ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
Objective To explore the certification management of specialty nurses in China based on the existent problems to provide evidence for practice and decision making for management of the specialty nurses. Methods The modified Delphi technique was applied in this study from July to December 2017. A structured consultation questionnaire based on expert interview and literature review was designed, and modified after preliminary experiment. Then the questionnaires were delivered to 32 nurse experts to complete 3 rounds of Delphi process, which reached consensus gradually. Results The response rates of three round consultations were 96.9% (31/32), 100.0% (31/31), and 96.8% (30/31), respectively. The suggestion rates were 25.8% (8/31), 16.1% (5/31), 0% (0/31), respectively. The familiar coefficient, adjustment coefficient and authority coefficient was 0.82, 0.87 and 0.85, respectively. The experts had the agreement finally for all of the 16 items in the consultation questionnaire, and they formed an expert opinion draft on specialty nurse certification and registration. Conclusion It’s crucial and essential to establish a certification and registration system in China and renew the credentials regularly to promote the management and construction of specialty nurse team.
Objective To establishadatabase to fully investigate current situation of antiepileptic drugs among pregnant women with epilepsy in West China. Analyzing the epidemiological characteristics and correlated influence factors of anti-epileptic drugs use among women with epilepsy in this area to promote management quality for women with epilepsy. Methods Adigital registration system was established with JAVA andastandard registration procedure was formulated. Standard registration was implemented in different levels of hospital of West China with regular follow-up. Results Registration system about antiepileptic drugs among pregnant women with epilepsy in West China was successfully established, which wasadigital registration within local area network. Information about registration centre and pregnant women with epilepsy was collected in the West China registration network. And elementary database was successfully established. Conclusion This is the first extensive and standard pregnancy register of antiepileptic drugs in China which meet the need of not only patient information management but also the development of academic subject.
Objective To analyze the current research status, characteristics and development trends of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyze the basic information of the trials, the diseases studied and the interventions. Results A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The trial sponsors of the study covered 9 countries and a total of 34 provinces/autonomous regions/municipalities in China, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. A total of 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and 213 large-sample studies with a sample size of more than 1 000 cases were included. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral prescription of herbal medicine interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule intervention studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.
ObjectiveTo systematically investigate the registration status, methodology and reporting quality of the systematic review protocols for animal experiment registered on PROSPERO platform.MethodsSystematic review protocols of animal experiments registered on PROSPERO platform were searched up to December 31st, 2019. Two reviewers independently screened literature, extracted data, and performed a descriptive analysis of the methodological quality and reporting characteristics of the included studies.ResultsA total of 351 protocols from 50 countries were included, involving 22 diseases. The intervention measures were primarily "pharmaceutical chemicals". Only approximately 1/3 of the studies reported the search strategy from at least one database, approximately half of the studies were prepared to report heterogeneity analysis and publication bias, and only approximately 1/3 of the studies were prepared to report sensitivity analysis.ConclusionsThe quantity of systematic reviews of animal experiments registered on the PROSPERO platform is increasing annually, however, there are still some limitations in the methodology and reporting quality.
ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations, post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) are also described. People conducting trials are advised to apply the basic philosophy of evidence-based medicine in their implementation, which is considered to be one of the guarantees of the validity of clinical trials.
Objective To explore and solve the key technologies of the three dimensional (3D) visual ization reconstruction of functional fascicular groups inside long segmented peri pheral nerve. Methods A 20 cm ulnar nerve from upper arm of fresh adult dead body was embedded by OCT with four pieces of woman’s hair which was used as locating material, then the samples were serially horizontally sl iced into 400 sl ices with 15 μm thickness and 0.5 mm interval. All sl iceswere stained with acetylcholinesterase (AchE) histochemical staining. After that, the 2D panorama images of the same sl ice were obtained with Olympus stereomicroscope and MSHOT MD90 micro figure image device before and after AchE staining. Using the layer processing technique of Photoshop image processing software, the recomposition images including complete 4 location pots were obtained, based on which the algorithm of optimized least square support vector machine (Optimized LS-SVM) and space transformation method was used to fulfill automatic registration. Finally, with artificial assistant outline obtaining, the 3D visual ization reconstruction model of functional fascicular groups of 20 cm ulnar nerve was made using Amira 4.1, and the effects of reverse reduction and the suitabil ity of 3D reconstruction software were evaluated. Results The two-time imaging technique based on the layer process of Photoshop image processing software had the advantages: the image outline had high goodness of fit; the locating pots of merging image was accurate; and the whole procedure was simple and fast. The algorithm of Optimized LS-SVM had high degree of accuracy, and the error rate was only 8.250%. The 3D reconstruction could display the changes of the chiastopic fusion of different nerve functional fascicular groups directly. It could extract alone, merge and combine arbitrarily, and revolve at any angles. Furthermore, the reverse reduction on arbitrarily level dissection of the 3D model was very accurately. Conclusion Based on the two-time imaging technique and computer image layer processing technology, the compute algorithm of auto-registration can be developed and appl ied to 3D visual ization reconstruction of long segmented peripheral nerve. The technological processes is fast, and the reconstruction effect is good.