bluuebunny/crossref_metadata_2025 huggingface dataset:
Sensitivity of Detection and Variant Typing of SARS-CoV-2 in European Laboratories
Authors: Mögling Ramona , Fischer Carlo , Stanoeva Kamelia R. , Melidou Angeliki , Almeida Campos Angélica C. , Drosten Christian , Biere Barbara , Meijer Adam , Kraus Annette , Reusken Chantal B. E. M. , Drexler Jan Felix
Published: November 2022

The molecular detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is key for clinical management and surveillance. Funded by the European Centre for Disease Prevention and Control, we conducted an external quality assessment (EQA) on the molecular detection and variant typing of SARS-CoV-2 that included 59 European laboratories in 34 countries.
Within-Host Genotypic and Phenotypic Diversity of Contemporaneous Carbapenem-Resistant Klebsiella pneumoniae from Blood Cultures of Patients with Bacteremia
Authors: Cheng Shaoji , Fleres Giuseppe , Chen Liang , Liu Guojun , Hao Binghua , Newbrough Anthony , Driscoll Eileen , Shields Ryan K. , Squires Kevin M. , Chu Ting-yu , Kreiswirth Barry N. , Nguyen M. Hong , Clancy Cornelius J.
Published: November 2022

The long-standing paradigm for pathogenesis of bacteremia is that, in most cases, a single organism passes through a bottleneck and establishes itself in the bloodstream (single-organism hypothesis). In keeping with this paradigm, standard practice in processing positive microbiologic cultures is to test single bacterial strains from morphologically distinct colonies.
Human Cytomegalovirus pUL11, a CD45 Ligand, Disrupts CD4 T Cell Control of Viral Spread in Epithelial Cells
Authors: Osanyinlusi Samuel A. , Zischke Jasmin , Jacobs Roland , Weissinger Eva M. , Schulz Thomas F. , Kay-Fedorov Penelope C.
Published: November 2022

Human cytomegalovirus (HCMV) is adept at avoiding its host’s immune defenses, both by evading detection and by directly inhibiting immune cells. This can lead to a loss of control of the infection, and dangerous disease can result, particularly in cases in which an individual’s immune system is immature, weak, or suppressed.
The PTEX Pore Component EXP2 Is Important for Intrahepatic Development during the
Plasmodium
Liver Stage
Authors: Hussain Tahir , Linera-Gonzalez Jose , Beck John M. , Fierro Manuel A. , Mair Gunnar R. , Smith Ryan C. , Beck Josh R.
Published: November 2022

After the mosquito bite that initiates a
Plasmodium
infection, parasites first travel to the liver and develop in hepatocytes. This liver stage is asymptomatic but necessary for the parasite to transition to the merozoite form, which infects red blood cells and causes malaria.
Identification of an α-(1
→
6)-Mannosyltransferase Contributing To Biosynthesis of the Fungal-Type Galactomannan α-Core-Mannan Structure in Aspergillus fumigatus
Authors: Kadooka Chihiro , Hira Daisuke , Tanaka Yutaka , Miyazawa Ken , Bise Masaaki , Takatsuka Shogo , Oka Takuji
Published: November 2022

Fungal-type galactomannan is a polysaccharide incorporated into the cell wall of filamentous fungi belonging to the subphylum Pezizomycotina. Biosynthetic enzymes of fungal-type galactomannan are potential targets for antifungal drugs and agrochemicals.
Identification of Novel Viruses and Their Microbial Hosts from Soils with Long-Term Nitrogen Fertilization and Cover Cropping Management
Authors: Duan Ning , Radosevich Mark , Zhuang Jie , DeBruyn Jennifer M. , Staton Margaret , Schaeffer Sean M.
Published: November 2022

Bacterial viruses are extremely small and abundant particles that can control the microbial abundance and community composition through infection, which gradually showed their vital roles in the ecological process to influence the nutrient flow. Compared to the substrate control, less is known about the influence of soil viruses on microbial community function, and even less is known about microbial and viral diversity in the soil system.
Competitive Transmission of Carbapenem-Resistant Klebsiella pneumoniae in a Newly Opened Intensive Care Unit
Authors: Hu Ya , Zhang Hui , Wei Li , Feng Yu , Wen Hongxia , Li Jingwen , Zhang Zhihui , Yang Yongqiang , Moran Robert A. , McNally Alan , Zong Zhiyong
Published: November 2022

Carbapenem-resistant
Klebsiella pneumoniae
(CRKP) is a global challenge for human health. In health care settings, patients have frequent interactions with other patients and the environment, rendering challenges for untangling the introduction and transmission of CRKP.
The Tricalbin-Family Endoplasmic Reticulum-Plasma Membrane Tethering Proteins Attenuate ROS-Involved Caspofungin Sensitivity in Candida albicans
Authors: Yang Li , Zhu Hangqi , Li Mingchun , Yu Qilin
Published: November 2022

