bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with symptoms suggestive of coronary artery disease: rationale and design of the prospective, randomised, controlled, parallel-group multicenter FILTER-SCAD trial
Authors: Bjerking Louise Hougesen , Hansen Kim Wadt , Biering-Sørensen Tor , Brønnum-Schou Jens , Engblom Henrik , Erlinge David , Haahr-Pedersen Sune Ammentorp , Heitmann Merete , Hove Jens Dahlgaard , Jensen Magnus Thorsten , Kruse Marie , Räder Sune , Strange Søren , Galatius Søren , Prescott Eva Irene Bossano 
Published: November 2022

IntroductionMost patients with symptoms suggestive of chronic coronary syndrome (CCS) have no obstructive coronary artery disease (CAD) and better selection of patients to be referred for diagnostic tests is needed. The CAD-score is a non-invasive acoustic measure that, when added to pretest probability of CAD, has shown good rule-out capabilities. We aimed to test whether implementation of CAD-score in clinical practice reduces the use of diagnostic tests without increasing major adverse cardiac events (MACE) rates in patients with suspected CCS.Methods and analysisFILTER-SCAD is a randomised, controlled, multicenter trial aiming to include 2000 subjects aged ≥30 years without known CAD referred for outpatient assessment for symptoms suggestive of CCS. Subjects are randomised 1:1 to either the control group: standard diagnostic examination (SDE) according to the current guidelines, or the intervention group: SDE plus a CAD-score. The subjects are followed for 12 months for the primary endpoint of cumulative number of diagnostic tests and a safety endpoint (MACE). Angina symptoms, quality of life and risk factor modification will be assessed with questionnaires at baseline, 3 months and 12 months after randomisation. The study is powered to detect superiority in terms of a reduction of ≥15% in the primary endpoint between the two groups with a power of 80%, and non-inferiority on the secondary endpoint with a power of 90%. The significance level is 0.05. The non-inferiority margin is set to 1.5%. Randomisation began on October 2019. Follow-up is planned to be completed by December 2022.Ethics and disseminationThis study has been approved by the Danish Medical Agency (2019024326), Danish National Committee on Health Research Ethics (H-19012579) and Swedish Ethical Review Authority (Dnr 2019-04252). All patients participating in the study will sign an informed consent. All study results will be attempted to be published as soon as possible.Trial registration numberNCT04121949; Pre-results.
Pragmatic, double-blind, randomised trial evaluating the impact of red
blood cell donor sex on recipient mortality in an academic hospital
population: the innovative Trial Assessing Donor Sex (iTADS)
protocol
Authors: Fergusson Dean A , Chassé Michael , Tinmouth Alan , Acker Jason P , English Shane , Forster Alan J , Hawken Steven , Shehata Nadine , Thavorn Kednapa , Wilson Kumanan , Tuttle Angie , Perelman Iris , Cober Nancy , Maddison Heather , Tokessy Melanie 
Published: November 2022

Introduction
With over 1 million units of blood transfused each year in Canada,
their use has a significant clinical and economic impact on our health
system. Adequate screening of blood donors is important to ensure the
safety and clinical benefit of blood products. Some adverse transfusion
reactions have been shown to be related to donor factors (eg, lung
injury), whereas other adverse outcomes have been theoretically related
to donor factors (mortality and infection). Our clinical trial will test
whether male donor blood leads to a greater benefit for transfusion
recipients compared with female donor blood.

Methods and analysis
We have designed a pragmatic, double-blind, randomised trial that
will allocate transfusion recipients to receive either male-only or
female-only donor transfusions. We will enrol 8850 adult patients
requiring at least one transfusion at four sites over an approximate
2-year period. Randomisation and allocation will occur in the blood bank
prior to release of the units of blood for transfusion. Our primary
outcome is mortality. An intent-to-treat analysis will be applied using
all randomised and transfused patients. The principal analysis will be a
survival analysis comparing the time from randomisation to death between
patients allocated to male donor red blood cells (RBCs) and female donor
RBCs.

