Phase 1 study of PSMA ADC, an antibody-drug conjugate targeting prostate-specific membrane antigen, in chemotherapy-refractory prostate cancer.

BACKGROUND: Prostate-specific membrane antigen (PSMA) is a well-characterized target that is overexpressed selectively on prostate cancer cells. PSMA antibody-drug conjugate (ADC) is a fully human IgG1 monoclonal antibody conjugated to the microtubule disrupting agent monomethyl auristatin E (MMAE), which is designed to specifically bind PSMA-positive cells, internalize, and then release its cytotoxic payload into the cells. PSMA ADC has demonstrated potent and selective antitumor activity in preclinical models of advanced prostate cancer. A Phase 1 study was conducted to assess the safety, pharmacokinetics, and preliminary antitumor effects of PSMA ADC in subjects with treatment-refractory prostate cancer. METHODS: In this first-in-man dose-escalation study, PSMA ADC was administered by intravenous infusion every three weeks to subjects with progressive metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with docetaxel chemotherapy. The primary endpoint was to establish a maximum tolerated dose (MTD). The study also examined the pharmacokinetics of the study drug, total antibody, and free MMAE. Antitumor effects were assessed by measuring changes in serum prostate-specific antigen (PSA), circulating tumor cells (CTCs), and radiologic imaging. RESULTS: Fifty-two subjects were administered doses ranging from 0.4 to 2.8 mg/kg. Subjects had a median of two prior chemotherapy regimens and prior treatment with abiraterone and/or enzalutamide. Neutropenia and peripheral neuropathy were identified as important first-cycle and late dose-limiting toxicities, respectively. The dose of 2.5 mg/kg was determined to be the MTD. Pharmacokinetics were approximately dose-proportional with minimal drug accumulation. Reductions in PSA and CTCs in subjects treated with doses of ≥1.8 mg/kg were durable and often concurrent. CONCLUSIONS: In an extensively pretreated mCRPC population, PSMA ADC demonstrated acceptable toxicity. Antitumor activity was observed over dose ranges up to and including 2.5 mg/kg. The observed anti-tumor activity supported further evaluation of this novel agent for the treatment of advanced metastatic prostate cancer.

Multisource Evaluation of Surgeon Behavior Is Associated With Malpractice Claims.

OBJECTIVE: We merged direct, multisource, and systematic assessments of surgeon behavior with malpractice claims, to analyze the relationship between surgeon 360-degree reviews and malpractice history. BACKGROUND: Previous work suggests that malpractice claims are associated with a poor physician-patient relationship, which is likely related to behaviors captured by 360-degree review. We hypothesize that 360-degree review results are associated with malpractice claims. METHODS: Surgeons from 4 academic medical centers covered by a common malpractice carrier underwent 360-degree review in 2012 to 2013 (n = 385). Matched, de-identified reviews and malpractice claims data were available for 264 surgeons from 2000 to 2015. We analyzed 23 questions, highlighting positive and negative behaviors within the domains of education, excellence, humility, openness, respect, service, and teamwork. Regression analysis with robust standard error was used to assess the potential association between 360-degree review results and malpractice claims. RESULTS: The range of claims among the 264 surgeons was 0 to 8, with 48.1% of surgeons having at least 1 claim. Multiple positive and negative behaviors were significantly associated with the risk of having malpractice claims (P < 0.05). Surgeons in the bottom decile for several items had an increased likelihood of having at least 1 claim. CONCLUSION: Surgeon behavior, as assessed by 360-degree review, is associated with malpractice claims. These findings highlight the importance of teamwork and communication in exposure to malpractice. Although the nature of malpractice claims is complex and multifactorial, the identification and modification of negative physician behaviors may mitigate malpractice risk and ultimately result in the improved quality of patient care.

An evidence-based intraoperative communication tool for emergency general surgery: a pilot study.

