Evaluating patient factors, operative management and postoperative outcomes in trauma laparotomy patients worldwide: a protocol for a global observational multicentre trauma study

Introduction
Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes.

Methods
We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres.

Discussion
The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.

Leggi
Aprile 2024

Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study

Introduction
Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation.

Objective
We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway.

Methods and analysis
This is a prospective, pragmatic, observational cohort study. Children (aged 0–17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9–15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value.

Ethics and dissemination
The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective.

Trial registration number
NCT05964764.

Leggi
Aprile 2024

Clinical practice guideline recommendations to improve the mental health of adult trauma patients: protocol for a systematic review

Introduction
Mental disorders are common in adult patients with traumatic injuries. To limit the burden of poor psychological well-being in this population, recognised authorities have issued recommendations through clinical practice guidelines (CPGs). However, the uptake of evidence-based recommendations to improve the mental health of trauma patients has been low until recently. This may be explained by the complexity of optimising mental health practices and interpretating CGPs scope and quality. Our aim is to systematically review CPG mental health recommendations in the context of trauma care and appraise their quality.

Methods and analysis
We will identify CPG through a search strategy applied to Medline, Embase, CINAHL, PsycINFO and Web of Science databases, as well as guidelines repositories and websites of trauma associations. We will target CPGs on adult and acute trauma populations including at least one recommendation on any prevention, screening, assessment, intervention, patient and family engagement, referral or follow-up procedure related to mental health endorsed by recognised organisations in high-income countries. No language limitations will be applied, and we will limit the search to the last 15 years. Pairs of reviewers will independently screen titles, abstracts, full texts, and carry out data extraction and quality assessment of CPGs using the Appraisal of Guidelines Research and Evaluation (AGREE) II. We will synthesise the evidence on recommendations for CPGs rated as moderate or high quality using a matrix based on the Grading of Recommendations Assessment, Development and Evaluation quality of evidence, strength of recommendation, health and social determinants and whether recommendations were made using a population-based approach.

Ethics and dissemination
Ethics approval is not required, as we will conduct secondary analysis of published data. The results will be disseminated in a peer-reviewed journal, at international and national scientific meetings. Accessible summary will be distributed to interested parties through professional, healthcare quality and persons with lived experience associations.

PROSPERO registration number
(ID454728).

Leggi
Marzo 2024

Co-design and evaluation of a youth-informed organisational tool to enhance trauma-informed practices in the UK public sector: a study protocol

Introduction
A trauma-informed approach (TIA) means working with awareness that people’s histories of trauma may shape the way they engage with services, organisations or institutions. Young people with adverse childhood experiences may be at risk of retraumatisation by organisational practices in schools and universities and by employers and health agencies when they seek support. There are limited evidence-based resources to help people working in the public sector to work with adolescents in trauma-informed ways and the needs of adolescents have not been central in resource development. This study contributes to public sector capacity to work in trauma-informed ways with adolescents by codesigning and evaluating the implementation of a youth-informed organisational resource.

Methods and analysis
This is an Accelerated Experience-based Co-design (AEBCD) Study followed by pre–post evaluation. Public sector organisations or services, and adolescents connected with them, will collaboratively reflect on lived experience data assembled through creative arts practice, alongside data from epidemiological national data sets. These will present knowledge about the impact of adverse childhood experiences on adolescents’ mental health (stage 1). Collaboratively, priorities (touch points) for organisational responses will be identified (stage 2), and a low-burden resource will be codesigned (stage 3) and offered for implementation (stage 4) and evaluation (stage 5) in diverse settings. The study will provide insights into what adolescents and public sector organisations in the UK want from a TIA resource, the experience of services/organisations in implementing this and recommendations for resource development and implementation.

Ethics and dissemination
The UK National Health Service Health Research Authority approved this study (23/WM/0105). Learning will be shared across study participants in a workshop at the end of the study. Knowledge products will include a website detailing the created resource and a youth-created film documenting the study process, the elements of the codesigned resource and experiences of implementation. Dissemination will target academic, healthcare, education, social care, third sector and local government settings via knowledge exchange events, social media, accessible briefings, conference presentations and publications.

