Hospital Costs Following Surgical Complications: A Value-driven Outcomes Analysis of Cost Savings Due to Complication Prevention.

OBJECTIVE: Surgical complications have substantial impact on healthcare costs. We propose an analysis of the financial impact of postoperative complications. SUMMARY OF BACKGROUND DATA: Both complications and preoperative patient risk have been shown to increase costs following surgery. The extent of cost increase due to specific complications has not been well described. METHODS: A single institution's American College of Surgeons National Surgical Quality Improvement Program data was queried from 2012 to 2018 and merged with institutional cost data for each encounter. A mixed effects multivariable generalized linear model was used to estimate the mean relative increase in hospital cost due to each complication, adjusting for patient and procedure-level fixed effects clustered by procedure. Potential savings were calculated based on projected decreases in complication rates and theoretical hospital volume. RESULTS: There were 11,897 patients linked between the 2 databases. The rate of any American College of Surgeons National Surgical Quality Improvement Program complication was 11.7%. The occurrence of any complication resulted in a 1.5-fold mean increase in direct hospital cost [95% confidence interval (CI) 1.49-1.58]. The top 6 most costly complications were postoperative septic shock (4.0-fold, 95% CI 3.58-4.43) renal insufficiency/failure (3.3-fold, 95% CI 2.91-3.65), any respiratory complication (3.1-fold, 95% CI 2.94-3.36), cardiac arrest (3.0-fold, 95% CI 2.64-3.46), myocardial infarction (2.9-fold, 95% CI 2.43-3.42) and mortality within 30 days (2.2-fold, 95% CI 2.01-2.48). Length of stay (6.5 versus 3.2 days, P < 0.01), readmission rate (29.1% vs 3.1%, P < 0.01), and discharge destination outside of home (20.5% vs 2.7%, P < 0.01) were significantly higher in the population who experienced complications. CONCLUSIONS: Decreasing complication rates through preoperative optimization will improve patient outcomes and lead to substantial cost savings.

Comparison of Patient Outcomes Among Integrated Residency Versus Fellowship-trained Vascular Surgeons.

OBJECTIVE: This study aims to evaluate whether graduates of integrated vascular surgery residency (IVSR) programs achieve similar surgical outcomes in clinical practice as compared to graduates of vascular surgery fellowships (VSF). SUMMARY OF BACKGROUND DATA: Early sub-specialization through IVSR programs decreases the total years of surgical training. However, it is unclear whether IVSR graduates achieve comparable outcomes to fellowship-trained surgeons once in clinical practice. METHODS: We identified all vascular surgeons who finished IVSR and VSF programs between 2013-2017 using American Board of Surgery data, which was linked to the Vascular Quality Initiative registry (2013-2019) to evaluate provider-specific clinical outcomes following carotid, lower extremity, and aortic aneurysm repair procedures. The association between training models and the composite outcome of 1-year mortality, major adverse cardiac events and/or other major complications were analyzed using mixed-effects logistic regression models. RESULTS: A total of 338 surgeons (31% IVSR, 69% VSF) submitted cases into the Vascular Quality Initiative registry, including 8155 carotid, 21,428 lower extremity, and 5800 aortic aneurysm repair procedures. Composite 1-year outcome rates were comparable between IVSR and VSF-trained surgeons following carotid endarterectomy (8%-IVSR vs 7%-VSF), lower extremity revascularization (19%-IVSR vs 16%-VSF), and aortic aneurysm repair (13%-IVSR vs 13%-VSF) procedures. These findings among IVSR-trained surgeons persisted following risk adjustment for severity of patient disease and indications for undertaking carotid [aOR: 1.04 (0.84-1.28)], lower extremity [aOR: 1.03 (0.84-1.26)], and aortic [aOR: 0.96 (0.76-1.21)] procedures when compared to VSF-trained surgeons. CONCLUSIONS: Despite fewer total years of training, graduates of IVSR programs achieve equivalent surgical outcomes as fellowship-trained vascular surgeons once in practice. These results suggest that concerns about differential competence among integrated residency graduates are not warranted.

Value Analysis of Methods of Inguinal Hernia Repair.

