bluuebunny/crossref_metadata_2025_split huggingface dataset:
Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leakage after hepatic resection: the PREBOT-II trial
Authors: Mack Claudia Eva , Klaiber Ulla , Sauer Peter , Kohlhas Laura , Baumann Lukas , Martin Eike , Mehrabi Arianeb , Buchler Markus W , Hackert Thilo 
Published: September 2023

IntroductionBile leakage represents a major cause of morbidity following hepatic resection. Although most patients can be managed non-operatively, this complication requires diagnostics and therapeutic interventions. Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent bile leakage. The aim of the PREBOT-II trial is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent bile leakage following hepatic resection.Methods and analysisThe PREBOT-II trial is an investigator-initiated, exploratory, multicentre, randomised, controlled, open-label, phase II clinical trial with two parallel study groups. 70 patients scheduled for hepatic resection will be randomised to either the intervention or the control group. Patients of the intervention group will undergo preoperative endoscopic injection of BTX into the sphincter of Oddi 3–10 days before surgery, whereas in the control group only hepatic resection will be performed. The primary endpoint is the occurrence of a postoperative bile leakage within 30 days after hepatic resection according to the definition of the International Study Group of Liver Surgery. The secondary endpoints comprise further postoperative morbidity parameters such as severity of postoperative bile leakage, post-hepatectomy haemorrhage or liver failure, mortality and quality of life up to 3 months after hepatic resection. Safety and feasibility of the procedure will also be recorded.Ethics, funding and disseminationThe PREBOT-II trial has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4044932) and the Ethics Committee of Heidelberg University (reference number AFmu-558/2021). This trial is supported by the German Federal Ministry of Education and Research. The results will be presented at national and international conferences and published in a peer-reviewed journal.Trial registration numberDRKS00024061, EudraCT: 2020-006001-35.
Patients’ experience of using colonoscopy as a diagnostic test after a positive FOBT/FIT: a systematic review of the quantitative literature
Authors: Kayal Ghalia , Kerrison Robert , Hirst Yasemin , von Wagner Christian 
Published: September 2023

ObjectivesFaecal occult blood testing (FOBT) and faecal immunochemical testing (FIT) are among the most used screening modalities for colorectal cancer (CRC). Colonoscopy is also widely used as a screening and diagnostic test for adults with a positive FOBT/FIT. Patient experience of colonoscopy is an important component for most CRC screening programmes. Individuals with negative experiences are less likely to engage with colonoscopy in the future and can deter others from attending colonoscopy when invited. This review synthesised data on patient experience with colonoscopy, following a positive result, to provide insights into how to improve patient experience within the English Bowel Cancer Screening Programme.MethodsMEDLINE, EMBASE and PsycINFO were searched for quantitative questionnaire studies evaluating patient-reported experience with colonoscopy, following a positive screening FOB/FIT result. The search was limited to studies published between 2000 and 2021 (ie, when the first FOBT/FIT screening programmes for CRC were introduced). Data-driven and narrative summary techniques were used to summarise the literature.ResultsIn total, six studies from the UK (n=4), Spain (n=1) and the Netherlands (n=1) were included in the review (total participants: 152 329; response rate: 68.0–79.3%). Patient experiences were categorised into three ‘stages’: ‘pre-colonoscopy’, ‘during the test’ and ‘post-colonoscopy’. Overall, patients reported a positive experience in all six studies. Bowel preparation was the most frequently endorsed issue experienced pre-test (experienced by 10.0–41.0% of individuals, across all studies), pain and discomfort for during the test (experienced by 10.0–21.0% of participants) and abdominal pain and discomfort after the test (these were experienced by 14.8–22% of patients).ConclusionThis review highlighted that patient-reported experiences associated with colonoscopy were generally positive. To improve the colonoscopy experience, bowel screening centres should investigate means to: make bowel preparation more acceptable, make colonoscopy less painful and reduce post-colonoscopy symptoms.
Prevalence and risk factors of stroke in high-altitude areas: a systematic review and meta-analysis
Authors: Zheng Bo , Luo Yuding , Li Yan , Gu Gangfeng , Jiang Junyao , Chen Chuanli , Chen Zhao , Wang Jian 
Published: September 2023

