bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trends of mean systolic and diastolic blood pressure among adults in Shenzhen, China, 1997–2018: findings from three rounds of the population-based survey
Authors: Peng Ke , Cai Weicong , Liu Xiaoying , Liu Yishu , Ouyang Menglu , Gong Jessica , Wang Zhihui , Wang Yunfeng , Hao Jing , Wang Wei , Zhao Honglei , Lin Kaihao , Han Guiyuan , Shi Yu , Xie Yinghao , Xie Yuxin , Lei Lin , Si Lei 
Published: February 2024

ObjectiveTo quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.DesignCross-sectional study.SettingsThe data were collected from all districts in Shenzhen, China in the years of 1997, 2009 and 2018 by multistage cluster sampling procedure.ParticipantsParticipants were residents aged 18–69 years in Shenzhen, China. A total of 26 621 people were included: 8266 people in 1997, 8599 people in 2009 and 9756 people in 2018.Primary and secondary outcome measuresAll participants were surveyed about their sociodemographic and lifestyle information. BP was measured by trained physicians using a mercury sphygmomanometer. Hypertension was defined as systolic BP of at least 140 mm Hg and diastolic BP of at least 90 mm Hg, self-reported use of antihypertensive medications or both. Hypertension control was defined as systolic BP values of less than 140 mm Hg and diastolic BP values of less than 90 mm Hg.ResultAge-adjusted mean systolic BP increased from 117±16 mm Hg to 123±15 mm Hg (p<0.001) in males, and from 113±18 mm Hg to 115±16 mm Hg (p<0.001) in females from 1997 to 2018. Diastolic BP among males increased from 75 mm Hg (SD=11) to 79 mm Hg (SD=11) and increased from 71 mm Hg (SD=10) to 73 mm Hg (SD=10) among females between 1997 and 2018 (p<0.001). Rate of hypertension rose rapidly from 17.71% (95% CI: 16.60% to 18.90%) in 2009 to 24.01% (95% CI: 22.84% to 25.22%) in 2018 among males (p<0.001), whereas the prevalence among females remained stable at around 13.5% (p=0.98). Both awareness and treatment rates of hypertension among males and females showed a decreased trend between 2009 and 2018, while no significant changes were observed for control rates.ConclusionsThe mean systolic BP and diastolic BP among adults in Shenzhen increased from 1997 to 2018, and no improvements in hypertension awareness, treatment and control rates were found.
Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol
Authors: Wu Liucheng , Yan Haiqing , Qin Yuzhou , Huang Mingwei , Wang Tingan , Jin Qinwen , Wei Weiyuan 
Published: February 2024

IntroductionCuring locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib’s low potential for drug–drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ.Methods and analysisThe FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2–4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate.Ethics and disseminationWritten informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ.Trial registration numberNCT05122091.
Experiences of fatigued persons with multiple sclerosis with multimodal agility-based exercise training and the ReFEx study protocol: a qualitative extension of a feasibility study
Authors: Wolf Florian , Folkerts Ann-Kristin , Zimmer Philipp , Nielsen Jörn 
Published: February 2024

Objectives(1) To explore experiences of fatigued persons with multiple sclerosis (pwMS) with a new multimodal agility-based exercise training (MAT) framework and (2) to investigate the demands of the Rehabilitation, Fatigue, and Exercise (ReFEx) study protocol, which compares high-frequency MAT and ‘traditional’ strength and endurance training (SET) to identify possible adaptations for a powered randomised controlled trial (RCT).DesignA qualitative interview study nested within a feasibility RCT, comparing MAT and SET.SettingNeurological inpatient rehabilitation centre in Germany.ParticipantsTwenty-two pwMS were recruited for the feasibility study. Six were selected from MAT and SET, respectively, for semistructured face-to-face interviews prior to discharge, following a purposive sampling strategy. Participants had low physical disability but were at least moderately fatigued.InterventionsDuring inpatient rehabilitation (4–6 weeks) MAT participants attended group-based and manual-based MAT sessions in the gym (5×/week, 30 min) and the pool (3×/week, 30 min). SET participants exercised individually on a cycle ergometer (5×/week, 22 min) and on strength training machines (3×/week, 30 min).ResultsThree key categories emerged from the interviews: (1)facilitatorsregarding MAT were variety and playfulness, group setting and challenging exercises.Barriersregarding MAT were feeling overburdened, feeling pressured in the group setting and the wish to perform ‘traditional’ strength training (not part of MAT). (2) MATbenefitswere of physical and psychological nature, with improved balance stated the most. (3)Demandsdescribed the perceived exertion during MAT and SET, reflecting that there is no accumulation of fatigue during the intervention.ConclusionsMAT is appreciated by pwMS and includes facilitators less attainable with ‘traditional’ SET. Evaluation of MAT in a powered RCT is indicated, if rest breaks postsession, and screening for negative self-evaluation and social comparison are considered. Future (qualitative) research should investigate the important factors of inpatient rehabilitation contributing to fatigue reduction in pwMS.Trial registration numberDRKS00023943; German Clinical Trials Register.
Development of a Core Outcome Set for Dysphagia Interventions in Parkinson’s disease (COS-DIP): study protocol
Authors: Hirschwald Julia , Duncan Sallyanne , Warnecke Tobias , Boyle Gary , Regan Julie , Walshe Margaret 
Published: February 2024

