ICPAMM Reviews International Safety Efforts in Anesthesia

Jeffrey B. Cooper, Ph.D.

For the sixth time in the past 10 years, the International Committee for Prevention of Anesthesia Mortality and Morbidity convened on October 2, 1994, to review studies of mortality and morbidity and generic topics related to patient safety. Dr. Jeffrey Cooper opened the day-long session with a brief review of seminal events in anesthesia safety since the group’s founding in 1984 in Boston. The Anesthesia Patient Safety Foundation and later the Australian Patient Safety Foundation had their roots in that first gathering. Standards for monitoring, a topic of heated debate in 1984, are now widely accepted throughout the world. Many studies of mortality and morbidity have been discussed at these meetings and the information has been useful to many participants in conducting similar studies tailored to the investigators’ home countries. Numerous collaborative efforts have arisen or derived energy or guidance from the supportive atmosphere of ICPAMM. This year’s congenial, but critical, discussions seemed to provide more of the same. It was a small (20 participants) but diverse (10 countries represented) attendance, one day before the start of the European Congress of Anaesthesiology in Jerusalem, Israel. The small-group format provided greater opportunity for detailed discussions and exchanges; the participants later suggested that future meetings be restricted to similar numbers.

The U.S. Closed Claims Study

Dr. J. S. Gravenstein, standing in for Dr. E.C. Pierce, Jr., highlighted key findings from the ASA sponsored study of closed malpractice claims in the U.S. He noted that the majority of cases in the study involve healthy patients for non-emergency procedures; inadequate ventilation cases make up the largest category of events and instances of nerve injury the second largest. The mechanism of the majority of nerve injuries remains unknown, presenting a challenge for clinical research. Obstetrical claims are another category of great importance and for which new insights are needed.

One of the most interesting problems identified in the U.S. Closed Claims Study is sudden cardiac arrest during spinal anesthesia. After reviewing the data and the possible mechanisms for this sudden event and a personal anecdote, Dr. Gravenstein emphasized the dramatic and dangerous character of this specific event and the need for research leading to better understanding its etiology and appropriate courses of treatment.

The closed claims data may only represent the tip of the iceberg; there are data to suggest that approximately 4% of cases may lead to potentially compensable injuries, while claims against anesthesiologists are made only in approximately I in 200 cases for all causes.

Perhaps one of the most interesting findings from the closed-claims data is how outcome of a case affects the judgment of reviewers of that case, in the sense that a severe adverse outcome is more likely to lead to a conclusion that the care was substandard than the same circumstances with a less severe outcome. This raises serious concerns about how reviewers may be biased in judging culpability of clinicians.

The discussion that followed focused on differences between medical-legal characteristics of various countries and about how well the U.S. system did or did not do in meeting the objectives of compensating for injury and deterring preventable injuries. Dr. David Gaba of Stanford noted that the closed claims data suggests that it does not do very well at either. Dr. William Runciman (Australia) offered that, despite such problems, the tort system does do an effective job in ‘getting the attention’ of those who can effect changes for the better. The discussions also suggest that the litigation climate of the U.S. is now being experienced more and more in other countries as well and can be expected to continue to increase.

NCEPOD

Dr. John Lunn reported on highlights of the latest National Confidential Enquiry on Perioperative Deaths (NCEPOD) in the U.K. The basis of this study is not epidemiologic investigation. Rather, it is aimed specifically toward the objective of improving quality of care. Dr. Lunn takes a definition of quality from the book ‘Kaisen,” which describes the Japanese concepts of continuous improvement of quality a ‘characteristic of an activity that can be improved.’ This contrasts with the emphasis of malpractice claims, which aim to assign fault and compensate victims. Dr. Lunn emphasized that one of the important attributes of the study is that it is not specific to anesthesia; both surgeons and anesthetists are involved in submitting reports, and aspects of both surgical and anesthesia care are scrutinized. After numerous attempts to seek agreement in assessments between reviewers, they have abandoned such notions because they have not been very successful

The NCEPOD has, in the past five years, examined numerous issues including pediatric deaths, a random selection of perioperative deaths, and deaths associated with specific operations. More recently, emphasis has been on different methods of eliciting increased cooperation from all surgeons and anesthetists. In 1995, it is planned that only the first death report by each surgical team will be examined.