Ethics and dissemination
Approval has been obtained from research ethics boards of all
involved institutions, as well as from privacy offices of Canadian Blood
Services, Institute for Clinical Evaluative Science and The Ottawa
Hospital Data Warehouse. Our findings will be published in peer-reviewed
journals and presented at relevant stakeholder conferences and
meetings.

Trial registration number
NCT03344887; Pre-results.
CATALYST trial protocol: a multicentre, open-label, phase II, multiarm
trial for an early and accelerated evaluation of the potential treatments
for COVID-19 in hospitalised adults
Authors: Veenith Tonny , Fisher Benjamin A. , Slade Daniel , Rowe Anna , Sharpe Rowena , Thickett David R. , Whitehouse Tony , Rowland Matthew , Scriven James , Parekh Dhruv , Bowden Sarah J. , Savage Joshua S. , Richards Duncan , Bion Julian , Kearns Pamela , Gates Simon 
Published: November 2022

Introduction
Severe SARS-CoV-2 infection is associated with a dysregulated immune
response. Inflammatory monocytes and macrophages are crucial, promoting
injurious, proinflammatory sequelae. Immunomodulation is, therefore, an
attractive therapeutic strategy and we sought to test licensed and novel
candidate drugs.

Methods and analysis
The CATALYST trial is a multiarm, open-label, multicentre, phase II
platform trial designed to identify candidate novel treatments to
improve outcomes of patients hospitalised with COVID-19 compared with
usual care. Treatments with evidence of biomarker improvements will be
put forward for larger-scale testing by current national phase III
platform trials. Hospitalised patients >16 years with a clinical
picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest
X-ray or CT scan, with or without a positive reverse transcription PCR
assay) and a C reactive protein (CRP) ≥40 mg/L are eligible. The primary
outcome measure is CRP, measured serially from admission to day 14,
hospital discharge or death. Secondary outcomes include the WHO Clinical
Progression Improvement Scale as a principal efficacy
assessment.

Ethics and dissemination
The protocol was approved by the East Midlands-Nottingham 2 Research
Ethics Committee (20/EM/0115) and given urgent public health status;
initial approval was received on 5 May 2020, current protocol version
(V.6.0) approval on 12 October 2020. The MHRA also approved all protocol
versions. The results of this trial will be disseminated through
national and international presentations and peer-reviewed
publications.

Trial registration numbers
EudraCT2020-001684-89,NCT40580903.
Supporting Parenting at Home-Empowering Rehabilitation through Engagement
(SPHERE): study protocol for a randomised control trial
Authors: Grumi Serena , Borgatti Renato , Provenzi Livio 
Published: November 2022

Introduction
Infants with neurodevelopmental disabilities (NDs) show emotional,
cognitive and sociointeractive dysregulation dramatically impacting on
caregiving behaviour. Early video-feedback interventions (VFIs) are
effective in promoting sensitive parenting, which in turn supports
infants’ development, even in case of ND. In the light of limited
resources of the healthcare systems, technological advances in
telemedicine may facilitate the delivery of VFI to a greater number of
families of infants with ND. To date, no study has implemented a
telemedicine VFI (TVFI) for families of infants diagnosed with
ND.

Methods and analysis
The Supporting Parenting at Home-Empowering Rehabilitation through
Engagement project is a randomised controlled trial aimed at assessing
the effectiveness of an early family-centred TVFI parenting support on
dyads with infants diagnosed with ND. It includes two arms (TVFI vs
Booklet Psychoeducational Intervention) and three assessment phases: T0,
baseline; T1, immediate postintervention; T2, 6-month
follow-up.

Ethics and dissemination
This study is funded by the Italian Ministry of Health and was
approved by the Ethics Committee (Pavia). Results will be published in
peer-reviewed journals and presented at national and international
scientific conferences.

