Adapting the World Health Organization's Surgical Safety Checklist to High-Income Settings: A Hybrid Effectiveness-Implementation Trial Protocol.

Objectives: The proposed study aims to assess users' perceptions of a surgical safety checklist (SSC) reimplementation toolkit and its impact on SSC attitudes and operating room (OR) culture, meaningful checklist use, measures of surgical safety, and OR efficiency at 3 different hospital sites. Background: The High-Performance Checklist toolkit (toolkit) assists surgical teams in modifying and implementing or reimplementing the World Health Organization's SSC. Through the explore, prepare, implement, and sustain implementation framework, the toolkit provides a process and set of tools to facilitate surgical teams' modification, implementation, training on, and evaluation of the SSC. Methods: A pre-post intervention design will be used to assess the impact of the modified SSC on surgical processes, team culture, patient experience, and safety. This mixed-methods study includes quantitative and qualitative data derived from surveys, semi-structured interviews, patient focus groups, and SSC performance observations. Additionally, patient outcome and OR efficiency data will be collected from the study sites' health surveillance systems. Data analysis: Statistical data will be analyzed using Statistical Product and Service Solutions, while qualitative data will be analyzed thematically using NVivo. Furthermore, interview data will be analyzed using the Consolidated Framework for Implementation Research and reach, effectiveness, adoption, implementation, maintenance implementation frameworks. Setting: The toolkit will be introduced at 3 diverse surgical sites in Alberta, Canada: an urban hospital, university hospital, and small regional hospital. Anticipated impact: We anticipate the results of this study will optimize SSC usage at the participating surgical sites, help shape and refine the toolkit, and improve its usability and application at future sites.

Remote Assessment of Real-World Surgical Safety Checklist Performance Using the OR Black Box: A Multi-Institutional Evaluation.

BACKGROUND: Large-scale evaluation of surgical safety checklist performance has been limited by the need for direct observation. The operating room (OR) Black Box is a multichannel surgical data capture platform that may allow for the holistic evaluation of checklist performance at scale. STUDY DESIGN: In this retrospective cohort study, data from 7 North American academic medical centers using the OR Black Box were collected between August 2020 and January 2022. All cases captured during this period were analyzed. Measures of checklist compliance, team engagement, and quality of checklist content review were investigated. RESULTS: Data from 7,243 surgical procedures were evaluated. A time-out was performed during most surgical procedures (98.4%, n = 7,127), whereas a debrief was performed during 62.3% (n = 4,510) of procedures. The mean percentage of OR staff who paused and participated during the time-out and debrief was 75.5% (SD 25.1%) and 54.6% (SD 36.4%), respectively. A team introduction (performed 42.6% of the time) was associated with more prompts completed (31.3% vs 18.7%, p < 0.001), a higher engagement score (0.90 vs 0.86, p < 0.001), and a higher percentage of team members who ceased other activities (80.3% vs 72%, p < 0.001) during the time-out. CONCLUSIONS: Remote assessment using OR Black Box data provides useful insight into surgical safety checklist performance. Many items included in the time-out and debrief were not routinely discussed. Completion of a team introduction was associated with improved time-out performance. There is potential to use OR Black Box metrics to improve intraoperative process measures.

ASO Author Reflections: The Evolution of Surgery for Patients with Stage IV Melanoma.

The role of surgery for patients with stage IV melanoma is rapidly evolving. In the past, limited treatment options were available and surgery was offered to carefully selected patients. Currently, in the era of effective immunotherapy, the role of surgery is still being defined. The present study examines outcomes for patients with stage IV melanoma receiving immunotherapy and surgery. Future studies will help to better identify which patients should receive surgery and when it should be performed in the setting of increasingly available therapeutic modalities for patients with stage IV melanoma.

Surgical Utilization and Outcomes for Patients with Stage IV Melanoma in the Modern Immunotherapy Era.

