Impacts of the surgical safety checklist on postoperative clinical outcomes in gastrointestinal tumor patients: A single-center cohort study.

A 19-item surgical safety checklist (SSC) was published by the World Health Organization in 2008 and was proved to reduce postoperative complications. To date, however, the impacts of SSC implementation in China have not been evaluated clearly. The study was performed to evaluate the impacts of the SSC on postoperative clinical outcomes in gastrointestinal tumor patients.Between April 2007 and March 2013, 7209 patients with gastrointestinal tumor who underwent elective surgery at the Affiliated Hospital of Qingdao University were studied. Data on the clinical records and outcomes of 3238 consecutive surgeries prior to SSC implementation were retrospectively collected; data on another 3971 consecutive surgeries performed after SSC implementation were prospectively collected. The clinical outcomes (including mortality, morbidity, readmission, reoperation, unplanned intervention and postoperative hospital stay) within postoperative 30 days were compared between the two groups. Univariate and multivariate logistic regression analysis were performed to identify independent factors for postoperative complications.The rates of morbidity and in-hospital mortality before and after SSC implementation were 16.43% vs 14.33% (P = .018), 0.46% vs 0.18% (P = .028), respectively. Median of postoperative hospital stay in post-implementation group was shorter than that in pre-implementation group (8 vs 9 days, P < .001). Multivariable analysis demonstrated that the SSC was an independent factor influencing postoperative complications (odds ratio = 0.860; 95% CI, 0.750-0.988).Implementation of the SSC could improve the clinical outcomes in gastrointestinal tumor patients undergoing elective surgery in China.

Introduction

Gastrointestinal tumors are some of the most common malignancies worldwide; in fact, gastric cancer and colorectal cancer represent the sixth and fourth most frequently detected malignancies among new cancer cases.[ Despite advances in medical treatment, radical resection combined with regional lymphadenectomy is considered the only potential curative method for gastrointestinal tumors. Perioperative mortality from gastrointestinal tumors has decreased with the development of medical technology, surgical techniques and perioperative care; however, significant morbidity associated with the treatment for gastric and colorectal cancer is still observed. Postoperative complication rates ranging from 10.5% to 40.1%[ and from 18% to 38%[ have been respectively determined among gastric and colorectal cancer patients. Postoperative complications may mean death, unplanned reoperation, readmission, and prolonged length of hospital stay,[ which are devastating to patients and costly to the health care system.[ In fact, the rates of postoperative mortality and unplanned reoperation ranged from 0 to 3.0%[ and from 1.7% to 1.9%[ among gastric cancer patients; from 0.5% to 3.9%[, and from 2% to 5%[ among colorectal cancer patients, respectively. Moreover, the 30-day readmission rate has been reported from 9% to 12%[ after general surgeries. Thus, reducing the occurrence of adverse events following gastrointestinal surgery has been studied by many researchers.

It has been reported that approximately half of all adverse events resulting in death or disability are attributable to errors and therefore preventable.[ Several studies have shown that postoperative mortality and morbidity can be reduced significantly with efficient team communication and teamwork.[ In 2008, the Safe Surgery Save Lives study group at the World Health Organization (WHO) published the results of implementing a perioperative SSC. A study has shown that the safety of surgery increases in developing and developed countries with WHO SSC implementation.[ Based on these results, the WHO developed a 19-item SSC system. Since its conception, an increasing number of countries, hospitals, and health care facilities have implemented or are planning to implement this guideline.[

In 2010, the SSC system was promulgated by the National Health and Family Planning Commission of the People's Republic of China.[ All hospitals in China were required to implement this system. Our previous investigation showed that the implementation of the SSC was feasible and effective for avoidance of risks in selective operations, and conducive to promoting communication among the surgical team and preventing surgical errors. Since the last four years, however, the effects of SSC implementation in China have not been evaluated. Moreover, until now, there was no research concentrating on gastrointestinal tumors in the world. This study aimed to evaluate the impact of the checklist on postoperative clinical outcomes following implementation in gastrointestinal tumor patients.

Methods

Study design

Data were obtained from the Gastrointestinal Tumor Database of the Affiliated Hospital of Qingdao University. The research proposal was approved by the ethics committee of the hospital. The study included all consecutively enrolled patients (16 years of age or older) with gastrointestinal tumors who underwent elective surgical procedures at the Affiliated Hospital of Qingdao University between April 2007 and March 2013. Operations were performed by doctors who had either over 5 years of experience or performed 500 operations. Patients were divided into two groups on April 1, 2010, on which day the SSC was implemented. Data was retrospectively studied as the baseline in the pre-implementation group. The SSC was strictly monitored in the post-implementation group and data obtained were prospectively studied.

