bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multi-Arm GlioblastoMa Australasia (MAGMA): protocol for a multiarm randomised clinical trial for people affected by glioblastoma
Authors: Kong Benjamin Y , Sim Hao-Wen , Barnes Elizabeth H , Nowak Anna K , Hovey Elizabeth J , Jeffree Rosalind , Harrup Rosemary , Parkinson Jonathon , Gan Hui K , Pinkham Mark B , Yip Sonia , Hall Merryn , Tu Emily , Carter Candace , Koh Eng-Siew , Lwin Zarnie , Dowling Anthony , Simes John S , Gedye Craig 
Published: September 2022

IntroductionGlioblastoma (GBM) is the most common malignant primary central nervous system cancer in adults. The objective of the Multi-Arm GlioblastoMa Australasia (MAGMA) trial is to test hypotheses in real world setting to improve survival of people with GBM. Initial experimental arms are evaluating the effectiveness of interventions in newly diagnosed GBM (ndGBM). This study will compare maximal surgical resection followed by chemoradiotherapy plus adjuvant chemotherapy for 6 months with the addition of (1) ‘neoadjuvant’ chemotherapy beginning as soon as possible after surgery and/or (2) adjuvant chemotherapy continued until progression within the same study platform.Methods and analysisMAGMA will establish a platform for open-label, multiarm, multicentre randomised controlled testing of treatments for GBM. The study began recruiting in September 2020 and recruitment to the initial two interventions in MAGMA is expected to continue until September 2023.Adults aged ≥18 years with ndGBM will be given the option of undergoing randomisation to each study intervention separately, thereby giving rise to a partial factorial design, with two separate randomisation time points, one for neoadjuvant therapy and one for extended therapy. Patients will have the option of being randomised at each time point or continuing on with standard treatment.The primary outcome for the study is overall survival from the date of initial surgery until death from any cause. Secondary outcomes include progression-free survival, time to first non-temozolomide treatment, overall survival from each treatment randomisation, clinically significant toxicity as measured by grade 3 or 4 adverse events and health-related quality-of-life measures. Tertiary outcomes are predictive/prognostic biomarkers and health utilities and incremental cost-effectiveness ratio.The primary analysis of overall survival will be performed separately for each study intervention according to the intention to treat principle on all patients randomised to each study intervention.Ethics and disseminationThe study (Protocol version 2.0 dated 23 November 2020) was approved by a lead Human Research Ethics Committee (Sydney Local Health District: 2019/ETH13297). The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice.Trial registration numberACTRN12620000048987.
Quickly identifying people at risk of opioid use disorder in emergency departments: trade-offs between a machine learning approach and a simple EHR flag strategy
Authors: Annis Izabela E , Jordan Robyn , Thomas Kathleen C 
Published: September 2022

ObjectivesEmergency departments (EDs) are an important point of contact for people with opioid use disorder (OUD). Universal screening for OUD is costly and often infeasible. Evidence on effective, selective screening is needed. We assessed the feasibility of using a risk factor-based machine learning model to identify OUD quickly among patients presenting in EDs.Design/settings/participantsIn this cohort study, all ED visits between January 2016 and March 2018 for patients aged 12 years and older were identified from electronic health records (EHRs) data from a large university health system. First, logistic regression modelling was used to describe and elucidate the associations between patient demographic and clinical characteristics and diagnosis of OUD. Second, a Gradient Boosting Classifier was applied to develop a predictive model to identify patients at risk of OUD. The predictive performance of the Gradient Boosting algorithm was assessed using F1 scores and area under the curve (AUC).OutcomeThe primary outcome was the diagnosis of OUD.ResultsAmong 345 728 patient ED visits (mean (SD) patient age, 49.4 (21.0) years; 210 045 (60.8%) female), 1.16% had a diagnosis of OUD. Bivariate analyses indicated that history of OUD was the strongest predictor of current OUD (OR=13.4, CI: 11.8 to 15.1). When history of OUD was excluded in multivariate models, baseline use of medications for OUD (OR=3.4, CI: 2.9 to 4.0) and white race (OR=2.9, CI: 2.6 to 3.3) were the strongest predictors. The best Gradient Boosting model achieved an AUC of 0.71, accuracy of 0.96 but only 0.45 sensitivity.ConclusionsPatients who present at the ED with OUD are high-need patients who are typically smokers with psychiatric, chronic pain and substance use disorders. A machine learning model did not improve predictive ability. A quick review of a patient’s EHR for history of OUD is an efficient strategy to identify those who are currently at greatest risk of OUD.
Late myocardial reperfusion in ST-elevation myocardial infarction: protocol for a systematic review and meta-analysis
Authors: Vargas-Fernández Rodrigo , Chacón-Diaz Manuel , Basualdo-Meléndez Gianfranco W , Barón-Lozada Francisco A , Visconti-Lopez Fabriccio J , Comandé Daniel , Hernández-Vásquez Akram 
Published: September 2022