BACKGROUND: Emergency general surgery (EGS) is characterized by high rates of morbidity and mortality. Though checklists and associated communication-based huddle strategies have improved outcomes, these tools have never been specifically examined in EGS. We hypothesized that use of an evidence-based communication tool aimed to trigger intraoperative discussion could improve communication in the EGS operating room (OR). MATERIALS AND METHODS: We designed a set of discussion prompts based on modifiable factors identified from previously published studies aimed to encourage all team members to speak up and to centralize awareness of patient disposition and intraoperative transfusion practices. This tool was pilot-tested using OR human patient simulators and was then rolled out to EGS ORs at an academic medical center. The perceived effect of our tool's implementation was evaluated through mixed-methodologic presurvey and postsurvey analysis. RESULTS: Preimplementation and postimplementation survey-based data revealed that providers reported the EGS-focused discussion prompts as improving team communication in EGS. A trend toward shared awareness of intraoperative events was observed; however, nurses described cultural impedance of discussion initiation. Providers described a need for further reinforcement of the tool and its indications during implementation. CONCLUSIONS: Use of a discussion-based communication tool is perceived as supporting team communication in the EGS OR and led to a trend toward improving a shared understanding of intraoperative events. Analyses suggest the need for enhanced reinforcement of use during implementation and improvement of team-based education regarding EGS. Furthermore work is needed to understand the full impact of this evidence-based tool on OR team dynamics and EGS patient outcomes.

Mortality Trends After a Voluntary Checklist-based Surgical Safety Collaborative.

OBJECTIVE: To determine whether completion of a voluntary, checklist-based surgical quality improvement program is associated with reduced 30-day postoperative mortality. BACKGROUND: Despite evidence of efficacy of team-based surgical safety checklists in improving perioperative outcomes in research trials, effective methods of population-based implementation have been lacking. The Safe Surgery 2015 South Carolina program was designed to foster state-wide engagement of hospitals in a voluntary, collaborative implementation of a checklist program. METHODS: We compared postoperative mortality rates after inpatient surgery in South Carolina utilizing state-wide all-payer discharge claims from 2008 to 2013, linked with state vital statistics, stratifying hospitals on the basis of completion of the checklist program. Changes in risk-adjusted 30-day mortality were compared between hospitals, using propensity score-adjusted difference-in-differences analysis. RESULTS: Fourteen hospitals completed the program by December 2013. Before program launch, there was no difference in mortality trends between the completion cohort and all others (P = 0.33), but postoperative mortality diverged thereafter (P = 0.021). Risk-adjusted 30-day mortality among completers was 3.38% in 2010 and 2.84% in 2013 (P < 0.00001), whereas mortality among other hospitals (n = 44) was 3.50% in 2010 and 3.71% in 2013 (P = 0.3281), reflecting a 22% difference between the groups on difference-in-differences analysis (P = 0.0021). CONCLUSIONS: Despite similar pre-existing rates and trends of postoperative mortality, hospitals in South Carolina completing a voluntary checklist-based surgical quality improvement program had a reduction in deaths after inpatient surgery over the first 3 years of the collaborative compared with other hospitals in the state. This may indicate that effective large-scale implementation of a team-based surgical safety checklist is feasible.

Perception of Safety of Surgical Practice Among Operating Room Personnel From Survey Data Is Associated With All-cause 30-day Postoperative Death Rate in South Carolina.

OBJECTIVE: To evaluate whether the perception of safety of surgical practice among operating room (OR) personnel is associated with hospital-level 30-day postoperative death. BACKGROUND: The relationship between improvements in the safety of surgical practice and benefits to postoperative outcomes has not been demonstrated empirically. METHODS: As part of the Safe Surgery 2015: South Carolina initiative, a baseline survey measuring the perception of safety of surgical practice among OR personnel was completed. We evaluated the relationship between hospital-level mean item survey scores and rates of all-cause 30-day postoperative death using binomial regression. Models were controlled for multiple patient, hospital, and procedure covariates using supervised principal components regression. RESULTS: The overall survey response rate was 38.1% (1793/4707) among 31 hospitals. For every 1 point increase in the hospital-level mean score for respect [adjusted relative risk (aRR) 0.78, 95% CI 0.65-0.93, P = 0.0059], clinical leadership (aRR 0.86, 95% CI 0.74-0.9932, P = 0.0401), and assertiveness (aRR 0.71, 95% CI 0.54-0.93, P = 0.01) among all survey respondents, there were associated decreases in the hospital-level 30-day postoperative death rate after inpatient surgery ranging from 14% to 29%. Higher hospital-level mean scores for the statement, "I would feel safe being treated here as a patient," were associated with significantly lower hospital-level 30-day postoperative death rates (aRR 0.83, 95% CI 0.70-0.97, P = 0.02). Although most findings seen among all OR personnel were seen among nurses, they were often absent among surgeons. CONCLUSIONS: Perception of OR safety of surgical practice was associated with hospital-level 30-day postoperative death rates.

