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.
To promote the accessibility and application of guidelines, it is necessary to establish a professional guideline database to adapt to the rapid growth of TCM clinical practice guidelines. This study described the framework design, technology module, information management, and quality control of the clinical practice guideline database of traditional Chinese medicine (G-TCM). G-TCM had included 658 TCM clinical practice guidelines, which would provide a platform for clinicians, researchers, guideline makers (revision), and evaluators to quickly query and obtain clinical guideline information, and play a supporting role in promoting the standardization and accessibility of TCM clinical practice guidelines and better guiding clinical practice.
ObjectiveTo explore impact factors related to the clinical applicability of guidelines, and provide suggestions for better development and implementation of guidelines. MethodsThe CNKI database was electronically searched to collect clinical guidelines issued by the Chinese Medical Association and the Chinese Medical Doctor Association from 2015 to 2020. Sixty-one guidelines were randomly selected from included guidelines and each guideline was evaluated by medical staff from three regions using the instrument for evaluating clinical applicability of guidelines (version 2.0). Statistical data were described, and t-test or rank sum test or chi-square test were used for comparison between groups. The impact factors were screened by stepwise logistic regression analysis. ResultsA total of 6 904 valid questionnaires were collected from 119 medical institutions in 26 provinces of China. The more familiar with the guidelines and the more consistent with the wishes of patients or their families, the overall standardized score of the clinical applicability of guidelines would be higher. In addition, the more familiar with the guidelines, the standardized scores in each field would be higher. The higher emphasis on guidelines compliance, the higher the feasibility standardized score. ConclusionIn order to improve the clinical applicability of guidelines, developers should pay attention to whether the recommendations are consistent with the wishes of patients or their families. Then, medical institutions should pay attention to the compliance of guidelines. Finally, medical personnel should be familiar with the recommendations.
Secondary and tertiary hyperparathyroidism are common complications in patients with chronic kidney disease, especially in end stage renal disease. Surgery is an important method for the treatment of secondary and tertiary hyperparathyroidism. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Secondary and Tertiary Renal Hyperparathyroidism is the first evidence based guideline focus on renal hyperparathyroidism surgical management. Recommendations using the best available evidence by a panel of 10 experts in secondary and tertiary renal hyperparathyroidism constructed this guideline, which provides evidence-based, individual and optimal surgical management of secondary and tertiary renal hyperparathyroidism. This paper made a guideline interpretation on the indications of surgery, imaging examination, preoperative and perioperative management, relevant evaluation and treatment during perioperative period, and intraoperative parathyroid hormone monitoring during operation, and so on.
The publication of the 2016 version of the Surviving Sepsis Campaign guidelines is a further step to the treatment of sepsis worldwide. This version of guidelines approves new definition of Sepsis-3. Overall, the new guidelines do not change the previous principle of treatment significantly. Some detailed and specific modifications have been made. Understanding and rational use of the new guidelines based on clinical practice, are the key to managing sepsis and performing accurate and effective treatment.
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 systematically analyze the distribution of research evidence on diabetes in current clinical practice guidelines of Chinese medicine (CM). MethodsThe PubMed, Embase, Cochrane Library, CBM, WanFang Data, CNKI, VIP databases and related guideline websites were electronically searched to collect clinical practice guidelines for CM in diabetes published before December 2023. We systematically reviewed the distribution of evidence in these guidelines. ResultsThe 27 CM guidelines on diabetes mainly covered syndrome differentiation and treatment, specific disease-specific drugs, diet, external therapies, and traditional exercises. The included guidelines used three different levels of evidence grading, with most of the evidence falling into the low-to-moderate level (67.3%). However, guidelines on diabetes-related osteoporosis, diabetic cardiomyopathy, prediabetes, and diabetic peripheral neuropathy had a relatively low proportion of high-level evidence, accounting for only 7.2%, 7.6%, 13.2%, and 13.3% respectively. Only guidelines on diabetic nephropathy provided evidence on the toxicity of Chinese herbal medicine, while other guidelines did not cover this aspect. Acupuncture, Tai Chi, Baduanjin, and other characteristics therapies had varying levels of evidence for different types of complications. Low-level evidence mainly focused on syndrome differentiation and treatment, symptom-based treatment, sign-based treatment, indicator-based treatment, Chinese patent medicine, specific disease-specific formulas, etc., for diabetes and related complications. ConclusionCurrently, topics supported by low/no evidence, new themes, inconsistent content between guidelines, evidence sources for overlapping targets, classical formulas, toxicity of Chinese herbal medicine, and characteristic CM therapies can provide directions for future research on CM in diabetes. We advocate addressing important issues related to diabetes specifically, to improve research value, eliminate unnecessary duplication of studies and resource waste, and promote the healthy development of CM research in the field of diabetes.