Intervention

The SSC was formally introduced on March 26, 2010. All of the doctors, anesthetists, and nurses participating in this program were trained adequately according to surgical safety checklist (SSC) published by WHO,[ as described in Table 1. Intervention included three phases: sign-in, time out, and sign-out. Prior to sign-in, the patient was identified by the nurses and doctors twice in the ward and outside of the operation room.

Table 1

The World Health Organization surgical safety checklist[.

The “sign-in” procedure was performed by the surgeon before anesthesia in accordance with the SSC. “Time out” was performed by the circulating nurse at the beginning of incision. At this time, all operating staff ceased from performing other tasks except completing the checklist. Upon completion of the operation, the circulating nurse accomplished the “sign-out” checklist. In this program, surgeons, anesthetists, circulating nurses, and scrubbing nurses were required to implement the checklist from the beginning to the end of the operation and signed their names on the sheets required afterward.

Data collection

Data were obtained from the Gastrointestinal Tumor Database of the Affiliated Hospital of Qingdao University. All data collectors received training and supervision from the primary investigators regarding the identification and classification of complications and process measures and had more than 5 years collecting experience. They followed up the patients until discharge or for 30 days. Clinical outcomes were identified through chart monitoring and communication with clinical staff. All patient data were entered into the electronic database.

Data included the demographic characteristics of patients, characteristics of tumors, procedural data, type of anesthetic administered, length of hospital stay, readmission, reoperation, unplanned intervention, mortality and postoperative complications. Postoperative complications, particularly major complications and death, were recorded. This variable included any occurrence of 20 complications recorded in the American College of Surgeons’ National Surgical Quality Improvement Program[; complications included surgical site infection (superficial, deep, or organ-space), wound disruption, pneumonia, unplanned intubation, pulmonary embolism, on ventilator for over 48 hours, progressive renal insufficiency or acute renal failure requiring dialysis, urinary tract infection, stroke, coma, cardiac arrest requiring cardiopulmonary resuscitation, myocardial infarction, bleeding requiring transfusion, deep venous thrombosis requiring therapy, sepsis or septic shock, unplanned return to the operating room, and death. Postoperative complications were also categorized according to the Clavien-Dindo classification.[

Statistical analysis

All statistical analyses were performed using Statistical Package for the Social Sciences (SPSS, version 18.0, Chicago, IL) and Microsoft Office Excel 2007. Differences between the pre- and post-implementation groups were assessed by chi-square test, independent-samples t test and Wilcoxon rank sum tests (nonparametric test, Mann–Whitney U test), as appropriate. Data were correspondingly reported as numbers (percentage), means (standard deviation), or medians with inter-quartile range (IQR).

Additionally, univariate and multivariate logistic regression analysis were performed to find out the relationship between SSC and postoperative complications after removing the confounding factors. The presence or absence of postoperative complications was used as a dependent variable. Variables, including preoperative conditions, tumor-related factors, surgical procedures, and SSC implementation, were designated as independent variables. Unordered categorical variables were analyzed by applying dummy variables, and odds ratios and 95% CIs were calculated for each parameter in both groups. A P value <.05 was considered statistically significant.

Results

Clinicopathologic and treatment characteristics

The pre-implementation cohort consisted of 3238 patients and 3971 patients were enrolled in the post-implementation cohort. Characteristics of the patients are listed in Table 2. There were no significant differences in gender, age-adjusted Charlson comorbidity index (ACCI), surgical procedures, TNM stage, invasion of neighbors, ASA classification, operative duration, and blood loss. However, some differences between the pre-implementation and post-implementation cohort were observed. There were more patients with comorbidities in the post-implementation cohort. Patients in the post-implementation cohort were more likely to undergo general anesthesia and combined resection procedures.

Table 2

Baseline characteristics of the cohort (N = 7209).

Clinical outcomes

A total of 1098 patients experienced postoperative complications within 30 days, for an overall morbidity rate of 15.23%. Figure 1 showed that in the first 3 years before SSC implementation, the morbidity rates were 16.14% (154/954), 16.18% (167/1032), and 16.61% (208/1252), respectively, which were higher than the overall rate; while the morbidity rates in the 3 years afterward were 14.29% (179/1253), 14.15% (191/1350), and 14.55% (199/1368), which were lower than the overall one. The morbidity rates were relatively stable in the 3-year period before implementation and afterward. Rates of complications in all sites decreased from 16.34% (529/3238) at baseline to 14.33% (569/3971) after introduction of the checklist (P = .018); total in-hospital mortality also decreased from 0.48% (15/3238) to 0.18% (7/3971) (P = .028; Table 3). The overall rate of surgical site infection decreased significantly in the post-implementation group (P = .003). There was no difference between two groups on unplanned reoperation or 30-day readmission. Median of postoperative hospital stays prior to checklist implementation was 9 days, which was 1 day longer than those observed afterward (P < .001).

