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.
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