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Evidence Based Plastic SurgeryIs it Real and Relevant?

Dr. Shymal Dhar

Surgical Research FellowThe Royal Melbourne HospitalThe University of Melbourne

Visiting Medical OfficerGreenslopes Plastic Surgery

Greenslopes Private Hospital QLD

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Evidence Based Medicine

The Integration of

• Best research evidence, with• Clinical expertise, and• Patient values

- David Sackett

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EBM is not…

• RCTs• Guidelines• Statistics

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The Reconstructive Surgeon’s Creed

Know the Ideal, Beautiful, Normal

Determine what is present, what is diseased,destroyed, displaced, or distorted and what is inexcess. Then guided by the normal in your mind’seye, utilize what you have, to make what you want--- and when possible, go for even better than whatwould have been!

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D. Ralph Millard, Jr., MDMaster of Soft Tissue Plastic Surgery

“…emphasis on the basic principles of plastic surgery, his meticulous surgical technique, his creativity and constant search for a better way of doing things, his prompt adoption and acknowledgment of the good ideas of others, and in particular, his fierce desire to get the best possible result for each patient, he has virtually established the modern American school of plastic surgery”

Dr. Anthony Wolfe, 1989Plastic Surgery of the Facial Skeleton

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The Art of Science

“imagination is more important……than knowledge” Albert Einstein

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Plastic Surgery Literature Trends

• Global improvement in study design and use of Level 1 “best” Evidence

• Sample size calculations pose a real challenge to surgical RCTs and often lead to “underpowered” studies

• Patient preferences and are a real barrier to surgical RCTs

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Seven Alternatives to EBMBasis for Decision Marker Measuring Device Unit

Evidence RCT Meta-analysis Odds ratioEminence White Hair Luminometer Optical DensityVehemence Stridency Audiometer DecibelsEloquence Smoothness Teflometer Adhesion scoreProvidence Religious Fervor Sextant for genuflection I U of PietyDiffidence Level of Gloom Nihilometer SighsNervousness Litigation phobia Every Conceivable Test Bank BalanceConfidence Bravado Sweat Test No Sweat

Isaacs and FitzgeraldBMJ 1999

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How Does EBM Work?

Ask the question

Access the information

Appraise the quality of the information

Apply the knowledge

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Contingency Table for New Surgical Procedure

Procedure Beneficial Procedure Harmful

New Procedure CORRECT Type 1 ErrorApproved DECISION Harmful procedure allowed

Victim IdentifiedError self-limiting

New Procedure Type 2 Error CORRECT Disapproved Disallow beneficial procedure DECISION

Victim not identifiedError NOT self-limiting

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The Force of Evidence will Overwhelm

Surgeons want the best outcome possible…

• Timely• Practical• Variations in performance and technique• Multiple aspects of care beyond our control

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Surgical and Medical Research is Inherently Different

• This must be considered in the design, interpretation and application of clinical trials

• The Research Question dictates the Methodology

• Clinical and Content Expertise is essential

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Surgical vs Medical Clinical Research

• Blinding• Bias Selection & Observer• Learning Curve• Equipose Patient & Surgeon• Effectiveness vs Efficacy• Technological Changes• Care Path and psychosocial factors

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Real and Relevant

• The evidence alone is never sufficient to make a clinical decision because the plastic surgeon must always consider the benefits and the risks, inconvenience and cost associated with alternative techniques, always considering patient values and preferences.

• EBPS requires a hierarchy of evidence to guide surgical decision making. The integration of clinical expertise with best available evidence has merit and is becoming ever more rigorous in the surgical literature.