ObjectiveThe primary objective of this study is to investigate the prevalence and risk factors of stroke in high-altitude areas through a comprehensive systematic review and meta-analysis.DesignThis study adopts a systematic review and meta-analysis design.Data sourcesA thorough search was conducted on databases including PubMed, Web of Science, Embase, Cochrane Library, MEDLINE and SCOPUS, covering the period up to June 2023.Eligibility criteriaStudies reporting the prevalence of stroke in high-altitude areas and exploring related risk factors were included, regardless of whether they involved clinical samples or the general population. Studies with incomplete, outdated or duplicate data were excluded.Data extraction and synthesisWe performed eligibility screening, data extraction and quality evaluation of the retrieved articles. Meta-analysis was employed to estimate the prevalence and risk factors of stroke in high-altitude areas. The Newcastle-Ottawa Scale was used to assess the risk of bias.ResultsA total of 17 studies encompassing 8 566 042 participants from four continents were included, with altitudes ranging from 1500 m to nearly 5000 m. The pooled prevalence of stroke in high-altitude areas was found to be 0.5% (95% CI 0.3%–7%). Notably, the prevalence was higher in clinical samples (1.2%; 0.4%–2.5%) compared with the general population (0.3%; 95% CI 0.1%–0.6%). When considering geographic regions, the aggregated data indicated that stroke prevalence in the Eurasia plate was 0.3% (0.2%–0.4%), while in the American region, it was 0.8% (0.4%–1.3%). Age (OR, 14.891), gender (OR, 1.289), hypertension (OR, 3.158) and obesity (OR, 1.502) were identified as significant risk factors for stroke in high-altitude areas.ConclusionsThe findings of this study provide insights into the pooled prevalence of stroke in high-altitude areas, highlighting variations based on geographic regions and sampling type. Moreover, age, gender, hypertension and obesity were found to be associated with the occurrence of stroke.PROSPERO registration numberCRD42022381541.
Development of a patient-centred medication management model for polymedicated home-dwelling older adults after hospital discharge: results of a mixed methods study
Authors: Pereira Filipa , Meyer-Massetti Carla , del Río Carral María , von Gunten Armin , Wernli Boris , Verloo Henk 
Published: September 2023

ObjectiveThis study aimed to investigate medication management among polymedicated, home-dwelling older adults after discharge from a hospital centre in French-speaking Switzerland and then develop a model to optimise medication management and prevent adverse health outcomes associated with medication-related problems (MRPs).DesignExplanatory, sequential, mixed methods study based on detailed quantitative and qualitative findings reported previously.SettingHospital and community healthcare in the French-speaking part of Switzerland.ParticipantsThe quantitative strand retrospectively examined 3 years of hospital electronic patient records (n=53 690 hospitalisations of inpatients aged 65 years or older) to identify the different profiles of those at risk of 30-day hospital readmission and unplanned nursing home admission. The qualitative strand explored the perspectives of older adults (n=28), their informal caregivers (n=17) and healthcare professionals (n=13) on medication management after hospital discharge.ResultsQuantitative results from older adults’ profiles, affected by similar patient-related, medication-related and environment-related factors, were enhanced and supported by qualitative findings. The combined findings enabled us to design an interprofessional, collaborative medication management model to prevent MRPs among home-dwelling older adults after hospital discharge. The model comprised four interactive fields of action: listening to polymedicated home-dwelling older adults and their informal caregivers; involving older adults and their informal caregivers in shared, medication-related decision-making; empowering older adults and their informal caregivers for safe medication self-management; optimising collaborative medication management practices.ConclusionBy linking the retrospective and prospective findings from our explanatory sequential study involving multiple stakeholders’ perspectives, we created a deeper comprehension of the complexities and challenges of safe medication management among polymedicated, home-dwelling older adults after their discharge from hospital. We subsequently designed an innovative, collaborative, patient-centred model for optimising medication management and preventing MRPs in this population.
Physical activity and physical fitness among children and adolescents after the onset of the COVID-19 pandemic in the WHO European Region: a systematic review protocol
Authors: Ludwig-Walz Helena , Siemens Waldemar , Heinisch Sarah , Dannheim Indra , Loss Julika , Bujard Martin 
Published: September 2023

