Abstract

Your initial reactions to the terms “outcomes” in medicine and “evidence-based medicine” (EBM), terms that have increasingly appeared in the medical literature over the last 15 years, may have been similar to ours: fear of the unknown, a sense of indignation that our surgical results would be subjected to undue scrutiny, and perhaps outright hostility. We all think that we are “experts” in what we do! How dare anyone question our results and think they could improve upon our work! We are taking great care of our patients and they are doing fine, so why do we need to consider changing? Furthermore, 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. How could EBM, a seemingly “emotionless” statistical science, help us improve outcomes on a group of people who do not on the surface seem to be subjected to statistics? Another thought was that we do not have time to become statistical experts. Will not EBM take too long to learn and practice? And who was it who wanted to impose this new type of medicine on us, anyway? These and other thoughts made us initially reluctant to consider EBM as something to consider. Over time, however, we began to realize that EBM was not something to be afraid of or to resist. Our resistance began to dissolve once we understood what it truly was and could do, not only for our patients but also for our own capabilities as surgeons. We are convinced that it will help you deliver ever-better surgical care for your patients and will make you determine what are truly the best techniques and interventions. DEFINITION OF EVIDENCE-BASED MEDICINE 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.1 It has five primary components1: Converting the need for information (e.g., about prevention, diagnosis, prognosis, therapy, causation) into an answerable question. Tracking down the best evidence with which to answer that question. Critically appraising that evidence for its validity (closeness to the truth), impact (size of effect), and applicability (usefulness in our clinical practice). Integrating the critical appraisal with our clinical expertise and with our patient’s unique biology, values, and circumstances. Evaluating our effectiveness and efficiency in executing steps 1 through 4 and seeking ways to improve for next time. Critical to evidence-based medicine is identifying the level of evidence being used for evaluation. There are numerous scales that rate levels of evidence, all of which rank the evidence more or less similarly. The American Society of Plastic Surgeons’ Level of Evidence Scale for Therapeutic Studies is shown in Table 1.1 Currently, most articles in the plastic surgery literature are level 4 or 5. Articles with these levels of evidence are indeed valuable, but our intent is to raise the overall level of evidence in the plastic surgery literature over the next several years, to provide plastic surgeons with higher-quality data and truly change how we practice plastic surgery (Table 2). Table 1. - American Society of Plastic Surgeons’ Levels of Evidence Ratings and Grading Recommendations: Evidence Rating Scale for Therapeutic Studies* Level of Evidence Qualifying Studies I High-quality, multicenter or single-center randomized controlled trial with adequate power; or systematic review of these studies II Lesser-quality randomized controlled trial; prospective cohort study; or systematic review of these studies III Retrospective comparative study; case-control study; or systematic review of these studies IV Case series V Expert opinion; case report or clinical example; or evidence based on physiology, bench research, or “first principles” *From Swanson J, Schmitz D, Chung KC. How to practice evidence-based medicine. Plast Reconstr Surg. 2010;126:286–294. Table 2. - Scale of Grading Recommendations* Grade Descriptor Qualifying Evidence Implications for Practice A Strong recommendation Level I evidence or consistent findings from multiple studies of level II, III, or IV Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present. B Recommendation Level II, III, or IV evidence and findings are generally consistent Generally, clinicians should follow a recommendation but should remain alert to new information and sensitive to patient preferences. C Option Level II, III, or IV evidence but findings are inconsistent Clinicians should be flexible in their decision making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role. D Option Level V evidence; little or no systematic empirical evidence Clinicians should consider all options in their decision making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preferences should have a substantial influencing role. For all of us in plastic surgery, our goal is to provide the best possible care for our patients. EBM is an invaluable methodology and discipline that will enable us to accomplish this goal. Its goal is to help us be better surgeons by helping us objectively analyze our outcomes, determine the best methods and treatments for our patients, and then constantly evaluate our outcomes in an ongoing manner to ensure that we are providing what truly is the best medicine for our patients2 (Table 2). It is important to remember that EBM does not dictate specific treatments or techniques or replace your clinical judgment. Rather it is a tool that helps the practitioner make the best decision weighing the particular circumstances and individual patient characteristics and needs. It is a lifelong process that we plastic surgeons need to incorporate into all of our daily routines, because it will make us better at what we do every day. How do we do this? Let’s explore some easy ways and the rationale behind our