Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery.

BACKGROUND: Intraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients. METHODS: In this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed. RESULTS: Participants received pudexacianinium 0.3 mg (n = 3), 1.0 mg (n = 6), or 3.0 mg (n = 3). Most participants were female (n = 10; 83.3%); median age was 54 years (range 24-69) and median BMI was 29.3 kg/m2 (range 18.7-38.1). Successful intraoperative ureter visualization occurred in 2/3, 5/6, and 3/3 participants who received pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg, respectively. Median intensity values per surgeon assessment were 1 (mild) with the 0.3-mg dose, 2 (moderate) with the 1.0-mg dose, and 3 (strong) with the 3.0-mg dose. A correlation was observed between qualitative (surgeon's recognition/identification of the ureter during surgery) and quantitative (video recordings of the surgeries after study completion) assessment of fluorescence intensity. Two participants experienced serious adverse events, none of which were drug-related toxicities. One adverse event (grade 1 proteinuria) was related to pudexacianinium. Plasma pudexacianinium concentrations were dose-dependent and the mean (± SD) percent excreted into urine during surgery was 22.3% ± 8.0% (0.3-mg dose), 15.6% ± 10.0% (1.0-mg dose), and 39.5% ± 12.4% (3.0-mg dose). CONCLUSIONS: In this study, 1.0 and 3.0 mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.

Extraction Site in Minimally Invasive Colorectal Surgery.

The widespread adoption of minimally invasive colorectal surgery has led to improved patient recovery and outcomes. Specimen extraction sites remain a major source of pain and potential postoperative morbidity. Careful selection of the extraction site incision may allow surgeons to decrease postoperative pain, infectious complications, or rates of hernia formation. Options include midline, paramedian, transverse, Pfannenstiel, and natural orifice sites. Patient, disease, and surgeon-related factors should all be considered when choosing a site. This article will review different options for specimen extraction sites.

Liposomal Bupivacaine Transversus Abdominis Plane Blocks in Laparoscopic Colorectal Resections: A Single-Institution Randomized Controlled Trial.

BACKGROUND: Transversus abdominis plane blocks improve postoperative pain after colon and rectal resections, but the benefits of liposomal bupivacaine use for these blocks have not been clearly demonstrated. OBJECTIVE: This study aimed to determine whether using liposomal bupivacaine in transversus abdominis plane blocks improves postoperative pain and reduces opioid use after colorectal surgery compared to standard bupivacaine. DESIGN: This study was a single-blinded, single-institution, prospective randomized controlled trial comparing liposomal bupivacaine to standard bupivacaine in transversus abdominis plane blocks in patients undergoing elective colon and rectal resections. SETTINGS: This study was conducted at a single-institution academic medical center with 6 staff colorectal surgeons and 2 colorectal surgery fellows. PATIENTS: Ninety-six patients aged 18 to 85 years were assessed for eligibility; 76 were included and randomly assigned to 2 groups of 38 patients. INTERVENTIONS: Patients in the experimental group received liposomal bupivacaine transversus abdominis plane blocks, whereas the control group received standard bupivacaine blocks. MAIN OUTCOME MEASURES: The primary outcome was maximum pain score on postoperative day 2. Secondary outcomes included daily maximum and average pain scores in the 3 days after surgery, as well as daily morphine milligram equivalent use and length of hospital stay. RESULTS: Patients receiving liposomal bupivacaine blocks had lower maximum pain scores on the day of surgery (mean, 6.5 vs 7.7; p = 0.008). No other difference was found between groups with respect to maximum or average pain scores at any time point postoperatively, nor was there any difference in morphine milligram equivalents used or length of stay (median, 3.1 d). LIMITATIONS: This was a single-institution study with only patients blinded to group assignment. CONCLUSIONS: Liposomal bupivacaine use in transversus abdominis plane blocks for patients undergoing laparoscopic colorectal resections does not seem to improve postoperative pain, nor does it reduce narcotic use or decrease length of stay. Given its cost, use of liposomal bupivacaine in transversus abdominis plane blocks is not justified for colon and rectal resections. See Video Abstract at http://links.lww.com/DCR/B979 . CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Identifier: NCT04781075. BLOQUEOS TAP DE BUPIVACANA LIPOSOMAL EN RESECCIONES COLORRECTALES LAPAROSCPICAS UN ENSAYO CONTROLADO ALEATORIO DE UNA SOLA INSTITUCIN: ANTECEDENTES:Los bloqueos del plano transverso del abdomen, mejoran el dolor posoperatorio después de las resecciones de colon y recto, pero los beneficios del uso de bupivacaína liposomal para estos bloqueos, no se han demostrado claramente.OBJETIVO:Investigar la eficacia de la inyección con tejido adiposo autólogo recién recolectado en fístulas anales criptoglandulares complejas.DISEÑO:Ensayo controlado, aleatorio, prospectivo, simple ciego, de una sola institución, que compara la bupivacaína liposomal con la bupivacaína estándar en bloqueos del plano transverso del abdomen, en pacientes sometidos a resecciones electivas de colon y recto. Identificador de ClinicalTrials.gov : NCT04781075.ENTORNO CLINICO:Centro médico académico de una sola institución con seis cirujanos de plantilla y becarios de cirugía colorrectal.PACIENTES:Se evaluó la elegibilidad de 96 pacientes de 18 a 85 años; 76 fueron incluidos y aleatorizados en dos grupos de 38 pacientes.INTERVENCIONES:Los pacientes del grupo experimental recibieron bloqueos del plano transverso del abdomen con bupivacaína liposomal, mientras que el grupo de control recibió bloqueos de bupivacaína estándar.PRINCIPALES MEDIDAS DE VALORACION:El resultado primario fue la puntuación máxima de dolor en el segundo día posoperatorio. Los resultados secundarios incluyeron las puntuaciones máximas y medias diarias de dolor en los 3 días posteriores a la cirugía, así como el uso diario equivalente en miligramos de morfina y la duración de la estancia hospitalaria.RESULTADOS:Los pacientes que recibieron bloqueos de bupivacaína liposomal, tuvieron puntuaciones máximas de dolor más bajas, el día de la cirugía (media 6,5 frente a 7,7, p = 0,008). No hubo ninguna otra diferencia entre los grupos con respecto a las puntuaciones de dolor máximas o promedio en cualquier momento después de la operación, ni hubo ninguna diferencia en los equivalentes de miligramos de morfina utilizados o la duración de la estancia (mediana de 3,1 días).LIMITACIONES:Estudio de una sola institución con cegamiento de un solo paciente.CONCLUSIONES:El uso de bupivacaína liposomal en bloqueos del plano transverso del abdomen, para pacientes sometidos a resecciones colorrectales laparoscópicas, no parece mejorar el dolor posoperatorio, ni reduce el uso de narcóticos ni la duración de la estancia hospitalaria. Dado su costo, el uso de bupivacaína liposomal en bloqueos TAP no está justificado para resecciones de colon y recto. Consulte Video Resumen en http://links.lww.com/DCR/B797 . Traducción Dr. Fidel Ruiz Healy.

When the p Value Doesn't Cut It: The Fragility Index Applied to Randomized Controlled Trials in Colorectal Surgery.