Implementation of the World Health Organization Trauma Care Checklist Program in 11 Centers Across Multiple Economic Strata: Effect on Care Process Measures.

BACKGROUND: Trauma contributes more than ten percent of the global burden of disease. Initial assessment and resuscitation of trauma patients often requires rapid diagnosis and management of multiple concurrent complex conditions, and errors are common. We investigated whether implementing a trauma care checklist would improve care for injured patients in low-, middle-, and high-income countries. METHODS: From 2010 to 2012, the impact of the World Health Organization (WHO) Trauma Care Checklist program was assessed in 11 hospitals using a stepped wedge pre- and post-intervention comparison with randomly assigned intervention start dates. Study sites represented nine countries with diverse economic and geographic contexts. Primary end points were adherence to process of care measures; secondary data on morbidity and mortality were also collected. Multilevel logistic regression models examined differences in measures pre- versus post-intervention, accounting for patient age, gender, injury severity, and center-specific variability. RESULTS: Data were collected on 1641 patients before and 1781 after program implementation. Patient age (mean 34 ± 18 vs. 34 ± 18), sex (21 vs. 22 % female), and the proportion of patients with injury severity scores (ISS) ≥ 25 (10 vs. 10 %) were similar before and after checklist implementation (p > 0.05). Improvement was found for 18 of 19 process measures, including greater odds of having abdominal examination (OR 3.26), chest auscultation (OR 2.68), and distal pulse examination (OR 2.33) (all p < 0.05). These changes were robust to several sensitivity analyses. CONCLUSIONS: Implementation of the WHO Trauma Care Checklist was associated with substantial improvements in patient care process measures among a cohort of patients in diverse settings.

Narrative feedback from OR personnel about the safety of their surgical practice before and after a surgical safety checklist intervention.

OBJECTIVE: To examine narrative feedback to understand surgical team perceptions about surgical safety checklists (SSCs) and their impact on the safety of surgical practice. DESIGN: We reviewed free-text comments from surveys administered before and after SSC implementation between 2011 and 2013. We categorized feedback thematically and as positive, negative or neutral. SETTING: South Carolina hospitals participating in a statewide collaborative on checklist implementation. PARTICIPANTS: Surgical teams from 11 hospitals offering free-text comments in both pre-and post-implementation surveys. INTERVENTION: Implementation of the World Health Organization SSC. MAIN OUTCOME MEASURE: Differences in comments made before and after implementation and by provider role; types of complications averted through checklist use. RESULTS: Before SSC implementation, the proportion of positive comments among provider roles differed significantly (P = 0.04), with more clinicians offering negative comments (87.9%, (29/33)) compared to other surgical team members (58.3% (7/12) to 60.9% (14/23)), after SSC implementation, these proportions did not significantly differ (clinicians 77.8% (14/18)), other surgical team members (50% (2/4) to 76.9% (20/26)) (P = 0.52). Distribution of negative comments differed significantly before and after implementation (P = 0.01); for example, there were more negative comments made about checklist buy-in after implementation (51.3 % (20/39)) compared to before implementation (24.5% (13/53)). Surgical team members most frequently reported that checklist use averted complications involving antibiotic administration, equipment and side/site of surgery. CONCLUSIONS: Narrative feedback suggested that SSC implementation can facilitate patient safety by averting complications; however, buy-in is a persistent challenge. Presenting information on the impact of the SSC on lives saved, teamwork and complications averted, adapting the SSC to fit the local context, demonstrating leadership support and engaging champions to promote checklist use and address concerns could improve checklist adoption and efficacy.

Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes.

