bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cardiac-associated biliary atresia (CABA): a prognostic subgroup
Authors: Aldeiri Bashar , Giamouris Vangelis , Pushparajah Kuberan , Miller Owen , Baker Alastair , Davenport Mark 
Published: July 2020

ObjectivesTo describe the range of concurrent cardiac malformations in biliary atresia (BA) while providing a functional framework of risk.MethodsDemographic and variables were collected from a prospectively maintained single-centre database. Infants were grouped according to a cardiac functional framework (A=acyanotic, B=cyanotic and C=insignificant shunt). Primary outcome was set as clearance of jaundice (bilirubin ≤20 μmol/L) following Kasai portoenterostomy (KPE). Native liver survival and overall actuarial survival were compared with a date-matched control infant with BA (n=77). P value <0.05 was regarded as significant.Results524 infants with histologically confirmed BA were treated between January 1999 and December 2018, 37 (7%) had a concurrent cardiac anomaly (A: n=23 (62%), B: n=10 (27%), C: n=4 (11%)). Infants with biliary atresia splenic malformation (BASM) or cat-eye syndrome (CES) contributed over half of the cases (21/37; 57%).Overall, 20 (54%) infants cleared jaundice (vs 50/77 (65%) controls; p=0.2), but with higher mortality compared with the non-cardiac controls (15/37 (40%) vs 3/77 (4%); HR 15.5 (95% CI 5.5 to 43.4); p<0.00001). Infants requiring cardiac intervention in the first year of life (n=15) were more likely to clear jaundice (6/7 vs 2/8; p=0.04) and had a trend towards higher survival (6/7 vs 3/8; p=0.1) when KPE followed cardiac surgery. Yet, the type of cardiac pathology did not impact clearance of jaundice or mortality.ConclusionWe propose the term cardiac-associated biliary atresia (CABA) as a high-risk group. We believe that restorative cardiac surgery should precede KPE wherever possible to improve outcome.
Novel patient-specific 3D-virtual reality visualisation software (SpectoVR) for the planning of spine surgery: a case series of eight patients
Authors: Croci Davide Marco , Guzman Raphael , Netzer Cordula , Mariani Luigi , Schaeren Stefan , Cattin Philippe C , Jost Gregory F 
Published: July 2020

BackgroundComplex spine surgery requires a sound three-dimensional (3D) understanding of anatomy.ObjectiveHere, we report the preoperative use a of novel software (SpectoVR) that presents DICOM data as virtual 3D holograms.MethodsThe software SpectoVR uses patient-specific DICOM data to render the anatomy as a hologram that is then viewed with a virtual reality (VR) headset. The surgeons used SpectoVR to prepare for complex surgeries.ResultsEight patients with the following diagnosis were presurgically studied with SpectoVR: (1) ankylosing spondylitis with fixed kyphotic cervical deformity treated with osteotomy reduction and cervicothoracic reconstruction; (2) persistent cervical foraminal stenosis after total disc replacement; (3) atlantoaxial osteoarthritis treated with C1–2 Magerl fixation; (4) adjacent segment degeneration with foraminal stenosis L5–S1; (5) C2–C4 chordoma; (6) spinal cord injury with rotational thoracolumbar fracture; (7) complex lumbopelvic deformity after prior hemipelvectomy for sarcoma and (8) atlantoaxial osteoarthritis and basilar impression in a patient with congenital craniosynostosis. Whereas VR did not omit the need for viewing the spine in the multiplane reconstruction mode, the authors feel that SpectoVR contributed to a better holistic understanding of the anatomy. Furthermore, positioning the spine like in the OR empowered the mental preparation for the surgery.ConclusionIntegrating SpectoVR in daily presurgical planning is feasible and appears to enhance the surgeon’s awareness of the case.
Development of a core outcome set for studies on prevention and management of pregnancy-associated venous thromboembolism (COSPVenTE): a study protocol
Authors: King Alexandria , D’Souza Rohan , Teshler Lizabeth , Shehata Nadine , Malinowski Ann K 
Published: July 2020

