bluuebunny/crossref_metadata_2025_split huggingface dataset:
Manuscript review continuing medical education: a retrospective investigation of the learning outcomes from this peer reviewer benefit
Authors: Kawczak Steven , Mustafa Sultana 
Published: November 2020

ObjectivesThis study investigates the learning outcomes for peer reviewers participating in a manuscript review continuing medical education (CME) process. CME from serving as a peer reviewer is one of the many benefits of serving as a reviewer.DesignThis is a descriptive study retrospectively analysing learning outcomes self-reported by peer reviewers from 2013 to 2017 using a CME assessment framework.Setting, participants and primary outcome measuresParticipant data are from 1985 peer reviewers who completed 2413 manuscript reviews over 32 medical journals from 2013 to 2017 and completed the CME process after their prepublication manuscript review. 417 reviewer responses were practice behaviour change(s) that were studied in depth using an assessment framework on changes in knowledge, competence and performance.ResultsThe results show positive learning outcomes reported by reviewers at the knowledge, competence and performance behaviour levels as a result of reviewing manuscripts. Higher levels of learning outcomes are more frequently achieved when reviewers consult multiple sources when conducting reviews. Reviewer demographics, such as gender or years of experience, did not have a significant association to learning outcomes.ConclusionsManuscript Review CME is an effective way that learning within the peer reviewer process can occur and helps reviewers gain knowledge, improve competence and make changes to their professional practice at all stages of their careers. Journal publishers should emphasise and support reviewers through offering CME to reviewers and encourage consultation of multiple sources when conducting reviews, which is an added benefit and resource to help professionals continue their development.
Women’s health-related vulnerabilities in natural disaster-affected areas of Bangladesh: a mixed-methods study protocol
Authors: Riyad Fatema Syadani 
Published: November 2020

IntroductionGlobal climate change has produced growing natural disasters across the world especially in Global South. Different countries experience varied vulnerabilities depending on their geographical location, economic status and ability of management. In a highly disaster susceptible developing country like Bangladesh, many individuals experience a greater rate of natural disasters with devastating health effects. Compare with men, women have a higher incidence of mortality and health effects following natural disasters. The study aims to explore women’s experience of physical and psychological health vulnerabilities with primary causes in natural disaster-affected areas of Bangladesh.Methods and analysisThis is an exploratory mixed-method study comprising survey and in-depth interviews with equal priority to identify physical and psychological health vulnerabilities of women living in natural disaster-affected areas of Bangladesh. Quantitative data will be collected using self-administered sociodemographic and perceived severity instrument, 12-item Short-Form, Impact of Event Scale-Revised and Brief Coping Scale, while specific open-ended guidelines will be used for the qualitative part. The instruments will be translated into Bangla following the Brislin (1970) model of translation. The survey will be administered in paper copies, with at least 384 respondents, whereas 30 participants will be in-depth interviewed using an audio recorder. Survey data will be analysed using SPSS V.25 following descriptive and inferential statistics as required. The recorded open-ended responses will be transcribed and analysed using thematic analysis. Finally, both data sets will be integrated and synthesised according to the sequential mixed-method approach.Ethics and disseminationThe study has been reviewed and approved by the Human Research Ethics Committee of the University of New England. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and various community engagement activities.
Role of formative assessment in predicting academic success among GP registrars: a retrospective longitudinal study
Authors: Heggarty Paula , Teague Peta-Ann , Alele Faith , Adu Mary , Malau-Aduli Bunmi S 
Published: November 2020

