Cost-Effectiveness of Aspirin for Extended Venous Thromboembolism Prophylaxis After Major Surgery for Inflammatory Bowel Disease.

BACKGROUND AND PURPOSE: Venous thromboembolism extended prophylaxis after inflammatory bowel disease surgery remains controversial. The purpose of this study was to evaluate if adopting an aspirin-based prophylaxis strategy may address current cost-effectiveness limitations. METHODS: A decision analysis model was used to compare costs and outcomes of a reference case patient undergoing inflammatory bowel disease-associated colorectal surgery considered for post-discharge thromboembolism prophylaxis. Low-dose aspirin was compared to an enoxaparin regimen as well as no prophylaxis. Source estimates were obtained from aggregated existing literature. Secondary analysis included out-of-pocket costs. A 10,000-simulation Monte Carlo probabilistic sensitivity analysis accounted for uncertainty in model estimates. RESULTS: An enoxaparin-based regimen compared to aspirin demonstrated an unfavorable incremental cost-effectiveness ratio of $908,268 per quality-adjusted life year. Sensitivity analysis supported this finding in > 75% of simulated cases; scenarios favoring enoxaparin included those with > 4% post-discharge event rates. Aspirin versus no prophylaxis demonstrated a favorable ratio of $106,601 per quality-adjusted life year. Findings were vulnerable to a post-discharge thromboembolism rate < 1%, aspirin-associated bleeding rate > 1%, median hospital costs of bleeding > 3 × , and decreased efficacy of aspirin (RR > 0.75). The average out-of-pocket cost of choosing an aspirin ePpx strategy increased by $54 per patient versus $708 per patient with enoxaparin. CONCLUSIONS: Low-dose aspirin extended prophylaxis following inflammatory bowel disease surgery has a favorable cost-safety profile and may be an attractive alternative approach.

Defining the Economic Burden of Perioperative Venous Thromboembolism in Inflammatory Bowel Disease in the United States.