IntroductionThe implementation of COVID-19 pandemic-related restrictions resulted in limitations for physical activity (PA) opportunities, which may have initiated a longer-term behavioural change. The protocol describes the methodology for a planned systematic review that aims to summarise changes in PA and physical fitness (PF) in children and adolescents in the WHO European Region after the onset of the COVID-19 pandemic.Methods and analysisThe protocol adheres to the ‘Preferred Reporting Items for Systematic Review and Meta-Analysis for Protocols’ (PRISMA-P) statement. Using a peer-reviewed search strategy according to the evidence-based checklist ‘Peer Review of Electronic Search Strategies’ (PRESS), we will perform a systematic literature search in seven databases. Inclusion criteria are all primary studies that gathered data on children and adolescents ≤19 years living in the WHO European Region and made a comparison to pre-pandemic data. Primary outcomes are PA and PF. We will assess the risk of bias with the ‘Risk of Bias Instrument for Non-Randomized Studies of Exposures’ (ROBINS-E). The ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) approach will be used for the evaluation of the certainty of evidence. Also, subgroup analyses will be performed (eg, for gender, age, stringency of pandemic restrictions).Ethics and disseminationEthical approval is not required, as primary data will not be collected in this study. The results will be presented in a peer-reviewed publication and at congresses relevant to the research field.PROSPERO registration numberCRD42023395871.
Efficacy of TTFields in high-grade gliomas: a protocol for systematic review and meta-analysis
Authors: Li Xinlong , Wang Juncheng , Yuan Guoqiang , Pan Yawen 
Published: September 2023

IntroductionDespite their recent FDA(Food and Drug Administration) approval, tumour treatment fields (TTFields) have not seen acceptance as part of standard of care (SOC) for the treatment of high-grade gliomas (HGGs). Few studies have reported the clinical effect of simultaneous or sequential use of TTFields with the current SOC. However, whether TTFields are beneficial over the standard treatment remains to be established with a meta-analysis. Therefore, we here performed a systematic review and meta-analysis to understand the benefit of TTFields for patients with HGGs.Methods and analysisWe registered this systematic review with the PROSPERO network (registration number: CRD42023398972) and aimed to follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines in the study. All articles related to TTFields in glioma will be systematically searched for in the following databases since their inception until November 2023: the China National Knowledge Infrastructure, Embase, Cochrane Library, Wanfang Database, China Science Journal Database, China Biomedical Documentation Database, VIP database, Web of Science and PubMed. Article screening and data extraction will be done independently by the authors and cross-checked by two of the authors on completion. The Cochrane risk of bias assessment tool will be used for quality assessment of the included studies. Review Manager V.5.3 (Cochrane Collaboration) will be used to perform the meta-analysis.Ethics and disseminationEthical approval is not required because the data used will be obtained from published studies, and there will be no concerns about privacy. The results of this study will be published in a peer-reviewed journal.PROSPERO registration numberCRD42023398972.
Relationship between household financial debt and depressive symptoms: a longitudinal study in China
Authors: Hu Mingzheng , Nie Weihao , Song Jiru , Wang Ting , Ye Xin 
Published: September 2023

