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Global Translational Medicine Evidence-based approach for TCM development

the endpoints may focus on long-term symptom development of a standardized, cross-cultural diagnostic
management and quality-of-life improvements, while framework that aligns TCM assessments with Western
in acute conditions; the endpoints may prioritize short- clinical standards. 29
term symptom relief and prevention of complications. This innovative framework would build on the existing
The choice of endpoints should also account for the TCM quantitative instrument, which rates disease severity
potential synergistic effects of multiple ingredients in on a scale from 0 to 100, and introduce a more granular,
TCM formulations, which may require the development of continuous scale that eliminates the broad categorization
composite endpoints that capture the overall therapeutic of disease states into quartiles (health, mild, moderate, and
effect.
severe). By adopting a linear scale, the framework would
6.3. Development and validation of an instrument allow for more precise differentiation between adjacent
scores, thereby addressing the critical limitations of the
To assess the safety and effectiveness of TCM treatments, current categorical approach.
it is often necessary to develop and validate quantitative
instruments that can capture the complex and multifaceted To ensure the validity and reliability of this new
nature of TCM outcomes. These instruments should be diagnostic framework, it is recommended to conduct a
25
designed to measure relevant domains, such as symptom rigorous calibration process involving multi-center, cross-
severity, quality of life, and overall well-being, in a manner cultural clinical trials. During these trials, patients would
that is consistent with TCM theory and practice. be assessed using both the enhanced TCM instrument
and gold-standard Western diagnostic tools. Statistical
The development process should involve a rigorous techniques, including structural equation modeling and
methodology, including item generation, pilot testing, and machine learning algorithms, should be employed to
psychometric evaluation. Item generation should be based uncover correlations and predictive relationships between
on a comprehensive review of TCM literature, expert TCM assessments and Western clinical outcomes.
opinion, and patient input to ensure that the instrument
covers all relevant aspects of the condition being treated. The successful development of a standardized, cross-
Pilot testing should be conducted to assess the clarity, cultural diagnostic framework has the potential to enhance
comprehensibility, and acceptability of the items, as well the precision of TCM diagnostics and promote a common
as to identify any potential issues with administration or language between TCM practitioners and Western
scoring. 26 clinicians. This shared understanding could facilitate the
exchange of knowledge, experiences, and best practices,
Psychometric evaluation is critical to establishing the potentially leading to the development of more effective
reliability and validity of the instrument. Reliability refers and personalized treatment strategies that incorporate
to the consistency and reproducibility of the instrument’s insights from both medical traditions. 30
scores, while validity refers to the extent to which the
instrument measures what it intends to measure. Various Moreover, the calibration of TCM diagnostics with
types of reliability (e.g., internal consistency, test-retest, Western clinical standards could support the integration of
inter-rater) and validity (e.g., content, construct, and TCM into international disease classification systems, such
3
criterion) should be assessed using appropriate statistical as the ICD. This integration would further validate TCM
methods. The resulting instrument should demonstrate as a complementary approach to WM, enabling healthcare
27
adequate psychometric properties to be considered a valid providers worldwide to utilize the unique perspectives and
tool for use in TCM clinical trials. therapeutic methods offered by TCM.
6.4. Calibrating TCM diagnostics with Western 7. Conclusion
standards The modernization of TCM clinical development is a
The integration of TCM into modern healthcare systems complex and multifaceted process that requires a delicate
presents a unique challenge, particularly in the realm balance between preserving TCM’s unique characteristics
of diagnostics. While TCM practitioners rely on time- and adopting rigorous scientific methods to evaluate its
honored quantitative instruments to assess disease safety and efficacy. As discussed in this article, this process
severity and treatment efficacy, these tools often face involves addressing fundamental differences between WM
skepticism from Western clinicians due to their perceived and TCM, developing innovative approaches to clinical
subjectivity and lack of alignment with established clinical trial design and analysis, and overcoming practical and
endpoints. To bridge this gap and foster the global methodological challenges encountered in TCM clinical
28
acceptance of TCM, we proposed a novel approach: the trials.

Volume 3 Issue 3 (2024) 8 doi: 10.36922/gtm.4190