IntroductionST-segment elevation myocardial infarction (STEMI) is the most severe clinical form of acute myocardial infarction, for which the current treatment consists of effective and timely myocardial reperfusion (within 12 hours of symptom onset). However, between 10% and 15% of patients with STEMI arrive at hospital facilities 12 hours after the onset of symptoms (late presentation). Therefore, the objective of the present study will be to determine if late revascularisation (12–72 hours after the onset of symptoms) affects the indicators of cardiovascular mortality, reinfarction, recurrent infarction, hospitalisation for heart failure and post infarction angina compared with no late revascularisation in patients with STEMI.Methods and analysisA systematic literature search of PubMed, The Cochrane Library, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, Scopus and Global Health will be conducted. Publications in English, Portuguese or Spanish that report the clinical results of primary percutaneous revascularisation (primary PCI) in adult patients with STEMI 12–72 hours after the onset of symptoms will be included. Studies with participants with a diagnosis other than STEMI or patients with STEMI of >12 hours complicated by heart failure, cardiogenic shock or ventricular arrhythmias, and studies of combined interventions (pharmacoinvasive strategy) were excluded. Two independent authors will identify the relevant publications, and discrepancies will be adjudicated by a third author. Data extraction will be performed by two independent authors and verified by a third author. Risk of bias of studies will be assessed using the Cochrane ‘risk of bias’ tool (RoB 2) or Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool. If appropriate, a meta-analysis will be performed in order to examine the effect of late revascularisation in clinical outcomes of interest.Ethics and discussionThis study will use published data only, thus, ethical approval will not be required. The results will be disseminated through peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42021283429.
Efficacy of Lactococcus lactis strain plasma (LC-Plasma) in easing symptoms in patients with mild COVID-19: protocol for an exploratory, multicentre, double-blinded, randomised controlled trial (PLATEAU study)
Authors: Yamamoto Kazuko , Hosogaya Naoki , Inoue Tsuyoshi , Jounai Kenta , Tsuji Ryohei , Fujiwara Daisuke , Yanagihara Katsunori , Izumikawa Koichi , Mukae Hiroshi 
Published: September 2022