The endoplasmic reticulum-plasma membrane contacts are important membrane contact structures in eukaryotic cells, functioning in material and message exchange between the ER and the PM. We observed that the two tricalbin-family endoplasmic reticulum-plasma membrane contact proteins are required for tolerance to caspofungin-induced cell wall stress in the pathogenic fungus
Candida albicans
.
Occurrence of Lagovirus europaeus (Rabbit Hemorrhagic Disease Virus) in Domestic Rabbits in Southwestern Poland in 2019: Case Report
Authors: Hrynkiewicz Rafał , Bębnowska Dominika , Kauppinen Ari , Gadd Tuija , Piasecki Tomasz , Niedźwiedzka-Rystwej Paulina
Published: November 2022

Lagovirus europaeus
(RHDV) causes a severe, highly infectious, and fatal disease in rabbits called RHD. The disease is a very serious threat to the global rabbit industry and the rabbit population in the wild. The aim of the study was to detect
Lagovirus europaeus
(RHDV) strains in domestic rabbits that died suddenly in Poland. The presence of RHDV was confirmed in 8 samples of all 14 samples collected. This is one of the very few reports on the existence of this virus in pet rabbits in Poland.
Epidemiology and Antifungal Susceptibility ofCandidaSpecies Isolated from 10 Tertiary Care Hospitals in Iran
Authors: Badiee Parisa , Boekhout Teun , Haddadi Pardis , Mohammadi Rasoul , Ghadimi-Moghadam Abdolkarim , Soltani Jafar , Zarei Mahmoudabadi Ali , Ayatollahi Mousavi Seyyed Amin , Najafzadeh Mohammad Javad , Diba Kambiz , Salimi-Khorashad Ali Reza , Amin Shahidi Maneli , Ghasemi Fatemeh , Jafarian Hadis
Published: November 2022

Candidaspecies cause severe invasive infections of the heart, brain, eyes, bones, and other parts of the body. Knowledge of regional distributions of causativeCandidaagents and their antifungal susceptibility patterns can help to monitor resistance to antifungal agents of various species and support local and national surveillance programs.
Unveiling the Wheat Microbiome under Varied Agricultural Field Conditions
Authors: Jaiswal Sarika , Aneja Bharti , Jagannadham Jaisri , Pandey Bharati , Chhokar Rajender Singh , Gill Subhash Chander , Ahlawat Om Parkash , Kumar Anuj , Angadi U. B. , Rai Anil , Tiwari Ratan , Iquebal Mir Asif , Kumar Dinesh
Published: November 2022

This investigation examined the wheat microbiome under six different agricultural field conditions to understand the role of cropping pattern on soil microbial diversity. This study also elaborated the community composition, which has importance in economic (role of beneficial community leading to higher production) and environmental (role of microbial diversity/community in safeguarding the soil health, etc.) arenas. This could lead to a sustainable farming approach for food security and improved ecosystem health.
Oral Bacteriome and Mycobiome across Stages of Oral Carcinogenesis
Authors: Heng Weiwei , Wang Wenmei , Dai Tingting , Jiang Ping , Lu Yong , Li Ruowei , Zhang Miaomiao , Xie Ruiqi , Zhou Yifan , Zhao Maomao , Duan Ning , Ye Zhengqin , Yan Fuhua , Wang Xiang
Published: November 2022

Abundant oral microorganisms constitute a complex microecosystem within the oral environment of the host, which plays a critical role in the adjustment of various physiological and pathological states of the oral cavity. In this study, we demonstrated that variations in the “core microbiome” may be used to predict carcinogenesis.
Algorithms for Screening for Active Tuberculosis among Individuals with Latent Tuberculosis Infection in a Rural Community in China
Authors: Xin Henan , Du Ying , Cao Xuefang , Wang Dakuan , Zhang Bin , Zhang Haoran , Feng Boxuan , He Yijun , He Yongpeng , Quan Zhusheng , Liu Zisen , Yan Jiaoxia , Guan Ling , Guan Xueling , Shen Fei , Liu Jianmin , Jin Qi , Pan Shouguo , Gao Lei
Published: November 2022

Enhancing community-wide active case screening in target LTBI populations is important for achieving the early treatment of active TB, and ruling active TB out is a prerequisite for initiating preventive treatment. The current study evaluated the performances of multiple tests and their combinations in screening for active TB among individuals with LTBI at the community level.
Facultative Endosymbiont Serratia symbiotica Inhibits the Apterization of Pea Aphid To Enhance Its Spread
Authors: Kang Zhi-Wei , Zhang Meng , Cao He-He , Guo Shan-Shan , Liu Fang-Hua , Liu Tong-Xian
Published: November 2022

Wing polyphenism is an important adaptative response to environmental changes for aphids. Endosymbionts are widespread in aphids and also confer the ability to withstand unfavorable conditions.
Host Cell Oxidative Stress Promotes Intracellular Fluoroquinolone Persisters of Streptococcus pneumoniae
Authors: Hernandez-Morfa Mirelys , Reinoso-Vizcaíno Nicolás M. , Olivero Nadia B. , Zappia Victoria E. , Cortes Paulo R. , Jaime Andrea , Echenique José
Published: November 2022