ObjectivesThe James Cook University General Practice Training (JCU GPT) programme’s internal formative exams were compared with the Royal Australian College of General Practitioners (RACGP) pre-entry exams to determine ability to predict final performance in the RACGP fellowship exams.DesignA retrospective longitudinal study.SettingGeneral Practice (GP) trainees enrolled between 2016 and 2019 at a Registered Training Organisation in regional Queensland, Australia.Participants376 GP trainees enrolled in the training programme.Exposure measuresThe pre-entry exams were Multiple-Mini Interviews (MMI), Situational Judgement Test (SJT) and Candidate Assessment and Applied Knowledge Test. The internal formative exams comprised multiple choice questions (MCQ1 and MCQ2), short answer questions, clinical skills and clinical reasoning.Primary outcome measureThe college exams were Applied Knowledge Test (AKT), Key Feature Problems (KFP) and Objective Structured Clinical Examination (OSCE).ResultsCorrelations (r), coefficients of determination (R2) and OR were used as parameters for estimating strength of relationship and precision of predictive accuracy. SJT and MMI were moderately (r=0.13 to 0.31) and MCQ1 and MCQ2 highly (r=0.37 to 0.53) correlated with all college exams (p<0.05 to p<0.01), with R2 ranging from 0.070 to 0.376. MCQ1 was predictive of failure in all college exams (AKT: OR=2.32, KFP: OR=3.99; OSCE: OR=3.46); while MCQ2 predicted failure in AKT (OR=2.83) and KFP (OR=3.15).ConclusionWe conclude that the internal MCQ formative exams predict performance in the RACGP fellowship exams. We propose that our formative assessment tools could be used as academic markers for early identification of potentially struggling trainees.
Azathioprine immunosuppression and disease modification in Parkinson’s disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial protocol
Authors: Greenland Julia C , Cutting Emma , Kadyan Sonakshi , Bond Simon , Chhabra Anita , Williams-Gray Caroline H 
Published: November 2020

IntroductionThe immune system is implicated in the aetiology and progression of Parkinson’s disease (PD). Inflammation and immune activation occur both in the brain and in the periphery, and a proinflammatory cytokine profile is associated with more rapid clinical progression. Furthermore, the risk of developing PD is related to genetic variation in immune-related genes and reduced by the use of immunosuppressant medication. We are therefore conducting a ‘proof of concept’ trial of azathioprine, an immunosuppressant medication, to investigate whether suppressing the peripheral immune system has a disease-modifying effect in PD.Methods and analysisAZA-PD is a phase II randomised placebo-controlled double-blind trial in early PD. Sixty participants, with clinical markers indicating an elevated risk of disease progression and no inflammatory or immune comorbidity, will be treated (azathioprine:placebo, 1:1) for 12 months, with a further 6-month follow-up. The primary outcome is the change in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period. Exploratory outcomes include additional measures of motor and cognitive function, non-motor symptoms and quality of life. In addition, peripheral and central immune markers will be investigated through analysis of blood, cerebrospinal fluid and PK-11195 positron emission tomography imaging.Ethics and disseminationThe study was approved by the London-Westminster research ethics committee (reference 19/LO/1705) and has been accepted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a clinical trials authorisation (reference CTA 12854/0248/001–0001). In addition, approval has been granted from the Administration of Radioactive Substances Advisory Committee. The results of this trial will be disseminated through publication in scientific journals and presentation at national and international conferences, and a lay summary will be available on our website.Trial registration numbersISRCTN14616801 and EudraCT- 2018-003089-14.
Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial
Authors: He Xuan , Cheng Kun-Ming , Zhang Linlin , Gu Hongqiu , Qu Xin , Xu Yuan , Ma Penglin , Zhou Jian-Xin 
Published: November 2020

IntroductionPostoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients are usually excluded from previous studies. The present study was designed to investigate the impact of prophylactic use of low-dose dexmedetomidine on the incidence of POD in patients after intracranial operation.Methods and analysisThis is a multicentre, randomised, double-blinded and placebo-controlled trial. Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio. For patients in the dexmedetomidine group, a continuous infusion of dexmedetomidine will be started at a rate of 0.1 μg/kg/hour immediately after enrolment on the day of operation and continued until 08:00 on postoperative day 1. For patients in the placebo group, normal saline will be administered at the same rate as in the dexmedetomidine group. The patients will be followed up for 28 days after enrolment. The primary endpoint is the incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU), during the first 5 postoperative days. The secondary endpoints include the incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality after the operation.Ethics and disseminationThe study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (No KY2019-091-02) and registered at ClinicalTrials.gov. The results of the trial will be presented at national and international conferences relevant to subject fields and submitted to international peer-reviewed journals.Trial registration numberTrial registration number: NCT04399343; Pre-results.
Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study
Authors: Trouillet-Assant Sophie , Albert Vega Chloe , Bal Antonin , Nazare Julie Anne , Fascia Pascal , Paul Adèle , Massardier-Pilonchery Amélie , d Aubarede Constance , Guibert Nicolas , Pitiot Virginie , Lahousse Matthieu , Boibieux André , Makhloufi Djamila , Simon Chantal , Rabilloud Muriel , Trabaud Mary Anne , Gueyffier François , Fassier Jean-Baptiste 
Published: November 2020

