bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus
Authors: Glaysher Michael Alan , Mohanaruban Aruchuna , Prechtl Christina Gabriele , Goldstone Anthony P , Miras Alexander Dimitri , Lord Joanne , Chhina Navpreet , Falaschetti Emanuela , Johnson Nicholas Andrew , Al-Najim Werd , Smith Claire , Li Jia V , Patel Mayank , Ahmed Ahmed R , Moore Michael , Poulter Neil , Bloom Stephen , Darzi Ara , Le Roux Carel , Byrne James P , Teare Julian P 
Published: May 2024

IntroductionThe prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight.Methods and analysisIn this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18–65 years with a body mass index 30–50 kg/m2and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58–97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression.Trial registration numberISRCTN30845205, ClinicalTrials.gov IdentifierNCT02459561.
Impact of UV-irradiation on electrical impedance spectroscopy of benign nevi: study protocol for a prospective, controlled, clinical study
Authors: Fink Christine , Schweizer Anissa , Uhlmann Lorenz , Haenssle Holger A 
Published: May 2024

IntroductionThe clinical and histological changes of nevi after ultraviolet (UV) irradiation have been studied in detail. In contrast, the impact of UV irradiation on electrical impedance spectroscopy scores of nevi has not been investigated. However, for physicians, it is essential to know the extent to which changes in electrical impedance spectroscopy scores of nevi may be attributed to seasonal effects of UV irradiation.MethodsThis is a prospective, controlled, clinical study evaluating the impact of UV irradiation on the electrical impedance spectroscopy scores of benign nevi in 50 patients undergoing phototherapy. To this end, benign nevi of patients with a medical indication for phototherapy will be measured by electrical impedance spectroscopy before, during and after UV irradiation. At the same time, non-irradiated nevi of the same patient will be measured to account for changes over time that are independent of direct UV irradiation.Ethics and disseminationEthical approval was obtained from the ethics committee of the medical faculty of the University of Heidelberg (ethics approval number S-279/2017). The design and the final results of the study will be published and made available to the public.Trial registration numberDRKS00012456; Pre-results.
Cohort profile of an early life observational cohort in China: Bone and MicroBiOme onset (BAMBOO) study
Authors: Wang Jing , Jiang Chang , Wang Shuo , Feng Lingyan , Zhang Yu , Guo Yuanyuan , Liu Gongshu , Li Xi , Zhang Guohong , Zhu Xiaowei , Ren Fangyi , Guan Lingyao , Chen Jiayu , Gao Ya , Chen Mo , Darwish Noura , Mottaz Sara Colombo , Horcajada Marie Noelle , Bonnet Nicolas , Dogra Shaillay Kumar , Wang Dantong 
Published: May 2024

PurposeThe Bone And MicroBiOme Onset (BAMBOO) study is an ongoing prospective observational cohort study conducted in Tianjin, China, aiming to determine age-appropriate trajectories for microbiome maturation and bone development and to identify the influence of dietary factors in the process.ParticipantsThe recruitment started in September 2021 and was completed in February 2023. A total of 1380 subjects were recruited, 690 at birth (group 1) and 690 at 6 months of age (group 2). Groups 1 and 2 will be followed up for 12 months and 36 months, respectively.Findings to dateThe age of the mothers was 31.1±3.7 (mean±SD), and the birth weight of infants was 3.3±0.5 kg with an incidence of caesarean section 50.4%. Food diary information of the first 100 subjects showed that 64 food items were introduced by 6 months. A pilot microbiome analysis revealed that at the species level, bacterial communities were composed of mostlyBacteroides dorei, Bacteroides vulgatusandEscherichia coli, which were consistent with that of previous reports. Feasibility assessments of breast milk vitamin D and human milk oligosaccharides were validated through certified reference measurements. The early data assessment showed a high reliability of the data generated from this study.Future plansData collection will be completed in August 2025. Four stage-statistical analyses will be performed as the cohort reaches certain age thresholds before the final report. Analysis of BAMBOO data will be used to develop age-appropriate trajectories for microbiome maturation and bone development for children aged 0–3 years and investigate the contribution of dietary factors in the process.Trial registration numberChiCTR2100049972
Feasibility and acceptability of a tailored health coaching intervention to improve type 2 diabetes self-management in Saudi Arabia: a mixed-methods randomised feasibility trial
Authors: Almulhim Abdullah N , Alhowaish Atheer , Madani Alaa , AlQaddan Munirah , Altuwalah Abdulaziz S , Goyder Elizabeth 
Published: May 2024

