bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial
Authors: Buse John B , Nordahl Christensen Helene , Harty Brian J , Mitchell Julie , Soule Benjamin P , Zacherle Emily , Cziraky Mark , Willey Vincent J 
Published: May 2023

IntroductionOnce-weekly subcutaneous semaglutide, a glucagon-like peptide-1 analog, is approved in the USA as an adjunct to diet and exercise for adults with inadequately controlled type 2 diabetes (T2D) to improve glycemic control and reduce the risk of major adverse cardiovascular events in people with T2D and established cardiovascular disease. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) phase III clinical trial program demonstrated the efficacy and safety of once-weekly subcutaneous semaglutide; however, determining its effectiveness in a real-world setting could support decision-making by clinicians, payers and policy makers in routine clinical practice.Research design and methodsSEmaglutide PRAgmatic (SEPRA) is an ongoing open-label, randomized, pragmatic clinical trial designed to compare the effects of once-weekly subcutaneous semaglutide versus standard of care in US health-insured adults with T2D and physician-determined inadequate glycemic control. The primary end point is the proportion of participants achieving glycated hemoglobin (HbA1c) <7.0% at year 1; other key outcomes include glycemic control, weight loss, healthcare utilization, and patient-reported outcomes. Individual-level data will be collected from routine clinical practice and health insurance claims. The last patient last visit is expected by June 2023.ResultsBetween July 2018 and March 2021, 1278 participants were enrolled from 138 study sites across the USA. At baseline, 54% were male with mean±SD age 57.4±11.1 years and body mass index 35.7±8.0 kg/m2. Mean diabetes duration was 7.4±6.0 years and mean HbA1c was 8.5±1.6%. At baseline, concomitant antidiabetes medications included metformin, sulfonylureas, sodium-glucose co-transporter-2 inhibitors, and dipeptidyl peptidase-4 inhibitors. The majority of participants had hypertension and dyslipidemia. The trial design was self-assessed using the PRagmatic Explanatory Continuum Indicator Summary-2 tool by the study steering group and was scored 4–5 in all domains suggesting a highly pragmatic study.ConclusionsSEPRA, a highly pragmatic ongoing study, will provide data on the effects of once-weekly subcutaneous semaglutide in a real-world setting when used during routine management of T2D.Trial registration numberNCT03596450.Trial registration number
Factors that influence the uptake of postnatal care from the perspective of fathers, partners and other family members: a qualitative evidence synthesis
Authors: Finlayson Kenneth , Sacks Emma , Brizuela Vanessa , Crossland Nicola , Cordey Sarah , Ziegler Daniela , Langlois Etienne V , Javadi Dena , Comrie-Thomson Liz , Downe Soo , Bonet Mercedes 
Published: May 2023

BackgroundPostnatal care (PNC) is a key component of maternity provision and presents opportunities for healthcare providers to optimise the health and well-being of women and newborns. However, PNC is often undervalued by parents, family members and healthcare providers. As part of a larger qualitative review exploring the factors that influence PNC uptake by relevant stakeholders, we examined a subset of studies highlighting the views of fathers, partners and family members of postpartum women.MethodsWe undertook a qualitative evidence synthesis using a framework synthesis approach. We searched multiple databases and included studies with extractable qualitative data focusing on PNC utilisation. We identified and labelled a subset of articles reflecting the views of fathers, partners and other family members. Data abstraction and quality assessment were carried out using a bespoke data extraction form and established quality assessment tools. The framework was developeda prioribased on previous research on the topic and adapted accordingly. Findings were assessed for confidence using the GRADE-CERQual approach and are presented by country income group.ResultsOf 12 678 papers identified from the original search, 109 were tagged as ‘family members views’ and, of these, 30 were eligible for this review. Twenty-nine incorporated fathers’ views, 7 included the views of grandmothers or mothers-in-law, 4 incorporated other family member views and 1 included comothers. Four themes emerged: access and availability; adapting to fatherhood; sociocultural influences and experiences of care. These findings highlight the significant role played by fathers and family members on the uptake of PNC by women as well as the distinct concerns and needs of fathers during the early postnatal period.ConclusionTo optimise access to postnatal care, health providers should adopt a more inclusive approach incorporating flexible contact opportunities, the availability of more ‘family-friendly’ information and access to psychosocial support services for both parents.
Antidepressant Advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care – a feasibility study
Authors: Harrison Phillippa , Carr Ewan , Goldsmith Kimberley , Young Allan , Ashworth Mark , Fennema Diede , Duan Suqian , Barrett Barbara M , Zahn Roland 
Published: May 2023