In
S. pneumoniae
, different mechanisms that counteract antibiotic effects have been described, such as vancomycin tolerance, heteroresistance to penicillin and fluoroquinolone resistance, which critically affect the therapeutic efficacy. Antibiotic persistence is a type of antibiotic tolerance that allows a bacterial subpopulation to survive lethal antimicrobial concentrations.
Supplemental Material: Triggering of episodic back-arc extensions in the northeast Asian continental margin by deep mantle flow
Authors: Dong Yu , Xu Wenliang , al. et
Published: November 2022

Figures S1–S5 and Tables S1 and S2. 
Proximal tibiofibular joint (PTFJ) dislocation due to Ehlers-Danlos syndrome: posterolateral open-wedge high tibial osteotomy combined with medial closed-wedge distal femoral osteotomy can correct the severe valgus deformity with a markedly increased tibial posterior slope
Authors: Amemiya Masaki , Nakamura Ryuichi , Yoshimura Mitsuo , Takagi Tomoharu
Published: November 2022

Ehlers-Danlos syndrome (EDS) causes joint hypermobility and joint dislocation. Since there are no reports of proximal tibiofibular joint (PTFJ) dislocation caused by EDS, little is known about the long-term course of this disease. A woman in her 40s presented with a posterolaterally depressed tibial condyle and severe valgus deformity caused by a long-standing PTFJ dislocation due to EDS. Considering the pathology, posterolateral open-wedge high tibial osteotomy (PLOWHTO) and medial closed-wedge distal femoral osteotomy were performed according to the deformity analysis. A favourable short-term clinical outcome was obtained and the PTFJ dislocation was reduced over time. Although PLOWHTO has several pitfalls, it is a logical and useful surgical technique that can help treat posterolateral dysplasia of the tibial plateau concomitant with severe valgus deformity, regardless of joint laxity, if performed with attention to pitfalls.
Carotid artery dissection presenting as exercise-induced monocular visual loss
Authors: Jiang Zhilin , Kadam Mustafa
Published: November 2022

A man in his 60s presented to the urgent treatment centre with isolated transient monocular visual loss in the right eye soon after completing a 5 km run. He had no preceding events, no history of neck pain and no other associated symptoms. His only medical history was presumed giant cell arteritis 3 months prior. The ophthalmology team reviewed the patient urgently and retinal artery occlusion was excluded. Carotid Doppler imaging showed a total occlusion of the right internal carotid artery. CT angiogram of the head and neck vessels revealed a dissection flap immediately proximal to the occlusion. The carotid dissection was treated with aspirin 300 mg for 2 weeks followed by clopidogrel 75 mg for a minimum of 3 months. The patient was discussed with the vascular team who confirmed that no surgical intervention would be required to treat the occlusion. With the relatively simple treatment of antiplatelet therapy, the patient is making good progress with no recurrence of symptoms.
Phlegmasia cerulea dolens: a swelling, cyanosis and discolouration of the extremity in the ICU
Authors: Alves João , Salgueiro Andrea , Baptista João Pedro , Coimbra Paulo
Published: November 2022

Phlegmasia cerulea dolens is a rare entity that causes critical limb ischaemia, which may lead to amputation of the limb and may be life-threatening. Here, we describe a case of a healthy man in his 50s with multiple trauma who was transferred to the intensive care unit (ICU) of a central hospital for neuromonitoring following splenectomy for the stabilisation of a hypovolaemic shock. On admission to the ICU, the patient developed a swollen and white leg. The condition was caused by early compromised arterial flow secondary to extensive deep vein thrombosis.
Detection of exhaled methane levels for monitoring trauma-related haemorrhage following blunt trauma: study protocol for a prospective observational study
Authors: Jávor Péter , Rárosi Ferenc , Horváth Tamara , Török László , Varga Endre , Hartmann Petra
Published: November 2022

Introduction

Early recognition and effective treatment of internal bleeding impose a cardinal challenge for trauma teams. The reduction of the superior mesenteric artery (SMA) blood flow is among the first compensatory responses to blood loss, thus being a promising candidate as a diagnostic tool for occult haemorrhage. Unfortunately, methods for monitoring the SMA flow have not been elaborated to date. Nevertheless, animal experiments suggest that exhaled methane (CH4) levels correspond to the SMA perfusion. We hypothesise that real-time detection of CH4concentrations in the exhaled air is an applicable technique for the early recognition of haemorrhage in severely injured patients. We also hypothesise that exhaled CH4levels reflect the volume of blood loss more accurately than conventional markers of blood loss and shock such as shock index, haemoglobin, base deficit, lactate, end-tidal carbon dioxide and sublingual microcirculatory indices.

