Stuart R. Lipsitz

A surgical safety checklist to reduce morbidity and mortality in a global population.

BACKGROUND Surgery has become an integral part of global health care, with an estimated 234 million operations performed yearly. Surgical complications are common and often preventable. We hypothesized that a program to implement a 19-item surgical safety checklist designed to improve team communication and consistency of care would reduce complications and deaths associated with surgery. METHODS 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 Organizations Safe Surgery Saves Lives program. We prospectively collected data on clinical processes and outcomes from 3733 consecutively enrolled patients 16 years of age or older who were undergoing noncardiac surgery. We subsequently collected data on 3955 consecutively enrolled patients after the introduction of the Surgical Safety Checklist. The primary end point was the rate of complications, including death, during hospitalization within the first 30 days after the operation. RESULTS The rate of death was 1.5% before the checklist was introduced and declined to 0.8% afterward (P=0.003). Inpatient complications occurred in 11.0% of patients at baseline and in 7.0% after introduction of the checklist (P<0.001). CONCLUSIONS Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals.

An estimation of the global volume of surgery: a modelling strategy based on available data

BACKGROUND Little is known about the amount and availability of surgical care globally. We estimated the number of major operations undertaken worldwide, described their distribution, and assessed the importance of surgical care in global public-health policy. METHODS We gathered demographic, health, and economic data for 192 member states of WHO. Data for the rate of surgery were sought from several sources including governmental agencies, statistical and epidemiological organisations, published studies, and individuals involved in surgical policy initiatives. We also obtained per-head total expenditure on health from analyses done in 2004. Major surgery was defined as any intervention occurring in a hospital operating theatre involving the incision, excision, manipulation, or suturing of tissue, usually requiring regional or general anaesthesia or sedation. We created a model to estimate rates of major surgery for countries for which such data were unavailable, then used demographic information to calculate the total worldwide volume of surgery. FINDINGS We obtained surgical data for 56 (29%) of 192 WHO member states. We estimated that 234.2 (95% CI 187.2-281.2) million major surgical procedures are undertaken every year worldwide. Countries spending US

Streptozocin–Doxorubicin, Streptozocin–Fluorouracil, or Chlorozotocin in the Treatment of Advanced Islet-Cell Carcinoma

100 or less per head on health care have an estimated mean rate of major surgery of 295 (SE 53) procedures per 100 000 population per year, whereas those spending more than

Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention

1000 have a mean rate of 11 110 (SE 1300; p<0.0001). Middle-expenditure (

Effect of A 19-item Surgical Safety Checklist During Urgent Operations in A Global Patient Population

401-1000) and high-expenditure (>

Simulation-based trial of surgical-crisis checklists.

1000) countries, accounting for 30.2% of the worlds population, provided 73.6% (172.3 million) of operations worldwide in 2004, whereas poor-expenditure (</=

Comparative Effectiveness of Minimally Invasive vs Open Radical Prostatectomy

100) countries account for 34.8% of the global population yet undertook only 3.5% (8.1 million) of all surgical procedures in 2004. INTERPRETATION Worldwide volume of surgery is large. In view of the high death and complication rates of major surgical procedures, surgical safety should now be a substantial global public-health concern. The disproportionate scarcity of surgical access in low-income settings suggests a large unaddressed disease burden worldwide. Public-health efforts and surveillance in surgery should be established.

Female Sex and Higher Drug Dose as Risk Factors for Late Cardiotoxic Effects of Doxorubicin Therapy for Childhood Cancer