BACKGROUND: Patients with IBD are at increased risk of venous thromboembolism. OBJECTIVE: This study aims to define the economic burden associated with inpatient venous thromboembolism after surgery for IBD that presently remains undefined. DESIGN: This study is a retrospective, cross-sectional analysis using the National Inpatient Sample from 2004 to 2014. SETTING: Participating hospitals across the United States were sampled. PATIENTS: The International Classification of Diseases, 9th Revision codes were used to identify patients with a primary diagnosis of IBD. INTERVENTIONS: Major abdominopelvic bowel surgery was performed. MAIN OUTCOME MEASURES: The primary outcome measured was the occurrence of inpatient venous thromboembolism. Univariate and multivariable patient- and hospital-level logistic regression models were used to compare patient characteristics, hospital characteristics, and outcomes between venous thromboembolism and non-venous thromboembolism cohorts. Total average direct costs were then compared between cohorts, and the resulting difference was extrapolated to the national population. RESULTS: Of 26,080 patients included, inpatient venous thromboembolism was identified in 581 (2.2%). On multivariable analysis, diagnosis of ulcerative colitis, transfer status, length of preoperative hospitalization, and insurance status were independently associated with inpatient venous thromboembolism. Patients with venous thromboembolism were observed to be associated with an increased median length of stay (17.6 vs 6.7 days; p < 0.001) and higher inpatient mortality (5.0% vs 1.1%; OR 4.7, SE 3.2-7.0; p < 0.001). After adjusting for clinically relevant covariates, the additional cost associated with each inpatient venous thromboembolism was $31,551 (95% CI, $29,136-$33,965). LIMITATIONS: Our study is limited by the administrative nature of the National Inpatient Sample database, which limits our ability to evaluate the impact of clinical covariates (eg, use of venous thromboembolism chemoprophylaxis, steroid use, and nutrition status). CONCLUSION: Inpatient venous thromboembolism in abdominopelvic surgery for IBD is an infrequent, yet costly, morbid complication. Given the magnitude of patient morbidity and economic burden, venous thromboembolism prevention should be a national quality improvement and research priority. See Video Abstract at http://links.lww.com/DCR/B544. DEFINICIN IMPACTO ECONMICO DE LA TROMBOEMBOLIA VENOSA PERIOPERATORIA EN LA ENFERMEDAD INFLAMATORIA INTESTINAL EN LOS ESTADOS UNIDOS: ANTECEDENTES:Pacientes con enfermedad inflamatoria intestinal (EII) tienen un mayor riesgo de tromboembolismo venoso (TEV).OBJETIVO:Definir el impacto económico de TEV hospitalaria después de la cirugía por EII, que en la actualidad permanece indefinida.DISEÑO:Un análisis transversal retrospectivo utilizando la Muestra Nacional de Pacientes Internos (NIS) de 2004 a 2014.ENTORNO CLINICO:Hospitales participantes muestreados en los Estados Unidos.PACIENTES:Se utilizaron los códigos de la 9ª edición de la Clasificación Internacional de Enfermedades (ICD-9) para identificar a los pacientes con diagnóstico primario de EII.INTERVENCIONES:Cirugía mayor abdominopélvica intestinal.PRINCIPALES MEDIDAS DE VALORACION:Incidencia de TEV en pacientes hospitalizados, utilizando modelos de regresión logística univariado y multivariable a nivel de pacientes y hospitales para comparar las características de los pacientes, las características del hospital y los resultados entre las cohortes de TEV y no TEV. Se compararon los costos directos promedio totales entre cohortes y la diferencia resultante extrapolando a la población nacional.RESULTADOS:De 26080 pacientes incluidos, se identificó TEV hospitalario en 581 (2,2%). En análisis multivariable, el diagnóstico de colitis ulcerosa, el estado de transferencia (entre centros hospitalarios), la duración de la hospitalización preoperatoria y el nivel de seguro medico se asociaron de forma independiente con la TEV hospitalaria. Se observó que los pacientes con TEV se asociaron con un aumento de la duración media de la estancia (17,6 versus a 6,7 días; p <0,001) y una mayor mortalidad hospitalaria (5,0% versus a 1,1%; OR 4,7, SE 3,2 -7,0; p <0,001). Después de ajustar las covariables clínicamente relevantes, el costo adicional asociado con cada TEV para pacientes hospitalizados fue de $ 31,551 USD (95% C.I. $ 29,136 - $ 33,965).LIMITACIONES:Estudio limitado por la naturaleza administrativa de la base de datos del NIS, que limita nuestra capacidad para evaluar el impacto de las covariables clínicas (por ejemplo, el uso de quimioprofilaxis de TEV, el uso de esteroides y el estado nutricional).CONCLUSIÓN:TEV hospitalaria en la cirugía abdominopélvica para la EII es una complicación mórbida infrecuente, pero costosa. Debido a la magnitud de la morbilidad el impacto económico, la prevención del TEV debería ser una prioridad de investigación y para mejoría de calidad a nivel nacional. Consulte Video Resumen en http://links.lww.com/DCR/B544.

Enhanced Recovery Pathway Benefits Patients Undergoing Nonelective Colorectal Surgery.

