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.
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.
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.
Objectives To investigate the participation of magazines or journals' editors in the clinical practice guidelines in China. Methods WanFang Data, VIP, CNKI, CBM databases, as well as Baidu, Google and www.medlive.cn were searched online to collect incorporated guidelines in which magazines or journal editors participated in. Data was then analyzed. Results In total, 68 guidelines were selected, with 51 (75.00%) led by magazines and 17 (25.00%) edited by editors. 55 guidelines (80.88%) were the same in published and participated journals. Circulatory diseases (27.94%), diagnosis and treatment (54.41%) were the most concerned. 15 guidelines (22.06%) were updated. 17 guidelines reported the roles of the editors who were mostly expert group members (13.24%). 7 guidelines, 3 of which affirmed no relevant conflicts of interest, reported the sponsorship. The quality was higher than the domestic average while lower than the international guidelines. Conclusions The number of clinical practice guidelines magazines or editors participating in China is relatively small, while the quality was higher. The primary form of the participation is journal-led, however, the process, methods, roles, and conflicts of interest in the guidelines require further definition.
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.
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.
ObjectivesTo evaluate the reporting quality of clinical practice guidelines published in Chinese journals in 2017.MethodsCBM, CNKI and WanFang Data databases were searched for articles published in 2017. Two reviewers independently screened literature, extracted data, and evaluated the reporting quality of clinical practice guidelines using the Reporting Items for Practice Guidelines in Healthcare (RIGHT).ResultsOne hundred and seven clinical practice guidelines were included and a total reporting rate of 34.8%±0.1% in RIGHT. Among the seven domains of RIGHT, field on basic information had the highest reporting rate (56.8%) and fields on review and quality assurance had the lowest reporting rate (9.3%).The average reporting rate of RIGHT items of Chinese Science Citation Database (CSCD) articles was lower than non-CSCD [MD=?0.73, 95%CI (?0.78, ?0.68)] articles. The average reporting rates of RIGHT items differed between Chinese Medical Association (CMA) journal articles and non-CMA journal articles [MD=2.30, 95%CI (2.26, 2.34)]. The average reporting rates of RIGHT items was lower in guidelines established by associations or institutes [MD=?3.78, 95%CI (?3.83, ?3.73)], and was higher reported in Chinese medicine guidelines [MD=21.94, 95%CI (21.91, 21.97)].ConclusionsThe reporting quality of clinical practice guidelines published in journals of mainland China in 2017 is low in general, especially in fields such as review and quality assurance, funding and declaration and management of interests and other information. To improve this phenomena, it is suggested that guideline developers report the guidelines rigorously with international standard.
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.
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.
Clavicle fracture is a common orthopedic injury, accounting for approximately 2.6%-4% of all adult skeletal fractures. In 2023, the American Academy of Orthopaedic Surgeons (AAOS) developed evidence-based treatment guidelines for clavicle fractures, which include 4 recommendations and 10 options. This article, based on a thorough review of the guidelines, discusses the clinical treatment of clavicle fractures, aiming to share advancements and the latest diagnostic and therapeutic considerations with orthopedic colleagues to enhance treatment outcomes.