BACKGROUND: It was previously estimated that 234·2 million operations were performed worldwide in 2004. The association between surgical rates and population health outcomes is not clear. We re-estimated global surgical volume to track changes over time and assess rates associated with healthy populations. METHODS: We gathered demographic, health, and economic data for 194 WHO member states. Surgical volumes were obtained from published studies and other reports from 2005 onwards. We estimated rates of surgery for all countries without available data based on health expenditure in 2012 and assessed the proportion of surgery comprised by caesarean delivery. The rate of surgery was plotted against life expectancy to describe the association between surgical care and this health indicator. FINDINGS: We identified 66 countries reporting surgical data between 2005 and 2013. We estimate that 312·9 million operations (95% CI 266·2-359·5) took place in 2012-a 33·6% increase over 8 years; the largest proportional increase occurred in countries spending US$400 or less per capita on health care. Caesarean delivery comprised 29·8% (5·8 million operations) of the total surgical volume in poor health expenditure countries compared with 10·8% (7·8 million operations) in low health expenditure countries and 2·7% (5·1 million operations) in high health expenditure countries. We noted a correlation between increased life expectancy and increased surgical rates up to 1533 operations per 100 000 people, with significant but less dramatic improvement above this rate. INTERPRETATION: Surgical volume is large and continues to grow in all economic environments. A single procedure-caesarean delivery-comprised almost a third of surgical volume in the most resource-limited settings. Surgical care is an essential part of health care and is associated with increased life expectancy, yet many low-income countries fail to achieve basic levels of service. Improvements in capacity and delivery of surgical services must be a major component of health system strengthening. FUNDING: None.

Avoidable maternal and neonatal deaths associated with improving access to caesarean delivery in countries with low caesarean delivery rates: an ecological modelling analysis.

BACKGROUND: Reducing maternal and neonatal deaths are important global health priorities. We have previously shown that up to a country-level caesarean delivery rate (CDRs) of roughly 19·0%, cesarean delivery rates and maternal mortality ratio (MMR) and neonatal mortality rate (NMR) were inversely correlated. We investigated the absolute reductions in maternal and neonatal deaths if countries with low CDR increased their rates to a range of greater than 7·2% but less than or equal to 19·1%. METHODS: We calculated maternal and neonatal deaths in 2013 and 2012, respectively, for countries with CDR 7·2% or less (N=45) with available data from the World Bank Development Indicators. We modelled the expected reduction in deaths in these countries if they had the 25th and 75th MMR and NMR percentiles observed for countries (N=48) with CDRs ranging from greater than 7·2% but less than or equal to 19·1%. This model assumes that if countries with low CDRs increased their rates of caesarean delivery to greater than 7·2% but less than or equal to 19·1%, they would achieve levels of MMR and NMR observed in countries with those CDRs. FINDINGS: We estimate 176 078 (95% CI 163 258-188 898) maternal and 1 117 257 (95% CI 1 033 611-1 200 902) neonatal deaths occurred in 45 countries with low CDRs in 2013 and 2012, respectively. If these countries had the 25th and 75th MMR and NMR percentiles (MMR, IQR 36-190; NMR, 9-24) observed in countries (N=48) with a CDR ranging from greater than 7·2% but less than or equal to 19·1%, there would be a potential reduction of 109 762-163 513 and 279 584-803 129 maternal and neonatal deaths, respectively. INTERPRETATION: Increasing caesarean delivery in countries with low CDRs could avert as many as 163 513 maternal deaths and 803 129 neonatal deaths annually. These findings assume that as health systems develop the capacity to deliver surgical care, there is a concurrent improvement in the quality of care and in the ability to rescue women and neonates who would otherwise die. Improving access to safe caesarean delivery should be a central focus in surgical care globally. FUNDING: None.

Simulation-based trial of surgical-crisis checklists.