BACKGROUND: The benefit of surgery for patients with stage IV melanoma in the modern era of effective immunotherapy is unclear. This study aimed to evaluate trends and outcomes after surgical resection of stage IV melanoma in the modern immunotherapy era. METHODS: Patients with stage IV melanoma who received surgery, immunotherapy, or both from 2012 to 2017 were identified from the National Cancer Database (NCDB). Demographics, facility-level characteristics, and use of immunotherapy were compared between patients who received surgery and those who did not. Multivariate Poisson regression modeling, Kaplan-Meier survival analysis, and Cox regression analysis were performed. RESULTS: The study identified 9800 patients with stage IV melanoma, and 2160 of these patients (22 %) underwent surgery. The patients who received surgery were more likely to be younger (P < 0.001), to have private insurance (P < 0.001), to have a higher median income (P = 0.008), and to receive treatment at academic/research programs (P < 0.001), whereas they were less likely to receive immunotherapy (33.7 % vs 36.6 %; P = 0.013). The patients who received immunotherapy had a lower likelihood of undergoing surgery (relative risk [RR], 0.82; 95 % confidence interval [CI[, 0.75-0.88; P < 0.001). The patients who received both surgery and immunotherapy had a better overall survival rate (hazard ratio [HR], 0.41; 95 % CI, 0.36-0.46; P < 0.01) than the patients who received neither immunotherapy nor surgery. CONCLUSIONS: The use of immunotherapy was associated with a lower use of surgery for patients with stage IV melanoma. The patients with stage IV disease who received both surgery and immunotherapy had the highest overall survival rates.

Development of an Enhanced Recovery After Surgery Surgical Safety Checklist Through a Modified Delphi Process.

Importance: Enhanced Recovery After Surgery (ERAS) guidelines and the World Health Organization Surgical Safety Checklist (SSC) are 2 well-established tools for optimizing patient outcomes perioperatively. Objective: To integrate the 2 tools to facilitate key perioperative decision-making. Evidence Review: Snowball sampling recruited international ERAS users from multiple clinical specialties. A 3-round modified Delphi consensus model was used to evaluate 27 colorectal or gynecologic oncology ERAS recommendations for appropriateness to include in an ERAS SSC. Items attaining potential consensus (65%-69% agreement) or consensus (≥70% agreement) were used to develop ERAS-specific SSC prompts. These proposed prompts were evaluated in a second round by the panelists with regard to inclusion, modification, or exclusion. A final round of interactive discussion using quantitative consensus and qualitative comments was used to produce an ERAS-specific SSC. The panel of ERAS experts included surgeons, anesthesiologists, and nurses within diverse practice settings from 19 countries. Final analysis was conducted in May 2022. Findings: Round 1 was completed by 105 experts from 18 countries. Eleven ERAS components met criteria for development into an SSC prompt. Round 2 was completed by 88 experts. There was universal consensus (≥70% agreement) to include all 37 proposed prompts within the 3-part ERAS-specific SSC (used prior to induction of anesthesia, skin incision, and leaving the operating theater). A third round of qualitative comment review and expert discussion was used to produce a final ERAS-specific SSC that expands on the current WHO SSC to include discussion of analgesia strategies, nausea prevention, appropriate fasting, fluid management, anesthetic protocols, appropriate skin preparation, deep vein thrombosis prophylaxis, hypothermia prevention, use of foley catheters, and surgical access. The final products of this work included an ERAS-specific SSC ready for implementation and a set of recommendations to integrate ERAS elements into existing SSCs. Conclusions and Relevance: The SSC could be modified to align with ERAS recommendations for patients undergoing major surgery within an ERAS protocol. The stakeholder- and expert-generated ERAS SSC could be adopted directly, or the recommendations for modification could be applied to an existing institutional SSC to facilitate implementation.

Association of Variation in US County-Level Rates of Liver Surgical Resection for Colorectal Liver Metastasis With Poverty Rates in 2010.