OBJECTIVE: Value is defined as health outcomes important to patients relative to cost of achieving those outcomes: Value = Quality/Cost. For inguinal hernia repair, Level 1 evidence shows no differences in long-term functional status or recurrence rates when comparing surgical approaches. Differences in value reside within differences in cost. The aim of this study is to compare the value of different surgical approaches to inguinal hernia repair: Open (Open-IH), Laparoscopic (Lap-IH), and Robotic (R-TAPP). METHODS: Variable and fixed hospital costs were compared among consecutive Open-IH, Lap-IH, and R-TAPP repairs (100 each) performed in a university hospital. Variable costs (VC) including direct materials, labor, and variable overhead ($/min operating room [OR] time) were evaluated using Value Driven Outcomes, an internal activity-based costing methodology. Variable and fixed costs were allocated using full absorption costing to evaluate the impact of surgical approach on value. As cost data is proprietary, differences in cost were normalized to Open-IH cost. RESULTS: Compared to Open-IH, VC for Lap-IH were 1.02X higher (including a 0.81X reduction in cost for operating room [OR] time). For R-TAPP, VC were 2.11X higher (including 1.36X increased costs for OR time). With allocation of fixed cost, a Lap-IH was 1.03X more costly, whereas R-TAPP was 3.18X more costly than Open-IH. Using equivalent recurrence as the quality metric in the value equation, Lap-IH decreases value by 3% and R-TAPP by 69% compared to Open-IH. CONCLUSIONS: Use of higher cost technology to repair inguinal hernias reduces value. Incremental health benefits must be realized to justify increased costs. We expect payors and patients will incorporate value into payment decisions.

Measuring the migration of surgical specialists.

BACKGROUND: The lack of access to essential surgical care in low-income countries is aggravated by emigration of locally-trained surgical specialists to more affluent regions. Yet, the global diaspora of surgeons, obstetricians, and anesthesiologists from low-income and middle-income countries has never been fully described and compared with those who have remained in their country of origin. It is also unclear whether the surgical workforce is more affected by international migration than other medical specialists. In this study, we aimed to quantify the proportion of surgical specialists originating from low-income and middle-income countries that currently work in high-income countries. METHODS: We retrieved surgical workforce data from 48 high-income countries and 102 low-income and middle-income countries using the database of the World Health Organization Global Surgical Workforce. We then compared this domestic workforce with more granular data on the country of initial medical qualification of all surgeons, anesthesiologists, and obstetricians made available for 14 selected high-income countries to calculate the proportion of surgical specialists working abroad. RESULTS: We identified 1,118,804 specialist surgeons, anesthesiologists, or obstetricians from 102 low-income and middle-income countries, of whom 33,021 (3.0%) worked in the 14 included high-income countries. The proportion of surgical specialists abroad was greatest for the African and South East Asian regions (12.8% and 12.1%). The proportion of specialists abroad was not greater for surgeons, anesthesiologists, or obstetricians than for physicians and other medical specialists (P = .465). Overall, the countries with the lowest remaining density of surgical specialists were also the countries from which the largest proportion of graduates were now working in high-income countries (P = .011). CONCLUSION: A substantial proportion of all surgeons, anesthesiologists, and obstetricians from low-income and middle-income countries currently work in high-income countries. In addition to decreasing migration from areas of surgical need, innovative strategies to retain and strengthen the surgical workforce could involve engaging this large international pool of surgical specialists and instructors.

Home Disposal Kits for Leftover Opioid Medications After Surgery: Do They Work?

BACKGROUND: Postoperative overprescribing is common, and many patients will have excess medications. An effective method to encourage disposal is lacking. We hypothesized that a convenient home disposal kit will result in more appropriate disposal of excess opioids. MATERIALS AND METHODS: We conducted a single-center prospective observational pilot study to evaluate the effectiveness of a postoperative opioid disposal kit. Patients in the intervention group received an opioid disposal kit and educational handout before discharge from the hospital. At the first follow-up visit, patients completed a survey in which they reported the remaining amount of pain medications from their original prescription and their plan for the excess medication. Patients were asked about risk factors for chronic opioid use. We used multivariable Poisson regression to identify independent factors associated with an increased likelihood of appropriate opioid disposal. RESULTS: The survey was offered to 904 patients with a response rate of 91.7%. After excluding those with missing data, 571 patients were included in the study. Overall, 83 (14.5%) patients never filled an opioid prescription, and 286 (60.0%) patients had tablets remaining at the time of the follow-up visit. Among those with tablets remaining, 52 received a home disposal kit, whereas 234 patients with tablets remaining did not. Patients who received the kit were more likely to dispose of opioid medications (54.9% versus 34.8%, relative risk = 1.8, 95% CI 1.3-2.5). No confounders were identified during multivariable analysis that increased a patient's likelihood of disposing excess medications. CONCLUSIONS: The provision of a convenient home disposal kit postoperatively increased patient-reported opioid disposal.