Figure 1

Annual postoperative morbidity rate of the cohort (N = 7209).

Table 3

The clinical outcomes of the cohort (N = 7209).

Relationship between the SSC and postoperative complications

Univariate logistic analysis showed that the variable selection process yielded 11 variables, including SSC, that were closely related to the occurrence of complications after surgery. Of the 11 variables, age, TNM stage, ASA score, combined resection, invasion of neighboring organs, comorbidity, surgical procedure, volume of intraoperative blood loss, operating time, and anesthesia were risk factors whereas the SSC was a protective factor. Statistical data are outlined in Table 4.

Table 4

Univariate logistic analysis of risk factors related to postoperative morbidity in 7209 patients.

Multivariate logistic analysis showed (Table 5) that variables, including SSC, age, TNM stage II, ASA score IV, combined resection, invasion of neighboring organs, comorbidities, surgical procedures of Dixon and Miles operations, volume of intraoperative blood loss, operation time, and epidural anesthesia were independent risk factors for postoperative complications. After adjustment, the SSC remained significantly related to postoperative complications with an OR of 0.853 (95% CI = 0.743–0.979).

Table 5

Multivariate logistic analysis of the postoperative morbidity.

Severity of postoperative complications

Nonparametric tests showed a significant difference between the two groups in terms of grade of postoperative complications according to the Clavien-Dindo surgical classification system (Z = –2.486, P = .013). Table 6 shows that there was no difference in the proportion of Grade I, Grade IIIa, Grade IIIb, and Grade IVa complications between two groups. While the proportion of Grade II, Grade IVb, and Grade V complications before checklist was significantly higher than that afterward. The complications before checklist implementation were more serious than those afterward.

Table 6

Clinical Outcomes of 7209 patients Classified according to the Clavien–Dindo System.

Discussion

Surgery is one of the most complex health interventions for patients with gastrointestinal tumor. It can prevent loss of life or limb but cause adverse events that vary between individual patients.[ On the one hand, surgical resection combined regional lymphadenectomy has always been considered as the only potentially curative method for gastrointestinal tumors; on the other hand, postoperative complications occasionally happen because the patients with gastrointestinal tumor are usually associated with risk factors such as old age, malnutrition, decreased organ reserve, neoadjuvant therapy, or concomitant comorbidities (hypertension, diabetes mellitus, ischemic heart disease, brain infarction, chronic lung disease, or chronic renal insufficiency) for morbidity. Moreover, intra-abdominal general surgery procedures, including resection and reconstruction, are much more likely to be associated with morbidity than those outside the abdomen all together.[

With the aim of reducing adverse events, a 19-item checklist was developed by the WHO Patient Safety Program. Previous studies suggest that implementation of this checklist can improve clinical outcomes. Haynes et al[ conducted a study on the effectiveness of the WHO SSC in eight hospitals worldwide and found that morbidity and mortality rates decreased from 11% to 7.0% and 1.5% to 0.8%, respectively. de Vries et al[ also evaluated the use of the WHO SSC prior and subsequent to implementation in a controlled multicenter prospective study; in their work, implementation of the checklist was associated with decreased surgical complications and mortality. Other studies on the effects of checklist implementation have been performed and similar results have been obtained.[ However, a Canadian study found that implementation of the SSC in Ontario did not correlate with significant reductions in operative mortality or complications.[ A systematic analysis[ showed that implementation of the WHO SSC results in decreased postoperative complications, mortality, and surgical site infection.

The present study revealed that implementation of the SSC in our hospital was associated with decreases in in-hospital 30-day morbidity from 16.34% to 14.33% as well as decreases in overall in-hospital mortality from 0.46% to 0.18%. The surgical site infection was responsible for the main reduction of postoperative complications and the complications in pre-implementation group were more serious, in spite of the patients in the post-implementation group were older and have more comorbidity than pre-implementation one.