IntroductionPregnancy and post partum are times of heightened risk for the development of venous thromboembolism (VTE), which in turn is one of the leading causes of maternal mortality and long-term morbidity. The current research aimed at improving health guidelines for women with pregnancy-associated VTE is limited by inconsistency in outcome reporting preventing comparison across studies, and lack of input from patients with respect to outcomes they propose are most important to measure. A suggested solution is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials and prospective studies. COSs function to facilitate data harmonisation and increase homogeneity in outcome reporting while incorporating the voice of women in this population in the planning of research to inform their ongoing care.Methods and analysisThe development of a COS for studies on pregnancy-associated VTE will comprise five steps. First, a systematic review of the published literature will identify currently reported outcomes, their definitions and measurements if applicable. This will be followed by in-person interviews with patients, clinicians, researchers, hospital administrators and policy-makers to identify outcomes they consider important. Third, the long list of outcomes obtained from steps I and II will be condensed through online Delphi surveys involving an international group of relevant stakeholders including patients. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Lastly, to determine how the identified core outcomes should be measured, another literature review and Delphi process will be carried out as necessary.Ethics and disseminationThis study has been approved by the Mount Sinai Hospital Research Ethics Board (REB 18-0314-E). Study results will be published in open-access journals and presented at obstetrics, maternal–fetal medicine and haematology conferences. All progress will be documented on the international prospective register of systematic reviews (PROSPERO) and Core Outcome Measures in Effectiveness Trials databases.PROSPERO registration numberCRD42019111479.
Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol
Authors: D’Souza Rohan , Villani Linda , Hall Chelsea , Seyoum Meron , Kingdom John , Krznaric Michael , Donnolley Natasha , Javid Nasrin 
Published: July 2020

IntroductionVasa previa is a condition where fetal blood vessels run unprotected in the membranes, outside the umbilical cord, and cross the internal opening of the cervix. During rupture of membranes, these vessels can rupture and put the baby at serious risk of severe blood loss and death. Numerous studies are being conducted to improve diagnostic modalities and establish clear management plans to improve pregnancy outcomes. However, the lack of a standardised set of outcomes for studies on vasa previa makes it difficult to compare study findings and draw meaningful conclusions. Through this project, we will be developing a core outcome set for studies on pregnant women with vasa previa (COVasP).Methods and analysisThe development of COVasP will involve five steps. The first will be a systematic review, in which we will generate a long list of outcomes based on published studies in pregnancies complicated with vasa previa. The second will involve in-depth interviews with current and former patients, their family members and healthcare providers who care for these patients. This will be followed by a two-round Delphi survey, which will aim to narrow down the long list of outcomes into those considered important by four groups of ‘stakeholders’: (1) patients, family members and patient advocates/representatives, (2) healthcare providers, (3) researchers, epidemiologists and methodologists and (4) other stakeholders directly or indirectly involved in the management of these pregnancies such as administrators, guideline developers and policymakers. The fourth step will involve a face-to-face consensus meeting using a nominal group approach to establish a finalised core outcome set. The final step will involve measuring and defining the identified outcomes using a combination of systematic reviews and Delphi surveys.Ethics and disseminationThis study as well as consent forms for stakeholder participation have received approval from the Mount Sinai Hospital Research Ethics Board (REB number 18-0173-E) on 05 September 2018 and the Human Research Ethics Committee at The University of Technology Sydney, Australia on 30 July 2019 (UTS HREC reference number ETH19-3718). All progress will be documented on the international prospective register of systematic reviews and Core Outcome Measures in Effectiveness Trials databases.Registration detailshttp://www.comet-initiative.org/studies/details/1117.
Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial
Authors: González Acero Carolina , Martinez Sebastian , Pérez-Expósito Ana , Winters Solis 
Published: July 2020

