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Randomized controlled trials in neurosurgery--how good are we?
K Schöller1, S Licht, J-C Tonn
1Department of Neurosurgery, University of Munich Medical Center, Grosshadern Marchioninistr. 15, 81377, Munich, Germany. Karsten.Schoeller@med.uni-muenchen.de
Acta Neurochirurgica
|April 2, 2009
Summary
Randomized controlled trials (RCTs) in neurosurgery are increasing in number and improving in quality over time. Adequate sample size and financial funding significantly enhance RCT quality.
Area of Science:
- Neurosurgery
- Clinical Research
- Evidence-Based Medicine
Background:
- Randomized controlled trials (RCTs) represent the highest level of evidence in medical literature.
- This study evaluates neurosurgically relevant RCTs published by neurosurgeons.
Purpose of the Study:
- To assess the quantity, characteristics, and quality of recently published neurosurgical RCTs.
- To identify factors influencing the quality of these trials.
Main Methods:
- Literature search of MEDLINE and EMBASE databases up to June 2006.
- Selection of RCTs with neurosurgical relevance authored by neurosurgeons.
- Quality assessment using a modified Scottish Intercollegiate Guidelines Network checklist by two independent investigators.
Main Results:
- 159 neurosurgical RCTs were identified, with 62% published since 1995.
- Median sample size was 78 patients, median follow-up 35.7 weeks.
- 52% of RCTs were rated good quality, showing improvement over time; financial funding and larger sample size correlated with better quality.
Conclusions:
- While RCTs form a small fraction of neurosurgical literature, their quality is satisfactory and improving.
- Financial support and adequate patient numbers are crucial for high-quality neurosurgical RCTs.
- Standardized checklists enable reliable quality assessment of clinical trials.