Outcomes and Costs for Major Lung Resection in the United States: Which Patients Benefit Most From High-Volume Referral?

BACKGROUND: Accountable care organizations are designed to improve value by decreasing costs and maintaining quality. Strategies to maximize value are needed for high-risk surgery. We wanted to understand whether certain patient groups were differentially associated with better outcomes at high-volume hospitals in terms of quality and cost. METHODS: In all, 37,746 patients underwent elective major lung resection in 1,273 hospitals in the Nationwide Inpatient Sample from 2007 to 2011. Patients were stratified by hospital volume quartile and substratified by preoperative mortality risk, age, and chronic obstructive pulmonary disease status. Mortality was evaluated using clustered multivariable hierarchical logistic regression controlling for patient comorbidity, demographics, and procedure. Adjusted cost was evaluated using generalized linear models fit to a gamma distribution. RESULTS: Patients were grouped into volume quartiles based on cases per year (less than 21, 21 to 40, 40 to 78, and more than 78). Patient characteristics and procedure mix differed across quartiles. Overall, mortality decreased across volume quartiles (lowest 1.9% versus highest 1.1%, p < 0.0001). Patients aged more than 80 years were associated with greater absolute and relative mortality rates than patients less than 60 years old in highest volume versus lowest volume hospitals (age more than 80 years, 4.2% versus 1.3%, p < 0.0001, odds ratio 3.31, 95% confidence interval: 1.89 to 5.80; age less than 60 years, 1.0% versus 0.8%, p = 0.19, odds ratio 1.38, 95% confidence interval: 0.74 to 2.56). Patients with high preoperative risk (more than 75th percentile) were also associated with lower absolute mortality in high-volume hospitals. Adjusted costs were not significantly different across quartiles or patient strata. CONCLUSIONS: Older patients show a significantly stronger volume-outcome relationship than patients less than 60 years of age. Costs were equivalent across volume quartile and patient strata. Selective patient referral may be a strategy to improve outcomes for elderly patients undergoing lung resection.

Measuring and Comparing the Cost-Effectiveness of Surgical Care Delivery in Low-Resource Settings: Cleft Lip and Palate as a Model.

Cleft lip and palate (CLP) care is the longest sustained global effort in humanitarian surgical care. However, the relative cost-effectiveness of surgical delivery approaches remains largely unknown. We assessed the cost-effectiveness of two strategies of CLP surgical care delivery in low resource settings: medical mission and comprehensive care center. We evaluated the medical records and costs for 17 India-based medical missions and a Comprehensive Cleft Care Center in Guwahati, India, from Operation Smile, a humanitarian nongovernmental organization. Age, sex, diagnosis, and procedures were extracted and cost/Disability-Adjusted Life Year (DALY) averted was calculated using a provider's perspective. The disability weights for CLP from the Global Burden of Disease (GBD) 2010 update were used as the reference case. Sensitivity analysis was performed using various disability weights, age-weighting, discounting, and cost perspective. The medical missions treated 3503 patients for first-time cleft procedures and averted 6.00 DALYs per intervention with a cost-effectiveness of $247.42/DALY. The care center cohort included 2778 patients with first-time operations for CLP and averted a mean of 5.96 DALYs per intervention with a cost-effectiveness of $189.81/DALY. The Incremental Cost-Effectiveness Ratio (ICER) of choosing medical mission over care center is $462.55. The care center provides cleft care with a higher cost-effectiveness, although both models are highly cost-effective in India, in accordance with WHO guidelines. Compared to other global health interventions, cleft care is very cost-effective and investment in cleft surgery might be realistic and achievable in similar resource-constrained environments.

Readmission destination and risk of mortality after major surgery: an observational cohort study.

