will be randomised to injections of 1.0 mg semaglutide once a week or placebo for 26 weeks. The primary endpoint is change from baseline in HbA1c. Secondary endpoints include changes in body weight, hip and waist circumference and plasma levels of insulin, glucagon, glucose, and C-peptide, insulin sensitivity, beta cell function, hepatic function, fibrosis-4 score, lipid profile, incretin hormones, bone markers, body composition, bone density, proteomic analyses and oxidative stress markers. Together with alcohol, tobacco and drug use, potential effects on the reward value of a sweet–fat stimulus, psychopathology, level of activity and quality of life will also be assessed.Ethics and disseminationThis study is approved by the Danish Medicines Agency and the regional scientific ethics committee of the Capital Region of Denmark (committee C, #H-20019008) and will be carried out in accordance with International Council for Harmonisation Good Clinical Practice guidelines and the Helsinki Declaration. The results will be disseminated through peer-review publications and conference presentations.Trial registration numberNCT04892199.
Pharmacokinetics of a microdosed cocktail of three direct oral anticoagulants in children with congenital heart defects: study protocol for a single-centre clinical trial (DOAC-Child)
Authors: Hermann Simon A , Mikus Gerd , Chobanyan-Jürgens Kristine , Gorenflo Matthias , Ziesenitz Victoria C. 
Published: January 2023

IntroductionDirect oral anticoagulants (DOACs) are direct inhibitors of coagulation factor Xa and are frequently used in adults for different indications such as deep vein thrombosis or non-valvular atrial fibrillation. Paediatric patients might benefit as well from DOACs because the simplicity and convenience of their use is likely to decrease physical and psychological stress related to invasive procedures associated with phenprocoumon and heparin therapy. Thus, it is expected that the future use of DOACs will ultimately improve compliance and overall safety of anticoagulant therapies in paediatric populations. To assure safe and effective use the clinical pharmacology and pharmacokinetics (PK) of these drugs need to be evaluated in children.Methods and analysisThis study is a single-centre, open-label, clinical trial in a paediatric population with non-cyanotic congenital heart defects. After having obtained informed consent from the parents, each participant will receive a single oral administration of a drinkable solution of a microdose cocktail of three FXa inhibitors consisting of apixaban (12.5 µg), rivaroxaban (12.5 µg), edoxaban (50 µg), plus a microdose of the two probe drugs midazolam (10 µg) and yohimbine (25 µg). Serial blood samples (n=up to 20) will be collected at specified time points before and up to 25 hours after cocktail administration. The primary PK endpoint will be the area under the plasma concentration time curve of apixaban, rivaroxaban and edoxaban. Secondary PK outcomes will be Cmax, tmax, t1/2, Cl/F and Vss/F. Safety and tolerability of the microdose cocktail will be evaluated as well by a collection of adverse events.EthicsThis study has been approved by the responsible Ethics Committee of the Medical Faculty of Heidelberg University.DisseminationStudy results will be presented at international scientific meetings and published in peer-reviewed journals.Trial registration numberEudraCT 2019-001759-38 16, DRKS00021455.
Sports-related traumatic brain injuries and acute care costs in children
Authors: Singh Sonia , Hoch Jeffrey S , Hearps Stephen , Dalziel Kim , Cheek John Alexander , Holmes James , Anderson Vicki , Kuppermann Nathan , Babl Franz E 
Published: January 2023

ObjectiveTo estimate traumatic brain injuries (TBIs) and acute care costs due to sports activities.MethodsA planned secondary analysis of 7799 children from 5 years old to <18 years old with head injuries enrolled in a prospective multicentre study between 2011 and 2014. Sports-related TBIs were identified by the epidemiology codes for activity, place and injury mechanism. The sports cohort was stratified into two age groups (younger: 5–11 and older: 12–17 years). Acute care costs from the publicly funded Australian health system perspective are presented in 2018 pound sterling (£).ResultsThere were 2903 children (37%) with sports-related TBIs. Mean age was 12.0 years (95% CI 11.9 to 12.1 years); 78% were male. Bicycle riding was associated with the most TBIs (14%), with mean per-patient costs of £802 (95% CI £644 to £960) and 17% of acute costs. The highest acute costs (21%) were from motorcycle-related TBIs (3.8% of injuries), with mean per-patient costs of £3795 (95% CI £1850 to £5739). For younger boys and girls, bicycle riding was associated with the highest TBIs and total costs; however, the mean per-patient costs were highest for motorcycle and horse riding, respectively. For older boys, rugby was associated with the most TBIs. However, motorcycle riding had the highest total and mean per-patient acute costs. For older girls, horse riding was associated with the most TBIs and highest total acute costs, and motorcycle riding was associated with the highest mean per-patient costs.ConclusionInjury prevention strategies should focus on age-related and sex-related sports activities to reduce the burden of TBIs in children.Trial registration numberACTRN12614000463673.
Early hearing detection and intervention (EHDI) programmes for infants and young children in low-income and middle-income countries in Asia: a systematic review
Authors: Joshi B Deepashree , Ramkumar Vidya , Nair Lekha S , Kuper Hannah 
Published: January 2023

