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Ann Thorac Surg 2000;69:676-677
© 2000 The Society of Thoracic Surgeons
A Department of Surgery, University of Missouri, Columbia, Missouri, USA
Address reprint requests to Dr Jones, Department of Surgery, University of Missouri, M580 Health Sciences Center, Columbia, MO 65212
e-mail: jonesjw{at}health.missouri.edu
Innovation and technology, inseparable necessities of the surgeon’s armamentarium, produce most of the major advances in surgical therapy. As creative people who regularly attempt to refine the way therapeutic procedures are performed, most surgeons practice in an individualized, continuous quality-improvement mode. But new technology has developed faster than the profession’s ability to provide evidence-based data before widespread acceptance and application. The American College of Surgeons addressed the need to protect society while promoting scientific progress in its 1994 statement on Emerging Surgical Technologies. The College warned, "...it is equally essential that the value and safety of a new procedure be established before it is widely used on patients" [1]. An account of the Heartport experience in the May 5, 1999, issue of the Wall Street Journal should cause all surgeons to examine their practices with respect to technology. Unchecked surgical innovation can be a devil’s bargain.
The social and technologic conditions of the last 20 years have precipitated an unprecedented rate of change in surgical practice. Internet, television, and other large-scale information systems make patients as well as surgeons more quickly aware of advances in medical technology, often encouraging patients to demand access to medical procedures before they are fully refined. The wide availability of new technology in cardiovascular surgery broadens opportunities for improved operative techniques, thereby stimulating the cycle of demand for still more technology to support novel surgical methods. The force of this cycle compounds a problem described by Francis Moore three decades ago, when he wrote that "new operations are being employed that depend for their success on complicated physiologic or pharmacological interactions" [2]. He implied that the consequences of these complex interactions had yet to be fully defined, creating ethical questions about the point at which innovation by the individual surgeon extends beyond appropriate clinical creativity to become reckless experimentation.
Our surgical culture must be protected from scientific regression. Surgeons have obligations to society for the continued development of new and improved therapies. Overregulation can threaten the development of scientific knowledge and the refinement of therapeutic approaches by intimidating potential innovators.
Nevertheless, there is a troubling enthusiasm abroad in the surgical community for adopting new procedures or significant changes in conventional ones before they are tested under controlled conditions and proved to be safe and effective. In years past, leading surgeons devoted whole careers to the study of single organ systems or treatments, but an abundance of new procedures championed by newly minted surgical authorities tempts the practicing surgeon to accept and implement them immediately. The scientific basis for many such novelties need only be theoretical.
Industry funds a great deal of medical research, and the industrial–medical complex drives the development and introduction of surgical technology. As editor-in-chief of the journal Chest, Soffer was critical of data from industry-supported programs and cautioned readers to evaluate the sources and intentions of material published in even the most prestigious periodicals [3]. Surgeon–inventors may find themselves becoming businesspersons rather than independent scientists, and, as such, their interests are unavoidably conflicted, particularly if their laboratory provides the introductory data for marketing. The American College of Cardiology’s Task Force IV on scientific responsibility and integrity in medical research identifies a financial interest, "by holding or receiving stock, stock options or other equity positions," as an investigator’s greatest conflict of interest. Furthermore, the task force points out that "stock holdings in a small company with relatively heavy dependence on an individual product or technology that is the topic of research would seem very troublesome" [4].
What are the boundaries between innovation and experimentation? When does clinical experimentation become research? These are important distinctions for ethical as well as medicolegal reasons. An incremental improvement in a conventional procedure in the course of a rational evolutionary process is typically within the bounds of acceptable clinical innovation. This may involve the use of a different incision or suture technique, but not the alteration of the fundamental concepts of the operation. Intraoperative innovations, which can sometimes be quite radical, emerge from unforeseen circumstances, with an unplanned unique measure taken as a specific therapy to resolve an individual emergency or correct a life-threatening error.
Society grants surgeons the latitude to depart from planned procedures when operative findings require unanticipated measures. This acceptance is acknowledged in most surgical consent forms by the phrase "and all other necessary procedures." Consistent with this trust, surgeons must remain alert to the possibility of acceptable clinical innovation creeping inexorably toward reckless experimentation. The line between them is clearly crossed when surgeons pose clinical questions to which they cannot anticipate the answers. This usually includes those occasions when surgeons attempt established procedures that they have never personally performed before. The distinction is important because it changes surgeons’ obligations toward their patients and the society that sanctions their actions.