Importance: Among patients with colorectal liver metastasis (CRLM) who are eligible for curative-intent liver surgical resection, only half undergo liver metastasectomy. It is currently unclear how rates of liver metastasectomy vary geographically in the US. Geographic differences in county-level socioeconomic characteristics may, in part, explain variability in the receipt of liver metastasectomy for CRLM. Objective: To describe county-level variation in the receipt of liver metastasectomy for CRLM in the US and its association with poverty rates. Design, Setting, and Participants: This ecological, cross-sectional, and county-level analysis was conducted using data from the Surveillance, Epidemiology, and End Results Research Plus database. The study included the county-level proportion of patients who had colorectal adenocarcinoma diagnosed between January 1, 2010, and December 31, 2018, underwent primary surgical resection, and had liver metastasis without extrahepatic metastasis. The county-level proportion of patients with stage I colorectal cancer (CRC) was used as a comparator. Data analysis was performed on March 2, 2022. Exposures: County-level poverty in 2010 obtained from the US Census (proportion of county population below the federal poverty level). Main Outcomes and Measures: The primary outcome was county-level odds of liver metastasectomy for CRLM. The comparator outcome was county-level odds of surgical resection for stage I CRC. Multivariable binomial logistic regression accounting for clustering of outcomes within a county via an overdispersion parameter was used to estimate the county-level odds of receiving a liver metastasectomy for CRLM associated with a 10% increase in poverty rate. Results: In the 194 US counties included in this study, there were 11 348 patients. At the county level, the majority of the population was male (mean [SD], 56.9% [10.2%]), White (71.9% [20.0%]), and aged between 50 and 64 (38.1% [11.0%]) or 65 and 79 (33.6% [11.4%]) years. The adjusted odds of undergoing a liver metastasectomy was lower in counties with higher poverty in 2010 (per 10% increase; odds ratio, 0.82 [95% CI, 0.69-0.96]; P = .02). County-level poverty was not associated with receipt of surgery for stage I CRC. Despite the difference in rates of surgery (mean county-level rates were 0.24 for liver metastasectomy for CRLM and 0.75 for surgery for stage I CRC), the variance at the county-level for these 2 surgical procedures was similar (F370, 193 = 0.81; P = .08). Conclusions and Relevance: The findings of this study suggest that higher poverty was associated with lower receipt of liver metastasectomy among US patients with CRLM. Surgery for a more common and less complex cancer comparator (ie, stage I CRC) was not observed to be associated with county-level poverty rates. However, county-level variation in surgical rates was similar for CRLM and stage I CRC. These findings further suggest that access to surgical care for complex gastrointestinal cancers such as CRLM may be partially influenced by where patients live.

Association of hospital-level factors with utilization of sentinel lymph node biopsy in patients with early-stage vulvar cancer.

OBJECTIVE: To evaluate utilization of sentinel lymph node biopsy (SLNB) for early-stage vulvar cancer at minority-serving hospitals and low-volume facilities. METHODS: Between 2012-2018, individuals with T1b vulvar squamous cell carcinoma were identified using the National Cancer Database. Patient, facility, and disease characteristics were compared between patients undergoing SLNB or inguinofemoral lymph node dissection (IFLD). Multivariable logistic regression, adjusted for patient, facility, and disease characteristics, was used to evaluate factors associated with SLNB. Kaplan-Meier survival analysis using log rank test and Cox regression was performed. RESULTS: Of the 3,532 patients, 2,406 (68.1%) underwent lymph node evaluation, with 1,704 (48.2%) undergoing IFLD and 702 (19.8%) SLNB. In a multivariable analysis, treatment at minority-serving hospitals (OR 0.39, 95% CI 0.19-0.78) and low-volume hospitals (OR 0.44, 95% CI 0.28-0.70) were associated with significantly lower odds of undergoing SLNB compared to receiving care at non-minority-serving and high-volume hospitals, respectively. While SLNB utilization increased over time for the entire cohort and stratified subgroups, use of the procedure did not increase at minority-serving hospitals. After controlling for patient and tumor characteristics, SLNB was not associated with worse OS compared to IFLD in patients with positive (HR 1.02, 95% CI 0.63-1.66) or negative (HR 0.92, 95% CI 0.70-1.21) nodal pathology. CONCLUSIONS: For patients with early-stage vulvar cancer, treatment at minority-serving or low-volume hospitals was associated with significantly decreased odds of undergoing SLNB. Future efforts should be concentrated toward ensuring that all patients have access to advanced surgical techniques regardless of where they receive their care.