IntroductionThe COVID-19 pandemic has been a major concern worldwide; however, easily accessible treatment options for patients with mild COVID-19 remain limited. Since the oral intake of Lactococcus lactis strain plasma (LC-Plasma) enhances both the innate and acquired immune systems through the activation of plasmacytoid dendritic cells (pDCs), we hypothesised that the oral intake of LC-Plasma could aid the relief or prevention of symptoms in patients with asymptomatic or mild COVID-19.Methods and analysisThis is an exploratory, multicentre, double-blinded, randomised, placebo-controlled trial. This study was initiated in December 2021 and concludes in April 2023. The planned number of enrolled subjects is 100 (50 subjects×2 groups); subject enrolment will be conducted until October 2022. Patients with asymptomatic or mild COVID-19 will be enrolled and randomly assigned in a 1:1 ratio to group A (oral intake of LC-Plasma-containing capsule, 200 mg/day, for 14 days) or group B (oral intake of placebo capsule, for 14 days). The primary endpoint is the change in subjective symptoms measured by the severity score. Secondary endpoints include SARS-CoV-2 viral loads, biomarkers for pDC activation, serum SARS-CoV-2-specific antibodies, serum cytokines, interferon and interferon-inducible antiviral effectors and the proportion of subjects with emergency room visits to medical institutions or who are hospitalised.Ethics and disseminationThe study protocol was approved by the Clinical Research Review Board of Nagasaki University, in accordance with the Clinical Trials Act of Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act, and other current legal regulations in Japan. Written informed consent will be obtained from all the participants. The results of this study will be reported in journal publications.Trial registration numberJapan Registry of Clinical Trials (registration number: jRCTs071210097).
Evaluating the impact of a sleep health education and a personalised smartphone application on sleep, productivity and healthcare utilisation among employees: results of a randomised clinical trial
Authors: Robbins Rebecca , Weaver Matthew D , Quan Stuart F , Sullivan Jason P , Qadri Salim , Glasner Laura , Cohen-Zion Mairav , Czeisler Charles A , Barger Laura K 
Published: September 2022

ObjectivesWe evaluated an online Sleep Health and Wellness (SHAW) programme paired with dayzz, a personalised sleep training programme deployed via smartphone application (dayzz app) that promotes healthy sleep and treatment for sleep disorders, among employees at a large healthcare organisation.DesignOpen-label, randomised, parallel-group controlled trial.SettingA healthcare employer in the USA.Participants1355 daytime workers.InterventionParticipants were randomised to intervention (n=794) or control (n=561) on consent. Intervention participants received the SHAW educational programme at baseline plus access to the personalised dayzz app for up to 9 months. The control condition received the intervention at month 10.Primary and secondary outcome measuresOur primary outcome measures were sleep-related behavioural changes (eg, consistent sleep schedule); sleep behaviour tracked on an electronic sleep diary and sleep quality. Our secondary outcome measures included employee absenteeism, performance and productivity; stress, mood, alertness and energy; and adverse health and safety outcomes (eg, accidents).ResultsAt follow-up, employees in the intervention condition were more likely to report increased sleep duration on work (7.20 vs 6.99, p=0.01) and on free (8.26 vs 8.04, p=0.03) nights. At follow-up, the prevalence of poor sleep quality was lower in the intervention (n=160 of 321, 50%) compared with control (n=184 of 327, 56%) (p=0.04). The mean total dollars lost per person per month due to reduced workplace performance (presenteeism) was less in the intervention condition (US$1090 vs US$1321, p=0.001). Employees in the intervention reported fewer mental health visits (RR 0.72, 95% CI 0.56 to 0.94, p=0.01) and lower healthcare utilisation over the study interval (RR 0.81, 95% CI 0.67 to 0.98, p=0.03). We did not observe differences in stress (4.7 (95% CI 4.6 to 4.8) vs 4.7 (95% CI 4.6 to 4.8)), mood (4.5 (95% CI 4.4 to 4.6) vs 4.6 (95% CI 4.5 to 4.7)), alertness (4.9 (95% CI 4.8 to 5.0) vs 5.0 (95% CI 4.9 to 5.1)) or adverse health and safety outcomes (motor vehicle crashes: OR 0.82 (95% CI 0.34 to 1.9); near-miss crashes: OR=0.89 (95% CI 0.5 to 1.5) and injuries: 0.9 (95% CI 0.6 to 1.3)); energy was higher at follow-up in the intervention group (4.3 vs 4.5; p=0.03).ConclusionsResults from this trial demonstrate that a SHAW programme followed by access to the digital dayzz app can be beneficial to both the employee and employer.Trial registration numberNCT04224285
Role of religious beliefs in adherence to antiretroviral therapy in the Cape Town metropole: a study protocol
Authors: Azia Ivo Nchendia , Carelse Shernaaz , Nyembezi Anam , Mukumbang Ferdinand C 
Published: September 2022

