Evidence based medicine andaesthetic surgery: reality or an          oxymoron
Art vs Science
Or both?
Evidence Based Medicine• the term itself sounds cold and too detached  for plastic surgery• a specialty that necessarily i...
What is EBM?“EBM is defined as the conscientious, explicit,and judicious use of current best evidence,combined with indivi...
It has five primary components1. Converting the need for information e.g. about prevention, diagnosis, prognosis,therapy o...
It has five primary components1. Converting the need for information e.g. about prevention, diagnosis, prognosis,therapy o...
It has five primary components3. Critically appraising that evidence for its:     -validity (closeness to the truth)     -...
It has five primary components4. Integrating the critical appraisal with ourclinical expertise and with our patientsunique...
• Currently, most articles in the plastic surgery  literature are level 3, 4 or 5• Articles with these levels of evidence ...
EBM and massive weight loss surgery
Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: Asystematic review and meta-analysis. J.A.M.A. 292: 172...
Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: Asystematic review and meta-analysis. J.A.M.A. 292: 172...
• American Society for Bariatric Surgery, its  member surgeons performed:  – 28,800 weight loss operations in 1999  – 63,0...
• American Society of Plastic Surgeons, nearly  56,000 body contouring procedures were  performed for massive weight loss ...
Implications of Weight Loss Method in Body Contouring                          Outcomes:                      Gusenoff, PR...
Implications of Weight Loss Method in Body Contouring Outcomes       Jeffrey A. Gusenoff, M.D. Devin Coon, B.A. J. Peter R...
• Conclusion, that diet and exercise had:  – Higher absolute complication rates,  – Significantly higher infection rates (...
• Conclusion, that diet and exercise had:  – Higher absolute complication rates,  – Significantly higher infection rates (...
EBM and Breast Augmentation•?Ab
EBM and Breast Augmentation– Khan (2009 Aesth Plastic surgery 34:42-47)   • 1628 patients (3256 breasts)      – Infection ...
EBM and Breast Augmentation
EBM and Breast Augmentation• Location of incision?  – Weiner (2008 Aesth plastic surgery)     • 400 patient group, looking...
EBM and Breast Augmentation• Compression garments post augmentation?
EBM and Breast Augmentation• Nathan (Aesth plastic surgery 2001)     • 130 patients randomised to wearing post-op       co...
EBM and Breast Augmentation• Drains?
EBM and Breast Augmentation• Drains  – Hipps (PRS 1978)     • Significantly reduced capsule formation when on low       su...
EBM and Breast Augmentation Pocket Irrigation?
EBM and Breast Augmentation• Pocket Irrigation  – Weiner ( PRS 2007)     • 50% betadine irrigation of pockets significantl...
EBM and Breast Augmentation• Adams (PRS 2006)     • Prospective 6 year clinical study using above solution       compared ...
EBM and Breast Augmentation Texturing?
EBM and Breast Augmentation Barnsley (PRS 2006) and Wong (PRS 2006)     Performed meta-analyses on effects of texturing ...
EBM and Breast Augmentation and            Cancer
EBM and Breast Augmentation and                 Cancer Silverstein (Cancer 1991)      presented a series of 20 women wit...
EBM and Breast Augmentation and                 Cancer  Deapen: LA County (PRS 1997; 99:1346)    3182 women with implant...
EBM and Breast Augmentation and                  Cancer Jakub (PRS Dec 2004; 114(7), pp1737-1753)    4186 breast ca pati...
EBM Breast Reduction and breast            feeding
EBM Breast Reduction• Cruz and Korchin (PRS 2004)   – Retrospective case series   – Control group of 149 women with a mean...
EBM Abdominoplasty
EBM Abdominoplasty• Smoking:  – Manassa (2003 PRS)     • 1st to look at smoking and abdominoplasty     • 132 patients     ...
EBM Abdominoplasty Antibiotics   Sevin (2007 JPRAS)       Prospective study of 200 patients            Nil Ab         ...
EBM Facelift• Drains?
EBM Facelift• Jones (2007 PRS)   – Prospective randomised clinical trial on 50     consecutive patients   – Demonstrated a...
“For surgeons who may accept average asadequate, evidence-based medicine can be ahaven”     John Tebbetts PRS vol 128 (2) ...
“Surgical innovations have never in history derivedfrom level I or II evidence studies… Benchmarking toaverage (even from ...
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
Evidence based-medicine-and-cosmetic-surgery
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Evidence based-medicine-and-cosmetic-surgery

  1. 1. Evidence based medicine andaesthetic surgery: reality or an oxymoron
  2. 2. Art vs Science
  3. 3. Or both?
  4. 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. 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. 6. It has five primary components1. Converting the need for information e.g. about prevention, diagnosis, prognosis,therapy or causation into an answerablequestion.
  7. 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. 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. 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. 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. 11. EBM and massive weight loss surgery
  12. 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. 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. 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. 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. 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. 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. 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. 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. 20. EBM and Breast Augmentation•?Ab
  21. 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. 22. EBM and Breast Augmentation
  23. 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. 24. EBM and Breast Augmentation• Compression garments post augmentation?
  25. 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. 26. EBM and Breast Augmentation• Drains?
  27. 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. 28. EBM and Breast Augmentation Pocket Irrigation?
  29. 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. 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. 31. EBM and Breast Augmentation Texturing?
  32. 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. 33. EBM and Breast Augmentation and Cancer
  34. 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. 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. 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. 37. EBM Breast Reduction and breast feeding
  38. 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. 39. EBM Abdominoplasty
  40. 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. 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. 42. EBM Facelift• Drains?
  43. 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. 44. “For surgeons who may accept average asadequate, evidence-based medicine can be ahaven” John Tebbetts PRS vol 128 (2) 596-597. 2011
  45. 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

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