How well did the consensus methods apply in the guideline development of traditional Chinese medicine: a web-based survey in China.

BACKGROUND AND OBJECTIVE: Consensus methods are crucial in developing clinical guidelines. Different methods, such as the Delphi and nominal group techniques, are commonly used, but there is a lack of detailed instructions on how to implement them effectively. The survey aims to explore the opinions and attitudes of the chair, panel and working group on the critical elements of the consensus methods during guideline development. METHODS: We used a cross-sectional design to conduct this study and sent a structured questionnaire to stakeholders, including the chair, panel members, and working group participants, through the popular mobile phone application WeChat.We selected participants using a combination of purposive and snowball sampling. The questionnaire gathered information on demographics, experiences, opinions, and concerns regarding consensus methods and guideline development. RESULTS: The sample comprised 290 participants representing 31 provinces or municipalities. Among them, the most significant number of respondents (n = 107, 36.9%) were from Beijing. Most participants, specifically 211 (72.76%), held senior professional titles, while 186 (64.14%) adhered to ongoing guidelines. The Delphi method was the most commonly used consensus method (n = 132, 42.31%), but the respondents had only a preliminary understanding of it (n = 147, 47.12%). The consensus process also revealed the insufficiency of involving pharmacoeconomists, patients, and nurses. CONCLUSIONS: Consensus methods have to be standardised and used consistently in the guideline development process. The findings of this study offer insights into diverse roles and more effective ways to apply the consensus process during guideline development.

[Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version)].

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

[Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

[Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

A predictive model for blood transfusion during liver resection.

BACKGROUND: A predictive model that can identify patients who are at increased risk of intraoperative blood transfusion could guide preoperative transfusion risk counseling, optimize health care resources, and reduce medical costs. Although previous studies have identified some predictors for particular populations, there is currently no existing model that uses preoperative variables to accurately predict blood transfusion during surgery, which could help anesthesiologists optimize intraoperative anesthetic management. METHODS: We collected data from 582 patients who underwent elective liver resection at a university-affiliated tertiary hospital between January 1, 2018, and December 31, 2020. The data set was then randomly divided into a training set (n = 410) and a validation set (n = 172) at a 7:3 ratio. The least absolute shrinkage and selection operating regression model was used to select the optimal feature, and multivariate logistic regression analysis was applied to construct the transfusion risk model. The concordance index (C-index) and the area under the receiver operating characteristic (ROC) curve (AUC) were used to evaluate the discrimination ability, and the calibration ability was assessed with calibration curves. In addition, we used decision curve analysis (DCA) to estimate the clinical application value. For external validation, the test set data were employed. RESULTS: The final model had 8 predictor variables for intraoperative blood transfusion, which included the following: preoperative hemoglobin level, preoperative prothrombin time >14 s, preoperative total bilirubin >21 µmol/L, respiratory diseases, cirrhosis, maximum lesion diameter >5 cm, macrovascular invasion, and previous abdominal surgery. The model showed a C-index of 0.834 (95% confidence interval, 0.789-0.879) for the training set and 0.831 (95% confidence interval, 0.766-0.896) for the validation set. The AUCs were 0.834 and 0.831 for the training and validation sets, respectively. The calibration curve showed that our model had good consistency between the predictions and observations. The DCA demonstrated that the transfusion nomogram was reliable for clinical applications when an intervention was decided at the possible threshold across 1%-99% for the training set. CONCLUSION: We developed a predictive model with excellent accuracy and discrimination ability that can help identify those patients at higher odds of intraoperative blood transfusion. This tool may help guide preoperative counseling regarding transfusion risk, optimize health care resources, reduce medical costs, and optimize anesthetic management during surgery.

Development and validation of a nomogram for determining patients requiring prolonged postanesthesia care unit length of stay after laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy (LC) is a common surgical procedure for managing gallbladder disease. Prolonged length of stay (LOS) in the postanesthesia care unit (PACU) may lead to overcrowding and a decline in medical resource utilization. In this work, we aimed to develop and validate a predictive nomogram for identifying patients who require prolonged PACU LOS. METHODS: Data from 913 patients undergoing LC at a single institution in China between 2018 and 2019 were collected, and grouped into a training set (456, cases during 2018) and a test set (457, cases during 2019). The definition of PACU LOS is the duration between admission to discharge from PACU, which we can derive from the electronic medical record system. Using the least absolute shrinkage and selection operator regression model, the optimal feature was selected, and multivariable logistic regression analysis was used to build the prolonged PACU LOS risk model. The C-index, calibration plot, and decision curve analysis (DCA) were used in assessing the model calibration, discrimination, and clinical application value, respectively. For external validation, the test set data was evaluated. RESULTS: The predictive nomogram had 8 predictor variables for prolonged PACU LOS, including age, American Society of Anesthesiologists (ASA) grade, active smoker, gastrointestinal disease, liver disease, and cardiovascular disease. This model displayed efficient calibration and moderate discrimination with a C-index of 0.662 (95% confidence interval, 0.603 to 0.721) for the training set, and 0.609 (95% confidence interval, 0.549 to 0.669) for the test set. DCA demonstrated that the prolonged PACU LOS nomogram was reliable for clinical application when an intervention was decided at the possible threshold of 7%. CONCLUSIONS: We developed and validated a predictive nomogram with efficient calibration and moderate discrimination, and can be applied to identify patients most likely to be subjected to prolonged PACU LOS. This novel tool may shun overcrowding in PACU and optimize medical resource utilization.

