Validation of the AJCC 8th Edition Breast Cancer Prognostic Staging System in Legacy Alliance Trials (AFT-01).

BACKGROUND: The 8th edition American Joint Committee on Cancer staging system combined anatomic stage (AS) with receptor status and grade to create prognostic stage (PS). PS has been validated in single-institution and cancer registry studies; however, missing human epidermal growth factor receptor 2 (HER2) status and variable treatment and follow-up create limitations. OBJECTIVE: Our objective was to compare the relative prognostic ability of PS versus AS to predict survival using breast cancer clinical trial data. METHODS: Women with non-metastatic breast cancer enrolled in six Alliance for Clinical Trials in Oncology trials were included (enrollment years 1997-2010). AS and PS were constructed using pathological tumor size, nodal status, estrogen receptor (ER), progesterone receptor (PR), HER2 status, and grade. Unadjusted Cox proportional hazard models were estimated to predict overall survival within 5 years, with AS and PS as predictor variables. The relative predictive power of staging models was assessed by comparing Harrell concordance indices (C-indices). Kaplan-Meier-based mortality estimates were compared by stage. RESULTS: Overall, 6924 women were included (median age 53 years); 45.2% were diagnosed with ER+/PR+/HER2- tumors, 26.2% with HER2+ tumors, and 17.1% with ER-/PR-/HER2- tumors. Median follow-up time was 5 years (interquartile range 2.95-5.00). PS significantly improved predictive performance (C-index 0.721) for overall survival compared with AS (0.700) (p = 0.020). Kaplan-Meier hazard estimates suggested PS did not distinguish mortality risk between patients with IIB and IIIA or IB and IIA disease. CONCLUSIONS: PS has significantly improved predictive performance for OS compared with AS. As systemic therapies evolve, it will be important to re-evaluate the prognostic staging system, particularly for patients with intermediate-stage cancers. CLINICALTRIALS: gov Identifier: NCT02171078.

The influence of anatomic stage and receptor status on first recurrence for breast cancer within 5 years (AFT-01).

BACKGROUND: Risk-stratified follow-up guidelines that account for the absolute risk and timing of recurrence may improve the quality and efficiency of breast cancer follow-up. The objective of this study was to assess the relationship of anatomic stage and receptor status with timing of the first recurrence for patients with local-regional breast cancer and generate risk-stratified follow-up recommendations. METHODS: The authors conducted a secondary analysis of 8007 patients with stage I-III breast cancer who enrolled in nine Alliance legacy clinical trials from 1997 to 2013 (ClinicalTrials.gov identifier NCT02171078). Patients who received standard-of-care therapy were included. Patients who were missing stage or receptor status were excluded. The primary outcome was days from the earliest treatment start date to the date of first recurrence. The primary explanatory variable was anatomic stage. The analysis was stratified by receptor type. Cox proportional-hazards regression models produced cumulative probabilities of recurrence. A dynamic programming algorithm approach was used to optimize the timing of follow-up intervals based on the timing of recurrence events. RESULTS: The time to first recurrence varied significantly between receptor types (p < .0001). Within each receptor type, stage influenced the time to recurrence (p < .0001). The risk of recurrence was highest and occurred earliest for estrogen receptor (ER)-negative/progesterone receptor (PR)-negative/Her2neu-negative tumors (stage III; 5-year probability of recurrence, 45.5%). The risk of recurrence was lower for ER-positive/PR-positive/Her2neu-positive tumors (stage III; 5-year probability of recurrence, 15.3%), with recurrences distributed over time. Model-generated follow-up recommendations by stage and receptor type were created. CONCLUSIONS: This study supports considering both anatomic stage and receptor status in follow-up recommendations. The implementation of risk-stratified guidelines based on these data has the potential to improve the quality and efficiency of follow-up.

Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01).

