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Evidence based medicine and cosmetic surgery

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  • 1. Evidence based medicine andaesthetic surgery: reality or an oxymoron
  • 2. Art vs Science
  • 3. Or both?
  • 4. Evidence Based Medicine• the term itself sounds cold and too detached for plastic surgery• a specialty that necessarily involves close interpersonal relationships with our patients, each of whom has unique needs and desires that do not seem amenable to a seemingly homogenized statistical review
  • 5. What is EBM?“EBM is defined as the conscientious, explicit,and judicious use of current best evidence,combined with individual clinical expertise andpatient preferences and values, in makingdecisions about the care of individualpatients” – Swanson J, Schmitz D, Chung KC. How to practice evidence- based medicine. Plast Reconstr Surg. 2010;126:286–294.
  • 6. It has five primary components1. Converting the need for information e.g. about prevention, diagnosis, prognosis,therapy or causation into an answerablequestion.
  • 7. It has five primary components1. Converting the need for information e.g. about prevention, diagnosis, prognosis,therapy or causation into an answerablequestion.2. Tracking down the best evidence withwhich to answer that question.
  • 8. It has five primary components3. Critically appraising that evidence for its: -validity (closeness to the truth) -impact (size of effect) and -applicability (usefulness in our clinical practice).
  • 9. It has five primary components4. Integrating the critical appraisal with ourclinical expertise and with our patientsunique biology, values, and circumstances.5. Evaluating our effectiveness and efficiencyin executing steps 1 through 4 and seekingways to improve for next time
  • 10. • Currently, most articles in the plastic surgery literature are level 3, 4 or 5• Articles with these levels of evidence are indeed valuable• Our intent as a society should not only be to raise the overall level of evidence in the plastic surgery literature BUT also practice it
  • 11. EBM and massive weight loss surgery
  • 12. Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: Asystematic review and meta-analysis. J.A.M.A. 292: 1724, 2004 • Comprehensive review and meta-analysis analyzed 136 bariatric surgery reports. • This study reviewed 22,094 patients with a mean age of 39 years (range, 16 to 64 years) • Average body mass index of 46.9 (range, 32.3 to 68.8). • The group was 72.6% female and 27.4% male.
  • 13. Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: Asystematic review and meta-analysis. J.A.M.A. 292: 1724, 2004 • The authors concluded that co- morbidities were improved by bariatric surgery – Lipid disorders improved in 70% of patients. – Diabetes improved in 76.8% of patients. – Hypertension improved in 78.5% of patients. – Obstructive sleep apnea improved in 85.7% of patients.
  • 14. • American Society for Bariatric Surgery, its member surgeons performed: – 28,800 weight loss operations in 1999 – 63,000 weight-loss operations in 2002, – 140,000 weight-loss operations in 2004 • Mayo Foundation for Medical Education and Research. Gastric bypass: Is this weight-loss surgery for you?
  • 15. • American Society of Plastic Surgeons, nearly 56,000 body contouring procedures were performed for massive weight loss patients in 2004 (140,000 weight loss operations)
  • 16. Implications of Weight Loss Method in Body Contouring Outcomes: Gusenoff, PRS 2009 499 patients (511 cases) were entered into a prospective registry. Diet and exercise patients were matched to bariatric patients based on identical procedures performed All patients with a weight loss of greater than 50 lb were included 477 cases (93.3 percent) had bariatric procedures 29 patients representing 34 cases (6.7 percent) lost weight exclusively through diet and exercise
  • 17. Implications of Weight Loss Method in Body Contouring Outcomes Jeffrey A. Gusenoff, M.D. Devin Coon, B.A. J. Peter Rubin, M.D. Plast. Reconstr. Surg. 123: 373, 2009
  • 18. • Conclusion, that diet and exercise had: – Higher absolute complication rates, – Significantly higher infection rates (p = 0.03). – When matched to 191 bariatric patients based on procedures performed, had a higher complication rate that did not reach significance (odds ratio, 1.5; p =0.28)
  • 19. • Conclusion, that diet and exercise had: – Higher absolute complication rates, – Significantly higher infection rates (p = 0.03). – When matched to 191 bariatric patients based on procedures performed, had a higher complication rate that did not reach significance (odds ratio, 1.5; p =0.28)
  • 20. EBM and Breast Augmentation•?Ab
  • 21. EBM and Breast Augmentation– Khan (2009 Aesth Plastic surgery 34:42-47) • 1628 patients (3256 breasts) – Infection lowest in the group that received IV Ab at induction and no post-op – Nil statistical difference if given IV Ab at induction and a course of post-op oral Ab
  • 22. EBM and Breast Augmentation
  • 23. EBM and Breast Augmentation• Location of incision? – Weiner (2008 Aesth plastic surgery) • 400 patient group, looking at capsule formation • IMF incision 0.59% compared with 9.5% in periareolar
  • 24. EBM and Breast Augmentation• Compression garments post augmentation?
  • 25. EBM and Breast Augmentation• Nathan (Aesth plastic surgery 2001) • 130 patients randomised to wearing post-op compression garments or not • NIL difference to bruising or haematoma • Level 2
  • 26. EBM and Breast Augmentation• Drains?
  • 27. EBM and Breast Augmentation• Drains – Hipps (PRS 1978) • Significantly reduced capsule formation when on low suction • But now thought outdated data – Araco (Aesth plastic surgery 2007) • 5 fold increase in infection – Although level 1 or 2 doesn’t exist large body of clinical data showing low capsular contractures rates when drains not used
  • 28. EBM and Breast Augmentation Pocket Irrigation?
