Clinical practice guidelines need to be based on evidence, but traditional Chinese medicine, especially integration of traditional Chinese and Western medicine guidelines, inevitably need to combine clinical research evidence, ancient literature, and expert experience and consensus. In the process of formulating, there are deviations in understanding and application of the expert consensus method and expert experience, resulting in opaque of the recommendations, unclear of the details of the diagnosis and treatment strategy, less prominent of the advantages and value of traditional Chinese medicine, which affects the scientificity, transparency, applicability, promotion and application of the guidelines of traditional Chinese medicine or integration of traditional Chinese and Western medicine. This study discusses the guiding principle of "evidence as a core, consensus as a supplement, and experience as a reference" that was generally followed and puts forward detailed methodological suggestions to the formulation of guidelines for traditional Chinese medicine and integration of traditional Chinese and Western medicine.
ObjectiveTo evaluate the methodological quality of clinical practice guidelines and expert consensus of chronic heart failure domestically and abroad.MethodsPubMed, EMbase, SinoMed, CNKI, WanFang Data, and VIP databases, and related websites were searched to collect guidelines and expert consensus on chronic heart failure published from January 1st, 2011 to December 31st, 2020. Four reviewers evaluated the methodological quality of the guidelines and expert consensus with the AGREE Ⅱ tool after the consistency evaluation training.ResultsA total of 17 studies were included (consisting of 11 English and 6 Chinese studies). The recommended levels were B level (recommend after modification) for 10 studies and C level (not recommended) for 7 studies. The AGREE Ⅱ standardized mean scores for various fields were 69.61% (scope and purpose), 34.20% (stakeholder involvement), 33.13% (rigor of development), 84.53% (clarity and presentation), 42.40% (applicability), and 37.09% (editorial independence). The methodological quality of English guidelines was generally high (level B for 10 and level C for 1), while all scores of Chinese guidelines or consensus in the 6 fields were mostly lower than the average (level C for 6).ConclusionsThe guidelines for the diagnosis and treatment of chronic heart failure requires further improvement in terms of stakeholder involvement and rigor of development. It should develop standards and methods to improve the quality for Chinese guidelines and expert consensus to better serve clinical practice.
Diabetic retinopathy is one of the microvascular complications of diabetes and a major cause of blindness in adults. Early screening is an effective way to reduce blindness caused by diabetic retinopathy. The diabetic retinopathy is one of the chronic retinal diseases highlighted in the “14th Five-Year” National Eye Health Plan (2021-2025). The establishment of effective and practical community screening model is a powerful guarantee to complete early screening. It is of great significance to standardize screening methods, screening personnel duties, equipment allocation, referral conditions and screening sustainability. Chinese fundus disease and related field experts developed the consensus through a serious, comprehensive, and complete discussion, to provide more reference for establishing a suitable community screening model of diabetic retinopathy and increasing the screening rate of diabetic retinopathy.
With the advancement of research on rare ocular diseases such as inherited retinal dystrophy (IRD) has advanced in recent years, especially breakthroughs in therapeutic approaches represented by cell and gene therapy, potential intervention strategies have emerged for these conditions. Establishing standardized endpoints and evaluation methods for visual function in patients with IRD has become crucial for assessing disease progression, safety, and therapeutic efficacy of innovative treatments. Best corrected visual acuity (BCVA) is widely recognized as one of the primary endpoints for assessing visual function. However, for IRD patients with severe rod photoreceptor dysfunction, who often present with profound low vision or even legal blindness, the applicability of BCVA as a traditional visual function indicator is limited. The multi-luminance mobility test (MLMT) has emerged as a functional visual assessment tool that evaluates the ability to navigate obstacle courses under varying illumination levels. By establishing graded evaluation standards, MLMT objectively quantifies the impact of lighting conditions on patients’ nobility and spatial orientation, providing a novel quantitative tool for assessing visual function in IRD clinical trials. Currently, there is a lack of unified and standardized guidelines for the use of MLMT in China, posing challenges to its implementation in practical clinical research. To address this, Ocular Fundus Disease Society of Chinese Medical Association and Chinese Medical Doctor Association convened a multidisciplinary team comprising clinical experts in genetic retinal diseases, statisticians, and optical specialists to investigate the current applications and technical characteristics of MLMT, ultimately formulating consensus recommendations for its use as a clinical trial endpoint for IRD gene therapies. This consensus aims to provide a set of MLMT operating norms applicable to China's national conditions, guide clinical practice and research in ophthalmology and related disciplines, and promote the standardization process of IRD clinical trials in China, so as to better serve the IRD patient population and promote the development of related fields.