BACKGROUND: Hospital readmissions are common after major surgery, although it is unknown whether patients achieve improved outcomes when they are readmitted to, and receive care at, the index hospital where their surgical procedure was done. We examined the association between readmission destination and mortality risk in the USA in Medicare beneficiaries after a range of common operations. METHODS: By use of claims data from Medicare beneficiaries in the USA between Jan 1, 2001, and Nov 15, 2011, we assessed patients who needed hospital readmission within 30 days after open abdominal aortic aneurysm repair, infrainguinal arterial bypass, aortobifemoral bypass, coronary artery bypass surgery, oesophagectomy, colectomy, pancreatectomy, cholecystectomy, ventral hernia repair, craniotomy, hip replacement, or knee replacement. We used logistic regression models incorporating inverse probability weighting and instrumental variable analysis to measure associations between readmission destination (index vs non-index hospital) and risk of 90 day mortality for patients who underwent surgery who needed hospital readmission. FINDINGS: 9,440,503 patients underwent one of 12 major operations, and the number of patients readmitted or transferred back to the index hospital where their operation was done varied from 186,336 (65·8%) of 283,131 patients who were readmitted after coronary artery bypass grafting, to 142,142 (83·2%) of 170,789 patients who were readmitted after colectomy. Readmission was more likely to be to the index hospital than to a non-index hospital if the readmission was for a surgical complication (189,384 [23%] of 834,070 patients readmitted to index hospital vs 36,792 [13%] of 276,976 patients readmitted non-index hospital, p<0·0001). Readmission to the index hospital was associated with a 26% lower risk of 90 day mortality than was readmission to a non-index hospital, with inverse probability weighting used to control for selection bias (odds ratio [OR] 0·74, 95% CI 0·66-0·83). This effect was significant (p<0·0001) for all procedures in inverse probability-weighted models, and was largest for patients who were readmitted after pancreatectomy (OR 0·56, 95% CI 0·45-0·69) and aortobifemoral bypass (OR 0·69, 95% CI 0·61-0·77). By use of hospital-level variation among regional index hospital readmission rates as an instrument, instrumental variable analysis showed that the patients with the highest probability of returning to the index hospital had 8% lower risk of mortality (OR 0·92 95% CI 0·91-0·94) than did patients who were less likely to be readmitted to the index hospital. INTERPRETATION: In the USA, patients who are readmitted to hospital after various major operations consistently achieve improved survival if they return to the hospital where their surgery took place. These findings might have important implications for cost-effectiveness-driven regional centralisation of surgical care. FUNDING: None.

Will there be a good general surgeon when you need one? (Part II) Solutions and taking back general surgery.

INTRODUCTION: Multiple reports have cited the looming shortage of physicians over the next decades related to increasing demand, an aging of the population, and a stagnant level in the production of new physicians. General surgery shares in this problem, and the specialty is "stressed" by a declining workforce related to increasing specialization that leaves gaps in emergency, trauma, and rural surgical care. SUMMARY: The Society of Surgery of the Alimentary Tract (SSAT) Public Policy and Advocacy Committee sponsored panel discussions regarding the general surgery workforce shortage at the Digestive Disease Week 2012 and 2013 meetings. The 2012 panel focused on defining the problem. This is the summation of the series with the solutions to the general surgery workforce shortage as offered by the 2013 panel.

An efficient risk adjustment model to predict inpatient adverse events after surgery.

BACKGROUND: Risk adjustment is an important component of surgical outcomes and quality analyses. Current models include numerous preoperative variables; however, the relative contribution of these variables may be limited. This research seeks to identify a model with the fewest number of variables necessary to perform an adequate risk adjustment to predict any inpatient adverse event for use in resource-limited settings. METHODS: All patients from the National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2010 were included. Outcomes were inpatient mortality or any surgical complication captured by NSQIP. Models were built by sequential addition of preoperative risk variables selected by their area under the receiver operator characteristic curve (AUC). RESULTS: Among 863,349 patients, the single variable with the highest AUC was American Society of Anesthesiologists (ASA) classification (AUC = 0.7127). AUC values reached 0.7923 with five variables (ASA classification, wound classification, functional status prior to surgery, albumin, and age) and 0.7945 with six variables. The sixth variable was one of the following: alkaline phosphatase, weight loss, principal anesthesia technique, gender, or emergency status. The model with the highest discrimination that did not require laboratories included ASA classification, functional status prior to surgery, wound classification, and age (AUC = 0.7810). Including all 66 preoperative variables produced little additional gain (AUC = 0.8006). CONCLUSIONS: Six variables are sufficient to develop a risk adjustment tool for inpatient surgical mortality and morbidity. This research has important implications for the field of surgical outcomes research by improving efficiency of data collection. This limited model can aid the expansion of risk-adjusted analyses to resource-limited settings worldwide.