The various NCEPOD reports have highlighted recommendations in many areas. The deployment of staff has been seen as an important issue. The anesthetists should be better matched to the patients clinical condition, and the supervision and appropriate skills of staff require improvement. As an example of how specific complications have been examined with data from the study, findings of cases involving thromboembolism were described in more detail. This has been identified as an area requiring further research, which will be funded by the Department of Health in the U.K. Also, guidelines are being published suggesting that each hospital prepare a protocol for treatment of Ns condition.

NCEPOD has extensively examined issues related to deaths occurring within 30 days of 15 specific procedures, whether of surgical or anesthetic origin. For instance, there is a collection of 100 reports of death following operation for strangulated hernia. Much larger samples are available for other operations, e.g., total hip replacement and CABG.

Dr. Lunn repeatedly emphasized the importance of NCEPOD being a collaboration between anesthetists and surgeons, which he believes has been vitally important for its success. He gave several examples of issues that have been identified specifically for surgeons: avoiding inappropriate surgery when death is imminent, increasing the frequency with which a specialist s opinion is sought prior to some operations, improving the preparation and ‘resuscitation” of a patient prior to surgery, and increasing the involvement of consultant anesthetists in the operating room.

One major suggestion addresses an idiosyncrasy of anesthesia in the UK induction of anesthesia outside of the operating room and then transporting the anesthetized patient into the actual operating “theater.” Findings of NCEPOD have resulted in the recommendation that induction of anesthesia be undertaken in the operating room itself.

There have been numerous general recommendations arising from the findings of NCEPOD. Cooperation of all anesthetists and surgeons continues to be encouraged and may be required by law. Efforts are being made to improve the access to essential medical services, to improve the supervision of trainees and to address specific issues such as the potential to improve the outcome from thromboembolism.

Dr. Ikuto Yoshiya from Japan inquired about the effect of studying perioperative deaths occurring within less than 30 days of operation. He noted that the ongoing Japanese study is based on a 7-day endpoint. Dr. Lunn commented that approximately 50% of perioperative deaths occur in the first 6 days so that many deaths potentially associated with operation and anesthesia may be lost from study with a 7-day cut off period.

Changing Physicians’ Practice Patterns

Dr. Marsha Cohen of the University of Toronto described early results of a study aimed at changing practice patterns in a way that would effect an improvement in a specific outcome. The outcome chosen was post operative nausea and vomiting (PONV). ‘Academic detailing’ (an intense, targeted educational effort) and individualized feedback were used in an attempt to increase the use of specific interventions (use of droperidol, metoclopramide, other antiemetic premedications, and naso-gastric tubes) at one hospital with a second hospital serving as a control. The use of the promoted preventive measures and the rates of PONV were tracked at both hospitals, but academic detailing, feedback to anesthesiologists, and announcement of the group rates of PONV were only done at the study hospital. Of 3,328 high-risk patients in the study, 97.3% were interviewed by the study’s research nurses. The results showed that, after the enhanced education, anesthesiologists at the study hospital significantly increased their use of ‘any preventive measure’ and specifically the use of high-dose droperidol. Individualized feedback to specific anesthesiologists as follow-up to the educational efforts at the study hospital even further increased the use of high-dose droperidol. Practice continued ‘as usual’ at the control hospital; during the study period, they used the promoted therapeutic measures significantly less frequently.

Did the increased use of promoted measures affect the rate of nausea and vomiting at the study hospital? Preliminary results (data are still being collected) indicated that the rate of PONV was not significantly changed at either the study or control hospitals as compared to baseline rates. However, during the two years of the study, the rate of PONV at the study hospital was lower.

There was no obvious explanation for the results. About 25% of patients were not receiving any preventive measures, and the promoted measures were not completely effective, only reducing the rate of PONV by 30%. The study shows that practices can be changed through various educational efforts, but studies designed to show improved patient outcomes are extremely difficult to execute.