Methods and analysis

One hundred and eleven severely injured (Injury Severity Score ≥16), intubated, bleeding patients sustaining blunt trauma will be included in this prospective observational study. Blood loss will be detected with CT and estimated with CT-linked radiologic software. Exhaled CH4concentrations will be monitored by attaching a near-infrared laser technique-based photoacoustic spectroscopy apparatus to the exhalation outlet of the ventilator on patient arrival. The primary outcome is the volume of blood loss. Need for massive transfusion and 24-hour mortality will constitute secondary outcomes. The relation of exhaled CH4to study outcomes and its performance in predicting blood loss in comparison with conventional shock markers and microcirculatory indices will be tested.

Ethics and dissemination

Our protocol (ID: 5400/2021-SZTE) has been registered on ClinicalTrials.gov (NCT04987411) and complies with the Declaration of Helsinki and has been approved by the medical ethics committee at the University of Szeged (Ref.nr.:121/2021-SZTE RKEB). It is in data collection phase, theresults will be shared with the scientific community through publication in a peer-reviewed journal.

Trial registration number

NCT04987411ClinicalTrials.gov, registered on 27 July 2021.
Pregnancy of unknown location: external validation of the hCG-based M6NP and M4 prediction models in an emergency gynaecology unit
Authors: Fistouris Johan , Bergh Christina , Strandell Annika
Published: November 2022

Objective

To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4.

Design

Retrospective cohort study.

Setting

University Hospital.

Participants

Women with PUL.

Methods

All consecutive women with a PUL during a study period of 3 years were screened for inclusion. Risk prediction of an EP was based on two serum human chorionic gonadotropin (hCG) levels taken at least 24 hours and no longer than 72 hours apart.

Main outcome measures

The area under the ROC curve (AUC) expressed the ability of a model to distinguish an EP from a non-EP (discrimination). Calibration assessed the agreement between the predicted risk of an EP and the true risk (proportion) of EP. The proportion of EPs and non-EPs classified as high risk assessed the model’s sensitivity and false positive rate (FPR). The proportion of non-EPs among women classified as low risk was the model’s negative predictive value (NPV). The clinical utility of a model was evaluated with decision curve analysis.

Results

1061 women were included in the study, of which 238 (22%) had a final diagnosis of EP. The AUC for EP was 0.85 for M6NP and 0.81 for M4. M6NP made accurate risk predictions of EP up to predictions of 20% but thereafter risks were underestimated. M4 was poorly calibrated up to risk predictions of 40%. With a 5% threshold for high risk classification the sensitivity for EP was 95% for M6NP, the FPR 50% and NPV 97%. M6NP had higher sensitivity and NPV than M4 but also a higher FPR. M6NP had utility at all thresholds as opposed to M4 that had no utility at thresholds≤5%.

Conclusions

M6NP had better predictive performance than M4 and is valid in women with PUL attending an emergency gynaecology unit. Our results can encourage implementation of M6NP in related yet untested clinical settings to effectively support clinical decision-making.
Studying intraprofessional and interprofessional learning processes initiated by an educational intervention applying a qualitative design with multimethod approach: a study protocol
Authors: Truong Anh Thuc , Winman Thomas , Ekström-Bergström Anette
Published: November 2022

Introduction

Interprofessional collaboration in education and practice has been highlighted as a premise for providing good care. Both the intraprofessional and interprofessional impacts have bearing on healthcare professionals’ performance and learning. Likewise, from the perspective of work-integrated learning, intraprofessional and interprofessional learning play an enduring part in studies about the development of healthcare organisations and professional competence. Educational-intervention research has become significant, which may indicate challenges the healthcare, for example, the area of disabilities is confronting. Earlier studies on intraprofessional and interprofessional learning have often focused on the learning outcome, whereas the learning process remains unexplored. The learning process is complex and is normally influenced by several factors. Therefore, develop knowledge about the intraprofessional and interprofessional learning processes initiated by an educational-intervention and the factors influencing this process may contribute to educational-intervention research, which is also the aim of the forthcoming study.

Methods and analysis

An inductive qualitative study design with interpretivism as the epistemological stand will be applied. Professionals in healthcare services for people with intellectual disabilities in four residential settings in Sweden are included in the educational-intervention based on web-based training and structured group reflections. Intended data collections are videorecordings of group reflections and individual interviews. An ethnomethodological approach will be applied for studying the details of conversation and interaction in group reflections. The interviews will be analysed using qualitative content analysis to gain participants’ viewpoints of the intervention.

Ethics and dissemination

Approval was obtained from the Swedish Ethical Review Authority, Dnr 35 517. In Addition, a supplemental application to the extended part of the intervention in the forthcoming study has been submitted and approval was received on 21 September 2021. Ethical principles following the Declaration of Helsinki will be strictly followed.

Trial registration number

NCT03390868; Post-results.
The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures
Authors: Tan Chia Wei , Cameron Maribel , Arlachov Yuriy , Bastounis Anastasios , Bishop Simon , Czernicki Michal , Drummond Avril , Fakis Apostolos , Pasku Dritan , Sahota Opinder
Published: November 2022

Introduction

Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.

A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients.

Method

A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data.

Ethics and dissemination

Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion.

