bluuebunny/crossref_metadata_2025_split huggingface dataset:
Understanding the role of physical activity on the pathway from intra-articular knee injury to post-traumatic osteoarthritis disease in young people: a scoping review protocol
Authors: Morgan Karl , Cowburn James , Farrow Matthew , Carter Josh , Cazzola Dario , Walhin Jean-Philippe , McKay Carly 
Published: May 2023

IntroductionThe prevalence of intra-articular knee injuries and reparative surgeries is increasing in many countries. Alarmingly, there is a risk of developing post-traumatic osteoarthritis (PTOA) after sustaining a serious intra-articular knee injury. Although physical inactivity is suggested as a risk factor contributing to the high prevalence of the condition, there is a paucity of research characterising the association between physical activity and joint health. Consequently, the primary aim of this review will be to identify and present available empirical evidence regarding the association between physical activity and joint degeneration after intra-articular knee injury and summarise the evidence using an adapted Grading of Recommendations Assessment, Development and Evaluations. The secondary aim will be to identify potential mechanistic pathways through which physical activity could influence PTOA pathogenesis. The tertiary aim will be to highlight gaps in current understanding of the association between physical activity and joint degeneration following joint injury.MethodsA scoping review will be conducted using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist and best-practice recommendations. The review will be guided by the following research question: what is the role of physical activity in the trajectory from intra-articular knee injury to PTOA in young men and women? We will identify primary research studies and grey literature by searching the electronic databases Scopus, Embase: Elsevier, PubMed, Web of Science: all databases, and Google Scholar. Reviewing pairs will screen abstracts, full texts and will extract data. Data will be presented descriptively using charts, graphs, plots and tables.Ethics and disseminationThis research does not require ethical approval due to the data being published and publicly available. This review will be submitted for publication in a peer-reviewed sports medicine journal irrespective of discoveries and disseminated through scientific conference presentations and social media.Trial registration numberhttps://osf.io/84pnh/.
Engaging emergency medical services to improve postacute management of behavioural health emergency calls: a protocol of a scoping literature review
Authors: Ding Marissa L , Gerberi Danielle J , McCoy Rozalina G 
Published: May 2023

IntroductionThe public health crisis of escalating mental health, behavioural and substance-related emergencies has revealed the need to approach these complex events from a health perspective, rather than the traditional criminal justice standpoint. Despite law enforcement officers often being the first responders to emergency calls concerning self or bystander harm, they are not optimally equipped to manage these crises holistically or to connect affected individuals to necessary medical treatment and social support. Paramedics and other emergency medical services (EMS) providers are well positioned to deliver comprehensive medicosocial care during and in the immediate aftermath of these emergencies, moving beyond their traditional role in emergency evaluation, stabilisation and transport to a higher level of care. The role of EMS in bridging this gap and helping shift emphasis to mental and physical health needs in crisis situations has not been examined in prior reviews.Methods and analysisIn this protocol, we delineate our approach to describing existing EMS programmes that focus specifically on supporting individuals and communities experiencing mental, behavioural and substance-related health crises. The databases to be searched are EBSCO CINAHL, Ovid Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid Medline, Ovid PsycINFO and Web of Science Core Collection, with search date limits being from database inception to 14 July 2022. A narrative synthesis will be completed to characterise populations and situations targeted by the programmes, describe programme staffing and composition, detail the interventions and identify collected outcomes.Ethics and disseminationAll data in the review will be publicly accessible and published previously, so approval by a research ethics board is not needed. Our findings will be published in a peer-reviewed journal and shared with the public.Trial registration numberhttps://doi.org/10.17605/OSF.IO/UYV4R
Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC)
Authors: Perin Marta , Magelssen Morten , Ghirotto Luca , De Panfilis Ludovica 
Published: May 2023