Objective To evaluate quality and current status of traditional Chinese medicine (TCM) guidelines and consensus, and to promote the improvements in the quality of guidelines and consensus. Methods A systematic collection of TCM guidelines and consensus published in medical journals in 2022 was conducted. We used scientific, transparent, and applicable ranking tools (STAR) for evaluation, analyzed the scoring rates (%), and assessed the quality level and influencing factors of guidelines and consensus through methods such as comparison and stratification. Results A total of 130 TCM guidelines and consensus were included. Guideline areas with higher scores included recommendations (65.3%), evidence (55.9%), and guideline development groups (54.2%). In the case of consensus, higher scores were observed in recommendations (38.7%), guideline development groups (37.0%), and funding (30.0%). The total score rate of TCM guidelines exceeded that of national guidelines, while the consensus rate was lower. Stratified analysis revealed statistical differences in guideline score rates among journals and issuing institutions, as well as significant differences in consensus score rates among journals, formulation institutions, subjects, and funding categories. Conclusion The quantity and quality of TCM guidelines and consensus are on a positive trajectory, with higher quality levels in guidelines than in consensus. The overall quality of TCM guidelines surpasses that of national guidelines, particularly emphasizing the scientificity of guideline formulation. However, the overall quality of consensus remains lower than that of the national consensus. Factors such as journals, formulation institutions, subjects, and funding categories are identified as potential influences on the quality of TCM guidelines and consensus.
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 second paper of this series introducing the composition, main work and functions of WHO-GRC.
Objective To systematically review published methodological guidelines for health technology assessment (HTA) at home and abroad. Methods Common electronic databases, guideline databases, international networks of HTA agencies/organizations, representative national HTA networks and official websites of governmental health departments were extensively searched and screened to identify guidelines for conducting or reporting HTA from inception to April 24, 2023. Basic information on guidelines, HTA processes, assessment indicators, reporting checklists and other information was extracted, analyzed and described using a systematic review methodology. Results A total of 41 guidelines were included in this study, published from January 2002 to January 2023; the publishing institutions involved 23 countries/international organizations, and 6 languages; the assessments were mainly for all health technologies (n=23), pharmaceuticals (n=4), diagnostic/testing technologies (n=4), non-pharmaceutical health technologies (n=3), medical devices/equipment (n=3), hospital health technologies (n=2), medical and surgical interventions (n=1), and screening technologies (n=1); the assessment perspectives were mainly health system perspectives (n=16), societal perspectives (n=12), and hospital perspectives (n=3), while the rest did not provide information on the perspectives; 28 guidelines described the detailed HTA assessment process, involving 11 steps; there were 39 guidelines described the assessment domains and related assessment indicators in detail, ranging from 2 to 9 assessment domains and involving 10 first-level assessment indicators; a checklist for HTA reports listed in 10 guidelines, involving 18 report entries; 17 guidelines reported conflicts of interest, mostly no conflicts of interest (n=10), and 3 of the remaining 7 guidelines did not indicate a specific conflict of interest, while 4 guidelines in which possible sources of conflict of interest were indicated. Conclusion The development of HTA has formed a relatively perfect assessment system, but there is a need to unify the criteria for classification of health technologies and reporting checklist, improve the specificity indicators for different types of health technologies, and clarify the assessment perspectives. Combined with the current situation of HTA development in China, contextualized guidelines for HTA implementation and reporting should be formulated to provide scientific information and methodological basis for decision-making on rational allocation of health resources.