ISO/TS 5118:2022
(Main)Health informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine
Health informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine
This document specifies the categorial structure within the field of TCMCPG application evaluation by defining a set of domain constraints of sanctioned characteristics each composed of a relationship. The development clinical practice guidelines is outside the scope of this document.
Informatique de santé — Structure catégorielle de représentation pour l'évaluation des lignes directrices de pratique clinique en médecine traditionnelle chinoise
General Information
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 5118
First edition
2022-07
Health informatics — Categorial
structure of representation for
evaluation of clinical practice
guidelines of traditional Chinese
medicine
Informatique de santé — Structure catégorielle de représentation
pour l'évaluation des lignes directrices de pratique clinique en
médecine traditionnelle chinoise
Reference number
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms . 1
3.2 Characterizing categories . 1
4 Categorial structure of TCMCPG evaluation . 5
4.1 Overview . 5
4.2 Semantic link . 5
4.2.1 is evaluated of . 5
4.2.2 is part of . 5
4.2.3 is manifested of . 6
4.2.4 is preceded by . 6
4.2.5 is based on . 6
4.2.6 according to . 6
Bibliography . 8
iii
Foreword
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This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
Clinical practice guideline (CPG) is one of the important measures to improve the quality of medical
services and standardize of diagnosis and treatment. The evaluation of clinical practice guidelines
for biomedicine has been shown to be useful. The appraisal of guidelines for research and evaluation
(AGREE) tool was published in 2003 and upgraded in 2009, which includes 23 items and covers six
quality assessment areas. It is widely used for the quality assessment of clinical practice guidelines.
However, AGREE doesn't cover the application evaluation of CPG.
Traditional Chinese medicine clinical practice guideline (TCMCPG) is mainly divided into consensus-
based guideline and evidence-based guideline. Consensus guideline is the main body of TCM Clinical
practice guidelines and evidence-based guideline is still in its infancy. Out of the 527 TCM and
acupuncture clinical practice guidelines/consensuses issued by December 2019, 403 (76,47 %) were
based on the expert consensus approach and 124 (23,53 %) were based on the evidence-based guide-
making approach. Different from evidence-based guidelines of biomedicine, the clinical promotion and
application effects of a large number of expert consensus-based guidelines need to be evaluated.
Furthermore, the application evaluation of the guidelines is an indispensable basic work, which is
different from the evaluation of the quality of guideline. No unified semantic information framework
exists in the application evaluation of TCMCPG, which affects the data exchange and sharing among
different institutions and databases. From the perspective of categorical structure, an overall
framework involving the whole process of application evaluation of the guidelines is needed so that the
exchange and utilization of data can be more convenient. Categorical structure of application evaluation
of TCMCPG is an essential part among this process. This document was developed to standardize the
effect of application evaluation of CPG in order to promote the implementation, popularization, further
revision and perfection of TCMCPG.
To sum up, evaluating the application effect of clinical practice guidelines can provide a basis for the
implementation, promotion and revision of the guidelines, which can promote the application effect of
TCMCPG and is beneficial to developers and practitioners of clinical guidelines. The establishment of a
unified categorial structure for the application evaluation of TCMCPG is necessary, which will greatly
improve the effect of the application evaluation of TCMCPG, establish a communication platform for the
research of TCMCPG, and lay a solid foundation for future sharing and utilization.
v
TECHNICAL SPECIFICATION ISO/TS 5118:2022(E)
Health informatics — Categorial structure of
representation for evaluation of clinical practice
guidelines of traditional Chinese medicine
1 Scope
This document specifies the categorial structure within the field of TCMCPG application evaluation by
defining a set of domain constraints of sanctioned characteristics each composed of a relationship.
The development clinical practice guidelines is outside the scope of this document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General terms
3.1.1
concept
general notion or idea of something
[SOURCE: ISO/TS 18876-1:2003, 3.1.3]
3.1.2
relationship
association between two or more entities that is significant for some intended purpose
Note 1 to entry: Can also be known as an association when the information model is based upon object classes.
[SOURCE: ISO 19440:2020, 3.64, modified — Note to entry added.]
3.2 Characterizing categories
3.2.1
traditional Chinese medicine clinical practice guidelines
TCMCPG
set of systematically developed statements to assist the decisions made by healthcare actors of TCM
about healthcare activities performed with regard to specified health issues
3.2.2
evaluation
action that assesses the value of traditional Chinese medicine clinical practice guidelines
Note 1 to entry: The rationality and accuracy of the contents of the guidelines and developing method, the
coordination of guidelines and clinical practice.
Note 2 to entry: The application effect and the application conformity of the guidelines.
3.2.3
applicability evaluation
internal characteristics of the guideline elements, the specific scope of the external environment and
the relationship between them
Note 1 to entry: The evaluation results determine whether a guideline should be used in whole or in part.
Note 2 to entry: It evaluates the applicability of the guidelines from technical level, coordination, structure and
content, etc.
[SOURCE: Applicability evaluation tool of Medical Guidelines, 2013]
3.2.4
consistency evaluation
degree of implementation uniformity between clinical practice guidelines and real clinical practice
scenarios in many conditions such as clinical diagnosis, syndrome differentiation, drug use
Note 1 to entry: Tools or other relevant resources to support the recommendations and evaluation criteria for
monitoring or auditing provided by the guidelines can improve consistency.
Note 2 to entry: The promotion and impediment factors in the application could be described in the guideline.
3.2.5
technical level
accuracy, clarity and rigor of traditional Chinese medicine clinical practice guidelines in disease,
syndrome diagnosis and suggestion of treatment
3.2.6
structure and contents
concrete clauses and details included in a traditional Chinese medicine clinical practice guideline
3.2.7
coordination and matching
not conflicting with other standard documents, enabling several documents to be used in conjunction
with each other
3.2.8
clarity
property of being clear, unambiguous and operable
Note 1 to entry: Different health problems and different choices have been listed clearly.
Note 2 to entry: The diagnostic points are accurate.
Note 3 to entry: The physical and chemical examinations are reasonable.
Note 4 to entry: The scope of application of the guidelines is clear.
3.2.9
preciseness
quality of being reproducible in amount or performance
Note 1 to entry: Preciseness can be shown in development, application and revision.
3.2.10
matching degree
degree of coordination and integration between the technical level of the guidelines and the hospital
itself
3.2.11
standardization
imposition of standards or regulations
3.2.12
integrity
completeness in content and structure
Note 1 to entry: Integrity means the guidelines meets the requirements of the clinical practice guidelines,
whether it contains the core elements of the guidelines.
3.2.13
consistency
conformity of clinical practice guidelines in clinical use regarding the aspects of diagnosis, syndrome
differentiation and intervention methods
3.2.14
diagnosis
identification of a health or disease state from its signs and/or symptoms, where the diagnostic process
can involve examinations and tests for classification of an individual's condition into separate and
distinct categories or subc
...
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