summit on EBM. THE COLORADO SPRINGS EBM SUMMIT With these goals of EBM in mind, where do we start? How can we begin to implement it into our clinical practices? What is the roadmap we can follow to start conducting EBM in our journals and operating rooms? To address these questions, a multispecialty group of journal editors, interested leaders from numerous plastic surgery and related specialty societies, and EBM experts both inside and outside of plastic surgery convened a unique meeting in plastic surgery in late summer in Colorado Springs, Colorado (Fig. 1). We discussed how we can integrate EBM into the basic daily fabric of resident training, clinical practice, educational venues, continuing medical education, and maintenance of certification courses and into the scientific literature and journal articles. Leaders from numerous groups contributed to this effort, including those from the following organizations:Fig. 1.: Participants in Evidence-Based Plastic Surgery: Transforming the Specialty Summit, Colorado Springs, Colorado, August 27 through 29, 2010. American Academy of Facial Plastic and Reconstructive Surgery American Board of Plastic Surgery American Society for Aesthetic Plastic Surgery American Society for Dermatologic Surgery Aesthetic Surgery Education and Research Foundation American Society of Plastic Surgeons American Society of Ophthalmic Plastic and Reconstructive Surgery See the Appendix for the complete list of meeting attendees. Among the attendees were the keynote speaker and the members of the Medical Outcomes Rankings for Efficacy and Safety (MORES) group: Mohit Bhandari (Keynote Speaker), Orthopaedic Surgery at McMaster University Felmont F. Eaves III, M.D. (Chair) Rod J. Rohrich, M.D. David Reiter, M.D. Achilles Thoma, M.D. Foad Nahai, M.D. Andrea Pusic, M.D. Kevin C. Chung, M.D. Steven Claypool, Vice President of Clinical Development and Informatics, Wolters Kluwer Health/Lippincott Williams & Wilkins GOAL OF THE SUMMIT The overall goal of the summit was to teach, invigorate, excite, and develop a uniform platform for EBM in plastic surgery and related specialties, to improve overall patient care and safety so that we can truly say that we are indeed “better.” We want to help teach a new generation of EBM experts, to create “disciples of EBM” who will go forth to propagate it throughout all of plastic surgery. We committed ourselves to learn, incorporate, and teach EBM in our practices, resident programs, society educational offerings, and journal content, to disseminate EBM at all levels and at every venue possible. We think it is crucial for the future of plastic surgery on the individual surgeon level and for the specialty as a whole. SYNOPSIS OF THE SUMMIT Ten EBM articles were preselected by the meeting organizers and sent in advance to all attendees.1,3–10 (Eight of these 10 articles are free on the PRSJournal.com Web site, and are located under “Evidence-Based Outcomes” articles on the “Collections” tab.) Five of the articles were “tutorial” articles, teaching what EBM is and how to practice it.1,3–6 The other five articles were directed toward a clinical question, showing how EBM can be applied to practical questions we all face as plastic surgeons.7–11 Afternoon meetings involved break-out sessions on eight topics: Incorporating EBM into residency training and board certification Incorporating EBM into plastic surgery meetings and symposia Incorporating EBM into plastic surgery research Advancing EBM in peer-reviewed journals EBM and patient safety and best practices Making evidence-based plastic surgery part of our culture Metrics development and closing the gap Spreading the EBM message: firing up the membership! THE CONSENSUS STATEMENT AND NEXT STEPS As a group, we were committed to developing a concrete action plan for the future. The following consensus statement is our combined declaration on what we plan to implement with regard to EBM in plastic surgery. Incorporating evidence-based medicine (EBM) into all the core specialties of plastic surgery, both aesthetic and reconstructive, is critical to ongoing improvements in patient safety and quality of care and must be a priority of all plastic surgery organizations, leadership, researchers, educators, practicing surgeons, and the public. A coordinated strategy with practical goals, assignment of responsibility, and impact metrics will be the most efficient and effective way to implement changes in EBM use and culture. The incorporation of EBM must involve a culture change beginning within leadership and educators that is consistently and constantly reinforced to all practicing physicians, trainees, and allied health personnel. Several factors are critical to fully incorporate EBM into the specialties of plastic surgery and to create a culture in which EBM is fully integrated. a. EBM must be embraced by all organizations within plastic surgery, including societies, journals, boards, residency training programs, and interspecialty groups. b. EBM must be incorporated within all functions of organized plastic surgery, including journal publication, meetings and symposia, residency training, board certification, and maintenance of certification, in a consistent manner, in accordance with the scope of specialty training. c. Standardized definitions of levels of evidence and standardized EBM and epidemiological methodologies should be utilized by all stakeholders within the specialties of plastic surgery. d. Broadly accepted, validated clinical metrics, including measurement of aesthetic quality, are needed and should be actively developed and promoted. e. Plastic surgery organizations must reach out to both internal and