Neurosurgical Randomized Controlled Trials-Distance Travelled

Area of Science:

• Neurosurgery
• Clinical Trials
• Evidence-Based Medicine

Background:

• The evidence base for neurosurgical procedures is often limited.
• Neurosurgical randomized controlled trials (RCTs) are critical for establishing evidence-based practice.
• Systematic analysis of neurosurgical RCTs is needed to assess their quality and impact.

Purpose of the Study:

• To systematically evaluate the design and reporting quality of neurosurgical randomized controlled trials (RCTs).
• To identify trends in study design, reporting, and outcomes of neurosurgical RCTs over time.

Main Methods:

• A comprehensive systematic review of neurosurgical RCTs published between January 1961 and June 2016.
• RCTs involving >5 patients comparing neurosurgical procedures, non-surgical treatments, or no treatment were included.
• Data on study design, reporting quality, and trial results were extracted from MEDLINE, Scopus, and Cochrane Library.

Main Results:

• 401 eligible RCTs were analyzed, with a median sample size of 73 patients.
• Reporting of allocation concealment (27.1%), power calculations (34.6%), and adequate power (28.9%) were suboptimal.
• Reporting of funding, randomization, primary outcomes, and power calculations improved significantly over time (P < .05).
• Government funding correlated with better reporting of power calculations and allocation concealment.
• Industry funding was associated with reporting significant efficacy.

Conclusions:

• Neurosurgical RCTs have shown improvements in design and reporting over recent decades.
• However, many trials remain underpowered and inadequately reported.
• There is a need for higher-quality, well-powered neurosurgical trials to advance evidence-based care and improve patient outcomes.