IntroductionThere are presently over four million people living with HIV (PLHIV) in the South African national antiretroviral therapy (ART) programme. However, some ART programmes are battling poor ART adherence emanating from patient-related factors, including their religious beliefs. In this paper, we outline a study protocol to understand the adherence behaviours of Pentecostal Christians living with HIV to ART and to develop guidelines that can be used to strengthen ART adherence.Methods and analysisWe propose an exploratory multimethod research design. In phase 1, a scoping review will be conducted. The data captured in this phase will be put into charting forms, analysed qualitatively, and then collated and summarised to hypothesise the relationship between religious beliefs and ART adherence. In phase 2, an explanatory qualitative approach will be used. Semistructured interviews will be conducted with purposefully selected religious leaders, Pentecostal Christians living with HIV who are not adhering to ART and healthcare workers delivering ART at selected healthcare facilities in the Milnerton subhealth district. The qualitative data obtained in this phase will be transcribed verbatim and analysed thematically using the ATLAS.ti V.8 software program towards strengthening the hypothesised relationship between religious beliefs and ART adherence. In phase 3, intervention mapping and nominal group techniques will be applied with purposefully selected stakeholders to develop guidelines to strengthen ART adherence among PLHIV.Ethics and disseminationPhase 1 of the study will not require ethics approval. Ethics approval for phases 2 and 3 has been received from the University of the Western Cape Biomedical Research and Ethics Committee and the Western Cape Department of Health. Informed consent forms will be obtained from all participants at the different phases of the study. The study findings will be disseminated through publications in scientific journals, presentations at conferences and workshops aimed at improving ART adherence.
Outcomes of proximal humerus fractures in children: a study protocol for a retrospective cohort study
Authors: Abbot Samuel Richard , Proudman Susanna , Hall Kelly , Williams Nicole 
Published: September 2022

IntroductionProximal humerus fractures (PHFs) comprise <3% of all fractures in children and adolescents. While it is accepted that minimally displaced PHFs can be treated conservatively, the management of severely displaced PHFs remains controversial, especially in older children. This study will aim to analyse the functional and quality-of-life outcomes of children with PHFs, in order to inform their optimal management.Methods and analysisWe will conduct a retrospective cohort study to evaluate the outcomes of patients who were diagnosed with a paediatric PHF at the Women’s and Children’s Hospital (WCH) in South Australia. The primary outcome will be each participant’s pain and quality-of-life outcome, determined by use of the Quick Disabilities of the Arm, Shoulder and Hand, Shoulder Pain and Disability Index and Paediatric Outcomes Data Collection Instrument. Secondary outcomes will include rates of non-union, persistent deformity and complications. The information for these variables will be acquired during a brief clinic appointment, and from the medical records and WCH radiology database. Multivariable logistic regression will be performed to determine the clinical variables associated with a worse clinical outcome.Ethics and disseminationThe study has been approved by the Women’s and Children’s Health Network Human Research Ethics Committee (protocol number: 2021/HRE00250). The study findings will be submitted to peer-reviewed scientific journals for publication and disseminated at conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12622000176763).
Diagnostic work-up of urinary tract infections in pregnancy: study protocol of a prospective cohort study
Authors: Werter Dominique Esmée , Kazemier Brenda M , van Leeuwen Elisabeth , de Rotte Maurits C F J , Kuil Sacha D , Pajkrt Eva , Schneeberger Caroline 
Published: September 2022

