bluuebunny/crossref_metadata_2025_split huggingface dataset:
School-based physical activity intervention for older adolescents: rationale and study protocol for the Burn 2 Learn cluster randomised controlled trial
Authors: Leahy Angus A , Eather Narelle , Smith Jordan J , Hillman Charles , Morgan Philip J , Nilsson Michael , Lonsdale Chris , Plotnikoff Ronald C , Noetel Michael , Holliday Elizabeth , Shigeta Tatsuya T , Costigan Sarah A , Walker Frederick R , Young Sarah , Valkenborghs Sarah R , Gyawali Prajwal , Harris Nigel , Kennedy Sarah G , Lubans David R 
Published: May 2019

IntroductionThis trial aims to investigate the impact of a school-based physical activity programme, involving high-intensity interval training (HIIT), on the physical, mental and cognitive health of senior school students.Methods and analysisThe Burn 2 Learn (B2L) intervention will be evaluated using a two-arm parallel group cluster randomised controlled trial with allocation occurring at the school level (to treatment or wait-list control). Schools will be recruited in two cohorts from New South Wales, Australia. The trial will aim to recruit ~720 senior school students (aged 16–18 years) from 20 secondary schools (ie, 10 schools per cohort). A range of implementation strategies will be provided to teachers (eg, training, equipment and support) to facilitate the delivery of HIIT sessions during scheduled classes. In phase I and II (3 months each), teachers will facilitate the delivery of at least two HIIT sessions/week during lesson-time. In phase III (6 months), students will be encouraged to complete sessions outside of lesson-time (teachers may continue to facilitate the delivery of B2L sessions during lesson-time). Study outcomes will be assessed at baseline, 6 months (primary end point) and 12 months. Cardiorespiratory fitness (shuttle run test) is the primary outcome. Secondary outcomes include: vigorous physical activity, muscular fitness, cognition and mental health. A subsample of students will (i) provide hair samples to determine their accumulated exposure to stressful events and (ii) undergo multimodal MRI to examine brain structure and function. A process evaluation will be conducted (ie, recruitment, retention, attendance and programme satisfaction).Ethics and disseminationThis study has received approval from the University of Newcastle (H-2016–0424) and the NSW Department of Education (SERAP: 2017116) human research ethics committees.Trial registration numberACTRN12618000293268; Pre-results.
Patients’ decision-making, experiences and preferences regarding pixantrone treatment in relapsed or refractory diffuse large B-cell lymphoma: study protocol for a longitudinal mixed methods study
Authors: van Hoogdalem Lothar E , Siemes Claire , Lugtenburg Pieternella J , Busschbach Jan J V , Ismail Sohal Y 
Published: May 2019

