bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol
Authors: Clemes Stacy A , Varela Mato Verónica , Munir Fehmidah , Edwardson Charlotte L , Chen Yu-Ling , Hamer Mark , Gray Laura J , Bhupendra Jaicim Nishal , Richardson Gerry , Johnson Vicki , Troughton Jacqui , Yates Thomas , King James A 
Published: April 2023

IntroductionHeavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related comorbidities, in comparison to other occupational groups. Their working environments are not conducive to a healthy lifestyle, yet there has been limited attention to health promotion efforts. We have developed a Structured Health Intervention For Truckers (the SHIFT programme), a multicomponent, theory-driven, health-behaviour intervention targeting physical activity, diet and sitting in HGV drivers. This paper describes the protocol of a cluster randomised controlled trial designed to evaluate the effectiveness and cost-effectiveness of the SHIFT programme.Methods and analysisHGV drivers will be recruited from a logistics company in the UK. Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers). The 6-month SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a ‘cab workout’). Objectively measured total daily physical activity (steps/day) will be the primary outcome. Secondary outcomes include: objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol). Self-report questionnaires will examine fruit and vegetable intake, psychosocial and work outcomes and mental health. Quality of life and resources used (eg, general practitioner visits) will also be assessed. Measures will be collected at baseline, 6 and 12 months and analysed according to a modified intention-to-treat principle. A full process evaluation and cost-effectiveness analysis will be conducted.Ethics and disseminationEthical approval was obtained from the Loughborough University Ethics Approvals Sub-Committee (reference: R17-P063). Study findings will be disseminated through publications in research and professional journals, through conference presentations and to relevant regional and national stakeholders via online media and at dissemination events.Trial registration numberNCT10483894.
Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial
Authors: Liossi Christina , Georgallis Tsampikos , Zhang Jin , Hamilton Fiona , White Paul , Schoth Daniel Eric 
Published: April 2023

IntroductionChronic musculoskeletal pain is a complex medical condition that can significantly impact quality of life. Patients with chronic pain demonstrate attentional biases towards pain-related information. The therapeutic benefits of modifying attentional biases by implicitly training attention away from pain-related information towards neutral information have been supported in a small number of published studies. Limited research however has explored the efficacy of modifying pain-related biases via the internet. This protocol describes a randomised, double-blind, internet-delivered attentional bias modification intervention, aimed to evaluate the efficacy of the intervention on reducing pain interference. Secondary outcomes are pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment. This study will also explore the effects of training intensity on these outcomes, along with participants’ perceptions about the therapy.Methods and analysisThe study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit. Participants with chronic musculoskeletal pain will be randomised to one of four groups: (1) 10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group. In the attentional modification groups, the probe-classification version of the visual-probe task will be used to implicitly train attention away from threatening information towards neutral information. Following the intervention, participants will complete a short interview exploring their perceptions about the online training. In addition, a subgroup analysis for participants aged 16–24 and 25–60 will be undertaken.Ethics and disseminationThis study has been approved by the University of Southampton Research Ethics Committee. Results will be published in peer-reviewed journals, academic conferences, and in lay reports for pain charities and patient support groups.Trial registration numberNCT02232100.
Fit for School Study protocol: early child growth, health behaviours, nutrition, cardiometabolic risk and developmental determinants of a child’s school readiness, a prospective cohort
Authors: Birken Catherine S , Omand Jessica A , Nurse Kim M , Borkhoff Cornelia M , Koroshegyi Christine , Lebovic Gerald , Maguire Jonathon L , Mamdani Muhammad , Parkin Patricia C , Randall Simpson Janis , Tremblay Mark S , Duku Eric , Reid-Westoby Caroline , Janus Magdalena 
Published: April 2023

Introduction
School readiness is a multidimensional construct that includes cognitive, behavioural and emotional aspects of a child’s development. School readiness is strongly associated with a child’s future school success and well-being. The Early Development Instrument (EDI) is a reliable and valid teacher-completed tool for assessing school readiness in children at kindergarten age. A substantial knowledge gap exists in understanding how early child growth, health behaviours, nutrition, cardiometabolic risk and development impact school readiness. The primary objective was to determine if growth patterns, measured by body mass index trajectories in healthy children aged 0–5 years, are associated with school readiness at ages 4–6 years (kindergarten age). Secondary objectives were to determine if other health trajectories, including health behaviours, nutrition, cardiometabolic risk and development, are associated with school readiness at ages 4–6 years. This paper presents the Fit for School Study protocol.