Anesthesia Safety in Developing Countries

Dr. Sidney Gassner, President of the European Congress of Anaesthesiology, spoke to the group of his experiences of many years ago in providing anesthesia and other medical services in the area that is now Malawi. Several people in the audience having singular experiences agreed that the availability of anesthesia and related services hasn’t improved much in most of the underdeveloped countries. There is a stark contrast between the predominantly physician-administered anesthesia with the availability of modern drugs and high technology of industrialized countries and the conditions found in Malawi, which was previously Niasaland. More striking are the differences in health of the populations, Dr. Gassner described the high prevalence of many serious diseases, e.g., malaria and schistosomiasis. In the face of such stark conditions, the delivery of basic medical care takes on a much more important role than anesthesia. Despite this, he provided anesthesia and performed surgery for a variety of ailments. He stressed that the underdeveloped countries are in great need of the most basic training in anesthesia, but that anesthesia can be delivered with relative safety using very basic techniques. Under such primitive conditions, he urged that prevention of critical events becomes even more important because so little is available to mount an effective response to serious problems. The efforts of many anesthetists from around the world who provide training and care in these conditions were noted and appreciated.

The Australian Incident Monitoring System

Dr. William Runciman reported on the status of this now six-year continuous effort, which is conducted under the auspices of the Australian Patient Safety Foundation. Thirty manuscripts have described analyses of various subsets of incidents and specific problems and attributes of the data (see Anesthesia Intensive Care, Vol. 21, No. 5, October, 1993). He emphasized how anonymity of reporting, which is protected by law in Australia, has been critical to the high rate of participation and the candor of reports. It is no longer necessary to recruit hospitals to participate since they volunteer on their own. The POS (person on the spot) is another critical feature. This is the person who organizes efforts at a hospital and to whom feedback is sent on pooled data; no individual reports are distributed. Feedback via newsletters and meetings has also been thought to be effective at increasing support for the study and spreading word of the findings.

There are now more than 4,000 incidents collected and available for direct access in the central database. Dr. Runciman described how this has been useful in addressing specific questions that are raised by individuals, companies, or the government. He described an example in which AIMS data was useful in preventing inappropriate government action to alter the design of vaporizers as a result of a publicized adverse event.

Currently, the AIMS leadership is working toward a Generic Occurrence Code that could be used by any medical specialty for this kind of event reporting. An international effort is also underway to broaden reporting to other countries using the AIMS system. Hospitals in about a dozen countries have expressed interest in being involved. Dr. Runciman believes that each country must collect data of its own to have the results accepted by the medical community.

Incident Reporting System in the U.S.

Dr. David Gaba described the concept of introducing an incident reporting and feedback system in the U.S. The Anesthesia Patient Safety Foundation (U.S.) Board of Directors examined this possibility at its retreat in 1992 and approved the idea of developing such a system, which would be similar in principle to that operated by NASA for American aviation. The objective is to improve safety, not necessarily to do scientific investigations. AU types of potentially adverse events would be reported. NASA experience is that getting information directed to plots is more important than reporting only to the leaders and managers in the aviation industry. Although the proposed system would be similar in some respects to AIMS, the expectation is that reporters would not be entirely anonymous Rather, additional information would be gathered after an initial report to provide more detail about the character of the events. Dr. Gaba noted the experience by NASA of the importance of a narrative from a reporter most involved with an event in helping to identify causes. Following the second phase of data gathering, all identifiers would be removed from the reports. The biggest impediment, which has hampered other attempts to create such a reporting mechanism, are the concerns about potential access to the information and its potential use against medical personnel making the report. It is much more difficult in the U.S. to acquire the kind of legal protection that has been afforded the AIMS and CEPOD studies. Progress toward establishing a system has been stalled by the lack of personnel to assist in the legal research and design of the system.

Prospective Study of Anesthesia Mortality and Morbidity in Holland

Dr. Anneke Meursing and her colleague, Dr. Sesmu Arbus, summarized key elements of a study of anesthesia mortality and morbidity that is intended to begin soon in the Netherlands. Dr. Meursing noted that standards for anesthesia equipment were promulgated in Holland in 1978. This followed from a controversy created by Dr. Smalhout, who had spoken out about unnecessary anesthesia deaths. Approval of the Mastricht Treaty for the European Community has created additional pressure to document current (presumed excellent) levels of anesthesia safety because of concern that high standards of care in Holland may be challenged.

