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.
The Essential of ACC/AHA Guidelines for the Management of Patients with ST-Elevation Myocardial Infarction was introduced, including epidemology, initial management in the emergency department and hospital management.
Spine is a common site of metastasis in patients with malignant tumors, and tumor metastasis to the spine can lead to pain, pathological fractures, and nerve compression. In order to optimize the diagnosis and management of patients with spinal metastases and metastatic spinal cord compression (MSCC), the National Institute for Health and Care Excellence (NICE) in the UK proposed the first diagnostic and treatment guidelines for patients with MSCC (or at risk of MSCC) in 2008. In recent years, with the rapid advancement of spinal surgery and radiotherapy technology, the standardized process of MSCC diagnosis and treatment urgently needs to be updated. In 2023, NICE launched new guidelines for spinal metastases and MSCC. Based on a thorough study of the guidelines, this article discusses and interprets pain management, corticosteroid treatment, application of bisphosphonates and denosumab, tools for assessing spinal stability and prognosis, radiation therapy, surgical timing and approach, etc., providing reference for clinical diagnosis and treatment in China.
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.
Infiltrative optic neuropathy (ION) is characterized by the infiltration of tumor cells or inflammatory cells in the optic nerve and its sheath. ION is rare in clinic practice, and ION caused by direct infiltration or metastasis of malignant tumors is easily misdiagnosed as optic perineuritis or optic neuritis, which means delayed proper treatment and makes patients risking possible side effects of steroid therapy. Currently, ophthalmologists are lack of sufficient knowledge about ION, which contributes to the high rate of misdiagnosis and missed diagnosis of ION in clinical practice. The diagnosis and treatment of ION have not yet formed systematic standardized guidelines. Therefore, Neuro-ophthalmology Group of Ophthalmology Branch of Chinese Medical Association organized experts to propose consenus of opinions on definition, diagnosis and treatment of ION, which helps to guide clinical diagnosis and treatment of ION, as well as basic researches about ION.
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
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.
The National Comprehensive Cancer Network (NCCN) released the latest version 1, 2022 of "NCCN guidelines for the clinical diagnosis and treatment of small cell lung cancer" (hereinafter referred to as "guideline"). Based on high-quality evidence-based medicine, this guideline provides references of clinical diagnosis and treatment for clinicians around the world. Compared with the version 3, 2021 of the "guideline", updates and revisions mainly focused on the progress of radiotherapy and systemic treatment. This article will interpret the updated therapy content in this new version of the "guideline".
Traditional Chinese Medicine (TCM) clinical practice guidelines play essential roles in the development of TCM. However, the existing TCM guidelines are not effectively used in clinic. Based on this phenomenon, this article addresses the characteristics of clinical practice guidelines of TCM, and analyzes its status, problems and resolutions, providing feasible suggestions for the development of high-quality clinical practice guidelines of TCM which are in accordance with clinical practice.