OBJECTIVE: The aim of our study was to determine if an enhanced recovery pathway (ERP) can successfully be applied in nonelective colorectal surgery. BACKGROUND: ERPs have been shown to reduce hospital length of stay (LOS), complications, and costs after elective colorectal surgery. Yet, little data exist regarding the benefits of ERPs in patients undergoing nonelective colorectal surgery. We hypothesized that ERP implementation in a nonelective colorectal surgery population is associated with decreased postoperative LOS. METHODS: A prospectively-maintained database was used to identify consecutive patients undergoing colorectal surgery after emergency room (ER) or hospital transfer admissions over a period from 2 years before until 1 year after implementation of a comprehensive ERP. The primary endpoint was LOS. Secondary endpoints included total LOS [TLOS = postoperative LOS + LOS of readmission(s)], readmission rates, complication rates, 30-day mortality, and hospital costs. Univariate and multivariate analyses were performed to assess the relationship between ERP implementation and LOS. RESULTS: We identified 269 pre-ERP and 135 ERP patients fulfilling the inclusion criteria. Admit source (ER 43.4% vs transfers 56.7%), Charlson comorbidity index, American Society of Anesthesiologists (ASA) status, diagnosis (inflammatory bowel disease 45.8%, malignancy 19.6%, benign intestinal obstructions 10.4%, diverticulitis 9.4%, others 10.4%), and blood loss were comparable (P > 0.05) between the cohorts. Pre-ERP patients had a higher number of previous abdominal surgeries, whereas post-ERP patients had more laparoscopy and more compliance with ERP elements. ERP patients had a shorter postoperative LOS [6 (4, 10) vs 7 (5, 12) days; P = 0.0007]. Hospital costs were 13.4% lower (P = 0.004). Postoperative 30-day morbidity, mortality, and readmissions were comparable, although reoperation rate was higher in the ERP group. On multivariate analysis, ERP implementation and laparoscopy were the only modifiable variables independently associated with shorter LOS, whereas longer operative times and higher ASA classification were associated with longer LOS. CONCLUSIONS: Patients undergoing nonelective colorectal surgery after ER or hospital transfer admission benefit from the use of an ERP, demonstrating decreased LOS and costs without an increase in complications.

Development of Entrustable Professional Activities for Advanced Inflammatory Bowel Disease Fellowship Training in the United States.

BACKGROUND: The level of inflammatory bowel disease (IBD) training in general gastroenterology fellowship is often insufficient to prepare trainees to deliver advanced IBD care in practice. Advanced IBD fellowships have been developed to fill this training gap, but there is no established curriculum, and significant variability exists across programs. Entrustable professional activities (EPAs) are practical and realistic objectives that define essential tasks of a specialty that physicians should master to be competent during independent practice. The American College of Gastroenterology (ACG) and Crohn's & Colitis Foundation (Foundation) established a task force to develop and appraise EPAs for advanced IBD fellowship. METHODS: Entrustable professional activities were developed using a multistep approach in a similar manner to other specialties. Initial EPAs identified via focus groups were evaluated, critiqued, and changed using an iterative model of feedback. The final EPAs were selected after the task force conducted a 3-phase modified Delphi method consisting of 2 sequential rounds of web-based voting and an in-person consensus meeting. RESULTS: Ten EPAs for advanced IBD fellowship were established including detailed descriptions with the associated knowledge, skills, and attitudes for each that can serve as curricular milestones. CONCLUSION: Ten EPAs describing the core work of an advanced IBD fellowship-trained physician have been established by a multisociety task force. Creating EPAs for an advanced curriculum comes with unique challenges, particularly the need to prevent duplication of prior training competencies while demonstrating the potential for unique milestones.

Do Patients With Inflammatory Bowel Disease Benefit from an Enhanced Recovery Pathway?

BACKGROUND: Enhanced recovery pathways (ERPs) have been shown to reduce length of stay (LOS), complications, and costs after colorectal surgery; yet, little data exists regarding patients with inflammatory bowel disease (IBD). We hypothesized that implementation of ERP for IBD patients is associated with shorter LOS and improved economic outcomes. METHODS: An IRB-approved prospective clinical database was used to identify consecutive patients from 2015 to 2017. Patients were grouped as "pre-ERP" and "post-ERP" based on the date of implementation of a comprehensive ERP. Ileostomy closures, redo pouch operations, and outpatient operations were excluded. The relationship between ERP, LOS, and secondary outcomes was assessed using univariate and multivariate analysis. RESULTS: Overall, a total of 671 patients were included: 345 (51.4%) with Crohn's disease (CD) and 326 (48.6%) with ulcerative colitis (UC). Of these, 425 were pre-ERP (63.4%), and 246 were post-ERP (36.6%). The groups did not differ in terms of age, gender, American Society of Anesthesiologist (ASA) scores, comorbidities, estimated blood loss, or ostomy construction. The post-ERP group had a significantly higher mean body mass index (BMI), more patients with CD, longer operative time, and more minimally invasive surgery (MIS; all P < 0.05). The post-ERP group had a significantly shorter LOS (6 vs 4.5 days, median), whereas mean hospital costs decreased by 15.7%. There was no difference in readmissions or complications. On multivariate analysis, MIS and ERP use were both associated with a shorter LOS. CONCLUSION: Inflammatory bowel disease patients benefit from the use of ERP, demonstrating decreased LOS and costs without an increase in complications and readmissions. Enhanced recovery pathways should be routinely implemented in this often challenging patient population.

