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.
ObjectivesTo investigate and analyze the status of pediatric internal medicine clinical practice guidelines published in journals of mainland China from 2010 to 2017.MethodsCBM, CNKI, VIP and WanFang Data databases were electronically searched to collect pediatric internal medicine clinical practice guidelines published in Chinese journals of mainland China from January 2010 to December 2017. Two reviewers independently screened literature, extracted data. The author's information was organized and co-word matrixes were produced using BICOMS 2 software. The visualization diagram was plotted using Ucinet 6.0 software to analysze the societal relationship of authors.ResultsA total of 135 pediatric clinical guidelines were included, involving 109 western medical guidelines, 24 Chinese traditional medicine guidelines and 2 guidelines on integrated traditional Chinese and western medicine. The main types of clinical practice guidelines for children were diagnosis and treatment (45.19%), followed by technical guidelines (15.56%). Most of the guidelines were on respiratory diseases (23.70%). 54.81% of the guidelines for children were formulated by seminars and consensus, and 28.89% of the guidelines mentioned the application of evidence-based methods to develop guidelines. The institutes (40.00%) were participated in the development of the guidelines, in which 11 research groups were participated in the development of the guidelines.ConclusionsThe quantity of pediatric internal medicine clinical practice guidelines in mainland China has increased from 2010 to 2017. The scope of the guidelines is limited, and cooperation is required to further improve the quality of children’s guidelines.
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.
ObjectivesTo summarize and compare the operative mechanisms of the most representative comprehensive clinical practice guideline (CPG) databases worldwide, so as to provide references for establishing and managing Chinese CPG database.MethodsCPG databases were collected worldwide by discussing with experts in the guideline and database fields. Studies on guideline databases were searched in PubMed and CNKI to further collect CPG databases mentioned in these studies. Representative comprehensive guideline databases were finally selected by consulting relevant guideline experts. The institutions’ names of establishing and managing CPG databases, funding sources, human resources, aims, quality control measures (including CPG inclusion and updating criteria) were extracted and summarized. Databases were divided into government-led, society-led, and enterprise-led models. A descriptive analysis was conducted.ResultsThere were four government-led databases, four society-led databases and merely one enterprise-led database. The institutions of establishing CPG databases were same as the institutions of managing databases in the seven databases. All CPG databases had set up offices, seven of which were located in the capital. Most databases’ funds came from the government. Four databases implemented board management. According to the division of functions, members involved in establishing and managing CPG databases mainly included leaders, expert teams, managerial personnel, secretaries, web developers, and patient representatives. Criteria for inclusion of CPG were relevant to the purpose of establishing databases. Most databases required guidelines that had be updated within three to five years.ConclusionsThis study provides comprehensive information on operative mechanism of different CPG databases which can assist guideline database builders to optimize their operative mechanism.
There is an increase in published studies relevant to the development of patient version of guidelines (PVGs). We reviewed, summarised and analysed the current developments in this field, with the aim of informing domestic scholars of the factors to consider when developing quality PVGs. We proposed three recommendations: (1) the concept of patient guidelines needs to be better defined; (2) a platform for the dissemination of PVGs should be established to support their implementation; and (3) a standardised PVGs development methodology should be developed to ensure the quality of the PVGs.
In recent years, the diagnosis and management technology of type B aortic dissection (TBAD) has developed rapidly worldwide along with evidence-based medicine practice and clinical research data. But the standard clinical criteria are still limited. Based on this, the Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS) established an expert group dominated by aortic surgeons to collate and analyze the comprehensive literature data of acute and chronic, complicated and uncomplicated TBAD. And then, the group formulated and officially released the clinical practice guidelines for TBAD in 2022. In this paper, we interpreted and analyzed the main contents of the guideline in combination with domestic research, in order to provide reference and help for the clinical diagnosis and treatment of TBAD at the present stage in China.
ObjectiveTo evaluate the quality of traditional Chinese medicine (TCM) guidelines, so as to provide evidence for developing similar guidelines.
MethodsWe systematically searched TCM guidelines published in domestic medical journals from WanFang Data, VIP, CNKI and CBM. We also searched Google, Amazon.cn and dangdang.com by hand in order to obtain TCM guidelines published in monographs. And we used AGREE II instrument to assess the methodological quality of included guidelines.
ResultsA total of 115 guidelines (87 published in domestic medical journals and 28 published in monographs) were included. Scaled domain percentages from highest to lowest were:scope and purpose (41%), stakeholder involvement (28%), clarity of presentation (33%), rigour of development (20%), editorial independence (9%) and applicability (7%).
ConclusionThere is still a large gap about methodological quality between TCM guidelines and international guidelines. So the guideline developers should systematically search, evaluate and synthesize the evidence based on structured problems. At the same time, they also need to consider the costs of recommendations, the implementation environment and the patients' preference and values. On this basis, the developer could further increase the transparency and independence during developing TCM guidelines.
ObjectivesTo evaluate the quality of evidence-based guidelines for the treatment of female stress urinary incontinence, so as to provide evidence for clinical stress urinary incontinence management research.MethodsWebsite of the professional society, clinical practice guide website, Yimaitong website, PubMed, CNKI, WanFang Data and VIP databases were electronically searched to collect stress urinary incontinence management related guidelines from January 1st, 2014 to January 1st, 2019. Two reviewers independently screened literature, extracted data and evaluated the quality of included guidelines using Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) and the characteristics of each guidelines were analyzed.ResultsWe identified totally 8 relevant evidence-based guidelines in this field. The average standardized scores in the 6 domains of AGREE II were 90.74% (scope and purpose), 78.71% (stakeholder involvement), 74.60% (rigor of development), 93.52% (clarity of presentations), 61.81% (applicability), and 91.67% (independence). The overall standardized scores of 8 guidelines were 77.70%, and the total scores were 5.31 (out of 7). For overall quality, 4 of them were grade A and 4 of them were grade B.ConclusionsThe overall quality of evidence-based guidelines for stress urinary incontinence is high, and scores in different fields are vary large. Fields of " stakeholder involvement”, " rigor of development” and " applicability” with lower scores still requires strengthening. The current guidelines for female stress urinary incontinence in China still fails to meet the standards of evidence-based guidelines, so the quality of the guidelines should be improved to improve guide clinical practice.