IntroductionCurrent clinical trials on swallowing disorders (dysphagia) in Parkinson’s disease (PD) apply a high variety of outcomes and different outcome measures making comparative effectiveness research challenging. Furthermore, views of patients and dysphagia clinicians when selecting trial outcomes have not been considered in the past, thus study results may have little importance to them. This study aims to develop an agreed standardised Core Outcome Set for Dysphagia Interventions in Parkinson’s disease (COS-DIP), systematically measured and reported as a minimum for all clinical trials. It will also comprise guidance on outcome definitions, outcome measures and time points of measurement.Methods and analysisThe COS-DIP development will comprise five stages following established methodology: (1) a recent scoping review on all applied outcomes, their definitions, methods and time points of measurement in clinical trials in dysphagia in PD, (2) online surveys and focus groups with clinicians, patients, caregivers and family members to identify outcomes that are important to them, (3) an identified list of outcomes based on results of stage 1 and 2, (4) three round online Delphi survey with up to 200 key stakeholders to determine core outcomes and (5) two online consensus meetings with up to 40 representative key stakeholders to agree on all outcomes, definitions, methods and time points of measurement in the final COS-DIP.Ethics and disseminationFull ethical approval was obtained from the Research Ethics Committee, School of Linguistic, Speech and Communication Sciences, Trinity College Dublin, on 15 May 2023 (HT27). Dissemination of the COS-DIP will be enhanced through presentations at (inter-) national conferences and through peer-reviewed, open access publications of related manuscripts. Lay and professional information sheets and infographics will be circulated through relevant patient and professional organisations and networks.Trial registration numberThe COS-DIP study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database on 24 September 2021 (www.comet-initiative.org/Studies/Details/1942).
Burden of diabetic ketoacidosis among patients with diabetes mellitus in Ethiopia: a systematic review and meta-analysis
Authors: Abera Eyob Girma , Yesho Dawit Hailemariam , Erega Fraol Tesfaye , Adulo Zeleke Alemu , Gebreselasse Mahlet Zerabiruk , Gebremichael Ermias Habte 
Published: February 2024

ObjectivesThis systematic review and meta-analysis aimed to assess the magnitude and determinants of diabetic ketoacidosis (DKA) among patients with diabetes mellitus (DM) in Ethiopia.DesignSystematic review and meta-analysis.ParticipantsAge 15 and above all patients with diabetes with the diagnosis of DKA in EthiopiaData sourcePubMed/MEDLINE, Cochrane Library, Science Direct, HINARI, Google Scholar and grey literatures were accessed to find relevant articles. Studies that have been conducted and reported in English language, articles with an available full-text, and observational studies were included. The task of searching sources was carried out from all stated electronic databases performed during 15 April–29 April 2023.Primary and secondary outcome measuresEligible studies were critically appraised by three independent reviewers for methodological quality in the review using standardised critical appraisal instruments from Joanna Briggs Institute (JBI) for observational studies. After the finally extracted studies were exported, systematic review and meta-analysis were conducted using Unified Management, Assessment and Review of Information (JBI SUMARI) (JBI, Adelaide, Australia) and STATA V.17 software. Sensitivity tests were done, and funnel plot inspections with Egger’s test were used to check for publication bias.ResultFrom a total of 19 studies with 6498 study participants, the pooled prevalence of DKA among patients with DM in Ethiopia was 30.92% (95% CI 29.96 to 31.89) with a significant statistical heterogeneity (I2=99.2, p=<0.001). Sensitivity analysis suggested that three studies showed deviations from the estimated pooled prevalence. A funnel plot inspection and Egger’s test indicated the absence of a publication bias.ConclusionThis systematic review and meta-analysis revealed that the prevalence of DKA among patients with DM in Ethiopia was 30.92%. Besides, different behavioural and clinical determinants of DKA among patients with DM were identified. However, further studies should be conducted, particularly on the possible determinants of DKA, and different stakeholders should be engaged to minimise its burden.
‘DANMM that’s good!’: evaluating the feasibility and acceptability of the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Programme across rural, regional and metropolitan NSW–a collaborative study protocol
Authors: Biles Brett , Christian Bradley , Marshall Charmaine , McMillan Faye , Sara Grant , Anderson Judith , Davies Nicolle , Fealy Shanna , Biles Jessica 
Published: February 2024