BACKGROUND: The American Statistical Association, among others, has called for the use of statistical methods beyond p ≤ 0.05. The fragility index is a statistical metric defined as the minimum number of patients for whom if an event rather than a nonevent occurred, then the p value would increase to ≥0.05. Previous reviews have demonstrated that many randomized controlled trials have a low fragility index, suggesting they may not be robust. OBJECTIVE: The purpose of this study was to review the fragility indices of randomized controlled trials in colorectal surgery. DATA SOURCES: A PubMed search was performed. STUDY SELECTION: Colorectal surgery randomized controlled trials with a dichotomous primary outcome p ≤ 0.05 and publication between 2016 and 2018 were systematically identified. INTERVENTIONS: All procedural interventions related to colorectal surgery were included. MAIN OUTCOME MEASURES: The main measures were the fragility index and the number of patients lost to follow-up for each trial. The percentage of trials with the number of patients lost to follow-up greater than the fragility index was calculated. RESULTS: In total, 712 abstracts were reviewed, with 90 trials meeting the inclusion criteria. The median fragility index was 3 (interquartile range of 1 to 10). In 51 of the 90 trials (57%), the number of patients lost to follow-up was greater than the fragility index. LIMITATIONS: The fragility index is only one measure of the robustness of a randomized clinical trial. CONCLUSIONS: Most colorectal surgery randomized controlled trials have a low fragility index. In 57% of trials, more patients were lost to follow-up than would be required to change the outcome of the trial from "significant" to "nonsignificant" based on the p value. This emphasizes the importance of assessing the robustness of clinical trials when considering their clinical application, rather than relying solely on the p value. See Video Abstract at http://links.lww.com/DCR/B741.CUANDO EL VALOR-P ES INSUFICIENTE: ÍNDICE DE FRAGILIDAD APLICADO EN ESTUDIOS ALEATORIOS CONTROLADOS EN CIRUGÍA COLORECTAL. ANTECEDENTES: La Sociedad Estadounidense de Estadística, entre otros, ha pedido el uso de métodos estadísticos más allá de p <0,05. El índice de fragilidad es una medida estadística definida como el número de desenlaces que podrían cambiar para revertir, o conseguir, la significación estadística, así el valor p aumentaría a ≥ 0,05. Las revisiones anteriores han demostrado que muchos estudios aleatorios controlados tienen un índice de fragilidad bajo, lo que sugiere que pueden poco sólidos. OBJETIVO: El propósito de la présente investigación fué de revisar los índices de fragilidad de los estudios aleatorios controlados en cirugía colorrectal. FUENTES DE DATOS: PubMed. SELECCIN DE ESTUDIOS: Se identificaron sistemáticamente estudios aleatorios controlados de cirugía colorrectal con un resultado primario dicotómico, valor de p ≤ 0,05 y publicados entre 2016-2018. INTERVENCIONES: Se incluyeron todas aquellas intervenciones con procedimientos relacionados con la cirugía colorrectal. PRINCIPALES MEDIDAS DE RESULTADO: Las principales medidas fueron: el índice de fragilidad y el número de pacientes perdidos durante el seguimiento en cada estudio. Se calculó el el índice de fragilidad en porcentaje de estudios con el mayor número de pacientes perdidos durante el seguimiento mas prolongado. RESULTADOS: En total, se revisaron 712 resúmenes con 90 ensayos que cumplieron con los criterios de inclusión. La mediana del índice de fragilidad fue de 3 (rango intercuartíl de 1 a 10). En 51 de los 90 estudios (57%), el número de pacientes perdidos durante el seguimiento fue mayor que el índice de fragilidad. LIMITACIONES: El índice de fragilidad es solo una medida de la robustez de un estúdio clínico aleatorio. CONCLUSIONES: La mayoría de los estudios aleatorios y controlados en cirugía colorrectal tienen un índice de fragilidad bajo. En el 57% de los estudios, se perdieron más pacientes durante el seguimiento de los que se necesitarían para cambiar el resultado del estudios de grado "significativo" a un grado "no significativo" según el valor-p. Este concepto enfatiza la importancia de evaluar la robustez de los estudios clínicos al considerar su aplicación verdadera aplicación clínica, en lugar de depender únicamente del valor-p. Consulte Video Resumen en http://links.lww.com/DCR/B741. (Traducción-Dr. Xavier Delgadillo).

Nanoparticle encapsulation of non-genotoxic p53 activator Inauhzin-C for improved therapeutic efficacy.

The tumor suppressor protein p53 remains in a wild type but inactive form in ~50% of all human cancers. Thus, activating it becomes an attractive approach for targeted cancer therapies. In this regard, our lab has previously discovered a small molecule, Inauhzin (INZ), as a potent p53 activator with no genotoxicity. Method: To improve its efficacy and bioavailability, here we employed nanoparticle encapsulation, making INZ-C, an analog of INZ, to nanoparticle-encapsulated INZ-C (n-INZ-C). Results: This approach significantly improved p53 activation and inhibition of lung and colorectal cancer cell growth by n-INZ-C in vitro and in vivo while it displayed a minimal effect on normal human Wi38 and mouse MEF cells. The improved activity was further corroborated with the enhanced cellular uptake observed in cancer cells and minimal cellular uptake observed in normal cells. In vivo pharmacokinetic evaluation of these nanoparticles showed that the nanoparticle encapsulation prolongates the half-life of INZ-C from 2.5 h to 5 h in mice. Conclusions: These results demonstrate that we have established a nanoparticle system that could enhance the bioavailability and efficacy of INZ-C as a potential anti-cancer therapeutic.

