he 1999 Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System was critical of the health care field and characterized medical error as the fifth-leading cause of death in the country. However, it singled out the achievements of anesthesiology as an exemplary model (Chapter 7, pages 124-125). “Professional societies, groups and associations can play an important role in improving patient safety by contributing to the creation of a culture that encourages the identification and prevention of errors. Few professional societies or groups have demonstrated a visible commitment to reducing errors in health care and improving patient safety … The exception most often cited is the work that has been done by anesthesiologists to improve safety and outcomes for patients.”

Leaders From the Past
The well-earned reputation of our profession as a leader in patient safety can be traced to innovative thinking a generation ago when anesthesiology was besieged with professional liability claims. Among others, leaders in the movement were Ellison C. “Jeep” Pierce, Jr., M.D., of Boston, Massachusetts, and Richard J. Ward, M.D., and Frederick W. Cheney, M.D., of Seattle, Washington.

To address this problem of escalating liability premiums, Dr. Ward, then a professor of anesthesiology at the University of Washington, examined closed malpractice claims against anesthesiologists in Washington state. He published his findings in a 1984 book, Analysis of Anesthesia Mishaps, edited by Jeffrey B. Cooper, Ph.D., and Dr. Pierce. Clearly the twin malpractice problems, unavailability of medical liability insurance in the 1970s and the crisis of affordability in the 1980s, suggested the need to examine closed claims on a national basis. The ASA Closed Claims Project, truly a major American effort to examine anesthesia risk, also arose from the work of Dr. Ward. In 1985 ASA gave its Committee on Professional Liability the charge to conduct a closed claim study of national scope. Dr. Cheney, the Committee Chair, noted “The relationship of patient safety to malpractice insurance premiums was easy to predict. If patients were not injured, they would not sue, and if the payout for anesthesia-related patient injury could be reduced, then insurance rates should follow.”

Safety Through Education
Following establishment of the Closed Claims Project and creation of the Anesthesia Patient Safety Foundation in 1985, ASA undertook an extraordinary educational initiative within our profession. The initiative was directed toward identification of the risks of adverse events and reducing their incidence with logical strategies based on the analysis of multiple anecdotes, in this instance, the closed claims data.

Today we are in the era of evidence-based medicine. The gold standard is a multicenter, randomized, controlled study, preferably several of them. Many of the practice standards adopted in the past would not pass muster today under the rigorous requirements of currently accepted scientific methodology for adopting standards of practice. Is this all for the good, or are there drawbacks?

Consider a recent article in U.S. News & World Report by Bernadine Healy, M.D. <www.usnews.com/usnews/opinion/articles/050530/30healy.htm>. Ordinarily the popular press is not a significant source for important scientific opinion. In this case, readers should note that Dr. Healy is one of the most accomplished physicians in the country. Among her achievements, after attaining the rank of professor of medicine at Johns Hopkins University, are serving as president of the American Heart Association and becoming the first woman to head the National Institutes of Health.

In the article, Dr. Healy reports the frustration of trying to gain approval for a new diagnostic test for ovarian cancer. Researchers have identified a novel pattern of four proteins that signal ovarian cancer in 95 percent of women with the disease and are normal in 95 percent of healthy women. The main reason that promising tests for ovarian cancer are stuck in the laboratory is that they are being held to higher standards than other cancer screens now widely in use: a specificity of 99.6 percent. Prostate specific antigen (PSA), for example, with a sensitivity of 75 percent to 85 percent and false positive as high as 30 percent, was approved by the Food and Drug Administration (FDA) in 1986 to monitor prostate cancer, but doctors subsequently began using it for screening as well.

The title of Dr. Healy’s article, “Deadly Perfectionism,” underscores her view of the consequences of requiring too rigorous validation of innovative procedures. She points out that if such perfection were applied to Pap smears for cervical cancer, mammograms for breast cancer or PSA measurements for prostate cancer, these screens would not exist — and many lives would not have been spared.

Reducing the issue to absurdity, an article in the 2003 British Medical Journal concluded that no randomized, controlled studies exist to prove the effectiveness of parachutes in reducing the incidence of death and major trauma related to the gravitational challenge of jumping from aircraft in flight. I can attest through personal experience that parachutes work, and I have no interest in volunteering to be a member of a control group.

Proof Positive?
The above concerns and comparisons are pertinent to ASA. This Society is a recognized leader in reducing medical error and improving patient safety. Its reputation was earned over the past generation by innovation based, for the most part, on observational data. Today there is a much higher standard of proof required for innovation to be accepted. Can ASA sustain its reputation as a leader in improving patient safety over the next generation, as reported in the 1999 IOM report, if it recommends adoption of new techniques and standards only after the most rigorous standards of scientific proof have been satisfied? Or will our patients be denied the potential benefits of innovation because of a “deadly perfectionism?”

In the coming months and years, ASA will consider new standards of practice, practice parameters and pay-for-performance measures. The interests of our patients will require the collective wisdom of all of us to determine the proper balance between perfectionism and lesser levels of scientific proof for implementing various new practices. Dr. Healy makes a recommendation for the ovarian cancer screening test:

“Pull together NCI, FDA, the Centers for Medicare & Medicaid Services, and perhaps private insurers. Give preliminary approval to promising tests once they are independently validated, but pay for them only if doctor and patient participate in a national registry. Conscientious physicians will do what they think is right. In record time, accumulated experience will tell which tests are worthwhile."

How will ASA address its challenges?

Eugene P. Sinclair, M.D., is Chief of Anesthesia Service, Orthopaedic Hospital of Wisconsin, Milwaukee, Wisconsin.