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.
Objective To analyze the methodological quality of clinical practice guideline mentioned “evidence-based” in China. Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012, and meanwhile, we conducted additional search for guidelines on clinical major diseases. Then, we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation (AGREE II). If the guidelines comply with the item, we recorded 1 point, otherwise 0 point. Results a) Among twenty-two included guidelines, 13 were originated and 9 were updated once every 3 to 5 years. b) Diseases covered stroke, diabetes, chronic hepatitis B, hypertension, pediatric nutrition, etc. c) The number of guideline references were 10 to 218, of which, nine guidelines cited 24 Cochrane systematic reviews (CDSRs), accounted for 2.62% (24/916). Among them, the acute ischemic stroke guideline cited the most (7 CDSRs). d) The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150. e) The guidelines’ quality generally scored 4 to 7, most of which described the process of guidelines development. The grades of recommendation were consistent with the levels of evidence. But most of the included guidelines did not clearly described literature research methods, peer reviewer, and update procedures. Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China. However, the quality of reporting and the methodological rigor of guidelines need further improvement. The citation rates of Cochrane systematic reviews in these guidelines were relatively low. We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions, and relevant support policies for guideline implementation in practice. In future, attention should be paid to the aspects of guideline development methods, reporting standard, guideline accessibility, and standard training for relevant personnel.
The shortage of health workforce in rural and remote areas has been commonly concerned by every country around the word. It is one of world health issues, challenging the aspirations of achieving equity. In this regard, WHO developed the Global Policy Recommendations to improve the accessibility of the health workforce in rural and remote areas through improved retention. This article focuses on the key steps of the policy guideline developed from evidence-based medicine methodology and from angle of guideline development, mainly about background, issues, evidence retrieval and selection, quality grading of evidence, and the forming of recommendation plan, in order to further explore how to correctly understand, obtain, evaluate and apply currently available research evidence, and how to use the GRADE system to make scientific and feasible recommendations in the decision-making process, emphasizing the importance of evidence and the GRADE system in the evidence-based health decision-making.
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.
In this article, three research cases are introduced to show the rationale of analysis of papers cited in evidence-based guidelines and the implementation steps. The ultimate goal of medical research is to promote health; evidence-based guidelines are of most importance to medical practice, which can be directly used in clinical practice and health prevention. One of the ways in which research can influence practice is through its contribution to being references of guidelines, and it’s a new way to evaluate biomedical research’s “payback” on health.
Objective To investigate and analyze the status of clinical guidelines of children in China, so as to regulate the development of children’s evidence-based clinical guidelines and provide recommendations for children’s clinical guidelines. Methods Names of guidelines, year and institution of publication, methodology of development and reference number were descriptively analyzed. Years of publication and diseases of guidelines were analyzed with statistical graphs. AGREE instrument was used to evaluate the evidence-based guidelines of children. Results a) Of 91 clinical guidelines of children, 62 were translations. Of 29 guidelines ourselves, nine were traditional Chinese medicine guidelines and five (17%) were evidence-based guidelines; b) Guideline on Rational Use of Antibiotics in Acute Respiratory Infections (Probation), the first guideline of children, was published in 1999. Guidelines of children was not published until 2005. Then, the number of guidelines was increasing each year and reached a peak in 2008. Of 13 guidelines in 2008, seven were traditional Chinese medicine guidelines. Guidelines on respiratory diseases were 14 ranked as the top; c) Guidelines on congenital deformity and chromosomal abnormalities, tumor, circulatory system disease, blood disease and western guideline on communicable disease were not formulated in China; and d) Average scores on six domain of five evidence-based guidelines were 84.4%, 37.5%, 74.3%, 90.0%, 22.2%, 46.6%, respectively. Guide on Diagnosis and Treatment of Children Aged 0 to 5 with Acute Fever of Unknown Etiology was bly recommended, Guide on Management of Children with Community-Acquired Pneumonia, Evidence-Based Guide on Diagnosis and Treatment of Children with Common Kidney Disease, Guide on Nutrition Support of Newborn, Guide on Diagnosis and Treatment of Children with Chronic Cough were recommended. Conclusion Clinical guidelines of children in China begin late, develop slowly and are lack of update. A standard on development of guidelines is needed. The government should increase the fund of development, implementation and promotion of guidelines. Recommendations for high-quality guidelines should be included in procedure of medical quality assurance. Compliance of guidelines should be provided by organization which formulatesd the guideline, so as to promote the application of high-quality guidelines.
Objective To collect the report guidelines for systematic reviews and meta-analyses, so as to provide support for the standardized publish and spread of those guidelines. Methods Such databases as Ovid MEDLINE (1996-2010) and EMbase (till April, 2010) were searched with the terms of “guideline”, “report”, “systematic review” and “meta-analysis” to collect the report guidelines for systematic reviews and meta-analyses. The irrelevant literatures (e.g. systematic review of a specific disease, clinical guideline for a certain disease, and other literatures focusing on the methodology of systematic review without mentioning reporting guideline) were excluded by reading the abstracts and titles, and then the further verification was done after the full-texts had been read. The contents about how to report a systematic review or meta-analyses were extracted from the included studies which were classified by its form of the original research (e.g. randomized controlled trial, observational study, diagnostic trial, etc.). Results Primary search ended up with 285 literatures, and 26 literatures of which were included. Among the included literatures about the report guidelines for systematic reviews and meta-analyses, eight were about RCTs, two about non-RCTs, two about observational study, no literature about diagnostic trial, one about animal experiment, two about report searching strategy, five about quality assessment, six about the influence on quality, and the other two about the update of guidelines. Conclusion The report guidelines for systematic reviews and meta-analyses are considerable in number, among which the QUOROM and its updated version PRISMA are relatively mature and widely applied. Report guidelines are beneficial to improve the quality of systematic reviews and meta-analyses, and the report guideline focusing on specific field is needs to be formulate.