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.
The 8th World International Symposium on the Diabetic Foot (ISDF) Conference which was sponsored by the International Working Group on Diabetic Foot (IWGDF) was held in the Hague between May 22nd and May 25th, 2019. The conference issued the 2019 IWGDF guidelines on the prevention and management of diabetic foot disease. The update to the 2015 edition of the guidelines involves the following 6 chapters: prevention of foot ulcers in patients with diabetes; offloading foot ulcers in patients with diabetes; diagnosis, prognosis, and management of peripheral arterial disease in patients with a foot ulcer and diabetes; diagnosis and treatment of foot infection in patients with diabetes; interventions to enhance healing of foot ulcers in patients with diabetes; classification of diabetic foot ulcers. This guideline has been changed more than the previous edition. In this paper, the guidelines will be interpreted to provide cutting-edge information for domestic diabetic foot researchers.
An intervention with clinical application must be effective and safe, therefore, when evaluating interventions, the benefit-harm ratio should be considered, and only those interventions with more benefits than harms have application value. To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials. To promote better reporting of harms in randomized controlled trials, the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement, and then in 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated, the reporting of harms is still inadequate. The CONSORT group has updated《Better reporting of harms in randomized trial: an extension of the CCONSORT statement.》, published《CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials》. This article presents and explains the Harms 2022, with the aim of helping researchers better understand and use the statement, with a view to improving the reporting quality of harms in clinical trials.
This paper interprets clinical practice guideline for abdominal aortic aneurysm of American Society for Vascular Surgery in 2018.
Clinical practice guidelines will be incorporated in different evidence sources and evidence types, the research and exploration of multiple sources of evidence at China and foreign, this paper advocates the construction of both characteristics of multi-source evidence of traditional Chinese medicine, by combing 70 guide manuals, analyze the necessity and advantages of multi-source evidence construction, and further from the multi-source evidence source and evidence logic theory interpretation and application, in order to provide methodological references for the formulation of evidence-based clinical practice guidelines of traditional Chinese medicine.
ObjectiveTo systematically review the methodological quality of Chinese clinical practice guidelines (CPGs) for diagnosis and management of diabetic foot.MethodsCNKI, WanFang Data, VIP, CBM, Yimaitong databases, website of Diabetes Branch of Chinese Medical Association, website of Chinese Integrative Medicine Association and website of Peripheral Vascular Disease Professional Committee of Chinese Society of Microcirculation were electronically searched to collect relevant CPGs from inception to May, 2020. Four researchers independently evaluated the CPGs methodological quality by using AGREEⅡ tool.ResultsA total of 10 Chinese CPGs for diabetes foot were included. The standardized mean scores for various fields were 75.74% for scope and purpose, 36.58% for stakeholder involvement, 28.61% for rigor of development, 86.30% for clarity and presentation, 43.47% for applicability, and 9.44% for editorial independence. ConclusionsThere are merely a small quantity of diabetic foot guidelines in China, and the methodological quality is insufficient. Therefore, more attention should be focused on the establishment of guidelines in the future, so as to further improve the quality of Chinese diabetic foot guidelines.
Lung cancer is the malignancy with the highest incidence and mortality rate in China. In recent years, the popular use of low-dose computed tomography in the population has led to an increase in the detection rate of pulmonary nodules. The National Comprehensive Cancer Network (NCCN) updated and released the NCCN clinical practice guidelines in oncology for non-small cell lung cancer (version 2.2023) on February 17, 2023. This article will interpret the main updates of the new guideline and compare it with the domestic lung cancer treatment guidelines, providing new ideas for the diagnosis and treatment of lung cancer for Chinese clinicians.
The formulation process of recommendations in evidence-based clinical practice guidelines was often complex and cumbersome. This paper described the evolution of levels of evidence and strength of recommendations in medical research and analyzed existing problems when making recommendations. We also summarized and introduced the method of formulating the final recommendation. At present, there isn’t a perfect and uniform method to guide the formulation of recommendations. But some organizations provided different content frameworks or auxiliary tools to guide formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experiences, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.
The diagnosis and management of congenital heart disease (CHD), the most common inborn defect, has been a tremendous success of modern medicine. With the development of diagnostic techniques, surgical procedures and interventional techniques, more than 90% of CHD children can survive to adulthood. Consequently, the prevalence of patients with CHD has shifted away from infancy and childhood towards adulthood. Adult CHD cardiology is now encompassing not only young or middle-aged adults but also patients aged above 60 years. Standardized guidelines can provide good theoretical support for the comprehensive management of adult CHD. Ten years after the European Society of Cardiology guidelines for the management of grown-up CHD released in 2010, the new version was officially released in August 2020. The new version of guidelines updated the classification and stratification of diseases, comprehensive intervention methods and intervention timing, and put forward some new concepts, new intervention standards and methods. For adult CHD that has not been repaired or needs to be repaired again, the indication and mode of surgical intervention and perioperative management have a great impact on the prognosis. The new version of the guidelines provides a detailed description of the surgical and intervention indications and methods for different diseases, and clarifies the management methods for high-risk groups. This article attempts to interpret this newly updated guideline from the perspective of a surgeon, sort out several key diseases introduced by the guideline, and strives to provide a concise and actionable guideline for domestic counterparts.