Trial registration number
The study protocol has been also registered on NIH Clinical Trials
(protocol codeNCT04656483; Pre-results).
Increased risk of COVID-19-related admissions in patients with active
solid organ cancer in the West Midlands region of the UK: a retrospective
cohort study
Authors: Akingboye Akinfemi , Mahmood Fahad , Amiruddin Nabeel , Reay Michael , Nightingale Peter , Ogunwobi Olorunseun O 
Published: November 2022

Objective
Susceptibility of patients with cancer to COVID-19 pneumonitis has
been variable. We aim to quantify the risk of hospitalisation in
patients with active cancer and use a machine learning algorithm (MLA)
and traditional statistics to predict clinical outcomes and
mortality.

Design
Retrospective cohort study.

Setting
A single UK district general hospital.

Participants
Data on total hospital admissions between March 2018 and June 2020,
all active cancer diagnoses between March 2019 and June 2020 and
clinical parameters of COVID-19-positive admissions between March 2020
and June 2020 were collected. 526 COVID-19 admissions without an active
cancer diagnosis were compared with 87 COVID-19 admissions with an
active cancer diagnosis.

Primary and secondary outcome measures
30-day and 90-day post-COVID-19 survival.

Results
In total, 613 patients were enrolled with male to female ratio of
1:6 and median age of 77 years. The estimated infection rate of COVID-19
was 87 of 22 729 (0.4%) in the patients with cancer and 526 of 404 379
(0.1%) in the population without cancer (OR of being hospitalised with
COVID-19 if having cancer is 2.942671 (95% CI: 2.344522 to 3.693425);
p<0.001). Survival was reduced in patients with cancer with COVID-19
at 90 days. R-Studio software determined the association between cancer
status, COVID-19 and 90-day survival against variables using MLA.
Multivariate analysis showed increases in age (OR 1.039 (95% CI: 1.020
to 1.057), p<0.001), urea (OR 1.005 (95% CI: 1.002 to 1.007),
p<0.001) and C reactive protein (CRP) (OR 1.065 (95% CI: 1.016 to
1.116), p<0.008) are associated with greater 30-day and 90-day
mortality. The MLA model examined the contribution of predictive
variables for 90-day survival (area under the curve: 0.749); with
transplant patients, age, male gender and diabetes mellitus being
predictors of greater mortality.

Conclusions
Active cancer diagnosis has a threefold increase in risk of
hospitalisation with COVID-19. Increased age, urea and CRP predict
mortality in patients with cancer. MLA complements traditional
statistical analysis in identifying prognostic variables for outcomes of
COVID-19 infection in patients with cancer. This study provides proof of
concept for MLA in risk prediction for COVID-19 in patients with cancer
and should inform a redesign of cancer services to ensure safe delivery
of cancer care.
Adjunctive virtual reality pain relief following traumatic injury:
protocol for a randomised within-subjects clinical trial
Authors: Felix Ryan B , Rao Aniruddha , Khalid Mazhar , Wang Yang , Colloca Luana , Murthi Sarah B , Morris Nicholas A 
Published: November 2022

Introduction
The annual mortality and national expense of the opioid crisis
continue to rise in the USA (130 deaths/day, $50 billion/year). Opioid
use disorder usually starts with the prescription of opioids for a
medical condition. Its risk is associated with greater pain intensity
and coping strategies characterised by pain catastrophising.
Non-pharmacological analgesics in the hospital setting are critical to
abate the opioid epidemic. One promising intervention is virtual reality
(VR) therapy. It has performed well as a distraction tool and pain
modifier during medical procedures; however, little is known about VR in
the acute pain setting following traumatic injury. Furthermore, no
studies have investigated VR in the setting of traumatic brain injury
(TBI). This study aims to establish the safety and effect of VR therapy
in the inpatient setting for acute traumatic injuries, including
TBI.

Methods and analysis
In this randomised within-subjects clinical study, immersive VR
therapy will be compared with two controls in patients with traumatic
injury, including TBI. Affective measures including pain
catastrophising, trait anxiety and depression will be captured prior to
beginning sessions. Before and after each session, we will capture pain
intensity and unpleasantness, additional affective measures and
physiological measures associated with pain response, such as heart rate
and variability, pupillometry and respiratory rate. The primary outcome
is the change in pain intensity of the VR session compared with
controls.

