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.
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.
Ovarian cancer is one of the common malignant tumors of female genital organs. In gynecological tumors, the incidence rate of ovarian cancer ranks the third after cervical cancer and uterine body cancer, but the death rate of ovarian cancer ranks the first, posing a serious threat to women’s life and health. In recent years, the National Comprehensive Cancer Network (NCCN) clinical practice guidelines for ovarian cancer has become an important basis for diagnosis and treatment of ovarian cancer. In this paper, we interpret the latest version (version 4. 2017) of NCCN clinical practice guidelines for ovarian cancer for its better clinical application.
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.
Objective To evaluate the quality of Chinese clinical practice guidelines published in domestic medical journals in 2011. Methods The following 4 Chinese databases including WanFang Data, VIP, CNKI and CBM were searched from January 2011 to December 2011. The quality of included guidelines was assessed by using AGREE II. Results A total of 75 guidelines published in 2011 were included. Among them, 10 guidelines (13%) stated the conflict of interest, 10 guidelines (13%) mentioned evidence-based developing, 5 guidelines (7%) performed evidence grading system, 8 guidelines (11%) performed recommendation strength grading system, and 4 guidelines (5%) performed both evidence and recommendation strength grading systems. The ratio of the 6 domains’ scores of AGREEⅡ were as follows: scope and purpose (18%), stakeholder involvement (11%), rigour of development (8%), clarity of presentation (34%), applicability (5%), and editorial independence (14%). Conclusion Compared with the guidelines published before, the guidelines of 2011 have a higher quality and some of them are progressively standardized in developing methodology.
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.
ObjectiveTo evaluate the reliability and validity of the instrument of clinical applicability of guidelines (version 2.0). MethodsThe experts of domestic medical institutions were investigated by questionnaire, and the instrument of clinical applicability of guidelines (version 2.0) were evaluated the guidelines for the diagnosis and treatment of tinea mantis and tinea pedis (revised edition 2017) and the guidelines for the diagnosis and treatment of cerebral hemorrhage in China (2019). Using Cronbach's α coefficient and Spearman-Brown coefficient to evaluate the inherent reliability and split-half reliability. The content validity was evaluated by calculating the content validity index of the item level and the adjusted Kappa value. The correlation coefficient between each item and the dimension and the hypothesis test were used to evaluate the convergent and discriminant validity. The structural validity was evaluated by using structural equation model to evaluate the structural validity of the tool. ResultsThe Cronbach's α coefficient and Spearman-Brown coefficient of the instrument of clinical applicability of guidelines (version 2.0) were both greater than 0.7, the content validity index (S-CVI/Ave) were more than 0.8, the success rates of convergent were 100%, and the success rates of discriminant validity calibration were 100% and 96%. In the second-order confirmatory factor analysis model, the χ2/ df were less than 3, the fitting index (CFI), the goodness of fit index (GFI) and the adjustment goodness of fit index (AGFI) were all greater than 0.9. The root mean square residual (RMR) were all less than 0.05, and approximate error root mean square (RMSEA) were less than 0.09. The P value of RESEA hypothesis test were more than 0.05. ConclusionThe instrument of clinical applicability of guidelines (version 2.0) has good reliability and validity, which can be further verified in practical application in the future.
Based on new clinical evidence, the National Comprehensive Cancer Network (NCCN) annually updates and releases the "NCCN Guidelines for the Clinical Diagnosis and Treatment of Non-Small Cell Lung Cancer" which has become the reference for clinical diagnosis and treatment approved and complied by clinicians worldwide. On November 25, 2020, the latest 2021 V1 version of "NCCN Clinical Diagnosis and Treatment Guidelines for Non-Small Cell Lung Cancer" (hereinafter referred to as "Guidelines") was released. Compared with the 8th edition of the "Guidelines" in 2020, many updates focused on the progress of targeted and immunotherapy. This article will provide the interpretations of the updated therapy content of this edition of the guidelines.
With the development of evidence-based medicine, an increasing amount of clinical care experts are paying attention to recommendations in the guidelines and the application of guidelines in clinical nursing practice. The demand for clinical practice guidelines is becoming increasingly important. Based on characteristics of nursing, this paper focuses on primary steps in the formulation of nursing-clinical practice guideline, such as clinical problems, outcomes, nursing evidence retrieval and selection, evidence and recommendations classification, methods from evidence to recommendations, patients' preference and value, and provides suggestions for development of nursing-clinical practice guidelines.
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.