OBJECTIVE: We sought to evaluate local/regional recurrence rates after breast-conserving surgery in a cohort of patients enrolled in legacy trials of the Alliance for Clinical Trials in Oncology and to evaluate variation in recurrence rates by receptor subtype. BACKGROUND: Multiple randomized controlled trials have demonstrated equivalent survival between breast conservation and mastectomy, albeit with higher local/regional recurrence rates after breast conservation. However, absolute rates of local/regional recurrence have been declining with multi-modality treatment. METHODS: Data from 5 Alliance for Clinical Trials in Oncology legacy trials that enrolled women diagnosed with breast cancer between 1997 and 2010 were included. Women who underwent breast-conserving surgery and standard systemic therapies (n=4,404) were included. Five-year rates of local/regional recurrence were estimated from Kaplan-Meier curves. Patients were censored at the time of distant recurrence (if recorded as the first recurrence), death, or last follow-up. Multivariable Cox proportional hazards models were used to identify factors associated with time to local/regional recurrence, including patient age, tumor size, lymph node status, and receptor subtype. RESULTS: Overall 5-year recurrence was 4.6% (95% CI=4.0-5.4%). Five-year recurrence rates were lowest in those with ER+ or PR+ tumors (Her2+ 3.4% [95% CI 2.0-5.7%], Her2- 4.0% [95% CI 3.2-4.9%]) and highest in the triple-negative subtype (7.1% [95% CI 5.4-9.3%]). On multivariable analysis, increasing nodal involvement and triple-negative subtype were positively associated with recurrence ( P <0.0001). CONCLUSIONS: Rates of local/regional recurrence after breast conservation in women with breast cancer enrolled in legacy trials of the Alliance for Clinical Trials in Oncology are significantly lower than historic estimates. This data can better inform patient discussions and surgical decision-making.

Surveillance Imaging vs Symptomatic Recurrence Detection and Survival in Stage II-III Breast Cancer (AFT-01).

BACKGROUND: Guidelines for follow-up after locoregional breast cancer treatment recommend imaging for distant metastases only in the presence of patient signs and/or symptoms. However, guidelines have not been updated to reflect advances in imaging, systemic therapy, or the understanding of biological subtype. We assessed the association between mode of distant recurrence detection and survival. METHODS: In this observational study, a stage-stratified random sample of women with stage II-III breast cancer in 2006-2007 and followed through 2016 was selected, including up to 10 women from each of 1217 Commission on Cancer facilities (n = 10 076). The explanatory variable was mode of recurrence detection (asymptomatic imaging vs signs and/or symptoms). The outcome was time from initial cancer diagnosis to death. Registrars abstracted scan type, intent (cancer-related vs not, asymptomatic surveillance vs not), and recurrence. Data were merged with each patient's National Cancer Database record. RESULTS: Surveillance imaging detected 23.3% (284 of 1220) of distant recurrences (76.7%, 936 of 1220 by signs and/or symptoms). Based on propensity-weighted multivariable Cox proportional hazards models, patients with asymptomatic imaging compared with sign and/or symptom detected recurrences had a lower risk of death if estrogen receptor (ER) and progesterone receptor (PR) negative, HER2 negative (triple negative; hazard ratio [HR] = 0.73, 95% confidence interval [CI] = 0.54 to 0.99), or HER2 positive (HR = 0.51, 95% CI = 0.33 to 0.80). No association was observed for ER- or PR-positive, HER2-negative (HR = 1.14, 95% CI = 0.91 to 1.44) cancers. CONCLUSIONS: Recurrence detection by asymptomatic imaging compared with signs and/or symptoms was associated with lower risk of death for triple-negative and HER2-positive, but not ER- or PR-positive, HER2-negative cancers. A randomized trial is warranted to evaluate imaging surveillance for metastases results in these subgroups.

Driving Time to Trauma Centers for Children Living in Wisconsin.

INTRODUCTION: Trauma is the number 1 cause of death among children. Shorter distance to definitive trauma care has been correlated with better clinical outcomes. There are only a small number of pediatric trauma centers (PTC) designated by the American College of Surgeons, and the resources available to treat injured children at non-PTCs are limited. To guide resource allocation and advocacy efforts for pediatric trauma care in Wisconsin, we determined the precise distance to trauma centers for all children living in the state. METHODS: The 2010 US Census data was used to determine ZIP-centroid geolocation. The Wisconsin Department of Health Services trauma classification database was used to identify trauma facilities in Wisconsin. SAS routines invoking the Google Maps application programming interface were used to calculate the driving distance to each of the trauma facilities. We quantified the percentage of children living within 30- and 60-minute driving distances of level I-IV trauma centers. RESULTS: Just 31.3% of Wisconsin children live within a 30-minute drive of a level I PTC; 32.7% live within 30 minutes of a level II center; 81.3% within 30 minutes of a level III center; and 74.6% within 30 minutes of a level IV center. CONCLUSION: Two-thirds of children in Wisconsin live beyond a 30-minute driving distance of a level I PTC, but most children live within 30 minutes of level III and IV trauma centers. As the closest hospitals for most children, smaller trauma centers should be adequately resourced to provide pediatric trauma care.

