Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial

Introduction
Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practices. Recently, there have been new insights into treatment strategies, such as early diagnosis and minimally invasive operative treatment. The aim of this study is to implement an evidence-based and experience-based treatment clinical pathway to improve outcomes in this fragile patient population.

Methods and analysis
This study will be a regional stepped-wedge cluster randomised controlled trial. All older adult patients (≥50 years old) who suffered a pelvic fragility fracture after low-energetic trauma are eligible for inclusion. The pathway aims to optimise the diagnostic process, to guide the decision-making process for further treatment (eg, operative or conservative), to structure the follow-up and to provide guidelines on pain management, weight-bearing and osteoporosis workup. The primary outcome is mobility, measured by the Parker Mobility Score. Secondary outcomes are mobility measured by the Elderly Mobility Scale, functional performance, quality of life, return to home rate, level of pain, type and dosage of analgesic medications, the number of falls after treatment, the number of (fracture-related) complications, 1-year and 2-year mortality. Every 6 weeks, a cluster will switch from current practice to the clinical pathway. The aim is a total of 393 inclusions, which provides an 80% statistical power for an improvement in mobility of 10%, measured by the Parker mobility score.

Ethics and dissemination
The Medical Research Ethics Committee of Academic Medical Center has exempted the PELVIC study from the Medical Research Involving Human Subjects Act (WMO). Informed consent will be obtained using the opt-out method and research data will be stored in a database and handled confidentially. The final study report will be shared via publication without restrictions from funding parties and regardless of the outcome.

Trial registration number
NCT06054165.

Protocol version
V.1.0, 19 July 2022

Leggi
Agosto 2024

False claims of equivalence in the neurosurgical trauma literature: prevalence and associated factors–a systematic review protocol

Introduction
Research quality within the neurosurgical field remains suboptimal. Therefore, many studies published in the neurosurgical literature lack enough statistical power to establish the presence or absence of clinically important differences between treatment arms. The field of neurotrauma deals with additional challenges, with fewer financial incentives and restricted resources in low-income and middle-income countries with the highest burden of neurotrauma diseases. In this systematic review, we aim to estimate the prevalence of false claims of equivalence in the neurosurgical trauma literature and identify its predictive factors.

Methods and analysis
The Preferred Reporting Items for Systematic Review and Meta-Analyses recommendations were followed. Randomised clinical trials that enrolled only traumatic brain injury patients and investigated any type of intervention (surgical or non-surgical) will be eligible for inclusion. The MEDLINE/PubMed database will be searched for articles in English published from January 1960 to July 2020 in 15 top-ranked journals. A false claim of equivalence will be identified by insufficient power to detect a clinically meaningful effect: for categorical outcomes, a difference of at least 25% and 50%, and for continuous outcomes, a Cohen’s d of at least 0.5 and 0.8. Using the number of patients in each treatment arm and the minimum effect sizes to be detected, the power of each study will be calculated with the assumption of a two-tailed alpha that equals 0.05. Standardised differences between the groups with and without a false claim of equivalence will be calculated, and the variables with a standardised difference equal or above 0.2 and 0.5 will be considered weakly and strongly associated with false claims of equivalence, respectively. The data analysis will be blinded to the authors and institutions of the studies.

Ethics and dissemination
This study will not involve primary data collection. Therefore, formal ethical approval will not be required. The final systematic review will be published in a peer-reviewed journal and presented at appropriate conferences.

Leggi
Luglio 2024

Post-traumatic stress disorder symptoms following exposure to acute psychological trauma in children aged 8-16 years in South Africa: protocol for the Sinethemba longitudinal study

Introduction
Children exposed to trauma are vulnerable to developing post-traumatic stress disorder (PTSD) and other adverse mental health outcomes. In low-and middle-income countries (LMICs), children are at increased risk of exposure to severe trauma and co-occurring adversities. However, relative to high-income countries, there is limited evidence of the factors that predict good versus poor psychological recovery following trauma exposure in LMIC children, and the role of caregiver support in these high-adversity communities.

Methods and analysis
We will conduct a longitudinal, observational study of 250 children aged 8–16 years and their caregivers in South Africa, following child exposure to acute trauma. Dyads will be recruited from community hospitals following a potentially traumatic event, such as a motor vehicle accident or assault. Potential participants will be identified during their hospital visit, and if they agree, will subsequently be contacted by study researchers. Assessments will take place within 4 weeks of the traumatic event, with 3-month and 6-month follow-up assessments. Participants will provide a narrative description of the traumatic event and complete questionnaires designed to give information about social and psychological risk factors. Child PTSD symptoms will be the primary outcome, and wider trauma-related mental health (depression, anxiety, behavioural problems) will be secondary outcomes. Regression-based methods will be used to examine the association of psychosocial factors in the acute phase following trauma, including caregiver support and responding, with child PTSD and wider mental health outcomes.