BackgroundAround one-third of the population of Saudi Arabia have been diagnosed with type 2 diabetes, a condition often requiring lifestyle changes. Personalised health coaching, a strategy developed to assist individuals in overcoming challenges to adopt healthy behaviours, has not yet been widely applied in the country.AimsWe aim to explore the feasibility and acceptability of tailored health coaching in Saudi Arabia, in order to help those with type 2 diabetes to more effectively manage their condition.MethodsUsing a mixed-methods approach, this research involved a randomised controlled trial with 30 Saudi adults who have type 2 diabetes. They were randomly allocated into either the intervention or control arm for 12 weeks. The Capability, Opportunity, Motivation and Behaviour framework was used to guide the intervention implementation along with the Behaviour Change Techniques Taxonomy V.1. The primary goal was to assess the suitability and duration of the intervention, recruitment, retention and completion rates. The secondary outcome focused on the preliminary efficacy of the health coaching measured by the glycaemic index, blood pressure, body mass index (BMI), waist circumference, weight, patient self-efficacy and diabetes self-management.ResultsThe results showed high rates of eligibility, recruitment and retention (a screening rate of 90%, a recruiting rate of 79% and a retention rate of 97%). Notable improvements were observed in the health coaching group across five outcomes: haemoglobin A1c, BMI, waist circumference, patient self-efficacy and diabetes self-care. Qualitative findings highlighted the participants’ perceived benefits from the intervention, including enhanced motivation, better understanding of diabetes management and a supportive coaching relationship. Participants expressed high satisfaction with the intervention and advocated for its expansion.ConclusionThe findings demonstrated positive outcomes, supporting the need for a larger randomised controlled trial to evaluate the efficacy of health coaching in improving diabetes self-management among individuals with type 2 diabetes in Saudi Arabia.
DIALOR (DIgitAL cOaching for fRailty): protocol for a single-arm mixed-methods feasibility study of a digital health coaching intervention for older people with frailty in primary care
Authors: Sait Matthew I , Christie Rachel A , Cox Chantel , Board Michele , Thomas Sarah , O'Sullivan Cheryl , Davies Cheryl , Walker Dawn-Marie , Vassallo Michael , Sadler E A , Allen-Pick Mark , Moore Patrick , Bradbury Katherine , Murphy Jane 
Published: May 2024

BackgroundMultidomain interventions in older adults offer the best opportunity to prevent, delay or reverse existing symptoms in the earlier stages of frailty and improve independence but can be costly, and difficult to deliver at scale. However, digital health interventions enable personalised care and empowerment through self-management of long-term conditions, used at any time and when combined with health coaching offer the potential to enhance well-being and facilitate the achievement of health-related goals. We aim to evaluate the feasibility and acceptability of a digital health platform for long-term disease management combined with health coaching for people living with mild-moderate frailty, targeting self-identified goals—activity, nutrition, mood, enhancing social engagement and well-being.Methods and analysisThis is a non-randomised feasibility, single-group, pretest/post-test study, using qualitative and quantitative methods. The digital health coaching intervention (DIALOR—DIgitAL cOaching for fRailty) has been developed for implementation to older adults, aged 65 years or older with mild to moderate frailty and diagnosis of one or more long-term health conditions in the community. Participants will receive 12 weeks of health coaching and have access to a mobile health platform for 6 months. The primary outcome measure is the acceptability and feasibility of DIALOR along with a range of secondary outcome measures (including frailty, functioning measures, quality of life, social engagement, diet quality and self-reported indicators) collected at baseline and at 6 months. The findings will inform whether a wider effectiveness trial is feasible and if so, how it should be designed.Ethics and disseminationEthical approval has been granted by the Southeast Scotland Research Ethics Committee 02 (reference: 22/SS/0064). Research findings will be disseminated in a range of different ways to engage different audiences, including publishing in open-access peer-reviewed journals, conference presentations, social media, dissemination workshop with patients, carers, and healthcare professionals and on institution websites.
Investigating consumer preferences and experiences of telehealth services in Australian allied health practice: a study protocol
Authors: Frith Madison , Boyd James , Savira Feby , Senyel Deniz , Norman Richard , Jones Janelle , Robinson Suzanne 
Published: May 2024