Effect of Transfer Status on Outcomes of Emergency General Surgery Patients.

INTRODUCTION: Transferred emergency general surgery (EGS) patients are a vulnerable, high acuity population. The outcomes of and health care utilization among transferred (TRAN) as compared to directly admitted (DA) patients have been studied primarily using single institution or hospital system data which limits generalizability. We evaluated these outcomes among EGS patients using a national database. METHODS: We identified encounters of patients aged ≥18 years with a diagnosis of EGS as defined by the American Association for the Surgery of Trauma in the 2008-2011 Nationwide Inpatient Sample (NIS). Multivariable regression analyses determined if transfer status independently predicted in-hospital mortality (logistic regression) and morbidity (presence of any complication among those who survived to discharge; logistic regression), cost (log-linear regression), and duration of stay (among those who survived to discharge; log-linear regression) accounting for the NIS sampling design. RESULTS: We identified 274,145 TRAN (57,885 unweighted) and 10,456,100 DA (2,187,132 unweighted) encounters. On univariate analysis, TRAN patients were more likely to have greater comorbidity scores, have Medicare insurance, and reside in an area with a lesser median household income compared to DA patients (p<0.0001). Mortality was greater in the TRAN vs DA groups (4.4% vs 1.6%; p<0.0001). Morbidity (presence of any complication) was also greater among TRAN patients (38.8% vs 26.1%; p<0.0001). Morbidity among TRAN patients was primarily due to urinary- (13.7%), gastrointestinal- (12.9%), and pulmonary-related (13.3%) complications. Median duration of hospital stay was 4.3 days for TRAN vs 3.0 days for DA (p<0.0001) patients. Median cost was greater for TRAN patients ($8,935 vs $7,167; p<0.0001). Regression analyses determined that after adjustment, TRAN patients had statistically significantly greater mortality, morbidity, and cost as well as longer durations of stay. CONCLUSIONS: EGS patients who are transferred experience increased in-hospital morbidity and mortality as well as increased durations of stay and cost. As the population and age of patients diagnosed with EGS conditions increase while the EGS workforce decreases, the need for inter-hospital transfers will increase. Identifying risk factors associated with worse outcomes among transferred patients can inform the design of initiatives in performance improvement and direct the finite resources available to this vulnerable patient population.

Factors Associated With the Interhospital Transfer of Emergency General Surgery Patients.

BACKGROUND: Transferred emergency general surgery (EGS) patients constitute a highly vulnerable, acutely ill population. Guidelines to facilitate timely, appropriate EGS transfers are lacking. We determined patient- and hospital-level factors associated with interhospital EGS transfers, a critical first step to identifying which patients may require transfer. METHODS: Adult EGS patients (defined by American Association for the Surgery of Trauma International Classification of Diseases, Ninth Revision diagnosis codes) were identified within the 2008-2013 Nationwide Inpatient Sample (n = 17,175,450). Patient- and hospital-level factors were examined as predictors of transfer to another acute care hospital with a multivariate proportional cause-specific hazards model with a competing risk analysis to assess the effect of risk factors for transfer. RESULTS: 1.8% of encounters resulted in a transfer (n = 318,286). Transferred patients were on average 62 y old and most commonly had Medicare (52.9% [n = 168,363]), private (26.7% [n = 84,991]), or Medicaid insurance (10.8% [n = 34,279]). 67.7% were white. The most common EGS diagnoses among transferred patients were related to hepatic-pancreatic-biliary (n = 90,989 [28.6%]) and upper gastrointestinal tract (n = 60,088 [18.9%]) conditions. Most transferred patients (n = 269,976 [84.8%]) did not have a procedure before transfer. Transfer was more likely if patients were in small (hazard ratio 2.52, 95% confidence interval 2.28-2.79) or medium (1.32, 1.21-1.44) versus large facilities, government (1.19, 1.11-1.28) versus private facilities, and rural (4.58, 3.98-5.27) or urban nonteaching (1.89, 1.70-2.10) versus urban teaching facilities. Patient-level factors were not strong predictors of transfer. CONCLUSIONS: We identified that hospital-level characteristics more strongly predicted the need for transfer than patient-related factors. Consideration of these factors by providers as care is delivered in the context of the resources and capabilities of local institutions may facilitate transfer decision-making.

