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EDITORIAL

Monitoring Quality and Safety in Anesthesia: Are Large Numbers Enough?

Dan Benhamou, MD^*, Yves Auroy, MD, and René Amalberti, MD, PhD

From the *Département d'Anesthésie-Réanimation; Université Paris XI; France; Department of Anaesthesia and Intensive Care, Service d'Anesthésie-Réanimation, Hôpital d'Instruction des Armées Percy, Clamart, France; and Patient Safety, Haute Autorité de Santé (HAS), Saint Denis La Plaine cedex, France.

Address correspondence and reprint requests to Dan Benhamou, Professor of Anaesthesia and Intensive Care, Chairman, Assistance Publique-Hôpitaux de Paris, AP-HP, Hôpital de Bicêtre, Département d'Anesthésie-Réanimation; Université Paris XI; France; 94275; Le Kremlin-Bicêtre, France. Address e-mail to dan.benhamou{at}bct.aphp.fr.

Quality can be defined as a practice in accordance with state-of-the art, while quality improvement is the combined and unceasing efforts of everyone (health care professionals, patients and their families, researchers, payers, planners, and educators) to make the changes that lead to improved patient outcomes (health), improved system performance (care) and improved professional development (learning).1 Safety can be defined as avoidance of complications and risk management as the process that ensures better patient safety. Increasing complexity and fragmentation of care, rapidly expanding medical knowledge, increasing use of technology and shifting health care needs from diagnosis and treatment of single, acute problems to the long-term management of multiple, interrelated chronic conditions are posing new challenges for the health care system. Consequently, patients may be experiencing unnecessary risk.2

When the practice of anesthesia and intensive care is considered, it is obvious that quality and safety are tightly linked, as our daily routine involves invasive procedures and drug administration which, even when performed adequately, have the potential of placing the patient in a life-threatening situation. However, due to the implementation of serial barriers, practice has become safer and the occurrence of severe iatrogenic events is now more the exception than the rule.

Ralston and Larson suggest that improving safety can be obtained by building a culture of safety and by proactively monitoring adverse events and outcomes while establishing a blame-free environment.2 Two studies published in this issue of Anesthesia & Analgesia3,4 demonstrate how implementation of large scale surveys can help. Several other studies with similar methods or results have already been published.5–10 Although there is no major new information described here, their publication is timely. The health care system of Western countries has identified during the last 10 yr, starting with the report of by Kohn et al.,11 some major flaws in design and functioning, which form the basis of unsafe practice. The studies reported in this issue of Anesthesia & Analgesia3,4 provide invaluable information as to the safety and quality of the practice of anesthesia in the institutions in which the surveys were performed. Such studies are useful at a local level to analyze local practice and identify specific problems of a given institution or country. In the Thai study, for example,3 the authors have identified an increased risk of cardiac arrest when spinal anesthesia is performed by the surgeon. This important result needs to be analyzed in the context of this specific country and may lead to important practice changes to prevent poor outcomes. They also identified that cardiac arrest was associated with a 91% risk of death which contrasts with the 65% chance of surviving in the large survey performed at the Mayo Clinic.10 In-depth analysis of practice is absolutely necessary to understand the differences in survival rate and to implement strategies that might lead to better outcomes. These studies are useful to everyone involved in anesthesia care as they identify some risk factors that are remarkably similar to those observed in other institutions. Overdosage of the spinal local anesthetic has also been found in other surveys as a major cause of extended sympathectomy,10,12 whereas prosthesis cementing can also cause cardiovascular collapse in frail elderly patients.10 These two underlying factors are of major importance as they can, and should, be modified. Reporting and highlighting these risk factors in local staff meetings or courses during meetings are natural ways to inform and prevent similar future events. Reporting is thus useful for the anesthetic community as these audits provide information that can be translated, at least partly, in other institutions and help suggest clinical strategies which can be implemented to reduce risk and improve quality.

