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Randomized controlled trials in neurosurgery—how good are we?

  • Neurosurgical Concepts
  • Published:
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Summary

Background

The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons.

Method

A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed.

Findings

From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators.

Conclusions

Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels.

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Authors and Affiliations

  1. Department of Neurosurgery, University of Munich Medical Center–Grosshadern, Ludwig-Maximilians-University, Munich, Germany

    S. Licht, J.-C. Tonn & E. Uhl

  2. Department of Neurosurgery, University of Munich Medical Center, Grosshadern Marchioninistr. 15, 81377, Munich, Germany

    K. Schöller

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  1. K. Schöller
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  2. S. Licht
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  3. J.-C. Tonn
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  4. E. Uhl
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Correspondence to K. Schöller.

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Comments

Every single neurosurgeon should read and study the randomized trials herself/himself and he/she should evaluate the value individually. One should be aware that not every trial gives level I evidence, and all are not drawn according to trial guidelines.

V. Benes

Prague, Czech Republic

The actual results reflect the state of RCTs during the EBM hype. The total number of RCTs is very small, actually too small to have a substantial impact on the developments in our field. The current situation is even less promising for RCTs because the premise of equipoise for studying neurosurgcal issues does not work anymore. The current distribution of information and the propagation of guidelines leave no database anymore for surgical trials under the equipoise premise. Only emerging new techniques can be compared with traditional ones under these preconditions.

H-J. Steiger

Dusseldorf, Germany

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Schöller, K., Licht, S., Tonn, JC. et al. Randomized controlled trials in neurosurgery—how good are we?. Acta Neurochir 151, 519–527 (2009). https://doi.org/10.1007/s00701-009-0280-y

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  • DOI: https://doi.org/10.1007/s00701-009-0280-y

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