Ethics and dissemination
Dissemination of this protocol will allow researchers and funding
bodies to stay abreast in their fields through exposure to research not
otherwise widely publicised. Study protocols are compliant with federal
regulation and University of Maryland Baltimore’s Human Research
Protections and Institutional Review Board (protocol number
HP-00090603). Study results will be published on completion of enrolment
and analysis, and deidentified data can be shared by request to the
corresponding author.

Trial registration number
NCT04356963; Pre-results.
Global mapping of exercise interventions among COVID-19 survivors: protocol for a scoping review
Authors: Sinha Mukesh Kumar , Soman Ajith , K Vaishali , Kovela Rakesh Krishna , Lakshminarayanan Monisha , Amin Revati , Verma Ashwani 
Published: November 2022

IntroductionThe COVID-19 pandemic has posed an unparalleled threat to all dimensions of human health and well-being. The Pan American Health Organization has acknowledged the crucial role of rehabilitation therapies for COVID-19 and emphasised the importance of exercise programmes for COVID-19 survivors. This scoping review outlines our strategy for systematically reviewing published and unpublished literature to investigate the volume of evidence for exercise interventions for COVID-19 survivors.Methods and analysisThis scoping review will be conducted based on the framework developed by Arksey and O'Malley. Six databases (PubMed/Medline, Scopus, Web of Science, Cochrane Central, ProQuest and CINAHL) will be searched in August 2022 and articles will be considered for inclusion published till July 2022. Studies will be screened by two independent reviewers at the title/abstract and full-text screening stages, as well as data extraction and critical assessment. Data will be extracted in a data extraction form and presented as figures and tables with narratives. This scoping review will give a thorough understanding of the current literature on exercise interventions for COVID-19 survivors, as well as identify knowledge gaps that will guide future research. Preliminary searches will be conducted after the publication of this scoping review protocol.Ethics and disseminationNo human or animal participants were involved in this review. Therefore, ethical committee approval is not required. Transparency will be followed at every review stage. Review findings will be disseminated through peer-review publications or through conference presentations.
Numbers and types of neurological emergencies in England and the influence of socioeconomic deprivation: a retrospective analysis of hospital episode statistics data
Authors: Jackson Michael , Szczepaniak Marta , Wall Jasmine , Maskery Mark , Mummery Catherine , Morrish Paul , Williams Adrian , Knight Joanne , Emsley Hedley C A 
Published: November 2022

ObjectivesIn this first large-scale analysis of neurological emergency admissions in England, we determine the number and types of emergency admissions with neurological emergency diagnostic codes, how many are under the care of a neurologist or neurosurgeon and how such admissions vary by levels of deprivation.DesignRetrospective empirical research employing a derived list of neurological emergency diagnostic codesSettingThis study used the Hospital Episode Statistics data set for the financial year 2019/2020 based on 17 million in-year inpatient admissions in England including 6.5 million (100%) emergency admissions with any diagnosis codes.ResultsThere were 1.4 million (21.2%) emergency inpatient admissions with a mention of any neurological code, approx. 248 455 (3.8%) with mention of a specific neurological emergency code from the derived list, and 72 485 (1.1%) included such a code as the primary reason for admission. The highest number of in-year admissions for adults was for epilepsy (145 995), with epilepsy as the primary diagnostic code in 15 945 (10.9%). Acute nerve root/spinal cord syndrome (41 215), head injury (29 235) and subarachnoid haemorrhage (18 505) accounted for the next three highest number of admissions. 3230 (1.4%) in-year emergency hospital admissions with mention of a neurological emergency code were under the care of a neurologist or neurosurgeon, with only 1315 (0.9%) admissions with mention of an epilepsy code under a neurologist. There was significant variation for epilepsy and functional neurological disorders (FNDs) in particular by Index of Multiple Deprivation decile. The association between deprivation and epilepsy and FND was significant with p-values of 2.5e-6 and 1.5e-8, respectively.ConclusionsThis study has identified important findings in relation to the burden of neurological emergency admissions but further work is needed, with greater clinical engagement in diagnostic coding, to better understand the implications for workforce and changes to service delivery needing to be implemented.
Use of a microsimulation method for assessing dynamics of smoking status and gains in life expectancy after quitting in a longitudinal cohort of US older adults
Authors: Jia Haomiao , Lubetkin Erica 
Published: November 2022

