5. 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
6. What is EBM?
“EBM is defined as the conscientious, explicit,
and judicious use of current best evidence,
combined with individual clinical expertise and
patient preferences and values, in making
decisions about the care of individual
patients”
– Swanson J, Schmitz D, Chung KC. How to practice evidence-
based medicine. Plast Reconstr Surg. 2010;126:286–294.
7. It has five primary components
1. Converting the need for information
e.g. about prevention, diagnosis, prognosis,
therapy or causation into an answerable
question.
8. It has five primary components
1. Converting the need for information
e.g. about prevention, diagnosis, prognosis,
therapy or causation into an answerable
question.
2. Tracking down the best evidence with
which to answer that question.
9. It has five primary components
3. Critically appraising that evidence for its:
-validity (closeness to the truth)
-impact (size of effect) and
-applicability (usefulness in our clinical
practice).
10. It has five primary components
4. Integrating the critical appraisal with our
clinical expertise and with our patient's
unique biology, values, and circumstances.
5. Evaluating our effectiveness and efficiency
in executing steps 1 through 4 and seeking
ways to improve for next time
11.
12. • 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
14. Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: A
systematic 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.
15. Buchwald, H., Avidor, Y., Braunnald, E., et al. Bariatric surgery: A
systematic 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.
16. • 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?
17. • 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)
18.
19.
20.
21.
22.
23. 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
24. 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
25. • 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)
26. • 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)
28. 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
30. 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
31. EBM and Breast Augmentation
• Compression garments post augmentation?
32. 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
34. 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
36. 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
37. 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
39. 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
41. 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
42. 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
43. 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
45. 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
47. 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
48. 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
50. 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?
– ????
51. “For surgeons who may accept average as
adequate, evidence-based medicine can be a
haven”
John Tebbetts PRS vol 128 (2) 596-597. 2011
52. “Surgical innovations have never in history derived
from level I or II evidence studies… Benchmarking to
average (even from an evidence level I or II study) and
excluding references to what is possible, regardless of
evidence level, guarantees mediocrity and suboptimal
outcomes for patients”
“Since when is best evidence (by evidence-based
medicine) better than evidence of what is best for
patients?”
– John Tebbetts PRS vol 128 (2) 596-597. 2011