Leggi
Marzo 2024

Predictive value of the Trauma Rating Index in Age, Glasgow Coma Scale, Respiratory rate and Systolic blood pressure score (TRIAGES) for the short-term mortality of older patients with isolated traumatic brain injury: a retrospective cohort study

Objectives
This study aimed to evaluate the effectiveness of the Trauma Rating Index in Age, Glasgow Coma Scale, Respiratory rate and Systolic blood pressure score (TRIAGES) in predicting 24-hour in-hospital mortality among patients aged 65 years and older with isolated traumatic brain injury (TBI).

Design
A retrospective, single-centre cohort study.

Setting
This study was conducted at a government-run tertiary comprehensive hospital.

Participants
This study included 982 patients aged 65 years or older with isolated TBI, who were admitted to the emergency department between 1 January 2020 and 31 December 2021.

Interventions
None.

Primary outcome
24-hour in-hospital mortality was the primary outcome.

Results
Among the 982 patients, 8.75% died within 24 hours of admission. The non-survivors typically had higher TRIAGES and lower GCS scores. Logistic regression showed significant associations of both TRIAGES and GCS with mortality; the adjusted ORs were 1.98 (95% CI 1.74 to 2.25) for TRIAGES and 0.72 (95% CI 0.68 to 0.77) for GCS. Receiver operating characteristic (ROC) analysis indicated an area under the ROC curve of 0.86 for GCS and 0.88 for TRIAGES, with a significant difference (p=0.012). However, precision–recall curve (PRC) analysis revealed an area under the PRC of 0.38 for GCS and 0.47 for TRIAGES, without a significant difference (p=0.107).

Conclusions
The TRIAGES system is a promising tool for predicting 24-hour in-hospital mortality in older patients with TBI, demonstrating comparable or slightly superior efficacy to the GCS. Further multicentre studies are recommended for validation.

Leggi
Marzo 2024

Sigh Breaths in Patients With Trauma Receiving Mechanical Ventilation

To the Editor We recently published a study showing that sigh breaths added to usual care of trauma patients receiving ventilation did not significantly increase the primary end point of ventilator-free days. However, the prespecified secondary and post hoc tertiary end points indicated that sighs were safe, shortened time with the ventilator, and may substantially decrease mortality. We linked these findings to the rationale that surfactant needs to be continuously secreted to prevent ventilator-induced lung injury and that stretching the lung is the strongest stimulus for secretion of surfactant from type II pneumocytes.

Leggi
Marzo 2024

Orthopaedic trauma patients experiences with emergency department care and follow-up through Virtual Fracture Care review: a qualitative study

Objectives
This study aimed to identify factors influencing orthopaedic trauma patients’ experiences and satisfaction with emergency department (ED) care and follow-up through Virtual Fracture Care (VFC) review workflow.

Design
This study employed an explorative, descriptive, qualitative design using individual, semistructured interviews.

Setting
An urban level 2 trauma centre and teaching hospital in Amsterdam, the Netherlands.

Participants
Eligible patients were Dutch-speaking or English-speaking orthopaedic trauma patients, aged 18 years or above, who visited the hospital’s ED between June and September 2022, and were treated through VFC review workflow. Exclusion criteria were: reason for follow-up other than injury, eye/motor/verbal score

Leggi
Febbraio 2024

Study to evaluate the readability and visual appearance of online resources for blunt chest trauma: an evaluation of online resources using mixed methods

Objectives
Blunt chest trauma (BCT) is characterised by forceful and non-penetrative impact to the chest region. Increased access to the internet has led to online healthcare resources becoming used by the public to educate themselves about medical conditions. This study aimed to determine whether online resources for BCT are at an appropriate readability level and visual appearance for the public.

Design
We undertook a (1) a narrative overview assessment of the website; (2) a visual assessment of the identified website material content using an adapted framework of predetermined key criteria based on the Centers for Medicare and Medicaid Services toolkit and (3) a readability assessment using five readability scores and the Flesch reading ease score using Readable software.

Data sources
Using a range of key search terms, we searched Google, Bing and Yahoo websites on 9 October 2023 for online resources about BCT.