A pilot comparison of standardized online surgical curricula for use in low- and middle-income countries.

IMPORTANCE: Surgical conditions are an important component of global disease burden, due in part to critical shortages of adequately trained surgical providers in low- and middle-income countries. OBJECTIVES: To assess the use of Internet-based educational platforms as a feasible approach to augmenting the education and training of surgical providers in these settings. DESIGN, SETTING, AND PARTICIPANTS: Access to two online curricula was offered to 75 surgical faculty and trainees from 12 low- and middle-income countries for 60 days. The Surgical Council on Resident Education web portal was designed for general surgery trainees in the United States, and the School for Surgeons website was built by the Royal College of Surgeons in Ireland specifically for the College of Surgeons of East, Central and Southern Africa. Participants completed an anonymous online survey detailing their experiences with both platforms. Voluntary respondents were daily Internet users and endorsed frequent use of both print and online textbooks as references. MAIN OUTCOMES AND MEASURES: Likert scale survey questionnaire responses indicating overall and content-specific experiences with the Surgical Council on Resident Education and School for Surgeons curricula. RESULTS: Survey responses were received from 27 participants. Both online curricula were rated favorably, with no statistically significant differences in stated willingness to use and recommend either platform to colleagues. Despite regional variations in practice context, there were few perceived hurdles to future curriculum adoption. CONCLUSIONS AND RELEVANCE: Both the Surgical Council on Resident Education and School for Surgeons educational curricula were well received by respondents in low- and middle-income countries. Although one was designed for US surgical postgraduates and the other for sub-Saharan African surgical providers, there were no significant differences detected in participant responses between the two platforms. Online educational resources have promise as an effective means to enhance the education of surgical providers in low- and middle-income countries.

Failure to rescue in safety-net hospitals: availability of hospital resources and differences in performance.

IMPORTANCE: Failure to rescue (FTR), the mortality rate among surgical patients with complications, is an emerging quality indicator. Hospitals with a high safety-net burden, defined as the proportion of patients covered by Medicaid or uninsured, provide a disproportionate share of medical care to vulnerable populations. Given the financial strains on hospitals with a high safety-net burden, availability of clinical resources may have a role in outcome disparities. OBJECTIVES: To assess the association between safety-net burden and FTR and to evaluate the effect of clinical resources on this relationship. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort of 46,519 patients who underwent high-risk inpatient surgery between January 1, 2007, and December 31, 2010, was assembled using the Nationwide Inpatient Sample. Hospitals were divided into the following 3 safety-net categories: high-burden hospitals (HBHs), moderate-burden hospitals (MBHs), and low-burden hospitals (LBHs). Bivariate and multivariate analyses controlling for patient, procedural, and hospital characteristics, as well as clinical resources, were used to evaluate the relationship between safety-net burden and FTR. MAIN OUTCOMES AND MEASURES: FTR. RESULTS: Patients in HBHs were younger (mean age, 65.2 vs 68.2 years; P = .001), more likely to be of black race (11.3% vs 4.2%, P < .001), and less likely to undergo an elective procedure (39.3% vs 48.6%, P = .002) compared with patients in LBHs. The HBHs were more likely to be large, major teaching facilities and to have high levels of technology (8.6% vs 4.0%, P = .02), sophisticated internal medicine (7.7% vs 4.3%, P = .10), and high ratios of respiratory therapists to beds (39.7% vs 21.1%, P < .001). However, HBHs had lower proportions of registered nurses (27.9% vs 38.8%, P = .02) and were less likely to have a positron emission tomographic scanner (15.4% vs 22.0%, P = .03) and a fully implemented electronic medical record (12.6% vs 17.8%, P = .03). Multivariate analyses showed that HBHs (adjusted odds ratio, 1.35; 95% CI, 1.19-1.53; P < .001) and MBHs (adjusted odds ratio, 1.15; 95% CI, 1.05-1.27; P = .005) were associated with higher odds of FTR compared with LBHs, even after adjustment for clinical resources. CONCLUSIONS AND RELEVANCE: Despite access to resources that can improve patient rescue rates, HBHs had higher odds of FTR, suggesting that availability of hospital clinical resources alone does not explain increased FTR rates.

