Randomised parallel trial on the effectiveness and cost-effectiveness in screening gait disorder of silent cerebrovascular disease assisted by artificial intelligent system versus clinical doctors (ACCURATE-1): study protocol

Abstract

IntroductionSilent cerebrovascular disease (SCD), which is a common disease in the elderly, leads to cognitive decline, gait disorders, depression and urination dysfunction, and increases the risk of cerebrovascular events. Our study aims to compare the accuracy of the diagnosis of SCD-related gait disorders between the intelligent system and the clinician. Our team have developed an intelligent evaluation system for gait. This study will evaluate whether the intelligent system can help doctors make clinical decisions and predictions, which aids the early prevention and treatment of SCD.Methods and analysisThis study is a multi-centred, prospective, randomised and controlled trial.SCD subjects aged 60–85 years in Shanghai and Guizhou will be recruited continuously. All subjects will randomly be divided into a doctor with intelligence assistance group or a doctor group, at a 1:1 ratio. The doctor and intelligent assistant group will accept the intelligent system evaluation. The intelligent system obtains gait parameters by an Red-Green-Blue-depth camera and computer vision algorithm. The doctor group will accept the clinicians’ routine treatment procedures. Meanwhile, all subjects will accept the panel’s gait assessment and recognition rating scale as the gold standard. The primary outcome is the sensitivity of the intelligent system and clinicians to screen for gait disorders. The secondary outcomes include the healthcare costs and the incremental cost effectiveness ratio of intelligent systems and clinicians to screen for gait disorders.Ethics and disseminationApproval was granted by the Ethics Committee of Zhongshan Hospital affiliated with Fudan University on 26 November 2019. The approval number is B2019-027(2) R. All subjects will sign an informed consent form before enrolment. Serious adverse events will be reported to the main researchers and ethics committees. The subjects’ data will be kept strictly confidential. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT04457908

Evolutionary trend analysis of the pharmaceutical management research field from the perspective of mapping the knowledge domain

“… Pharmaceutical ethics and legal issues: With the development of pharmaceutical science and technology, pharmaceutical ethical and legal issues have become increasingly prominent. In the future, ethical and legal research on these issues, such as gene editing in the field of pharmaceutical research and artificial intelligence-assisted decision-making, will become popular ( 82 , 83 ). In addition, research on the protection of pharmaceutical intellectual property rights ( 84 ) and data privacy ( 85 ) will also become a focus of attention.…”