IntroductionThe COVID-19 pandemic caused by SARS-CoV-2 threatens global public health, and there is an urgent public health need to assess acquired immunity to SARS-CoV-2. Serological tests might provide results that can be complementary to or confirm suspected COVID-19 cases and reveal previous infection. The performance of serological assays (sensitivity and specificity) has to be evaluated before their use in the general population. The neutralisation capacity of the produced antibodies also has to be evaluated.Methods and analysisWe set up a prospective, multicentric clinical study to evaluate the performance of serological kits among a population of healthcare workers presenting mild symptoms suggestive of SARS-CoV-2 infection. Four hundred symptomatic healthcare workers will be included in the COVID-SER study. The values obtained from a control cohort included during the prepandemic time will be used as reference. A workflow was set up to study serological response to SARS-CoV-2 infection and to evaluate antibody neutralisation capacity in patients with a confirmed SARS-CoV-2 infection. The sensitivity and specificity of the tests will be assessed using molecular detection of the virus as a reference. The measurement of IgM and IgG antibodies will be performed once per week for 6 consecutive weeks and then at 6, 12, 18, 24 and 36 months after the diagnosis. The kinetics of IgM and IgG will determine the optimal period to perform serological testing. The proportion of false negative PCR tests in symptomatic subjects will be determined on the basis of subsequent seroconversions.Ethics and disseminationEthical approval has been obtained from the national review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France) (ID RCB 2020-A00932-37). Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals.Trial registration numberNCT04341142.
Cost-effectiveness analysis of population salt reduction interventions to prevent cardiovascular disease in Cameroon: mathematical modelling study
Authors: Aminde Leopold Ndemnge , Cobiac Linda , Veerman J. Lennert 
Published: November 2020

BackgroundReducing dietary sodium (salt) intake has been proposed as a population-wide strategy to reduce blood pressure and cardiovascular disease (CVD). The cost-effectiveness of such strategies has hitherto not been investigated in Cameroon.MethodsA multicohort multistate life table Markov model was used to evaluate the cost-effectiveness of three population salt reduction strategies: mass media campaign, school-based salt education programme and low-sodium salt substitute. A healthcare system perspective was considered and adults alive in 2016 were simulated over the life course. Outcomes were changes in disease incidence, mortality, health-adjusted life years (HALYs), healthcare costs and incremental cost-effectiveness ratios (ICERs) over the lifetime. Probabilistic sensitivity analysis was used to quantify uncertainty.ResultsOver the life span of the cohort of adults alive in Cameroon in 2016, substantial numbers of new CVD events could be prevented, with over 10 000, 79 000 and 84 000 CVD deaths that could be averted from mass media, school education programme and salt substitute interventions, respectively. Population health gains over the lifetime were 46 700 HALYs, 348 800 HALYs and 368 400 HALYs for the mass media, school education programme and salt substitute interventions, respectively. ICERs showed that all interventions were dominant, with probabilities of being cost-saving of 84% for the school education programme, 89% for the mass media campaign and 99% for the low sodium salt substitute. Results were largely robust in sensitivity analysis.ConclusionAll the salt reduction strategies evaluated were highly cost-effective with very high probabilities of being cost-saving. Salt reduction in Cameroon has the potential to save many lives and offers good value for money.
Unscheduled and out-of-hours care for people in their last year of life: a retrospective cohort analysis of national datasets
Authors: Mason Bruce , Kerssens Joannes Joseph , Stoddart Andrew , Murray Scott A , Moine Sébastien , Finucane Anne M , Boyd Kirsty 
Published: November 2020