ObjectivesTo develop and probe the first computerised decision-support tool to provide antidepressant treatment guidance to general practitioners (GPs) in UK primary care.DesignA parallel group, cluster-randomised controlled feasibility trial, where individual participants were blind to treatment allocation.SettingSouth London NHS GP practices.ParticipantsTen practices and eighteen patients with treatment-resistant current major depressive disorder.InterventionsPractices were randomised to two treatment arms: (a) treatment-as-usual, (b) computerised decision support tool.ResultsTen GP practices participated in the trial, which was within our target range (8–20). However, practice and patient recruitment were slower than anticipated and only 18 of 86 intended patients were recruited. This was due to fewer than expected patients being eligible for the study, as well as disruption resulting from the COVID-19 pandemic. Only one patient was lost to follow-up. There were no serious or medically important adverse events during the trial. GPs in the decision tool arm indicated moderate support for the tool. A minority of patients fully engaged with the mobile app-based tracking of symptoms, medication adherence and side effects.ConclusionsOverall, feasibility was not shown in the current study and the following modifications would be needed to attempt to overcome the limitations found: (a) inclusion of patients who have only tried one Selective Serotonin Reuptake Inhibitor, rather than two, to improve recruitment and pragmatic relevance of the study; (b) approaching community pharmacists to implement tool recommendations rather than GPs; (c) further funding to directly interface between the decision support tool and self-reported symptom app; (d) increasing the geographic reach by not requiring detailed diagnostic assessments and replacing this with supported remote self-report.Trial registration numberNCT03628027.
Institutional delivery and postnatal care utilisation among reproductive-aged women who had completed four or more antenatal care visits in Myanmar: a secondary analysis of 2015–2016 Demographic and Health Survey
Authors: Oo Htun Yadanar , Tun Thandar , Khaing Cho Thet , Mya Kyaw Swa 
Published: May 2023

ObjectivesTo examine the prevalence of institutional delivery and postnatal care after home delivery and to identify their determinants in Myanmar mothers who received at least four antenatal care visits.DesignThe study used the Myanmar Demographic and Health Survey data (2015–2016), a nationally representative cross-sectional study.ParticipantsThe study included women aged 15–49 years who had at least one birth within the 5 years preceding the survey and completed four or more antenatal visits.Outcome measuresInstitutional delivery and postnatal care after home delivery were used as outcomes. We used two separate samples, that is, 2099 women for institutional delivery and 380 mothers whose most recent birth was within 2 years before the survey and delivered at home for postnatal care utilisation. We used multivariable binary logistic regression analyses.SettingFourteen states/regions and Nay Pyi Taw Union Territory in Myanmar.ResultsThe prevalence of institutional delivery was 54.7% (95% CI: 51.2%, 58.2%) and postnatal care utilisation was 76% (95% CI: 70.2%, 80.9%). Women who lived in urban areas, women who had higher education, women who had higher wealth status, women who had educated husbands and women having their first childbirth were more likely to have institutional delivery than their counterparts. The institutional delivery was lower among women who live in rural areas, poor women and women with husbands who worked in agriculture than their counterparts. Postnatal care utilisation was significantly higher among women living in central plains and coastal regions, women who received all seven components of antenatal care and women who had skilled assistance at birth than their counterparts.ConclusionsPolicymakers should address the identified determinants to improve the service continuum and reduce maternal mortality in Myanmar.
Protocol and statistical analysis plan for the Antibiotic Choice On ReNal outcomes (ACORN) randomised clinical trial
Authors: Qian Edward Tang , Casey Jonathan D , Wright Adam , Wang Li , Siemann Justin , Dear Mary Lynn , Stollings Joanna , Lloyd Bradley Daniel , Seitz Kevin , Nelson George , Wright Patty , Siew Edward D , Dennis Bradley , Wrenn Jesse , Andereck Jonathan , Self Wesley H , Semler Matthew W , Rice Todd W 
Published: May 2023

