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临床试验/NCT03264417
NCT03264417已完成不适用

Pulmonary Function Test Study - Automated Interpretation

KU Leuven1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
50
试验地点
1
主要终点
Interclass correlation coëfficiënt for whole group

研究概览

简要总结

A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.

详细描述

This is a multi-center non-interventional retrospective study that will use data obtained from clinical routine. In the hospital, subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests if clinically indicated. Results of these tests, expressed as numerical values are send to the clinical workstation (KWS) for immediate clinical use. These results are subsequently being interpreted by a clinician.

A random sample of 50 lung function printouts of subjects followed at the Leuven pulmonary service with a final diagnosis of a respiratory disease have been randomised. These anonymized printouts will be given to different pulmonologists for examination in 18 different centers and compared with the interpretation of in-house developed software.

研究设计

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

入排标准

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

入选标准

  • •Age more than 18 years
  • •Completed one or more pulmonary function tests

排除标准

  • •Younger than 18
  • •Lung transplantation, lung cancer.

结局指标

主要结局

Interclass correlation coëfficiënt for whole group

时间窗: 6 months

Variation in preferred primary diagnosis of respiratory disease given by every physician for every case (selection of one diagnosis out of a fixed panel of 9 possible diagnoses).

次要结局

  • Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case(6 months)
  • Interclass correlation coëfficiënt for every case(6 months)
  • Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)(6 months)
  • Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)(6 months)
  • Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)(6 months)
  • Comparison of accuracy (% of correct diagnoses) of physicians with software(6 months)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wim Janssens

Prof. Dr.

KU Leuven

研究点 (1)

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