IntroductionSymptoms of urinary tract infections in pregnant women are often less specific, in contrast to non-pregnant women where typical clinical symptoms of a urinary tract infection are sufficient to diagnose urinary tract infections. Moreover, symptoms of a urinary tract infection can mimic pregnancy-related symptoms, or symptoms of a threatened preterm birth, such as contractions. In order to diagnose or rule out a urinary tract infection, additional diagnostic testing is required.The diagnostic accuracy of urine dipstick analysis and urine sediment in the diagnosis of urinary tract infections in pregnant women has not been ascertained nor validated.Methods and analysisIn this single-centre prospective cohort study, pregnant women (≥16 years old) with a suspected urinary tract infection will be included. The women will be asked to complete a short questionnaire regarding complaints, risk factors for urinary tract infections and baseline characteristics. Their urine will be tested with a urine dipstick, urine sediment and urine culture. The different sensitivities and specificities per test will be assessed. Our aim is to evaluate and compare the diagnostic accuracy of urine dipstick analysis and urine sediment in comparison with urine culture (reference test) in pregnant women. In addition, we will compare these tests to a predefined ‘true urinary tract infection’, to distinguish between a urinary tract infection and asymptomatic bacteriuria.Ethics and disseminationApproval was requested from the Medical Ethics Review Committee of the Academic Medical Centre; an official approval of this study by the committee was not required. The outcomes of this study will be published in a peer-reviewed journal.
Exploring experiences with telehealth-delivered allied healthcare services for people with permanent and significant disabilities funded through a national insurance scheme: a qualitative study examining challenges and suggestions to improve services
Authors: Filbay Stephanie , Bennell Kim L , Morello Renata , Smith Lizzie , Hinman Rana S , Lawford Belinda J 
Published: September 2022

ObjectivesIn people with a disability, or their caregivers, who reported suboptimal experiences, the objectives were to explore: (1) challenges with telehealth-delivered allied health services during the COVID-19 pandemic and (2) suggestions to improve such services.DesignQualitative study based on an interpretivist paradigm and a phenomenological approach.SettingParticipants who accessed allied healthcare via telehealth during the pandemic.ParticipantsData saturation was achieved after 12 interviews. The sample comprised three people with permanent or significant disabilities, and nine carers/partners/family members of people with permanent or significant disabilities, who were funded by the Australian National Disability Insurance Scheme and had suboptimal experiences with telehealth. Semistructured one-on-one interviews explored experiences with telehealth and suggestions on how such services could be improved. An inductive thematic analysis was performed.ResultsSix themes relating to the first study objective (challenges with telehealth) were developed: (1) evoked behavioural issues in children; (2) reliant on caregiver facilitation; (3) inhibits clinician feedback; (4) difficulty building rapport and trust; (5) lack of access to resources and (6) children disengaged/distracted. Five themes relating to the second study objective (suggestions to improve telehealth services) were developed: (1) establish expectations; (2) increase exposure to telehealth; (3) assess suitability of specific services; (4) access to support workers and (5) prepare for telehealth sessions.ConclusionsSome people with permanent and significant disabilities who accessed allied healthcare via telehealth during the pandemic experienced challenges, particularly children. These unique barriers to telehealth need customised solutions so that people with disabilities are not left behind when telehealth services become more mainstream. Increasing experience with telehealth, setting expectations before consultations, supplying resources for therapy and assessing the suitability of clients for telehealth may help overcome some of the challenges experienced.
Sex-based differences in atrial fibrillation ablation adverse events
Authors: Mszar Reed , Friedman Daniel J , Ong Emily , Du Chengan , Wang Yongfei , Zeitler Emily P , Cunningham Shayna D , Akar Joseph , Curtis Jeptha P , Freeman James V 
Published: September 2022

ObjectiveOlder, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF.MethodsIn this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events.ResultsAmong 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p<0.001), had more comorbidities, and had lower AF-related quality of life at the time of ablation (mean Atrial Fibrillation Effect on QualiTy-of-life Questionnaire) score: 51.8 vs 62.2, p<0.001). Women had a higher risk of hospitalisation >1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation.ConclusionsAmong almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation.