Enhancing the American College of Surgeons NSQIP Surgical Risk Calculator to Predict Geriatric Outcomes.

BACKGROUND: The American College of Surgeons (ACS) NSQIP Surgical Risk Calculator (SRC) plays an important role in risk prediction and decision-making. We sought to enhance the existing ACS NSQIP SRC with functionality to predict geriatric-specific outcomes and assess the predictive value of geriatric-specific risk factors by comparing performance in outcomes prediction using the traditional ACS NSQIP SRC with models that also included geriatric risk factors. STUDY DESIGN: Data were collected from 21 ACS NSQIP Geriatric Surgery Pilot Project hospitals between 2014 and 2017. Hierarchical regression models predicted 4 postoperative geriatric outcomes (ie pressure ulcer, delirium, new mobility aid use, and functional decline) using the traditional 21-variable ACS NSQIP SRC models and 27-variable models that included 6 geriatric risk factors (ie living situation, fall history, mobility aid use, cognitive impairment, surrogate-signed consent, and palliative care on admission). RESULTS: Data from 38,048 patients 65 years or older undergoing 197 unique operations across 10 surgical subspecialties were used. Stable model discrimination and calibration between developmental and validation datasets confirmed predictive validity. Models with and without geriatric risk factors demonstrated excellent performance (C statistic >0.8) with inclusion of geriatric risk factors improving performance. Of the 21 ACS NSQIP variables, CPT code, COPD, age, functional dependence, sex, disseminated cancer, diabetes, and sepsis were the strongest risk predictors, and impaired cognition, fall history, and mobility aid use were the strongest geriatric predictors. CONCLUSIONS: The ACS NSQIP SRC can predict 4 unique outcomes germane to geriatric surgical patients, with improvement of predictive capability after accounting for geriatric risk factors. Augmentation of ACS NSQIP SRC can enhance shared decision-making to improve the quality of surgical care in older adults.

Postoperative Delirium as a Target for Surgical Quality Improvement.

OBJECTIVE: To explore hospital-level variation in postoperative delirium using a multi-institutional data source. BACKGROUND: Postoperative delirium is closely related to serious morbidity, disability, and death in older adults. Yet, surgeons and hospitals rarely measure delirium rates, which limits quality improvement efforts. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Geriatric Surgery Pilot (2014 to 2015) collects geriatric-specific variables, including postoperative delirium using a standardized definition. Hierarchical logistic regression models, adjusted for case mix [Current Procedural Terminology (CPT) code] and patient risk factors, yielded risk-adjusted and smoothed odds ratios (ORs) for hospital performance. Model performance was assessed with Hosmer-Lemeshow (HL) statistic and c-statistics, and compared across surgical specialties. RESULTS: Twenty thousand two hundred twelve older adults (≥65 years) underwent inpatient operations at 30 hospitals. Postoperative delirium occurred in 2427 patients (12.0%) with variation across specialties, from 4.7% in gynecology to 13.7% in cardiothoracic surgery. Hierarchical modeling with 20 risk factors (HL = 9.423, P = 0.31; c-statistic 0.86) identified 13 hospitals as statistical outliers (5 good, 8 poor performers). Per hospital, the median risk-adjusted delirium rate was 10.4% (range 3.2% to 27.5%). Operation-specific risk and preoperative cognitive impairment (OR 2.9, 95% confidence interval 2.5-3.5) were the strongest predictors. The model performed well across surgical specialties (orthopedic, general surgery, and vascular surgery). CONCLUSION: Rates of postoperative delirium varied 8.5-fold across hospitals, and can feasibly be measured in surgical quality datasets. The model performed well with 10 to 12 variables and demonstrated applicability across surgical specialties. Such efforts are critical to better tailor quality improvement to older surgical patients.

Optimizing Surgical Quality Datasets to Care for Older Adults: Lessons from the American College of Surgeons NSQIP Geriatric Surgery Pilot.