ObjectivesPrevious studies were unable to estimate the dynamics of smoking status in the US elderly general population, and no study has assessed the benefit of quitting in terms of resultant gains in life expectancy. We proposed a novel method to estimate the per cent of quitting in remaining lifetime, successful quitting and relapse, as well as life expectancy by participants’ baseline smoking status.DesignLongitudinal cohort.SettingUS community-dwelling population.ParticipantsRespondents from the Medicare Health Outcome Survey Cohort 15 (baseline 2012, follow-up 2014). We included respondents who were aged ≥65 years and alive at the baseline and participated in the baseline survey (n=164 597).Primary and secondary outcome measuresAttempt quitting, successful quitting, relapse rates and life expectancy by smoking status at age 65–95 years.ResultsAmong daily smokers aged 65 years, 61% would attempt to quit during their remaining lifetime, and 31% would quit successfully. Among some days smokers aged 65 years, 69% would attempt to quit during their remaining lifetime, and 37% would quit successfully. Among recent ex-smokers aged 65 years, 53% would relapse. Life expectancy at age 65 years was 20.0 (SE=0.27), 17.2 (SE=0.30), 16.2 (SE=0.29) and 15.9 (SE=0.29) years for long time non-smokers, recent ex-smokers, some days smokers and daily smokers, respectively. Although recent ex-smokers had a higher 2-year mortality than current smokers, those who quit up to 77 years (77 years for men and 87 years for women) had a significantly longer (p<0.05) life expectancy. Sensitivity analysis demonstrated that the model assumptions had a relatively small impact on estimates with a maximum relative bias within ±7%.ConclusionsThis study provides detailed information regarding the dynamics of smoking status in an understudied and growing population and demonstrates the benefit of smoking cessation on life expectancy. Future research should focus on understanding specific predictors of smoking cessation.
Protocol for a systematic review on effective patient positioning for rapid sequence intubation
Authors: Sivajohan Asaanth , Krause Sarah CT , Hegazy Ahmed , Slessarev Marat 
Published: November 2022

IntroductionRapid sequence intubation (RSI) is an advanced airway technique to perform endotracheal intubation in patients at high risk of aspiration. Although RSI is recognised as a life-saving technique and performed by many physicians in various settings (emergency departments, intensive care units), there is still a lack of consensus on various features of the procedure, most notably patient positioning. Previously, experts have commented on the unique drawbacks and benefits of various positions and studies have been published comparing patient positions and how it can affect endotracheal intubation in the context of RSI. The purpose of this systematic review is to compile the existing evidence to understand and compare how different patient positions can potentially affect the success of RSI.Methods and analysisWe will use MEDLINE, EMBASE and the Cochrane Library to source studies from 1946 to 2021 that evaluate the impact of patient positioning on endotracheal intubation in the context of RSI. We will include randomised control trials, case–control studies, prospective/retrospective cohort studies and mannequin simulation studies for consideration in this systematic review. Subsequently, we will generate a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram to display how we selected our final studies for inclusion in the review. Two independent reviewers will complete the study screening, selection and extraction, with a third reviewer available to address any conflicts. The reviewers will extract this data in accordance with our outcomes of interest and display it in a table format to highlight patient-relevant outcomes and difficulty airway management outcomes. We will use the Risk of Bias tool and the Newcastle-Ottawa Scale to assess included studies for bias.Ethics and disseminationThis systematic review does not require ethics approval, as all patient-centred data will be reported from published studies.PROSPERO registration numberCRD42022289773.