ObjectiveTo evaluate the implementability of traditional Chinese medicine (TCM) guidelines in the field of paediatrics. MethodsWe searched the paediatrics-related TCM guidelines published in CNKI, WanFang Data, VIP, SinoMed and PubMed databases, and related websites from inception to November 1, 2023. The implementability of the included guidelines was evaluated using the clinical practice guideline implementability assessment tool. ResultsA total of 47 guidelines were included, covering 37 paediatric diseases and recommending 27 TCM therapies, including TCM decoction, Chinese patent medicines, acupuncture, paediatric massage, and acupoints. The results of the guideline implementability evaluation showed that 5 guidelines (10.6%) were of high grade, 12 guidelines (25.5%) were of medium grade, and 30 guidelines (63.8%) were of low grade. With the exception of accessibility (multi-channel access methods) and communicability, which was of high quality, there is room for improvement in all areas, particularly in the areas of applicability and ease of recognition. ConclusionThe overall quality of implementability of the included paediatric TCM guidelines was low, and it is recommended that in the process of developing paediatric TCM guidelines in the future, we focus on improving the quality of implementability of the guidelines themselves from the source, so as to promote the implementation and application of the guidelines.
Rapid development of recently emerging precision medicine techniques represented by gene therapy has brought hope for the treatment of rare blinding eye diseases such as inherited retinal diseases (IRDs) for which there was no effective treatment previously. Although the globally growth of clinical trials for IRDs has increased rapidly over the past decade, due to the highly genetic and clinical phenotypic heterogeneity, as well as limited data on epidemiology and natural history of the disease, along with severe loss of vision function of majority patients for which the established measurements may not be appropriate, such studies lack standard outcome measurements and endpoints to asses clinical meaningful effectiveness, posing great challenges in terms of study design and evaluation of treatment efficacy, as well as clinical practice application. At present, there is no systematic nor standardized guidance on safety measures, clinical outcomes and endpoints of visual function for clinical trial design in IRDs. Therefore, in order to standardize the validated evaluation of IRDs clinical efficacy outcome measurements and endpoints, the Fundus Disease Group of Chinese Medical Association Ophthalmology Branch and Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch organized domestic experts to put forward consensus and recommendations on standardizing outcome measurements and endpoints for clinical study design in IRDs, aiming to advance the study design of IRDs natural history research and clinical trials and to effectively evaluate disease progression and intervention efficacy. Along with the development of medical science and clinical trials, relevant content will be improved and updated accordingly.
Objective To investigate the awareness of rational use of drug (RUD) on medical workers in hospitals of different ranks, the establishment and execution of relevant strategies in hospitals of different ranks, and the main factors affecting RUD on medical workers, so as to provide references for the generalization of RUD. Methods A certain number of different ranks of hospitals in Chengdu and Zigong were randomly selected by the convenience sample method. Medical workers in each hospital were selected through face-to-face interviews with a self-designed questionnaire. Monte Carlo Chi-square analysis was applied on the hospital ranks and formulation of RUD guidelines, and logistic regression analysis was performed on the awareness of RUD knowledge of the respondents. Results Among 700 questionnaires distributed, 672 were retrieved (response rate 96.0%). The numbers of respondents who were familiar with the Pharmaceutical Affairs Councils (PACs) as well as the Pharmacy and Therapeutics Committees (PTCs) were 217 (32.29%) and 83 (12.35%), respectively. The number of respondents who understood the concept of essential medicine was 502 (74.71%). A total of 441 (61.16%) medical workers had been trained on RUD, 199 (29.61%) medical workers denied there were PTCs in their hospitals, and 60.71% of the medical workers mentioned that the use of drug was monitored and controlled with the feedback in their hospitals. The result of logistic regression analysis indicated that the professional title (P=0.038), awareness of essential medicine (Plt;0.001) and participation of RUD training (P=0.008) were the factors influencing the awareness of RUD. Conclusion Both management and education should be executed at the same time to elevate the level of rational use of drug. In order to increase the level of RUD we should complete monitoring institution and improving RUD awareness of workers. Additionally enhancing the rationality of medication should be performed by establishing guidelines of treatment or medication. Improving personal knowledge, scientific information and medication custom should be performed by standardizing regulations, strengthening management, emphasizing education and promoting communication between doctors and patients.
Adapting the existing guidelines in the context of specific regions can improve the efficiency of guidelines development, and reduce cost and time for developing guidelines. ADOLOPMENT is a methodological tool for guidelines adaptation, which was developed by the GRADE Working Group based on the standardized international guidelines making process. With ADOLOPMENT, developers can effectively use existing guidelines and evidence, avoid duplication of the evidence evaluation, and record the process from evidence to recommendations, which will ensure the transparency of adaptation, help users to understand the process, and improve the acceptability and credibility of guideline adaptation. This paper aims to introduce the ADOLOPMENT and its application.