Trial registration number

NCT18334053.
Mental Imagery to Reduce Alcohol-related harm in patients with alcohol dependence and alcohol-related liver damaGE: the MIRAGE pilot trial protocol
Authors: Dhanda Ashwin D , Allende Hannah , Allgar Victoria , Andrade Jackie , Bailey Matthew Peter , Callaghan Lynne , Cocking Laura , Goodwin Elizabeth , Hawton Annie , Hayward Christopher , Hudson Ben , Jeffery Alison , King Angela , Lavers Victoria , Lomax Joe , McCune C Anne , Parker Richard , Rollinson Christopher , Wilks Jonny , Creanor E Siobhan
Published: November 2022

Introduction

In the UK, alcohol use is the main driver of chronic liver disease and each year results in over 1 million unplanned hospital admissions and over 25 000 deaths from alcohol-related liver disease (ArLD). The only effective treatment to prevent progression of liver damage is reducing or ceasing alcohol consumption. Psychological and pharmacological therapies for alcohol misuse are ineffective in patients with ArLD. Functional imagery training (FIT) is a novel psychological therapy that builds on motivational interviewing techniques with multisensory imagery. This pilot trial aims to test the feasibility of training alcohol liaison nurses to deliver FIT therapy and of recruiting and retaining patients with ArLD and alcohol dependence to a randomised trial of FIT and treatment as usual (TAU) versus TAU alone.

Methods and analysis

This is a randomised pilot trial of FIT and TAU versus TAU alone in 90 patients with ArLD and alcohol dependence admitted to one of four UK centres. The primary objectives are to estimate rates of screening, recruitment, randomisation, retention, adherence to FIT/TAU and a preliminary assessment of the FIT intervention in the ArLD population. Data from the pilot study will be used to finalise the design of a definitive randomised controlled trial to assess the effectiveness and cost-effectiveness of FIT. The proposed primary outcome measure for the definitive trial is self-reported alcohol use assessed using timeline follow-back.

Ethics and dissemination

Research ethics approval was given by the Yorkshire and Humber–Bradford Leeds Research Ethics Committee (reference: 21/YH/0044). Eligible patients will be approached and written informed consent obtained prior to participation. Results will be disseminated through peer-reviewed open access journals, international conferences and a lay summary published on the Trials Unit website and made available to patient groups.

Trial registration number

NCT41353774.
Women’s EmotionS, Trauma and EmpowErMent (W-ES.T.EEM) study protocol: a psychoeducational support intervention for victims of domestic violence – a randomised controlled trial
Authors: Taccini Federica , Rossi Alessandro Alberto , Mannarini Stefania
Published: November 2022

Introduction

Intimate partner violence (IPV) is a widespread phenomenon that affects the physical and mental well-being of victims. Several barriers prevented sufferers from receiving face-to-face interventions. These obstacles increased with the advent of the COVID-19 pandemic, and online psychological intervention can represent a valid solution to increase the well-being of IPV victims. This manuscript describes the study protocol for a single blind randomised controlled trial that examines the efficacy of a web-based psychoeducational intervention for IPV victims that integrates dialectical behavioural therapy and the empowerment approach.

Methods and analysis

Eighty-six women who were victims of IPV during the COVID-19 outbreak will be recruited by the Interdepartmental Center for Family Research (CIRF) staff from the several antiviolence centres located in Italy. Participants will be randomly allocated to the Women’s EmotionS, Trauma and EmpowErMent experimental group or the treatment as usual control condition. Both interventions will be administered individually to each woman.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the University of Padua (protocol no 4300). Written informed consent will be obtained from all research participants before study entry. Study results will be published as peer-reviewed articles. Any relevant protocol changes will be reported in the published articles. The results will be reported anonymously.

Trial registration number

NCT12880309.
Vitamin D status in children and its association with glucose metabolism in northern China: a combination of a cross-sectional and retrospective study
Authors: Liu Junyi , Fu Liqun , Jin Shanshan , Jia Yubing , Zhang Jingyi , Sun Changhao , Na Lixin
Published: November 2022

Objectives

This study aimed to explore the vitamin D status of children in northern China and the association between vitamin D and glucose metabolism.

Design

Cross-sectional study was conducted among child participants and retrospective study designs were conducted among adult participants.

Setting and participants

Both studies were recruited from Harbin, 326 children were included in children’s study, 8469 adults were included in adult study.

Primary and secondary outcome measures

Physical examination, lifestyle and dietary habit data were recorded in all the participants. Serum insulin, glucose, 25(OH)D3concentrations in children and serum glucose and lipids levels in adults were measured. Rickets history was also investigated in adults, which was used to define vitamin D deficiency in childhood. The associations were tested by linear regression and binary logistic regression.

Result

In the children’s study, only 10.7% of participants were vitamin D sufficient (≥30 ng/mL). Inverse correlations between serum 25(OH)D3concentration and fasting insulin and homeostasis model assessment - insulin resistance (HOMA-IR) were found, and children with lower serum 25(OH)D3concentrations were likely to have insulin resistance (IR) (OR: 0.955, 95% CI: 0.917 to 0.995, p value: 0.027). In an adult study, rickets in childhood increased the risk of type 2 diabetes in male participants (OR=1.414, 95% CI=1.013 to 1.972; p value=0.042), but this result was not observed in female participants.

