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diagnostic threshold clinical diagnostic criteria standard development stage key technology methodological requirements output diagnostic item pulse weight coefficient threshold calculation roc curve analysis auc≥0.7 diagnostic diagnostic item list weight determination analytical hierarchy process petition work agencies single-layer coatings nickel-copper-based corrosion-resistant alloy
T/CACM 1336-2020 in English

T/CACM 1336-2020 in English

VALID

Development and application specification of clinical diagnostic criteria for traditional Chinese medicine syndrome based on combination of disease and syndrome

  • Issued on:2020-06-24
  • Implemented on:-
  • File Format:PDF
  • Delivery:Via email within 5 business days
Price(USD): $310.00
$301.00
Standard No: T/CACM 1336-2020
Document status: VALID
Title in English: Development and application specification of clinical diagnostic criteria for traditional Chinese medicine syndrome based on combination of disease and syndrome
Title in Chinese: 基于病证结合的中医证临床诊断标准研制与应用规范
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 5 business days
Issued on: 2020-06-24
ICS Classification: 01.040.11-Health care technology (Vocabularies)
Chinese Classification: C04-Basic standards and general methods
Professional Classification: T/-Social Organization Standard
Related Keywords: diagnostic threshold
clinical diagnostic criteria
standard development stage key technology methodological requirements output diagnostic item
pulse weight coefficient threshold calculation roc curve analysis auc≥0.7 diagnostic
diagnostic item list weight determination analytical hierarchy process
Related Topics: develop
Standard development
certificate
combine
Standard Verification and Application
clinical diagnosis
Based on a large number of clinical samples
used in clinical
Based on clinical phase 2 approval
clinically proven clinical
bed diagnosis
clinically proven medicine
confirmatory clinical
Clinical certificate
in clinical application
clinical diagnosis
CSI
Clinical self-diagnosis system
inconsistent with clinical
and develop applications
Diagnosis and Curative Effect of Syndrome in Internal Medicine of Traditional Chinese Medicine
Standard application certificate
Clinical application and standardization
Gold standards and reference reagents in clinical trials
Industry-standard application proven

本标准规定了基于病证结合的中医证临床诊断标准的主要研制流程和标准配套“使用说明书”编撰要点。
本标准适用于病证结合模式下中医证临床诊断标准的研制与应用。


Introduction

Analysis of the core content of the standard

Development stage Key technology Methodological requirements Output
Diagnostic item screening Delphi method/RAND method Expert consensus ≥ 75% Preliminary diagnostic item list
Weight determination Analytical hierarchy process (AHP) CR value<0.1 Symptom/sign/tongue and pulse weight coefficient
Threshold calculation ROC curve analysis AUC≥0.7 Diagnostic critical value

Key technical implementation points

Case study of phlegm and blood stasis syndrome in coronary heart disease

Take the tongue parameters collected by the tongue diagnosis instrument as an example:

  • Main indicators: purple tongue (3 points), varicose veins under the tongue (3 points)
  • Secondary indicators: chest pain (2 points), sluggish pulse (1 point)
  • Diagnostic threshold: cumulative ≥12 points

Application value of the standard

The standard innovatively proposes:

  1. Technical requirements for establishing a four-diagnosis combined auxiliary diagnosis system
  2. Develop a matching electronic diagnostic scale
  3. Formulate a standard instruction manual template

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