IntroductionThere is a lot of speculation about why and how patients decide to use invasive treatment in an advanced stage of cancer, but the body of research is limited. The present longitudinal qualitative and quantitative study reflects real-life practice of pixantrone use and aims to collect data on patients’ considerations for, expectations of and experiences with pixantrone and trajectories in their quality-of-life (QoL) values in a Dutch clinical setting. Hence, two questions emerge. Why do patients choose for this treatment, while the treatment success rate is limited and curation cannot be achieved? And second, once chosen, what conditions would patients like to satisfy and how do they experience the treatment?Methods and analysisThis is a non-interventional longitudinal and multicentre study. Patients are eligible if they are >18 years, have never been treated with pixantrone before, have an Eastern Cooperative Oncology Group performance score ≤2, have a relapsed or refractory diffuse large B-cell lymphoma and have been treated with at least two prior regimens. The decision to treat patients with pixantrone has been taken by the treating physician before patients are asked to participate in the study. If patients refuse study participation after being informed by the investigator, reasons for refusal (if given) will be recorded. Participants will receive at least three interviews accompanied by three QOL questionnaires. Based on the required sample size, we aim to include 20 patients over a period of 2 years.Ethics and disseminationThe Medical Ethical Committee of Erasmus MC, Rotterdam, The Netherlands, has approved this study. The results will be disseminated in peer-reviewed journals and major international conferences. The study is non-interventional and falls therefore not under Medical Research Involving Human Subjects Act (In Dutch: Wet medisch-wetenschappelijk onderzoek met mensen; WMO). Hence, this study is approved to be carried out in the Erasmus MC. Each other participating centre will receive this approval and will separately undergo the ethical approval to be able to participate. In addition to the ethical approval, the participating centres need to obtain written informed consent of their patients. Given the non-interventional nature of this study, a study registration was considered but deemed unnecessary. The study will be conducted in accordance with the Declaration of Helsinki (Tokyo, Venice, Hong Kong and Somerset West amendments). A sequential identification number will be automatically attributed to each patient that has given consent to participate in the study. This number will identify the patient and must be included on all documents. Only the main researcher can link the code to the patient’s identity.
Performance of host blood transcriptomic signatures for diagnosing and predicting progression to tuberculosis disease in HIV-negative adults and adolescents: a systematic review protocol
Authors: Mulenga Humphrey , Bunyasi Erick Wekesa , Mbandi Stanley Kimbung , Mendelsohn Simon C , Kagina Benjamin , Penn-Nicholson Adam , Scriba Thomas , Hatherill Mark 
Published: May 2019

IntroductionOne-quarter of the global population, including the majority of adults in tuberculosis (TB) endemic countries, are estimated to beMycobacterium tuberculosis(MTB) infected. An estimated 10 million new TB cases occurred in 2017. One of the biggest challenges confronting TB control is the lack of accurate diagnosis and prediction of prevalent and incident TB disease, respectively. Several host blood transcriptomic messenger RNA (mRNA) signatures that reflect the host immune response following infection with MTB and progression to TB disease in different study populations have recently been published, but these TB biomarkers have not been systematically described. We will conduct a systematic review of the performance of host blood transcriptional signatures for TB diagnosis and prediction of progression to TB disease.Methods and analysisThis systematic review will involve conducting a comprehensive literature search of cohort, case–control, cross-sectional and randomised-controlled studies of the performance of host blood transcriptomic signatures for TB diagnosis and prediction of progression to TB disease. We will search Medline via PubMed, Scopus, Web of Science and EBSCO libraries, complemented by a search of bibliographies of selected articles for other relevant articles. The literature search will be restricted to studies published in English from 2005 to 2018 and conducted in HIV-uninfected adults and adolescents (≥12 years old). Forest plots and a narrative synthesis of the findings will be provided. The primary outcomes will be sensitivity, specificity, as well as true/false positives and true/false negatives. Heterogeneity resulting from differences in the design, composition and structure of individual signatures will preclude meta-analysis and pooling of results.Ethics and disseminationEthics approval is not required for this systematic review protocol. The results of this review will be disseminated through a peer-reviewed journal as well as conference presentations.PROSPERO registration numberCRD42017073817.
Retrospective evaluation of healthcare utilisation and mortality of two post-discharge care programmes in Singapore
Authors: Ang Ian Yi Han , Tan Chuen Seng , Nurjono Milawaty , Tan Xin Quan , Koh Gerald Choon-Huat , Vrijhoef Hubertus Johannes Maria , Tan Shermin , Ng Shu Ee , Toh Sue-Anne 
Published: May 2019