Health Care Policy and Outcomes after Colon and Rectal Surgery: What Is the Bigger Picture?-Cost Containment, Incentivizing Value, Transparency, and Centers of Excellence.

Early in the 21st century, the costs of health care in the United States have spiraled out of control, where the per capita spending is $9,237 per person-the highest in the world. By 2020, an estimated 20% of GDP will be spent on health care. The issue of cost and quality is now becoming a national crisis, with ∼50% of hospitals losing money on clinical operations, forcing closure of essential critical access hospitals, and forcing health care workers to relocate or change professions. This crisis will only worsen with the graying of America, as an estimated 17% of Americans will be over the age of 65 years by the year 2020. The policy and financial structures on which these changes are based are important factors of which practicing surgeons should be aware. This review discusses recent national health care policy reform and specific topics including cost-containment legislation, value-based incentives and penalties, transparency, and centers of excellence in colorectal surgery.

Extended Venous Thromboembolism Prophylaxis After Elective Surgery for IBD Patients: Nomogram-Based Risk Assessment and Prediction from Nationwide Cohort.

BACKGROUND: Identification of risk factors for postoperative venous thromboembolism is an important step to reduce the morbidity associated with this potentially preventable complication after elective surgery for patients with IBD. OBJECTIVE: This study aimed to determine the risk factors for 30-day venous thromboembolism after abdominal surgery for patients with venous thromboembolism, identify potential indications for extended thromboprophylaxis, and develop a nomogram for prediction of risk. DESIGN: This is a retrospective cohort study from a prospectively collected database. SETTING: The American College of Surgeons National Surgical Quality Improvement Program Participant User File from 2005 to 2016 was used for data analysis. PATIENTS: All patients with IBD undergoing elective abdominopelvic bowel surgery were included. MAIN OUTCOME MEASURES: The primary outcomes were the incidence of in-hospital and postdischarge venous thromboembolism within 30 days of the index abdominopelvic surgery. RESULTS: A total of 24,182 patients met the inclusion criteria. Thirty-day total and postdischarge rates of venous thromboembolism were 2.5% (n = 614) and 1% (n =252). Forty-one percent (252/614) of venous thromboembolism events occurred after hospital discharge. Univariate analysis assessed 37 variables for association with study outcomes. On multivariate logistic regression analysis, older age, steroid use, bleeding disorders, open surgery, hypertension, longer operative time, and preoperative hospitalization were associated with venous thromboembolism before discharge and also postoperative transfusion, steroid use, pelvic and enterocutaneous fistula surgery, and longer operative time were associated with venous thromboembolism after discharge. A nomogram was constructed for each outcome, translating multivariate model parameter estimates into a visual scoring system where the estimated probability of venous thromboembolism can be calculated. LIMITATIONS: This study was limited by its retrospective nature and the limitations inherent to a database. CONCLUSION: Given the higher risk of venous thromboembolism in patients with IBD after elective abdominopelvic surgery compared with other indications, an accurate prediction of venous thromboembolism before and after discharge using the proposed nomogram can facilitate decision making for individualized extended thromboprophylaxis in the preoperative setting as a screening tool. See Video Abstract at http://links.lww.com/DCR/A711.

Drivers of cost after surgical and medical therapy for chronic ulcerative colitis: a nested case-cohort study in Olmsted County, Minnesota.