Medicaid expansion and surgery for HPB/GI cancers: NCDB difference-in-difference analysis.

BACKGROUND: It is unclear if Medicaid expansion improved access to surgical resection for hepatopancreatobiliary (HPB) and gastrointestinal (GI) cancers. METHODS: This was a quasi-experimental, cohort study using difference-in-difference analysis to evaluate differences in surgical resection for HPB/GI cancers in the post-Medicaid expansion era compared to the pre-Medicaid expansion era among patients residing in states that had Medicaid expansion versus not. RESULTS: During the pre- (2011-2013) and post-Medicaid expansion (2015-2017) eras, there were 49,954 patients between the ages of 40-64 who had liver cancer (n = 19,384; 38.8%), pancreatic cancer (n = 14,351; 28.7%), colorectal liver metastasis (n = 7566; 15.1%), or gastric cancer (n = 8653; 17.3%). 43.2% resided in expansion states (n = 21,577). There were no significant differences in the overall rates of surgical resection between expansion and non-expansion states before and after Medicaid expansion. CONCLUSIONS: Medicaid expansion did not impact surgical resection for HPB/GI cancers.

Guideline-Discordant Care in Early-Stage Vulvar Cancer.

OBJECTIVE: To describe the use of National Comprehensive Cancer Network guideline-concordant inguinofemoral lymph node (LN) evaluation in individuals with early-stage vulvar cancer. METHODS: This retrospective cohort study identified patients with T1b and T2 vulvar squamous cell carcinoma diagnosed between 2012 and 2018 using the National Cancer Database. Factors associated with LN evaluation were examined using logistic regression analyses, adjusting for patient, disease, and facility-level characteristics. Kaplan-Meier survival analysis using log rank test and Cox regression was performed for the entire cohort and a subgroup of older patients , defined as individuals aged 80 years or older. RESULTS: Of the 5,685 patients with vulvar cancer, 3,756 (66.1%) underwent guideline-concordant LN evaluation. In our adjusted model, age 80 years or older (odds ratio [OR], 0.30; 95% CI 0.22-0.42) and Black race (OR 0.72; 95% CI 0.54-0.95) were associated with lower odds of LN evaluation. High-volume hospitals were associated with increased odds of LN evaluation compared with low-volume hospitals (OR 1.62; 95% CI 1.28-2.05). Older individuals who did not undergo LN evaluation had significantly worse overall survival than those with pathologically negative LNs (hazard ratio [HR] 0.45; 95% CI 0.37-0.55) and similar overall survival as those with pathologically positive LNs (HR 1.05; 95% CI 0.77-1.43). CONCLUSION: Guideline-concordant LN evaluation for early-stage vulvar squamous cell carcinoma is low. Lower utilization is associated with older age, Black race, and care at a low-volume hospital.

Advances and Remaining Challenges in the Treatment for Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest malignancies in the United States. Improvements in imaging have permitted the categorization of patients according to radiologic involvement of surrounding vasculature, i.e., upfront resectable, borderline resectable, and locally advanced disease, and this, in turn, has influenced the sequence of chemotherapy, surgery, and radiation therapy. Though surgical resection remains the only curative treatment option, recent studies have shown improved overall survival with neoadjuvant chemotherapy, especially among patients with borderline resectable/locally advanced disease. The role of radiologic imaging after neoadjuvant therapy and the potential benefit of adjuvant therapy for borderline resectable and locally advanced disease remain areas of ongoing investigation. The advances made in the treatment of patients with borderline resectable/locally advanced disease are promising, yet disparities in access to cancer care persist. This review highlights the significant advances that have been made in the treatment of borderline resectable and locally advanced PDAC, while also calling attention to the remaining challenges.