Ethics and dissemination
Ethical approvals have been granted by Stellenbosch University and the University of Bath, with additional approvals to recruit via hospitals and healthcare clinics being granted by the University of Cape Town, the Department of Health and the City of Cape Town. Study findings will be disseminated via publication in journals, workshops for practitioners and policy-makers, and public engagement events.

Leggi
Luglio 2024

Healing the Past by Nurturing the Future: trauma-aware, healing-informed care to improve support for Aboriginal and Torres Strait Islander families – implementation and evaluation study protocol

Introduction
Complex trauma can have serious impacts on the health and well-being of Aboriginal and Torres Strait Islander families. The perinatal period represents a ‘critical window’ for recovery and transforming cycles of trauma into cycles of healing. The Healing the Past by Nurturing the Future (HPNF) project aims to implement and evaluate a programme of strategies to improve support for Aboriginal and Torres Strait islander families experiencing complex trauma.

Method
The HPNF programme was codesigned over 4 years to improve awareness, support, recognition and assessment of trauma. Components include (1) a trauma-aware, healing-informed training and resource package for service providers; (2) trauma-awareness resources for parents; (3) organisational readiness assessment; (4) a database for parents and service providers to identify accessible and appropriate additional support and (5) piloting safe recognition and assessment processes. The programme will be implemented in a large rural health service in Victoria, Australia, over 12 months. Evaluation using a mixed-methods approach will assess feasibility, acceptability, cost, effectiveness and sustainability. This will include service user and provider interviews; service usage and cost auditing; and an administrative linked data study of parent and infant outcomes.

Analysis
Qualitative data will be analysed using reflexive thematic analysis. Quantitative and service usage outcomes will be described as counts and proportions. Evaluation of health outcomes will use interrupted time series analyses. Triangulation of data will be conducted and mapped to the Consolidated Framework for Implementation Research and Reach, Effectiveness, Adoption, Implementation and Maintenance frameworks to understand factors influencing feasibility, acceptability, effectiveness, cost and sustainability.

Ethics and dissemination
Approval granted from St Vincent’s Melbourne Ethics Committee (approval no. 239/22). Data will be disseminated according to the strategy outlined in the codesign study protocol, in-line with the National Health and Medical Research Council Aboriginal and Torres Strait Islander Research Excellence criteria.

Leggi
Luglio 2024

Trauma nursing competency in the emergency department: a concept analysis

Objectives
Despite numerous published concept analyses of nursing competency, the specific understanding of trauma nursing competency in emergency departments remains limited, with no clear definition. This study aimed to clarify the definitions and attributes of trauma nursing competencies in emergency departments.

Design
Walker and Avant’s method was used to clarify the concept of trauma nursing competency in emergency departments.

Data sources
PubMed, EMBASE, CINAHL and RISS were searched from inception to 23 April 2023.

Eligibility criteria
Relevant studies that included combinations of the terms ‘nurse’, ‘nursing’, ‘emergency’, ‘trauma’, ‘competency’, ‘capability’ and ‘skill’ were selected. We restricted the literature search to English and Korean full-text publications, with no limit on the publication period; grey literature was excluded.

Data extraction and synthesis
This study uses defining attributes, antecedents and consequences extracted through data analysis. To aid comprehension of the model, related and contrary cases of the concept were created, and empirical referents were defined.

Results
After excluding duplicates, irrelevant studies, incomplete texts and articles unrelated to the context and study population, 15 of the initial 927 studies were included. Five additional studies were added after a manual search of the references. The final concept analysis therefore included 20 studies. The attributes of trauma nursing competency for emergency nurses included ‘rapid initial assessments considering injury mechanisms’, ‘priority determinations based on degrees of urgency and severity’, ‘clinical knowledge of trauma nursing’, ‘skills of trauma nursing’, ‘interprofessional teamwork’ and ‘emotional care’.

Conclusions
The concept analysis revealed that it is possible to promote the enhancement and development of trauma nursing competency in emergency departments across various contexts, such as clinical practice, education, research and organisational settings. This could ultimately improve trauma nursing quality and treatment outcomes.

Leggi
Giugno 2024

Development and validation of a model to predict the need for artificial airways for acute trauma patients in the emergency department: a retrospective case-control study

Objective
To develop scores for predicting the need for artificial airway procedures for acute trauma patients in the emergency department (ED).

Design
Retrospective case–control.

Setting
A tertiary comprehensive hospital in China.

Participants
8288 trauma patients admitted to the ED within 24 hours of injury and who were admitted from 1 August 2012 to 31 July 2020.