BACKGROUND The combination of streptozocin and fluorouracil has become the standard therapy for advanced islet-cell carcinoma. However, doxorubicin has also been shown to be active against this type of tumor, as has chlorozotocin, a drug that is structurally similar to streptozocin but less frequently causes vomiting. METHODS In this multicenter trial, we randomly assigned 105 patients with advanced islet-cell carcinoma to receive one of three treatment regimens: streptozocin plus fluorouracil, streptozocin plus doxorubicin, or chlorozotocin alone. The 31 patients in whom the disease did not respond to treatment were crossed over to chlorozotocin alone or to one of the combination regimens. RESULTS Streptozocin plus doxorubicin was superior to streptozocin plus fluorouracil in terms of the rate of tumor regression, measured objectively (69 percent vs. 45 percent, P = 0.05), and the length of time to tumor progression (median, 20 vs. 6.9 months; P = 0.001). Streptozocin plus doxorubicin also had a significant advantage in terms of survival (median, 2.2 vs. 1.4 years; P = 0.004) that was accentuated when we considered long-term survival (greater than 2 years). Chlorozotocin alone produced a 30 percent regression rate, with the length of time to tumor progression and the survival time equivalent to those observed with streptozocin plus fluorouracil. Crossover therapy after the failure of either chlorozotocin alone or one of the combination regimens produced an overall response rate of only 17 percent, and the responses were transient. Toxic reactions to all regimens included vomiting, which was least severe with chlorozotocin; hematologic depression; and, with long-term therapy, renal insufficiency. CONCLUSIONS The combination of streptozocin and doxorubicin is superior to the current standard regimen of streptozocin plus fluorouracil in the treatment of advanced islet-cell carcinoma. Chlorozotocin alone is similar in efficacy to streptozocin plus fluorouracil, but it produces fewer gastrointestinal side effects than the regimens containing streptozocin. It therefore merits study as a constituent of combination drug regimens.

Chronic Progressive Cardiac Dysfunction Years After Doxorubicin Therapy for Childhood Acute Lymphoblastic Leukemia

Objectives To assess the relationship between changes in clinician attitude and changes in postoperative outcomes following a checklist-based surgical safety intervention. Design Pre- and post intervention survey. Setting Eight hospitals participating in a trial of a WHO surgical safety checklist. Participants Clinicians actively working in the designated study operating rooms at the eight hospitals. Survey instrument Modified operating-room version Safety Attitudes Questionnaire (SAQ). Main outcome measures Change in mean safety attitude score and correlation between change in safety attitude score and change in postoperative outcomes, plus clinician opinion of checklist efficacy and usability. Results Clinicians in the preintervention phase (n=281) had a mean SAQ score of 3.91 (on a scale of 1 to 5, with 5 representing better safety attitude), while the postintervention group (n=257) had a mean of 4.01 (p=0.0127). The degree of improvement in mean SAQ score at each site correlated with a reduction in postoperative complication rate (r=0.7143, p=0.0381). The checklist was considered easy to use by 80.2% of respondents, while 19.8% felt that it took a long time to complete, and 78.6% felt that the programme prevented errors. Overall, 93.4% would want the checklist used if they were undergoing operation. Conclusions Improvements in postoperative outcomes were associated with improved perception of teamwork and safety climate among respondents, suggesting that changes in these may be partially responsible for the effect of the checklist. Clinicians held the checklist in high regard and the overwhelming majority would want it used if they were undergoing surgery themselves.

Multiple Imputation in Practice: Comparison of Software Packages for Regression Models With Missing Variables

Objective:To assess whether implementation of a 19-item World Health Organization (WHO) Surgical Safety Checklist in urgent surgical cases would improve compliance with basic standards of care and reduce rates of deaths and complications. Background:Use of the WHO Surgical Safety Checklist has been shown to be associated with significant reductions in complications and deaths. Before evaluation of this safety tool, concern was raised about whether its use would be practical or beneficial during urgent surgical procedures. Methods:We prospectively collected clinical process and outcome data for 1750 consecutively enrolled patients 16 years of age or older undergoing urgent noncardiac surgery before and after introduction of the WHO Surgical Safety Checklist in 8 diverse hospitals around the world; 842 underwent urgent surgery—defined as an operation required within 24 hours of assessment to be beneficial—before introduction of the checklist and 908 after introduction of the checklist. The primary end point was the rate of complications, including death, during hospitalization up to 30 days following surgery. Results:The complication rate was 18.4% (n = 151) at baseline and 11.7% (n = 102) after the checklist was introduced (P = 0.0001). Death rates dropped from 3.7% to 1.4% following checklist introduction (P = 0.0067). Adherence to 6 measured safety steps improved from 18.6% to 50.7% (P < 0.0001). Conclusions:Implementation of the checklist was associated with a greater than one-third reduction in complications among adult patients undergoing urgent noncardiac surgery in a diverse group of hospitals. Use of the WHO Surgical Safety Checklist in urgent operations is feasible and should be considered.