Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.
The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.
Objective The objective of this research was to develop a core traditional Chinese medicine (TCM) syndromes set for non-valvular atrial fibrillation (NVAF). MethodsA dataset of TCM syndrome names via systematic review and medical records was developed, and common TCM syndromes classification for NVAF via cross-sectional study were identified. A questionnaire was then developed according to the results of cross-sectional study and the TCM syndrome names dataset. Two rounds of the Delphi survey were carried; clinicians, researchers of TCM/integrated medicine, and nurses were included in the Delphi survey. After a face to face consensus meeting, a core TCM syndromes set for NVAF was developed. ResultsThe core TCM syndromes set for NVAF included four core TCM syndromes, which involved qi stagnation and blood stasis syndrome (core symptoms/signs: palpitations, chest distress or pain, dark purple tongue, or tongue with ecchymosis or petechial, irregular pulse or uneven pulse), heart-kidney yang deficiency syndrome (core symptoms/signs: palpitation, chest distress, fatigue, weakness, chills, pale complexion, frequent urination, wheezing, edema on the face or both lower extremities, oliguria, slippery pulse or slender pulse or deep pulse), qi and yin deficiency (core symptoms/signs: palpitation, chest distress, fatigue, shortness of breath, fine pulse, spontaneous perspiration, night sweats, forgetfulness, lassitude, red tongue, little or no moss on the tongue, and fine pulse), heart and spleen deficiency (core symptoms/signs: palpitation, chest tightness, spontaneous perspiration, abdominal distension after eating, loose stools, pale tongue, weak pulse). ConclusionsThe core TCM syndromes set of NVAF may improve the consistency of TCM syndromes efficacy evaluation in clinical trials of NVAF.
Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.
The characteristics of traditional Chinese medicine (TCM) practice include treatment based on syndrome differentiation and holism, which determines it is difficult to reflect the individualized therapeutic evaluation and overall regulation of TCM through traditional randomized controlled trials, which is based on quantitative evaluation. The implementation of N-of-1 trials will provide opportunities for quantitative evaluation of individualized therapeutic evaluation of TCM. Using mixed methods research, such as exploratory sequence design, interpretive sequence design or convergent design can provide abundant data to individualized therapeutic evaluation of TCM in different aspects, which may reflect holism and humanities characteristics of TCM in individual level.