Natural language processing (NLP) is the embodiment of computer intelligence in acquiring knowledge, understanding, processing and expressing consciously and actively. It is the scientific key to promoting the informatization of medical practice and research. This paper reviews the development history and research basis of NLP, and focuses on the current application of NLP and large language models in biomedicine and traditional Chinese medicine (TCM), including the intelligent reading, information extraction and feedback of medical texts and ancient books of TCM, as well as the construction of medical knowledge graph and question-answering system. NLP is the technical support to explore the treasure house of TCM, which is of great practical significance to further promote the development of efficient and high-quality core values of TCM and to improve the service capacity.
The inverse problem of electrical impedance tomography (EIT) is seriously ill-posed, which restricts the clinical application of EIT. Regularization is an important numerical method to improve the stability of the EIT inverse problem as well as the resolution of the imaging. This paper proposes a self-diagnosis regularization method based on Tikhonov regularization and diagonal weight regularization method (DWRM). Firstly, the ill-posedness of the inverse problem is analyzed by sensitivity. Then, the performance of the self-diagnosis regularization is analyzed through the singular value theory. Finally, some simulated experiments including simulations and flume experiment are carried out and verify that the self-diagnosis regularization has better image quality and anti-noise ability than those of traditional regularization methods. The self-diagnosis regularization method weakens the ill-posedness of inverse problem of EIT and can prompt the practical application of EIT.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
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.
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
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.
背景 隨機對照臨床試驗的報告質量欠佳。當今，提高研究透明度至關重要，不充分的報告影響了對試驗結果的可靠性和有效性的評估。臨床試驗報告的統一標準（Consolidated Standards of Reporting Trials，CONSORT）2010 聲明是為提升隨機對照臨床試驗的報告質量而制定的，但其最初關注的是兩組平行對照試驗。多臂試驗常采用多個平行組設計方案，將試驗者以相同概率隨機分配至其中一個治療組，比較多種干預措施的效應，但以三組或者更多的組別為常見。多臂試驗的報告質量差異很大，使得對結果的判斷和解釋變得困難。盡管 CONSORT 2010 聲明的大部分內容同樣適用于多臂試驗，但其中一些要素需要修改，并且在某些情況下還有額外的問題需要澄清。 目的 推出 CONSORT 2010 聲明的多臂試驗報告擴展版，以便于此類試驗的報告。 設計 2014 年 CONSORT 工作組會議后，成立了一個包括所有作者的指南撰寫工作組。工作組在 2014 年至 2018 年間，每兩個月進行會面或電話會議，并通過電子郵件進行交流，討論并制定了修訂清單及其相關文本。草稿隨后發給了包含 36 人的 CONSORT 工作組及另外 5 名在臨床試驗領域的知名專家，以供他們審閱。14 人提供了詳細的反饋意見，工作組經過詳細考慮，形成了擴展版的最終修訂版。 結果 CONSORT 聲明多臂試驗擴展版，擴展了 CONSORT 2010 清單中的 10 個條目，并提供了良好的報告示例及對每個擴展條目重要性的詳盡解釋。核心要點是對多臂試驗的明確定義，并要求清楚地報告涉及所有治療組的目的和研究假設。應明確主要治療方案的比較，并且作者應完整、透明地報告由各組得出的計劃內和非計劃內的比較。如果對多重性進行了統計校正，則應描述所使用的理由和方法。 結論和相關影響 CONSORT 2010 聲明擴展版為多臂平行隨機對照臨床試驗報告提供了具體指導，并有助于在此類試驗報告中提供更高的透明度和準確性。
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.