ObjectivesTo analyse patterns of use and costs of unscheduled National Health Service (NHS) services for people in the last year of life.DesignRetrospective cohort analysis of national datasets with application of standard UK costings.Participants and settingAll people who died in Scotland in 2016 aged 18 or older (N=56 407).Main outcome measuresFrequency of use of the five unscheduled NHS services in the last 12 months of life by underlying cause of death, patient demographics, Continuous Unscheduled Pathways (CUPs) followed by patients during each care episode, total NHS and per-patient costs.Results53 509 patients (94.9%) had at least one contact with an unscheduled care service during their last year of life (472 360 contacts), with 34.2% in the last month of life. By linking patient contacts during each episode of care, we identified 206 841 CUPs, with 133 980 (64.8%) starting out-of-hours. People with cancer were more likely to contact the NHS telephone advice line (63%) (χ2 (4)=1004, p<0.001) or primary care out-of-hours (62%) (χ2 (4)=1924,p<0.001) and have hospital admissions (88%) (χ2 (4)=2644, p<0.001). People with organ failure (79%) contacted the ambulance service most frequently (χ2 (4)=584, p<0.001). Demographic factors associated with more unscheduled care were older age, social deprivation, living in own home and dying of cancer. People dying with organ failure formed the largest group in the cohort and had the highest NHS costs as a group. The cost of providing services in the community was estimated at 3.9% of total unscheduled care costs despite handling most out-of-hours calls.ConclusionsOver 90% of people used NHS unscheduled care in their last year of life. Different underlying causes of death and demographic factors impacted on initial access and subsequent pathways of care. Managing more unscheduled care episodes in the community has the potential to reduce hospital admissions and overall costs.
T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX)
Authors: Thille Arnaud W , Coudroy Rémi , Gacouin Arnaud , Ehrmann Stephan , Contou Damien , Dangers Laurence , Romen Antoine , Guitton Christophe , Lacave Guillaume , Quenot Jean-Pierre , Lacombe Béatrice , Pradel Gael , Terzi Nicolas , Prat Gwenael , Labro Guylaine , Reignier Jean , Beduneau Gaetan , Dellamonica Jean , Nay Mai-Anh , Rouze Anahita , Delbove Agathe , Sedillot Nicholas , Mira Jean-Paul , Bourenne Jeremy , Lautrette Alexandre , Argaud Laurent , Levrat Quentin , Devaquet Jérôme , Vivier Emmanuel , Azais Marie-Ange , Leroy Christophe , Dres Martin , Robert René , Ragot Stéphanie , Frat Jean-Pierre 
Published: November 2020

IntroductionIn intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.Methods and analysisThis study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.Ethics and disseminationThe study has been approved by the central ethics committee ‘Ile de France V’ (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04227639.
Household medication safety practices during the COVID-19 pandemic: a descriptive qualitative study protocol
Authors: Grimes Tamasine C , Garfield Sara , Kelly Dervla , Cahill Joan , Cromie Sam , Wheeler Carly , Franklin Bryony Dean 
Published: November 2020

IntroductionThose who are staying at home and reducing contact with other people during the COVID-19 pandemic are likely to be at greater risk of medication-related problems than the general population. This study aims to explore household medication practices by and for this population, identify practices that benefit or jeopardise medication safety and develop best practice guidance about household medication safety practices during a pandemic, grounded in individual experiences.Methods and analysisThis is a descriptive qualitative study using semistructured interviews, by telephone or video call. People who have been advised to ‘cocoon’/‘shield’ and/or are aged 70 years or over and using at least one long-term medication, or their caregivers, will be eligible for inclusion. We will recruit 100 patient/carer participants: 50 from the UK and 50 from Ireland. Recruitment will be supported by our patient and public involvement (PPI) partners, personal networks and social media. Individual participant consent will be sought, and interviews audio/video recorded and/or detailed notes made. A constructivist interpretivist approach to data analysis will involve use of the constant comparative method to organise the data, along with inductive analysis. From this, we will iteratively develop best practice guidance about household medication safety practices during a pandemic from the patient’s/carer’s perspective.Ethics and disseminationThis study has Trinity College Dublin, University of Limerick and University College London ethics approvals. We plan to disseminate our findings via presentations at relevant patient/public, professional, academic and scientific meetings, and for publication in peer-reviewed journals. We will create a list of helpful strategies that participants have reported and share this with participants, PPI partners and on social media.