Response to “Level 2 Observational Studies: A Practical Alternative to Randomized Trials in Plastic Surgery”: Table 1.

One day when I was a junior medical student, a very important Boston surgeon visited the school and delivered a great treatise on a large number of patients who had undergone successful operation for vascular reconstruction. At the end of the lecture, a young student at the back of the room timidly asked, “Do you have any controls?” Well, the great surgeon drew himself up to his full height, hit the desk, and said, “Do you mean did I not operate on half of the patients?” The hall grew very quiet then. The voice at the back of the room very hesitantly replied, “Yes, that's what I had in mind.” Then the visitor's fist really came down as he thundered, “Of course not. That would have doomed half of them to their death.” God, it was quiet then, and one could scarcely hear the small voice ask, “Which half?”— Although evidence-based medicine (EBM) principles have been developed over decades, only recently has a systematic, organized commitment to incorporate EBM principles into the specialty of plastic surgery been undertaken. 2 , 3 As such, we are all learning as a group how EBM principles can help us and our patients make better care decisions. In his commentary, Dr Swanson casts doubt on the value of the randomized controlled trial design in surgery; 4 however, the collective wisdom of hundreds of scientists, statisticians, epidemiologists, and researchers from around the world have established the randomized controlled trial in the last half century as the best scientific study design to answer important clinical questions. 5-7 We would strongly disagree with Dr Swanson's assertions that randomization is of extremely limited use in plastic surgery (including aesthetic surgery). Quite to the contrary, increasing the number and quality of randomized, controlled trials (RCT) in our specialty is critical in answering frequently argued but unresolved questions. Dr Swanson is correct in saying that randomizing patients to treatments that have been proven inferior is unethical; however, personal opinion that one technique is superior to another is not proof, no matter how strongly held. For example, Dr Swanson promotes that the vertical scar reduction is superior (and in his hands it may be), yet at the inception of the cited Thoma et al RCT, 8 there was true ambivalence of any superiority of either the vertical or inferior pedicle techniques as evidenced by 2 surveys of plastic surgeons in North America. 9 , 10 It was this prevailing controversy that stimulated the investigators to carry out the RCT with patient Quality of Life (QOL) as the main outcome. Neither the scar nor the cosmetic appearance of the breast were considered in this trial of government-approved reduction mammoplasties. (We are not saying that scar and cosmetic appearance are not important, as they clearly are; it is just that this particular RCT did not seek to answer these questions.) In fact, the Thoma et al trial showed that QOL was equivalent in the 2 techniques. 8 (Note: A subsequent cost-effectiveness analysis of the same study by the same research group suggested that the vertical scar reduction may in fact be cost-effective when the reduction is limited to <500 g per breast from the perspective of the patient, the third party payer, and the society. 11 ) It is critical to note that observational studies cannot readily generate this degree of therapeutic comparative data or conclusion reliability, evidenced by the decades of observational studies, arguments, and controversy among experts supporting their preferred breast reduction technique with no resolution. At the same time, we have no issues with the use of observational studies that Dr Swanson espouses. The observational study is the most common design used in aesthetic surgery and clearly has a role in the advancement of our specialty. For various reasons, the observational study design may be the only feasible study for investigators with challenges such as unavailability of resources, the question can only be answered by an observational study design (as the “boundary of knowledge” does not allow head to head comparison yet), ethical considerations, and patient recruitment issues. Although RCTs are indeed more expensive, complex, and as Dr Swanson notes, may be “beyond the capacity of most plastic surgeons,” just because an RCT is difficult to execute does not mean we shouldn't pursue it. Despite the challenges of performing RCTs correctly, observational studies are significantly more prone to bias and faulty conclusions than RCTs. Many biases that are largely mitigated by the RCT structure are unopposed in observational studies. These include selection bias, where the more favorable patients go into the “my favorite technique” cohort; recall bias as we tend to remember the complications/problems from the technique we like less and the satisfied patients from the preferred one; and validation bias, as we naturally think the operation we are currently doing now is superior, validating our choice. Think about it : can you remember a study where the earlier technique was shown to be superior? (Of note, this demonstrates yet another bias—the optimism bias, and both surgeons and patients are highly prone to it.) Table 1 below outlines the key methodological strengths and weaknesses of RCTs and observational studies. The merits of the RCT have been eloquently addressed by prominent epidemiologists whose publications we recommend reading. 12-14 Key Methodological Strengths and Weaknesses of RCTs and Observational Studies Adapted from Levine et al. 15 RCT, randomized controlled trials. Key Methodological Strengths and Weaknesses of RCTs and Observational Studies Adapted from Levine et al. 15 RCT, randomized controlled trials. While on 1 hand, concluding that failure to properly randomize patients should push us away from RCTs, Swanson criticizes the use of randomization techniques that utilize remote-site computer generation in proximity to surgery. The truth of the matter is that this method of randomization is the most stringent method to avoid selection bias. 8 The resistance to randomization, however, goes far deeper and may relate in large part to our own biases and egos. When we are convinced that our preferred technique is superior, then we ourselves can become resistant to having our patients participate in a clinical trial, as surely our patients must have the same conviction. Yet patients do participate in clinical trials with the ultimate outcome on the line, as every day patients with severe conditions volunteer for clinical trials where the outcome can be life or death. Most of our patients are never asked of their willingness, rather their attitude is assumed. Dr Swanson states that “If the surgeon does not believe there is an advantage to the newer method, why is he or she conducting the study in the first place?” It is a far different thing to prove something is true by rigorous criteria rather than to believe something is true. Bias is a ubiquitous, unconscious, and powerful force that affects our beliefs, interpretations, and judgments. The innovator cannot help but to want their new technique to be better—he or she wants to improve the care of patients, grow their practice, win recognition among their peers, and sense the admiration of grateful patients. Failure of our favorite is challenging to our egos, and we may equate that with personal failure. As in the quotation above by the legendary Earl Peacock, bombastic declarations of therapeutic superiority do not equate with proof, regardless of how much the individual believes it. Bias is unconscious and ubiquitous to the human experience, and only through disciplined, validated, and systematic study methodologies (of which the randomized, controlled trial is the pinnacle), can we rest assured that it has been held to the absolute minimum. The authors have no conflict of interests to disclose related to the content of this article. The authors received no financial support for the research, authorship, and publication of this article.

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