external experts in EBM, epidemiology, and study methodology and must promote the training and development of EBM experts within the specialties. f. Plastic surgery organizations should provide educational resources and EBM tools to interested individuals—from procedural expert educators to seasoned researchers—to improve the quality and evidence level of education and to promote clinically relevant translational research with proper methodology and study size. g. Within our educational venues and academic publications, we must make levels of evidence consistently visible and educate all involved physicians in EBM principles so that they can appropriately assess content and improve quality of care and patient safety. h. The results of this coordinated strategy to incorporate EBM into plastic surgery should be measured and documented and the results shared with the collective memberships. i. Plastic surgery organizations must encourage and support industry to join in this process and to adopt EBM in product development, product assessment, and marketing in order that both organized plastic surgery and industry are held to the same standards. j. We must educate the public on the value of legitimate evidence in protecting their safety and providing them with the highest quality of care. What comes next? In a word, our goal is to help educate plastic surgeons in EBM, at all levels: continuing medical education and maintenance of certification courses, educational meetings and symposia, the scientific literature, and the industries associated with plastic surgery. Implementing EBM will take time, and we must be patient with the lengthy process ahead of us. However, we commit ourselves to move forward and make EBM a part of our lifelong practice. We cannot do this alone. We invite, encourage, and challenge you to join with us to make EBM part of our culture. Plastic surgery has the opportunity to take a leading role in transforming medicine through EBM, and we personally solicit your involvement and help in this movement. APPENDIX Attendees of the EBM Summit in Plastic Surgery were as follows: Felmont F. Eaves III, M.D. President, ASAPS Co-Chair Rod J. Rohrich, M.D. Editor-in-Chief, Plastic and Reconstructive Surgery; ASPS Co-Chair Michael McGuire, M.D. President, ASPS Greg Evans, M.D. Board Vice President, Education, ASPS Phil Haeck, M.D. President-Elect, ASPS Malcolm Roth, M.D. Board Vice President, Health Policy and Advocacy, ASPS Andrea Pusic, M.D. Memorial Sloan-Kettering Cancer Center Jeffrey Kenkel, M.D. President-Elect, ASAPS Jack Fisher, M.D. Treasurer/Education Commissioner, ASAPS Jim Grotting, M.D. Vice Commissioner Education, ASAPS Geoffrey Keyes, M.D. President, ASERF Kevin Chung, M.D. Section Editor, Outcomes, Plastic and Reconstructive Surgery Jim Mulligan, M.D. Publisher, Lippincott, Williams & Wilkins Daniel Sullivan Managing Editor, Plastic and Reconstructive Surgery James Stuzin, M.D. Co-Editor, Plastic and Reconstructive Surgery Steven Claypool, M.D. Vice President of Clinical Development and Informatics, Wolters Kluwer Health/ Lippincott Williams & Wilkins Foad Nahai, M.D. Editor, Aesthetic Surgery Journal Melissa Knoll Managing Editor, Aesthetic Surgery Journal Henry Spinelli, M.D. Editor, Aesthetic Plastic Surgery Journal Don Lalonde, M.D. Chair-Elect, ABPS; Section Editor, CME/MOC, Plastic and Reconstructive Surgery R. Barry Noone, M.D. Executive Director, ABPS Peter Hilger, M.D. Past President, AAFPRS Daniel E. Rousso, M.D. President, AAFPRS Jonathan Sykes, M.D. President-Elect, AAFPRS Donn Chatham, M.D. Immediate Past President, AAFPRS Steve Duffy Executive Vice President, AAFPRS Katherine Duerdoth, CAE Executive Director, ASDS Murad Alam, M.D. Board of Directors, ASDS Achilles Thoma, M.D. Clinical Professor, Head of the Division of Plastic Surgery, McMaster University David Reiter, M.D. Professor of Otolaryngology, Jefferson Medical College Mohit Bhandari, M.D., Ph.D. Keynote Speaker, Orthopedic Surgery, McMaster University J. Peter Rubin, M.D. Associate Professor of Plastic Surgery, University of Pittsburgh Jill Foster, M.D. Vice President, ASOPRS John O’Leary Director of Marketing and Public Education, ASAPS Stacey Morrison Meetings Manager, ASAPS Sue Dykema Executive Director, ASAPS Darlene Oliver Continuing Medical Education Compliance Manager, ASAPS Debi Toombs Educational Programs Manager, ASAPS Bob Aicher Legal Counsel, ASAPS Michael Costelloe Executive Director, ASPS Bill Seward Vice President, Health Policy and Advocacy, ASPS DeLaine Schmitz Senior Director, Health Policy, ASPS Jennifer Swanson Senior Associate of Evidence-Based Projects, ASPS Gina McClure Team Leader, Education, ASPS ASAPS, American Society for Aesthetic Plastic Surgery; ASPS, American Society of Plastic Surgeons; ASERF, Aesthetic Surgery Education and Research Foundation; ABPS, American Board of Plastic Surgery; AAFPRS, American Academy of Facial Plastic and Reconstructive Surgery; ASDS, American Society for Dermatologic Surgery; ASOPRS, American Society of Ophthalmic Plastic and Reconstructive Surgery. ACKNOWLEDGMENTS We thank the many societies and associations for their forward thinking and advocacy of EBM. We are especially grateful to the American Society of Plastic Surgeons, the American Society for Aesthetic Plastic Surgery, the American Academy of Facial Plastic and Reconstructive Surgery, and Karen Abramson, CEO and President of Wolters Kluwer Health Medical Research/Lippincott Williams & Wilkins, for their generous support of the EBM Summit. Come and join us as we make plastic surgery and medicine as a whole better and safer for our patients!

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