Methods and analysis
This is an ongoing prospective cohort study. Parents of children enrolled in the The Applied Health Research Group for Kids (TARGet Kids!) practice-based research network are invited to participate in the Fit for School Study. Child growth, health behaviours, nutrition, cardiometabolic risk and development data are collected annually at health supervision visits and linked to EDI data collected by schools. The primary and secondary analyses will use a two-stage process: (1) latent class growth models will be used to first determine trajectory groups, and (2) generalised linear mixed models will be used to examine the relationship between exposures and EDI results.

Ethics and dissemination
The research ethics boards at The Hospital for Sick Children, Unity Health Toronto and McMaster University approved this study, and research ethics approval was obtained from each school board with a student participating in the study. The findings will be presented locally, nationally and internationally and will be published in peer-reviewed journals.

Trial registration number

NCT01869530
.
Update on the prevalence of persistent post-traumatic headache in adult civilian traumatic brain injury: protocol for a systematic review and meta-analysis
Authors: Arbour Caroline , Bouferguene Yasmine , Beauregard Roxanne , Lavigne Gilles , Herrero Babiloni Alberto 
Published: April 2023

IntroductionTraumatic brain injury (TBI) is a major public health concern. Persistent post-traumatic headache (PTH) is a common consequence of TBI affecting productivity and quality of life. The only review providing information about headache prevalence after TBI was published in 2008, combined data from civilian and military TBI, and was strictly derived from Medline database. Due to recent changes in TBI diagnosis and trauma epidemiology, the aim of the current study is to perform a systematic review and meta-analysis to derive updated prevalence estimates of persistent PTH in adult civilian TBI.Methods and analysisThe methods have been defined following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies published from 2008 to 2019 will be identified searching the electronic databases Medline, Embase, Cochrane, Google Scholar, Directory of Open Access Journals and Web of Science. Retrieved records will be independently screened by two authors and relevant data will be extracted from studies reporting data on persistent PTH prevalence among civilian TBI individuals (≥16 years). The pooled prevalence estimates of any form of headache will be computed applying random-effects meta-analysis. Heterogeneity will be assessed using the I2statistic and explored through subgroup analyses considering TBI severity (mild vs moderate/severe). Estimations of risk of bias will be performed using the Risk of Bias Tool for Prevalence Studies.Ethics and disseminationThe result of this systematic review will be published in a peer-reviewed journal and disseminated at relevant conferences presentations. Formal ethical approval is not required because we will search and evaluate only existing sources of literature. By focusing on studies conducted in the last decade, this review will provide the most up-to-date information about the global prevalence of persistent PTH after TBI. Considering the economical and social burden of persistent PTH after TBI, accurate estimates of this problematic disorder is of utmost importance for planning, implementing and evaluating prevention interventions.PROSPERO registration numberNCT42018094138
Development of a system based on artificial intelligence to identify visual problems in children: study protocol of the TrackAI project
Authors: Pueyo Victoria , Pérez-Roche Teresa , Prieto Esther , Castillo Olimpia , Gonzalez Inmaculada , Alejandre Adrian , Pan Xian , Fanlo-Zarazaga Alvaro , Pinilla Juan , Echevarria Jose Ignacio , Gutierrez Diego , Altemir Irene , Romero-Sanz María , Cipres Marta , Ortin Marta , Masia Belen 
Published: April 2023