Results
We identified and assessed 85 websites. The median visual assessment score for the identified websites was 22, with a range of –14 to 37. The median readability score generated was 9 (14–15 years), with a range of 4.9–15.8. There was a significant association between the visual assessment and readability scores with a tendency for websites with lower readability scores having higher scores for the visual assessment (Spearman’s r=–0.485; p

Leggi
Febbraio 2024

Study of Whole blood in Frontline Trauma (SWiFT): implementation study protocol

Introduction
Uncontrolled bleeding is a major cause of death for patients with major trauma. Current transfusion practices vary, and there is uncertainty about the optimal strategy. Whole blood (WB) transfusion, which contains all components in one bag, is considered potentially advantageous, particularly for resuscitating patients with major bleeding in the prehospital setting. It could potentially improve survival, reduce donor risk and simplify the processes of delivering blood transfusions outside hospitals. However, the evidence supporting the effectiveness and safety of WB compared with the standard separate blood component therapy is limited. A multicentre randomised controlled trial will be conducted, alongside an implementation study, to assess the efficacy, cost-effectiveness and implementation of prehospital WB transfusion in the prehospital environment. The implementation study will focus on evaluating the acceptability and integration of the intervention into clinical settings and on addressing broader contextual factors that may influence its success or failure.

Methods and analysis
A type 1 effectiveness–implementation hybrid design will be employed. The implementation study will use qualitative methods, encompassing comprehensive interviews and focus groups with operational staff, patients and blood donor representatives. Staff will be purposefully selected to ensure a wide range of perspectives based on their professional background and involvement in the WB pathway. The study design includes: (1) initial assessment of current practice and processes in the WB pathway; (2) qualitative interviews with up to 40 operational staff and (3) five focus groups with staff and donor representatives. Data analysis will be guided by the theoretical lenses of the Normalisation Process Theory and the Theoretical Framework of Acceptability.

Ethics and dissemination
The study was prospectively registered and approved by the South Central—Oxford C Research Ethics Committee and the Health Research Authority and Health and Care Research Wales. The results will be published in peer-reviewed journals and provided to all relevant stakeholders.

Trial registration number
ISRCTN23657907; EudraCT: 2021-006876-18; IRAS Number: 300414; REC: 22/SC/0072.

Leggi
Febbraio 2024

Abstract WMP31: Lifetime Trauma Exposure Types Are Linked to Stroke Recovery: Findings From the STRONG Study

Stroke, Volume 55, Issue Suppl_1, Page AWMP31-AWMP31, February 1, 2024. Introduction:The STRONG (Stroke, sTress, RehabilitatiON, and Genetics) study has documented the role of cumulative lifetime stress/trauma exposure (LSE) in stroke recovery. Understanding the types of trauma most closely linked with functional outcomes may identify specific risk factors for stroke recovery. We examined specific types of life stress linked with functional and cognitive disability at 1-year post-stroke.Methods:Adults with a new stroke enrolled at 28 US sites were assessed 4 times over 1 year. Assessments included LSE 90 days post-stroke, and Stroke Impact Scale (SIS), modified Rankin Scale (mRS), & Telephone Montreal Cognitive Assessment (tMOCA) at 1-year post-stroke. Bivariate and multivariate analyses examined relationships among LSE and outcomes.Results:The 763 enrollees had age 63.1±14.9 yrs; initial NIHSS score 4 [2-9]; 41.2% Female; 69.4% White. Controlling for age, gender, race, and 3-mo NIHSS score, lifetime exposure to being raped was associated with worse SIS-ADL, mRS, and tMOCA scores 12-mo post-stroke. Several other LSE were also independently associated with worse 12-mo SIS-ADL scores: witnessing a family member be injured or killed, divorce, and emotional abuse. Having a loved one be seriously ill was associated with better 12-mo t-MOCA scores. These findings were robust when early post-stroke acute stress levels were also included in the model. Women were significantly more likely to report being raped, experiencing emotional abuse, and having a seriously ill loved one. Demographics were not significantly associated with divorce or witnessing a family member injured or killed.Conclusions:Assessing specific types of exposure to LSE early in the post-stroke period may help identify at-risk patients who might benefit from additional post-stroke support to enhance their long-term functional and cognitive abilities.

Leggi
Febbraio 2024

Effectiveness of trauma-focused art therapy (TFAT) for psychological trauma: study protocol of a multiple-baseline single-case experimental design

Introduction
Treatments such as eye movement desensitisation and reprocessing and (narrative) exposure therapies are commonly used in psychological trauma. In everyday practice, art therapy is also often used, although rigorous research on its efficacy is lacking. Patients seem to benefit from the indirect, non-verbal experiential approach of art therapy. This protocol paper describes a study to examine the effectiveness of a 10-week individual trauma-focused art therapy (TFAT) intervention.

