Suchergebnisse

BACKGROUND: Patient compliance is essential to the effectiveness of brace treatment for adolescent idiopathic scoliosis (AIS) patients. Subjective measurements like questionnaires and inquiries proved to be arguably inaccurate. Although some scholars have applied temperature/force monitors to measuring patient compliance objectively, few studies to date could monitor patient compliance in real time. The objective of this study is to describe and evaluate a compliance real-time monitoring system of the brace usage in AIS patients. METHODS: A compliance real-time monitoring system (specifically consisting of a compliance monitor, a WeChat Mini Program, a cloud-based storage system and a website backstage management system) was designed to manage the brace treatment. Thirty patients receiving brace treatment were enrolled. They were told to upload the data at least once a day. Clinicians downloaded the compliance data and communicated with the patients online based on their analysis of data at least once every 3 months. The measured force, quality compliance (measured force / baseline force), measured time, and quantity compliance (measured time/ prescribed time) were used to evaluate patient compliance. Patients were also asked to rate their satisfaction at the final follow-up. RESULTS: Twenty-eight patients were included in the final analysis. The mean baseline force was 1.23 ± 0.28 N. The mean measured force was 0.79 ± 0.29 N. The mean quality compliance was 64.8 ± 22.2%. The prescribed time of all patients was 23 h. The mean measured time was 14.1 ± 2.9 h. The mean quantity compliance was 61.3 ± 12.6%. Both the quality and quantity compliance during the first 3 months of treatment was significantly lower than the latter 3 months. In this study, 96.4% (27/28) patients were satisfied with the use of the monitoring system, among whom 21.4% (6/28) are very satisfied and 75.0% (21/28) are somewhat satisfied. CONCLUSIONS: The compliance real-time monitoring system, without evaluating the clinical and radiographic ...

OBJECTIVE: Clinical trials of children's drugs are of great significance to rational drug use in children. However, paediatric drugs trials in China are facing complex challenges. At present, the investigation data on registration status of paediatric drug trials in China are still relatively lacking, and relevant research is urgently needed. METHODS: The advanced retrieval function is used to retrieve clinical trials data in the Clinical Trial.gov and Chinese Clinical Trial Registry databases in 22 April 2019. Fifteen key items were analysed to describe trial characteristics, including: registration number, study start date (year), mode of funding, type of disease, medicine type, research stage, research design, sample size, number of experimental groups, placebo group, blind method, implementation centre, child specific, newborn specific and participant age. RESULTS: A total of 1388 clinical trials of paediatric drugs conducted in China were registered. The number of paediatric drug trials grew steadily over time, from less than 20 per year before 2005 to more than 100 per year after 2012. Most clinical trials were postmarketing (n=800, 57.6%), single-centre (n=1045, 75.3%), intervention studies (n=1161, 83.6%) without blinded methods (1169, 84.2%) and funded by non-profit organisations (n=838, 60.4%). The number of clinical trials for antineoplastic agents (n=254, 18.3%), anti-infectives (n=156, 11.2%) and vaccines (n=154, 11.1%) is the largest. CONCLUSION: Paediatric drug trials in China made a significant progress in recent years. Innovative method and trial design optimisation should be encouraged to accelerate paediatric clinical research. Pharmaceutical companies need to be further stimulated to carry out more high-quality paediatric clinical trials with support of paediatric drug legislation.