The Importance of a Surgical Safety Checklist...

THE IMPORTANCE OF A SURGICAL SAFETY CHEKLIST TO REDUCE MORBIDITY AND MORTALITY IN NIGERIAN HOSPITALS

Surgical care is an integral part of health care throughout the world, with an estimated 234 million operations performed annually. This yearly volume now exceeds that of childbirth. Surgery is performed in every community: wealthy and poor, rural and urban, and in all regions. The World Bank reported that in 2002, an estimated 164 million disability-adjusted life-years, representing 11% of the entire disease burden, were attributable to surgically treatable conditions. Although surgical care can prevent loss of life or limb, it is also associated with a considerable risk of complications and death. The risk of complications is poorly characterized in many parts of the world, but studies in industrialized countries have shown a perioperative rate of death from inpatient surgery of 0.4 to 0.8% and a rate of major complications of 3 to 17%. These rates are likely to be much higher in developing countries. Thus, surgical care and its attendant complications represent a substantial burden of disease worthy of attention from the public health community worldwide.

Data suggest that at least half of all surgical complications are avoidable. Previous efforts to implement practices designed to reduce surgical-site infections or anesthesia-related mishaps have been shown to reduce complications significantly. A growing body of evidence also links teamwork in surgery to improved outcomes, with high-functioning teams achieving significantly reduced rates of adverse events.

In 2008, the World Health Organization (WHO) published guidelines identifying multiple recommended practices to ensure the safety of surgical patients worldwide. On the basis of these guidelines, a team of medical experts in America designed a 19-item checklist intended to be globally applicable and to reduce the rate of major surgical complications. They hypothesized that implementation of this checklist and the associated culture changes it signified would reduce the rates of death and major complications after surgery in diverse settings.

Methods

Study Design

They conducted a prospective study of preintervention and postintervention periods at the eight hospitals participating as pilot sites in the Safe Surgery Saves Lives program. Between October 2007 and September 2008, eight hospitals in eight cities (Toronto, Canada; New Delhi, India; Amman, Jordan; Auckland, New Zealand; Manila, Philippines; Ifakara, Tanzania; London, England; and Seattle, WA) representing a variety of economic circumstances and diverse populations of patients participated in the World Health Organization's Safe Surgery Saves Lives program. These institutions were selected on the basis of their geographic distribution within WHO regions, with the goal of representing a diverse set of socioeconomic environments in which surgery is performed. Each hospital identified between one and four operating rooms to serve as study rooms. Patients who were 16 years of age or older and were undergoing non-cardiac surgery in those rooms were consecutively enrolled in the study.

Intervention

The intervention involved a two-step checklist-implementation program. After collecting baseline data, each local investigator was given information about areas of identified deficiencies and was then asked to implement the 19-item WHO safe-surgery checklist to improve practices within the institution. The checklist consists of an oral confirmation by surgical teams of the completion of the basic steps for ensuring safe delivery of anesthesia, prophylaxis against infection, effective teamwork, and other essential practices in surgery. It is used at three critical junctures in care: before anesthesia is administered, immediately before incision, and before the patient is taken out of the operating room.

Data Collection

Perioperative data included the demographic characteristics of patients, procedural data, type of anesthetic used, and safety data. Data collectors followed patients prospectively until discharge or for 30 days, whichever came first, for death and complications. Outcomes were identified through chart monitoring and communication with clinical staff.

They enrolled 3733 patients during the baseline period and 3955 patients after implementation of the checklist.

Outcomes

The primary end point was the occurrence of any major complication, including death, during the period of postoperative hospitalization, up to 30 days. Complications were defined as they are in the American College of Surgeons' National Surgical Quality Improvement Program: acute renal failure, bleeding requiring the transfusion of 4 or more units of red cells within the first 72 hours after surgery, cardiac arrest requiring cardiopulmonary resuscitation, coma of 24 hours' duration or more, deep-vein thrombosis, myocardial infarction, unplanned intubation, ventilator use for 48 hours or more, pneumonia, pulmonary embolism, stroke, major disruption of wound, infection of surgical site, sepsis, septic shock, the systemic inflammatory response syndrome, unplanned return to the operating room, vascular graft failure, and death. Urinary tract infection was not considered a major complication. A group of physician reviewers determined, by consensus, whether postoperative events reported as “other complications” qualified as major complications, using the Clavien classification for guidance.

They assessed adherence to a subgroup of six safety measures as an indicator of process adherence. The six measures were the objective evaluation and documentation of the status of the patient's airway before administration of the anesthetic; the use of pulse oximetry at the time of initiation of anesthesia; the presence of at least two peripheral intravenous catheters or a central venous catheter before incision in cases involving an estimated blood loss of 500 ml or more; the administration of prophylactic antibiotics within 60 minutes before incision except in the case of preexisting infection, a procedure not involving incision, or a contaminated operative field; oral confirmation, immediately before incision, of the identity of the patient, the operative site, and the procedure to be performed; and completion of a sponge count at the end of the procedure, if an incision was made. They recorded whether all six of these safety measures were taken for each patient.