In vitro and ex vivo anti­tumor effect and mechanism of Tucatinib in leukemia stem cells and ABCG2­overexpressing leukemia cells.

Leukemia stem cells (LSCs), which evade standard chemotherapy, may lead to chemoresistance and disease relapse. The overexpression of ATP­binding cassette subfamily G member 2 (ABCG2) is an important determinant of drug resistance in LSCs and it can serve as a marker for LSCs. Targeting ABCG2 is a potential strategy to selectively treat and eradicate LSCs, and, hence, improve leukemia therapy. Tucatinib (Irbinitinib) is a novel tyrosine kinase inhibitor, targeting ErbB family member HER2, and was approved by the Food and Drug Administration in April 2020, and in Switzerland in May 2020 for the treatment of HER2­positive breast cancer. In the present study, the results demonstrated that tucatinib significantly improved the efficacy of conventional chemotherapeutic agents in ABCG2­overexpressing leukemia cells and primary leukemia blast cells, derived from patients with leukemia. In addition, tucatinib markedly decreased the proportion of leukemia stem cell­like side population (SP) cells. In SP cells, isolated from leukemia cells, the intracellular accumulation of Hoechst 33342, which is an ABCG2 substrate, was significantly elevated by tucatinib. Furthermore, tucatinib notably inhibited the efflux of [3H]­mitoxantrone and, hence, there was a higher level of [3H]­mitoxantrone in the HL60/ABCG2 cell line. The result from the ATPase assay revealed that tucatinib may interact with the drug substrate­binding site and stimulated ATPase activity of ABCG2. However, the protein expression level and cellular location of ABCG2 were not affected by tucatinib treatment. Taken together, these data suggested that tucatinib could sensitize conventional chemotherapeutic agents, in ABCG2­overexpressing leukemia cells and LSCs, by blocking the pump function of the ABCG2 protein. The present study revealed that combined treatment with tucatinib and conventional cytotoxic agents could be a potential therapeutic strategy in ABCG2­positive leukemia.

[Thoughts and suggestions on arrangement, analysis and summary of medical data during COVID-19 epidemic].

The analysis and utilization of clinical scientific research data is an effective means to promote the progress of diagnosis and treatment, and a key step in the development of medical sciences. During the epidemic of coronavirus disease 2019(COVID-19), how to transform the limited diagnostic data into clinical research resources has attracted much attention. Based on the low efficiency of data collection and extraction, the inconsistency of data analysis, the irregularity of data report and the high timeliness of data update during the epidemic, this paper briefly analyzed the background and reasons of data application under the current situation, and then discusses the problems and feasible solutions of clinical data applications under the epidemic situation and, more importantly, for future medical clinical research methods. We put forward several methodological suggestions: ① gradually improve the medical big data model and establish the national medical health data center; ② improve the scientific research literacy of medical staff and popularize the basic skills and knowledge of GCP; ③ promote a scientific, networked and shared data collection and management mode; ④ use the mixed research method and collective analysis to improve the efficiency of clinical data analysis; ⑤ pay attention to narration of the medical feelings and emphasize the humanistic data of clinical medicine. It is expected to promote the standardized and reasonable use of clinical scientific research data, the rigorous integration of expert opinions, and ultimately the development of big data for national health care.

[Thoughts and suggestions on analysis of death cases report during COVID-19 epidemic].

It is an essential task to discuss the death cases for clinicians. During the emergent public events, the report and analysis of death cases is of far-reaching significance. The epidemic of coronavirus disease 2019(COVID-19) has brought huge losses to China, and the medical system has been sustaining tremendous pressure. The best weapon to defeat the epidemic is medical data and related scientific research, of which the systematic analysis and efficient use of death cases is a key step. Based on the incomplete record of death case report, the lack of humanistic perspective and patient report, every department and institution is facing great challenge in terms of data management. Given that the relevant systems need to be improved, and that the integration of standardized reports and clinical research is not mature,as well as other problems, we put forward several methodological suggestions: ① Establish national medical and health data center and improve relevant laws and regulations. ② Increase investment in medical data management and start data collection and analysis as early as possible during the epidemic. ③ Refine the content of death case report and promote the standardization of report. ④ Pay close attention to the report of death cases, review, summary and analysis. More importantly, we should continue to build and improve platforms and programs related to disease control, carry out epidemic-associated scientific research, enhance the managing efficiency of public health data, elevate the anti-risk capability of our medical system, and promote the steady progress of the health China strategy.