Advances in Treatment and Long-term Survival in Patients with Descending Thoracic Aortic Aneurysms Treated at a Single Tertiary Center from 1984 to 2014.

BACKGROUND: We report long-term survival in open surgical and endovascular patients treated for descending thoracic aortic aneurysms (TAAs) at a single tertiary center from 1984 to 2014 to study the impact of transition to thoracic endovascular aortic repair (TEVAR) for TAA repair. METHODS: Using a prospectively maintained registry, all patients (n = 202) having open or endovascular repair (TEVAR) of descending TAAs were studied. Date of last contact or death was obtained on all patients from hospital records, Social Security Death Database, and verified online records. Survival curves were computed and compared by age, preoperative variables, surgical approach, and hospital complications. Proportional hazards models were used for multivariate analysis of survival. RESULTS: In total, 28% had dissection, 41.6% presented acutely, 68.8% had TEVAR, and 31.1% had open surgery. Spinal cord injury (SCI) occurred in 0.5% and stroke in 1%. Operative mortality (5.9%) was associated with acuity, respiratory failure, open approach, and age. One-year survival in all patients was 83.7%. One-year mortality was associated with acuity, open surgery, respiratory failure, hospital complications, and coronary artery bypass surgery (CABG). Five-year survival was 60.4% and not associated with other variables. One-year survival was 76% in open patients and 87% in TEVAR patients. When operative mortality was excluded, 1-year survival was 89% and 5-year survival was 64.2% and there was no difference in long-term survival between TEVAR and open surgery. One-year mortality was associated with CABG and hospital complications. No variables were associated with 5-year survival. Ten-year survival was 35% and predicted only by age at operation. CONCLUSIONS: Operative mortality was higher in open surgery than TEVAR, but after 30 days, long-term survival was the same. Eighty-nine percent of patients were alive 1 year after surgery and 64% were alive 5 years after surgery. Low SCI contributed to longer survival.

Analysis of 90-day cost for open versus minimally invasive distal pancreatectomy.

BACKGROUND: Minimally invasive distal pancreatectomy (MIDP) is associated with improved peri-operative outcomes compared to the open approach, though cost-effectiveness of MIDP remains unclear. METHODS: Patients with pancreatic tumors undergoing open (ODP), robotic (RDP), or laparoscopic distal pancreatectomy (LDP) between 2012-2014 were identified through the Truven Health MarketScan® Database. Median costs (payments) for the index operation and 90-day readmissions were calculated. Multivariable regression was used to predict associations with log 90-day payments. RESULTS: 693 patients underwent ODP, 146 underwent LDP, and 53 RDP. Compared to ODP, LDP and RDP resulted in shorter median length of stay (6 d. ODP vs. 5 d. RDP vs. 4 d. LDP, p<0.01) and lower median payments ($38,350 ODP vs. $34,870 RDP vs. $32,148 LDP, p<0.01) during the index hospitalization. Total median 90-day payments remained significantly lower for both minimally invasive approaches ($40,549 ODP vs. $35,160 RDP vs. $32,797 LDP, p<0.01). On multivariable analysis, LDP and RDP resulted in 90-day cost savings of 21% and 25% relative to ODP, equating to an amount of $8,500-$10,000. CONCLUSION: MIDP is associated with >$8,500 in lower cost compared to the open approach. Quality improvement initiatives in DP should ensure that lack of training and technical skill are not barriers to MIDP.