Discussion

Introduction of the WHO Surgical Safety Checklist into operating rooms in eight diverse hospitals was associated with marked improvements in surgical outcomes. Postoperative complication rates fell by 36% on average, and death rates fell by a similar amount. All sites had a reduction in the rate of major postoperative complications, with a significant reduction at three sites, one in a high-income location and two in lower-income locations. The reduction in complications was maintained when the analysis was adjusted for case-mix variables. In addition, although the effect of the intervention was stronger at some sites than at others, no single site was responsible for the overall effect, nor was the effect confined to high-income or low-income sites exclusively. The reduction in the rates of death and complications suggests that the checklist program can improve the safety of surgical patients in diverse clinical and economic environments.

Whereas the evidence of improvement in surgical outcomes is substantial and robust, the exact mechanism of improvement is less clear and most likely multifactorial. Use of the checklist involved both changes in systems and changes in the behavior of individual surgical teams. To implement the checklist, all sites had to introduce a formal pause in care during surgery for preoperative team introductions and briefings and postoperative debriefings, team practices that have previously been shown to be associated with improved safety processes and attitude and with a rate of complications and death reduced by as much as 80%. The philosophy of ensuring the correct identity of the patient and site through preoperative site marking, oral confirmation in the operating room, and other measures proved to be new to most of the study hospitals.

In addition, institution of the checklist required changes in systems at three institutions, in order to change the location of administration of antibiotics. Checklist implementation encouraged the administration of antibiotics in the operating room rather than in the preoperative wards, where delays are frequent. The checklist provided additional oral confirmation of appropriate antibiotic use, increasing the adherence rate from 56 to 83%; this intervention alone has been shown to reduce the rate of surgical-site infection by 33 to 88%. Other potentially lifesaving measures were also more likely to be instituted, including an objective airway evaluation and use of pulse oximetry, though the change in these measures was less dramatic. Although the omission of individual steps was still frequent, overall adherence to the subgroup of six safety indicators increased by two thirds. The sum of these individual systemic and behavioral changes could account for the improvements observed.

Another mechanism, however, could be the Hawthorne effect, an improvement in performance due to subjects' knowledge of being observed. The contribution of the Hawthorne effect is difficult to disentangle in this study. The checklist is orally performed by peers and is intentionally designed to create a collective awareness among surgical teams about whether safety processes are being completed. However, their analysis does show that the presence of study personnel in the operating room was not responsible for the change in the rate of complications.

This study has several limitations. The design, involving a comparison of preintervention data with postintervention data and the consecutive recruitment of the two groups of patients from the same operating rooms at the same hospitals, was chosen because it was not possible to randomly assign the use of the checklist to specific operating rooms without significant cross-contamination. One danger of this design is confounding by secular trends. They therefore confined the duration of the study to less than 1 year, since a change in outcomes of the observed magnitude is unlikely to occur in such a short period as a result of secular trends alone. In addition, an evaluation of the American College of Surgeons' National Surgical Quality Improvement Program cohort in the United States during 2007 did not reveal a substantial change in the rate of death and complications. They also found no change in their study groups with regard to the rates of urgent cases, outpatient surgery, or use of general anesthetic, and they found that changes in the case mix had no effect on the significance of the outcomes. Other temporal effects, such as seasonal variation and the timing of surgical training periods, were mitigated, since the study sites are geographically mixed and have different cycles of surgical training. Therefore, it is unlikely that a temporal trend was responsible for the difference they observed between the two groups in this study.

Another limitation of the study is that data collection was restricted to inpatient complications. The effect of the intervention on outpatient complications is not known. This limitation is particularly relevant to patients undergoing outpatient procedures, for whom the collection of outcome data ceased on their discharge from the hospital on the day of the procedure, resulting in an underestimation of the rates of complications. In addition, data collectors were trained in the identification of complications and collection of complications data at the beginning of the study. There may have been a learning curve in the process of collecting the data. However, if this were the case, it is likely that increasing numbers of complications would be identified as the study progressed, which would bias the results in the direction of an underestimation of the effect.

One additional concern is how feasible the checklist intervention might be for other hospitals. Implementation proved neither costly nor lengthy. All sites were able to introduce the checklist over a period of 1 week to 1 month. Only two of the safety measures in the checklist entail the commitment of significant resources: use of pulse oximetry and use of prophylactic antibiotics. Both were available at all the sites, including the low-income sites, before the intervention, although their use was inconsistent.

Surgical complications are a considerable cause of death and disability around the world. They are devastating to patients, costly to health care systems, and often preventable, though their prevention typically requires a change in systems and individual behavior. In this study, a checklist-based program was associated with a significant decline in the rate of complications and death from surgery in a diverse group of institutions around the world. Applied on a global basis, and especially in developing countries like Nigeria, this checklist program has the potential to prevent large numbers of deaths and disabling complications, although further study is needed to determine the precise mechanism and durability of the effect in specific settings.

Adapted from The New England Journal of Medicine.