BACKGROUND: We previously reported the costs associated with surgery for chronic ulcerative colitis in the Olmsted County population and found that direct medical costs after surgery were significantly reduced compared with before surgery. However, in that study, costs associated with chronic medical therapy for ulcerative colitis were not assessed in nonsurgical patients. OBJECTIVE: To gain insight into the drivers of costs of treatment for chronic ulcerative colitis, we assessed direct costs after surgical and medical therapy in 120 patients in the Rochester Epidemiology Project database. METHODS: A cohort of 60 patients who recovered from surgery for ulcerative colitis from 1988 to 2006 were 1:1 matched by age, sex, and referent year to medically managed patients. Direct health care costs were estimated from an institutional database, and observed cost differences over a 2-year period were calculated. Statistical significance was assessed by paired t tests and bootstrapping; mean costs are adjusted 2009 constant dollars. RESULTS: Two-year direct health care costs in the surgical and medical cohorts were $10,328 vs $6,586 (p = 0.19). In the surgical cohort, Brooke ileostomy patients were observed to have higher costs than patients with ileal pouches ([INCREMENT]$8187, p = 0.04), and after ileal pouch, pouchitis was associated with increased costs ([INCREMENT]$12,763, p < 0.01). In the medical cohort, disease extent ([INCREMENT]$6059, p = 0.04) but not disease severity was associated with increased costs. LIMITATIONS: This study was limited by the relatively small population size and by its performance in a county with a tertiary referral center. CONCLUSIONS: Before the introduction of biologic therapies for ulcerative colitis, patients were observed to have similar health care costs after surgical and medical therapy. In medically treated patients, disease extent was associated with increased costs, whereas in surgically treated patients, permanent ileostomy and pouchitis were observed to be associated with increased costs.

Application of total care time and payment per unit time model for physician reimbursement for common general surgery operations.

BACKGROUND: The relative value unit system relies on subjective measures of physician input in the care of patients. A payment per unit time model incorporates surgeon reimbursement to the total care time spent in the operating room, postoperative in-house, and clinic time to define payment per unit time. We aimed to compare common general surgery operations by using the total care time and payment per unit time method in order to demonstrate a more objective measurement for physician reimbursement. STUDY DESIGN: Average total physician payment per case was obtained for 5 outpatient operations and 4 inpatient operations in general surgery. Total care time was defined as the sum of operative time, 30 minutes per hospital day, and 30 minutes per office visit for each operation. Payment per unit time was calculated by dividing the physician reimbursement per case by the total care time. RESULTS: Total care time, physician payment per case, and payment per unit time for each type of operation demonstrated that an average payment per time spent for inpatient operations was $455.73 and slightly more at $467.51 for outpatient operations. Partial colectomy with primary anastomosis had the longest total care time (8.98 hours) and the least payment per unit time ($188.52). Laparoscopic gastric bypass had the highest payment per time ($707.30). CONCLUSIONS: The total care time and payment per unit time method can be used as an adjunct to compare reimbursement among different operations on an institutional level as well as on a national level. Although many operations have similar payment trends based on time spent by the surgeon, payment differences using this methodology are seen and may be in need of further review.

Assessment of screening colonoscopy competency in colon and rectal surgery fellows: a single institution experience.

