ISO/TS 16601:2026

Technical
Specification
ISO/TS 16601
First edition
Health informatics — Patient,
2026-02
intervention, comparison and
outcomes (PICO) information model
of traditional Chinese medicine
(TCM) clinical studies
Informatique de santé — Modèle d'information PICO (patient,
intervention, comparaison et résultats) des études cliniques sur la
médecine traditionnelle chinoise (MTC)
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 .1
3.2 Characterizing categories .2
4 PICO information model . . 3
4.1 Overview .3
4.2 Attributes of the categories .5
4.2.1 Attributes of ‘acupuncture intervention’ or ‘acupuncture comparison’ .5
4.2.2 Attributes of ‘formula for TCM decoction pieces intervention’ or ‘formula for
TCM decoction pieces comparison’ .5
4.2.3 Attributes of ‘other TCM therapy intervention’ or ‘other TCM therapy
comparison’ .5
4.2.4 Attributes of patients .5
4.2.5 Attributes of ‘traditional Chinese medicinal products intervention’ or
‘traditional Chinese medicinal products comparison’ . .5
4.2.6 Attributes of ‘integrative medicine intervention’ or ‘integrative medicine
comparison’ .5
4.2.7 Attributes of ‘chemical drugs comparison’ .5
4.2.8 Attributes of ‘other western medicine therapy comparison’.5
4.2.9 Attributes of ‘study design’ .6
4.2.10 Attributes of ‘TCM clinical studies’ .6
4.2.11 Attributes of evaluation .6
4.2.12 Attributes of outcome .6
Bibliography . 7

iii
Foreword
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iv
Introduction
Clinical practice guidelines (CPGs) are recommendations to provide the best health care for patients
based on systematic evaluation of evidence and to balance the advantages and disadvantages of different
interventions. In the formulation of clinical practice guidelines, the patient, intervention, comparison and
outcome (PICO) principle is often used to help express clinical issues in a standardized manner. Systematic
review is significant for evidence collection, evidence evaluation and decision making in clinical practice
guidelines.
PICO is a mnemonic process used to describe the elements of a clinical question in evidence-based medicine,
and it includes:
— participants, patients or population;
— intervention;
— comparison, control or comparator;
— outcome.
The purpose of this document is to establish an information model (conceptual model, not a database
implementation) based on the well-recognized PICO principle for constructing research questions. The
model can support data extraction of the PICO element from traditional Chinese medicine (TCM) clinical
trials and studies to facilitate the development of clinical guidelines, decision support, metadata analysis
of researches, information exchange and consistency of data structure within TCM. TCM clinical trials and
studies include pharmacological interventions and non-pharmacological interventions such as acupuncture,
tiuna, tai chi, and other TCM therapies.
This document can help to rapidly identify, extract, evaluate and share key elements of evidence in clinical
trials and studies, especially randomized clinical trials (RCTs), to save time and labour costs and provide a
reference for the evidence classification stage of the guidelines.
Information models of TCM clinical studies can make the process efficient and consistent by:
— helping guideline developers to quickly obtain the required information, understand and use basic PICO
information, and providing a reference for TCM clinical questions;
— providing normalized reference model for various mainstream scales and tools (i.e. Grading of
Recommendations Assessment, Development and Evaluation, GRADE), avoiding repeated reading of
articles;
— improving efficiency and provide support for subsequent automatic information extraction of clinical
questions from clinical trials and guidelines.

v
Technical Specification ISO/TS 16601:2026(en)
Health informatics — Patient, intervention, comparison and
outcomes (PICO) information model of traditional Chinese
medicine (TCM) clinical studies
1 Scope
This document establishes the information model of traditional Chinese medicine (TCM) clinical studies by
defining categories and their attributes designed to extract patient, intervention, comparison and outcomes
(PICO) data elements from the reports of TCM clinical studies.
2 Normative references
ISO 3534-1, Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in
probability
ISO 11249, Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis
and interpretation of clinical studies
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 24153, Random sampling and randomization procedures
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 browsin
...