ObjectiveTo evaluate the impact on healthcare utilisation frequencies and charges, and mortality of a programme for frequent hospital utilisers and a programme for patients requiring high acuity post-discharge care as part of an integrated healthcare model.DesignA retrospective quasi-experimental study without randomisation where patients who received post-discharge care interventions were matched 1:1 with unenrolled patients as controls.SettingThe National University Health System (NUHS) Regional Health System (RHS), which was one of six RHS in Singapore, implemented the NUHS RHS Integrated Interventions and Care Extension (NICE) programme for frequent hospital utilisers and the NUHS Transitional Care Programme (NUHS TCP) for high acuity post-discharge care. The programmes were supported by the Ministry of Health in Singapore, which is a city-state nation located in Southeast Asia with a 5.6 million population.ParticipantsLinked healthcare administrative data, for the time period of January 2013 to December 2016, were extracted for patients enrolled in NICE (n=554) or NUHS TCP (n=270) from June 2014 to December 2015, and control patients.InterventionsFor both programmes, teams conducted follow-up home visits and phone calls to monitor and manage patients’ post-discharge.Primary outcome measuresOne-year pre- and post-enrolment healthcare utilisation frequencies and charges of all-cause inpatient admissions, emergency admissions, emergency department attendances, specialist outpatient clinic (SOC) attendances, total inpatient length of stay and mortality rates were compared.ResultsPatients in NICE had lower mortality rate, but higher all-cause inpatient admission, emergency admission and emergency department attendance charges. Patients in NUHS TCP did not have lower mortality rate, but had higher emergency admission and SOC attendance charges.ConclusionsBoth NICE and NUHS TCP had no improvements in 1 year healthcare utilisation across various setting and metrics. Singular interventions might not be as impactful in effecting utilisation without an overhauling transformation and restructuring of the hospital and healthcare system.
Perioperative Pain and Addiction Interdisciplinary Network (PAIN): protocol of a practice advisory for the perioperative management of buprenorphine using a modified Delphi process
Authors: Goel Akash , Azargive Saam , Weissman Joel S , Shanthanna Harsha , Ladha Karim S , Lamba Wiplove , Duggan Scott , Hanlon John G , Di Renna Tania , Peng Philip , Clarke Hance 
Published: May 2019

IntroductionThe ongoing opioid epidemic has necessitated increasing prescriptions of buprenorphine, which is an evidence-based treatment for opioid use disorder, and also shown to reduce harms associated with unsafe opioid administration. A systematic review of perioperative management strategies for patients taking buprenorphine concluded that there was little guidance for managing buprenorphine perioperatively. The aim of this project is to develop consensus guidelines on the optimal perioperative management strategies for this group of patients. In this paper, we present the design for a modified Delphi technique that will be used to gain consensus among patients and multidisciplinary experts in addiction, pain, community and perioperative medicine.Methods and analysisA national panel of experts identified by perioperative, pain and/or addiction systematic review authorship established an international profile in perioperative, pain and/or addiction research, community clinical excellence and by peer referral. A steering group will develop the first round with a list of indications to be rated by the panel of national experts, patients and allied healthcare professionals. In round 1, the expert panel will rate the appropriateness of each individual item and provide additional suggestions for revisions, additions or deletions. The definition of consensus will be seta priori. Consensus will be gauged for both appropriateness and inappropriateness of treatment strategies. Where an agreement is not reached and items are suggested for addition/deletion/modification, round 2 will take place over teleconference in order to obtain consensus.Ethics and disseminationInstitutional research ethics board provided a waiver for this modified Delphi protocol. We plan on developing a national guideline for the management of patients taking buprenorphine in the perioperative period that will be generalisable across three sets of preoperative diagnoses including opioid use disorder and/or co-occurring pain disorders. The findings will be published in peer-reviewed publications and conference presentations.
Proactive healthcare for frail elderly persons: study protocol for a prospective controlled primary care intervention in Sweden
Authors: Marcusson Jan , Nord Magnus , Johansson Maria M , Alwin Jenny , Levin Lars-Åke , Dannapfel Petra , Thomas Kristin , Poksinska Bonnie , Sverker Annette , Olaison Anna , Cedersund Elisabet , Kelfve Susanne , Motel-Klingebiel Andreas , Hellström Ingrid , Kullberg Agneta , Böttiger Ylva , Dong Huan-Ji , Peolsson Anneli , Wass Malin , Lyth Johan , Andersson Agneta 
Published: May 2019

