Battle Ceri, Abbott Zoe, Hutchings Hayley A, O'Neill Claire, Groves Sam, Watkins Alan, Lecky Fiona E, Jones Sally, Gagg James, Body Richard, Evans Philip A
Emergency Department, Welsh Institute of Biomedical and Emergency Medicine Research, Morriston Hospital, Swansea, UK.
Swansea University Medical School,Swansea University, Swansea, UK.
BMJ Open. 2017 Jul 10;7(7):e015972. doi: 10.1136/bmjopen-2017-015972.
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). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design.
METHODS/ANALYSIS: This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed.
Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed , presentation at appropriate conferences and to stakeholders at professional meetings.
ISRCTN95571506; Pre-results.
已开发并进行了外部验证的一种新的预后模型，其目的是协助急诊科（ED）对钝性胸壁创伤患者进行管理。在该新模型被临床实践接受之前，需要进行一项确定性随机对照试验（影响试验）来评估其临床和成本效益。本试验的目的是评估此类确定性试验的可行性和可接受性，并为其设计提供信息。
方法/分析：本可行性试验旨在测试一项多中心、整群随机（阶梯式楔形）试验的方法，并包含大量定性成分。英格兰和威尔士的四家急诊科将在5个月内收集所有钝性胸壁创伤患者的数据；在初始阶段作为对照（常规护理），在第二阶段作为干预措施（使用新模型）。在急诊科进行初始评估时将获取包括完成SF-12v2在内的基线测量数据。然后将收集任何后续住院患者的结局数据。数据收集将以完成两项调查（SF-12v2和客户服务收据清单）的6周随访结束。结局分析将侧重于可行性、可接受性和试验过程，包括招募和保留率、临床医生培训出勤率以及急诊科对模型的使用情况。将通过临床医生访谈和研究护士焦点小组获得定性反馈。将完成对卫生经济学结局数据可行性的评估。
威尔士研究伦理委员会6于2016年9月批准了该试验。患者招募将于2017年2月开始。计划通过在同行评审期刊上发表、在适当会议上进行展示以及在专业会议上向利益相关者进行传播。
ISRCTN95571506；预结果。