IntroductionAround 70% to 80% of the 19 million visually disabled children in the world are due to a preventable or curable disease, if detected early enough. Vision screening in childhood is an evidence-based and cost-effective way to detect visual disorders. However, current screening programmes face several limitations: training required to perform them efficiently, lack of accurate screening tools and poor collaboration from young children.Some of these limitations can be overcome by new digital tools. Implementing a system based on artificial intelligence systems avoid the challenge of interpreting visual outcomes.The objective of the TrackAI Project is to develop a system to identify children with visual disorders. The system will have two main components: a novel visual test implemented in a digital device, DIVE (Device for an Integral Visual Examination); and artificial intelligence algorithms that will run on a smartphone to analyse automatically the visual data gathered by DIVE.Methods and analysisThis is a multicentre study, with at least five centres located in five geographically diverse study sites participating in the recruitment, covering Europe, USA and Asia.The study will include children aged between 6 months and 14 years, both with normal or abnormal visual development.The project will be divided in two consecutive phases: design and training of an artificial intelligence (AI) algorithm to identify visual problems, and system development and validation. The study protocol will consist of a comprehensive ophthalmological examination, performed by an experienced paediatric ophthalmologist, and an exam of the visual function using a DIVE.For the first part of the study, diagnostic labels will be given to each DIVE exam to train the neural network. For the validation, diagnosis provided by ophthalmologists will be compared with AI system outcomes.Ethics and disseminationThe study will be conducted in accordance with the principles of Good Clinical Practice. This protocol was approved by the Clinical Research Ethics Committee of Aragón, CEICA, on January 2019 (Code PI18/346).Results will be published in peer-reviewed journals and disseminated in scientific meetings.Trial registration numberNCT17316993.
Longitudinal team training programme in a Norwegian surgical ward: a qualitative study of nurses’ and physicians’ experiences with teamwork skills
Authors: Ballangrud Randi , Aase Karina , Vifladt Anne 
Published: April 2023

ObjectivesTeamwork and interprofessional team training are fundamental to ensuring the continuity of care and high-quality outcomes for patients in a complex clinical environment. Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an evidence-based team training programme intended to facilitate healthcare professionals’ teamwork skills. The aim of this study is to describe healthcare professionals’ experiences with teamwork in a surgical ward before and during the implementation of a longitudinal interprofessional team training programme.DesignA qualitative descriptive study based on follow-up focus group interviews.SettingA combined gastrointestinal surgery and urology ward at a hospital division in a Norwegian hospital trust.ParticipantsA convenience sample of 11 healthcare professionals divided into three professionally based focus groups comprising physicians (n=4), registered nurses (n=4) and certified nursing assistants (n=3).InterventionsThe TeamSTEPPS programme was implemented in the surgical ward from May 2016 to June 2017. The team training programme included the three phases: (1) assessment and planning, (2) training and implementation and (3) sustainment.ResultsBefore implementing the team training programme, healthcare professionals were essentially satisfied with the teamwork skills within the ward. During the implementation of the programme, they experienced that team training led to greater awareness and knowledge of their common teamwork skills. Improved teamwork skills were described in relation to a more systematic interprofessional information exchange, consciousness of leadership-balancing activities and resources, the use of situational monitoring tools and a shared understanding of accountability and transparency.ConclusionsThis study suggests that the team training programme provides healthcare professionals with a set of tools and terminology that promotes a common understanding of teamwork, hence affecting behaviour and communication in their daily clinical practice at the surgical ward.Trial registration numberNCT13997367.
Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project
Authors: Palacios-Baena Zaira R , Valiente de Santis Lucia , Maldonado Natalia , Rosso-Fernández Clara M , Borreguero Irene , Herrero-Rodríguez Carmen , López-Cárdenas Salvador , Martínez-Marcos Franciso J , Martín-Aspas Andrés , Jiménez-Aguilar Patricia , Castón Juan J , Anguita-Santos Francisco , Ojeda-Burgos Guillermo , Aznarte-Padial M Pilar , Praena-Segovia Julia , Corzo-Delgado Juan E , Esteban-Moreno M Ángeles , Rodríguez-Baño Jesús , Retamar Pilar 
Published: April 2023

IntroductionCeftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appropriate use of the new antibiotics will be improved by including consensual indications for their use in local antibiotic guidelines, together with educational interventions providing advice to prescribers to ensure that the recommendations are clearly understood.Methods and analysisThis study will be implemented in two phases. First, a preliminary historical cohort (2017–2019) of patients from 13 Andalusian hospitals treated with novel antibiotics will be analysed. Second, a quasiexperimental intervention study will be developed with an interrupted time-series analysis (2020–2021). The intervention will consist of an educational interview between prescribers and ASP leaders at each hospital to reinforce the proper use of novel antibiotics. The educational intervention will be based on a consensus guideline designed and disseminated by leaders after the retrospective cohort data have been analysed. The outcomes will be acceptance of the intervention and appropriateness of prescription. Incidence of infection and colonisation with MDR organisms as well as incidence ofClostridioides difficileinfection will also be analysed. Changes in prescription quality between periods and the safety profile of the antibiotics in terms of mortality rate and readmissions will also be measured.Ethics and disseminationEthical approval will be obtained from the Andalusian Coordinating Institutional Review Board. The study is being conducted in compliance with the protocol and regulatory requirements consistent with International Council of Harmonisation E6 Good Clinical Practice and the ethical principles of the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and disseminated at national and international conferences.Trial registration numberNCT03941951.
Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial
Authors: Garfinkle Richard , Loiselle Carmen G , Park Jason , Fiore Jr Julio F , Bordeianou Liliana G , Liberman A Sender , Morin Nancy , Faria Julio , Ghitulescu Gabriela , Vasilevsky Carol-Ann , Bhatnagar Sahir R , Boutros Marylise 
Published: April 2023

