Emergency Department, Welsh Centre for Emergency Medicine Research, Swansea, UK.
Swansea Trials Unit, Swansea University Medical School, Swansea, UK.
BMJ Open. 2019 Jul 26;9(7):e029187. doi: 10.1136/bmjopen-2019-029187.
A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). The aim of this trial is to assess the feasibility and acceptability of a definitive impact trial investigating the clinical and cost-effectiveness of a new prognostic model for the management of patients with blunt chest wall trauma in the ED.
Stepped wedge feasibility trial.
Four EDs in England and Wales.
Adult blunt chest wall trauma patients presenting to the ED with no concurrent, life-threatening injuries.
A prognostic model (the STUMBL score) to guide clinical decision-making.
Primary: participant recruitment rate and clinicians' use of the STUMBL score. Secondary: composite outcome measure (mortality, pulmonary complications, delayed upgrade in care, unplanned representations to the ED), physical and mental components of quality of life, clinician feedback and health economic data gathering methodology for healthcare resource utilisation.
Quantitative data were analysed using the intention-to-treat principle. 176 patients were recruited; recruitment targets were achieved at all sites. Clinicians used the model in 96% of intervention cases. All feasibility criteria were fully or partially met. After adjusting for predefined covariates, there were no statistically significant differences between the control and intervention periods. Qualitative analysis highlighted that STUMBL was well-received and clinicians would support a definitive trial. Collecting data on intervention costs, health-related quality of life and healthcare resource use was feasible.
We have demonstrated that a fully powered randomised clinical trial of the STUMBL score is feasible and desirable to clinicians. Minor methodological modifications will be made for the full trial.
ISRCTN95571506; Post-results.
已经开发并外部验证了一种新的预后模型，旨在帮助急诊科（ED）的钝性胸壁创伤患者进行管理。本试验旨在评估一项确定性影响试验的可行性和可接受性，该试验旨在评估一种新的预后模型在 ED 管理钝性胸壁创伤患者的临床和成本效益。
阶梯式可行性试验。
英格兰和威尔士的 4 个 ED。
无并发危及生命损伤的成人钝性胸壁创伤患者就诊 ED。
指导临床决策的预后模型（STUMBL 评分）。
参与者招募率和临床医生使用 STUMBL 评分。次要：复合结局指标（死亡率、肺部并发症、护理升级延迟、无计划到 ED 就诊）、身体和心理健康生活质量、临床医生反馈和健康经济数据收集方法用于医疗资源利用。
使用意向治疗原则对定量数据进行分析。共招募了 176 名患者；所有地点均达到了招募目标。干预病例中，医生 96%使用了该模型。所有可行性标准均得到充分或部分满足。在调整了预定义协变量后，干预期和对照组之间没有统计学上的显著差异。定性分析表明，STUMBL 得到了很好的接受，医生会支持确定性试验。收集干预成本、健康相关生活质量和医疗资源使用的数据是可行的。
我们已经证明，STUMBL 评分的全面随机临床试验是可行的，也是临床医生所期望的。将对全试验进行微小的方法学修改。
ISRCTN95571506；试验后。
