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临床试验/NCT05648227
NCT05648227进行中(未招募)不适用

Validation of an Artificial Intelligence Enabled Diagnostic Support Software (ArtiQ.Spiro) in Primary Care Spirometry Datasets - a Retrospective Analysis

Royal Brompton & Harefield NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
Evaluate diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

研究概览

简要总结

A retrospective study to evaluate the diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

详细描述

This is a retrospective analysis of existing clinical datasets with consecutive spirometry collected in a primary care setting in the UK. Individual patient data will be included if the individual meets the study protocol eligibility criteria.

Clinical datasets will be de-identified (name, date of birth, address, postcode, occupation GP, ethnicity, medications data removed). Individuals will be identified by a study ID number. The de-identified datasets will contain the minimum information needed for spirometry and ArtiQ.Spiro - namely age, smoking history, height, weight, primary respiratory symptom - and the deidentified data exported from the primary care spirometry software.

ArtiQ.Spiro Evaluation (Index Tests for Diagnosis and Quality):

A deidentified dataset will be provided to a machine learning analyst who will apply the machine learning algorithm of ArtiQ.Spiro. For each individual, the algorithm will produce a preferred diagnosis (highest probability diagnostic category) (Index Test for Diagnosis) and an assessment of spirometry quality (Acceptable, Usable, Not Acceptable/Usable) (Index Test for Quality). No clinical information outside of the spirometry dataset nor reference standard data will be made available to the analyst.

Reference Standard for Diagnosis:

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Adult aged 18 years or over
  • At least one of the following respiratory symptoms: cough, wheeze, shortness of breath, reduced exercise tolerance
  • Spirometry performed for clinical purposes in a non-hospital lung function setting (such as a community clinic, a GP practice, or at home)
  • Spirometry was supervised by a doctor or non-medical allied health professional

排除标准

  • Aged 17 or under
  • No respiratory symptoms
  • Spirometry performed for pre-operative assessment
  • Spirometry performed exclusively as part of a research study
  • Spirometry performed at home without supervision.

结局指标

主要结局

Evaluate diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

时间窗: 24 months

Evaluate diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK care spirometry datasets.

次要结局

  • To evaluate the performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in the quality grading of Forced Expiratory Volume in One second (FEV1) and Forced Vital Capacity (FVC) from UK primary care spirometry datasets.(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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