  • 29. EBM and Breast Augmentation• Pocket Irrigation – Weiner ( PRS 2007) • 50% betadine irrigation of pockets significantly lowered capsule formation compared with saline • No deflation of the implant device – Adams (PRS 2001) • In-vivo study using triple Ab solution (50000 unit bacitracin, 1gm cefazolin, 80mg gent and 500mls saline) – 3-4 decrease in capsule formation
  • 30. EBM and Breast Augmentation• Adams (PRS 2006) • Prospective 6 year clinical study using above solution compared with saline • 1.8% vs 9.0% in augmentation group • 9.5% vs 27.5% in reconstructive group – Adams (Clinic Plastic Surgery 2009) • Final solution with most broad spectrum cover is: • 50mls betadine, 1gm cefazolin, 80mg gentamicin and 500mls saline
  • 31. EBM and Breast Augmentation Texturing?
  • 32. EBM and Breast Augmentation Barnsley (PRS 2006) and Wong (PRS 2006)  Performed meta-analyses on effects of texturing on capsule formation  Although many conflicting studies there is evidence that when placed in subglandular position textured implants produce less capsule formation than smooth  HOWEVER, this benefit is lost in the submuscular position  Level 1 Studies on types of implants, saline vs silicone, highly cohesive vs less cohesive all have good results BUT majority funded by manufacturer or the surgeons were paid by them
  • 33. EBM and Breast Augmentation and Cancer
  • 34. EBM and Breast Augmentation and Cancer Silverstein (Cancer 1991)  presented a series of 20 women with breast ca who had implants.  13 of these women had involved nodes. Suggested implants had delayed diagnosis because silicone obscured the breast tissue on mammography  Level 2 Xie (Int Journal of Cancer 2010)  Implants delayed the diagnosis of breast cancer but there was no survival difference  Level 2
  • 35. EBM and Breast Augmentation and Cancer Deapen: LA County (PRS 1997; 99:1346)  3182 women with implants (1953-1990) f/u for 18.7 yrs –  No evidence of delayed diagnosis or more advanced staging.  Augmentation in fact had 31 ca detected compared with expected 49 in general population  Level 2 Bryant & Brasher: Alberta, Canada (NEJM 1995; 332:1535)  10,835 women with implants (1973-1990)  no evidence for an increased risk of breast ca  Level 2 McLaughlin (J of National Cancer Inst 2006)  3486 patients followed up 9-37 years  Cancer rate was lower in the augmentation group but not statistically significant  Level 2
  • 36. EBM and Breast Augmentation and Cancer Jakub (PRS Dec 2004; 114(7), pp1737-1753)  4186 breast ca patients in Florida.  78 had prior augmentation.  If had augment:  More likely to present with a palpable mass - ?due to a smaller volume of breast tissue which is pushed to the surface making examination easier.  Tumour size, nodal positivity, stage or prognosis was no different to the non-augmented group.  Level 2 Hoshaw (PRS 2001; 107:1393)  Meta analysis of current literature.  Concluded that women with implants have no increased risk of breast cancer nor is there a delay in diagnosis, an increased risk of of recurrence or decreased survival.  Level 1
  • 37. EBM Breast Reduction and breast feeding
  • 38. EBM Breast Reduction• Cruz and Korchin (PRS 2004) – Retrospective case series – Control group of 149 women with a mean age of 27 who had children and were evaluated for breast reduction – Study group of 58 with mean age of 29 who had children after breast reduction – 61% control group vs 65% of study group were successful at breast feeding (nil significant difference) – 36% of control vs 28% of study group needed to supplement breast feeding with formula – Level 4
  • 39. EBM Abdominoplasty
  • 40. EBM Abdominoplasty• Smoking: – Manassa (2003 PRS) • 1st to look at smoking and abdominoplasty • 132 patients • 49.7% vs 14.8% (p<0.01) • Also related to number of cigarettes smoked over a lifetime….with cut-off value of smoking and infection being 8.5 pack years • Relative risk 12-14 times • Level 2
  • 41. EBM Abdominoplasty Antibiotics  Sevin (2007 JPRAS)  Prospective study of 200 patients  Nil Ab  Pre-op Ab only  Pre-op and post-op Ab  Significant increase in infection in no Ab group  Nil difference between the either Ab group  Level 2  Casear (2009 PRS)  300 patients with nil Ab with only 8% post-op infection rate requiring Ab therefore advocated nil pre-op Ab  Level 4
  • 42. EBM Facelift• Drains?
  • 43. EBM Facelift• Jones (2007 PRS) – Prospective randomised clinical trial on 50 consecutive patients – Demonstrated a statistically significant decrease in bruising as assessed by the patient and the surgeon – Level 2• Tissue sealants? – ????
  • 44. “For surgeons who may accept average asadequate, evidence-based medicine can be ahaven” John Tebbetts PRS vol 128 (2) 596-597. 2011
  • 45. “Surgical innovations have never in history derivedfrom level I or II evidence studies… Benchmarking toaverage (even from an evidence level I or II study) andexcluding references to what is possible, regardless ofevidence level, guarantees mediocrity and suboptimaloutcomes for patients”“Since when is best evidence (by evidence-basedmedicine) better than evidence of what is best forpatients?”– John Tebbetts PRS vol 128 (2) 596-597. 2011