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.
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.
To overview the methodology and procedure used in developing evidence-based guidelines for migraine headache, the article described the two procedures systematically: 1. the Methods used in the Agency for Health Care Policy and Research’s Technical Reviews. 2. US Headache Consortium’s Methods used in developing clinical guidelines
Objective To improve care and outcomes for all migraine suffers, the USHC created these evidence-based guidelines for migraine headache. Methods Firstly, 5 relative Technical reviews were done according to the Methods used in the AHCPR Technical Reviews. Secondly, based on the results of the 5 technical reviews, the 4 treatment guidelines were developed in direction of the USHC’S Methods used in developing clinical guidelines. Results Evidence supporting the acute treatment and preventive treatment were exclusively Class 1 studies, evidence supporting the diagnostic testing were either Class 2 or Class 3 studies , only very few expert judgment was given on some compelling issues without evidence. The recommendations they supporting were high-qualified, middle-qualified, and poor-qualified respectively. Conclusion This Evidence-Based Guidelines is one of the first and most extensive cooperative projects available for creating guidelines. The guideline was developed with systematical and scientific methods and stroven to base all of its recommendations on evidence.
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.
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.
In order to help Chinese guideline developers, clinicians, health policy makers and other relevant researchers fully understand and make appropriate use of World Health Organization (WHO) guidelines, Chinese GRADE Center and Guidelines Review Committee of World Health Organization (WHO-GRC) have written a series of papers about development methods, review principles and the structure and content of WHO guidelines. This is the third (also last) paper which interpreted Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection and Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection as examples with the process and steps of WHO guideline development.
In order to help Chinese guideline developers, clinicians, health policy makers and other relevant researchers fully understand and make appropriate use of the World Health Organization (WHO) guidelines, Chinese GRADE Center and Guidelines Review Committee of WHO (WHO-GRC) have written a series of papers about development methods, review principles and the structure and content of WHO guidelines. This is the first paper of this series introducing the basic principles and methods of development based on the WHO Handbook of Guideline Development and WHO Handbook of Guideline Development 2nd edition. We aim to provide guidance for Chinese guideline developers, and promote the development of high-quality guideline.