Evidence-based medicine, a term coined by Dr. Gordon Guyatt in 1991,1 describes the integration of best research evidence with clinical expertise and patient values.2 The evidence-based medicine, or evidence-based surgery model, has been refined over the years to include five components, with “surgical expertise” being central to its framework (Fig. 1).3 The goal of the evidence-based medicine movement is to educate front-line clinicians on assessing the credibility of research evidence, understanding the results of clinical studies, and determining how to best apply results to their practice.1,4,5 In 2009, Drs. Rohrich and Chung, along with key staff from the American Society of Plastic Surgeons, officially introduced evidence-based medicine to the readership of Plastic and Reconstructive Surgery.6 In 2011, Plastic and Reconstructive Surgery introduced the level-of-evidence hierarchy7 and the associated pyramid graphic (Fig. 2)3,4,7–10; the level of evidence is published with each article, in text and graphically, to help readers conceptualize the study and its potential impact on their practice. Readers are able to better understand the objective assessment of clinical research questions and the evidence rating of each article. The embrace, education, and application of the evidence-based medicine and evidence-based surgery movements by (and in) Plastic and Reconstructive Surgery and beyond have highlighted the importance of (1) quality of evidence11; (2) patient-reported outcomes12–14; (3) the use of standardized guidelines, including those from the EQUATOR (Enhancing the Quality and Transparency of Health Research) Network15–18; and (4) the creation and use of outcomes studies.16 The valued contributions of experts including Drs. Chung, Pusic, and McCarthy have produced primers on randomized controlled trials, statistics, scientific writing, survey research, and decision analysis, as well as the outcomes collection (https://journals.lww.com/plasreconsurg/pages/collectiondetails.aspx?TopicalCollectionId=121).
The level of evidence is used to classify a study based on the limitations of its design. Level I evidence (e.g., randomized controlled trials and meta-analyses of randomized controlled trials) has the highest validity and the least amount of bias.20,21 The widespread adoption of the level-of-evidence hierarchy has been credited with the increase in “high–level-of-evidence” studies seen within plastic surgery over the past decade.11,22,23 This accomplishment should be of great pride for both the contributors and readership of Plastic and Reconstructive Surgery. Only one decade ago, the article introducing the Plastic and Reconstructive Surgery community to evidence-based medicine highlighted the need for studies with higher levels of evidence.6 Chung and colleagues6 emphasized that randomized controlled trials could be used for “introspective scrutiny” and lead to “a strong voice when advocating for patient welfare.” Furthermore, randomized controlled trials were recognized as an important way to “differentiate” plastic surgery from other “wannabe specialties encroaching on this field.”6 As of 2019, there was an increase in Level I and II studies in the areas of aesthetics, craniofacial, and upper limb; the percentage of such studies in breast research stayed consistent.11 Between 2008 and 2018, there was a consistent decrease in the percentage of expert opinion, case report, and case series articles; a consistent increase in randomized controlled trials; and a relatively stable percentage of systematic reviews and meta-analyses.11 The increase of randomized controlled trials produced within plastic surgery is commendable, given their inherent difficulties. Proper randomized controlled trials can offer valuable and less-biased information on important concepts within plastic surgery. For example, Neubrech and colleagues24 conducted a randomized controlled trial that was the first study to demonstrate superior outcomes of the additional use of the chitosan nerve tube in primary nerve repair.24 Data from this study can now be used to help improve patient care.
According to the level-of-evidence hierarchy, a systematic review or meta-analysis of randomized controlled trials is just as valuable to evidence-based medicine as randomized controlled trials of similar quality. Such reviews can be helpful in answering controversial questions and addressing the outcomes primary studies are underpowered to analyze. Take for example a meta-analyses of randomized controlled trials comparing the effectiveness of endoscopic carpal tunnel release and open carpal tunnel release to improve clinical outcomes.25 At the time of completing this meta-analysis, while randomized controlled trials and other reviews had been performed, it was not clear which procedure was superior.25 Using key outcomes from 13 randomized controlled trials, the authors reported that endoscopic carpal tunnel release was favored over open release for reduction in scar tenderness and grip and pinch strength at 12 weeks postoperatively; data regarding symptom relief and return-to-work results were inconclusive. However, reversible nerve damage was found to be three times more likely to occur with endoscopic carpal tunnel release. This adverse outcome had not been quantified before the time of this meta-analysis because individual randomized controlled trials were underpowered to illuminate this outcome differential. Such meta-analyses can provide definitive answers or guidance on required future research.