BACKGROUND: Operating-room crises (e.g., cardiac arrest and massive hemorrhage) are common events in large hospitals but can be rare for individual clinicians. Successful management is difficult and complex. We sought to evaluate a tool to improve adherence to evidence-based best practices during such events. METHODS: Operating-room teams from three institutions (one academic medical center and two community hospitals) participated in a series of surgical-crisis scenarios in a simulated operating room. Each team was randomly assigned to manage half the scenarios with a set of crisis checklists and the remaining scenarios from memory alone. The primary outcome measure was failure to adhere to critical processes of care. Participants were also surveyed regarding their perceptions of the usefulness and clinical relevance of the checklists. RESULTS: A total of 17 operating-room teams participated in 106 simulated surgical-crisis scenarios. Failure to adhere to lifesaving processes of care was less common during simulations when checklists were available (6% of steps missed when checklists were available vs. 23% when they were unavailable, P<0.001). The results were similar in a multivariate model that accounted for clustering within teams, with adjustment for institution, scenario, and learning and fatigue effects (adjusted relative risk, 0.28; 95% confidence interval, 0.18 to 0.42; P<0.001). Every team performed better when the crisis checklists were available than when they were not. A total of 97% of the participants reported that if one of these crises occurred while they were undergoing an operation, they would want the checklist used. CONCLUSIONS: In a high-fidelity simulation study, checklist use was associated with significant improvement in the management of operating-room crises. These findings suggest that checklists for use during operating-room crises have the potential to improve surgical care. (Funded by the Agency for Healthcare Research and Quality.).

Size and distribution of the global volume of surgery in 2012.

OBJECTIVE: To estimate global surgical volume in 2012 and compare it with estimates from 2004. METHODS: For the 194 Member States of the World Health Organization, we searched PubMed for studies and contacted key informants for reports on surgical volumes between 2005 and 2012. We obtained data on population and total health expenditure per capita for 2012 and categorized Member States as very-low, low, middle and high expenditure. Data on caesarean delivery were obtained from validated statistical reports. For Member States without recorded surgical data, we estimated volumes by multiple imputation using data on total health expenditure. We estimated caesarean deliveries as a proportion of all surgery. FINDINGS: We identified 66 Member States reporting surgical data. We estimated that 312.9 million operations (95% confidence interval, CI: 266.2-359.5) took place in 2012, an increase from the 2004 estimate of 226.4 million operations. Only 6.3% (95% CI: 1.7-22.9) and 23.1% (95% CI: 14.8-36.7) of operations took place in very-low- and low-expenditure Member States representing 36.8% (2573 million people) and 34.2% (2393 million people) of the global population of 7001 million people, respectively. Caesarean deliveries comprised 29.6% (5.8/19.6 million operations; 95% CI: 9.7-91.7) of the total surgical volume in very-low-expenditure Member States, but only 2.7% (5.1/187.0 million operations; 95% CI: 2.2-3.4) in high-expenditure Member States. CONCLUSION: Surgical volume is large and growing, with caesarean delivery comprising nearly a third of operations in most resource-poor settings. Nonetheless, there remains disparity in the provision of surgical services globally.

Postoperative acute care use after freestanding ambulatory surgery.

BACKGROUND: Surgical procedures in the United States are increasingly performed in the ambulatory setting, including freestanding ambulatory surgery centers (ASCs). However, there is a lack of research and tracking of surgical outcomes in this setting. MATERIALS AND METHODS: We analyzed data from a state all-payer claims database to produce a retrospective cohort study on the rate of acute care use (emergency department [ED] visits and inpatient admissions) within 7 d after operations performed in freestanding ASCs in South Carolina. Two-level reliability-adjusted generalized linear mixed models accounting for random facility-level effects were used to adjust for patient-level and facility-level characteristics. RESULTS: A total of 1,328,708 procedures were performed in 86 freestanding ASCs in South Carolina from 2006-2013. The overall rate of postoperative acute care per 1000 procedures within 7 d was 17.3 (95% confidence interval [CI], 15.3-19.5). Patient characteristics associated with the highest postoperative acute care use within 7 d included Medicaid insurance (adjusted odds ratio [aOR], 1.79; 95% CI, 1.70-1.90), lowest median household income (aOR, 1.36; 95% CI, 1.30-1.43), and preoperative Charlson Comorbidity Index (CCI) score 3+ (aOR, 4.14; 95% CI, 3.95-4.34). Total charges for postoperative ED visits (n = 14,682) and inpatient admissions (n = 8945) within 7 d were approximately $51.4 and $361.1 million, respectively from 2006-2013. CONCLUSIONS: Acute care use within 7 d was commonly ≥10 per 1000 procedures performed in freestanding ASCs in South Carolina. These measures may be targets for quality and cost improvement and innovation. Patients at risk for acute care utilization may benefit from improvements in postoperative follow-up after procedures in ASCs.

Relationship Between Cesarean Delivery Rate and Maternal and Neonatal Mortality.