Conclusion

Our findings suggest that vitamin D deficiency is widespread in northern China. Vitamin D deficiency in childhood was associated with IR and increased the risk of type 2 diabetes in male adults.
Gestational diabetes mellitus and offspring’s carotid intima–media thickness at birth: MySweetHeart Cohort study
Authors: Epure Adina Mihaela , Di Bernardo Stefano , Mivelaz Yvan , Estoppey Younes Sandrine , Chiolero Arnaud , Sekarski Nicole
Published: November 2022

Objective

Hyperglycaemia during pregnancy is associated with cardiometabolic risks for the mother and the offspring. Mothers with gestational diabetes mellitus (GDM) have signs of subclinical atherosclerosis, including increased carotid intima–media thickness (CIMT). We assessed whether GDM is associated with increased CIMT in the offspring at birth.

Design and setting

MySweetHeart Cohort is a prospective cohort study conducted in Switzerland.

Participants, exposure and outcome measures

This work included pregnant women with and without GDM at 24–32 weeks of gestation and their singleton live-born offspring with data on the primary outcome of CIMT. GDM was diagnosed based on the criteria of the International Association of Diabetes and Pregnancy Study Groups. Offspring’s CIMT was measured by ultrasonography after birth (range 1–19 days).

Results

Data on CIMT were available for 99 offspring of women without GDM and 101 offspring of women with GDM. Maternal age ranged from 18 to 47 years. Some 16% of women with GDM and 6% of women without GDM were obese. Smoking during pregnancy was more frequent among women with GDM (18%) than among those without GDM (4%). Neonatal characteristics were comparable between the two groups. The difference in CIMT between offspring of women with and without GDM was of 0.00 mm (95% CI −0.01 to 0.01; p=0.96) and remained similar on adjustment for potential confounding factors, such as maternal prepregnancy body mass index, maternal education, smoking during pregnancy, family history of diabetes, as well as offspring’s sex, age, and body surface area (0.00 mm (95% CI −0.02 to 0.01; p=0.45)).

Conclusions

We found no evidence of increased CIMT in neonates exposed to GDM. A longer-term follow-up that includes additional vascular measures, such as endothelial function or arterial stiffness, may shed further light on the cardiovascular health trajectories in children born to mothers with GDM.

Trial registration number

NCT02872974; Pre-results.
Effect of lifting COVID-19 restrictions on utilisation of primary care services in Nepal: a difference-in-differences analysis
Authors: Kapoor Neena R , Aryal Amit , Mehata Suresh , Dulal Mahesh , Kruk Margaret E , Bauhoff Sebastian , Arsenault Catherine
Published: November 2022

Introduction

An increasing number of studies have reported disruptions in health service utilisation due to the COVID-19 pandemic and its associated restrictions. However, little is known about the effect of lifting COVID-19 restrictions on health service utilisation. The objective of this study was to estimate the effect of lifting COVID-19 restrictions on primary care service utilisation in Nepal.

Methods

Data on utilisation of 10 primary care services were extracted from the Health Management Information System across all health facilities in Nepal. We used a difference-in-differences design and linear fixed effects regressions to estimate the effect of lifting COVID-19 restrictions. The treatment group included palikas that had lifted restrictions in place from 17 August 2020 to 16 September 2020 (Bhadra 2077) and the control group included palikas that had maintained restrictions during that period. The pre-period included the 4 months of national lockdown from 24 March 2020 to 22 July 2020 (Chaitra 2076 to Ashar 2077). Models included month and palika fixed effects and controlled for COVID-19 incidence.

Results

We found that lifting COVID-19 restrictions was associated with an average increase per palika of 57.5 contraceptive users (95% CI 14.6 to 100.5), 15.6 antenatal care visits (95% CI 5.3 to 25.9) and 1.6 child pneumonia visits (95% CI 0.2 to 2.9). This corresponded to a 9.4% increase in contraceptive users, 34.2% increase in antenatal care visits and 15.6% increase in child pneumonia visits. Utilisation of most other primary care services also increased after lifting restrictions, but coefficients were not statistically significant.

Conclusions

Despite the ongoing pandemic, lifting restrictions can lead to an increase in some primary care services. Our results point to a causal link between restrictions and health service utilisation and call for policy makers in low- and middle-income countries to carefully consider the trade-offs of strict lockdowns during future COVID-19 waves or future pandemics.
Effects of air pollution on clinical pregnancy rates after in vitro fertilisation (IVF): a retrospective cohort study
Authors: Tartaglia Marie , Chansel-Debordeaux Lucie , Rondeau Virginie , Hulin Agnès , Levy Alexandre , Jimenez Clément , Bourquin Patrick , Delva Fleur , Papaxanthos-Roche Aline
Published: November 2022

Objective

To evaluate the effect of air pollution, from oocyte retrieval to embryo transfer, on the results of in vitro fertilisation (IVF) in terms of clinical pregnancy rates, at two fertility centres, from 2013 to 2019.