BACKGROUND: Surgical quality datasets can be better tailored toward older adults. The American College of Surgeons (ACS) NSQIP Geriatric Surgery Pilot collected risk factors and outcomes in 4 geriatric-specific domains: cognition, decision-making, function, and mobility. This study evaluated the contributions of geriatric-specific factors to risk adjustment in modeling 30-day outcomes and geriatric-specific outcomes (postoperative delirium, new mobility aid use, functional decline, and pressure ulcers). STUDY DESIGN: Using ACS NSQIP Geriatric Surgery Pilot data (January 2014 to December 2016), 7 geriatric-specific risk factors were evaluated for selection in 14 logistic models (morbidities/mortality) in general-vascular and orthopaedic surgery subgroups. Hierarchical models evaluated 4 geriatric-specific outcomes, adjusting for hospitals-level effects and including Bayesian-type shrinkage, to estimate hospital performance. RESULTS: There were 36,399 older adults who underwent operations at 31 hospitals in the ACS NSQIP Geriatric Surgery Pilot. Geriatric-specific risk factors were selected in 10 of 14 models in both general-vascular and orthopaedic surgery subgroups. After risk adjustment, surrogate consent (odds ratio [OR] 1.5; 95% CI 1.3 to 1.8) and use of a mobility aid (OR 1.3; 95% CI 1.1 to 1.4) increased the risk for serious morbidity or mortality in the general-vascular cohort. Geriatric-specific factors were selected in all 4 geriatric-specific outcomes models. Rates of geriatric-specific outcomes were: postoperative delirium in 12.1% (n = 3,650), functional decline in 42.9% (n = 13,000), new mobility aid in 29.7% (n = 9,257), and new or worsened pressure ulcers in 1.7% (n = 527). CONCLUSIONS: Geriatric-specific risk factors are important for patient-centered care and contribute to risk adjustment in modeling traditional and geriatric-specific outcomes. To provide optimal patient care for older adults, surgical datasets should collect measures that address cognition, decision-making, mobility, and function.

Evaluation of the ProPublica Surgeon Scorecard "Adjusted Complication Rate" Measure Specifications.

OBJECTIVES: The ProPublica Surgeon Scorecard is the first nationwide, multispecialty public reporting of individual surgeon outcomes. However, ProPublica's use of a previously undescribed outcome measure (composite of in-hospital mortality or 30-day related readmission) and inclusion of only inpatients have been questioned. Our objectives were to (1) determine the proportion of cases excluded by ProPublica's specifications, (2) assess the proportion of inpatient complications excluded from ProPublica's measure, and (3) examine the validity of ProPublica's outcome measure by comparing performance on the measure to well-established postoperative outcome measures. METHODS: Using ACS-NSQIP data (2012-2014) for 8 ProPublica procedures and for All Operations, the proportion of cases meeting all ProPublica inclusion criteria was determined. We assessed the proportion of complications occurring inpatient, and thus not considered by ProPublica's measure. Finally, we compared risk-adjusted performance based on ProPublica's measure specifications to established ACS-NSQIP outcome measure performance (eg, death/serious morbidity, mortality). RESULTS: ProPublica's inclusion criteria resulted in elimination of 82% of all operations from assessment (range: 42% for total knee arthroplasty to 96% for laparoscopic cholecystectomy). For all ProPublica operations combined, 84% of complications occur during inpatient hospitalization (range: 61% for TURP to 88% for total hip arthroplasty), and are thus missed by the ProPublica measure. Hospital-level performance on the ProPublica measure correlated weakly with established complication measures, but correlated strongly with readmission (R = 0.834, P < 0.001). CONCLUSIONS: ProPublica's outcome measure specifications exclude 82% of cases, miss 84% of postoperative complications, and correlate poorly with well-established postoperative outcomes. Thus, the validity of the ProPublica Surgeon Scorecard is questionable.

Comparison of National Operative Mortality in Gastroenterological Surgery Using Web-based Prospective Data Entry Systems.