Shortage of doctors, shortage of data: a review of the global surgery, obstetrics, and anesthesia workforce literature.

INTRODUCTION: The global surgery workforce is in crisis in many low- and middle-income countries (LMICs). The shortage of surgery, obstetrics, and anesthesia providers is an important cause of the unmet need for surgical care in LMICs. The goal of this paper is to summarize the available literature about surgical physicians in LMICs and to describe ongoing initiatives to supplement the existing surgical workforce data. METHODS: We performed a systematic search and literature review of the English-language literature regarding the number of surgeons, obstetrician-gynecologists, and anesthesiologists practicing in LMICs. RESULTS: Literature describing the number of surgeons, obstetricians, and anesthesiologists practicing in LMICs represents a small minority of LMICs, and indicates consistently low levels of surgical physicians. Our literature search yielded comprehensive data for only six countries. No national data were found for 23 of the 57 countries considered by the World Health Organization (WHO) to be in health workforce 'crisis.' Across LMICs, general surgeon density ranged from 0.13 to 1.57 per 100,000 population, obstetrician density ranged from 0.042 to 12.5 per 100,000, and anesthesiologist density ranged from 0 to 4.9 per 100,000. Total anesthesiologist, obstetrician, and surgeon density was significantly correlated with gross domestic product (GDP) per capita (r (2) = 0.097, p = 0.0002). CONCLUSION: The global surgery workforce is in crisis, yet is poorly characterized by the current English-language literature. There is a critical need for systematically collected, national-level data regarding surgery providers in LMICs to guide improvements in surgery access and care. The Harvard Global Surgery Workforce Initiative and the WHO global surgical workforce database are working to address this need by surveying Ministries of Health and surgical professional organizations around the world.

Cost-effectiveness of preoperative nasal mupirocin treatment in preventing surgical site infection in patients undergoing total hip and knee arthroplasty: a cost-effectiveness analysis.

OBJECTIVE: To perform a cost-effectiveness analysis to evaluate preoperative use of mupirocin in patients with total joint arthroplasty (TJA). DESIGN: Simple decision tree model. SETTING: Outpatient TJA clinical setting. PARTICIPANTS: Hypothetical cohort of patients with TJA. INTERVENTIONS: A simple decision tree model compared 3 strategies in a hypothetical cohort of patients with TJA: (1) obtaining preoperative screening cultures for all patients, followed by administration of mupirocin to patients with cultures positive for Staphylococcus aureus; (2) providing empirical preoperative treatment with mupirocin for all patients without screening; and (3) providing no preoperative treatment or screening. We assessed the costs and benefits over a 1-year period. Data inputs were obtained from a literature review and from our institution's internal data. Utilities were measured in quality-adjusted life-years, and costs were measured in 2005 US dollars. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio. RESULTS: The treat-all and screen-and-treat strategies both had lower costs and greater benefits, compared with the no-treatment strategy. Sensitivity analysis revealed that this result is stable even if the cost of mupirocin was over $100 and the cost of SSI ranged between $26,000 and $250,000. Treating all patients remains the best strategy when the prevalence of S. aureus carriers and surgical site infection is varied across plausible values as well as when the prevalence of mupirocin-resistant strains is high. CONCLUSIONS: Empirical treatment with mupirocin ointment or use of a screen-and-treat strategy before TJA is performed is a simple, safe, and cost-effective intervention that can reduce the risk of SSI. S. aureus decolonization with nasal mupirocin for patients undergoing TJA should be considered. LEVEL OF EVIDENCE: Level II, economic and decision analysis.

Adverse events do not outweigh benefits of combination therapy for Crohn's disease in a decision analytic model.