IMPORTANCE: Based on older analyses, the World Health Organization (WHO) recommends that cesarean delivery rates should not exceed 10 to 15 per 100 live births to optimize maternal and neonatal outcomes. OBJECTIVES: To estimate the contemporary relationship between national levels of cesarean delivery and maternal and neonatal mortality. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional, ecological study estimating annual cesarean delivery rates from data collected during 2005 to 2012 for all 194 WHO member states. The year of analysis was 2012. Cesarean delivery rates were available for 54 countries for 2012. For the 118 countries for which 2012 data were not available, the 2012 cesarean delivery rate was imputed from other years. For the 22 countries for which no cesarean rate data were available, the rate was imputed from total health expenditure per capita, fertility rate, life expectancy, percent of urban population, and geographic region. EXPOSURES: Cesarean delivery rate. MAIN OUTCOMES AND MEASURES: The relationship between population-level cesarean delivery rate and maternal mortality ratios (maternal death from pregnancy related causes during pregnancy or up to 42 days postpartum per 100,000 live births) or neonatal mortality rates (neonatal mortality before age 28 days per 1000 live births). RESULTS: The estimated number of cesarean deliveries in 2012 was 22.9 million (95% CI, 22.5 million to 23.2 million). At a country-level, cesarean delivery rate estimates up to 19.1 per 100 live births (95% CI, 16.3 to 21.9) and 19.4 per 100 live births (95% CI, 18.6 to 20.3) were inversely correlated with maternal mortality ratio (adjusted slope coefficient, -10.1; 95% CI, -16.8 to -3.4; P = .003) and neonatal mortality rate (adjusted slope coefficient, -0.8; 95% CI, -1.1 to -0.5; P < .001), respectively (adjusted for total health expenditure per capita, population, percent of urban population, fertility rate, and region). Higher cesarean delivery rates were not correlated with maternal or neonatal mortality at a country level. A sensitivity analysis including only 76 countries with the highest-quality cesarean delivery rate information had a similar result: cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio (slope coefficient, -21.3; 95% CI, -32.2 to -10.5, P < .001). Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (slope coefficient, -1.4; 95% CI, -2.3 to -0.4; P = .004). CONCLUSIONS AND RELEVANCE: National cesarean delivery rates of up to approximately 19 per 100 live births were associated with lower maternal or neonatal mortality among WHO member states. Previously recommended national target rates for cesarean deliveries may be too low.

Pilot testing of a model for insurer-driven, large-scale multicenter simulation training for operating room teams.

OBJECTIVE: To test the feasibility of implementing a standardized teamwork training program with full operating room teams in multiple institutions, driven by malpractice insurer support and incentives. BACKGROUND: Failures in intraoperative teamwork are among the leading causes of preventable patient injury and death in surgical patients. Teamwork training, particularly using simulation, can be an effective intervention but is difficult to scale. METHODS: A malpractice insurer convened a collaborative with 4 Harvard-affiliated simulation programs to develop a standardized operating room teamwork training curriculum, including principles of communication, assertiveness, and use of the World Health Organization Surgical Safety Checklist. Participant teams were compensated for lost operative time via malpractice premium discounts, continuing education credits, and compensation for lost wages. The course was delivered through a simulation program involving the management of intraoperative emergency scenarios. Participants were surveyed for their perceptions of the program and of its impact on clinical practice. RESULTS: A total of 221 active operating room staff members participated in the program. Each team contained at least 1 attending surgeon, 1 attending anesthesiologist, and 1 operating room nurse (mean size per team: 7 ± 2 participants). No study dates were cancelled because of lack of attendance. The survey response rate was 99% (218/221). Overall, the vast majority of participants found the scenarios realistic [94% (95% confidence interval: 90.9%, 97.2%)], appropriately challenging [95.4% (92.6%, 98.2%)], relevant to their practice [96.3% (93.8%, 98.8%)], and found the training would help them provide safer patient care [92.6% (89.1%, 96.1%)]. Surgeons reported their greatest personal deficit as communication skills. Operating room nurses and anesthesiologists reported a greater need than surgeons to work on personal assertiveness. CONCLUSIONS: A standardized multicenter team training program involving full operative teams is feasible with high-fidelity simulation and modest compensation for lost time. The vast majority of the multidisciplinary participants believed the course to have had a meaningful impact on their approach to clinical practice.