ObjectivesTo examine the impacts of household financial debt on depressive symptoms and its possible mediating mechanisms.DesignA nationally representative longitudinal study using the ordinary least squares regression model, fixed-effects model, and instrumental variable approach to explore the relationship between household financial debt and depressive symptoms and further using structural equation models and the Bootstrap method to analyse the mediating effects.SettingThe China Family Panel Studies (CFPS) database.ParticipantsThree waves of longitudinal data in 2012, 2016, and 2018 from CFPS were used. A total of 103,247 individuals over the age of 18 were included in our study sample.Outcome measuresDepression symptoms were assessed using an eight-item version of the Center for Epidemiologic Studies Depression Scale (CES-D8). We summed these eight items to conduct a depressive symptoms index to measure depressive symptoms.ResultsAmong the sample, 35.3% of the households have financial debt, 49.7% of the sample are male, 73.2% of them have rural hukou, and the average age was 46.6. Regression results showed that household financial debt had a negative effect on depressive symptoms (β=0.655, 95% CI 0.602 to 0.707, p<0.01). This result remained robust after using instrumental variables with fixed effects (β=0.483, 95% CI 0.311 to 0.656, p<0.01). Household financial debt could affect depressive symptoms through mediating variables such as working pressure (p<0.05) and life happiness (p<0.01).ConclusionOur study showed that household indebtedness in China had a negative effect on depressive symptoms. Also, we found some mediating mechanisms for this effect, which might help provide new guidance for psychological interventions to promote the mental health of indebted residents.
Association between ethnic background and COVID-19 morbidity, mortality and vaccination in England: a multistate cohort analysis using the UK Biobank
Authors: Urdiales Tomás , Dernie Francesco , Català Martí , Prats-Uribe Albert , Prats Clara , Prieto-Alhambra Daniel 
Published: September 2023

ObjectivesDespite growing evidence suggesting increased COVID-19 mortality among people from ethnic minorities, little is known about milder forms of SARS-CoV-2 infection. We sought to explore the association between ethnic background and the probability of testing, testing positive, hospitalisation, COVID-19 mortality and vaccination uptake.DesignA multistate cohort analysis. Participants were followed between 8 April 2020 and 30 September 2021.SettingThe UK Biobank, which stores medical data on around half a million people who were recruited between 2006 and 2010.Participants405 541 subjects were eligible for analysis, limited to UK Biobank participants living in England. 23 891 (6%) of participants were non-white.Primary and secondary outcome measuresThe associations between ethnic background and testing, testing positive, hospitalisation and COVID-19 mortality were studied using multistate survival analyses. The association with single and double-dose vaccination was also modelled. Multistate models adjusted for age, sex and socioeconomic deprivation were fitted to estimate adjusted HRs (aHR) for each of the multistate transitions.Results18 172 (4.5%) individuals tested positive, 3285 (0.8%) tested negative and then positive, 1490 (6.9% of those tested positive) were hospitalised, and 129 (0.6%) tested positive at the moment of hospital admission (ie, direct hospitalisation). Finally, 662 (17.4%) died after admission. Compared with white participants, Asian participants had an increased risk of negative to positive transition (aHR 1.24 (95% CI 1.02 to 1.52)), testing positive (95% CI 1.44 (1.33 to 1.55)) and direct hospitalisation (1.61 (95% CI 1.28 to 2.03)). Black participants had an increased risk of hospitalisation following a positive test (1.71 (95% CI 1.29 to 2.27)) and direct hospitalisation (1.90 (95% CI 1.51 to 2.39)). Although not the case for Asians (aHR 1.00 (95% CI 0.98 to 1.02)), black participants had a reduced vaccination probability (0.63 (95% CI 0.62 to 0.65)). In contrast, Chinese participants had a reduced risk of testing negative (aHR 0.64 (95% CI 0.57 to 0.73)), of testing positive (0.40 (95% CI 0.28 to 0.57)) and of vaccination (0.78 (95% CI 0.74 to 0.83)).ConclusionsWe identified inequities in testing, vaccination and COVID-19 outcomes according to ethnicity in England. Compared with whites, Asian participants had increased risks of infection and admission, and black participants had almost double hospitalisation risk, and a 40% lower vaccine uptake.
Incidence of vasa praevia: a systematic review and meta-analysis
Authors: Zhang Weiyu , Giacchino Tara , Chanyarungrojn Pannapat Amy , Ionescu Olivia , Akolekar Ranjit 
Published: September 2023