IntroductionThis paper will describe the research protocol for the Deadly Aboriginal and Torres Strait Islander Nursing and Midwifery Mentoring (DANMM) Project, which will determine the feasibility and acceptability of a cultural mentoring programme designed for Aboriginal and Torres Strait Islander nurses and midwives across five diverse local health districts in New South Wales, Australia. Government and health agencies highlight the importance of culturally appropriate and safe environments for Aboriginal people. Specifically, New South Wales Health prioritises workforce strategies that support Aboriginal people to enter and stay in the health workforce. However, retaining Aboriginal nurses and midwives remains challenging. The DANMM Project aligns with these local and state-wide health plans and strategies, addressing critical issues of workforce cultural safety and retention.Methods and analysisA mixed-methods study design will be employed to assess feasibility, acceptability and preliminary efficacy of the DANMM Programme across five publicly funded local health districts in New South Wales, Australia. Adhering to cultural safety, a project cultural governance group will be formed. Quantitative outcome measures include the use of questionnaires (Nursing Workplace Satisfaction Questionnaire, Ganngaleh nga Yagaleh Cultural Safety assessment tool). Resource implications will be measured using the Organisational Commitment and Health Professional Program Readiness Assessment Compass. These will be triangulated with individual and group yarning circles to provide a holistic evaluation of the programme.Ethics and disseminationThe study has ethics approval: Aboriginal Health and Medical Research Council (#2054/23); New South Wales Health Human Research Committees (Greater Western Human Research Committee #2022/ETH01971, Murrumbidgee—site-specific approval, Sydney Local Health District—site-specific approval, Western Sydney Local Health District—site-specific approval and Mid North Coast—site-specific approval); and Charles Sturt University Human Research Committee (#2054/23). Findings will be disseminated through peer-reviewed articles, conferences and through roundtable discussions with key stakeholders.
Barriers And Challenges Of Multidisciplinary Teams In Oncology Management: A Scoping Review Protocol
Authors: Law Nicholas Lee Wei , Hong Lai Wei , Tan Shirley Siang Ning , Foo Chuan Jie , Lee Daniel , Voon Pei Jye 
Published: February 2024

IntroductionMultidisciplinary teams (MDTs) are integral to oncology management, involving specialised healthcare professionals who collaborate to develop individualised treatment plans for patients. However, as cancer care grows more complex, MDTs must continually adapt to better address patient needs. This scoping review will explore barriers and challenges MDTs have encountered in the past decade; and propose strategies for optimising their utilisation to overcome these obstacles and improve patient care.Methods and analysisThe scoping review will follow Arksey and O’Malley’s framework and begin with a literature search using keywords in electronic databases such as PubMed/MEDLINE, Scopus and PsychINFO, covering the period from January 2013 to December 2022 and limited to English language publications. Four independent reviewers will screen titles and abstracts based on predefined inclusion criteria, followed by full-text review of selected titles. Relevant references cited in the publications will also be examined. A Preferred Reporting Items for Systematic reviews and Meta-Analyses flow diagram will be utilised to illustrate the methodology. Data from selected publications will be extracted, analysed, and categorised for further analysis.Ethics and disseminationThe results of the scoping review will provide a comprehensive overview of the barriers and challenges encountered by oncology MDTs over the past decade. These findings will contribute to the existing literature and provide insights into areas that require improvement in the functioning of MDTs in oncology management. The results will be disseminated through publication in a scientific journal, which will help to share the findings with the wider healthcare community and facilitate further research and discussion in this field.Trial registration detailsThe protocol for this scoping review is registered with Open Science Framework, available at DOI 10.17605/OSF.IO/R3Y8U.
Cohort profile: PRESTIGIO, an Italian prospective registry-based cohort of people with HIV-1 resistant to reverse transcriptase, protease and integrase inhibitors
Authors: Clemente Tommaso , Galli Laura , Lolatto Riccardo , Gagliardini Roberta , Lagi Filippo , Ferrara Micol , Cattelan Anna Maria , Focà Emanuele , Di Biagio Antonio , Cervo Adriana , Calza Leonardo , Maggiolo Franco , Marchetti Giulia , Cenderello Giovanni , Rusconi Stefano , Zazzi Maurizio , Santoro Maria Mercedes , Spagnuolo Vincenzo , Castagna Antonella 
Published: February 2024

