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.
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.
Peritoneal dialysis (PD) is widely used to treat acute kidney injury (AKI) in low-resource and higher income countries. This paper summarizes the key points and improvements of the 2020 International Society for Peritoneal Dialysis guidelines in five aspects of outcomes for AKI treatment, peritoneal access, dialysis solutions, prescription of dialysis with targets of solute clearance and complications, so as to provide references for AKI in clinical practice.
Clinical practice guidelines (CPGs) serve as the cornerstone of medical decision-making, with evaluation tools such as AGREE and RIGHT designed to ensure that these guidelines are grounded in the best available evidence and contribute to enhancing healthcare quality. This article reviews the historical development and current status of CPG evaluation tools, examining their diversity, complexity, application challenges, and inconsistencies in evaluation outcomes. A thorough discussion is provided on the strengths and weaknesses of existing evaluation tools, along with proposed future developmental directions. It is recommended that future efforts prioritize the creation of more streamlined tool designs, foster enhanced international collaboration strategies, and incorporate artificial intelligence technologies. These initiatives aim to improve both the efficiency and accuracy of evaluative processes while facilitating advancements in healthcare practices towards elevated quality standards.
Strengthening the management and evaluation of clinical pathways is one of the most important strategies of "Healthy China 2030" Strategic Plan. Evidence-based assessment and clinical guidelines can provide the best relevant evidence to develop clinical pathways. We planned to analyze the current situation of clinical pathways in China and explore how to apply evidence-based assessment on clinical pathway management. We searched PubMed, EMbase, ISI, CNKI, WanFang Data, VIP and the The Cochrane Library using "critical pathways" and "clinical guidelines" as key words or subject terms. And we conducted a comparison of their published volume, definitions, differences and connections. The management system of clinical pathway in China is fundamentally flawed, it is still a challenge to implement the clinical pathways effectively without scientific methodologies and standardized evidence-based evaluation system. In order to improve the management quality of clinical pathway in China, we should develop clinical pathways based on national situation and innovate the evaluation system to standardize the clinical pathway management according to WHO recommendations of clinical guideline and appraisal.
ObjectiveTo systematically investigate the current status of reporting health economics evidence in clinical practice guidelines and expert consensuses published in China from 2021 to 2023, providing references for the formulation and revision of guidelines and consensuses in our country. MethodsComputer searches were conducted in the CNKI, CBM, WanFang Data, China Academic Journals Full-text Database, PubMed, and Web of Science to collect clinical practice guidelines and expert consensuses published in China from 2021 to 2023. Two researchers independently screened the literature, extracted information on the inclusion of economic evidence in guidelines and consensuses, and then used quantitative analysis methods for description. ResultsA total of 4 236 relevant articles were included, of which 1 066 (25.17%) reported health economics evidence; 120 (11.26%) reported health economics evidence in the formation of recommendation opinions; 109 (10.23%) reported health economics evidence in the grading of evidence quality; 832 (78.05%) reported health economics evidence in the interpretation and explanation of recommendation opinions. ConclusionThe reporting rate of health economics evidence in clinical practice guidelines and expert consensuses published in China is not high. The reporting rate of health economics evidence in consensuses is lower than that in guidelines. It is recommended that during the formulation process of guidelines and consensuses, the application of health economics evidence should be further strengthened in aspects such as the formation of recommendation opinions, the grading of evidence quality, and the interpretation and explanation of recommendation opinions, in order to improve the scientific, rigorous, and applicability of clinical practice guidelines and expert consensuses, and to play the role of guidelines and consensuses in optimizing the allocation of health resources, improving clinical diagnosis and treatment effects, and enhancing the quality of medical care.
Objective To evaluate the methodological quality and reporting quality of clinical guidelines and consensus on central venous catheters. Methods The PubMed, EMbase, Web of Science, CBM, WanFang Data, CNKI databases and Guidelines International Network, National Institute for Health and Clinical Excellence, National Guideline Clearinghouse, Medive.cn websites were searched to collect clinical guidelines and consensus related to central venous catheters. The retrieval time was from the establishment of the database to October 2022. Two researchers independently screened the literature, extracted data and used evaluation tools AGREE Ⅱ and RIGHT to evaluate the quality of the included studies. Results A total of 34 central venous catheter guidelines and consensus were included. The average score for each field of AGREE II was 53.73% for scope and purpose, 39.26% for participants, 39.57% for rigor, 46.76% for clarity, 30.23% for application and 49.18% for editorial independence. Items 1a, 1b, 3, and 4 (100.00%) had the highest reporting rate in the RIGHT evaluation items, followed by items 19a (97.05%), 2/19b (94.11%), 20 (91.17%), 7b/11a (88.23%), and 7a (85.29%). The reporting rate of the remaining items was below 60%. Subgroup analysis results showed that the average score and RIGHT score of the guidance class in the four fields of AGREE Ⅱ (rigor, clarity, application and editorial independence) were higher than those of the consensus class. Guidelines and consensus formulated based on evidence-based medicine methods were higher than those formulated based on expert opinions or reviews in the three fields of AGREE II (rigor, application and editorial independence). The average scores of foreign guidelines and consensus in 6 fields and RIGHT scores of AGREE Ⅱ were higher than those of domestic guidelines and consensus. Conclusion The AGREE Ⅱ of 6 fields average score and RIGHT score in foreign guidelines are higher than those in domestic guidelines.
Ovarian cancer is one of the common malignant tumors of female genital organs. In gynecological tumors, the incidence rate of ovarian cancer ranks the third after cervical cancer and uterine body cancer, but the death rate of ovarian cancer ranks the first, posing a serious threat to women’s life and health. In recent years, the National Comprehensive Cancer Network (NCCN) clinical practice guidelines for ovarian cancer has become an important basis for diagnosis and treatment of ovarian cancer. In this paper, we interpret the latest version (version 4. 2017) of NCCN clinical practice guidelines for ovarian cancer for its better clinical application.
Objective To improve care and outcomes for all migraine suffers, the USHC created these evidence-based guidelines for migraine headache. Methods Firstly, 5 relative Technical reviews were done according to the Methods used in the AHCPR Technical Reviews. Secondly, based on the results of the 5 technical reviews, the 4 treatment guidelines were developed in direction of the USHC’S Methods used in developing clinical guidelines. Results Evidence supporting the acute treatment and preventive treatment were exclusively Class 1 studies, evidence supporting the diagnostic testing were either Class 2 or Class 3 studies , only very few expert judgment was given on some compelling issues without evidence. The recommendations they supporting were high-qualified, middle-qualified, and poor-qualified respectively. Conclusion This Evidence-Based Guidelines is one of the first and most extensive cooperative projects available for creating guidelines. The guideline was developed with systematical and scientific methods and stroven to base all of its recommendations on evidence.
By employing the nominal group technique, as per the process standard of the EQUATOR Collaboration Network, experts were selected through purposeful sampling. Two rounds of nominal group discussions were conducted, and the essential information of the utilization of the consensus method was extracted from the literature. After comparison, discussion, evaluation, and optimization, a list of 3 fields, 11 themes, 63 necessary items, and 28 supplementary items was eventually constructed to upgrade the standardization and rigor of the application of the consensus method in the future, assisting guideline developers to plan the consensus process.