Innovation is the first resort of the surgeon among choices of alternative therapies. Some innovative decisions carry no obligation for approval from others. Individual surgeons may choose different medications or different doses of the same medication for the same problem. In this respect, many of the hundreds of decisions in the treatment of a single patient are the products of the surgeon’s clinical judgment. If an unusual therapeutic technique is not contraindicated, does not depart from conventional scientific theory, carries no substantive risk, would be used or considered a viable option under equivalent circumstances by other competent physicians, and offers a therapeutic advantage, then its use should be considered an appropriate clinical innovation and not a reckless experiment.
The skills required to perform an operation can demarcate the appropriate clinical boundaries between innovation and experimentation. New technologies require that even the most technically experienced surgeon submit to additional formal training. There is, inevitably, a learning curve in such cases, and the surgeon learns new skills at the expense of early patients. As the surgeon seeks intellectual and technical familiarity with a new application that promises to improve the standard of care, current standards must be maintained, and the patient must not be placed at increased risk without giving informed consent. Innovation becomes reckless experimentation when it breaches the unknown without sufficient basis. This may occur when an individual practitioner is unaware of available medical knowledge; innovation becomes experimentation because of insufficient data or experience to reasonably predict the outcome of an action. Other more-experienced or better-trained surgeons could perform the same act and be within the bounds of acceptable clinical innovation because their knowledge and experience give them a reliable sense of what will result. Thus, the more limited the fund of information, the more frequently one engages in reckless experimentation. Experimentation may or may not require society’s approval in advance, but it always requires notification of the patient or the family of what is done, even if consent can be acquired only after the fact.
The Code of Federal Regulations from the National Institutes of Health defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [5]. Thus, clinical innovation becomes research when the intervention is undertaken according to a protocol aimed at producing generalizable knowledge. As a clinical endeavor becomes research by being conducted within a systematic attempt to acquire knowledge, regulations require a detailed advance written plan, conformity with scientific method, approval by an institutional review board, and the patient’s informed consent. Crossing the boundaries between clinical innovation and research imposes on the surgeon a new series of behaviors and associated obligations.
In the case of research, patients require special protection. In particular, patients may perceive a personal obligation to participate as subjects in clinical research trials because they often benefit directly from past research participants’ contributions to the current state of therapy. Nevertheless, potential volunteers must be afforded the opportunity of informed consent, including the provision of all information that could reasonably be expected to affect their decision to grant or withhold participation. Variations in the patient consent process to ensure that criteria for adequate information are met become necessary even when clinical innovation is not nested in research. Tonelli and associates [6] examined lung volume reduction surgery and concluded that the different nature of the informed consent can provide a test of whether a new treatment is experimental in the sense of involving clinical innovation. The consent process in conventional treatment includes a discussion of what is known, but in experimental treatment the discussion must concentrate on what is not known. Information should be specific to the institution and surgeon. The patient should be informed of the number of procedures performed and the morbidity and mortality to date. It is not sufficient in these circumstances to cite statistics from other surgeons and institutions alone.
The Helsinki Code of Ethics for Biomedical Research confirms that "concern for the interests of the subject must always prevail over the interests of science and society." Shinebourne [7] proposes that "no patient (in particular a child) should be operated on more for the benefit of future patients than for himself." Although technology is essential to surgeons, our primary obligation is to rationally improve our art and science by minimizing harm and promoting healing in an ethical manner.
References
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  S. Hagl Cardiothoracic surgery: time for reappraisal! Eur. J. Cardiothorac. Surg., May 1, 2008; 33(5): 759 - 766. [Full Text] [PDF]
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 T. P. Carrel, F. S. Eckstein, L. Englberger, P. A. Berdat, and J. Schmidli Clinical experience with devices for facilitated anastomoses in coronary artery bypass surgery Ann. Thorac. Surg., March 1, 2004; 77(3): 1110 - 1120. [Abstract] [Full Text] [PDF]
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M. R. de Leval From art to science: a fairy tale? The future of academic surgery Ann. Thorac. Surg., July 1, 2001; 72(1): 9 - 12. [Full Text] [PDF]
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S. B. Colvin, E. A. Grossi, and A. C. Galloway Regarding ethics of rapid surgical technological advancement Ann. Thorac. Surg., November 1, 2000; 70(5): 1758 - 1758. [Full Text] [PDF]
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J. W. Jones Reply Ann. Thorac. Surg., November 1, 2000; 70(5): 1758 - 1758. [Full Text] [PDF]
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