Beyond volume: does hospital complexity matter?: an analysis of inpatient surgical mortality in the United States.

BACKGROUND: Hospitals show wide variation in outcomes and systems of care. It is unclear whether hospital complexity-the range of services and technologies provided-affects outcomes and in what direction. We sought to determine whether complexity was associated with inpatient surgical mortality. METHODS: Using national Medicare data, we identified all fee-for-service inpatients who underwent 1 of 5 common high-risk surgical procedures in 2008-2009 and measured complexity by the number of unique primary diagnoses admitted to each hospital over the 2-year period. We calculated 30-day postoperative mortality rates, adjusting for patient and hospital characteristics, and used multivariable Poisson regression models to test for an association between hospital complexity and mortality rates. We then used this model to generate predicted mortality rates for low-volume and high-volume hospitals across the spectrum of hospital complexity. RESULTS: A total of 2691 hospitals were analyzed, representing a total of 382,372 admissions. After adjusting for hospital characteristics, including hospital volume, increasing hospital complexity was associated with lower surgical mortality rates. Patients receiving care at the hospitals in the lowest quintile of unique diagnoses had a 27% higher risk of death than those at the highest quintile. The effect of complexity was largest for low-volume hospitals, which were capable of achieving mortality rates similar to high-volume hospitals when in the most complex quintile. CONCLUSIONS: Hospital complexity matters and is associated with lower surgical mortality rates, independent of hospital volume. The effect of complexity on outcomes for nonsurgical services warrants investigation.

Updated 5-year results for short course abiraterone acetate and LHRH agonist for unfavorable intermediate and favorable high-risk prostate cancer.

Combined androgen deprivation therapy (ADT) and radiotherapy (RT) improves outcomes for intermediate and high-risk prostate cancer. Treatment intensification with abiraterone acetate/prednisone (AAP) provides additional benefit for high-risk disease. We previously reported 3-year outcomes of a single-arm prospective multicenter trial (AbiRT trial) of 33 patients with unfavorable intermediate risk (UIR) and favorable high risk (FHR) prostate cancer undergoing short course, combination therapy with ADT, AAP, and RT. Here we report the final analysis demonstrating a high rate of testosterone recovery (97%) and excellent biochemical progression-free survival (97%) at 5 years. These data support comparative prospective studies of shorter, more potent ADT courses in favorable high-risk prostate cancer.

Implementation of the World Health Organization surgical safety checklist, including introduction of pulse oximetry, in a resource-limited setting.

OBJECTIVE: To introduce the World Health Organization Surgical Safety Checklist into every operating room within a severely resource-limited hospital located in a developing country and to measure its impact on surgical hazards and complications. BACKGROUND: The checklist has been shown to reduce surgical morbidity and mortality, but the ability to successfully implement the checklist program hospital-wide in lower income settings without basic resources is unknown. METHODS: We conducted a pre- versus postintervention study of the implementation of the checklist, including the introduction of universal pulse oximetry at a hospital in Chisinau, Moldova, where only 3 oximeters were available for their 22 operating stations. We supplied data-recording oximeters for all operating stations and trained a local checklist implementation team. The primary outcomes were process adherence, major complications, and rates of hypoxemia (SpO2 <90%). Propensity score weighing was conducted to adjust process and outcome measures. Regression models were used to evaluate adherence to process measures and hypoxemia trends over time. RESULTS: Data from 2145 pre- and 2212 postintervention cases were collected. Adherence to all safety processes increased significantly from 0.0% to 66.9% (P < 0.001). After checklist implementation, the overall complication rate decreased from 21.5% to 8.8% (P < 0.001). Infectious and noninfectious complications decreased significantly after checklist implementation from 17.7% to 6.7% (P < 0.001) and from 2.6% to 1.5% (P = 0.018), respectively. The number of hypoxemic episodes lasting 2 minutes or longer per 100 hours of oximetry decreased from 11.5 to 6.4 (P < 0.002). CONCLUSIONS: Successful hospital-wide Surgery Safety Checklist implementation can be achieved in a resource-limited setting and can significantly reduce surgical hazards and complications.

Hospital management practices and availability of surgery in sub-Saharan Africa: a pilot study of three hospitals.