Improvements in outcomes after checklist implementation could be attributed to several mechanisms. First, all of the operating room staff was required to participate in the SSC program. Surgeons, anesthetists, and nurses were required to communicate with each other regarding the patient's condition, surgical procedure, estimated operative time, and intraoperative blood loss, among others. Several studies show that efficient team communication and teamwork could improve patient safety and quality, as well as prevent death and major complications during surgery,[ with rates of complications and deaths reduced by as much as 80%.[ Effective communication can also lead to reductions in time in the operating room, which is correlated with reductions in adverse events.[ In our study, with the SSC implementation, the rates of postoperative complications and mortality decreased as much as 12.3% and 60.9%, respectively, and the median of postoperative hospital stays prior to checklist implementation was 1 day longer than those observed afterward, venous thromboembolism (VTE), manifesting as deep vein thrombosis (DVT), or pulmonary embolism (PE), represents clinically significant complication among the patients undergoing surgery for gastrointestinal malignancy. The incidence of DVT ranges from 2.1% to 5% in this population.[ In the present study, the incidence of DVT was 0.31% in the pre-implementation group, and 0.08% in the post-implementation group (P = .02). This incidence was lower than the rates reported in the previous studies. The difference may be associated with our emphasis of VTE prophylaxis during perioperative period. And also, there were no essential differences in terms of prophylaxis for VTE in the different periods. Intensive prophylaxis for VTE was routinely given to all the patients either in post- or pre-implementation group to minimize the risk of sudden death from fatal PE. The prophylaxis for VTE included dynamic assessment, patient education, mechanical prophylaxis (graduated compression stockings and intermittent pneumatic compression devices), early ambulation, and pharmacologic prophylaxis (if no contraindication). In our study, the implementation of surgical safety checklist decreased the incidence of DVT. The mechanisms of benefits from checklist implementation remains unclear. However, specific items on the checklist may directly prevent adverse events. For example, checking the timely intraoperative usage of intermittent pneumatic compression device and graduated compression stockings could prevent the DVT. Finally, item by item, the checklist implementation may result in decreased morbidity and mortality by improving teamwork, communication, and attitudes toward quality and safety.

The WHO SSC emphasizes the application of potentially lifesaving measures, such as anesthesia instrument check, pulse oximetry, preparing for intravenous, etc. These measures can improve patient safety in the operating room.[ Antibiotics must be administered 30 minutes before incision in the operating room rather than in the ward, where delays are frequent. Using the checklist, the rate of surgical site infection is significantly decreased and complications become less serious.[ Our study showed that with the SSC, the rate of surgical site infection was reduced from 8.46% to 6.62%. Finally, Hawthorne effect could be another possible reason. Data of the post-implementation group were prospectively collected. In this group, the surgical teams maybe pay more attention on the patients, which results in reducing the postoperative complications.

This study presents several limitations. First, the WHO SSC was introduced in March 26, 2010 and all hospitals in China were required to implement this system; however, a randomized study design was not presented. Second, the study was conducted for six years to obtain sufficient numbers of cases; thus, some of the variables may have changed and surgeon experience may have improved. Patients with gastrointestinal tumors who underwent surgery in a single institute were enrolled to prevent differences in diseases, hospitals, and doctors. Operating doctors were required to have over five years of experience or performed 500 operations to ensure that their surgical skills are relatively stable. In this study, the morbidity rates were relatively stable in the 3-year period before checklist and afterward, respectively. To decrease confounding factors, multivariate logistic regression analysis was used to obtain independent risk factors. In the model of postoperative complications, the WHO SSC emerged as a significant predictor of patient outcome, even after controlling for age, gender, comorbidity, surgical procedures, TNM stage, ASA score, anesthesia, combined resection, operative time, and intraoperative blood loss. Findings showed that postoperative complications in patients intervened under the WHO SSC decreased by about 14%.

Compliance with the WHO SSC further limited this study. The effectiveness of the WHO SSC depends on checklist compliance.[ However, we and other researchers found that compliance with the guidelines of the SSC varies worldwide.[ Pickering et al[ found that meaningful compliance with the WHO SSC is lower than that indicated by administrative data, particularly in the sign-out section. A previous investigation from us showed that the compliance of SSC was different in different operating team.[ In the present study, all operating staff members participated in three 60-minute training sessions, including formatting a multidisciplinary team, making a “how-to” video, and small simulation testing, to ensure correct and proper completion of the checklist. The supervisor in charge checked the compliance of the checklist regularly and occasionally. Regular and extra meetings with the entire operating room staff were conducted, during which records were reviewed and the importance of the checklist was emphasized. All of the SSC in this study were completed appropriately.

In conclusion, the WHO SSC decreases postoperative complication rates, particularly surgical-site infection, mortality rates and hospital stay. The WHO SSC is a simple and inexpensive method that helps improve postoperative clinical outcomes for patients with gastrointestinal tumors. As this research is a single-center study concentrating on gastrointestinal tumors, multicenter studies should be undertaken in future work.

Author contributions

Data curation: Dong Chen, Xiaobin Zhou.

Formal analysis: Xiaobin Zhou.

Funding acquisition: Yanbing Zhou.

Investigation: Hao Wang, Taohua Zheng.

Methodology: Dong Chen.

Resources: Shikuan Li, Yanbing Zhou.

Software: Taohua Zheng.

Supervision: Shougen Cao, Yanbing Zhou.

Validation: Zhaojian Niu.

Visualization: Zhaojian Niu.

Writing – original draft: Hao Wang.

Writing – review & editing: Shougen Cao.