Role of single-dose intravenous iron therapy for the treatment of anaemia after orthopaedic trauma: protocol for a pilot randomised controlled trial

Introduction
Orthopaedic 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 analysis
This 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 dissemination
This 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 number
NCT05292001; ClinicalTrials.gov.

Leggi
Marzo 2023

Feasibility evaluation of the Reaching Out to Kids with Emotional Trauma (ROcKET) intervention in an elementary school: a single-arm, single-centre, feasibility study based on the RE-AIM framework

Objective
The study purpose was to describe feasibility of implementation of the Reaching Out to Kids with Emotional Trauma (ROcKET) intervention. We hypothesised that the ROcKET Intervention would be feasible in a poor resource school.

Design
We performed a single-arm, single-centr feasibility study of an intervention pilot, based on the RE-AIM framework.

Setting
The intervention was delivered in a single K-4th elementary charter school in the Nashville, TN area, in a low-resource community.

Participants
57 elementary school children attending our partner school and reporting exposure to at least one adverse childhood experience (ACE) and their parents.

Interventions
The Reaching Out to Kids with Emotional Trauma (ROcKET) intervention is a school-based multilevel intervention (individual child, family and school) that promotes positive health behaviours in children who have been exposed to ACEs.

Outcomes
Outcomes were gathered qualitatively via focus groups. The primary outcome was feasibility. The secondary outcomes were implementation outcomes according to the RE-AIM framework, including Reach, Effectiveness, Adoption and Implementation.

Results
Of 105 eligible children, 57 children and their parents participated (54%) with 31 (54%) girls, 47 (82%) Black/African American, 5 (9%) Hispanic and 5 (9%) white. The school staff implemented all planned ROcKET sessions with >90% fidelity in each session, and 52 (91%) of children who completed the final intervention session went on to complete 6 month follow-up assessments. The average attendance at the in-school child sessions was 57 students (87%), and 35 (61%) of parents attended at least one family session, with 25 (44%) of parents attending at least half of the family sessions. 13 (23%) parents participated in the focus groups. Qualitative data suggested high parent participant satisfaction, uptake of positive health behaviours targeted by the intervention and increased quality of life.

Conclusions
Our study suggests that the ROcKET intervention was feasible and acceptably delivered in a local elementary school with high reach to low-income and minority populations. These data suggest that schools, especially those serving low-income and minority children, can be an appropriate avenue for interventions designed to address health disparities. Data from this study will be used to advise a pilot study of the intervention.

Leggi
Marzo 2023

Configurations and outcomes of acute hospital care for frail and older patients with moderate to major trauma: a systematic review

Objective
To systematically review research on acute hospital care for frail or older adults experiencing moderate to major trauma.

Setting
Electronic databases (Medline, Embase, ASSIA, CINAHL Plus, SCOPUS, PsycINFO, EconLit, The Cochrane Library) were searched using index and key words, and reference lists and related articles hand-searched.

Included articles
Peer-reviewed articles of any study design, published in English, 1999–2020 inclusive, referring to models of care for frail and/or older people in the acute hospital phase of care following traumatic injury defined as either moderate or major (mean or median Injury Severity Score ≥9). Excluded articles reported no empirical findings, were abstracts or literature reviews, or referred to frailty screening alone.

Methods
Screening abstracts and full text, and completing data extractions and quality assessments using QualSyst was a blinded parallel process. A narrative synthesis, grouped by intervention type, was undertaken.

Outcome measures
Any outcomes reported for patients, staff or care system.

Results
17 603 references were identified and 518 read in full; 22 were included—frailty and major trauma (n=0), frailty and moderate trauma (n=1), older people and major trauma (n=8), moderate or major trauma (n=7) 0r moderate trauma (n=6) . Studies were observational, heterogeneous in intervention and with variable methodological quality.
Specific attention given to the care of older and/or frail people with moderate to major trauma in the North American context resulted in improvements to in-hospital processes and clinical outcomes, but highlights a relative paucity of evidence, particularly in relation to the first 48 hours post-injury.

Conclusions
This systematic review supports the need for, and further research into an intervention to address the care of frail and/or older patients with major trauma, and for the careful definition of age and frailty in relation to moderate or major trauma.

International Prospective Register of Systematic Reviews (PROSPERO)
CRD42016032895.