IntroductionIn Latin America, a rapid increase in obesity alongside persistent malnutrition has resulted in a double burden of disease that affects the most vulnerable segments of the population. Infant and young child feeding practices are important factors that affect both sides of the growth curve. Interventions such as behavioural change strategies and home fortification using products like small-quantity lipid-based nutrient supplements (SQ-LNS) have the potential to reduce the presence of both these conditions, especially if they are implemented during the first 1000 days of life. This paper details the protocol for SPOON: Sustained Programme for Improving Nutrition, an innovative strategy to prevent stunting and reduce risk for obesity in children under 24 months old in high-poverty areas in Baja Verapaz, Guatemala.Methods and analysisSPOON: Sustained Programme for Improving Nutrition Guatemala is a three-arm randomised control trial: treatment group 1 will receive the programme behavioural change strategy and SQ-LNS, treatment group 2 will receive the programme behavioural change strategy and micronutrient powders; the control group will receive the standard of care provided by the Ministry of Health, which includes micronutrient powders. A modified formula of SQ-LNS has been especially developed for this trial. A total of 76 communities are included in the study and 1628 households with a pregnant woman in the third trimester or a child under 4.5 months were recruited at baseline. Baseline data were collected between September and November 2018. Follow-up data will be collected 2 years after the start of the intervention. The primary outcomes of interest are related to mothers’ infant feeding knowledge and practice, and indicators of children’s nutritional status and growth including height, weight, weight gain rate and prevalence of stunting, overweight, obesity and anaemia. After follow-up data have been collected, differences of simple means and regression models including covariates such as child’s age and sex, characteristics of the primary caregiver and household socioeconomic indicators will be estimated. Heterogeneous effects will also be estimated within subgroups of age at exposure, sex, caregiver characteristics and household socioeconomic status.Ethics and disseminationThis study was approved by the National Health Ethics Committee of the Ministry of Health of Guatemala (resolution 10–2018). Informed consent was obtained from all mothers and caregivers prior to enrolment in the programme. Results will be submitted to a peer-reviewed medical or public health journal, and disseminated internally at the Inter-American Development Bank, with the Government and Stakeholders in Guatemala and through international conferences and seminars.Trial registration numberNCT03399617
Estimation of total cardiovascular risk using the 2019 WHO CVD prediction charts and comparison of population-level costs based on alternative drug therapy guidelines: a population-based study of adults in Bangladesh
Authors: Islam Jessica Yasmine , Zaman M Mostafa , Moniruzzaman Mohammad , Ara Shakoor Shawkat , Hossain A H M Enayet 
Published: July 2020

ObjectiveThe objective of this study was to estimate the population distribution of 10-year cardiovascular disease (CVD) risk among Bangladeshi adults aged 40 years and above, using the 2019 WHO CVD risk prediction charts. Additionally, we compared the cost of CVD pharmacological treatment based on the total CVD risk (thresholds ≥30%/≥20%) and the single risk factor (hypertension) cut-off levels in the Bangladeshi context.Study designCross-sectional, population-based study.Setting and participantsFrom 2013 to 2014, we collected data from a nationally representative cross-sectional survey of adults aged ≥40 years from urban and rural areas of Bangladesh (n=6189). We estimated CVD risk using the 2019 WHO CVD risk prediction charts and categorised as very low (<5%), low (5% to <10%), moderate (10% to <20%), high (20% to <30%) and very high risk (≥30%). We estimated drug therapy costs using the lowest price of each drug class available (aspirin, thiazide diuretics, statins and ACE inhibitors). We compared the total cost of drug therapy using the total CVD risk versus single risk factor approach.Primary outcome measuresOur primary outcome was 10-year CVD risk categorised as very low (<5%), low (5% to <10%), moderate (10% to <20%), high (20% to <30%) and very high risk (≥30%).ResultsThe majority of adults (85.2%, 95% CI 84.3 to 86.1) have a 10-year CVD risk of less than 10%. The proportion of adults with a 10-year CVD risk of ≥20% was 0.51%. Only one adult was categorised with a 10-year CVD risk of ≥30%. Among adults with CVD risk groups of very low, low and moderate, 17.4%, 27.9% and 41.4% had hypertension (blood pressure (BP) ≥140/90) and 0.1%, 1.7% and 2.9% had severe hypertension (BP ≥160/100), respectively. Using the total CVD risk approach would reduce drug costs per million populations to US$144 540 (risk of ≥20%).ConclusionTo reduce healthcare expenditure for the prevention and treatment of CVD, a total risk approach using the 2019 WHO CVD risk prediction charts may lead to cost savings.
HIV and other STIs self-testing to reduce risk compensation among men who have sex with men who use oral pre-exposure prophylaxis in China: protocol for a randomised waitlist-controlled trial
Authors: Zhang Jing , Huang Xiaojie , Chen Yaokai , Wang Hui , Zhang Yonghui , Wang Hongyi , Mei Zhu , Jia Yueru , Chu ZhenXing , Hu Qing-Hai , He Xiaoqing , Zhang Lukun , Hu Zhili , Bao Rantong , Li Shangcao , Ding Haibo , Jiang Yongjun , Geng Wenqing , Tang Weiming , Xu Junjie 
Published: July 2020