IntroductionTelehealth service provision and uptake has rapidly increased since the COVID-19 pandemic, allowing healthcare to be delivered safely and reducing non-essential face-to-face (F2F) contact. In Australia, the expansion of subsidisation of telehealth during COVID has led to its permanent installation within Australian primary care in 2022. However, little is known about consumer preferences and experiences with these services, particularly in relation to allied health practice (AHP). Previous studies on telehealth services have focused on general practice rather than allied health (AH) and broader primary care. Given that AH professionals make up a large proportion of the Australian healthcare workforce, the purpose of this study is to explore consumer preferences and experiences with telehealth AHP healthcare.Methods and analysisThis study uses a mixed methods research design that incorporates three independent but interrelated phases. Phase 2 of the study will use a focus group methodology to discuss consumer attitudes and experiences via a semistructured interview format. Phase 3 involves a discrete choice experiment (DCE) involving a large online survey conducted across the general population. The DCE will be informed by the qualitative findings from phases 1 and 2. The experiment aims to elicit consumer preferences in relation to AH services delivered through telehealth or F2F consultations, based on several hypothetical scenarios and preferences over several different dimensions.Ethics and disseminationEthics approval has been obtained from La Trobe University (approval number HEC23404). Findings will be disseminated as reports, presentations and peer-reviewed journal articles.
Preferred sources of information on diabetes prevention programmes: a population-based cross-sectional study in Poland
Authors: Grudziąż-Sękowska Justyna , Sękowski Kuba , Pinkas Jarosław , Jankowski Mateusz 
Published: May 2024

ObjectiveThis study aimed to analyse preferred sources of information on diabetes prevention programmes and to identify sociodemographic determinants influencing these preferences among adults in Poland.DesignA cross-sectional survey was carried out between 15 and 18 September 2023 using a computer-assisted web interview. A self-prepared questionnaire included 10 questions on sources of information on type 2 diabetes prevention.ParticipantsData were obtained from 1046 adults (18–82 years); 53.4% were females.ResultsMost respondents preferred email communication (46.4%), followed by a doctor or nurse (33.5%), and a letter or leaflet directly delivered to the mailbox (25.8%) for type 2 diabetes mellitus (DM2) prevention information. Younger respondents were more likely to indicate mass media (OR=1.81, 95% CI=1.12 to 2.95, p=0.01) and digital media (OR=1.65, 95% CI=1.02 to 2.67, p=0.04) as a source of information on DM2 prevention. Those who had higher education (OR=1.51, 95% CI=1.16 to 1.96, p=0.002), as well as those with chronic diseases (OR=1.50, 95% CI=1.14 to 1.97, p=0.004), were more likely to indicate digital media. Out of 10 different variables analysed in this study, passive occupational status (OR=1.43, 95% CI=1.04 to 1.96, p=0.03) as well as having chronic diseases (OR=1.51, 95% CI=1.16 to 1.96, p=0.002) were associated with higher odds of indicating healthcare workers as a preferred source of information. Marital status, having children, place of residence, household characteristics and financial status do not significantly decide communication preferences.ConclusionCommunication on DM2 prevention should be adjusted to public preferences and expectations. Tailoring interventions to different demographic groups can enhance outreach and engagement. Email emerged as a popular choice, suggesting the potential of digital communication in preventive health programmes.
Do studies evaluating early-life policy interventions fully adhere to the critical conditions of difference-in-differences? A systematic review
Authors: Klootwijk Anouk , Struijs Jeroen , Petrus Annelieke , Leemhuis Marlin , Numans Mattijs , de Vries Eline 
Published: May 2024

ObjectivesTo assess the reporting and methodological quality of early-life policy intervention papers that applied difference-in-differences (DiD) analysis.Study designSystematic review.Data sourcesPapers applying DiD of early-life policy interventions in high-income countries as identified by searching Medline, Embase and Scopus databases up to December, 2022.Study eligibility criteria, participants and interventionsStudies evaluating policy interventions targeting expectant mothers, infants or children up to two years old and conducted in high income countries were included. We focused on seven critical conditions of DiD as proposed in a comprehensive checklist: data requirements, parallel trends, no-anticipation, standard statistical assumptions, common shocks, group composition and spillover.ResultsThe DiD included studies (n=19) evaluating early-life policy interventions in childhood development (n=4), healthcare utilisation and providers (n=4), nutrition programmes (n=3) and economic policies such as prenatal care expansion (n=8). Although none of the included studies met all critical conditions, the most reported and adhered to critical conditions were data requirements (n=18), standard statistical assumptions (n=11) and the parallel trends assumption (n=9). No-anticipation and spillover were explicitly reported and adhered to in two studies and one study, respectively.ConclusionsThis review highlights current deficiencies in the reporting and methodological quality of studies using DiD to evaluate early-life policy interventions. As the validity of study conclusions and consequent implications for policy depend on the extent to which critical conditions are met, this shortcoming is concerning. We recommend that researchers use the described checklist to improve the transparency and validity of their evaluations. The checklist should be further refined by adding order of importance or knock-out criteria and may also help facilitate uniform terminology. This will hopefully encourage reliable DiD evaluations and thus contribute to better policies relating to expectant mothers, infants and children.
Improving the care of children with GENetic Rare disease: Observational Cohort study (GenROC)—a study protocol
Authors: Low Karen Jaqueline , Watford Amy , Blair Peter , Nabney Ian , Powell John , Wynn Sarah L , Foreman Julia , Firth Helen , Ingram Jenny 
Published: May 2024