Leggi
Febbraio 2023

Facilitators and barriers impacting in-hospital Trauma Quality Improvement Program (TQIP) implementation across country income levels: a scoping review

Objective
Trauma is a leading cause of mortality and morbidity globally, disproportionately affecting low/middle-income countries (LMICs). Understanding the factors determining implementation success for in-hospital Trauma Quality Improvement Programs (TQIPs) is critical to reducing the global trauma burden. We synthesised topical literature to identify key facilitators and barriers to in-hospital TQIP implementation across country income levels.

Design
Scoping review.

Data sources
PubMed, Web of Science and Global Index Medicus databases were searched from June 2009 to January 2022.

Eligibility criteria
Published literature involving any study design, written in English and evaluating any implemented in-hospital quality improvement programme in trauma populations worldwide. Literature that was non-English, unpublished and involved non-hospital TQIPs was excluded.

Data extraction and synthesis
Two reviewers completed a three-stage screening process using Covidence, with any discrepancies resolved through a third reviewer. Content analysis using the Consolidated Framework for Implementation Research identified facilitator and barrier themes for in-hospital TQIP implementation.

Results
Twenty-eight studies met the eligibility criteria from 3923 studies identified. The most discussed in-hospital TQIPs in included literature were trauma registries. Facilitators and barriers were similar across all country income levels. The main facilitator themes identified were the prioritisation of staff education and training, strengthening stakeholder dialogue and providing standardised best-practice guidelines. The key barrier theme identified in LMICs was poor data quality, while high-income countries (HICs) had reduced communication across professional hierarchies.

Conclusions
Stakeholder prioritisation of in-hospital TQIPs, along with increased knowledge and consensus of trauma care best practices, are essential efforts to reduce the global trauma burden. The primary focus of future studies on in-hospital TQIPs in LMICs should target improving registry data quality, while interventions in HICs should target strengthening communication channels between healthcare professionals.

Leggi
Febbraio 2023

Design, development and randomised controlled trial protocol of a smartphone-delivered version of 'SOLAR for emergency service workers to manage stress and trauma

Introduction
Emergency service workers are routinely exposed to stress and trauma, and there is a need to address mental health symptoms early to prevent chronic impairment and/or psychiatric disorder. Digital health innovations mean that face-to-face psychosocial interventions can now be delivered remotely, which is particularly appealing to populations who have strong preferences for digital delivery, such as emergency service workers. This two phase study aims to first adapt the Skills fOr Life Adjustment and Resilience (SOLAR) programme into a smartphone application (‘app’), and then evaluate the effectiveness of this new app.
Methods and analyses
First, focus groups and codesign activities with mental health professionals and emergency service workers will be conducted to develop and test the prototype smartphone version of SOLAR (ie, SOLAR-m). Second, a multicentre randomised controlled trial will investigate the effectiveness of the new app, compared with an active control app, in reducing symptoms of anxiety and depression (primary outcome), as well as other indicators of mental health and work performance. Firefighters from one of the largest urban fire and rescue services in Australia who are currently experiencing distress will be invited to participate. After screening and baseline assessment, 240 will be randomised to receive either SOLAR-m or the control app for 5 weeks, with measurements pre, post and 3-month follow-up. Analyses will be conducted within an intention-to-treat framework using mixed modelling.

Ethics and dissemination
The current trial has received ethics approval from the University of Melbourne Human Research Ethics Committee (2021-20632-18826-5). Study results will be disseminated through peer-reviewed journals and conferences, with a focus on how to expand the new app to other trauma-affected populations if proven effective.

Trial registration number
ANZCTRN12621001141831.

Leggi
Febbraio 2023

Trauma

This essay describes the author’s experience with childhood trauma through the lens of a cancer diagnosis.

Leggi
Gennaio 2023

Hospital-based patient navigation programs for patients who experience injury-related trauma and their caregivers: a scoping review

Objective
This review’s objective is to map the literature on the characteristics, impact, barriers and facilitators of hospital-based patient navigation programmes that support patients who experience injury-related trauma and their caregivers. Patients who experience injury-related trauma frequently require support from multiple care teams and face many challenges to care, both in hospital and when transitioning across settings and services. Patient navigation can improve their care.

Design
This review is conducted according to JBI methodology for scoping reviews. The initial database search took place on 6 June 2021 and the grey literature search took place between September and October 2021. The results are presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses for Scoping Reviews flow diagram.

Setting
This review considered materials where the patient navigation programmes were delivered in hospital settings. There was no geographical limit to this study.