IntroductionPre-exposure prophylaxis (PrEP) reduces the risk of HIV infection among men who have sex with men by up to 99%. However, in real-world settings, PrEP users may exhibit risk compensation after uptake of PrEP, including more condomless anal intercourse (CAI) and increased sexually transmitted infection (STI) acquisition. HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one’s sexual partners. Here, we describe the rationale and design of a randomised waitlist-controlled trial to examine the impact of HIVST on risk compensation among PrEP users.Methods and analysisThe study is a two-arm randomised waitlist-controlled trial with 1000 HIV-negative MSM in four major cities in China who will be taking oral PrEP (involving tenofovir disoproxil fumarate/emtricitabine) either daily (n=500) or in an event-driven regimen (n=500). The participants will be randomised (1:1) to either the immediate HIVST intervention arm (HIVST plus standard facility-based counselling and testing from 0 to 12 months) or the waitlist arm (standard facility-based counselling and testing from 0 to 6 months, then crossover to receive the HIVST intervention in months 7–12). Participants will provide blood samples to assess the incidence of syphilis and herpes simplex virus type 2 (HSV-2) during a follow-up. The primary outcomes will be the occurrence of CAI, number of sexual partners and incidence of syphilis and HSV-2 during a follow-up. The secondary outcomes will be the HIV and STI testing frequency and STI treatment adherence during a follow-up. The planned start and end dates for the study is 26 December 2018 and 31 December 2020.Ethics and disseminationThe Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).Trial registration numberChiCTR1800020374
How well are sepsis and a sense of urgency documented throughout the acute care chain in the Netherlands? A prospective, observational study
Authors: Latten Gideon , Hensgens Kirsten , de Bont Eefje G P M , Muris Jean W M , Cals Jochen W L , Stassen Patricia 
Published: July 2020

ObjectiveTo investigate the documentation of sepsis and a sense of urgency throughout the acute care chain.DesignProspective cohort study.SettingEmergency department (ED) in a large district hospital in Heerlen, The Netherlands.ParticipantsParticipants included patients ≥18 years with suspected sepsis who visited the ED during out-of-hours between September 2017 and January 2018 (n=339) and had been referred by a general practitioner and/or transported by ambulance. We defined suspected sepsis as suspected or proven infection and the presence of ≥2 quick Sepsis-related Organ Failure Assessment and/or ≥2 Systemic Inflammatory Response Syndrome criteria.Outcome measuresWe analysed how often sepsis and a sense of urgency were documented in the prehospital and ED medical records. A sense of urgency was considered documented when a medical record suggested the need of immediate assessment by a physician in the ED. We described documentation patterns throughout the acute care chain and investigated whether documentation of sepsis or a sense of urgency is associated with adverse outcomes (intensive care admission/30-day all-cause mortality).ResultsSepsis was documented in 16.8% of medical records and a sense of urgency in 22.4%. In 4.1% and 7.7%, respectively, sepsis and a sense of urgency were documented by all involved professionals. In patients with an adverse outcome, sepsis was documented more often in the ED than in patients without an adverse outcome (47.9% vs 13.7%, p<0.001).ConclusionsOur study shows that in prehospital and ED medical records, sepsis and a sense of urgency are documented in one out of five patients. In only 1 out of 20 patients sepsis or a sense of urgency is documented by all involved professionals. It is possible that poor documentation causes harm, due to delayed diagnosis or treatment. Hence, it could be important to raise awareness among professionals regarding the importance of their documentation.
Person-centred care by a combined digital platform and structured telephone support for people with chronic obstructive pulmonary disease and/or chronic heart failure: study protocol for the PROTECT randomised controlled trial
Authors: Ali Lilas , Wallström Sara , Barenfeld Emmelie , Fors Andreas , Fredholm Eva , Gyllensten Hanna , Swedberg Karl , Ekman Inger 
Published: July 2020