IntroductionAround 2000 children are born in the UK per year with a neurodevelopmental genetic syndrome with significantly increased morbidity and mortality. Often little is known about expected growth and phenotypes in these children. Parents have responded by setting up social media groups to generate data themselves. Given the significant clinical evidence gaps, this research will attempt to identify growth patterns, developmental profiles and phenotypes, providing data on long-term medical and educational outcomes. This will guide clinicians when to investigate, monitor or treat symptoms and when to search for additional or alternative diagnoses.Methods and analysisThis is an observational, multicentre cohort study recruiting between March 2023 and February 2026. Children aged 6 months up to 16 years with a pathogenic or likely pathogenic variant in a specified gene will be eligible. Children will be identified through the National Health Service and via self-recruitment. Parents or carers will complete a questionnaire at baseline and again 1 year after recruitment. The named clinician (in most cases a clinical geneticist) will complete a clinical proforma which will provide data from their most recent clinical assessment. Qualitative interviews will be undertaken with a subset of parents partway through the study. Growth and developmental milestone curves will be generated through the DECIPHER website (https://deciphergenomics.org) where 5 or more children have the same genetic syndrome (at least 10 groups expected).Ethics and disseminationThe results will be presented at national and international conferences concerning the care of children with genetic syndromes. Results will also be submitted for peer review and publication.
Compressive taping to prevent postmastectomy seroma: patient adherence and satisfaction
Authors: Fernandes Maíra Carneiro , Fabro Erica Alves Nogueira , Ximenes Matheus Albino , Costa Rejane Medeiros Medeiros , Soares Nathalia Bordinhon , Aguiar Suzana Sales de , Thuler Luiz Claudio Santos , Bergmann Anke 
Published: May 2024

ObjectiveEvaluate patient adherence and satisfaction concerning postmastectomy compressive taping.MethodsThis comprises a preintervention and postintervention study carried out with women ≥18 years old who underwent taping during the first 7 postoperative days at the Cancer Hospital III/National Cancer Institute. Good adherence was considered as taping maintenance for 7 days. Satisfaction levels were classified as satisfied and dissatisfied.ResultsA total of 124 women with a mean age of 56.54 (±11.24) were included in the study. Most lived without a partner (58.1%), had more than 8 years of study (59.7%), referred to themselves as white (68.5%) and considered their health status to be good or very good (69.4%). Regarding treatment adherence, 90.3% patients displayed adherence. Patients with no bullous lesions were more likely to adhere to taping (OR 7.00; 95% CI 1.98 to 24.74; p=0.003). Regarding satisfaction, 78.2% of the patients felt satisfied. The absence of local discomfort (OR 4.51; 95% CI 1.73 to 11.74; p=0.002) and non-existence of self-reported oedema (OR 5.81; 95% CI 1.81 to 18, 66; p=0.003) were associated with greater patient satisfaction.ConclusionPatients exhibited good adherence and felt very satisfied with the use of postmastectomy compressive taping.Trial registration numberNCT04471142.
Optimizing Mutation-Based Fault Localization Through Contribution-Based Test Case Reduction
Authors: Wang Haifeng , Yang Kun , Wu Tong 
Published: May 2024

Fault localization is an expensive phase of software debugging processes. Although Mutation-based Fault Localization (MBFL) is a promising technique, its computational cost remains high due to the extensive mutation executions involved in mutation analysis. Previous studies have primarily focused on reducing costs by decreasing the mutant numbers and optimizing the execution, yielding promising results. However, test case reduction has also proven to be effective in reducing costs in MBFL. In this paper, we propose an approach called Contribution-Based Test Case Reduction (CBTCR) aimed at enhancing MBFL efficiency. CBTCR assesses the contribution value of each test case and selects them accordingly. The reduced test suite is then used for mutant execution. We evaluate CBTCR on 543 real software faults from Defects4J benchmark. Results show that CBTCR outperforms other MBFL test case reduction strategies (e.g. FTMES, IETCR), in terms of the Top-N and MAP metrics. Moreover, CBTCR achieves an average cost reduction of 87.06%, while maintaining accuracy comparable to those of the original MBFL techniques. This research paper presents an innovative and effective solution for optimizing MBFL, which can significantly reduce the cost and time required for software debugging.