A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.
It is crucial to select outcomes in clinical trials. Appropriate outcomes can improve value and significance of trials and reduce the cost of investment. This paper describes how to develop core outcome sets and core outcome measurement instrument sets with the theory of mixed methods research, so as to standardize the choice of outcomes and outcome measurement instruments in clinical trials.
Core outcome set (COS) is an agreed and minimal set of outcomes that should be measured and reported in all clinical trials in specific areas of health or healthcare, which can reduce the heterogeneity of outcomes in similar clinical trials, so that much more trials can merge in systematic reviews. Meanwhile, using COS may be easy to identify potential selective reporting bias in clinical trials. The research of COS has been developed for more than 30 years in western countries. At present there are much more researchers focusing on this area in China. However the status and progress of COS remain unclear. This paper reviewed the quantity of COS, the disease distributions of COS, the geographical locations involved in the development of COS, as well as the methodological progress of COS, so as to clarify the general situation of COS.
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.