BackgroundA core feature of chronic obstructive pulmonary disorder (COPD) and chronic heart failure (CHF) is that symptoms may change rapidly because of illness progression. Thus, these chronic conditions are associated with high rehospitalisation rates. Person-centred care (PCC) has been shown to have several benefits for patients with COPD or CHF (or both disorders) but it has not yet been investigated through e-health services.AimThe project aims to evaluate the effects of PCC by a combined digital platform and structured telephone support for people with COPD and/or CHF.Methods and analysisA randomised controlled trial with open, parallel groups which employs a participatory design process will be used. This project will also include process and health economic evaluation of the intervention.Ethics and disseminationEthical approval has been secured from the Regional Ethical Review Board in Gothenburg, Sweden (Dnr 063-17 and T063-18). Results will be presented at conferences and to healthcare professionals, participants and patient organisations. Findings will also be submitted for publication in peer-reviewed journals.Trial registration numberNCT03183817
Study protocol for a 9-month randomised controlled trial assessing the effects of almonds versus carbohydrate-rich snack foods on weight loss and weight maintenance
Authors: Carter Sharayah , Hill Alison M , Yandell Catherine , Buckley Jonathan D , Tan Sze-Yen , Rogers Geraint B , Childs Jessie , Matheson Mark , Lamb Kate , Ward Susan , Stanton Tasha R , Fraysse Francois , Hills Andrew P , Coates Alison M 
Published: July 2020

IntroductionEpidemiological studies indicate an inverse association between nut consumption and body mass index (BMI). However, clinical trials evaluating the effects of nut consumption compared with a nut-free diet on adiposity have reported mixed findings with some studies reporting greater weight loss and others reporting no weight change. This paper describes the rationale and detailed protocol for a randomised controlled trial assessing whether the inclusion of almonds or carbohydrate-rich snacks in an otherwise nut-free energy-restricted diet will promote weight loss during 3 months of energy restriction and limit weight regain during 6 months of weight maintenance.Methods and analysisOne hundred and thirty-four adults aged 25–65 years with a BMI of 27.5–34.9 kg/m2will be recruited and randomly allocated to either the almond-enriched diet (AED) (15% energy from almonds) or a nut-free control diet (NFD) (15% energy from carbohydrate-rich snack foods). Study snack foods will be provided. Weight loss will be achieved through a 30% energy restriction over 3 months, and weight maintenance will be encouraged for 6 months by increasing overall energy intake by ~120–180 kcal/day (~500-750kJ/day) as required. Food will be self-selected, based on recommendations from the study dietitian. Body composition, resting energy expenditure, total daily energy expenditure (via doubly labelled water), physical activity, appetite regulation, cardiometabolic health, gut microbiome, liver health, inflammatory factors, eating behaviours, mood and personality, functional mobility and pain, quality of life and sleep patterns will be measured throughout the 9-month trial. The effects of intervention on the outcome measures over time will be analysed using random effects mixed models, with treatment (AED or NFD) and time (baseline, 3 months and 9 months) being the between and within factors, respectively in the analysis.Ethics and disseminationEthics approval was obtained from the University of South Australia Human Research Ethics Committee (201436). Results from this trial will be disseminated through publication in peer-reviewed journals, national and international presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001861246).