Association of Liver Resection and Visiting More Than One Commission on Cancer Hospital for Colorectal Cancer With Liver Metastasis.

INTRODUCTION: Despite the advances in treatment, there are low rates of liver metastasectomy for colorectal cancer with liver metastasis (CRLM) in the United States. The aim of this study was to investigate the association between likelihood of liver metastasectomy for CRLM and seeking care at >1 versus 1 Commission on Cancer (CoC) hospital. METHODS: We performed a retrospective analysis of the National Cancer Database (2011-2017) for patients with CRLM. Patients were grouped based on seeking care at 1 CoC hospital or >1 CoC hospital. An adjusted multivariable Poisson regression interaction analysis was used to evaluate likelihood of liver metastasectomy for CRLM according to race and whether care was sought at >1 CoC hospital. RESULTS: We identified 25,956 patients with CRLM without extra-hepatic disease. 23,088 (89.0%) patients visited 1 CoC hospital and 2868 (11.1%) visited >1 CoC hospital. Black patients were less likely to seek care at >1 CoC hospital (relative risk [RR] 0.68, confidence intervalCI 0.60-0.76, P < 0.001). Undergoing liver metastasectomy was associated with higher likelihood of seeking care at >1 CoC hospital (RR 1.27, CI 1.26-1.52, P < 0.001). Among patients who sought care at >1 CoC hospital, there was no significant difference between White and Black patients undergoing liver metastasectomy (RR 0.86, 95% CI 0.71-1.04, P = 0.11). CONCLUSIONS: Patients with CRLM who sought care at >1 CoC hospital were more likely to undergo a liver metastasectomy. Among White and Black patients who sought care at >1 CoC hospital, there was no difference in likelihood of undergoing a liver metastasectomy.

Association between race, hospital volume of major liver surgery, and access to metastasectomy for colorectal liver metastasis.

BACKGROUND: Previous studies have demonstrated that non-White patients with colorectal liver metastasis (CRLM) were significantly less likely to undergo liver metastasectomy compared to White patients. The aim of this study is to evaluate differences in access to liver metastasectomy for CRLM according to race and hospital-year volume of liver surgery (HVLS). METHODS: The National Cancer Database (2011-2017) was used to identify patients with CRLM. Hospitals were stratified into quartiles according to HVLS. An adjusted Poisson regression model was used to evaluate the interaction between race and HVLS and access to liver metastasectomy. RESULTS: We identified 27,340 patients with CRLM. Non-White patients were less likely to undergo a liver metastasectomy compared to White patients (RR 0.87, 95% CI 0.82-0.91, p < 0.001). This racial disparity persisted at the highest quartile HVLS hospitals. CONCLUSIONS: Receiving cancer care at hospitals with the highest HVLS did not translate into equal access to liver metastasectomy for non-White patients with CRLM.

Socioeconomic Disparities in Pancreas Cancer Resection and Survival in the Veterans Health Administration.

BACKGROUND: Disparities based on socioeconomic factors such as race, ethnicity, marital status, and insurance status are associated with pancreatic cancer resection, but these disparities are usually not observed for survival after resection. It is unknown if there are disparities when patients undergo their treatment in a non-fee-for-service, equal-access healthcare system such as the Veterans Health Administration (VHA). METHODS: Patients having T1-T3 M0 pancreatic adenocarcinoma diagnosed between 2006 and 2017 were identified from the VHA Corporate Data Warehouse. Socioeconomic, demographic, and tumor variables associated with resection and survival were assessed. RESULTS: In total, 2580 patients with early-stage pancreatic cancer were identified. The resection rate was 36.5%. Surgical resection was independently associated with younger age [odds ratio (OR) 0.94, p < 0.001], White race (OR 1.35, p = 0.028), married status (OR 1.85, p = 0.001), and employment status (retired vs. unemployed, OR 1.41, p = 0.008). There were no independent associations with Hispanic ethnicity, geographic region, or Social Deprivation Index. Resection was associated with significantly improved survival (median 21 vs. 8 months, p = 0.001). Among resected patients, survival was independently associated with younger age (HR 1.019, p = 0.002), geographic region (South vs. Pacific West, HR 0.721, p = 0.005), and employment (employed vs. unemployed, HR 0.752, p = 0.029). Race, Hispanic ethnicity, marital status, and Social Deprivation Index were not independently associated with survival after resection. CONCLUSIONS: Race, marital status, and employment status are independently associated with resection of pancreatic cancer in the VHA, whereas geographic region and employment status are independently associated with survival after resection. Further studies are warranted to determine the basis for these inequities.