Design

Exploratory retrospective cohort study.

Setting

This retrospective cohort study was performed in the Reproductive Biology Department of Bordeaux University Hospital localised in Bordeaux, France and the Jean Villar Fertility Center localised in Bruges, France.

Participants

This study included 10 763 IVF attempts occurring between January 2013 and December 2019, 2194 of which resulted in a clinical pregnancy.

Primary and secondary outcome measures

The outcome of the IVF attempt was recorded as the presence or absence of a clinical pregnancy; exposure to air pollution was assessed by calculating the cumulative exposure of suspended particulate matter, fine particulate matter, black carbon, nitrogen dioxide and ozone (O3), over the period from oocyte retrieval to embryo transfer, together with secondary exposure due to the presence of the biomass boiler room, which was installed in 2016, close to the Bordeaux University Hospital laboratory. The association between air pollution and IVF outcome was evaluated by a random-effects logistic regression analysis.

Results

We found negative associations between cumulative O3exposure and clinical pregnancy rate (OR=0.92, 95% CI = (0.86 to 0.98)), and between biomass boiler room exposure and clinical pregnancy rate (OR=0.75, 95% CI = (0.61 to 0.91)), after adjustment for potential confounders.

Conclusion

Air pollution could have a negative effect on assisted reproductive technology results and therefore precautions should be taken to minimise the impact of outdoor air on embryo culture.
Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial
Authors: Tassinari Cerys Joyce , Higham Ruchi , Smith Isabelle Louise , Arnold Susanne , Mujica-Mota Ruben , Metcalfe Andrew , Simpson Hamish , Murray David , McGonagle Dennis G , Sharma Hemant , Hamilton Thomas William , Ellard David R , Fernandez Catherine , Reynolds Catherine , Harwood Paul , Croft Julie , Stocken Deborah D , Pandit Hemant
Published: November 2022

Introduction

Knee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated with higher mortality and inferior outcomes. With more young people presenting with knee OA and increasing life expectancy, there is an unmet need to postpone time to first KR. Knee joint distraction (KJD), the practice of using external fixators to open up knee joint space, is proposed as potentially effective to preserve the joint following initial studies in the Netherlands, however, has not been researched within an NHS setting. The KARDS trial will investigate whether KJD is non-inferior to KR in terms of patient-reported postoperative pain 12 months post-surgery.

Methods and analysis

KARDS is a phase III, multicentre, pragmatic, open-label, individually randomised controlled non-inferiority trial comparing KJD with KR in patients with severe knee OA, employing a hybrid-expertise design, with internal pilot phase and process evaluation. 344 participants will be randomised (1:1) to KJD or KR. The primary outcome measure is the Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain domain score at 12 months post-operation. Secondary outcome measures include patient-reported overall KOOS, Pain Visual Analogue Scale and Oxford Knee Scores, knee function assessments, joint space width, complications and further interventions over 24 months post-operation. Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling.

Ethics and dissemination

Ethics approval was obtained from the Research Ethics Committee (REC) and Health Research Authority (HRA). Trial results will be disseminated at clinical conferences, through relevant patient groups and published in peer-reviewed journals.

Trial registration number

NCT14879004;recruitment opened April 2021.
Thirst in adult patients in the intensive care unit: protocol for a scoping review
Authors: Flim Marleen , Rustøen Tone , Blackwood Bronagh , Spronk Peter
Published: November 2022

Introduction

Thirst is one of the most bothersome symptoms experienced by intensive care unit (ICU) patients. Effective diagnosis and management of thirst in the ICU is essential, particularly as patients are less sedated than previously and more aware of this problem. Currently, no overview of publications on thirst identification and management in ICU patients exists. The scoping review will address the broad question ‘What is known about thirst as a symptom in adult critically ill patients?’ It aims to provide an overview of the causes and risk factors, diagnosis and measurement, the symptom dimensions and its interaction with other symptoms, and thirst management.

Methods and analysis

The review will follow the Joanna Briggs Institute methodology framework to guide the process and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Methods include: defining the review questions, eligibility criteria, concepts of interest and context; and outlining the search strategy, study selection process, data extraction and analysis. PubMed, MEDLINE, EMBASE and CINAHL will be searched from inception to April 2022.

Ethics and dissemination

Ethical approval is not required, as the scoping review will synthesise information from available publications. The scoping review will be submitted for publication to a scientific journal, presented at relevant conferences and disseminated as part of future workshops with ICU support groups and the critical care professional community.
Enablers and barriers to implementing obesity assessments in clinical practice: a rapid mixed-methods systematic review
Authors: Atlantis Evan , Chimoriya Ritesh , Seifu Canaan Negash , Peters Kath , Murphy Gill , Carr Bernadette , Lim David , Fahey P
Published: November 2022

Objectives

This systematic review aims to improve our knowledge of enablers and barriers to implementing obesity-related anthropometric assessments in clinical practice.