The progeny of the evidence-based medicine movement, including the Cochrane Collaboration and the level-of-evidence hierarchy, are woven into the very foundation of modern-day research.20,26 The Cochrane Collaboration promotes evidence-informed health care decisions by producing, interpreting, and making high-quality and relevant research available.27 Since its development, the level-of-evidence system28,29 has been adapted and used to help form the basis of the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation).30,31 This system is a “transparent approach” to evaluating the quality of evidence and strength of recommendations within health care research. It is now being used to appraise the evidence and recommendations in clinical practice guidelines. Alongside the GRADE system, the AGREE (Appraisal of Guidelines, Research, and Evaluation) Checklist32 has also been introduced to help with consistent and clear reporting of clinical practice guidelines. These tools have become increasingly valuable to the evidence-based medicine/evidence-based surgery community in recent years given the constant influx of new information, technology, and suggestions in the field of surgery. As more information is discovered, and more clinical practice guidelines are published, clinicians and researchers need to understand how to properly appraise this information. Table 1 summarizes examples of clinical practice guidelines and recommendation pieces published in Plastic and Reconstructive Surgery.33–37
Table 1. -
A Selection of Clinical Practice Guidelines and Recommendations in Plastic and Reconstructive Surgery
|Lee et al., 201733
||“Evidence-Based Clinical Practice Guideline: Autologous Breast Reconstruction with DIEP or Pedicled TRAM Abdominal Flaps”
|Alderman et al., 201434
||“ASPS Clinical Practice Guideline Summary on Breast Reconstruction with Expanders and Implants”
|Temple-Oberle et al., 201735
||“Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations”
|Signorini et al., 201636
||“Global Aesthetics Consensus: Avoidance and Management of Complications from Hyaluronic Acid Fillers. Evidence- and Opinion-Based Review and Consensus Recommendations”
|Ariyan et al., 201537
||“Antibiotic Prophylaxis for Preventing Surgical-Site Infection in Plastic Surgery: An Evidence-Based Consensus Conference Statement from the American Association of Plastic Surgeons”
DIEP, deep inferior epigastric perforator; TRAM, transverse rectus abdominis musculocutaneous; ASPS, American Society of Plastic Surgeons.
In addition to the AGREE Checklist,32 many guidelines exist to help improve the transparency of reporting in research (Table 2).32,38–43 Increasing the application of these guidelines is just as important as increasing high–level-of-evidence studies. Unfortunately, very few plastic surgery journals require reporting guidelines or trial registration.14 As adherence to the guidelines and trial registration are linked to unbiased reporting and higher quality research,44,45 it is critical that research within plastic surgery use available guidelines. In accordance with the goal of Plastic and Reconstructive Surgery, to integrate evidence-based medicine into plastic surgery, in 201515 it was announced that the Journal’s Editorial Board would be adopting and implementing the use of the EQUATOR Network reporting guidelines to both the authorship and the peer-review process.
Table 2. -
Examples of Reporting Guidelines from the Enhancing the Quality and Transparency of Health Research Network*
|Clinical practice guidelines
CONSORT; Consolidated Standards of Reporting Trials; STROBE, Strengthening the Reporting of Observational Studies in Epidemiology; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; STARD, Standards for Reporting Diagnostic Accuracy; AGREE, Appraisal of Guidelines, Research, and Evaluation; CHEERS, Consolidated Health Economic Evaluation Reporting Standards.
