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.
ObjectivesTo investigate the awareness and knowledge of Chinese guideline developers on the patient version of guidelines (PVG).MethodsA questionnaire was developed and distributed to participants of the guideline development workshop on the " 2017 Chinese Medical Doctor Association Annual Conference on Evidence-Based Medicine & Gansu Medical Doctor Association/ Gansu Medical Association Annual Conference on Evidence-Based Medicine”, and guideline developers in Shenzhen, Guangzhou, Xi’an, Beijing and other places were investigated through field surveys. The questionnaire included ten questions centred on respondents’ awareness and their views on the development of PVG. After the invalid questionnaire was excluded, Excel 2013 software was used for data entry, and SPSS 19.0 software was used for data analysis.Results150 questionnaires were distributed and 107 (71.3%) were collected, from which 90 (60.0%) questionnaires with complete response were analyzed. For the awareness of PVG: 30.0% of respondents chose " just know it without more knowledge”, 34.4% chose " never heard of”. The awareness was not associated with educational or departmental background, majors and regions (P>0.05). For opinions on PVG and its development process: 86.7% of the respondents thought PVG is necessary, 90% thought the presentation of PVG needs to follow reporting standards, and 45.6% thought the primary barrier of the development of PVG is lack of cognition.ConclusionsResearch work on PVGs is at an initial stage in China. The awareness among Chinese guideline developers and relevant researchers is lacking and the development methodology requires further exploration. Carrying out research relevant to PVG can promote its development and application in China, so as to improve the 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.
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.
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.
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.