BackgroundEarly hearing detection and intervention (EHDI) measures initiated in high-income countries (HICs) were attempted in low-income and middle-income countries (L&MICs). However, information regarding the models of EHDI, context-specific adaptations made to strategies and outcomes are not known.AimsThe aims of this systematic review were to identify the various models of EHDI used in Asian L&MICs in the published scientific literature and to describe their efficacy and validity.MethodsThe studies were eligible if the programme was from Asian L&MICs, implemented for children below 6 years of age and published between 2010 and 2021. Google Scholar, PubMed, Web of Science, Scopus, EBSCOHost and EBSCO–CINAHL were used to find articles. Data were extracted from each selected article, and the risk of bias was assessed. The search results were summarised using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. For primary outcomes, narrative synthesis was used, and forest plots were generated for secondary outcomes.ResultsIn all, 82 studies were included, and these studies were divided into two categories: newborn and infant screening programmes and screening programmes for older children. Predominantly, a two-stage objective otoacoustic emission (Distortion Product/Transient Evoked) or automated auditory brainstem response screening, followed by a detailed auditory brainstem response to confirm the hearing loss, was used in newborn and infant screening programmes. Audiologists were the most frequent screening personnel. Screening of older children was mostly done by otolaryngologists, school instructors and nurses. They performed a single-stage pure tone audiometry screening followed by a detailed examination.ConclusionThe screening tools and protocols used were similar to those used in HICs. However, no uniform protocols were followed within each country. Long-term viability of EHDI programmes was not known as there was limited information on impact outcomes such as cost–benefit.PROSPERO registration numberCRD42021240341.
Tobacco endgame and priority populations: a scoping review
Authors: Puljević Cheneal , Feulner Leah , Hobbs Maria , Erku Daniel , Bonevski Billie , Segan Catherine , Baker Amanda , Hefler Marita , Cho Ara , Gartner Coral 
Published: January 2023

AimTo summarise the research literature on the impacts or perceptions of policies to end tobacco use at a population level (ie, tobacco endgame policies) among people from eight priority population groups (experiencing mental illness, substance use disorders, HIV, homelessness, unemployment or low incomes, who identify as lesbian, gay, bisexual, transgender, queer or intersex (LGBTQI+) or who have experienced incarceration).MethodsGuided by JBI Scoping Review Methodology, we searched six databases for original research examining the impacts or perceptions of 12 tobacco endgame policies among eight priority populations published since 2000. We report the results according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.ResultsOf the 18 included studies, one described perceptions of five endgame policies among people on low incomes in Aotearoa (New Zealand), and 17 focused on the effectiveness or impacts of a very low nicotine content (VLNC) cigarette standard among people experiencing mental illness (n=14), substance use disorders (n=8), low incomes (n=6), unemployment (n=1) or who identify as LGBTQI+ (n=1) in the USA. These studies provide evidence that VLNC cigarettes can reduce tobacco smoking, cigarette cravings, nicotine withdrawal and nicotine dependence among these populations.ConclusionsMost of the tobacco endgame literature related to these priority populations focuses on VLNC cigarettes. Identified research gaps include the effectiveness of endgame policies for reducing smoking, impacts (both expected and unexpected) and policy perceptions among these priority populations.
Analysis and comparison of failure causes of minimally invasive surgical closure of ventricular septal defects in children
Authors: Yu Jin , Shi Zhuo , Qian Jingjing , Ma Lianglong , Zhang Baofu , Ying Liyang , Shu Qiang 
Published: January 2023

ObjectivesThe aims of the present study were to explore the causes of minimally invasive surgical ventricular septal defect (VSD) closure failure under transesophageal echocardiography guidance and thus to improve the success rate of surgical VSD closure.MethodsFrom January 2015 to December 2019, 522 children with VSD underwent minimally invasive surgical closure. Nineteen procedures (3.64%) were unsuccessful. The failure causes, VSD locations and surgical incision approaches were retrospectively analyzed.ResultsAmong the 19 patients (3.64%) with unsuccessful outcomes, 18 were switched to cardiopulmonary bypass (CPB) surgery, and 1 was closed successfully using an occlusion device a year later. The causes of failure included occlusion device shedding or shifting (n=6), failure of the guidewire (or the sheath) to pass through a small defect (n=5), device-related valve regurgitation (n=4), significant residual shunt (n=2), ventricular fibrillation (n=1), and continuous sharp blood pressure decreases (n=1). Patients with high VSD had a slightly higher failure rate than those with perimembranous VSD (p=0.049), and its key reason is the high proportion of occlusion device shedding or shifting (p=0.005). No significant difference in the failure rate was found between patients with different surgical incision approaches.ConclusionsMinimally invasive surgery has a high success rate for perimembranous VSDs. Occlusion device shedding or shifting is the most common cause of failure. The shedding or shifting risk of eccentric occlusion devices being used only for high VSDs is much greater than that of concentric occlusion devices being used for perimembranous VSDs, which increases the risk of conversion to CPB surgery for high VSDs.