As outlined above, the integration of evidence-based medicine in plastic surgery has highlighted the importance of using patient-reported outcome measures in our studies. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative46,47 and the International Consortium for Health Outcomes Measurement (ICHOM)48 emphasize the importance of measuring outcomes most relevant to both the patient and the medical community. The COMET Initiative hosts a database of critical outcome sets available to researchers in all disciplines. A list of systematic reviews focusing on outcome measures, such as patient-reported outcome measures, has been created by the COMET Initiative49; this database is publicly available and can be used to search for outcome measures applicable to different health states and populations. The use of reliable patient-reported outcome measures can be used to inform surgeons and help guide patients with difficult, life-altering decisions. Plastic and Reconstructive Surgery has published many articles outlining the development and validation of popular patient-reported outcome measures (Table 3).50–58 One such measure, the BREAST-Q, was used to compare patient satisfaction and quality of life in patients undergoing unilateral and bilateral autologous breast reconstruction.59 Using an 8-year follow-up, the authors concluded that satisfaction rates did not differ up to 3 years postoperatively; however, a “possible divergence” of satisfaction beyond this time was noted.59 Such information is critical in helping patients understand long-term satisfaction rates, and may help in the decision-making process. The authors conclude that such articles help in the “shared-decision making process” which is critical in the management of breast cancer from the perspectives of both the clinician and the patient.59
Table 3. -
Examples of Articles Developing and/or Validating Patient-Reported Outcome Measures Published in Plastic and Reconstructive Surgery
MHQ, Michigan Hand Outcomes Questionnaire; DASH, Disabilities of the Arm, Shoulder, and Hand questionnaire.
On the seventy-fifth Anniversary of Plastic and Reconstructive Surgery, we can pride ourselves for embracing the principles of evidence-based medicine/evidence-based surgery (Fig. 3). Not only did the Journal help to introduce evidence-based medicine into plastic surgery, it has also published numerous noteworthy and highly cited articles. Plastic and Reconstructive Surgery has been named the journal with the most cited articles in reviews of lower extremity reconstruction,60 microsurgery,61 and general plastic surgery62,63; 74 percent to 82 percent of the studies included are published in Plastic and Reconstructive Surgery, exhibiting the valuable research that the Journal is putting out into the world. As captured in these reviews, the Journal has continuously published insightful and prominent articles since its inception. Plastic and Reconstructive Surgery continues to publish influential articles in the areas of breast,64–66 reconstructive,67–72 cosmetic,73–77 head/neck,78,79 and upper extremity.57,80–82 There have also been numerous informative articles published within the domains of continuing medical education83–87 and patient safety.88–95 Although the accomplishments of the Plastic and Reconstructive Surgery community are commendable, there are still obstacles to overcome as we fully integrate evidence-based medicine/evidence-based surgery into the discipline of plastic surgery. As contributors to the Journal, we will need to address (1) the failure to publish/suppression of results; (2) the length of time it takes to create and disseminate reviews and clinical practice guidelines; (3) studies using “big data”; and (4) health care decision-making.10 By following the direction of Plastic and Reconstructive Surgery and using reporting guidelines in the planning, publishing and reviewing of articles, and registering clinical trials, we can help to address some of these obstacles. Let us as surgeons, investigators, and learners strive to continue the respected and reputable legacy that Plastic and Reconstructive Surgery has built over the past 75 years.
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33. Lee BT, Agarwal JP, Ascherman JA, et al. Evidence-based clinical practice guideline: Autologous breast reconstruction with DIEP or pedicled TRAM abdominal flaps. Plast Reconstr Surg. 2017;140:651e–664e.
34. Alderman A, Gutowski K, Ahuja A, Gray D; Postmastectomy Expander Implant Breast Reconstruction Guideline Work Group. ASPS clinical practice guideline summary on breast reconstruction with expanders and implants. Plast Reconstr Surg. 2014;134:648e–655e.
35. Temple-Oberle C, Shea-Budgell MA, Tan M, et al. ERAS Society. Consensus review of optimal perioperative care in breast reconstruction: Enhanced Recovery after Surgery (ERAS) Society recommendations. Plast Reconstr Surg. 2017;139:1056e–1071e.
36. Signorini M, Liew S, Sundaram H, et al. Global Aesthetics Consensus Group. Global aesthetics consensus: Avoidance and management of complications from hyaluronic acid fillers. Evidence- and opinion-based review and consensus recommendations. Plast Reconstr Surg. 2016;137:961e–971e.
37. Ariyan S, Martin J, Lal A, et al. Antibiotic prophylaxis for preventing surgical-site infection in plastic surgery: An evidence-based consensus conference statement from the American Association of Plastic Surgeons. Plast Reconstr Surg. 2015;135:1723–1739.
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53. Cano SJ, Klassen AF, Scott AM, Cordeiro PG, Pusic AL. The BREAST-Q: Further validation in independent clinical samples. Plast Reconstr Surg. 2012;129:293–302.
