Abstract

Background. Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined. Traditional Chinese medicine (TCM) diagnosis is one example where inconsistency between practitioners has been found. We hypothesise that the use of a validated instrument may improve consistency. Biochemical biomarkers may also be used enhance reliability. Methods. Twenty-seven participants with prediabetes were assessed by two TCM practitioners using a validated instrument (TEAMSI-TCM). Inter-rater reliability was summarised using percentage agreement and the kappa coefficient. One-way ANOVA and Tukey's post hoc test were used to test links between TCM diagnosis and biomarkers. Results. The two practitioners agreed on primary diagnosis of 70% of participants. kappa = 0.56 (P < 0.001). The three predominant TCM diagnostic patterns for people with prediabetes were Yin deficiency, Qi and Yin deficiency and Spleen qi deficiency. The Spleen Qi deficiency with Damp cohort had statistically significant higher fasting glucose, higher insulin, higher insulin resistance, higher HbA1c and lower HDL than those with Qi and Yin deficiency. Conclusions. Using the TEAMSI-TCM resulted in moderate interrater reliability between TCM practitioners. This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different TCM patterns which may suggest a route to further improving interrater reliability.

Highlights

  • Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined

  • This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different Traditional Chinese medicine (TCM) patterns which may suggest a route to further improving interrater reliability

  • Prediabetes is defined as having a fasting plasma glucose (FPG) level of

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Summary

Introduction

Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined. Traditional Chinese medicine (TCM) diagnosis is one example where inconsistency between practitioners has been found. This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different TCM patterns which may suggest a route to further improving interrater reliability. INTERRATER reproducibility is regarded as one of the foundations of high quality research design Achieving this standard is challenging when patient cohorts under study are poorly or inconsistently defined and in the absence of objective laboratory data [1, 2]. That it is possible to improve diagnostic consistency between practitioners, through the use of a validated instrument designed to reflect clinical practice and systematically guide practitioners. Once a TCM diagnosis is made, it may be possible to identify relationships between biochemical biomarkers and the diagnosis

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