PurposeThe PRESTIGIO Registry was established in 2017 to collect clinical, virological and immunological monitoring data from people living with HIV (PLWH) with documented four-class drug resistance (4DR). Key research purposes include the evaluation of residual susceptibility to specific antiretrovirals and the validation of treatment and monitoring strategies in this population.ParticipantsThe PRESTIGIO Registry collects annual plasma and peripheral blood mononuclear cell samples and demographic, clinical, virological, treatment and laboratory data from PLWH followed at 39 Italian clinical centres and characterised by intermediate-to-high genotypic resistance to ≥1 nucleoside reverse transcriptase inhibitors, ≥1 non-nucleoside reverse transcriptase inhibitors, ≥1 protease inhibitors, plus either intermediate-to-high genotypic resistance to ≥1 integrase strand transfer inhibitors (INSTIs) or history of virological failure to an INSTI-containing regimen. To date, 229 people have been recorded in the cohort. Most of the data are collected from the date of the first evidence of 4DR (baseline), with some prebaseline information obtained retrospectively. Samples are collected from the date of enrollment in the registry.Findings to dateThe open-ended cohort has been used to assess (1) prognosis in terms of survival or development of AIDS-related or non-AIDS-related clinical events; (2) long-term efficacy and safety of different antiretroviral regimens and (3) virological and immunological factors predictive of clinical outcome and treatment efficacy, especially through analysis of plasma and cell samples.Future plansThe registry can provide new knowledge on how to implement an integrated approach to study PLWH with documented resistance to the four main antiretroviral classes, a population with a limited number of individuals characterised by a high degree of frailty and complexity in therapeutic management. Given the scheduled annual updates of PLWH data, the researchers who collaborate in the registry can send study proposals at any time to the steering committee of the registry, which evaluates every 3 months whether the research studies can be conducted on data and biosamples from the registry and whether they are aimed at a better understanding of a specific health condition, the emergence of comorbidities or the effect of potential treatments or experimental drugs that may have an impact on disease progression and quality of life. Finally, the research studies should aim to be inclusive, innovative and in touch with the communities and society as a whole.Trial registration numberNCT04098315.
Enhanced active case finding of drug-resistant tuberculosis in Namibia: a protocol for the hotspots, hospitals, and households (H3TB) study
Authors: Shavuka Olga , Iipumbu Etuhole , Boois Lorraine , Günther Gunar , Hoddinott Graeme , Lin Hsien-Ho , Nepolo Emmanuel , Niemann Stefan , Ruswa Nunurai , Seddon James , Claassens Mareli M 
Published: February 2024

IntroductionNamibia is a high tuberculosis (TB)-burden country with an estimated incidence of 460/100 000 (around 12 000 cases) per year. Approximately 4.5% of new cases and 7.9% of previously treated TB cases are multidrug resistant (MDR) and 47% of patients with MDR-TB are HIV coinfected. Published data suggest a clustering of MDR-TB transmission in specific areas. Identifying transmission clusters is key to implementing high-yield and cost-effective interventions. This includes knowing the yield of finding TB cases in high-transmission zones (eg, community hotspots, hospitals or households) to deliver community-based interventions. We aim to identify such transmission zones for enhanced case finding and evaluate the effectiveness of this approach.Methods and analysisH3TB is an observational cross-sectional study evaluating MDR-TB active case finding strategies. Sputum samples from MDR-TB cases in three regions of Namibia will be evaluated by whole genome sequencing (WGS) in addition to routine sputum investigations (Xpert MTB/RIF, culture and drug susceptibility testing). We will collect information on household contacts, use of community spaces and geographical map intersections between participants, synthesising these data to identify transmission hotspots. We will look at the feasibility, acceptability, yield and cost of case finding strategies in these hotspots, and in households of patients with MDR-TB and visitors of hospitalised patients with MDR-TB. A compartmental transmission dynamic model will be constructed to evaluate the impact and cost-effectiveness of the strategies if scaled.Ethics and disseminationEthics approval was obtained. Participants will give informed consent. H3TB will capitalise on a partnership with the Ministry of Health and Social Services to follow up individuals diagnosed with MDR-TB and integrate WGS data with innovative contact network mapping, to allow enhanced case finding. Study data will contribute towards a systems approach to TB control. Equally important, it will serve as a role model for similar studies in other high-incidence settings.