Integrated traditional Chinese and Western medicine has been used to treat acute pancreatitis (AP) for more than 50 years. It has become a dominant and specialized disease treated by integrated traditional Chinese and Western medicine. After many years of clinical practice, a relatively mature and complete treatment system has been formed. Therefore, it was proposed by the Chinese Society of Integrated Traditional Chinese and Western Medicine, the Chinese Medical Association, and the Chinese Association of Traditional Chinese Medicine to update and formulate the “Guidelines for the Diagnosis and Treatment of Acute Pancreatitis with Integrated Traditional Chinese and Western Medicine” (2021) group standards in 2022, and “Integrated Traditional Chinese and Western Medicine Practice Guidelines for Diagnosis and Treatment of Acute Pancreatitis” finally published. The guideline condenses 25 kinds of important clinical issues, which guide to explain the diagnosis and treatment of AP in detail, focusing on the integration of traditional Chinese medicine and Western medicine in the management of AP, such as staging and syndrome differentiation, early fluid therapy, pain management, and organ function support in early stage. The advantages and the timing of early intervention of traditional Chinese medicine in AP are emphasized. This guideline also proposes suggestions on nutritional support, management of causes, treatment of late local complications and infections, as well as prevention of recurrence and follow-up strategies for long-term complications. This paper provides an interpretation of this guideline.
Inherited retinal diseases (IRDs) are a group of severe retinal degenerative diseases leading to permanent visual impairment. IRDs are the major cause of irreversible blindness in children and working age groups. Gene therapy is a new clinical treatment method and currently the only clear and effective treatment for IRDs, while, there are still risks in clinical research and application. How to standardize perioperative management and reduce the potential risks of treatment is one of the keys to ensure the safety and effectiveness of treatment. However, there is no systematic and standardized guidance on the perioperative management for IRDs gene therapy. Therefore, in order to standardize the perioperative management, the Fundus Disease Group of Ophthalmology Society of Chinese Medical Association and Chinese Medical Doctor Association organized domestic experts to put forward standardized opinions on the perioperative management of IRDs gene therapy in China after repeated discussion and combined with domestic and foreign research experience, so as to provide clinicians with reference and application in clinical research and practice.
Objective The purpose of the extension of the RIGHT statement for introductions and interpretations of clinical practice guidelines (RIGHT for INT) was to promote the development of comprehensive and clear article those introduced and interpreted clinical practice guidelines. MethodsThe RIGHT for INT checklist was developed following methods recommended by the EQUATOR Network. The development process included three stages. In the first stage, a multidisciplinary team of experts was recruited by email and WeChat and further divided into three groups (a steering group, a consensus group, and a secretariat group); in the second stage, the initial items were collected by literature review and brainstorming; and in the third stage, the final items were formed through a Delphi survey and expert consultation. ResultsA total of 40 initial items were collected through literature review and brainstorming. A final checklist of 27 items was formed after the Delphi survey and expert consultation. ConclusionThe RIGHT for INT checklist provides guidance for guideline interpreters on how to introduce and interpret clinical practice guidelines in a scientific and comprehensive manner.
Surgical site infections are the common healthcare-associated infections. This article introduced the guidelines on the prevention and control of surgical site infection in using from background, making progress, and recommendations, to give directions for clinicians and infection prevention and control professionals choosing appropriately for decreasing surgical site infection risks.
Objective To systematically review the methodological quality of guidelines concerning infertility, so as to provide references for clinical practice. Methods Guidelines concerning infertility were electronically retrieved (from inception to Feb. 2013) in PubMed, EMbase, CBM, WanFang Data, CNKI, GIN guideline database guideline development websites (including NGC, NICE, SIGN, NZGG, SOGC, etc.), and medical associtation websites (including IFFS, FIGO, ESHRE, NFOG, RCOG, ASRM, ACOG, etc.). We also searched Chinese guideline websites including the website of the National Health and Family Planning Commission of People’s Republic of China, CGC (China Guideline Clearinghouse), and CPGN (Clinical Practice Guideline Net). Two reviews independently screened literature according to the inclusion and exclusion criteria, and assessed the quality of guideline development and reporting using the Appraisal of Guidelines for Research and Evaluation (AGREE II). Results a) A total of 16 guidelines concerning infertility were included, with development time ranging from 1998 to 2012. Among 16 guidelines, 10 guidelines were made by the USA, 3 by Britan, 1 by the Europe, and 1 by America and Europe. b) The scores of guidelines according to the domains of AGREE II decreased from “Clarity of presentations, scope and purpose”, “Participants”, “Applicability”, “Rigour of development”, and “Editorial independence”. 16 guidelines were generally low in quality. The levels of recommendations were Level A (5 guidelines), Level B (8 guidelines), and Level C (3 guidelines). c) Four evidence-based guidelines scored the top three in the domain of “Rigour of development”. d) The recommendations of different guidelines were fairly the same. e) No guidelines on infertility have been developed in China. Conclusion a) The guidelines on infertility should be improved in “Rigour of development” and “Applicability” in future. Conficts of interest should be addressed. b) Guidelines are recommended to be developed on the basis of the methods of evidence-based medicine, and best evidence is recommended. c) National organizations such as ASRM should be established in China, so as to develop biomedicine and TCM guidelines based on evidence and regulate the treatment. d) For the general assessment of guidelines, AGREE II should offer threshold criteria of suggestion.
The publication of the 2016 version of the Surviving Sepsis Campaign guidelines is a further step to the treatment of sepsis worldwide. This version of guidelines approves new definition of Sepsis-3. Overall, the new guidelines do not change the previous principle of treatment significantly. Some detailed and specific modifications have been made. Understanding and rational use of the new guidelines based on clinical practice, are the key to managing sepsis and performing accurate and effective treatment.