The Value of an Opposing Perspective and the Importance of Evidence-Based Medicine in Plastic Surgery

In their recent editorial,¹ Drs Colwell and Chung, co-editors of Plastic and Reconstructive Surgery, discuss the elements of a well-run meeting. They reference the term, “social mind,” defined by Antony Jay in a 1976 business communication with the same title, as the capacity to share information and experience “as a single mind dispersed among a number of skulls.”² Colwell and Chung write, “a meeting helps individuals understand the collective aim of the group and how everyone individually fits into it,” a place where you “share a collective identity.”¹ Such a perspective would seem to leave little room for the individual or the nonconformer who chooses not to fit in.

By way of example, Colwell and Chung write, “recommendations from the Venous Thromboembolism Task Force for the prevention of deep venous thrombosis are more likely to be followed in practice compared with recommendations from a single-surgeon experience.” There is little doubt regarding the identity of this single surgeon. In fact, I debated Dr Colwell on this topic in 2014.³ For the last decade, I have challenged the efficacy and safety of individual risk stratification and chemoprophylaxis.

A problem with venous thromboembolism (VTE) research has been the paucity of studies on plastic surgery patients (recognized by the task force in 2012),⁴ forcing extrapolation from other specialties, and a lack of studies that use a reliable diagnostic tool to detect VTEs in patients. To remedy this deficiency, I undertook a prospective 5-year clinical trial that included ultrasound scans of 1000 consecutive plastic surgery outpatients.⁵ A separate level 1 randomized study evaluated the fibrinolytic effect of sequential compression devices in 50 patients.⁶ Both self-funded studies were institutional review board–approved and registered clinical trials, and both were published in successive issues of Plastic and Reconstructive Surgery, in 2020. For the first time, reliable high level-of-evidence data were available regarding the frequency of VTEs in plastic surgery outpatients, when they develop after surgery, which veins are affected, how long they take to resolve with treatment, and the benefit, if any, of sequential compression devices. A logistic regression identified risk associations.

Evidence-based medicine is not concerned about expert opinion, conventional wisdom, or institutional authority.^7,8 The number of surgeons is not a consideration. History shows that medical advances often come from individuals, not committees. In the 19th century, French physician Pierre Louis challenged the ubiquitous, and harmful, practice of bloodletting. Fortunately, Louis remained relatively marginal to the medical academic establishment, affording him a measure of freedom to espouse original ideas.⁹ His less fortunate contemporary, Ignaz Semmelweis, famously challenged the practice of not washing hands in obstetrical clinics, showing that antiseptics could drastically reduce the risk of infection and postpartum mortality.¹⁰ More recently, Barry Marshall upended the whole field of ulcer treatment with his radical, and ultimately Nobel prize worthy, theory that Helicobacter pylori infection causes peptic ulcers.¹¹ These pioneers faced heavy resistance from the medical community, and each demonstrated remarkable courage. Indeed, medical breakthroughs rarely originate in position articles or guidelines; the evidence on which protocols are based is often already obsolete when they are published.¹² Medical advances typically come from challenging the status quo, not accepting it. Nobel prizes are awarded to individuals, not committees.

The history of medicine is rife with examples of unenlightened committee recommendations. Many routine medical practices today represented radical departures from standard practice when they were introduced. In 1904, Harvard’s Department of Surgery research committee advised surgeons Cushing and Crile that “the adoption of blood-pressure observations in surgical patients does not at present appear to be necessary as a routine measure.”¹³

One advantage of private practice is the freedom to implement quality improvements.¹⁴ An example is total intravenous anesthesia to preserve the calf muscle pump during surgery (and reduce VTE risk).¹⁵ Surgeons in hospital-based academic practice may find this conversion difficult because their anesthesia providers routinely administer general endotracheal anesthesia. Guidelines may call for risk assessment models and anticoagulation, increasing the risk of bleeding. Once protocols are in place, it can be difficult to remove them.

In her book titled, “In Defense of Troublemakers, The Power of Dissent in Life and Business,”¹⁶ Nemeth makes the case for dissenters. Remarkably, dissenting opinions bring groups far closer to the truth, even if the dissenting opinion turns out to be wrong. Dissent broadens our thinking. An insidious effect of consensus is that it shapes the way we think. We start to view the world from the majority perspective. Politically, majority rule has been called “the tyranny of the majority.”¹⁷ Mandatory consensus is a hallmark of cults. The antidote to consensus is just one challenge, because the power of the majority lies in its unanimity.¹⁶

Colwell and Chung¹ write, “the group decision also dilutes individual authority and responsibility. Hospital protocols are designed to foster improved patient outcomes, but they may also serve to protect physicians who follow the protocols in the case of an adverse event.” In other words, individual judgment by a physician is subjugated to a hospital protocol. A chilling corollary to this statement is that if a plastic surgeon refuses to conform with institutional policy, that plastic surgeon may find himself or herself accused of negligence if a patient develops a VTE. No doubt many plastic surgeons routinely prescribe (off-label) anticoagulants and apply sequential compression devices for medicolegal protection, regardless of their own convictions. This uncritical compliance is not evidence-based medicine. In fact, this is the behavior evidence-based medicine was intended to eliminate.

