Objective To form the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single arm trial, and initially construct a methodological guiding tool for the selection and evaluation of target value, so as far to provide a research basis for improving the system of single-arm trial quality evaluation by objective performance criteria method. Methods Combining the bias risk assessment method of observational study, interventional trails, domestic and foreign policy documents, and systematically collecting the common bias and evaluation key points, preliminarily proposing the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, via two rounds of expert consensus voting using nominal group method, finally formulating the list based on the voting results and expert opinions. Results Through two rounds of discussion, sorting, comprehensive expert opinions, we improved the corresponding items in the list and finally formed the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, which included four areas: authority, traceability, comparability, and reliability, including 10 items. The entries in each field considered both design and implementation throughout the clinical trial. Conclusion The methodology list developed in this study provides methodological guidance for the selection of objective performance criteria and quality evaluation, and provides a solid theoretical basis for the establishment of a complete methodological system of quality evaluation for objective performance criteria single arm trails.
Pneumoconiosis is the most harmful and common occupational disease in China. The development of a pneumoconiosis rehabilitation expert consensus can improve utilization of the unique advantages of Chinese and Western medicine rehabilitation strategies, and provide effective and feasible guidance for the clinical rehabilitation of pneumoconiosis. We conducted clinical problem investigation, evidence collection and evaluation, Delphi consultation, and other technical links following the WHO guidelines to formulate manual procedures. Relevant rehabilitation guidelines, systematic reviews, clinical researches, and other current best evidence and expert opinions were extensively solicited to formulate the consensus. The reporting of consensus followed the RIGHT statement. The 14 types of rehabilitation strategies recommended by this consensus can be used by clinical rehabilitation physicians, rehabilitation therapists, respiratory therapists, nursing staff, community rehabilitation, health education, and other professionals for the rehabilitation of pneumoconiosis patients.
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.
Ocular trauma is the most common cause of monocular vision loss in children. Among the patients with eye trauma in China, 15%-20% are children. The complexity of diagnosis and treatment and the uncertainty of prognosis are high because the ocular tissue of children is not fully developed and the history collection and examination are difficult. In order to further standardize the treatment of children's eye trauma and improve the treatment level, China Ocular Trauma Society has formulated Expert consensus of the treatment of pediatric ocular trauma in China by combining domestic and foreign literature and the actual medical situation in China. This consensus provides detailed recommendations on the classification, cause of injury, history collection, examination methods, diagnosis and treatment principles of pediatric eye trauma. This consensus applies to Chinese ophthalmologists and medical personnel engaged in the treatment of children's eye trauma, aiming to provide scientific guidance for the diagnosis and treatment of children's eye trauma, assist clinical decision-making, and further improve the treatment level of children's eye trauma in China.
Choroideremia (CHM) is a rare X-linked recessive genetic inherited degeneration. Affected males present with progressively worsening night blindness, visual field loss, and decreased central vision, which can cause blindness in middle age. Although female carriers typically exhibit mild symptoms, it is essential to understand their clinical features for early diagnosis of patients as well as genetic counseling of family members. The pathogenesis of CHM remains incompletely understood, and currently there is no approved effective treatment. To enhance clinicians’ comprehension of CHM and establish standardized clinical approaches to its diagnosis and management, the Chinese Hereditary Ocular Disease Diagnosis and Treatment Group and the Chinese Hereditary Ocular Disease Alliance assembled authoritative experts, through in-depth discussions, formed China's standardized recommedations for the on clinical diagnosis and treatment of CHM. The purpose of this advice is to provide a standardized diagnostic framework, monitoring indicators, and an integrated management strategy for clinicians to use in practice, thereby optimizing the care and genetic guidance for patients with CHM.
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.
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.
Anti-tumor necrosis factor-α monoclonal antibody agents have been widely applied in the management of autoimmune diseases. Among them, Adalimumab and Infliximab have been used for years in clinical practice in treating non-infectious uveitis and achieved satisfactory effects and safety. However, no guideline or expert consensus for their usage is available in China currently. It hopefully promotes standardized clinical application of anti-tumor necrosis factor -α monoclonal antibody in treating non-infectious uveitis, together with other senior experts in uveitis, the Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association form this evidence-based recommendations for clinicians’ reference.
With the continuous aging of the population in China, the aging of skeletal muscle in the elderly has seriously affected national health and poses a severe challenge to the public health system. Early detection of skeletal muscle aging, and early warning, prevention, and treatment are of great significance for achieving healthy aging. In order to select a series of clinically operable biomarkers for skeletal muscle aging, and to further standardize the early identification and precise diagnosis of skeletal muscle aging, a multidisciplinary team of experts has registered and written this protocol to provide a detailed introduction to the planning process for the development of the consensus.