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.
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.
ObjectiveTo compare the recommended medicines of cardiovascular and cerebrovascular diseases guidelines, expert consensus, or diagnosis and treatment specifications with essential medicines from the 2023 World Health Organization Model List of Essential Medicines (WHO-EML) and the 2018 National Essential Medicine List (NEML) in differences and similarities. MethodsSix guideline websites and one association website including Guidelines International Network and National Guideline Clearinghouse, etc. were searched from inception to July 2023. The latest cardiovascular and cerebrovascular diseases guidelines, expert consensus, diagnosis and treatment specifications involving medicine treatment were included, and we extracted the data (year, title, target disease, authors and recommended medicines), and the statistical analysis of recommended medicines included in the WHO-EML and NEML was performed by Excel 2016. ResultsA total of 83 guidelines, expert consensus, and diagnosis and treatment specifications were included, covering cerebrovascular diseases, ischemic heart diseases, hypertensive diseases, chronic rheumatic heart diseases, diseases of arteries, arterioles and capillaries and other unspecified circulatory system disorders. They were issued from 2002 to 2023. Fifty-five (66.3%) were published in the past 5 years. For the 246 recommended medicines, they were divided into 14 categories according to the pharmacological effect. 27.2% (67/246) were included in WHO-EML and 32.9% (81/246) were included in NEML, among which 41 medicines were included both in WHO-EML and NEML, 40 in NEML only, 26 in WHO-EML only, and 139 in neither. The number of excluded medicines in antihypertensive medicines, lipid-regulating medicines and antiatherosclerotic medicines and anticoagulants exceeded 10. ConclusionThe number of cardiovascular and cerebrovascular disease guidelines, expert consensus, and diagnosis and treatment specifications recommended for WHO-EML and NEML is lower than 50%, and the coverage rate of NEML for cardiovascular and cerebrovascular disease guidelines recommended treatment medicines is higher than that of WHO-EML.
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.
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.
In November 2019, the American Heart Association updated guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care. This update is not a comprehensive revision of the 2015 version. The updates for children and newborns mainly include three aspects: ① Pediatric basic life support: A. It is recommended that emergency medical dispatch centers offer dispatcher-assisted CPR instructions for presumed pediatric cardiac arrest. B. It is recommended that emergency dispatchers provide CPR instructions for pediatric cardiac arrest when no bystander CPR is in progress. ② Pediatric advanced life support: A. The bag-mask ventilation is reasonable compared with advanced airway interventions (endotracheal intubation or supraglottic airway) in the management of children during out-of-hospital cardiac arrest (OHCA). B. The extracorporeal CPR may be considered for pediatric patients with cardiac diagnoses who have in-hospital cardiac arrest (IHCA) in settings with existing extracorporeal membrane oxygenation protocols, expertise, and equipment. C. Continuous measurement of core temperature during targeted temperature management is recommended; for infants or children between 24 hours and 18 years of age who remain comatose after OHCA or IHCA, targeted temperature management is recommened. ③ Neonatal resuscitation: A. In term and late-preterm newborns (≥35 weeks of gestation) receiving respiratory support at birth, the initial use of 21% oxygen is reasonable. B. One hundred percent oxygen should not be used to initiate resuscitation because it is associated with excess mortality. C. In preterm newborns (<35 weeks of gestation) receiving respiratory support at birth, it may be reasonable to begin with 21% to 30% oxygen.
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.
In November 2018, the American Heart Association (AHA) updated Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Rather than a comprehensive revision of the 2015 edition guidelines, the 2018 AHA guidelines update was updated again according to the rule " the update of the guideline is whenever new evidence is available”, providing the evidence review and treatment recommendation for antiarrhythmic drug therapy in pediatric shock-refractory ventricular fibrillation/pulseless ventricular tachycardia cardiac arrest. The Pediatric Task Force of the International Liaison Committee on Resuscitation updated the guideline, reaffirming the 2015 pediatric advanced life support guideline recommendation that either lidocaine or amiodarone may be used to treat pediatric patients with shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.
Objective To evaluate quality and current status of traditional Chinese medicine (TCM) guidelines and consensus, and to promote the improvements in the quality of guidelines and consensus. Methods A systematic collection of TCM guidelines and consensus published in medical journals in 2022 was conducted. We used scientific, transparent, and applicable ranking tools (STAR) for evaluation, analyzed the scoring rates (%), and assessed the quality level and influencing factors of guidelines and consensus through methods such as comparison and stratification. Results A total of 130 TCM guidelines and consensus were included. Guideline areas with higher scores included recommendations (65.3%), evidence (55.9%), and guideline development groups (54.2%). In the case of consensus, higher scores were observed in recommendations (38.7%), guideline development groups (37.0%), and funding (30.0%). The total score rate of TCM guidelines exceeded that of national guidelines, while the consensus rate was lower. Stratified analysis revealed statistical differences in guideline score rates among journals and issuing institutions, as well as significant differences in consensus score rates among journals, formulation institutions, subjects, and funding categories. Conclusion The quantity and quality of TCM guidelines and consensus are on a positive trajectory, with higher quality levels in guidelines than in consensus. The overall quality of TCM guidelines surpasses that of national guidelines, particularly emphasizing the scientificity of guideline formulation. However, the overall quality of consensus remains lower than that of the national consensus. Factors such as journals, formulation institutions, subjects, and funding categories are identified as potential influences on the quality of TCM guidelines and consensus.
In October 2020, the American Heart Association issued the 2020 edition of guidelines for cardiopulmonary resuscitation and cardiovascular first aid, which comprehensively revised cardiopulmonary resuscitation and emergency cardiovascular care guidelines related to adults, children, newborns, resuscitation education science and treatment system. According to the latest edition of International Liaison Committee on Resuscitation’s classes of recommendation and levels of evidence, relevant suggestions are put forward. This article interprets the main updated and revised content, including children’s basic and advanced life support and neonatal resuscitation, in order to better guide emergency personnel and improve the quality of cardiopulmonary resuscitation and cardiovascular first aid.