The high incidence of hydatid disease in seven northwestern provinces, is one of the reason of "Poverty due to illness, and return poverty due to illness" in China. The incidence of chest hydatid disease in China after hepatic hydatid disease ranks second. Department of thoracic surgery in the First Affiliated Hospital of Xinjiang Medical University is on the domestic leading position of the treatment of chest hydatid disease. Since 1956 the first case of pulmonary hydatid cyst were completed, we have successfully finished the surgical treatment of pediatric chest hydatid disease, chest hydatid disease complex, huge pulmonary hydatid cyst, mediastinal and pleural hydatid cyst, and rib hydatid in our department. To further standardize the treatment of chest hydatid disease, a special formulation of "technical specification for chest hydatid disease diagnosis expert consensus" by our department were produced, in order to help clinicians treat chest hydatid disease by more suitable strategies. This consensus was released in July 2015, for the original version. The definition, diagnosis, treatment principle, and prevention of chest hydatid disease were elaborated and clinical experiences of 60 years were combined with in this consensus, in order to help the clinicians for diagnosis, treatment, and prevention of hydatid disease.
Intravitreal drug injection is a treatment for common chronic fundus diseases such as age-related macular degeneration and diabetic retinopathy. The “14th Five-Year” National Eye Health Plan (2021-2025) recommends focusing on fundus diseases and improve the management mode of patients with chronic eye diseases. Therefore, it is imperative to explore how to further optimize the service process of intravitreal injection under the premise of guaranteeing patients' medical safety, to promote medical service efficiency and standardized management level and improve the medical experience of patients. Based on the quality control standard of vitreous cavity injection for retinopathy in China, Chinese fundus disease and related field experts developed the present expert consensus on the establishment of a one-stop intravitreal injection model and the management of its organization after a serious, comprehensive, and complete discussion, focusing on a standardized operation process, quality control, and safety management, providing more references for establishing a suitable intravitreal injection management model for ophthalmology and promoting the development of diagnostic and treatment models for fundus disease in China.
Retinopathy of prematurity (ROP) is a blinding eye disease of neonates. Early screening and regular follow-up can prevent the disease from leading to serious functional impairment. Rop is classified by the World Health Organization as the prevention target of avoidable blindness in neonates. Since the National Health Commission of the People's Republic of China issued "Guidelines for the treatment of oxygen and the prevention and treatment of retinopathy in prematurity" in 2004, the Ophthalmology Group of the Chinese Academy of Ophthalmology has actively promoted the screening and treatment of ROP, and updated "Guidelines for screening retinopathy of prematurity" in China in 2014. After nearly 20 years of hard work, the disease of stage 5 ROP in China has basically disappeared. In order to reasonably grasp the classification criteria of ROP and the indications of drug treatment, Fundus Disease Group of Ophthalmological Society of Chinese Medical Association, Fundus Disease Group of Ophthalmologist Branch of Chinese Medical Doctor Association organize experts in related fields to reach consensus opinions through serious, comprehensive and full discussion, and update the classification of ROP in China and the Chinese translation of new terms with reference to international standard terms. The standard of anti-vascular endothelial growth factor drug treatment indication is also added to provide reference for clinicians in clinical practice.