IntroductionAntibiotics are time-critical in the management of sepsis. When infectious organisms are unknown, patients are treated with empiric antibiotics to include coverage for gram-negative organisms, such as antipseudomonal cephalosporins and penicillins. However, in observational studies, some antipseudomonal cephalosporins (eg, cefepime) are associated with neurologic dysfunction while the most common antipseudomonal penicillin (piperacillin–tazobactam) is associated with acute kidney injury (AKI). No randomised control trials have compared these regimens. This manuscript describes the protocol and analysis plan for a trial designed to compare the effects of antipseudomonal cephalosporins and antipseudomonal penicillins among acutely ill patients receiving empiric antibiotics.Methods and analysisThe Antibiotic Choice On ReNal outcomes trial is a prospective, single-centre, non-blinded randomised trial being conducted at Vanderbilt University Medical Center. The trial will enrol 2500 acutely ill adults receiving gram-negative coverage for treatment of infection. Eligible patients are randomised 1:1 to receive cefepime or piperacillin–tazobactam on first order entry of a broad-spectrum antibiotic covering gram-negative organisms. The primary outcome is the highest stage of AKI and death occurring between enrolment and 14 days after enrolment. This will be compared between patients randomised to cefepime and randomised to piperacillin–tazobactam using an unadjusted proportional odds regression model. The secondary outcomes are major adverse kidney events through day 14 and number of days alive and free of delirium and coma in 14 days after enrolment. Enrolment began on 10 November 2021 and is expected to be completed in December 2022.Ethics and disseminationThe trial was approved by the Vanderbilt University Medical Center institutional review board (IRB#210591) with a waiver of informed consent. Results will be submitted to a peer-reviewed journal and presented at scientific conferences.Trial registration numberNCT05094154.
Piloting an online telecoaching community-based exercise intervention with adults living with HIV: protocol for a mixed-methods implementation science study
Authors: O'Brien Kelly K , Ibáñez-Carrasco Francisco , Carusone Soo Chan , Bayoumi Ahmed M , Tang Ada , McDuff Kiera , Jiancaro Tizneem , Da Silva George , Torres Brittany , Loutfy Mona R , Islam Shaz , Lindsay Joanne , Price Colleen , Zobeiry Mehdi , Pandovski Zoran , Illic Ivan , Ahluwalia Puja , Brown Darren A , Avery Lisa , Solomon Patricia 
Published: May 2023

IntroductionOur aim is to evaluate the implementation of an online telecoaching community-based exercise (CBE) intervention with the goal of reducing disability and enhancing physical activity and health among adults living with HIV.Methods and analysisWe will conduct a prospective longitudinal mixed-methods two-phased intervention study to pilot the implementation of an online CBE intervention with ~30 adults (≥18 years) living with HIV who consider themselves safe to participate in exercise. In the intervention phase (0–6 months), participants will take part in an online CBE intervention involving thrice weekly exercise (aerobic, resistance, balance and flexibility), with supervised biweekly personal training sessions with a fitness instructor, YMCA membership providing access to online exercise classes, wireless physical activity monitor to track physical activity and monthly online educational sessions on topics related to HIV, physical activity and health. In the follow-up phase (6–12 months), participants will be encouraged to continue independent exercise thrice weekly. Quantitative assessment: Bimonthly, we will assess cardiopulmonary fitness, strength, weight, body composition and flexibility, followed by administering self-reported questionnaires to assess disability, contextual factor outcomes (mastery, engagement in care, stigma, social support), implementation factors (cost, feasibility, technology), health status and self-reported physical activity. We will conduct a segmented regression analyses to describe the change in level and trend between the intervention and follow-up phases. Qualitative assessment: We will conduct online interviews with a subsample of ~10 participants and 5 CBE stakeholders at baseline (month 0), postintervention (month 6) and end of follow-up (month 12) to explore experiences, impact and implementation factors for online CBE. Interviews will be audiorecorded and analysed using content analytical techniques.Ethics and disseminationProtocol approved by the University of Toronto Research Ethics Board (Protocol # 40410). Knowledge translation will occur in the form of presentations and publications in open-access peer-reviewed journals.Trial registration numberNCT05006391.
Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in extremely preterm infants with respiratory distress syndrome: study protocol for a multicentre randomised controlled, superiority trial
Authors: Li Yang , Zhu Xingwang , Shi Yuan 
Published: May 2023

