Characteristics of Nursing Related Clinical Trials Registered on the Chinese Clinical Trial Registry (ChiCTR) from 2009 to 2023

Vollständiger Abstract

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Background: The retrieval and analysis of nursing-related clinical trials registered in the Chinese Clinical Trial Registry (Chi CTR) database are conducive to understanding the registration characteristics and development trends of such trials in China and can offer guidance for nursing researchers to standardize their clinical research. Objectives: This research aims to explore the registration characteristics and development trend of nursing-related clinical trials in the Chi CTR. Methods: This is a retrospective observational study. The Chi CTR database was searched for nursing-related clinical trials from its establishment until December 31, 2023. The retrieved clinical trials were re-checked and extract relevant data from retrieved clinical trials. Excel software was utilized to analyze the data of the included studies and summarize the characteristics of the clinical trials. Results: A total of 1,314 nursing-related trials were included, of which 1,102 trials were registered as prospective registration. The registered trials were distributed across 33 regional areas and 498 clinical registration institutions, The top 1 registered clinical trials regions, organization and sources of funds were Guangdong province(138, 10.50%), School of Nursing, Jilin University(73, 5.56%) and local finance (312, 23.75%) respectively. The main types of studies were intervention studies(1031, 78.46%), and randomized parallel controlled trials were the main study design(773, 58.83%) . A total of 812 studies (61.80%) used the simple randomized method, and 243 studies (18.49%) used the blind method. Discussion: The number of nurse-related clinical trial registrations in China present a tendency of increasing overall, but the experimental design, methodology and reporting quality were poor, and the regional distribution of trial registration was unbalanced, Chi CTR should strengthen the control of registration, standardize clinical trial registration, and improve the level and quality of clinical trial registration reports.