Objective: To investigate of e-cigarette use among middle school students in Hainan Province, so as to provide insights into tobacco control among adolescents. Methods: Students were randomly sampled using a multistage stratified cluster random sampling method from three junior high schools, two high schools and one vocational high school in Hainan Province from July to October, 2021. Participants' basic features, use of e-cigarettes, e-cigarette advertising exposure were collected using the Questionnaire on Tobacco and Alcohol Prevalence among Chinese Adolescents in 2021 prepared by Chinese Center for Disease Control and Prevention. Following data weighting, students' use of e-cigarettes and exposure to e-cigarette advertisements were descriptively analyzed, and factors affecting current use of e-cigarettes were identified using a multivariable logistic regression model. Results: A total of 8 561 questionnaires were allocated, and 8 538 valid questionnaires were recovered, with an effective recovery rate of 99.73%. The respondents included 4 470 boys (52.35%) and 4 068 girls (47.65%), and there 4 367 junior high school students (51.15%), 3 482 high school students (40.78%), and 689 vocational high school students (8.07%). The rate of e-cigarette use was 25.01% and the rate of current e-cigarette use was 4.68%. There were 2 728 respondents with exposure to e-cigarette advertising during the past 30 days, and the number of weighted individuals were 210 932 (32.60%). The route of e-cigarette advertising exposure mainly included point-of-sale (21.59%), stores (13.61%), and shopping websites (9.01%). Multivariable logistic regression analysis identified region (OR=0.610, 95%CI: 0.482-0.772), males (OR=1.332, 95%CI: 1.062-1.669), high school students (OR=0.376, 95%CI: 0.259-0.545), companion smoking (OR=6.645, 95%CI: 4.935-8.948) and advertising exposure (OR=3.229, 95%CI: 2.581-4.040) as factors affecting current use of e-cigarettes. Conclusions The use of e-cigarettes among middle school students is higher in Hainan Province than the national level, and exposure to e-cigarette advertisements may facilitate use of e-cigarettes. It is necessary to strengthen the supervision of e-cigarettes, strictly restrict e-cigarettes advertisements and promotions.

In recent years, researchers, pharmaceutical companies, and political makers gradually using more real-world data (RWD) to produce real-world evidence (RWE) for policy-making. A research team of Harvard University launched the RCT DUPLICATE project in 2018, aiming to replicate 30 randomized controlled trials using the medical claims database in order to explore methods for quantifying the efficacy-effectiveness gap and explain its potential sources, to enhance the credibility of the RWE. This paper reviews the background of RCT DUPLICATE Initiative, highlights the research purposes, research design and implementation process of the RCT DUPLICATE Initiative, to help domestic scholars better understand the scope and application value of RWE.
Humans ; Randomized Controlled Trials as Topic ; Cognition ; Databases, Factual ; Research Personnel ; Universities

With the promotion and application of big medical data, non-interventional real-world evidence (RWE) has been used by regulators to assess the effectiveness of medical products. This paper briefly introduces the latest progress and research results of the RCT DUPLICATE Initiative launched by the research team of Harvard University in 2018 and summarizes relevant research experience based on the characteristics of China's medical service to provide inspiration and reference for domestic scholars to conduct related RWE research in the future.
Humans ; Randomized Controlled Trials as Topic ; Cognition ; Big Data ; Universities

Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.

Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.

IDEAL framework and recommendations provide a scientific and integrated evaluation pathway for surgical innovations and other complex therapeutic interventions, and underline that the preliminary studies are needed to prepare for a successful randomized controlled trial. IDEAL framework provides a series of recommendations in terms of nature stages of surgical innovation. We have reported the introduction and reporting guidelines of the IDEAL framework and recommendations in our IDEAL series paper. This paper aimed to provide some empirical evidence, focusing specifically on stages 2a and 2b, to help surgeons and researchers to understand how to imply IDEAL framework and recommendations into their clinical practice.