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临床试验/NCT03414853
NCT03414853已完成不适用

Prospective Study of a Free-text Diagnosis Prediction Algorithm for Appendicitis in the Emergency Department

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 689 人开始时间: 2017年12月4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
689
试验地点
1
主要终点
Accuracy of predictive algorithm for acute appendicitis

研究概览

简要总结

Computer-aided diagnostic software has been used to assist physicians in various ways. Text-based prediction algorithms have been trained on past medical records through data mining and feature analysis. Currently, all text-based machine learning prediction problem models have been built on extracted data with no research completed on free text based prediction algorithms. This study aims to determine the accuracy of a free text prediction algorithm in predicting the probability of appendicitis in patients presenting to the Emergency Department with abdominal pain and gastrointestinal symptoms.

详细描述

Developing machine learning models that have a strong prediction power for diagnosis of appendicitis from physician entered free text input can improve diagnostic accuracy of doctors. It also offers the possibility of using prediction algorithms to improve routine clinical care. In the future, multiple machine learning models can be combined to increase prediction accuracy and prediction algorithms can be extended to other diagnoses.

18,000 cases of emergency department presentations over 10 years were used as a training and validation dataset. To develop the appendicitis prediction model, deep learning neural networks with a customized medical ontology were used. The diagnostic accuracy of the model is expressed as sensitivity (recall), specificity and F1 score (harmonic mean). The developed diagnosis predictive model shows high sensitivity (86.3%), specificity (91.9%) and F1 score (88.8) in diagnosing appendicitis from patients presenting with abdominal pain.

The predictive model algorithm will also highlight words in the free text (entered by the attending physician) that it assigns higher probability for predicting an outcome. The doctors will be instructed to provide a percentage likelihood of appendicitis based on the clinical presentation and any available laboratory investigations. The doctor is then shown the prediction of the algorithm as well as the highlighted words for the patient entered. He/she must then provide another prediction of the likelihood of appendicitis after seeing the algorithm generated prediction.

The aim is to evaluate the performance of the algorithm and to assess if usage of the algorithm is able to help emergency doctors improve their diagnosis of appendicitis. The prediction results will be tabulated to assess accuracy of the algorithm, doctors before algorithm input and doctors after receiving algorithm input. The accuracy will be expressed as sensitivity, specificity, accuracy, positive prediction value, F1 score and F0.5 score.

Approximately 100 emergency doctors will be recruited over the course of 1 year as participants in the study. The doctors will be split randomly assigned to two groups - the algorithm arm and the no algorithm arm. The randomization will be by time (weekly) using variable block randomization of 4 and 6. The patients will be followed up for the final discharge diagnoses.

研究设计

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

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presence of abdominal pain, OR
  • •Presence of gastrointestinal symptoms such as nausea, vomiting or diarrhea, OR
  • •Fever with anorexia

排除标准

  • •Previous history of appendicectomy
  • •Refusal of consent

结局指标

主要结局

Accuracy of predictive algorithm for acute appendicitis

时间窗: 30 days

Accuracy of predictive algorithm and accuracy of doctors with input from the algorithm in diagnosing acute appendicitis

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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