The practice of anesthesia has become safer and complications or poor outcomes are now rare. Anesthesia-induced mortality is the primary negative outcome indicator of interest for anesthesiologists. Death is a prime outcome because its definition is clear (although causes and mechanisms may not be as easy to define) and death certification is mandatory in most countries, reducing the risk of under-reporting. Death, however, is so rare an occurrence that individual practice surveillance would not be efficient to perform analysis and to detect trends. Large scale surveys, which include large numbers of patients, are thus necessary to collect sufficient information, explaining why surveys enrolling multiple institutions (or even performed at a national level) have been published. Even when cases have been captured, imputability is often the next difficult step. Although sometimes easy to define (an anaphylactic shock leading to death in an otherwise healthy patient and occurring immediately after administration of an anesthetic drug can easily be defined as anesthesia-related), in most cases it is a complex task to define whether death can be attributed solely or mainly to anesthesia care. Not only can there be interaction with the preoperative patient status or with surgery, but death occurs at the end of the process in which multiple actions have been undertaken and in which prevention or damage containment have failed. Analysis of each step is therefore more difficult and the final classification as being related, or not related, to anesthesia remains often expert-dependent. Severe morbidity is also of interest because of its impact on the patient's life and, although rare, it may be frequent enough to warrant monitoring and analysis. It is what our Turkish colleagues4 accomplished in their survey of major complications of epidural anesthesia/analgesia in gynecologic or obstetric patients. The authors expected that a 13-yr period would ensure disclosure of a sufficient number of poor outcomes. However, this did not prove to be of adequate duration as they did not encounter a single case of epidural hematoma, epidural infection or cardiac arrest in their series. The authors state that they reviewed all patients' hospital charts but apparently retrospectively checked the occurrence of complications on a database in which poor outcomes had been selected. In our opinion, this is a serious limitation also found in most other voluntary reporting systems. Studies assessing negative outcomes and based on voluntary reporting are indeed hampered by the risk of under-reporting. In a classic study, Cullen et al. reported that voluntary declaration disclosed only 6% of all adverse events found by retrospectively analyzing patients' files.13 Since then, numerous studies have found that voluntary reporting rarely exceeds 10%–15% of the total number of events that actually occurred. An uncertain definition of what should be reported, the risk of litigation, an insufficient culture of safety and a poorly designed reporting system have been suggested as factors explaining why under-reporting is so impressive.14,15 With information which is automatically captured by the system, such as laboratory values, electronically obtained triggers can be used to identify adverse events.16 When the whole patient's file is electronically stored (including anesthesia chart), investigations can be automatically performed on a larger number of events, without the uncertainty of under-reporting.

Since small numbers do not allow us to aggregate events and to make reasonable recommendations, one might believe that it is no more useful to monitor rare events. Rather, in-depth qualitative analysis of each untoward serious event should only be performed and would be powerful enough to improve local practices. The search of contributory factors and mechanisms that led to systems failure is a modern way to perform this qualitative approach.17 Most investigators today, however, combine a search of adequate numbers and an analysis of contributory factors12,18 to obtain a "window on the system."19

The level of safety can be estimated by monitoring the occurrence of negative outcomes, as shown above with death or major morbidity surveys and by estimating the rate of untoward/adverse events. Postdural puncture headache (PDPH) as measured in the Turkish survey4 is indeed such an event but is not an outcome measure. The study thus recorded real outcome variables (epidural anesthesia-related seizure for example) and untoward events (PDPH for example). PDPH may lead to headache or subdural hematoma but may not be followed by any symptom. An untoward event may, or may not, lead to a poor outcome, depending on the patient health status, the quality of care undertaken by health care givers and probably on several other undefined factors. Human errors and systems failure are factors which can lead to either adverse outcome or adverse events; in-depth analyses will likely increase the safety culture of health care givers involved.

Quality is more related to process analysis and linkage between real practice and recommendations. Numerous studies have shown that, although some recommendations have been published and widely disseminated, outcomes remain poor. Bratzler et al., for example, reported in a large series of cases from Veterans Hospitals that antibiotic prophylaxis provided to surgical patients was performed according to established standards (as determined by the main three indicators defining adequate care) in half of patients.20 The ENDORSE study21 also recently demonstrated that prophylaxis against thromboembolic disease was adequately performed in slightly more than 50% of orthopedic patients. This is especially worrisome since these two practice guidelines are well defined and evidence-based, theoretically leaving less room for individual decision.

Quality and safety intuitively seem to be strongly linked. In a case of difficult intubation (i.e., an adverse event), hypoxia-related death (i.e., an outcome indicator) can ensue, but this is more likely to occur if the procedure defining how to manage this crisis (i.e., a recommendation of good care) has not been well followed. In addition, difficult intubation is more likely to occur if the preanesthetic visit has not included a search of risk factors. These examples show the association that can be established between indicators of quality and safety. The conclusions that are taken from this association are demonstrated by the observation that in maternal mortality studies, death is often thought to be avoidable as suboptimal care (i.e., deviation from standard practice) has been often noticed.22 However, this is not always the case, and one should take care to avoid over-simplification which could lead to abandonment of outcome measures and reliance on quality of care, which is more easily assessed. Using United States airlines databases, it has been shown that the rate of adverse events is inversely correlated to the number of crashes.23 In other words, reporting of more adverse events results in a lower rate of negative outcomes. There might also be an improvement in the number of factors contributing to poor outcomes, but it is elusive to say that this would lead automatically to risk reduction.24 Improvement of safety has always been associated with risk measurement, even though this is a complex task. Given the constraints that are exerted on the health care system, it is tempting to simplify the process and limit measurement to quality of care indicators by over-emphasizing that they are both easier to collect and an adequate assessment of the system. Measurement of safety itself remains necessary because changes in the quality of care do not always translate to better outcomes. Large surveys, using mandatory or voluntary reporting, are one effective means to gain information and lead to corrective measures. They also are a means to increase safety culture, both ultimately having the potential to improve patients' outcomes.

	Footnotes

 
Accepted for publication August 5, 2008.

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