IntroductionTracheal intubation and invasive mechanical ventilation (IMV) significantly decreased mortality of respiratory distress syndrome (RDS) in extremely preterm infants (28 weeks’ gestational age) whereas bronchopulmonary dysplasia increased. Thus, consensus guidelines recommend the use of non-invasive ventilation (NIV), as the preferred first-line approach for these infants. This trial aims to compare the effect of nasal continuous positive airway pressure (NCPAP) and non-invasive high-frequency oscillatory ventilation (NHFOV) as the primary respiratory support in extremely preterm infants with RDS.Methods and analysisWe designed a multicentre, randomised, controlled, superiority trial investigating the effect of NCPAP and NHFOV as the primary respiratory support in extremely preterm infants with RDS in neonatal intensive units in China. At least 340 extremely preterm infants with RDS will be randomised to NHFOV or NCPAP as a primary mode of NIV. The primary outcomes will be the respiratory support failure determined by the need for IMV within 72 hours from birth.Ethics and disseminationOur protocol has been approved by the Ethics Committee of Children’s Hospital of Chongqing Medical University. We will present our findings at national conferences and peer-reviewed paediatrics journals.Trial registration numberNCT05141435.
Psychological treatments for the mental health symptoms among individuals infected with COVID-19: a scoping review protocol
Authors: Sugita So , Hata Kotone , Takamatsu Naoki , Kimura Kentaro , Gonzalez Lecsy , Kodaiarasu Krandhasi , Miller Christian , Umemoto Ikue , Murayama Keitaro , Nakao Tomohiro , Kito Shinsuke , Ito Masaya , Kuga Hironori 
Published: May 2023

IntroductionMental health symptoms such as depression, anxiety and sleep problems are commonly observed in individuals suffering from acute COVID-19 infection to post-COVID-19 syndrome. Studies have provided preliminary evidence for the efficacies of cognitive behavioural therapy, mindfulness-based interventions, acceptance and commitment therapy, and many other treatments for this population. Although there have been attempts to synthesise the literature on these psychological interventions, previous reviews have been limited in terms of the sources, symptoms and interventions that they included. Furthermore, most studies reviewed were conducted in early 2020, when COVID-19 had only recently been classified as a global pandemic. Since then, substantial research has been conducted. As such, we sought to provide an updated synthesis of the available evidence of treatments for the range of mental health symptoms associated with COVID-19.Methods and analysisThis scoping review protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Systematic searches were carried out on scientific databases (PubMed, Web of Science, PsycINFO and Scopus) and clinical trial registries (ClinicalTrials.gov, WHO ICTRP, EU Clinical Trials Register and Cochrane Central Register of Controlled Trials) to identify studies that have or will assess the efficacy or any aspects of psychological treatment for acute to post-COVID-19 syndrome. The search was conducted on 14 October 2022 and identified 17 855 potentially eligible sources/studies published since 1 January 2020 (duplicates removed). Six investigators will independently carry out titles and abstract screening, full-text screening and data charting and the results will be summarised using descriptive statistics and narrative synthesis.Ethics and disseminationEthical approval is not required for this review. The results will be disseminated through a peer-reviewed journal, conference presentations and/or academic newspapers. This scoping review has been registered with Open Science Framework (https://osf.io/wvr5t).
Analysis of the determinants of sleep quality in a Spanish population: a study protocol for a cross-sectional study
Authors: Jiménez-Vaquero César , Alonso-Dominguez Rosario , Garcia-Yu Irene A , Martín-Nogueras Ana M , Sánchez-Aguadero Natalia , Crespo-Sedano Andrea , Rihuete-Galve María I , García-Alonso María A , García-Prieto María L , González-Sánchez Jesús , Recio José-Ignacio 
Published: May 2023