IntroductionA Clinical Ethics Committee (CEC) is a multi-professional service whose aim is to support healthcare professionals (HPs) and healthcare organisations to deal with the ethical issues of clinical practice.Although CEC are quite common worldwide, their successful implementation in a hospital setting presents many challenges.EVAluating a Clinical Ethics Committee implementation process (EvaCEC) will evaluate the implementation of a CEC in a comprehensive cancer centre in Northern Italy 16 months after its establishment.Methods and analysisEvaCEC is a mixed-method study with a retrospective quantitative analysis and a prospective qualitative evaluation by a range of data collection tools to enable the triangulation of data sources and analysis. Quantitative data related to the amount of CEC activities will be collected using the CEC's internal databases. Data on the level of knowledge, use and perception of the CEC will be collected through a survey with closed-ended questions disseminated among all the HPs employed at the healthcare centre. Data will be analysed with descriptive statistics.The Normalisation Process Theory (NPT) will be used for the qualitative evaluation to determine whether and how the CEC can be successfully integrated into clinical practice. We will perform one-to-one semistructured interviews and a second online survey with different groups of stakeholders who had different roles in the implementation process of the CEC. Based on NPT concepts, the interviews and the survey will assess the acceptability of the CEC within the local context and needs and expectations to further develop the service.Ethics and disseminationThe protocol has been approved by the local ethics committee. The project is co-chaired by a PhD candidate and by a healthcare researcher with a doctorate in bioethics and expertise in research. Findings will be disseminated widely through peer-reviewed publications, conferences and workshops.Trial registration numberNCT05466292.
Study design and methods of the Wells and Enteric disease Transmission (WET) Trial: a randomised controlled trial
Authors: Lee Debbie , Denno Donna , Tarr Phillip , Wu Jingwei , Stokdyk Joel P , Borchardt Mark , Murphy Heather M 
Published: May 2023

IntroductionThe burden of disease attributed to drinking water from private wells is not well characterised. The Wells and Enteric disease Transmission trial is the first randomised controlled trial to estimate the burden of disease that can be attributed to the consumption of untreated private well water. To estimate the attributable incidence of gastrointestinal illness (GI) associated with private well water, we will test if the household treatment of well water by ultraviolet light (active UV device) versus sham (inactive UV device) decreases the incidence of GI in children under 5 years of age.Methods and analysisThe trial will enrol (on a rolling basis) 908 families in Pennsylvania, USA, that rely on private wells and have a child 3 years old or younger. Participating families are randomised to either an active whole-house UV device or a sham device. During follow-up, families will respond to weekly text messages to report the presence of signs and symptoms of gastrointestinal or respiratory illness and will be directed to an illness questionnaire when signs/symptoms are present. These data will be used to compare the incidence of waterborne illness between the two study groups. A randomly selected subcohort submits untreated well water samples and biological specimens (stool and saliva) from the participating child in both the presence and absence of signs/symptoms. Samples are analysed for the presence of common waterborne pathogens (stool and water) or immunoconversion to these pathogens (saliva).EthicsApproval has been obtained from Temple University’s Institutional Review Board (Protocol 25665). The results of the trial will be published in peer-reviewed journals.Trial registration numberNCT04826991.
Early diagnostic BioMARKers in exacerbations of chronic obstructive pulmonary disease: protocol of the exploratory, prospective, longitudinal, single-centre, observational MARKED study
Authors: Waeijen-Smit Kiki , DiGiandomenico Antonio , Bonnell Jessica , Ostridge Kristoffer , Gehrmann Ulf , Sellman Bret R , Kenny Tara , van Kuijk Sander , Peerlings Daphne , Spruit Martijn A , Simons Sami O , Houben-Wilke Sarah , Franssen Frits M E 
Published: May 2023

IntroductionAcute exacerbations of chronic obstructive pulmonary disease (AECOPD) play a pivotal role in the burden and progressive course of chronic obstructive pulmonary disease (COPD). As such, disease management is predominantly based on the prevention of these episodes of acute worsening of respiratory symptoms. However, to date, personalised prediction and early and accurate diagnosis of AECOPD remain unsuccessful. Therefore, the current study was designed to explore which frequently measured biomarkers can predict an AECOPD and/or respiratory infection in patients with COPD. Moreover, the study aims to increase our understanding of the heterogeneity of AECOPD as well as the role of microbial composition and hostmicrobiome interactions to elucidate new disease biology in COPD.Methods and analysisThe ‘Early diagnostic BioMARKers in Exacerbations of COPD’ study is an exploratory, prospective, longitudinal, single-centre, observational study with 8-week follow-up enrolling up to 150 patients with COPD admitted to inpatient pulmonary rehabilitation at Ciro (Horn, the Netherlands). Respiratory symptoms, vitals, spirometry and nasopharyngeal, venous blood, spontaneous sputum and stool samples will be frequently collected for exploratory biomarker analysis, longitudinal characterisation of AECOPD (ie, clinical, functional and microbial) and to identify host–microbiome interactions. Genomic sequencing will be performed to identify mutations associated with increased risk of AECOPD and microbial infections. Predictors of time-to-first AECOPD will be modelled using Cox proportional hazards’ regression. Multiomic analyses will provide a novel integration tool to generate predictive models and testable hypotheses about disease causation and predictors of disease progression.Ethics and disseminationThis protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands (NL71364.100.19).Trial registration numberNCT05315674.
Role of single-dose intravenous iron therapy for the treatment of anaemia after orthopaedic trauma: protocol for a pilot randomised controlled trial
Authors: Peterson Danielle F , McKibben Natasha S , Hutchison Catherine E , Lancaster Karalynn , Yang Chih Jen , Dekeyser Graham J , Friess Darin M , Schreiber Martin A , Willett Nick J , Shatzel Joseph J , Aslan Joseph E , Working Zachary M 
Published: May 2023

IntroductionOrthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this perioperative anaemia is an opportunity to impact outcomes in orthopaedic trauma surgery. The primary outcome of this pilot study is feasibility for a large randomised controlled trial (RCT) to evaluate intravenous iron therapy (IVIT) to improve patient well-being following orthopaedic injury. Measurements will include rate of participant enrolment, screening failure, follow-up, missing data, adverse events and protocol deviation.Methods and analysisThis single-centre, pilot, double-blind RCT investigates the use of IVIT for acute blood loss anaemia in traumatically injured orthopaedic patients. Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000 mg) or placebo (normal saline) postoperatively during their hospital stay for trauma management. Eligible subjects include adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7–11 g/dL within 7 days postoperatively during inpatient care. Exclusion criteria include history of intolerance to intravenous iron supplementation, active haemorrhage requiring ongoing blood product resuscitation, multiple planned procedures, pre-existing haematologic disorders or chronic inflammatory states, iron overload on screening or vulnerable populations. We follow patients for 3 months to measure the effect of iron supplementation on clinical outcomes (resolution of anaemia and functional iron deficiency), patient-reported outcomes (fatigue, physical function, depression and quality of life) and translational measures of immune cell function.Ethics and disseminationThis study has ethics approval (Oregon Health & Science University Institutional Review Board, STUDY00022441). We will disseminate the findings through peer-reviewed publications and conference presentations.Trial registration numberNCT05292001; ClinicalTrials.gov.
Effects of physical, psychosocial and dual-career loads on injuries and illnesses among elite handball players: protocol of prospective cohort study
Authors: Drole Kristina , Paravlic Armin , Steffen Kathrin , Doupona Mojca 
Published: May 2023

IntroductionHealth problems in sport cause a major burden on several pillars: sport clubs, health and insurance system and mostly the individual athlete. There is limited knowledge in supporting dual-career athletes firmed on evidence-based research in injury/illness prevention, load and stress management. The main goal of this research approach is to determine how specific physical, psychosocial and dual-career loads affect the occurrence of injuries and illnesses in elite handball players and how much of a variation in the athlete’s load leads to an occurrence of an injury/illness. A secondary aim is to determine the association between objective and subjective measures of stress as well as examine the benefits of certain biomarkers to monitor stress, load and injury/illness occurrence in athletes.Methods and analysisThis prospective cohort study, as part of a PhD project, will be carried out on 200 elite handball players of first men's handball league in Slovenia during an entire handball season, lasting from July 2022 to June 2023. Primary outcomes, including health problems, loads and stress, will be assessed weekly on a player level. Other player-related outcomes will include anthropometry, life event survey and blood biomarkers (cortisol, free testosterone and Ig-A), which will be taken three to five times across the observation period according to the players’ training cycle.Ethics and disseminationThe project was approved by the National Medical Ethics Committee of Slovenia (number: 0120-109/2022/3) and will be conducted in compliance with the most recent version of Helsinki Declaration. The study results will be published as peer-reviewed articles, congress presentations and as a Doctoral thesis. The results will not only be of importance for the medical and sports community for development of new injury prevention and rehabilitation strategies but also for structuring the correct policy recommendations for athletes’ general health.Trial registration numberNCT0547129.
Telehealth use in primary healthcare collaborative interprofessional practice: protocol for a scoping review
Authors: Belber Gisele Silvestre , Vasconcelos Raíssa Ottes , Agreli Heloise Lima Fernandes , Haddad Ana Estela , Peduzzi Marina , Leonello Valéria Marli 
Published: May 2023