Implementation of the surgical safety checklist at a tertiary academic center: Impact on safety culture and patient outcomes.

BACKGROUND: The impact and efficacy of the World Health Organization Surgery Safety Checklist (SSC) is uncertain. We sought to determine if the SSC decreases complications and examined the attitudes of the surgical team members following implementation of the SSC. METHODS: A 28-question survey was developed to assess perspectives of surgical team members at the University of Vermont Medical Center (UVMC). The University Health System Consortium database was examined to compare the rates of nine complications before and after SSC implementation using Chi square analysis and Fisher's exact test. RESULTS: There was no significant decrease in any of the nine complications 2 years after SSC implementation. There was overall agreement that the SSC improved communication, safety, and prevented errors in the operating room. However, there was disagreement between nursing and surgeons over whether all three parts of the SSC were always completed. CONCLUSIONS: Implementation of the SSC did not result in a significant decrease in perioperative morbidity or mortality. However, it did improve the perception of safety culture by operating room staff.

Does Performance Vary Within the Same Hospital When Separately Examining Different Patient Subgroups?

BACKGROUND: Surgical quality programs, such as the American College of Surgeons NSQIP, provide reports based on specialty or procedure, with patients aggregated together. It is unknown whether hospital performance differs by patient subgroup (eg cancer vs noncancer patients), masking opportunities for improvement. Our objectives were to determine whether performance differs within a given hospital for 6 contrasting patient subgroups and to identify the percentage of hospitals with greater than chance differences in performance. STUDY DESIGN: Using the American College of Surgeons NSQIP data, adults undergoing lung resection, esophagectomy, hepatectomy, pancreatectomy, colectomy, and proctectomy (2005 through 2012) were divided into 6 contrasting subgroups (elderly vs nonelderly, white vs nonwhite, obese vs nonobese, renal insufficiency vs normal renal function, cancer vs noncancer, emergency vs nonemergency). The main end point was serious morbidity or mortality. Observed to expected ratios were constructed using hierarchical models and compared using paired t-tests (eg observed to expected for cancer cases compared with noncancer). Variation in performance differences was assessed using a randomization test and z-tests for proportions. RESULTS: From 433 hospitals, 221,518 patients were included. Overall quality differed for elderly vs nonelderly, renal insufficiency vs normal renal function patients, cancer vs noncancer, and emergency vs nonemergency (p < 0.05). Variation in within-hospital performance differences exceeded chance expectations for renal insufficiency vs normal renal function in 31.1% of hospitals, cancer vs noncancer in 40.8%, and emergency vs nonemergency patients in 55.4% (p < 0.001). CONCLUSIONS: Hospital performance within a given hospital varies by patient subgroup. Quality programs can consider separate reports for these subgroups to identify opportunities for quality improvement.

Patterns and Predictors of Chemotherapy Use for Resected Non-Small Cell Lung Cancer.

BACKGROUND: Chemotherapy combined with surgical resection improves survival in patients with stage II to IIIA non-small cell lung cancer (NSCLC) and may benefit selected patients with stage IB disease. We sought to evaluate chemotherapy use in resected stage IB to IIIA NSCLC over time and to identify predictors of perioperative chemotherapy administration. METHODS: Patients with resected stage IB to IIIA NSCLC were identified from the National Cancer Data Base (2002 to 2011). Administration of chemotherapy was assessed over time. Hierarchical regression models were developed to assess patient, hospital, and tumor-level characteristics predicting perioperative chemotherapy administration. RESULTS: In 55,016 stage IB patients, chemotherapy use significantly increased between 2002 and 2011 from 5.3% to 15.1% (p < 0.001). In 57,033 patients with stage II to IIIA disease, perioperative chemotherapy administration also significantly increased from 29.3% to 58.4% (p < 0.001). Multivariable analyses demonstrated stage IB and II to IIIA patients were less likely to receive chemotherapy if they were older, treated at an academic center (vs community), had more comorbidities, or had lower-grade tumors (all p < 0.05). Stage IB patients with tumors sized 4 cm or larger were more likely to receive chemotherapy (odds ratio, 3.16; 95% confidence interval, 2.73 to 3.65) than those with tumors smaller than 4 cm. Compared with stage IIA patients, stage IIB patients were no more likely to receive perioperative chemotherapy (odds ratio, 1.06; 95% confidence interval, 0.96 to 1.17), whereas stage IIIA patients received chemotherapy significantly more often (odds ratio, 2.82; 95% confidence interval, 2.55 to 3.11). CONCLUSIONS: The use of chemotherapy has significantly increased in patients with resected stage IB to IIIA NSCLC. Although clinicians have increasingly adopted evidence-based recommendations, significant treatment gaps persist and represent areas for quality improvement.