Redeployment of Health Care Workers in the COVID-19 Pandemic: A Qualitative Study of Health System Leaders' Strategies.

OBJECTIVES: This study aimed to determine the strategies used and critical considerations among an international sample of hospital leaders when mobilizing human resources in response to the clinical demands associated with the COVID-19 pandemic surge. METHODS: This was a cross-sectional, qualitative research study designed to investigate strategies used by health system leaders from around the world when mobilizing human resources in response to the global COVD-19 pandemic. Prospective interviewees were identified through nonprobability and purposive sampling methods from May to July 2020. The primary outcomes were the critical considerations, as perceived by health system leaders, when redeploying health care workers during the COVID-19 pandemic determined through thematic analysis of transcribed notes. Redeployment was defined as reassigning personnel to a different location or retraining personnel for a different task. RESULTS: Nine hospital leaders from 9 hospitals in 8 health systems located in 5 countries (United States, United Kingdom, New Zealand, Singapore, and South Korea) were interviewed. Six hospitals in 5 health systems experienced a surge of critically ill patients with COVID-19, and the remaining 3 hospitals anticipated, but did not experience, a similar surge. Seven of 8 hospitals redeployed their health care workforce, and 1 had a redeployment plan in place but did not need to use it. Thematic analysis of the interview notes identified 3 themes representing effective practices and lessons learned when preparing and executing workforce redeployment: process, leadership, and communication. Critical considerations within each theme were identified. Because of the various expertise of redeployed personnel, retraining had to be customized and a decentralized flexible strategy was implemented. There were 3 concerns regarding redeployed personnel. These included the fear of becoming infected, the concern over their skills and patient safety, and concerns regarding professional loss (such as loss of education opportunities in their chosen profession). Transparency via multiple different types of communications is important to prevent the development of doubt and rumors. CONCLUSIONS: Redeployment strategies should critically consider the process of redeploying and supporting the health care workforce, decentralized leadership that encourages and supports local implementation of system-wide plans, and communication that is transparent, regular, consistent, and informed by data.

We Asked the Experts: The WHO Surgical Safety Checklist and the COVID-19 Pandemic: Recommendations for Content and Implementation Adaptations.

BACKGROUND: As surgical systems are forced to adapt and respond to new challenges, so should the patient safety tools within those systems. We sought to determine how the WHO SSC might best be adapted during the COVID-19 pandemic. METHODS: 18 Panelists from five continents and multiple clinical specialties participated in a three-round modified Delphi technique to identify potential recommendations, assess agreement with proposed recommendations and address items not meeting consensus. RESULTS: From an initial 29 recommendations identified in the first round, 12 were identified for inclusion in the second round. After discussion of recommendations without consensus for inclusion or exclusion, four additional recommendations were added for an eventual 16 recommendations. Nine of these recommendations were related to checklist content, while seven recommendations were related to implementation. CONCLUSIONS: This multinational panel has identified 16 recommendations for sites looking to use the surgical safety checklist during the COVID-19 pandemic. These recommendations provide an example of how the SSC can adapt to meet urgent and emerging needs of surgical systems by targeting important processes and encouraging critical discussions.