BACKGROUND: Sub-Saharan Africa has a high surgical burden of disease but performs a disproportionately low volume of surgery. Closing this surgical gap will require increased surgical productivity of existing systems. We examined specific hospital management practices in three sub-Saharan African hospitals that are associated with surgical productivity and quality. METHODS: We conducted 54 face-to-face, structured interviews with administrators, clinicians, and technicians at a teaching hospital, district hospital, and religious mission hospital across two countries in sub-Saharan Africa. Questions focused on recommended general management practices within five domains: goal setting, operations management, talent management, quality monitoring, and financial oversight. Records from each interview were analyzed in a qualitative fashion. Each hospital's management practices were scored according to the degree of implementation of the management practices (1 = none; 3 = some; 5 = systematic). RESULTS: The mission hospital had the highest number of employees per 100 beds (226), surgeons per operating room (3), and annual number of operations per operating room (1,800). None of the three hospitals had achieved systematic implementation of management practices in all 14 measures. The mission hospital had the highest total management score (44/70 points; average = 3.1 for each of the 14 measures). The teaching and district hospitals had statistically significantly lower management scores (average 1.3 and 1.1, respectively; p < .001). CONCLUSIONS: It is possible to meaningfully assess hospital management practices in low resource settings. We observed substantial variation in implementation of basic management practices at the three hospitals. Future research should focus on whether enhancing management practices can improve surgical capacity and outcomes.

Review article: perioperative checklist methodologies.

PURPOSE: Checklists are increasingly being used by surgical teams in the perioperative period to improve clinical care and increase patient safety. In this article, we review some of the mechanisms by which checklists work and evaluate evidence supporting their use. PRINCIPAL FINDINGS: There is a growing body of evidence showing the importance of team-based checklists in clinical care. In multiple complex clinical environments, from the operating room to the intensive care unit, checklists can help ensure adherence to known standards of care and improve communication amongst team members. In addition, the efficacy of checklists is being shown in both developed and developing settings. CONCLUSION: Checklists can aid clinicians involved in complex processes and multidisciplinary team interactions to improve the quality and safety of care by prompting dialogue and exchange of information.

Relationship between occurrence of surgical complications and hospital finances.

IMPORTANCE: The effect of surgical complications on hospital finances is unclear. OBJECTIVE: To determine the relationship between major surgical complications and per-encounter hospital costs and revenues by payer type. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of administrative data for all inpatient surgical discharges during 2010 from a nonprofit 12-hospital system in the southern United States. Discharges were categorized by principal procedure and occurrence of 1 or more postsurgical complications, using International Classification of Diseases, Ninth Revision, diagnosis and procedure codes. Nine common surgical procedures and 10 major complications across 4 payer types were analyzed. Hospital costs and revenue at discharge were obtained from hospital accounting systems and classified by payer type. MAIN OUTCOMES AND MEASURES: Hospital costs, revenues, and contribution margin (defined as revenue minus variable expenses) were compared for patients with and without surgical complications according to payer type. RESULTS: Of 34,256 surgical discharges, 1820 patients (5.3%; 95% CI, 4.4%-6.4%) experienced 1 or more postsurgical complications. Compared with absence of complications, complications were associated with a $39,017 (95% CI, $20,069-$50,394; P < .001) higher contribution margin per patient with private insurance ($55,953 vs $16,936) and a $1749 (95% CI, $976-$3287; P < .001) higher contribution margin per patient with Medicare ($3629 vs $1880). For this hospital system in which private insurers covered 40% of patients (13,544), Medicare covered 45% (15,406), Medicaid covered 4% (1336), and self-payment covered 6% (2202), occurrence of complications was associated with an $8084 (95% CI, $4903-$9740; P < .001) higher contribution margin per patient ($15,726 vs $7642) and with a $7435 lower per-patient total margin (95% CI, $5103-$10,507; P < .001) ($1013 vs -$6422). CONCLUSIONS AND RELEVANCE: In this hospital system, the occurrence of postsurgical complications was associated with a higher per-encounter hospital contribution margin for patients covered by Medicare and private insurance but a lower one for patients covered by Medicaid and who self-paid. Depending on payer mix, many hospitals have the potential for adverse near-term financial consequences for decreasing postsurgical complications.