IntroductionThe provision of healthcare services is not dedicated to promoting maintenance of function and does not target frail older persons at high risk of the main causes of morbidity and mortality. The aim of this study is to evaluate the effects of a proactive medical and social intervention in comparison with conventional care on a group of persons aged 75 and older selected by statistical prediction.Methods and analysisIn a pragmatic multicentre primary care setting (n=1600), a prediction model to find elderly (75+) persons at high risk of complex medical care or hospitalisation is used, followed by proactive medical and social care, in comparison with usual care. The study started in April 2017 with a run-in period until December 2017, followed by a 2-year continued intervention phase that will continue until the end of December 2019. The intervention includes several tools (multiprofessional team for rehabilitation, social support, medical care home visits and telephone support). Primary outcome measures are healthcare cost, number of hospital care episodes, hospital care days and mortality. Secondary outcome measures are number of outpatient visits, cost of social care and informal care, number of prescribed drugs, health-related quality of life, cost-effectiveness, sense of security, functional status and ability. We also study the care of elderly persons in a broader sense, by covering the perspectives of the patients, the professional staff and the management, and on a political level, by using semistructured interviews, qualitative methods and a questionnaire.Ethics and disseminationApproved by the regional ethical review board in Linköping (Dnr 2016/347-31). The results will be presented in scientific journals and scientific meetings during 2019–2022 and are planned to be used for the development of future care models.Trial registration numberNCT03180606.
Feasibility of wearable cameras to assess screen time and time spent restrained in children aged 3 to 5 years: a study protocol
Authors: Downing Katherine L , Janssen Xanne , Reilly John J 
Published: May 2019

IntroductionWearable cameras may help overcome the limitations of existing tools to measure young children’s sedentary behaviour, but their use introduces a range of ethical challenges. The primary aim of this study is to determine the feasibility of using wearable cameras to measure the two aspects of sedentary behaviour currently included in evidence-based guidelines (ie, screen time and time spent restrained). If shown to be feasible, a secondary aim will be to validate subjective measures against the directly measured screen time and time spent restrained.Methods and analysisA convenience sample (n=20) will be recruited via flyers at the University of Strathclyde and advertisements on online forums for parents of young children (aged 3 to 5 years). Children will be provided with a wearable camera, attached to the front of their clothing with a clip, to be worn for 3 days (2 non-childcare days and 1 weekend day) in non-public settings. Once switched on, the camera will record continuous video footage. Parents will complete an online survey providing their feedback on their own and their child’s experience of the wearable camera. They will also report their own and their child’s demographical characteristics and their child’s usual daily screen time and time spent restrained in the past week. Data will be downloaded using specialised software and second-by-second coding will be undertaken. Feasibility and acceptability will be assessed using percentages and by analysing qualitative data. If feasibility is shown, intraclass coefficients will be used to determine agreement between video data and parent-reported sedentary behaviours.Ethics and disseminationEthical approval has been granted by the School of Psychological Sciences and Health Ethics Committee at the University of Strathclyde. Results will be used to inform future studies and will be disseminated in peer-reviewed journals and at major international conferences.
Clinical value of cerebrospinal fluid neurofilament light chain in semantic dementia
Authors: Meeter Lieke H H , Steketee Rebecca M E , Salkovic Dina , Vos Maartje E , Grossman Murray , McMillan Corey T , Irwin David J , Boxer Adam L , Rojas Julio C , Olney Nicholas T , Karydas Anna , Miller Bruce L , Pijnenburg Yolande A L , Barkhof Frederik , Sánchez-Valle Raquel , Lladó Albert , Borrego-Ecija Sergi , Diehl-Schmid Janine , Grimmer Timo , Goldhardt Oliver , Santillo Alexander F , Hansson Oskar , Vestberg Susanne , Borroni Barbara , Padovani Alessandro , Galimberti Daniela , Scarpini Elio , Rohrer Jonathan D , Woollacott Ione O C , Synofzik Matthis , Wilke Carlo , de Mendonca Alexandre , Vandenberghe Rik , Benussi Luisa , Ghidoni Roberta , Binetti Giuliano , Niessen Wiro J , Papma Janne M , Seelaar Harro , Jiskoot Lize C , de Jong Frank Jan , Donker Kaat Laura , Del Campo Marta , Teunissen Charlotte E , Bron Esther E , Van den Berg Esther , Van Swieten John C 
Published: May 2019