BACKGROUND: The American Board of Surgery and the American Board of Colorectal Surgery requirements for certification include 80 and 140 colonoscopic procedures, respectively. However, little data support the attainment of colonoscopic competency. The aim of this retrospective study is to report the colonoscopy learning experience for colorectal surgery fellows at a single high-volume training program. MATERIAL AND METHODS: A prospective database recorded the experience of six colorectal fellows over two consecutive academic years. Univariate, moving average curves, and change point analysis were used to assess learning curve trends over time. Screening colonoscopy competency was defined by a significant reduction in total procedure time and 80% cecal intubation rate within 35 min. RESULTS: From 2004 to 2006, a total of 2904 screening colonoscopies were performed, including 1498 (52%) by fellows (mean 249 procedures per fellow). The mean procedure time for fellows was 30.2 ± 15 min. Procedure time decreased significantly up to 120 procedures but not thereafter. Overall, fellows' total procedure time decreased by 7.6 min over the course of the year (P < 0.0001); 66% of fellows were able to complete 80% of the procedure in 40 min in the last 2 mo of training. The combined learning curve of all the fellows and the change point analysis showed a significant change occurs at 94 procedures. Using the moving average curve, we have shown 114 procedures are needed to achieve 80% completion rate in 35 min in majority of the fellows. CONCLUSIONS: Colorectal surgery fellows were observed to achieve screening colonoscopy competency approximately between 94 and 114 procedures. In the era of working time restrictions, prospective documentation of individual trainee performance may allow tailored training based on observed competency.

Assessment of Colon Cancer Literacy in screening colonoscopy patients: a validation study.

BACKGROUND: Few, if any, instruments assess disease-specific health literacy in colon cancer patients. We aimed to validate the Assessment of Colon Cancer Literacy (ACCL) compared with a standard health literacy test, the Newest Vital Sign (NVS). MATERIALS AND METHODS: A convenience sample of screening colonoscopy patients was surveyed. General health literacy was assessed with the NVS and colon cancer literacy with the ACCL. Contingency table analysis was performed. Results are frequency (proportion) or mean. RESULTS: Sixty-one subjects completed our survey, mean age 64 ± 9 y, 33 (54%) were women, 28 (46%) had a college degree, 38 (62%) had prior colonoscopy, and 19 (31%) worked in healthcare. The sensitivity and specificity of NVS to identify limited colon cancer literacy was 45.7% and 86.7%, respectively, while the sensitivity and specificity of ACCL to identify limited general health literacy was 91.3% and 34.2%, respectively. CONCLUSIONS: The ACCL is a valid, sensitive measure of health literacy. Furthermore, given its focus on clinically relevant content, this instrument may facilitate discussion of diagnosis, treatment, and prognosis with colon cancer patients. ACCL is a novel, valid health literacy instrument that may aid gastroenterologists, colorectal surgeons, and medical oncologists in optimizing patient education.

Long-term direct costs before and after proctocolectomy for ulcerative colitis: a population-based study in Olmsted County, Minnesota.

PURPOSE: This study was designed to test the hypothesis that patients undergoing definitive surgery for chronic ulcerative colitis have reduced direct medical costs after, as compared with before, total proctocolectomy. METHODS: A population-based cohort of patients who underwent proctocolectomy for ulcerative colitis from 1988 to 2007 was identified using the Rochester Epidemiology Project. Total direct healthcare costs were estimated from an administrative database. The primary outcome was the observed cost difference between the two-year period before surgery and the two-year period after a surgery/recovery period (surgery + 180 days). Statistical significance was assessed using paired t-tests and bootstrapping methods. Demographic data were presented as median (interquartile range) or frequency (proportion). Mean costs are reported in 2007 constant dollars. RESULTS: Sixty patients were Olmsted County, Minnesota, residents at the time of surgery and for the entire period of observation. Overall 40 patients (66%) were men, median age was 42 (range, 31-52) years, and duration of median colitis was four (range, 1-11) years. Operations included ileal pouch-anal anastomosis (n = 45, mean cost of surgery/recovery period = $50,530) and total proctocolectomy with Brooke ileostomy (n = 15, mean cost of surgery/recovery period = $39,309). In the pouch subgroup, direct medical costs on average were reduced by $9,296 (P < 0.001, bootstrapped 95% confidence interval: $324-$15,628) during the two years after recovery. In the Brooke ileostomy subgroup, direct medical costs on average were reduced by $12,529 (P < 0.001, bootstrapped 95% confidence interval: $6,467-$18,688) in the two years after recovery. CONCLUSION: Surgery for chronic ulcerative colitis resulted in reduced direct costs in the two years after surgical recovery. These observations suggest that surgical intervention for ulcerative colitis is associated with long-term economic benefit.