BACKGROUND & AIMS: The Study of Biologic and Immunomodulator-Naïve Patients With Crohn's Disease (SONIC) showed that combination therapy with infliximab and azathioprine (IFX/AZA) is more effective than treatment with IFX alone. Numbers and types of adverse events were roughly equivalent among groups, although enrollment was limited, so it was not clear how rare adverse events might affect overall outcomes in practice. We sought to define the frequency at which a rare adverse event would have to occur for the risks of combination therapy to outweigh the benefits of treatment. METHODS: We constructed a decision model to compare the risks and benefits of IFX/AZA with IFX monotherapy. Model parameters were taken from SONIC and other published literature. The base-case analysis was patients with active Crohn's disease who are naïve to both medications (similar to those in SONIC) who were treated for 1 year. We used sensitivity analyses to determine the thresholds at which the risks of side effects from IFX/AZA outweigh its benefits. RESULTS: During 1 year, the benefits of IFX/AZA would outweigh the risks, unless serious infections occurred in 20% or more of the population or lymphoma in 3.9% or more. These thresholds are 5-fold and 65-fold higher than base-case estimates, respectively. CONCLUSIONS: On the basis of data from 1 year of SONIC, the combination of IFX/AZA was more effective than IFX alone in patients with Crohn's disease who are naïve to either drug. For the risks of combination therapy to outweigh the benefits in this time frame, the incidence of serious adverse events would have to be higher than seems clinically realistic.

Small area variation in endoscopic sinus surgery rates among the Medicare population.

OBJECTIVES: To determine endoscopic sinus surgery (ESS) rates among 306 hospital referral regions (HRRs) and to assess whether variability in ESS rates correlates with population density of beneficiaries, per capita number of otolaryngologists within an HRR, or proportion of patients diagnosed as having chronic rhinosinusitis. DESIGN: Retrospective cohort analysis. SETTING: Academic research. PATIENTS: A 20% sample of Medicare beneficiaries aged 65 to 99 years diagnosed as having chronic rhinosinusitis and undergoing ESS in 2006. MAIN OUTCOME MEASURES: Variation in per capita rates of chronic rhinosinusitis diagnosis and ESS in 2006. RESULTS: Among 306 HRRs nationally, ESS was performed in sufficient volume to be reported in 148 HRRs. Per capita ESS rates (sinus surgical procedures per 1000 beneficiaries) varied 5-fold, from 0.02 to 0.10, with significant variations within states. Nationally, no geographic or regional patterns were noted, and high-use HRRs were often geographically proximal to low-use HRRs. Higher rates of chronic rhinosinusitis diagnosis and more beneficiaries in particular HRRs did not predict increased ESS within the HRRs. CONCLUSIONS: Local ESS rates in the Medicare population vary considerably across the United States. Variability in high-use vs low-use regions seems to be random and independent of climate or the number of beneficiaries diagnosed as having chronic rhinosinusitis. Given that the appropriate rate of sinus surgery is unknown, this study points to the need for identifying and adopting more rigorous clinical criteria for ESS.

Perforated appendicitis among rural and urban patients: implications of access to care.

OBJECTIVE: To determine whether rural patients are more likely to present with perforated appendicitis compared with urban patients. BACKGROUND: Appendiceal perforation has been associated with increased morbidity, length of hospital stay, and overall health care costs. Recent arguments suggest that high rates of appendiceal rupture may be unrelated to the quality of hospital care, and rather associated with inadequate access to surgical care. METHODS: We performed a retrospective cohort study of 122,990 patients with acute appendicitis from the Nationwide Inpatient Sample from 2003 to 2004. International Classification of Diseases diagnosis 9 (ICD-9) codes were used to determine appendiceal perforation. Urban influence codes from the US Department of Agriculture were used to determine rural versus urban status. Univariate and multivariate analyses were used to determine patient and hospital factors associated with perforation. RESULTS: Overall, 32.07% of patients presented with perforation. Rural patients were more likely than urban patients to present with perforation (35.76% vs. 31.48%). Factors associated with perforation in multivariate analysis were age more than 40 years, male gender, transfer from another facility, black race, poorest 25th percentile, Charlson score of 3 or higher, and rural residence. Thirty percent of rural patients were treated in urban hospitals. Rural patients treated at urban hospitals were more likely to present with perforation compared with rural patients treated at rural hospitals (OR = 1.23). CONCLUSIONS: Patients from rural areas have higher rates of perforation with acute appendicitis than urban patients. This difference persists when accounting for other factors associated with perforation. These differences in perforation rates suggest disparities in access to timely surgical care.

