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临床试验/NCT04810039
NCT04810039已完成不适用

Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
The primary outcome is the number of errors the doctor makes when predicting the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records

研究概览

简要总结

PREDICT II is an observational, prospective design, single-center study aiming to determine whether the prognosis of neurological outcome at 6 months in patients undergoing traumatic brain injury established by a doctor at his initial management is more accurate in experienced doctors versus junior doctors.

详细描述

Head injury is a non-rare cause of mortality and morbidity in young adults. It is difficult and often uncertain to assess the long-term neurological prognosis in these patients. However, this element is of major importance because it allows the clinician to determine the intensity of the therapies used and to adapt the information given to the patient and his relatives.

Numerous studies have been carried out to study the prognosis of these patients, of which two are the most important: CRASH-study and IMPACT-study. However, of all these studies, none of them had the objective of comparing whether the experience of the clinician influenced the accuracy of his prognosis. Similarly, the PREDICT-TBI study conducted at our center, which aimed to compare the clinician's assessment with a prognostic score already in use (IMPACT score) for determining the prognosis of the brain injured person, did not study the influence of the clinician's experience on the accuracy of the prognosis.

Assessment of clinicians' judgment of neurological outcome in 20 patient charts.

20 records will be randomly selected from the N patients included in the PREDICT-TBI study.

These 20 pseudonymities records will be presented, including admission scans and pre-hospital clinical data.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Senior group: intensive care anaesthesists with more than 4 years of experience in neuro-intensive care unit
  • Junior group : advanced semester intensive care anaesthesists interns at the end of an internship composed of 5 months specialized in neuro-ICU

排除标准

  • 未提供

结局指标

主要结局

The primary outcome is the number of errors the doctor makes when predicting the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records

时间窗: Baseline (At inclusion of physicians) or minimum 6 month after patient inclusion

variability between physicians

时间窗: Baseline (At inclusion)

We will ask the intensivists for each patients' data the patient's risk of becoming GOS \< 4 at 6 months between 0 and 100. This measure will be analyzed as a response variable (16\*38 = 576 assessments) in a three-level hierarchical linear mixed model. We will introduce random intercepts for patients within the intensivists and we will add fixed effects as the patient's real becoming and the intensivist's seniority. This model will yield an estimate of a variance between intensivists and another method to test the effect of seniority to determine the patient's becoming. We will carry out analysis with nlme package in R.

confidence in their prognosis

时间窗: Baseline (At inclusion)

measured with the multiple choice question: "How confident are you in the prognosis you just made?" and possible answers: Certain, Very confident, Confident, Not Confident, Unsure.

the information offered to relatives

时间窗: Baseline (At inclusion)

measured with the multiple choice question: " The family arrives distressed ond would like more information on the prognosis and disability at 6 months. You are the first point of contact. Do you insist on?" and possible answers: "The good prognosis factors", "prognostic uncertainty", "disability or possible death".

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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