ObjectivesTo derive accurate estimates of the incidence of vasa praevia (VP) in a routine population of unselected pregnancies.DesignSystematic review and meta-analysis.Data sourcesA search of MEDLINE, EMBASE, CINAHL and the Cochrane database was performed to review relevant citations reporting outcomes in pregnancies with VP from January 2000 until 5 April 2023.Eligibility criteria for selection of studiesProspective or retrospective cohort or population studies that provided data regarding VP cases in routine unselected pregnancies during the study period. We included studies published in the English language after the year 2000 to reflect contemporary obstetric and neonatal practice.Data extraction and synthesisTwo reviewers independently screened the retrieved citations and extracted data. The methodological quality of studies was assessed using the Newcastle–Ottawa Scale, and Preferred Reporting Items for Systematic reviews and Meta-Analyses was used to ensure standardised reporting of studies.ResultsA total of 3847 citations were screened and 82 full-text manuscripts were retrieved for analysis. There were 24 studies that met the inclusion criteria, of which 12 studies reported prenatal diagnosis with a systematic protocol of screening. There were 1320 pregnancies with VP in a total population of 2 278 561 pregnancies; the weighted pooled incidence of VP was 0.79 (95% CI: 0.59 to 1.01) per 1000 pregnancies, corresponding to 1 case of VP per 1271 (95% CI: 990 to 1692) pregnancies. Nested subanalysis of studies reporting screening for VP based on a specific protocol identified 395 pregnancies with VP in a population of 732 654 pregnancies with weighted pooled incidence of 0.82 (95% CI: 0.53 to 1.18) per 1000 pregnancies (1 case of VP per 1218 (95% CI: 847 to 1901) pregnancies).ConclusionThe incidence of VP in unselected pregnancies is 1 in 1218 pregnancies. This is higher than is previously reported and can be used as a basis to assess whether screening for this condition should be part of routine clinical practice. Incorporation of strategies to screen for VP in routine clinical practice is likely to prevent 5% of stillbirths.PROSPERO registration numberCRD42020125495.
Decreasing appointment waiting days for first consultation for patients attending adult weight management clinic in a tertiary hospital
Authors: Lulla Dypti , Neo Jeslyn Hwee Teng , Cheah Rui En Lynette , Soedar Zaiton Bte , Puvanendran Rukshini 
Published: September 2023

Adult weight management (AWM) clinic at our tertiary institution is a clinical service run for overweight or obese adult women, who are also under the care of gynaecologists for subfertility or menstrual irregularities. Unfortunately, the appointment waiting days for the first consultation at AWM clinic were long, which affected the timeliness of care given to our patients. We suspect that the referred patients are more likely to forget or lose motivation during the long waiting days, resulting in higher non-attendance rates.Baseline data confirmed that average of median appointment waiting days for the first consultation was 74 days. A multidisciplinary team of weight management clinic stakeholders was created to address this issue. Following a root cause analysis, the team implemented two interventions to improve appointment waiting days.The first intervention was offering video consultation to new cases for AWM clinic. This increased the clinic capacity without requiring additional physical clinic space. The referral criteria were refined to target patients who are most likely to benefit from the services provided at our institution. The second intervention was creating AWM clinic appointments only after patients completed the required laboratory investigations for obesity workup.A run chart demonstrated average of median appointment waiting days decreased from 74 days to 34 days after implementation of the second intervention (p=0.0104). The team successfully decreased and sustained the lower appointment waiting days through innovative interventions that increased clinic capacity and improved patient selection, with the potential to further increase clinic capacity if the demand surges.