Participants
This review focused on hospital-based patient navigation programmes for patients who experience injury-related trauma and/or their caregivers.

Results
This review captured 11 records that describe 10 programmes. All programmes were based in the USA. Most programmes provided education, care coordination, discharge planning, and referrals to resources, services, and programmes to assist patients and/or their families in the hospital or the community. Half the programmes were based in level 1 trauma centres. Common impacts included decreases in readmission rates and increases in satisfaction rates. Barriers included difficulty recruiting or enrolling patients with short hospital stays and hospital administrators’ and healthcare providers’ lack of understanding of the navigator role. Navigator background, either professional or experiential, was identified as a facilitator, as was flexibility in programme delivery and communication methods.

Conclusions
Eleven records show a small but distinct sample. Reported characteristics, impact, barriers and facilitators were consistent with findings from other patient navigation studies. The results can inform the development and implementation of similar programmes in trauma centres and support changes in policy to improve the delivery of care.

Leggi
Dicembre 2022

Quality evaluation of clinical practice guidelines for thromboprophylaxis in orthopaedic trauma based on AGREE II and AGREE-REX: a systematic review protocol

Introduction
Orthopaedic trauma patients are at high risk of venous thromboembolism (VTE). As VTE prophylaxis has gradually raised public concerns, guidelines related to this topic have increased over time. However, the existing recommendations of thromboprophylaxis guidelines in orthopaedic trauma patients are still inconsistent, and the quality of the guidelines and recommendations for the topic still lacks comprehensive assessments. This review aims to critically appraise clinical practice guidelines for thromboprophylaxis in orthopaedic trauma patients.

Methods and analysis
We will conduct a comprehensive literature search up to 31 October 2022 in databases (PubMed, EMBASE, CINAHL, Web of Science, the Cochrane Library, etc), academic websites and guideline repositories. The quality of the guidelines and recommendations will be assessed by five reviewers independently using the Appraisal of Guidelines Research and Evaluation II instrument (AGREE-II) and the AGREE – Recommendation EXcellence (AGREE-REX). We will summarise the characteristics of the guidelines and compare the differences between these recommendations.

Ethics and dissemination
This study will follow the Declaration of Helsinki and has received approval from the Ethics Committee on Biomedical Research, West China Hospital, Sichuan University (ethics approval no. 2021-989). The results will be summarised as a paper, disseminated through peer-reviewed journals, and will help guide further research in the future.

Protocol registration number
CRD42021273405.

Leggi
Novembre 2022

Comparing restrictive versus liberal oxygen strategies for trauma patients — the TRAUMOX2 trial: protocol for a randomised clinical trial

Introduction
Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma.

Methods and analysis
TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial.
Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen ( >21%) that ensures an SpO2 of 94%. The liberal group receives 12–15 L O2/min or FiO2=0.6–1.0.
The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome).
With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group.

Ethics and dissemination
TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal.

Trial registration numbers
EudraCT 2021-000556-19; NCT05146700.

Leggi
Novembre 2022

Comparative analysis of all-terrain vehicles, motorcycle and automobile-related trauma in a rural border community of the USA

Introduction
There is widespread use of all-terrain vehicles (ATVs) in the USA for both work-related and recreational activities. In this study, we aimed to determine the difference in injury severity, Glasgow Coma scales and length of stay between ATV-related injuries and injuries sustained from motorcycles (MOTOs) and automobiles (AUTOs).

Methods
We retrospectively analysed ATV, MOTO and AUTO injuries from a Level 2 Trauma Center between 01 January 2015 and 31 August 2020. Proportional odds regression analyses, as well as multivariable regression models, were used to analyse the data.

Results
There were significantly more male and paediatric patients that suffered ATV-related injuries compared with MOTO or AUTO injuries. Victims of ATV-related injuries were also more likely to have open fractures. Paediatric patients were less likely to sustain an injury from either AUTO or MOTO accidents compared with ATV accidents. Patients with no drug use during injury and those who used protective equipment such as seat belts and child seats were significantly associated with lower Injury Severity Scores and higher Glasgow Coma Scale scores, indicating less severe injuries.

Discussion
Paediatric patients are very likely to suffer sequela and long-term disability due to the severity of ATV-related injuries. Public awareness campaigns to educate our population, especially our youth, about the danger of ATV use are highly needed.

Leggi
Ottobre 2022