Clinical trials are the most reliable means for scientifically rigorous evaluation of the efficacy and safety of drugs, and are the most crucial part receiving the most investment in development and innovation in the pharmaceutical industry. In recent years, the nation has formulated a set of policies and guiding principles to encourage pharmaceutical innovation, promote the independent innovation of China’s pharmaceutical industry and enhance clinical trial capacity. To further improve Chinese researchers’ ability to perform clinical trials, the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and the National Center for Cardiovascular Diseases invited a multi-disciplinary team of experts from various areas including clinical trial methodology and supervision to work on this consensus. In view of the common concern and puzzles regarding the issues in clinical trials, such as recruitment and retention of participants, outcome selection, quality control, information technology application, and ethics in data security, the expert consensus is based on domestic and international guidelines, the latest advancement of clinical research, and the advice and opinions from national experts. It aims to provide reference information and guidance for clinical trial researchers, and serves as a reference for relevant authorities to formulate clinical trial management policies.
ObjectiveTo systematically investigate the current status of reporting health economics evidence in clinical practice guidelines and expert consensuses published in China from 2021 to 2023, providing references for the formulation and revision of guidelines and consensuses in our country. MethodsComputer searches were conducted in the CNKI, CBM, WanFang Data, China Academic Journals Full-text Database, PubMed, and Web of Science to collect clinical practice guidelines and expert consensuses published in China from 2021 to 2023. Two researchers independently screened the literature, extracted information on the inclusion of economic evidence in guidelines and consensuses, and then used quantitative analysis methods for description. ResultsA total of 4 236 relevant articles were included, of which 1 066 (25.17%) reported health economics evidence; 120 (11.26%) reported health economics evidence in the formation of recommendation opinions; 109 (10.23%) reported health economics evidence in the grading of evidence quality; 832 (78.05%) reported health economics evidence in the interpretation and explanation of recommendation opinions. ConclusionThe reporting rate of health economics evidence in clinical practice guidelines and expert consensuses published in China is not high. The reporting rate of health economics evidence in consensuses is lower than that in guidelines. It is recommended that during the formulation process of guidelines and consensuses, the application of health economics evidence should be further strengthened in aspects such as the formation of recommendation opinions, the grading of evidence quality, and the interpretation and explanation of recommendation opinions, in order to improve the scientific, rigorous, and applicability of clinical practice guidelines and expert consensuses, and to play the role of guidelines and consensuses in optimizing the allocation of health resources, improving clinical diagnosis and treatment effects, and enhancing the quality of medical care.
Acute pharyngitis belongs to the category of “acute throat impediment” in traditional Chinese medicine (TCM), which has a high incidence and is easy to recur. In clinical practice of TCM, Chinese patent medicines with the effects of clearing heat and detoxifying, reducing swelling and relieving pain are widely used in the treatment of acute pharyngitis. These medicines have the advantages of definite efficacy, low side effects, and low risk of developing drug resistance. However, at present, there are no standardized clinical diagnostic and therapeutic evaluation norms for acute pharyngitis in TCM, which has hindered the application of TCM in the prevention and treatment of acute pharyngitis and the development of new TCM preparations. Therefore, the China Association of Chinese Medicine initiated this expert consensus, which was led the formulation by Xiyuan Hospital, China Academy of Chinese Medical Sciences. This expert consensus integrates the current best evidence and extensive clinical expert experience from the front line, covering seven aspects: applicable scope, diagnosis in both Chinese and Western medicine, syndrome classification and evaluation scales, basis for efficacy evaluation, and time for efficacy evaluation. It has formed 8 types of TCM syndromes for acute pharyngitis, as well as the diagnostic criteria, syndrome classification and evaluation scales, evaluation basis for efficacy, and scoring standards for syndromes and diseases. This expert consensus can be used to standardize the diagnosis of the TCM syndromes of acute pharyngitis, as well as the core indicators and evaluation methods for syndrome and disease efficacy, with the aim of providing references for clinical practice and scientific research on acute pharyngitis.