American Journal of Obstetrics & Gynecology
Volume 199, Issue 2 , Pages 108.e1-108.e6, August 2008

Surgeons' experience and interaction effect in randomized controlled trials regarding new surgical procedures

Presented at the 16th Annual Congress of the European Society for Gynaecological Endoscopy, Portoroz, Slovenia, Sept. 4-8, 2007.

  • Horace Roman, MD, PhD

      Affiliations

    • Department of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC
    • Department of Gynecology and Obstetrics, University Hospital Rouen, Rouen, France.
    • Corresponding Author InformationReprints: Horace Roman, MD, Department of Pediatric Epidemiology, Medical University of South Carolina, 135 Rutledge Ave, PO Box 250566, Charleston, SC 29425.
  • ,
  • Loïc Marpeau, MD

      Affiliations

    • Department of Gynecology and Obstetrics, University Hospital Rouen, Rouen, France.
  • ,
  • Thomas C. Hulsey, ScD, MSPH

      Affiliations

    • Department of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC

Received 30 September 2007; received in revised form 5 December 2007; accepted 3 March 2008. published online 06 May 2008.

The most reliable information on any type of medical intervention is provided through the results of randomized controlled trials (RCTs). However, RCTs comparing a new surgical technique with an older one may provide inaccurate conclusions when surgeons participating in the study have disparate experience with the new technique. In this case, the surgeon-to-surgeon variability may confound the outcome and lead to a significant interaction effect between surgeon and surgical technique. Subsequently the RCT design does not ensure the same outcome probability among patients assigned to the group undergoing the new technique. Overlooking the interaction effect may be responsible for inaccurate conclusions, which are usually unfavorable with regard to the new technique. We discuss how this interaction effect could be involved in conclusions provided by several RCTs that compared laparoscopic hysterectomy to vaginal hysterectomy. We demonstrate how this interaction may be revealed using a hypothetical RCT whose data was reasonably presumed on the basis of literature data.

Key words: confounding variables, interaction effect, laparoscopic hysterectomy, randomized controlled trial, vaginal hysterectomy

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 Cite this article as: Roman H, Marpeau L, Hulsey TC. Surgeons' experience and interaction effect in randomized controlled trials regarding new surgical procedures. Am J Obstet Gynecol 2008;199:108.e1-108.e6.

PII: S0002-9378(08)00263-9

doi:10.1016/j.ajog.2008.03.002

American Journal of Obstetrics & Gynecology
Volume 199, Issue 2 , Pages 108.e1-108.e6, August 2008