International collaboration is important in healthcare quality evaluation; however, few international comparisons of general surgery outcomes have been accomplished. Furthermore, predictive model application for risk stratification has not been internationally evaluated. The National Clinical Database (NCD) in Japan was developed in collaboration with the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), with a goal of creating a standardized surgery database for quality improvement. The study aimed to compare the consistency and impact of risk factors of 3 major gastroenterological surgical procedures in Japan and the United States (US) using web-based prospective data entry systems: right hemicolectomy (RH), low anterior resection (LAR), and pancreaticoduodenectomy (PD).Data from NCD and ACS-NSQIP, collected over 2 years, were examined. Logistic regression models were used for predicting 30-day mortality for both countries. Models were exchanged and evaluated to determine whether the models built for one population were accurate for the other population.We obtained data for 113,980 patients; 50,501 (Japan: 34,638; US: 15,863), 42,770 (Japan: 35,445; US: 7325), and 20,709 (Japan: 15,527; US: 5182) underwent RH, LAR, and, PD, respectively. Thirty-day mortality rates for RH were 0.76% (Japan) and 1.88% (US); rates for LAR were 0.43% versus 1.08%; and rates for PD were 1.35% versus 2.57%. Patient background, comorbidities, and practice style were different between Japan and the US. In the models, the odds ratio for each variable was similar between NCD and ACS-NSQIP. Local risk models could predict mortality using local data, but could not accurately predict mortality using data from other countries.We demonstrated the feasibility and efficacy of the international collaborative research between Japan and the US, but found that local risk models remain essential for quality improvement.

Profiling Individual Surgeon Performance Using Information from a High-Quality Clinical Registry: Opportunities and Limitations.

BACKGROUND: There is increasing interest in profiling the quality of individual medical providers. Valid assessment of individuals should highlight improvement opportunities, but must be considered in the context of limitations. STUDY DESIGN: High quality clinical data from the American College of Surgeons NSQIP, gathered in accordance with strict policies and specifications, was used to construct individual surgeon-level assessments. There were 39,976 cases evaluated, performed by 197 surgeons across 9 hospitals. Both 2-level (cases by surgeon) and 3-level (cases by surgeon by hospital) risk-adjusted, hierarchical regression analyses were performed. Outcomes were 30-day postoperative morbidity, surgical site infection, and mortality. Surgeon performance was compared in both absolute and relative terms. "Signal-to-noise" reliability was calculated for surgeons and models. Projected case requirements for reliability levels were generated. RESULTS: Surgeon performances could be distinguished to different degrees: morbidity distinguished best, mortality least. Outliers could be identified for morbidity and infection, but not mortality. Reliability was also highest for morbidity and lowest for mortality. Even models with high overall reliability did not assess all providers reliably. Incorporating institutional effects had predictable effects: penalizing providers at "good" institutions, benefiting providers at "poor" institutions. CONCLUSIONS: Individual surgeon profiles can, at times, be distinguished with moderate or good reliability, but to different degrees in different models. Absolute and relative comparisons are feasible. Incorporating institutional level effects in individual provider modeling presents an interesting policy dilemma, appearing to benefit providers at "poor-performing" institutions, but penalizing those at "high-performing" ones. No portrayal of individual medical provider quality should be accepted without consideration of modeling rationale and, critically, reliability.

Inhibition of protein translation by the DISC1-Boymaw fusion gene from a Scottish family with major psychiatric disorders.