Methods and analysis
A mixed-methods multiple-baseline single-case experimental design will be conducted with 25–30 participants with psychological trauma. Participants will be randomly assigned to a baseline period lasting 3–5 weeks, followed by the TFAT intervention (10 weeks) and follow-up (3 weeks). Quantitative measures will be completed weekly: the Beck Depression Inventory-II, the Mental Health Continuum Short Form, the Resilience Scale, the Rosenberg Self-Esteem Scale and the Self-expression and Emotion Regulation in Art Therapy Scale. The Post-Traumatic Stress Disorder Checklist-5 will be completed at week 1 and week 10. Qualitative instruments comprise a semistructured interview with each individual patient and therapist, and a short evaluation for the referrer. Artwork will be used to illustrate the narrative findings. Quantitative outcomes will be analysed with linear mixed models using the MultiSCED web application. Qualitative analyses will be performed using thematic analysis with ATLAS.ti.

Ethics and dissemination
This study has been approved by the ethics committee of the HAN University of Applied Sciences (ECO 394.0922). All participants will sign an informed consent form and data will be treated confidentially. Findings will be published open access in peer-reviewed journals.

Trial registration number
NCT05593302.

Leggi
Gennaio 2024

What are the barriers and enablers to trauma-informed emergency departments? A scoping review protocol

Introduction
There is a high prevalence of psychological trauma among the population. Such people are more likely to have poorer health outcomes and these factors may contribute to increased use of the emergency department. There has been some attempt to implement a trauma-informed approach across public services, especially in health and social care. However, it is unclear how this concept applies to the challenging and high-demand emergency department context. The review aims to locate, examine and describe the literature on trauma-informed care in the unique and challenging healthcare delivery context that is the emergency department. The review aims to identify the barriers and enablers that may facilitate trauma-informed care in the emergency department context.

Methods and analysis
This scoping review will use the Joanna Briggs Institute methodology for scoping reviews. Systematic searches of relevant databases (CINAHL, MEDLINE, PsycINFO, EMBASE, Knowledge Network and Web of Science) will be conducted. Empirical studies of any methodological approach, published in English between January 2001 and September 2023 will be included. The ‘grey’ literature will also be accessed. Two reviewers will independently screen all studies. Data will be extracted, collated and charted to summarise all the relevant methods, outcomes and key findings in the articles.

Ethics and dissemination
Formal ethical approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for key stakeholders in the field. The data generated will be used to inform a programme of work related to trauma-informed care.

Leggi
Gennaio 2024

Effectiveness of photobiomodulation therapy on pain intensity in postpartum women with nipple or perineal trauma: protocol for a multicentre, double-blinded, parallel-group, randomised controlled trial

Introduction
Photobiomodulation (PBM) using low-level laser can affect tissue repair mechanisms and seems promising in reducing pain intensity. However, few studies support the effectiveness of PBM on postpartum period complications, such as nipple and/or perineal trauma and pain, probably due to the low doses used. The primary objective of this study is to analyse the effectiveness of PBM on pain intensity in the nipple and perineal trauma in women in the immediate postpartum period. Secondary objectives are to evaluate the effect on tissue healing and the women’s satisfaction.

Methods and analysis
A double-blind, multicentre, parallel-group, randomised controlled trial will be performed in two public referral maternity hospitals in Brazil with 120 participants, divided into two arms: 60 participants in the nipple trauma arm and 60 participants in the perineal trauma arm. Participants will be women in the immediate postpartum period, who present with nipple trauma or perineal trauma and report pain intensity greater than or equal to 4 points on the Numerical Rating Scale for Pain. Block randomisation will be performed, followed by blinding allocation. In the experimental group, one application of PBM will be performed between 6 hours and 36 hours after birth. For the sham group, the simulation will be carried out without triggering energy. Both participants and the research evaluator will be blinded to the allocation group. Intention-to-treat method and the between-group and within-group outcome measures analysis will be performed.

Ethics and dissemination
This research protocol was approved by the Research Ethics Committees of the University of Campinas, Brazil, and of the School Maternity Assis Chateaubriand, Brazil (numbers CAAE: 59400922.1.1001.5404; 59400922.1.3001.5050). Participants will be required to sign the informed consent form to participate. Results will be disseminated to the health science community.

Trial registration number
Brazilian Registry of Clinical Trials (RBR-2qm8jrp).

Leggi
Dicembre 2023