ASA Panel Examines Future of Safety Research by Richard L. Keenan, M.D.

Richard L. Keenan, M.D.

A Panel Discussion on “Needed Research in Patient Safety” attracted an audience of over 1 50 at the October ASA annual meeting. In his introduction, Dr. Arthur S. Keats of the Tom Heart Institute announced that the purpose of the Panel was to stimulate the submission of more and better grant applications to the Anesthesia Patient Safety Foundation, which awards over S I 00,000 per year in research support. Maximum support is $35,000 per year, and last year 3 of 20 applications were funded. Applications must be for applied research relating directly to patient safety in anesthesia, and, because each grant is for one year only with no provisions for renewal, proposals which could be completed within one year are considered most favorably.

“Clinical Problems” were addressed by Dr. Frederic Cheney of the University of Washington. Citing his experience with the ASA Closed Claims study, he described the high incidence of severe patient injury in malpractice actions against anesthesiologists, noting that most problems were respiratory in origin, and that most were preventable. His specific recommendations for future development include a means of predicting difficult intubation, foolproof indicators of tracheal (not esophageal) tube placement, ventilatory monitors for non-intubated patients, and predictors of sudden bradycardia and arrest during spinal as well as general anesthesia. Dr. Cheney also indicated a need for proof that pulse oximetry and capnometry really do decrease the incidence of mishaps.

Dr. William New, an anesthesiologist from Stanford who is now Chairman of the Board of the Nellcor company, discussed “Technology Questions” A major problem in the development of new technology is the fact the innovation in medicine comes from the university and not the business world, whereas in engineering the reverse is true. The trick, Dr. New believes, is to bring clinicians and engineers together. He also stressed the ‘,applied” nature of technologic research. Sensors and microchips are places in industry where clinicians will find exciting new developments that might be applied to patient safety.

Dr. David Gaba of Stanford addressed “Human Factors” Dr. Gaba, an active investigator in the area of simulation, observed that most mishaps involve human error. We need to study ourselves, he suggested, as well as our tools. What does an anesthesiologist do? What differentiates an expert from a novice? Better knowledge of external factors which shape performance (fatigue, environmental, psychological) is needed. Ergonomics and organizational aspects also deserve study. Problems specific to the study of human factors include heterogeneity, the fact that “we don’t have Sprague-Dawley anesthesiologists”. Dr. Gaba also echoed a common theme among investigators of safety: Outcome studies are difficult because bad outcomes are ram

Jeffrey Cooper, Ph.D. from Harvard, who is well known for his “critical incident” studies, discussed a “Potpourri of Research Questions”. Noting the problem of small numerators over large denominators inherent in studies of mortality and major morbidity, Dr. Cooper suggested that, for all its inconsistencies and “rough numbers”, epidemiology is an acceptable means of investigating anesthesia safety. A mass of data already exists in the literature which may be amenable to analysis, and from which useful information might be extracted. He suggested also that subsets of events requiring intervention to prevent damage or death can also be studied, and built into a quality assurance program as well. And perhaps the ultimate study of safety is one designed to prove whether quality assurance efforts really do work to improve safety. Accident investigation is another fruitful area of work which, while well developed in the aircraft industry, is still in its infancy in anesthesiology.

Grant Getting

Finally, Dr. Donald Stanski, a senior faculty member from Stanford with extensive experience in reviewing grant applications for the ASA as well as the APSF, described how to get a safety grant. He noted that most applications received by the APSF in the past three years were unacceptable. Some were excellent proposals but not related directly to safety; other were meritorious projects which couldn’t be completed in a year. And some were simply poorly prepared. He gave the following advice to potential applicants: First, find a mentor, a successful investigator who knows how to write a good proposal. Provide evidence that you will be successful, either by having a proven track record, or with convincing preliminary data. Make a clear statement of the importance of the study. Spend a lot of time in the preparation of the grant (Dr. Stanski suggested that it takes him six to ten months to write a grant). Finally, use what one of Dr. Stanski’s colleagues calls the “mud on the wall” technique: If a proposal is rejected, keep revising and re-submitting. “If you keep throwing mud on the wall, some will eventually stick!”

In the discussion period, Dr. Cheney was asked by members of the audience whether other investigators could access the ASA Closed Claims Study data base. Dr. Cheney gave a qualified “yes”. He and his colleagues would be willing to share data with other investigators, but only in a joint project.

Concern was voiced from the floor regarding possible negative liability consequences of risk studies. The panel agreed that while this might be a problem, it should not deter such studies. (It occurs to this reporter that safety studies to date have had the opposite effect; with the implementation of monitoring standards, the escalation of malpractice premiums has moderated in many jurisdictions.)

Lastly, Dr. New cited the experience in Holland, where advanced monitoring technologies have been used extensively, and where anesthetic mortality has reached very low levels. He expressed the hope that some day (assuredly not today) mortality will be so low that it will no longer be worth studying.

Dr. Keenan is Professor and Chairman of Anesthesiology at the Medical College of Virginia, Richmond.