Alexander A. Hannenberg, M.D.

n his 2006 Emery A. Rovenstine Memorial Lecture, J.G. Reves, M.D., showed us that anesthesiology ranked 24th of 25 medical specialties in the amount of National Institutes of Health research support received. In a comprehensive discussion of this disheartening observation, he asked “Why is research important?” Dr. Reves provided an educator’s answer to the question:

“It is essential because when the faculty are learning through research and the students are learning from the faculty, we have an exciting intellectual environment where everyone is learning."¹

I propose here an additional dimension to this answer, but I do so with unqualified endorsement of the original. The importance of research goes beyond education and supports ASA’s strategic goals in the area of advocacy for our patients and members.

We live in an age of evidence-based medicine in which clinical outcomes research is frequently the basis for health policy debates. An excellent and timely example is ASA’s opposition to health plan policies limiting coverage of anesthesia care for gastrointestinal endoscopy. The plans, with the support of the gastroenterology societies, contend that there is no improvement in patient outcomes when the procedures are done under propofol sedation administered by an anesthesiologist. When ASA members ask our organization to challenge the plans, we vigorously defend the general principle of retaining physician-patient autonomy, but the discussion would be entirely different if the literature existed to demonstrate that propofol were a superior agent and that it is most safely administered by an anesthesiologist. The gastroenterology literature has a growing number of large case series purporting to demonstrate the safety of nurse-administered propofol sedation (NAPS).² Is there a clinical outcomes study to show that the results are superior with anesthesiologist-administered propofol? We are learning the limitations of common sense, experience and passion in a high-stakes health policy debate.

We can expect that a related issue will occupy us in the years to come. The first clinical feasibility trial of Ethicon’s Computer-Assisted Personalized Sedation (CAPS) device appeared in the gastroenterology literature recently.³ This device uses physiologic data from a number of patient monitors to control a propofol infusion pump. Clearly, the intent of the device’s maker is to broaden the scope of nurse-administered sedation, perhaps into areas historically requiring an anesthesia provider. One can anticipate a steady stream of industry-sponsored clinical trials to demonstrate the safety of “CAPS-supported NAPS.” Many of us will again be skeptical and feel a duty to protect patients from care that may be less safe than it could be. How will we make that argument? Will we have the interest and resources to do the studies that identify hazards with this approach — or will the knowledge about CAPS come only from its proponents?

We have entered an era in which physician performance measurement will be increasingly important in payment, credentialing and public reporting. On what metrics do we wish to be measured for these purposes? The optimal approach would be to measure on evidence-based elements of practice that lead to improved patient outcomes. The ability to achieve this goal is entirely dependent on the adequacy of the scientific knowledge proving “best practices.” In the absence of this research, we create a void into which others can step to establish performance metrics. Such was the plight of the cardiac surgeons in the 1990s when state health departments published scorecards in heart surgery. A monumental effort to collect clinical data allowed them to define quality measurement in cardiac surgery. Research is the first step in the cycle, research > guidelines > measures > incentives. Practice guidelines in anesthesiology rely too much on opinion and too little on science — a reflection of the insufficiency of outcomes research in our specialty.

We are in the midst of a very public debate about the problem of anesthesia awareness and the role (or lack thereof) of cerebral function monitoring (CFM) in its prevention. The results of studies on the effectiveness of the devices yield confusing results and are often viewed with skepticism because of the prevalence of industry-supported studies and investigators. Anesthesiologists are unable to clearly judge the place of the monitors in their clinical practice. An ASA task force concluded that the literature was inconclusive.⁴ Despite this, public demand for the routine use of CFMs grows, fueled by commercial interests and well-intentioned victims of awareness. In response, ASA took the unusual step of commissioning an independent research study to “to prove or disprove to a reasonable degree of scientific probability whether brain function monitoring reduces the incidence of intraoperative awareness under general anesthesia” and provided funding to the Foundation for Anesthesia Education and Research specifically for such an investigation. When completed, we expect that this study will allow us to take a scientifically sound position in the court of public opinion on this controversy.

Such a commitment to unbiased scientific research in areas of public controversy is in the best interests of the specialty and the public. We cannot allow others to frame the questions and generate the answers in areas vital to the future of the specialty and the safety of our patients. And we cannot successfully advocate for these interests without the data to support our positions. While acknowledging that integrity requires that we be prepared to alter our positions when the science demands, support for research to inform our advocacy agenda is nonetheless a critical and strategic investment.

References:
1. Reves, JG. We are what we make: Transforming research in anesthesiology: The 45th Rovenstine Lecture. Anesthesiology. 2007; 106:826-835.
2. Cohen LB, Delegge MH, et al. AGA Institute Review of Endoscopic Sedation Gastroenterology. 2007; 133:675-701.
3. Pambiance DJ, McRorie J, et al. Feasibility assessment of computer-assisted personalized sedation: A sedation delivery system to administer propofol for gastrointestinal endoscopy. Gastrointestinal Endosc. 2006; 63(5):AB189.
4. Practice Advisory for Intraoperative Awareness and Brain Function Monitoring: A Report by the American Society of Anesthesiologists Task Force on Intraoperative Awareness. Anesthesiology. 2006; 104:847-864.

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