Randomized trials of neurosurgical interventions: a systematic appraisal.

OBJECTIVE

To systematically appraise the study design and quality of reporting of randomized controlled trials (RCTs) on neurosurgical procedures and to identify potential defects and biases.

METHODS

Randomized controlled trials with at least five patients comparing any neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, EMBASE, and the Cochrane Library. We analyzed study design, quality of reporting, and trial results.

RESULTS

The median sample size in the 108 eligible reports was 68 patients. Ninety-nine trials (91.7%) reported inclusion and exclusion criteria, 55 (50.9%) mentioned the randomization mode, and 87 (80.6%) adequately described withdrawals, but only 31 (28.7%) described allocation concealment, only 23 (21.3%) gave power calculations, and only 20 (18.5%) were adequately powered. Significant efficacy or trend for efficacy was claimed in 46 reports (42.6%), and no difference between the compared procedures was found in 60 trials (55.6%). Trials with a larger sample size were more likely to report withdrawals (P = 0.02) and power calculations (P = 0.006). Only 14 trials (13.6%) were double-blind, and this was less frequent in longer trials (P = 0.02). Among quality criteria, only the reporting of randomization mode improved significantly over time (P = 0.015).

CONCLUSION

Several aspects of the design and reporting of randomized controlled trials on neurosurgical procedures can be improved. Larger, adequately powered, and accurately reported trials are needed.