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.
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.
ObjectiveTo understand the current national status of the rating of published orthopedic guidelines and consensus in China, to help users select the appropriate use of these clinical guidelines, to guide clinical practice, and to promote the targeted improvement of the quality of Chinese orthopedic guidelines and consensus. MethodsChinese biomedical databases, including CNKI, WanFang Data, and SinoMed were searched electronically from January 2016 to October 2023, and relevant Chinese orthopedic clinical practice guidelines and consensus documents were collected. Two evaluators independently screened the retrieved literature and extracted data. The scientificity, transparency, and applicability rankings (STAR) tool was used to comprehensively rate Chinese orthopedic guidelines and consensus documents published in medical journals since 2016. Any dispute between the two evaluators was resolved by consulting a third evaluator. Kappa values were used to evaluate the consistency of the results between the two evaluators. ResultsA total of 191 orthopedic-related guidelines and consensus documents were obtained, including 74 guidelines and 117 consensus documents. The average score of the guidelines included in the evaluation was 34.4 points, while the average score of consensus documents included in the evaluation was 21.7 points. Guidelines scored higher than consensus documents in areas such as registration, planning, workgroups, clinical issues, evidence, consensus methods, recommendations, accessibility, and other fields. The Kappa value test result was 0.684. ConclusionThere has been a progressive increase in methodological scores of Chinese orthopedic clinical practice guidelines and consensus documents published in recent years, but the overall quality is not high. Future guidelines development needs to improve methodology further, especially in terms of transparent funding, formation of recommendations, guidelines release, and dissemination.
In 2017, the Acute Dialysis Quality Initiative (ADQI) Consensus Group released a series of guidelines on the topic of "Precision Continuous Renal Replacement Therapy (CRRT)". The updated content in this guideline included four parts: patient selection and timing of CRRT, precision CRRT and solute control, precision fluid management in CRRT, and role of technology for the management of AKI in critically ill patients. This review will interpret the 2017 ADQI guidelines update in detail.
ObjectivesTo investigate Chinese health practitioners’ usage and demand for clinical practice guidelines in general so as to improve the development and implementation of guidelines.MethodsWe conducted a cross-sectional questionnaire survey that covered health practitioners from different levels of medical institutions in 17 provinces in China. Attitudes, adherence, usage barriers and demands for clinical practice guidelines were investigated.ResultsA total of 953 health practitioners were involved in the survey in which 931 completed the questionnaires. Respondents generally held positive attitudes toward guidelines and agreed that they improved quality of care and standardized diagnosis and treatment. More than 80% of the respondents reported a fine adherence to guidelines. The most reported barriers to follow the guidelines were " several guidelines are competing” and " lack of facilities and medical resources”. Most respondents agreed that it was necessary to establish a national guideline database, appraise implementation effect of guidelines, develop evaluation tools for guidelines that are applicable for Chinese clinical practice, and provide guidelines training.ConclusionsThis study finds favorable attitudes and fine adherence towards clinical guidelines in general in China. However, internal barriers, such as authority of guidelines, and external barriers, such as supplying system and patients’ preference, can affect guideline dissemination and implementation. It is suggested that establishing a national guidelines database, developing evaluation tools for guidelines that fit for Chinese clinical practice, and provision of guideline training, would facilitate the use of guidelines.
Rapid, living evidence-based points, as a new model promoting the rapid translation of evidence, aim to integrate the current best evidence, clinical status, public/patient preferences and values, and provide concise and practical guidance rapidly to important questions concerned in clinical medicine and public health. This paper introduces the methodological framework for the development of "Rapid, Living Evidence-Based Points" from 4 aspects: initiation and planning, evidence search and review, development, update, publication and dissemination of evidence-based points, in order to provide a reference for domestic scholars in developing rapid, living evidence-based points.
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.
ObjectivesTo evaluate the reporting status of conflict of interest and economic evidence in Chinese clinical practice guidelines published in 2017 and to provide implications for the guideline development in China.MethodsCNKI, WanFang Data and Google Scholar were electronically searched to collect clinical practice guidelines published in 2017 from January 1st to December 31st, 2017. Two authors independently screened literature, extracted information of interest, such as conflict of interest disclosure and economic evidences, then, the analysis was performed by using the Microsoft Excel 20013 software.ResultsA total of 53 guidelines were included; in which, 14 (26.42%) disclosed conflict of interest, 10 (18.87%) stated sources of funding, and 6 (11.32%) mentioned economics evidence.ConclusionIn China, inadequate attention is addressed to the conflict of interest disclosure and economics evidence during the development of clinical practice guidelines. We propose the inclusion of conflict of interest and economics evidence disclosure in clinical practice guidelines, which will improve their objectivity, independence, and transparency.
Lung cancer is the leading cause of cancer-related deaths worldwide, especially non-small cell lung cancer (NSCLC). With the popularization of low-dose CT and the improvement of people’s awareness of physical examinations, the number of detected pulmonary nodules is gradually increasing, and there is a greater demand for standardized diagnostic and treatment guidelines. On April 23, 2024, the National Comprehensive Cancer Network updated its clinical practice guidelines for NSCLC to the version 5. Compared with the version 5 in 2023, the version 5 in 2024 updates focus on diagnostic evaluation, perioperative systemic therapy, treatment of advanced NSCLC, and molecular marker testing, which will be interpreted in this article with the aim of providing the latest guidance and reference for the diagnosis and treatment of lung cancer in China.