BackgroundSemantic dementia (SD) is a neurodegenerative disorder characterised by progressive language problems falling within the clinicopathological spectrum of frontotemporal lobar degeneration (FTLD). The development of disease-modifying agents may be facilitated by the relative clinical and pathological homogeneity of SD, but we need robust monitoring biomarkers to measure their efficacy. In different FTLD subtypes, neurofilament light chain (NfL) is a promising marker, therefore we investigated the utility of cerebrospinal fluid (CSF) NfL in SD.MethodsThis large retrospective multicentre study compared cross-sectional CSF NfL levels of 162 patients with SD with 65 controls. CSF NfL levels of patients were correlated with clinical parameters (including survival), neuropsychological test scores and regional grey matter atrophy (including longitudinal data in a subset).ResultsCSF NfL levels were significantly higher in patients with SD (median: 2326 pg/mL, IQR: 1628–3593) than in controls (577 (446–766), p<0.001). Higher CSF NfL levels were moderately associated with naming impairment as measured by the Boston Naming Test (rs=−0.32, p=0.002) and with smaller grey matter volume of the parahippocampal gyri (rs=−0.31, p=0.004). However, cross-sectional CSF NfL levels were not associated with progression of grey matter atrophy and did not predict survival.ConclusionCSF NfL is a promising biomarker in the diagnostic process of SD, although it has limited cross-sectional monitoring or prognostic abilities.
Thalamic arousal network disturbances in temporal lobe epilepsy and improvement after surgery
Authors: González Hernán F J , Chakravorti Srijata , Goodale Sarah E , Gupta Kanupriya , Claassen Daniel O , Dawant Benoit , Morgan Victoria L , Englot Dario J 
Published: May 2019

ObjectiveThe effects of temporal lobe epilepsy (TLE) on subcortical arousal structures remain incompletely understood. Here, we evaluate thalamic arousal network functional connectivity in TLE and examine changes after epilepsy surgery.MethodsWe examined 26 adult patients with TLE and 26 matched control participants and used resting-state functional MRI (fMRI) to measure functional connectivity between the thalamus (entire thalamus and 19 bilateral thalamic nuclei) and both neocortex and brainstem ascending reticular activating system (ARAS) nuclei. Postoperative imaging was completed for 19 patients >1 year after surgery and compared with preoperative baseline.ResultsBefore surgery, patients with TLE demonstrated abnormal thalamo-occipital functional connectivity, losing the normal negative fMRI correlation between the intralaminar central lateral (CL) nucleus and medial occipital lobe seen in controls (p < 0.001, paired t-test). Patients also had abnormal connectivity between ARAS and CL, lower ipsilateral intrathalamic connectivity, and smaller ipsilateral thalamic volume compared with controls (p < 0.05 for each, paired t-tests). Abnormal brainstem–thalamic connectivity was associated with impaired visuospatial attention (ρ = −0.50, p = 0.02, Spearman’s rho) while lower intrathalamic connectivity and volume were related to higher frequency of consciousness-sparing seizures (p < 0.02, Spearman’s rho). After epilepsy surgery, patients with improved seizures showed partial recovery of thalamo-occipital and brainstem–thalamic connectivity, with values more closely resembling controls (p < 0.01 for each, analysis of variance).ConclusionsOverall, patients with TLE demonstrate impaired connectivity in thalamic arousal networks that may be involved in visuospatial attention, but these disturbances may partially recover after successful epilepsy surgery. Thalamic arousal network dysfunction may contribute to morbidity in TLE.