Reply: The Reconstructive Ladder in Light of Evidence-Based Medicine

Abstract

Sir: We would like to thank Drs. Knobloch and Vogt for their commentary on our recent article. They bring up the important subject of evidence-based medicine as an aid to decision-making in plastic surgery and cite the paucity of well-designed randomized controlled clinical trials within plastic surgery. We certainly support their view that plastic surgeons should be involved in more randomized controlled clinical trials and have previously made this same plea.1 As we examined the dramatic technological, surgical, and sociocultural changes influencing all subspecialties of reconstructive plastic surgery on a global level, we concluded there exists a need for a better framework to aid reconstructive surgeons in deciding among a multitude of options to address specific reconstructive needs. Often, the breathtaking pace of innovation exceeds our ability to conduct randomized controlled clinical trials before new technologies or procedures are used clinically. Compared with previously proposed reconstructive algorithms, the reconstructive matrix is a shared framework allowing surgeons the ability to navigate between newer combinations of technology and surgery while accounting for each individual patient's surgical risk and reconstructive environment. In certain situations, evidence-based medicine is the surest way of comparing the efficacy of newer combinations against time-proven standards of care. This is exemplified by case study 1 in our article. In these situations, the reconstructive matrix allows surgeons to compare two options from the nearly infinite that exist in the three-dimensional matrix to facilitate decision-making based on evidence. Although the reconstructive matrix provides a useful framework for conceptualizing and comparing all viable alternatives, we believe that in many circumstances it is the responsibility of the surgeon to then use the most cost-effective, proven solution. Furthermore, it is the responsibility of the plastic surgery community to undertake the necessary studies that compare and assess, through well-designed studies, the seemingly endless combinations of therapeutic options available to address a reconstructive challenge. In fact, it is our intention and hope that the reconstructive matrix will provide the necessary framework to conceptualize, delineate, and understand with better precision the multitude of existing options, each in need of better studies to evaluate it against other potential strategies or to established standards of care. Clearly, this is where evidence-based medicine and the reconstructive matrix can and should act in synergy. More than any other specialty, outcomes in plastic surgery are highly dependent on patient-specific factors and subjective evaluations by patients and physicians. Therefore, although evidence-based medicine clearly has a role in helping physicians navigate between the various axes of the reconstructive matrix, evidence-based medicine cannot alone guide reconstructive surgeons in their decision-making. This point is illustrated by case studies 2 and 3 in our article. In such situations, the patient and his or her reconstructive environment often dictate care. Practically, randomized controlled clinical trials remain challenging to perform because of high costs, inadequate subject availability, and difficulty enrolling and/or blinding subjects to various treatment modalities. Furthermore, as a specialty, we have struggled to develop reliable and objective aesthetic outcome tools that could be applied using an evidence-based medicine approach. Despite the challenges of obtaining quality evidence-based medicine studies, the reconstructive matrix is still useful as a framework for assessing all available options, as each surgeon amasses personal experience with various methodologies for solving a particular reconstructive challenge. By providing a framework for conceptualizing technology, surgical sophistication, and patient-specific factors, surgeons use the reconstructive matrix to find optimal solutions on a case-by-case basis within the realm of patient-specific factors and the surgeon's own knowledge base and level of comfort. There is a growing movement to design registry studies as a randomized controlled clinical trial alternative that allow for useful review of large amounts of data on diverse patient populations. Still, the reality is that we have few high-level evidence-based studies to guide our practice. For those decisions where evidence is clear from multiple well-designed clinical trials, we owe it to our patients to be well-educated on their results and to implement them in our practice whenever possible. We believe that the proposed reconstructive matrix is an appropriate tool to integrate evidence-based medicine in reconstructive surgery when available while still keeping in mind the need to organize, understand, and evaluate the myriad of still not fully proven reconstructive approaches now available to us. Paolo Erba, M.D. Division of Plastic Surgery Brigham and Women's Hospital Harvard Medical School Boston, Mass., and Department of Plastic, Reconstructive, and Aesthetic Surgery University Hospitals of Basel and Lausanne Switzerland Rei Ogawa, M.D. Division of Plastic Surgery Brigham and Women's Hospital Harvard Medical School Boston, Mass., and Department of Plastic, Reconstructive, and Aesthetic Surgery Nippon Medical School Tokyo, Japan Raj Vyas Dennis P. Orgill, M.D. Division of Plastic Surgery Brigham and Women's Hospital Harvard Medical School Boston, Mass.