Development of a model to predict breast cancer survival using data from the National Cancer Data Base.

BACKGROUND: With the large amounts of data on patient, tumor, and treatment factors available to clinicians, it has become critically important to harness this information to guide clinicians in discussing a patient's prognosis. However, no widely accepted survival calculator is available that uses national data and includes multiple prognostic factors. Our objective was to develop a model for predicting survival among patients diagnosed with breast cancer using the National Cancer Data Base (NCDB) to serve as a prototype for the Commission on Cancer's "Cancer Survival Prognostic Calculator." PATIENTS AND METHODS: A retrospective cohort of patients diagnosed with breast cancer (2003-2006) in the NCDB was included. A multivariable Cox proportional hazards regression model to predict overall survival was developed. Model discrimination by 10-fold internal cross-validation and calibration was assessed. RESULTS: There were 296,284 patients for model development and internal validation. The c-index for the 10-fold cross-validation ranged from 0.779 to 0.788 after inclusion of all available pertinent prognostic factors. A plot of the observed versus predicted 5 year overall survival showed minimal deviation from the reference line. CONCLUSION: This breast cancer survival prognostic model to be used as a prototype for building the Commission on Cancer's "Cancer Survival Prognostic Calculator" will offer patients and clinicians an objective opportunity to estimate personalized long-term survival based on patient demographic characteristics, tumor factors, and treatment delivered.

Adjusted Hospital Sentinel Lymph Node Positivity Rates in Melanoma: A Novel Potential Measure of Quality.

OBJECTIVE: Our objectives were to examine whether hospital characteristics are associated with lower- and higher-than-expected sentinel lymph node biopsy (SLNB) positivity rates and whether hospitals with lower- or higher-than-expected SLNB positivity rates have worse patient outcomes. BACKGROUND: Surgeon and pathologist SLNB technical errors may lead to incorrect melanoma staging. A hospital's SLNB positivity rate may reflect its SLNB proficiency for melanoma, but this has never been investigated. METHODS: Stage IA-III melanoma patients undergoing SLNB were identified from the National Cancer Data Base (2004-2010). Hospital-level SLNB positivity rates were adjusted for patient- and tumor factors. Hospitals were divided into terciles of adjusted SLNB positivity rates. Hospital characteristics (using multinomial logistic regression) and survival (using Cox modeling) were examined across terciles. RESULTS: Of 33,639 SLNB patients (from 646 hospitals), 2916 (8.7%) had at least 1 positive lymph node. Hospitals with lower- (low tercile) and higher-than-expected (high tercile) SLNB positivity rates were more likely to be low-volume hospitals (low tercile: relative risk ratio (RRR) = 2.57, P = 0.002; high tercile: RRR = 2.3, P = 0.004) compared to hospitals with expected rates (middle tercile). Stage I patients treated at lower-than-expected SLNB positivity rate hospitals had worse 5-year survival than those treated at expected SLNB positivity rate hospitals (90.0% vs 91.9%, P = 0.014; hazard ratio = 1.28, 95% CI: 1.05-1.57); survival differences were not observed by SLNB positivity rates for stage II/III. CONCLUSIONS: Adjusted hospital SLNB positivity rates varied widely. Surgery at hospitals with lower-than-expected SLNB positivity rates was associated with decreased survival. Hospital SLNB positivity rates may be a novel measure to confidentially report to hospitals for internal quality assessment.

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.

Impact of gastrectomy procedural complexity on surgical outcomes and hospital comparisons.