Primary and secondary outcome measures
The study outcome was the establishment of an artificial airway within 24 hours of admission to the ED. Based on the different feature compositions, two scores were developed in the development cohort by multivariable logistic regression. The predictive performance was assessed in the validation cohort.

Results
The O-SPACER (Oxygen saturation, Systolic blood pressure, Pulse rate, Age, Coma Scale, Eye response, Respiratory rate) score was developed based on the patient’s basic information with an area under the curve (AUC) of 0.85 (95% CI 0.80 to 0.89) in the validation group. Based on the basic information and trauma scores, the IO-SPACER (Injury Severity Score, Oxygen saturation, Systolic blood pressure, Pulse rate, Age, Coma Scale, Eye response, Respiratory rate) score was developed, with an AUC of 0.88 (95% CI 0.84 to 0.92). According to the O-SPACER and IO-SPACER scores, the patients were stratified into low, medium and high-risk groups. According to these two scores, the high-risk patients were associated with an increased demand for artificial airways, with an OR of 40.16–40.67 compared with the low-risk patients.

Conclusions
The O-SPACER score provides risk stratification for injured patients requiring urgent airway intervention in the ED and may be useful in guiding initial management. The IO-SPACER score may assist in further determining whether the patient needs planned intubation or tracheotomy early after trauma.

Leggi
Giugno 2024

Childbirth Acquired Perineal Trauma study (CHAPTER): a UK prospective cohort study protocol

Introduction
Childbirth-related perineal trauma (CRPT) is the most common complication of childbirth affecting 80% of women overall after vaginal birth. There remains a lack of comprehensive evidence relating to the prevalence of subsequent health problems. Current evidence is related to short-term outcomes, for example, pain, but there is less known about longer-term outcomes such as infection, wound dehiscence, pelvic floor function and psychological outcomes. This is a protocol for a cohort study assessing outcomes of women after CRPT.

Methods and analysis
A multicentre, prospective UK cohort study aiming to include 1000 women. All women who have sustained CRPT will be eligible for inclusion and will be followed-up for 12 months after childbirth. The primary outcome will be perineal infection at 6 weeks post-birth. Secondary outcomes will include antibiotic use for perineal infection, wound breakdown, use of analgesia, the requirement for admission or surgical intervention, urinary and faecal incontinence, anxiety and depressive symptoms, sexual function and impact on daily activities. Outcomes will be measured at 6 weeks, 6 months and 12 months post partum, with some outcomes being measured at all time points and others at selected most appropriate time points only. Outcome data will be obtained from a review of clinical notes and from patient questionnaires. Simple descriptive statistics will be used to summarise characteristics and outcomes, with categorical variables expressed as percentages and continuous variables as mean averages, alongside the corresponding standard deviatons.

Ethics and dissemination
Ethical approval has been granted by the Research Ethics Council with reference 23/WA/0169. Data collected from the Childbirth Acquired Perineal Trauma (CHAPTER) cohort study will highlight the prevalence and type of complications after CRPT and which women are more at risk. After the conclusion of this study, findings will be used to work with governmental organisations and Royal Colleges to target resources and ultimately improve care.

Leggi
Maggio 2024

Research priorities for the management of major trauma: an international priority setting partnership with the James Lind Alliance

Objective
The objective of this study is to determine research priorities for the management of major trauma, representing the shared priorities of patients, their families, carers and healthcare professionals.

Design/setting
An international research priority-setting partnership.

Participants
People who have experienced major trauma, their carers and relatives, and healthcare professionals involved in treating patients after major trauma. The scope included chest, abdominal and pelvic injuries as well as major bleeding, multiple injuries and those that threaten life or limb.

Methods
A multiphase priority-setting exercise was conducted in partnership with the James Lind Alliance over 24 months (November 2021–October 2023). An international survey asked respondents to submit their research uncertainties which were then combined into several indicative questions. The existing evidence was searched to ensure that the questions had not already been sufficiently answered. A second international survey asked respondents to prioritise the research questions. A final shortlist of 19 questions was taken to a stakeholder workshop, where consensus was reached on the top 10 priorities.

Results
A total of 1572 uncertainties, submitted by 417 respondents (including 132 patients and carers), were received during the initial survey. These were refined into 53 unique indicative questions, of which all 53 were judged to be true uncertainties after reviewing the existing evidence. 373 people (including 115 patients and carers) responded to the interim prioritisation survey and 19 questions were taken to a final consensus workshop between patients, carers and healthcare professionals. At the final workshop, a consensus was reached for the ranking of the top 10 questions.

Conclusions
The top 10 research priorities for major trauma include patient-centred questions regarding pain relief and prehospital management, multidisciplinary working, novel technologies, rehabilitation and holistic support. These shared priorities will now be used to guide funders and teams wishing to research major trauma around the globe.

Leggi
Maggio 2024