Chinese Neurosurgical Randomized Controlled Trials: Dynamics in Trial Implementation and Completion.

Area of Science:

• Neurosurgery
• Evidence-based medicine
• Clinical trials

Background:

• Neurosurgery increasingly relies on evidence-based practices, particularly randomized controlled trials (RCTs).
• A systematic appraisal of China's contribution to neurosurgical RCTs is lacking.
• Understanding changes in Chinese neurosurgical RCTs before and during the COVID-19 pandemic is limited.

Purpose of the Study:

• To conduct a detailed examination and comprehensive analysis of Chinese neurosurgical RCT characteristics.
• To assess differences in RCT characteristics before and during the COVID-19 pandemic.
• To investigate factors influencing the quality and trends of Chinese neurosurgical RCTs.

Main Methods:

• A comprehensive database search of PubMed, Web of Science, Embase, and Cochrane Library up to March 2023.
• Inclusion criteria required an impact factor above 0.
• Examination of design and quality parameters, with comparisons made between pre- and during-pandemic periods (pre- vs. post-January 2020).

Main Results:

• 91 neurosurgical RCTs were analyzed, primarily focusing on vascular disease (47.3%) and trauma (18.7%).
• Over half utilized Consolidated Standards of Reporting Trial (CONSORT) diagrams (69.2%), and most compared non-surgical treatments (63.7%).
• Larger trials showed better quality, but significant efficacy trials often lacked power calculations; CONSORT use and outcome specification increased over time. The pandemic minimally impacted design and quality but may have hindered completion.

Conclusions:

• Chinese neurosurgeons have progressed in conducting RCTs despite challenges.
• Shortcomings in sample size and power calculations require attention.
• Enhancing the rigor, rationality, and completeness of neurosurgical RCT design is essential.