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.
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
To improve the comprehensive and accurate of overviews of reviews, BMJ published the guideline for overviews of reviews of healthcare interventions: the PRIOR statement. This paper explained the background and core contents of PRIOR statement and interpreted each item with examples to provide references for domestic scholars to write overviews of reviews.
Peripheral artery disease (PAD) of the lower extremities, which poses a major challenge in the field of global public health, has seen a rising trend in its incidence and disability rate year by year. With the continuous innovation of new diagnostic techniques, imaging evaluation methods, and treatment strategies, profound changes have taken place in the diagnosis and treatment paradigm in this field. Based on the “European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication” issued by the European Society for Vascular Surgery in 2024, we systematically reviewed the relevant international guidelines in recent years and conducted horizontal comparisons. Combining with the latest clinical research evidence, we conducted an in-depth analysis from the perspective of evidence-based medicine on the strategic evolution, technical key point updates, and clinical evidence levels of endovascular treatment for lower extremity PAD. The aim is to provide an evidence-based medical basis for clinical decision-making.
There are several main obstacles to structure clinical questions in the process of developing evidence-based clinical practice guidelines, such as clinicians have misconceptions about clinical question structure, and clinical questions do not fit clinical practice. These obstacles results in the incomplete structure and not standardized expression of the clinical questions, and reduce the quality and applicability of guidelines. To overcome these obstacles, this article introduced the application and specific details of clinical question framing and expression with practical examples, to assist clinicians in understanding clinical questions and to provide methodological references for clinical question formulation in the guidelines.
Patient values and preferences is one of the elements of evidence-based medicine research, which is also an important part that should be considered in the development of evidence-based guidelines in the present and future. However, the research in this field in China has just begun. This article gives a brief introduction of its concepts, methods, influence factors based on the international researches of patient values and preferences and a brief description of the development in China, in order to provide references for the development of evidence-based guidelines based on the consideration of patient values and preferences in the future.
Implementation science is a relatively emergent and growing research area. Implementation research can assist to transform what is possible in theory to reality in practice and address the challenge of implementing proven interventions in the real world. Implementation research has a wide range of usages and complex research problems, so appropriate research methods, designs, and outcomes variables are required to address different research objectives. To better conduct implementation research, this paper systematically introduces the research designs, outcome variables, and reporting guideline of the implementation research in health care, based on the purposes and research questions of implementation research.
ObjectiveTo systematically review the quality of evidence-based guidelines (EBGs) on medication therapy for children with vitamin D deficiency, and to compare differences and similarities of the drugs recommended, in order to provide guidance for clinical practice. MethodsDatabases such as the TRIP, PubMed, EMbase, CNKI, VIP, WanFang Data, CBM, National Guideline Clearinghouse and Guidelines International Network were searched to collect EBGs on medication therapy for children with vitamin D deficiency. The methodological quality of the guideline was evaluated according to the AGREE Ⅱ instrument, and the differences between recommendations were compared. ResultsA total of 9 EBGs were included. Among them, 3 guidelines were developed by America, 1 by Europe, 1 by France, 1 by China, 1 by Poland, 1 by Canadian and 1 guideline was by Australia and New Zealand. Seven guidelines were developed specially for children, while others were for people of different ages. According to the AGREE Ⅱ instrument, only "Scope and purpose" and "clarity and presentation" were scored more than 60%. The recommendations of different guidelines were of large different. ConclusionThe quality of included guidelines concerning children with vitamin D deficiency is vary. Although only the America 2011 guideline is of high quality, the strength of recommendation is not high. Thus, the development of national guidelines is urgently needed.
Chinese medicine case report, a special method, records the experience of practitioners and guides students to inherit and develop Chinese medicine. It can transfer a large amount of medical and humanistic information and contribute to the development of Chinese medicine. It is a literary style that has been widely accepted and helps to document and disseminate the culture of Chinese medicine. With the advent of big data and information, more Chinese medicine case reports have been published. However, many have insufficient quality to properly guide and apply in the clinical practice, which might be caused by little guidance of Chinese medicine case report standards published. This paper summarized the case report standards, synthesized and appraised the feasibility and problems specific for improving the quality of Chinese medicine case reports, and proposed suggestions and guidance for developing the standardization of Chinese medicine medical case reports.