The t(1; 11) translocation appears to be the causal genetic lesion with 70% penetrance for schizophrenia, major depression and other psychiatric disorders in a Scottish family. Molecular studies identified the disruption of the disrupted-in-schizophrenia 1 (DISC1) gene by chromosome translocation at chromosome 1q42. Our previous studies, however, revealed that the translocation also disrupted another gene, Boymaw (also termed DISC1FP1), on chromosome 11. After translocation, two fusion genes [the DISC1-Boymaw (DB7) and the Boymaw-DISC1 (BD13)] are generated between the DISC1 and Boymaw genes. In the present study, we report that expression of the DB7 fusion gene inhibits both intracellular NADH oxidoreductase activities and protein translation. We generated humanized DISC1-Boymaw mice with gene targeting to examine the in vivo functions of the fusion genes. Consistent with the in vitro studies on the DB7 fusion gene, protein translation activity is decreased in the hippocampus and in cultured primary neurons from the brains of the humanized mice. Expression of Gad67, Nmdar1 and Psd95 proteins are also reduced. The humanized mice display prolonged and increased responses to the NMDA receptor antagonist, ketamine, on various mouse genetic backgrounds. Abnormal information processing of acoustic startle and depressive-like behaviors are also observed. In addition, the humanized mice display abnormal erythropoiesis, which was reported to associate with depression in humans. Expression of the DB7 fusion gene may reduce protein translation to impair brain functions and thereby contribute to the pathogenesis of major psychiatric disorders.

Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2-11 years in Malaysia: a randomized, placebo-controlled, Phase III study.

BACKGROUND: Dengue disease is a major public health problem across the Asia-Pacific region for which there is no licensed vaccine or treatment. We evaluated the safety and immunogenicity of Phase III lots of a candidate vaccine (CYD-TDV) in children in Malaysia. METHODS: In this observer-blind, placebo-controlled, Phase III study, children aged 2-11 years were randomized (4:1) to receive CYD-TDV or placebo at 0, 6 and 12 months. Primary endpoints included assessment of reactogenicity following each dose, adverse events (AEs) and serious AEs (SAEs) reported throughout the study, and immunogenicity expressed as geometric mean titres (GMTs) and distribution of dengue virus (DENV) neutralizing antibody titres. RESULTS: 250 participants enrolled in the study (CYD-TDV: n=199; placebo: n=51). There was a trend for reactogenicity to be higher with CYD-TDV than with placebo post-dose 1 (75.4% versus 68.6%) and post-dose 2 (71.6% versus 62.0%) and slightly lower post-dose 3 (57.9% versus 64.0%). Unsolicited AEs declined in frequency with each subsequent dose and were similar overall between groups (CYD-TDV: 53.8%; placebo: 49.0%). Most AEs were of Grade 1 intensity and were transient. SAEs were reported by 5.5% and 11.8% of participants in the CYD-TDV and placebo groups, respectively. No deaths were reported. Baseline seropositivity against each of the four DENV serotypes was similar between groups, ranging from 24.0% (DENV-4) to 36.7% (DENV-3). In the CYD-TDV group, GMTs increased post-dose 2 for all serotypes compared with baseline, ranging from 4.8 (DENV-1) to 8.1-fold (DENV-3). GMTs further increased post-dose 3 for DENV-1 and DENV-2. Compared with baseline, individual titre increases ranged from 6.1-fold (DENV-1) to 7.96-fold (DENV-3). CONCLUSIONS: This study demonstrated a satisfactory safety profile and a balanced humoral immune response against all four DENV serotypes for CYD-TDV administered via a three-dose regimen to children in Malaysia.

Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons.