IntroductionLow anterior resection syndrome (LARS) is described as disordered bowel function after rectal resection that leads to a detriment in quality of life, and affects the majority of individuals following restorative proctectomy for rectal cancer. The management of LARS includes personalised troubleshooting and effective self-management behaviours. Thus, affected individuals need to be well informed and appropriately engaged in their own LARS management. This manuscript describes the development of a LARS patient-centred programme (LPCP) and the study protocol for its evaluation in a randomised controlled trial.Methods and analysisThis will be a multicentre, randomised, assessor-blind, parallel-groups, pragmatic trial evaluating the impact of an LPCP, consisting of an informational booklet, patient diaries and nurse support, on patient-reported outcomes after restorative proctectomy for rectal cancer. The informational booklet was developed by a multidisciplinary LARS team, and was vetted in a focus group and semistructured interviews involving patients, caregivers, and healthcare professionals. The primary outcome will be global quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire—Core 30 (QLQ-C30), at 6 months after surgery. The treatment effect on global QoL will be modelled using generalised estimating equations. Secondary outcomes include symptom change, patient activation, bowel function measures, emotional distress, knowledge about LARS and satisfaction with the LPCP.Ethics and disseminationThe Research Ethics Committee (REC) at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) is the overseeing REC for all Quebec sites. They have granted ethical approval (MP-05-2019-1628) for all Quebec hospitals (Jewish General Hospital, McGill University Health Center, CHU de Quebec) and have granted full authorisation to begin research at the Jewish General Hospital. Patient recruitment will not begin at the other Quebec sites until inter-institutional contracts are finalised and feasibility/authorisation for research is granted by their respective REC. The results of this study will be presented at national and international conferences, and a manuscript with results will be submitted for publication in a high-impact peer-reviewed journal.Trial registration numberNCT03828318Pre-results.
Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double-blind randomised controlled feasibility trial
Authors: Desborough Michael J R , Al-Shahi Salman Rustam , Stanworth Simon J , Havard Diane , Brennan Paul M , Dineen Robert A , Coats Timothy J , Hepburn Trish , Bath Philip M , Sprigg Nikola 
Published: April 2023

IntroductionIntracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not using antithrombotic drugs. We aim to assess the feasibility of conducting a randomised controlled testing the safety and efficacy of desmopressin for patients with antiplatelet-associated ICH.Methods and analysisWe aim to include 50 patients within 24 hours of spontaneous ICH onset, associated with oral antiplatelet drug(s) use in at least the preceding 7 days. Patients will be randomised (1:1) to receive intravenous desmopressin 20 µg in 50 mL sodium chloride 0.9% infused over 20 min or matching placebo. We will mask participants, relatives and outcome assessors to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, number of patients receiving allocated treatment, rate of recruitment and adherence to treatment and follow-up. Secondary outcomes include change in ICH volume at 24 hours; hyponatraemia at 24 hours, length of hospital stay, discharge destination, early death less than 28 days, death or dependency at day 90, death up to day 90, serious adverse events (including thromboembolic events) up to day 90; disability (Barthel index, day 90), quality of life (EuroQol 5D (EQ-5D), day 90), cognition (telephone mini-mental state examination day 90) and health economic assessment (EQ-5D).Ethics and disseminationThe Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH) trial received ethical approval from the East Midlands—Nottingham 2 research ethics committee (18/EM/0184). The DASH trial is funded by National Institute for Health and Care Research RfPB grant: PB-PG-0816-20011. Trial results will be published in a peer reviewed academic journal and disseminated through academic conferences and through patient stroke support groups. Reporting will be in compliance with Consolidated Standards of Reporting Trials recommendations.Trial registration numbersNCT03696121;NCT67038373; EudraCT 2018-001904-12.