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.
Peritoneal dialysis (PD) is widely used to treat acute kidney injury (AKI) in low-resource and higher income countries. This paper summarizes the key points and improvements of the 2020 International Society for Peritoneal Dialysis guidelines in five aspects of outcomes for AKI treatment, peritoneal access, dialysis solutions, prescription of dialysis with targets of solute clearance and complications, so as to provide references for AKI in clinical practice.
Different from modern medicine, traditional Chinese medicine (TCM) has its unique thought patterns and decision methods. In the process of developing TCM clinical practice guidelines, not only the modern clinical researches should be included, but also the TCM ancient books which had influenced TCM for thousands of years should be included. As an important carrier of TCM, the characteristics of researches in TCM ancient books are different from modern clinical researches. In this paper, we introduced the present situation of the TCM guidelines and how to use TCM ancient books for developing TCM clinical guideline with the guidance of evidence-based method. We used the example of developing of headache TCM guideline to explain how to use TCM ancient books as evidence source for guideline development and explored the application of evidence-based research of TCM ancient books to promote TCM clinical guidelines development.
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.
In the process of formulation, traditional Chinese medicine clinical practice guidelines are often faced with the dilemma of lack of evidence. Guidelines development groups tend to make final decisions based on expert experience or expert opinion, but the limitations of cognitive bias reduce the credibility and transparency of the guidelines. By clarifying the difference between the expert experience and expert opinion and expert evidence, the expert evidence of traditional Chinese medicine discipline advantages and necessity, providing the recommendation form link using expert evidence methodology design and implementation details, retaining the empirical characteristics of traditional Chinese medicine and improving the lack of evidence, has certain practical application value.
ObjectiveTo get known of the application of Preferred Items of Systematic Review and Meta Analysis (PRISMA).
MethodsWe searched PubMed, EMbase, The Cochrane Library (Issue 10, 2013), CBM, WanFang Data and CNKI, to collect relevant literature about the application of PRISMA during 2009-2013. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and then bibliometric analysis was performed using Excel software.
ResultsWe finally included 175 papers, including 26 conference abstracts and 149 full texts. The results of bibliometric analysis of full texts showed that, they were published in 118 journals, and PRISMA official website announced that 176 journals endorsed the application of PRISMA. According to study type, there were 111 systematic reviews and meta-analyses (SRs/MAs) for development and reporting, 20 overviews of SRs for reporting quality assessments, 7 versions of PRISMA interpretation, and 11 articles of other kinds. In 131 SRs/MAs as well as overviews, the studies about western medicine accounted for 77.8%, followed by public health (8.4%), and traditional Chinese medicine (4.6%).
ConclusionThe application of PRISMA statement is still at the first phase and mainly confined to the field of western medicine, which needs more attention and understanding. Thus, it's necessary to interpret and disseminate the PRISMA statement.
ObjectiveTo investigate the application status of survival analysis in studies published in Chinese oncology journals, and assess their reporting quality and summarize the existing problems, so as to promote the application of survival analysis and reporting quality.
MethodsStudies that used survival analysis were collected from 1 492 studies published in Chinese Journal of Oncology, Chinese Journal of Clinical Oncology, Chinese Journal of Radiation Oncology and Chinese Journal of Cancer Prevention and Treatment in 2013. The application status of survival analysis of included studies was analysed and their reporting quality was evaluated.
ResultsA total of 242 survival analysis studies were included. Among them, the utilization rates of Kaplan-Meier method, life table method, log-rank test, Breslow test and Cox proportional hazards model were 91.74%, 3.72%, 78.51%, 0.41% and 46.28%, respectively. 112 studies did multivariate analysis through Cox proportional hazards model. A total of 396 end points and 10 different types of survival time were reported. Overall survival (OS) was reported in 233 studies (92.15%). Survival terms were defined to 158 end points (39.90%) of 103 studies (42.56%). The follow-up rates were mentioned in 155 studies (64.05%), of which 4 studies were under 80% and the lowest was 75.25%, 55 studies were 100%. The main problems of survival analysis studies published in Chinese journals were as follows:None of the studies which used Cox proportional hazards model reported the proportional hazards assumption. None of the studies used the method of parametric survival analysis. 130 studies (53.72%) did not use the method of multiple factor analysis. 139 studies (57.44%) did not define the survival terms. Only 11 of 100 studies which reported loss to follow-up had stated how to treat it in the analysis. None of the studies reported the methods of calculating sample size. None of the studies reported the censoring proportion.
ConclusionThe methods of survival analysis are used in a low rate in studies published in Chinese oncology journals, and the overall reporting quality of survival analyses is poor. So the reporting guideline of survival analysis should be developed and the authors should be encouraged to cooperate with professional statisticians, in order to improve the design, analysis and reporting quality of survival analysis studies.
ObjectiveTo investigate the awareness situation on the ARRIVE guideline and the Gold Standard Publication Checklist (GSPC) of animal experiments in researchers in animal experiments field in Lanzhou city, in order to improve the promotion of the two reporting guidelines in China.
MethodsA self-designed questionnaire was used to investigate the clinical graduate students and teachers in medical college in Lanzhou city. The investigation contents mainly included the basic information of the respondents, the awareness situation on the ARRIVE guideline, GSPC and other medical reporting guidelines. SPSS 21.0 software was used for data analysis.
ResultsA total of 329 questionnaires (40 were from teachers and 289 were from graduate students) were issued, of which, 287 questionnaires were effective. The results showed that the awareness rate on the ARRIVE guideline and GSPC in clinical graduate students and teachers in medical college in Lanzhou city were 11.8% and 12.5%, respectively, and there was no significant difference between students and teachers in awareness rate (P=0.903). The survey approaches, the age, education, job, and the organization of the respondents were all not the influence factors of awareness rate (P>0.05). The respondents knew about the reporting guidelines mainly through the website (33.4%), related studies (21.2%) and academic reports (17.4%).
ConclusionThe awareness rate on the ARRIVE guideline and GSPC is relative low in researchers in animal experiments field in Lanzhou city, and it needed to take purposeful measures to promote and popularize them.
Objective
To summarize and compare the functional characteristics and technical parameters of the comprehensive global clinical practice guideline (CPG) databases, so as to provide references for the construction of CPG database of China.
Methods
CPG 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 additionally collect CPG databases mentioned in these studies. Representative comprehensive CPG databases were finally selected by consulting relevant guideline experts. The basic information, functional characteristics (including column settings, service contents, and related file types) and technical parameter data were extracted and summarized. A descriptive analysis was conducted to compare different CPG databases.
Results
Nine guideline databases which are distributed in eight countries of the Americas, Europe, Oceania and Asia were included. The number of included guidelines of the nine databases ranged from 31 to 15 410. The earliest database was established in 1993. Except that the MINDS database didn’t provide search function, eight databases provided basic search function, and six provided further advanced search function. PDF and HTML formats of guidelines were available in most databases, but the XML format was only available in National Guideline Clearinghouse (NGC). Responsive Web design was an important feature for most websites of databases and four databases developed mobile applications. Local mainstream social media sharing function was provided by six databases. All databases’ construction was professional in technical parameters including network transmission, Web server, programming language and the selection of server room.
Conclusion
This study compares the functional features and technical parameters of the comprehensive global CPG databases, which provides important information that should be considered in establishing a guideline database, to strengthen the top-level design or to help optimize the functionality of a guideline database. It also helps guideline databases users to find more proper resources.