IntroductionSleep problems are a growing public health concern being related, among others, to an increased risk of cardiovascular diseases or worse cognitive functioning. In addition, they can affect aspects related to personal motivation and quality of life. However, very few studies have analysed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these determinants.The objectives are to evaluate the determinants of sleep quality in a representative sample of the general adult population between 25 and 65 years old, and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities, sociodemographic variables, biological markers and other possible determinants.Methods and analysisDescriptive observational cross-sectional study. The study population will include a representative sample of 500 people between 25 and 65 years old from the cities of Salamanca and Ávila (Spain) selected by random sampling stratified by age groups and sex. A 90-minute visit will be performed, during which sleep quality will be assessed. The variables collected will be: morbidity, lifestyles (physical activity, diet, toxic habits), psychological factors (depression, stress, occupational stress and anxiety), socioeconomic and work-related variables, habitability conditions of the habitual residence and rest area, screen time, relaxation techniques and melatonin as a biological marker related to sleep quality.DiscussionWith the results of this work, improved interventions for behaviour modification could be designed, as well as intervention and education programmes or other research aimed at improving sleep quality.Ethics and disseminationThis study has a favourable opinion from the Ethics Committee for Drug Research of the Health Areas of Salamanca and Ávila (CEim Code: PI 2021 07 815). The results of this study will be published in international impact journals of different specialties.Trial registration numberNCT05324267.
Outcomes of discontinuing renin-angiotensin system inhibitors: a study protocol for conducting systematic review and meta-analysis
Authors: Suzuki Taihei , Nishiwaki Hiroki , Watanabe Yoshitaka , Abe Yoshifusa , Noma Hisashi , Ota Erika , Honda Hirokazu , Hasegawa Takeshi 
Published: May 2023

IntroductionRenin-angiotensin system (RAS) plays a key role in various types of cardiovascular disease and many kinds of RAS inhibitors have been developed. The effect of discontinuation of RAS inhibitors on clinical outcomes is still controversial. This study aims to evaluate the effects of discontinuing RAS inhibitor medication on the clinical outcomes of patients continuously taking these agents.Methods and analysisThis article presents a systematic review protocol described in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include randomised controlled trials in which the effects of RAS inhibitor withdrawal were evaluated. Initially, four authors will search for eligible studies in MEDLINE, EMBASE, the Cochrane Database Trial Register, European trial registry and ClinicalTrials.gov. Abstracts and full-text screenings will be performed by the four authors with data extraction performed by each author independently. We will include patients taking RAS inhibitors—including ACE inhibitor, angiotensin receptor blocker and angiotensin receptor neprilysin inhibitor and exclude the patients undergoing renal replacement therapy (RRT), adolescents (under 18 years of age) and patients with acute infectious diseases. Our search will be performed on 1 May 2023. Studies in which the patients discontinued RAS inhibitors due to any reason will be included. Patients who continuously took RAS inhibitors under conditions in which the intervention group discontinued these agents will be considered eligible as the comparison group. Death (any cause), Death (cardiovascular disease (CVD)) and CVD events will be set as primary outcomes. Secondary outcomes will be set as RRT, acute kidney injury, renal function (analysis of the change in estimated glomerular filtration rate), hyperkalaemia, proteinuria and blood pressure.Ethics and disseminationResearch ethics approval was not required in this study due to it being a systematic review, and any data belonging to individuals cannot be identified. The results of this study will be disseminated through peer-reviewed journals and conferences.Trial registration numberPROSPERO CRD42022300777.