Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.
FilhoJV, CastroAA, VeigaDFQuality of reports of randomized clinical trials in plastic surgery.Plast Reconstr Surg2005; 155: 320-3.
2.
MomeniA, BeckerA, AntesGEvidence-based plastic surgery: Controlled trials in three plastic surgical journals (1990 to 2005).Ann Plast Surg2009; 62: 293-9.
3.
TaghiniaAH, LiaoEC, MayJWJr. Randomized controlled trials in plastic surgery: A 20 year review of reporting standards, methodologic quality, and impact.Plast Reconstr Surg2008; 122: 1253-64.
4.
GelijnsAC, AscheimDD, ParidesMKRandomized trials in surgery.Surgery2009; 145: 581-7.
5.
ChangEY, PannucciCJ, WilkinsEG. Quality of clinical studies in aesthetic surgery journals: A 10-year review.Aesthet Surg J2009; 29: 144-7.
6.
McCullochP, TaylorI, SasakoMRandomised trials in surgery: Problems and possible solutions.BMJ2002; 324: 1448-51.
7.
JohnsonN, LilfordRJ, BrazierW. At what level of collective equipoise does a clinical trial become ethical?J Med Ethics1991; 17: 30-4.
CobbLA, ThomasGI, DillardDHAn evaluation of internal-mammary-artery ligation by double-blind technique.N Engl J Med1959; 260: 1115-8.
10.
Council on ethical, judicial affairs, American Medical Association,. Opinion 2.076: Surgical “placebo” controls. In: The American Medical Association's Council on Ethical and Judicial Affairs. Code of Medical Ethics.Chicago: American Medical Association, 2000.
11.
MargoCE. When is surgery research? Towards an operational definition of human research.J Med Ethics2001; 27: 40-3.
12.
MooreMJ, BennettCL. The learning curve for laparoscopic cholecystectomy. The Southern Surgeons Club.Am J Surg1995; 170: 55-9.
13.
CartyMJ, ChanR, HuckmanRA detailed analysis of the reduction mammaplasty learning curve: A statistical process model for approaching surgical performance improvement.Plast Reconstr Surg2009; 124: 706-14.