The Dutch study will be a prospective, case-control design, examining mortality and morbidity within 24 hours of surgery in 63 hospitals in three provinces. This will include more than 500,000 procedures. There will be a ‘correspondent” in each hospital and anonymity will be preserved.

Concern was expressed that the use of controls will prove difficult; this approach was abandoned in the CEPOD effort because of the difficulty of defining what characteristics should be matched. Drs. Meursing and Arbus will take the group’s suggestions under advisement.

Safety Progress in Japan

Dr. Yoshiya presented a paper prepared by Dr. Yoshihro Shimada, who could not attend. Dr. Yoshiya described how deficiencies in the first survey of anesthesia outcomes, about which Dr. Shimada reported at the last ICPAMM meeting, have led to the design of a new study, with an expanded number of hospitals and a more rigorous statistical design. Japan has adopted standards for minimal monitoring that are almost identical to that of the American Society of Anesthesiologists (see APSF Newsletter, 9: 23, Fall 1994).

International Study of Prolonged Postoperative Cognitive Dysfunction in the Elderly

A pilot study recently reported in the British Journal of Anaesthesia has led to the design of an international study of prolonged postoperative cognitive dysfunction (PPOCD) in the elderly. Dr. Jakob Trier-Moller described the equivocal results from the first study (a subcomponent of the well known Danish pulse oximeter prospective study), in which no statistically significant correlation was found between the use of pulse oximetry and PPOCD. He explained how the deficiencies in testing in that study and deficiencies in the design of other studies have failed to verify a commonly held perception that anesthesia is sometimes associated with varying degrees of PPOCD. A potential key reason is that most psychometric testing is not designed to identify physiologic/pathophysiologic issues. In the earlier study that Dr. Moller led, for instance, it was learned after the fact that a key test, the Wechsler Memory Scale, was not well standardized, especially in translation to Danish. Problems with repetitive testing and subject drop-out also hampered the power of the statistics.

The new international study of PPOCD will focus on elderly patients since it is suspected that a larger effect will be seen in that population. A more sensitive battery of psychomotor tests has been devised and will be performed pre and post-operatively. There will be several control groups to separate the effects of anesthesia from confounders. Ten hospitals from ten countries will participate (including one in the U.S., funded from a grant awarded this year by the APSF). Pilot studies of data collection have been completed; data collection for the main study is planned to begin presently.

Patient Satisfaction

Dr. Fred Orkin spoke in favor of broadening the ICPAMM focus to include outcomes other than the most serious. He based his argument on several beliefs: because serious adverse events are now rare, studies cannot have sufficient statistical power to reach significance; anesthesia now contributes little to serious adverse outcomes; anesthetists are not sufficiently sensitive to quality measures; there are substantial opportunities to improve care to patients who are apparently not injured by anesthesia; patients have a different perspective than providers about what constitutes quality care.

Dr. Orkin asked, “What really concerns patients?; what do they want?” He described how the process of conjoint analysis is used to identify customer needs in the consumer market, e.g. hotel industry, and how this can be applied to anesthesia services. The basis of the measurement is that patients place a dollar value on different levels of services from which a ranking is created. Different lists of symptoms are presented to a subject, who then ranks them. One sample list included “wide-awake post-operatively, no dysphoria, no nausea, extra cost $50.” Dr. Orkin has been conducting a sporadic, long-term study with this methodology to examine and demonstrate the concept. Preliminary data suggest, for instance, that patients place a high value on not having nausea and vomiting.

The book Through the Patient’s Eyes by Gereis et al. was suggested as a reference for these kinds of ideas. There ensued a lively debate about adding this topic to future ICPAMM meetings. Some felt that there was a danger of diluting the message of the continued need to press for safety from adverse outcomes, especially in the increasing climate of economic pressures to cut costs. The issue was not resolved.

ICPAMM Will Meet Again

Participants at this meeting unanimously agreed to plan the next meeting in conjunction with the June 1996 World Congress of Anaesthesiology in Sydney. It is felt that the small group format should be retained since it is conducive to open, frank discussion.

Dr. Cooper is the Coordinator of the International Committee for Prevention of Anesthesia Mortality and Morbidity. Comments and requests for participation should be addressed to him at the Department of Anesthesia, Massachusetts General Hospital, Boston, MA 02114.