BACKGROUND: Accurately estimating surgical risks is critical for shared decision making and informed consent. The Centers for Medicare and Medicaid Services may soon put forth a measure requiring surgeons to provide patients with patient-specific, empirically derived estimates of postoperative complications. Our objectives were to develop a universal surgical risk estimation tool, to compare performance of the universal vs previous procedure-specific surgical risk calculators, and to allow surgeons to empirically adjust the estimates of risk. STUDY DESIGN: Using standardized clinical data from 393 ACS NSQIP hospitals, a web-based tool was developed to allow surgeons to easily enter 21 preoperative factors (demographics, comorbidities, procedure). Regression models were developed to predict 8 outcomes based on the preoperative risk factors. The universal model was compared with procedure-specific models. To incorporate surgeon input, a subjective surgeon adjustment score, allowing risk estimates to vary within the estimate's confidence interval, was introduced and tested with 80 surgeons using 10 case scenarios. RESULTS: Based on 1,414,006 patients encompassing 1,557 unique CPT codes, a universal surgical risk calculator model was developed that had excellent performance for mortality (c-statistic = 0.944; Brier score = 0.011 [where scores approaching 0 are better]), morbidity (c-statistic = 0.816, Brier score = 0.069), and 6 additional complications (c-statistics > 0.8). Predictions were similarly robust for the universal calculator vs procedure-specific calculators (eg, colorectal). Surgeons demonstrated considerable agreement on the case scenario scoring (80% to 100% agreement), suggesting reliable score assignment between surgeons. CONCLUSIONS: The ACS NSQIP surgical risk calculator is a decision-support tool based on reliable multi-institutional clinical data, which can be used to estimate the risks of most operations. The ACS NSQIP surgical risk calculator will allow clinicians and patients to make decisions using empirically derived, patient-specific postoperative risks.

Optimizing ACS NSQIP modeling for evaluation of surgical quality and risk: patient risk adjustment, procedure mix adjustment, shrinkage adjustment, and surgical focus.

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) collects detailed clinical data from participating hospitals using standardized data definitions, analyzes these data, and provides participating hospitals with reports that permit risk-adjusted comparisons with a surgical quality standard. Since its inception, the ACS NSQIP has worked to refine surgical outcomes measurements and enhance statistical methods to improve the reliability and validity of this hospital profiling. From an original focus on controlling for between-hospital differences in patient risk factors with logistic regression, ACS NSQIP has added a variable to better adjust for the complexity and risk profile of surgical procedures (procedure mix adjustment) and stabilized estimates derived from small samples by using a hierarchical model with shrinkage adjustment. New models have been developed focusing on specific surgical procedures (eg, "Procedure Targeted" models), which provide opportunities to incorporate indication and other procedure-specific variables and outcomes to improve risk adjustment. In addition, comparative benchmark reports given to participating hospitals have been expanded considerably to allow more detailed evaluations of performance. Finally, procedures have been developed to estimate surgical risk for individual patients. This article describes the development of, and justification for, these new statistical methods and reporting strategies in ACS NSQIP.

Penetrating oesophageal injury: a contemporary analysis of the National Trauma Data Bank.

BACKGROUND: Oesophageal trauma is uncommon. The aim of this study was to conduct a descriptive analysis of penetrating oesophageal trauma and determine risk factors for oesophageal related complications and mortality in the National Trauma Data Bank (NTDB). METHODS: Patients with penetrating oesophageal trauma from Levels 1 and 2 trauma centres in the NTDB (2007 and 2008) that specified how complication and comorbidity data were recorded were selected. Data collected included age, injury severity score (ISS), abbreviated injury scores (AIS), lengths of stay (LOS) and ventilation days, systolic blood pressure (SBP) in the emergency department (ED), comorbidities, oesophageal related procedures, and oesophageal related complications. Univariate and multivariable analyses were conducted to identify significant predictors of oesophageal-related complications and mortality in patients with LOS>24 h. RESULTS: 227 patients from 107 centres were studied. The mean number of patients per centre was 2 (range 1-15). Overall mortality was found to be 44% with 92% of these deaths in less than 24 h. In patients with LOS>24 h, 62% had primary repair, 13% drainage, 4% resection, 1% diversion, and 20% unspecified. No significant difference in mortality was found in patients with oesophageal related complications. The time to first oesophageal related procedure was not significantly different in those with oesophageal related complications or those who died. Significant predictors of oesophageal related complications were age and AIS of the abdomen or pelvic contents ≥3 and the only significant predictor of mortality was ISS. CONCLUSIONS: Most deaths in penetrating oesophageal trauma occur in the first 24 h due to severe associated injuries. Primary repair was the most common intervention, followed by drainage and resection. Oesophageal related complications were not found to significantly increase mortality and time to first oesophageal related procedure did not affect outcomes in this subset of patients from the NTDB.