Objective To understand the current status of the preferences and opinions on the investigator-initiated trails (IIT) of the neurosurgeons participating in INTERACT3 in China, as well as the design preference for IIT projects, and to provide a basis for the design and organization of multi-center clinical studies in the future. Methods Neurosurgeons with different seniority and professional titles from 89 domestic research institutions participating in the INTERACT3 project were collected from September to October 2023. The questionnaires were collected by questionnaire star. Results A total of 56 valid questionnaires were collected from 29 units. Among the 56 respondents, 52 neurosurgeons (92.86%) were from teaching hospitals and 45 (80.36%) were from grade A tertiary hospitals. 30 neurosurgeons (53.57%) had experience in conducting various clinical studies, and 55 neurosurgeons (98.21%) had experience in participating in various clinical studies. The main purposes of presiding over or participating in clinical research focused on “accumulating relevant experience and preparing for future projects” and “standardizing clinical diagnosis and treatment”, which were 89.29% and 83.93%. Respectively, regarding the way the case report form completing, respondents preferred to use electronic data collection systems (83.93%). Conclusions The purpose of the neurosurgeons interviewed to host or participate in clinical research is mainly to assist clinical and scientific research. Economic reasons have little impact on whether to participate in clinical research. The rationality and ease of operation of the trail design are the keys to attracting respondents to participate in clinical researches, and the level of remuneration has little impact on the decision-making of the respondents. The safety of clinical studies and the difficulty of enrolling subjects are the key factors that hinder respondents’ participation in clinical studies.
The western medicine are main drugs in treatment of infectious diseases, but the combination of Traditional Chinese and western medicine are used in China. In recent years, proportion of proprietary Chinese medicine increased significantly in this field. However, the classification of proprietary Chinese medicine and matching with the counterparts of western medicine were difficult, and the package inserts were less scientific and normative. By searching the terms of "Qing kai ling" and "Infection", the paper found the quality of post-marketing clinical researches was low. The use proportion of Qing kai ling combined with other drugs was more than 50%, 70% of which was western medicine. The further studies are needed to explore some proprietary Chinese medicine with obvious competitive advantage and improve the quality of methodology and reporting, in order to standardize and guide the rational use of proprietary Chinese medicine in infectious diseases.
New interventions are rapidly progressing into clinical practice through the preclinical study stage. The animal experiments should be comprehensive and critically evaluated for their pivotal role in this process. To integrate the evidence of animal studies by systematic review throws light on intervention outcomes and could decrease risk of participants in human trials. The methodological weakness of animal studies is easy to highlight but robust methods to synthesize evidence is essential. Here, we discuss some problems in systematic review of animal experiments and whether animal models of diverse species contribute to bias of meta-analysis conclusions.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
ObjectiveTo review the clinical research progress of mesenchymal stem cells (MSCs) in the treatment of chronic wounds.MethodsThe literature related to the chronic wound repair with MSCs at home and abroad in recent years was extensively reviewed, and the possible mechanism of MSCs in the treatment of chronic wounds, as well as its application and existing problems were summarized.ResultsMSCs can participate in all aspects of chronic wound healing to promote wound healing, and has shown broad application prospects in clinical trials. MSCs commonly used in clinical research include bone marrow-derived MSCs, adipose-derived tissue MSCs, and umbilical cord-derived MSCs.ConclusionMSCs treatment is a promising strategy for the chronic wounds, but there are still many problems in its widespread clinical application that require further research.
Objective To investigate current status and latest progress of clinical research on distal femoral fractures. Methods The related literature was extensively reviewed to summarize the trend of the researches and their clinical application in the treatment of distal femoral fractures. Results Distal femoral fractures are likely to occur in young people who suffer from high-energy damage and the elderly with osteoporosis, which is always comminuted and unstable fractures, and often involved in the articular surface and combined with serious soft tissue injury. Therefore, the treatment faces many challenges. External fixation is now used as a temporary means of controlling injury. The vast majority of patients are feasible to internal fixation, including plates system and intramedullary nail system. Different internal fixator also has its own characteristics, such as double plates can strengthen the medial support of the femur, less invasive stabilization system protects the blood supply of fractures, distal cortial locking plate is theoretically more fit for the requirements of bone healing, retrograde intramedullary nail can resist varus and valgus. Conclusion The treatment of distal femoral fractures should be based on the type of fracture and the characteristics of internal fixators.
Segmentectomy is the removal of certain segments of the lung with lesions and retaining the normal lung tissue of the lobe. Lung segmentectomy is considered difficult due to the lack of clear anatomical boundaries between lung segments. Segmentectomy has a variety of indications, such as lung cancer, metastatic lung tumors, and many non-malignant diseases. In the treatment of early stage lung cancer, segmentectomy was initially considered only as a treatment option for patients not suitable for conventional lobectomy. As more evidence emerged, the indications for segmentectomy have continued to change over time, and segmentectomy has been widely performed in patients with early stage lung cancer. Theoretically, segmentectomy leads to better preservation of lung function than lobectomy, but the risk of incomplete tumor resection is higher, so the indication of segmentectomy has become a focus of debate. This article will introduce the surgical techniques of segmentectomy and summarize the published and unpublished clinical studies on segmentectomy for the treatment of early stage lung cancer.
Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disease caused by mutations in the NF1 gene. The disease is characterized by neurofibromatosis, which simultaneously affects multiple systems such as nerves, skin, and bone, and has complex clinical manifestations. Since the National Institutes of Health (NIH) established diagnostic criteria in 1988, the diagnosis and treatment of NF1 have progressed significantly. However, due to the complexity of the disease and the lack of effective treatments, the diagnosis and treatment of NF1 still face many challenges. Strengthening multidisciplinary collaboration, improving and popularizing disease diagnosis and treatment strategies, and developing more effective drugs and treatment methods are the keys to further improve the treatment level of NF1 diseases.
With the continuous development of China's aging society and the prevalence of unhealthy lifestyles, the incidence of cardiovascular disease in China has been increasing in recent years. Among them, atrial fibrillation (AF) is the most common arrhythmia disease. In recent years, pulsed field ablation (PFA) has been continuously applied to AF treatment as a novel treatment. This paper first introduces the principle of PFA applied to AF treatment, and introduces the research progress of PFA in different directions, such as the comparison of different ablation methods, the study of physical parameters, the study of ablation area, the study of tissue specificity and clinical research. Then, the clinical prior research of PFA is discussed, including the use of simulation software to obtain the simulation effect of different parameters, the evaluation of ablation effect during animal research, and finally the current AF treatment. Various prior studies and clinical studies are summarized, and suggestions are made for the shortcomings found in the study of AF treatment and the future research direction is prospected.
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.