54. Wong Riff KWY, Tsangaris E, Forrest CR, et al. CLEFT-Q: Detecting differences in outcomes among 2434 patients with varying cleft types. Plast Reconstr Surg. 2019;144:78e–88e.
55. Klassen AF, Kaur M, Poulsen L, et al. Development of the BODY-Q chest module evaluating outcomes following chest contouring surgery. Plast Reconstr Surg. 2018;142:1600–1608.
56. Waljee JF, Kim HM, Burns PB, Chung KC. Development of a brief, 12-item version of the Michigan Hand Questionnaire. Plast Reconstr Surg. 2011;128:208–220.
57. Klassen AF, Cano SJ, Schwitzer JA, Scott AM, Pusic AL. FACE-Q scales for health-related quality of life, early life impact, satisfaction with outcomes, and decision to have treatment: Development and validation. Plast Reconstr Surg. 2015;135:375–386.
58. Novak CB, Mackinnon SE, Anastakis DJ, McCabe SJ. Factor structure of the Disabilities of the Arm, Shoulder and Hand questionnaire in upper extremity nerve injury. Plast Reconstr Surg. 2019;144:1116–1122.
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60. Mbaidjol Z, Rothenberger J, Chetany R. A scientometric analysis of the 50 most cited articles for reconstruction of the lower extremity. Surg Res Pract. 2019;2019:3068028.
61. Joyce CW, Carroll SM. Microsurgery: The top 50 classic papers in plastic surgery. A citation analysis. Arch Plast Surg. 2014;41:153–157.
62. Loonen MP, Hage JJ, Kon M. Plastic surgery classics: Characteristics of 50 top-cited articles in four plastic surgery journals since 1946. Plast Reconstr Surg. 2008;121:320–327.
63. Zhang WJ, Li YF, Zhang JL, Xu M, Yan RL, Jiang H. Classic citations in main plastic and reconstructive surgery journals. Ann Plast Surg. 2013;71:103–108.
64. Brody GS, Deapen D, Taylor CR, et al. Anaplastic large cell lymphoma occurring in women with breast implants: Analysis of 173 cases. Plast Reconstr Surg. 2015;135:695–705.
65. Hu H, Johani K, Almatroudi A, et al. Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg. 2016;137:1659–1669.
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74. Winocour J, Gupta V, Ramirez JR, Shack RB, Grotting JC, Higdon KK. Abdominoplasty: Risk factors, complication rates, and safety of combined procedures. Plast Reconstr Surg. 2015;136:597e–606e.
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88. Orbay H, Hinchcliff KM, Charvet HJ, Sahar DE. Fat graft safety after oncologic surgery: Addressing the contradiction between in vitro and clinical studies. Plast Reconstr Surg. 2018;142:1489–1499.
89. Jung JA, Park BY, Kang SR, Kim MJ. Asymptomatic deep vein thrombosis during free flap: Concerns in free flap surgery. Plast Reconstr Surg. 2018;142:551e–560e.
90. Gitman M, Fettiplace MR, Weinberg GL, Neal JM, Barrington MJ. Local anesthetic systemic toxicity: A narrative literature review and clinical update on prevention, diagnosis, and management. Plast Reconstr Surg. 2019;144:783–795.
91. Nuzzi LC, Firriolo JM, Pike CM, DiVasta AD, Labow BI. Complications and quality of life following reduction mammaplasty in adolescents and young women. Plast Reconstr Surg. 2019;144:572–581.
92. Egan KG, De Souza M, Muenks E, Nazir N, Korentager R. Predictors of opioid consumption in immediate, implant-based breast reconstruction. Plast Reconstr Surg. 2020;146:734–741.
93. Merola D, Calotta NA, Lu ZA, Lifchez SD, Aliu O, Coon D. Initial opioid prescriptions predict continued narcotic use: Analysis of 24,594 reduction mammaplasty patients. Plast Reconstr Surg. 2020;145:20–30.
94. Sharabi SE, Baumann DP, Selber JC, et al. Complications of contralateral prophylactic mastectomy: Do they delay adjuvant therapy? Plast Reconstr Surg. 2020;146:945–953.
95. Taylor GI, Shoukath S, Gascoigne A, Corlett RJ, Ashton MW. The functional anatomy of the ophthalmic angiosome and its implications in blindness as a complication of cosmetic facial filler procedures. Plast Reconstr Surg. 2020;146:745.