Trends in endoscopic sinus surgery rates in the Medicare population.

OBJECTIVE: To examine the trends in rates of endoscopic sinus surgery, open sinus procedures (open sinus surgery), and the prevalence of diagnosis of chronic rhinosinusitis in the Medicare population from 1998 to 2006. DESIGN: Retrospective cohort analysis. PATIENTS: Twenty-percent sample of Medicare beneficiaries aged 65 to 99 years for the years 1998 to 2006. MAIN OUTCOME MEASURES: Change in per capita annual rates of endoscopic sinus surgery, open sinus surgery, and chronic rhinosinusitis diagnosis among Medicare beneficiaries. RESULTS: From 1998 to 2006, the rate of patients undergoing endoscopic sinus surgery per 1000 Medicare beneficiaries increased by 20%, from 0.72 (95% confidence interval [CI], 0.70-0.74) to 0.92 (95% CI, 0.89-0.95). Over the same period, the rate of open sinus surgery declined 40%, from 0.20 (95% CI, 0.19-0.21) to 0.11 (95% CI, 0.10-0.12). However, the per capita rate of beneficiaries diagnosed as having chronic rhinosinusitis declined by 1.4% over the study period. Further analysis by age cohort revealed significantly higher rates of surgery and diagnosis rates in the 65- to 69-year-old beneficiaries relative to older age groups. Over the study period, the per capita rate of diagnosis of chronic rhinosinusitis declined or remained stable across age groups. Despite this, all age groups showed increases in endoscopic sinus surgery rates. CONCLUSIONS: Our findings indicate that endoscopic sinus surgery is increasingly becoming the mainstay of chronic rhinosinusitis management in the Medicare population. Because of the uncertainty regarding the outcomes of surgical vs medical management, the root causes of the observed increase in endoscopic sinus surgery rates need to be investigated. Given that sinusitis is a common diagnosis necessitating physician visits, comparative effectiveness studies examining medical vs surgical management would be warranted.

Causes of late mortality after endovascular and open surgical repair of infrarenal abdominal aortic aneurysms.

INTRODUCTION: Several reports suggest unexpectedly high rates of late abdominal aortic aneurysm (AAA) rupture occur after endovascular AAA repair (EVAR). However, a population-based study examining causes of late death after EVAR vs open surgical repair has not been performed. METHODS: We performed a retrospective cohort study of patients undergoing infrarenal AAA repair using information from the Medicare inpatient hospital discharge records (MedPAR files), physician claim files (Part B files, 20% sample), and Medicare Denominator Files for the years 2001 to 2004. Using the Social Security Death Index, we identified all "late" deaths, defined as deaths occurring >30 days and after hospital discharge. We used the National Death Index to identify cause of death information; in particular, those deaths that were likely caused by late rupture. We compared causes of late death and survival between EVAR and open repair using Wilcoxon log-rank and rank-sum tests. RESULTS: Between 2001 and 2004, 13,971 patients underwent AAA repair (6119 EVAR, 7852 open repair). After a mean follow-up of 1.6 years in the EVAR cohort and 1.9 years in the open cohort, mortality rates were similar across repair type (15.4% EVAR, 15.9% open repair), with an adjusted odds ratio for death after open repair of 0.98 (95% confidence interval, 0.90-1.07). Of the 2194 documented deaths, 523 occurred before discharge or 30 days and after hospital discharge. Cause of death information for the 1671 late deaths was available from the National Death Index for 1515 (91%). The 15 most common codes for causes of late death were dominated by cardiac disease (atherosclerotic heart disease, acute myocardial infarction) and pulmonary disease (lung cancer, respiratory failure). Causes of late death with specific mention of aneurysm were identified in 37 patients (2.4% of all deaths), but this event was not more common in EVAR or open repair (15 [0.3%] in the EVAR group, 22 [0.3%], in the open repair group; P = .71). CONCLUSIONS: Late deaths from aneurysm rupture after EVAR or open repair appear to be relatively infrequent and similarly distributed across procedure type. Our results emphasize that the effectiveness of EVAR is comparable to open AAA repair in preventing aneurysm-related death.