BACKGROUND: Most risk adjustment approaches adjust for patient comorbidities and the primary procedure. However, procedures done at the same time as the index case may increase operative risk and merit inclusion in adjustment models for fair hospital comparisons. Our objectives were to evaluate the impact of surgical complexity on postoperative outcomes and hospital comparisons in gastric cancer surgery. METHODS: Patients who underwent gastric resection for cancer were identified from a large clinical dataset. Procedure complexity was characterized using secondary procedure CPT codes and work relative value units (RVUs). Regression models were developed to evaluate the association between complexity variables and outcomes. The impact of complexity adjustment on model performance and hospital comparisons was examined. RESULTS: Among 3,467 patients who underwent gastrectomy for adenocarcinoma, 2,171 operations were distal and 1,296 total. A secondary procedure was reported for 33% of distal gastrectomies and 59% of total gastrectomies. Six of 10 secondary procedures were associated with adverse outcomes. For example, patients who underwent a synchronous bowel resection had a higher risk of mortality (odds ratio [OR], 2.14; 95% CI, 1.07-4.29) and reoperation (OR, 2.09; 95% CI, 1.26-3.47). Model performance was slightly better for nearly all outcomes with complexity adjustment (mortality c-statistics: standard model, 0.853; secondary procedure model, 0.858; RVU model, 0.855). Hospital ranking did not change substantially after complexity adjustment. CONCLUSION: Surgical complexity variables are associated with adverse outcomes in gastrectomy, but complexity adjustment does not affect hospital rankings appreciably.

Risk of discharge to postacute care: a patient-centered outcome for the american college of surgeons national surgical quality improvement program surgical risk calculator.

IMPORTANCE: Individualized risk prediction tools have an important role as decision aids for use by patients and surgeons before surgery. Patient-centered outcomes should be incorporated into such tools to widen their appeal and improve their usability. OBJECTIVE: To develop a patient-centered outcome for the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator, a web-based, individualized risk prediction tool. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study using data from the ACS NSQIP, a national clinical data registry. A total of 973 211 patients from July 2010 to June 2012, encompassing 392 hospitals, were used in this analysis. MAIN OUTCOMES AND MEASURES: Risk of discharge to a postacute care setting. RESULTS: The overall rate of discharge to postacute care was 8.8%. Significant predictors of discharge to postacute care included being 85 years or older (odds ratio [OR] = 9.17; 95% CI, 8.84-9.50), the presence of septic shock (OR = 2.43; 95% CI, 2.20-2.69) or ventilator dependence (OR = 2.81; 95% CI, 2.56-3.09) preoperatively, American Society of Anesthesiologists class of 4 or 5 (OR = 3.59; 95% CI, 3.46-3.71), and totally dependent functional status (OR = 2.27; 95% CI, 2.11-2.44). The final model predicted risk of discharge to postacute care with excellent accuracy (C statistic = 0.924) and calibration (Brier score = 0.05). CONCLUSIONS AND RELEVANCE: Individualized risk of discharge to postacute care can be predicted with excellent accuracy. This outcome will be incorporated into the ACS NSQIP Surgical Risk Calculator.

Risk prediction tools in surgical oncology.

Healthcare has increasingly focused on patient engagement and shared decision-making. Decision aids can promote engagement and shared decision making by providing patients and their providers with care options and outcomes. This article discusses decision aids for surgical oncology patients. Topics include: short-term risk prediction following surgery, long-term risk prediction of survival and recurrence, the combination of short- and long-term risk prediction to help guide treatment choice, and decision aid usability, transparency, and accessibility.

Comparison of postoperative complication risk prediction approaches based on factors known preoperatively to surgeons versus patients.