Design

A mixed-methods systematic review.

Data sources

Medline, Embase and CINAHL to November 2021.

Eligibility criteria

Quantitative studies that reported patient factors associated with obesity assessments in clinical practice (general practice or primary care); and qualitative studies that reported views of healthcare professionals about enablers and barriers to their implementation.

Data extraction and synthesis

We used random-effects meta-analysis to pool ratios for categorical predictors reported in ≥3 studies expressed as pooled risk ratio (RR) with 95% CI, applied inverse variance weights, and investigated statistical heterogeneity (I2), publication bias (Egger’s test), and sensitivity analyses. We used reflexive thematic analysis for qualitative data and applied a convergent integrated approach to synthesis.

Results

We reviewed 22 quantitative (observational) and 3 qualitative studies published between 2004 and 2020. All had ≥50% of the quality items for risk of bias assessments. Obesity assessment in clinical practice was positively associated with patient factors: female sex (RR 1.28, 95% CI 1.10 to 1.50, I299.8%, mostly UK/USA), socioeconomic deprivation (RR 1.21, 95% CI 1.18 to 1.24, I273.9%, UK studies), non-white race/ethnicity (RR 1.27, 95% CI 1.03 to 1.57, I299.6%) and comorbidities (RR 2.11, 95% CI 1.60 to 2.79, I299.6%, consistent across most countries). Obesity assessment was also most common in the heaviest body mass index group (RR 1.55, 95% CI 0.99 to 2.45, I299.6%). Views of healthcare professionals were positive about obesity assessments when linked to patient health (convergent with meta-analysis for comorbidities) and if part of routine practice, but negative about their role, training, time, resources and incentives in the healthcare system.

Conclusions

Our evidence synthesis revealed several important enablers and barriers to obesity assessments that should inform healthcare professionals and relevant stakeholders to encourage adherence to clinical practice guideline recommendations.
Reasons for dropout in the transition from hospital to municipality during exercise-based cardiac rehabilitation in a Danish cross-sectorial setting: a qualitative study
Authors: Damlund Anders Ravnholt Schüsler , Jørgensen Lars Bo , Blume Birgitte , Skou Søren T , Tang Lars H , Møller Tom
Published: November 2022

Objectives

Despite documented benefits of cardiac rehabilitation (CR), attrition rates remain relatively high. Insights on patient perspectives concerning dropout during transition phases are deficient. This deeper understanding may help to inform on the perceived benefits and barriers in CR. This qualitative study explores the reasons why patients’ dropout during the transition from a hospital-based CR programme to local healthcare facilities.

Setting

A Danish hospital and seven local healthcare centres.

Participants

Twelve patients, who had dropped out of exercise-based cardiac rehabilitation (exCR) during the transition from hospital-based rehabilitation to local healthcare centres, were recruited to semistructured interviews based on a purposeful sampling.

Results

Important patient needs during rehabilitation was the ability to identify and reflect oneself in a group of peers in a safe, specialised hospital-based environment. At the transition point, the meaningfulness of continuation of CR was revaluated. Findings showed that reasons for discontinuation varied within individuals. It encompassed on a balanced choice of reassessing benefits against competing agendas as work demands versus expectations of benefits in a changed exercise environment and own exercise capabilities.

Conclusion

The study indicated that patient needs as timely relevance, a specialised safe environment and peer support are significant for participation in exCR. These needs may change during the transition stage due to competing agendas as work obligations and assessment of own ability to take control themselves. Perceived meaningfulness may be a major motivational driver for both initiating and making a judiciously choice of leaving an exCR programme.
Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial
Authors: Yu Chunyu , Li Haojie , Wang Yang , Chen Sipeng , Zhao Yan , Zheng Zhe
Published: November 2022

Introduction

Atrial fibrillation (AF) is common in patients with rheumatic mitral valve disease (RMVD) and increase the risk of stroke and death. Bi-atrial or left atrial ablation remains controversial for treatment of AF during mitral valve surgery. The study aims to compare the efficacy and safety of bi-atrial ablation with those of left atrial ablation among patients with RMVD and persistent or long-standing persistent AF.

Methods and analysis

The ABLATION trial (Bi-atrial vs Left Atrial Ablation for Patients with RMVD and Non-paroxysmal AF) is a prospective, multicentre, randomised controlled study. The trial will randomly assign 320 patients with RMVD and persistent or long-standing persistent AF to bi-atrial ablation procedure or left atrial ablation procedure in a 1:1 randomisation. The primary end point is freedom from documented AF, atrial flutter or atrial tachycardia of >30 s at 12 months after surgery off antiarrhythmic drugs. Key secondary end point is the probability of freedom from permanent pacemaker implantation at 12 months after surgery. Secondary outcomes include the probability of freedom from any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs, AF burden, incidence of adverse events and cardiac function documented by echocardiography at 12 months after operation.

Ethics and dissemination

The central ethics committee at Fuwai Hospital approved the ABLATION trial. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial registration number

NCT05021601.