Jurkiewicz considered intelligence in patient care a moral responsibility, squaring the best judgment of the doctor with the best course of treatment for a particular patient. Presenting dilution of responsibility as a virtue betrays the patient's trust in an individual physician, who may be placing committee recommendations above the interests of the patient.¹⁸

According to the Institute of Medicine, unnecessary services add over $200 billion to health care spending in the United States annually.¹⁹ Elimination of even some of this expense and time commitment might allow more spending on care that actually works.¹⁹ As Chung and Ram⁷ emphasize, insistence on evidence-based medicine is needed to curb rising costs and deliver rational care, and avoid relying on hearsay, habits, and standardized protocols.

In the mid-1990s, the most common sort of guideline was a “consensus statement.”¹² Tricia Greenhalgh, author of the popular reference, “How to Read a Paper, the Basics of Evidence-Based Medicine and Healthcare,” comments that these guidelines were often “the fruits of a weekend's hard work by a dozen or so eminent experts who had been shut in a luxury hotel, usually at the expense of a drug company.”¹² This sort of decision-making has been ridiculed as “GOBSAT,” which stands for “good old boys sitting around a table.”¹²

Evidence-based medicine is defined as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”^20–22 The lack of science in plastic surgery is well-recognized.^7,21–23 Medical practice guidelines often fall short in meeting methodological standards.²³ The importance of evidence-based medicine has been emphasized in the plastic surgery literature.^7,21–23 A scientific approach is recognized as especially relevant to the evaluation of new treatments.²² Although they are considered the highest level of evidence,²² randomized controlled trials are often not feasible in plastic surgery.^21,23 Fortunately, observational studies with solid methodology can provide high level-of-evidence data.^21,23 A prospective study among consecutive patients meeting eligibility criteria, with a reported inclusion rate, the use of contemporaneous controls when indicated, and consideration of confounders is a realistic goal.²³ Objective measuring devices are preferred.²³

Surprisingly, evidence-based medicine still faces resistance in the plastic surgery community.²⁴ Some plastic surgeons believe that expert opinion and innovation should take precedence over a “pool of data.”²⁴ Far from stifling innovation, evidence-based medicine empowers the pioneer to challenge the status quo on an even playing field, where only the facts matter.²⁵ Ironically, evidence-based medicine is commonly used to debunk practices that were once believed to be evidence-based.¹² In the United Kingdom, it is now a contractual requirement for doctors to practice according to the best research evidence.¹²

Coincidentally, Louis, in rejecting bloodletting, introduced his “numerical method,” the idea that new and valid medical knowledge could be derived from aggregated clinical data.⁹ Today, we recognize that evidence-based medicine is, in many ways, measurement-based medicine.²⁶

Both individuals and committees can make good and bad recommendations. The pertinent issue is not the number of people supporting a recommendation, but whether the decision is based on the best available evidence. An example is provided by the March 2019 public advisory committee of the US Food and Drug Administration.²⁷ The first decision of this committee was reached after 2 days of presentations, which included the unanimous testimony of 40 plastic surgeons defending the continued use of textured implants.²⁸ These experts formed a consensus, and the committee initially favored this consensus opinion.²⁷ The decision was wrong. The second decision, which came less than 3 months later, banned macrotextured breast implants.²⁹ The second decision—the correct one—was based on the evidence, which included increasing numbers of women dying of breast implant–associated anaplastic large-cell lymphoma, and the clear link to textured implants. The second decision was based on numbers, statistics, and mortality rates, not much different from the early evidence-based efforts of Louis and Semmelweis.^9,10

Practice advisories often (wisely) contain a disclaimer. For example, the 2012 ASPS Venous Thromboembolism Task Force cautioned that its report was not intended to serve as the standard of care. This committee recognized that “given inevitable changes in the state of scientific information and technology, periodic review and revision will be necessary.”⁴ At the time of the report, no large series of consecutive plastic surgery patients had been evaluated using diagnostic ultrasound to detect VTEs. No information was available regarding the efficacy of sequential compression devices in plastic surgery patients. Sequential compression devices, considered by many to be a mainstay of VTE prophylaxis, were not evaluated by the task force and, to its credit, no recommendation was made regarding their use.⁴ Prioritizing old recommendations, which anticipate change⁴ over more recent evidence,^5,6 is not in keeping with the principles of evidence-based medicine. New evidence can be accepted or rejected, but not simply ignored.³⁰

Fortunately, plastic surgeons who are willing to think for themselves, and resist dogma, can defend their practices by using the best available evidence.^5,6 Plastic surgeons wish to hear both sides of a debate. They do not want to be corralled into compliance by thought leaders. Controversy forces us to think. Indeed, what is the point of a meeting if the same collaborative viewpoint is being recited? As physicians, we should be concerned about using the best evidence as a guide to treat our patients, nothing else, and especially not the consensus of a committee.

“The reasonable man adapts himself to the world; the unreasonable one persists in trying to adapt the world to himself. Therefore, all progress depends on the unreasonable man.”—George Bernard Shaw³¹