BACKGROUND: Estimating the risk of postoperative complications can be performed by surgeons with detailed clinical information or by patients with limited information. Our objective was to compare three estimation models: (1) the All Information Model, using variables available from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP); (2) the Surgeon Assessment Model, using variables available to surgeons preoperatively, and (3) the Patient-Entered Model, using information that patients know about their own health. STUDY DESIGN: Using the ACS NSQIP 2011 data for general and colon surgery, standard ACS NSQIP regression methods were used to develop models. Each model examined Overall and Serious Morbidity as outcomes. The models were assessed using the c-statistic, Hosmer-Lemshow statistic, and Akaike Information Criterion. RESULTS: The overall morbidity rate was 13.0%, and the serious morbidity rate was 10.5% for patients undergoing general surgery (colon surgery: 31.8% and 26.0%, respectively). There was a small decrement in the c-statistic as the number of predictors decreased. The Akaike Information Criterion likelihood ratio increased between the All Information and Surgeon Assessment models, but decreased in the Patient-Entered Model. The Hosmer-Lemshow statistic suggested good model fit for five colon surgery models and one general surgery model. CONCLUSION: Although a small decline in model performance was observed, the magnitude suggests that it may not be clinically meaningful as the risk predictions offered are superior to simply providing unadjusted complications rates. The Surgeon Assessment and Patient-Entered models with fewer predictors can be used with relative confidence to predict a patient's risk.

Impact of hepatectomy surgical complexity on outcomes and hospital quality rankings.

BACKGROUND: There is substantial variation in the surgical complexity of hepatectomy. Currently, the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) risk adjusts for hospital quality comparisons using only the primary procedure code. Our objectives were to (1) assess the association between secondary procedures and complications; (2) assess model performance with inclusion of surgical complexity adjustment; and (3) examine whether secondary procedures affect hospital quality rankings. METHODS: Using ACS NSQIP (2007-2012), patients undergoing hepatectomy were identified. Secondary procedure codes and total work relative value units (RVUs) were used to approximate procedural complexity. The effect of procedural complexity variables on outcomes and hospital quality rankings were examined using hierarchical models. RESULTS: Among 11,826 patients who underwent hepatectomy at 261 hospitals, 32.8 % underwent at least one secondary procedure. Serious morbidity occurred in 18.0 % of patients. Seven of nine secondary procedures were significantly associated with death or serious morbidity on multivariable analysis. Model performance improved when secondary procedure categories were included, and secondary procedure categories outperformed total RVUs. The C-statistic for death or serious morbidity was 0.689 in the standard NSQIP model, 0.703 when total RVU was included, and 0.718 when secondary procedure categories were included. Of the 26 hospitals that were poor performers for death or serious morbidity using the standard ACS NSQIP model, three became average performers when secondary procedure categories were included in the model. CONCLUSIONS: Secondary procedures are associated with an increased risk of postoperative complications. Inclusion of secondary procedure code categories in research and risk prediction models should be considered for hepatectomy.

Relationship between cancer center accreditation and performance on publicly reported quality measures.

OBJECTIVE: To evaluate differences in hospital structural quality characteristics and assess the association between national publicly reported quality indicators and cancer center accreditation status. BACKGROUND: Cancer center accreditation and public reporting are 2 approaches available to help guide patients with cancer to high-quality hospitals. It is unknown whether hospital performance on these measures differs by cancer accreditation. METHODS: Data from Medicare's Hospital Compare and the American Hospital Association were merged. Hospitals were categorized into 3 mutually exclusive groups: National Cancer Institute-Designated Cancer Centers (NCI-CCs), Commission on Cancer (CoC) centers, and "nonaccredited" hospitals. Performance was assessed on the basis of structural, processes-of-care, patient-reported experiences, costs, and outcomes. RESULTS: A total of 3563 hospitals (56 NCI-CCs, 1112 CoC centers, and 2395 nonaccredited hospitals) were eligible for analysis. Cancer centers (NCI-CCs and CoC centers) were more likely larger, higher volume teaching hospitals with additional services and specialists than nonaccredited hospitals (P < 0.001). Cancer centers performed better on 3 of 4 process measures, 8 of 10 patient-reported experience measures, and Medicare spending per beneficiary than nonaccredited hospitals. NCI-CCs performed worse than both CoC centers and nonaccredited hospitals on 8 of 10 outcome measures. Similarly, CoC centers performed worse than nonaccredited hospitals on 5 measures. For example, 35% of NCI-CCs, 13.5% of CoC centers, and 3.5% of nonaccredited hospitals were poor performers for serious complications. CONCLUSIONS: Accredited cancer centers performed better on most process and patient experience measures but showed worse performance on most outcome measures. These discordant findings emphasize the need to focus on oncology-specific measurement strategies.