IntroductionTelehealth is a growing topic, with potential to improve access to primary healthcare. However, there is a lack of knowledge regarding how telehealth could facilitate interprofessional collaboration that is recommended to strengthen the comprehensive approach of primary healthcare. The objective is to identify the characteristics and applications of telehealth services related to the interprofessional collaborative practice of primary healthcare professionals.Methods and analysisThis review will cover studies including as target population those health professionals who work in telehealth services; as concept, telehealth in relation to collaborative interprofessional practice; and as context, primary healthcare. A scoping review will be carried out according to the Joanna Briggs Institute methodology. Databases to be searched include MEDLINE, CINAHL, Embase, Eric, Scopus, LILACS and Web of Science. All identified records will be grouped, duplicates will be removed, titles and abstracts will be selected by two independent reviewers, and the full text of selected articles will be evaluated in detail. A data extraction tool developed by the reviewers will be used for data extraction. The results will be presented in data map format in a logical way, in a diagram or in a tabular format, accompanied by a descriptive summary.Ethics and disseminationNo ethical approval is required for this study. A manuscript based on this scoping review will be submitted to a journal and we hope it will contribute to scientific knowledge on the interprofessional field and key research findings will be sent to key events on interprofessional practice and education.Systematic review registrationThis scoping review was registered in the Open Science Framework (https://doi.org/10.17605/OSF.IO/2BV8D).
Effectiveness of a targeted brief intervention for recent suicide attempt survivors: a randomised controlled trial protocol
Authors: Pisani Anthony , Connor Kenneth , Van Orden Kimberly , Jordan Neil , Landes Sara , Curran Geoffrey , McDermott Michael , Ertefaie Ashkan , Kelberman Caroline , Ramanathan Seethalakshmi , Carruthers Jay , Mossgraber Kristina , Goldston David 
Published: May 2023

IntroductionEffective, brief, low-cost interventions for suicide attempt survivors are essential to saving lives and achieving the goals of the National Strategy for Suicide Prevention and Zero Suicide. This study aims to examine the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP) in averting suicide reattempts in the United States healthcare system, its psychological mechanisms as predicted by the Interpersonal Theory of Suicide, and the potential implementation costs, barriers and facilitators for delivering it.Methods and analysisThis study is a hybrid type 1 effectiveness–implementation randomised controlled trial (RCT). ASSIP is delivered at three outpatient mental healthcare clinics in New York State. Participant referral sites include three local hospitals with inpatient and comprehensive psychiatric emergency services, and outpatient mental health clinics. Participants include 400 adults who have had a recent suicide attempt. All are randomised to ‘Zero Suicide-Usual Care plus ASSIP’ or ‘Zero Suicide-Usual Care’. Randomisation is stratified by sex and whether the index attempt is a first suicide attempt or not. Participants complete assessments at baseline, 6 weeks, and 3, 6, 12 and, 18 months. The primary outcome is the time from randomisation to the first suicide reattempt. Prior to the RCT, a 23-person open trial took place, in which 13 participants received ‘Zero Suicide-Usual Care plus ASSIP’ and 14 completed the first follow-up time point.Ethics and disseminationThis study is overseen by the University of Rochester, with single Institutional Review Board (#3353) reliance agreements from Nathan Kline Institute (#1561697) and SUNY Upstate Medical University (#1647538). It has an established Data and Safety Monitoring Board. Results will be published in peer-reviewed academic journals, presented at scientific conferences, and communicated to referral organisations. Clinics considering ASSIP may use a stakeholder report generated by this study, including incremental cost-effectiveness data from the provider point of view.Trial registration numberNCT03894462.
Gender-affirming care in undergraduate nursing education: a scoping review protocol
Authors: Crawford Jess , Schultz Annette S H , Linton Janice , Kramer Marnie , Ristock Janice 
Published: May 2023

IntroductionTransgender and gender-diverse (TGD) people face a multitude of barriers to safe, accessible healthcare. One way to overcome access inequities is through the provision of gender-affirming care. Gender-affirming care is culturally safe and engaged care that values TGD identities and is focused on depathologising TGD people. Additionally, gender-affirming care encompasses awareness and support of TGD individuals as unique beings, including supporting gender-affirming medical goals for those who are interested. The discipline of nursing is well situated to advocate for gender-affirming care, however, receives little undergraduate education in the subject. Undergraduate schools of nursing (including faculty and curriculum) are in a crucial position to implement gender-affirming care, though how they have done this is not widely known. Our scoping review aims to understand how Canadian and US undergraduate schools of nursing teach and integrate gender-affirming education.Methods and analysisOur scoping review will follow the six stages by Arksey and O’Malley and the advancements by Levacet al, reported on as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. The review will be completed in 2023, with the database searches carried out in spring 2023, followed by screening and analysis.Ethics and disseminationEthics approval is not required for this protocol. To aid in knowledge translation, a visual representation of the findings will be created. Results from the final scoping review will be published in a peer-reviewed journal, promoted on social media to schools of nursing, and presented at conferences and seminars.Protocol registration numberOpen Science Framework (https://doi.org/10.17605/OSF.IO/Q68BD).