Using Medicaid Data to Improve Childhood Lead Poisoning Prevention Program Outcomes and Blood Lead Surveillance.

CONTEXT: Wisconsin-specific data revealed that not all Medicaid providers were testing children appropriately for blood lead levels and not all blood lead tests were reported to the Department of Health Services, Childhood Lead Poisoning Prevention Program. The Medicaid program requires blood lead screening for all Medicaid-enrolled children at specific ages. Wisconsin state law requires reporting of all blood lead test results. Projects were implemented to encourage appropriate testing for Medicaid-enrolled children and improve blood lead surveillance. METHODS: Medicaid billing data were linked to blood lead data to identify Medicaid-enrolled children who had not received the required tests. Medicaid provider report cards were distributed annually from 2006 to 2011 to inform providers of their compliance with federal testing requirements and of the names of children within their practice who had not been tested. Blood lead tests billed to Medicaid but not in the blood lead database were identified and billing providers were contacted to obtain the test report. RESULTS: The number of children tested increased from 81 834 children per year in 2006 to 106 003 children per year in 2010. Testing of Medicaid-enrolled children increased by 31% from 2006 to 2010. The percentage of Medicaid-enrolled children receiving an age-appropriate test increased from 46% in 2004 to a high of 55% in 2010. There were 9035 blood lead tests identified in the Medicaid billing data that had not been reported from 2007 to 2015. There were 468 billing providers who had unreported tests. All sites with unreported tests were contacted, 84% of test results were obtained, and 14% of test records could not be retrieved. Outpatient clinics accounted for the majority of all unreported tests (72%) and irretrievable test records (74%). DISCUSSION: Childhood lead poisoning prevention programs can effectively utilize Medicaid data to increase testing and improve blood lead surveillance. Primary health care providers should ensure that Medicaid-enrolled children in their care receive the age-appropriate tests. Many Wisconsin health care providers lack awareness of blood lead test reporting requirements. Outpatient clinics account for the largest proportion of unreported tests and highest priority should be given working with these sites to improve reporting practices.

Characteristics and Timing of Interhospital Transfers of Emergency General Surgery Patients.

BACKGROUND: Transferred emergency general surgery (EGS) patients have increased morbidity, mortality, and costs, yet little is known about the characteristics of such transfers. Increasing specialization and a decreasing general surgery workforce have led to concerns about access to care, which may lead to increased transfers. We sought to evaluate the reasons for and timing of transfers for EGS diagnoses. METHODS: We performed a retrospective medical record review of patients transferred to a tertiary academic medical center between January 4, 2014 and March 31, 2016 who had an EGS diagnosis (bowel obstruction, appendicitis, cholecystitis/cholangitis/choledocholithiasis, diverticulitis, mesenteric ischemia, perforated viscus, or postoperative surgical complication). RESULTS: Three hundred thirty-four patients were transferred from 70 hospitals. Transfer reasons varied with the majority due to the need for specialized services (44.3%) or a surgeon (26.6%). Imaging was performed in 95.8% and 35.3% had surgeon contact before transfer. The percentage of patients who underwent procedures at referring facilities was 7.5% (n = 25), while 60.6% (n = 83) underwent procedures following transfer. Mean time between transfer request and arrival at the accepting hospital was lower for patients who subsequently underwent a procedure at the accepting hospital compared to those who did not for patients originating in emergency departments (2.6 versus 3.4 h, P < 0.05) and inpatient units (6.9 versus 14.3 h, P < 0.05). CONCLUSIONS: Interhospital transfers for EGS conditions are frequently motivated by a need for a higher level of care or specialized services as well as a need for a general surgeon. Understanding reasons for transfers can inform decisions regarding the allocation and provision of care for this vulnerable population.

A National Study of the Use of Asymptomatic Systemic Imaging for Surveillance Following Breast Cancer Treatment (AFT-01).

BACKGROUND: Although not guideline recommended, studies suggest 50% of locoregional breast cancer patients undergo systemic imaging during follow-up, prompting its inclusion as a Choosing Wisely measure of potential overuse. Most studies rely on administrative data that cannot delineate scan intent (prompted by signs/symptoms vs. asymptomatic surveillance). This is a critical gap as intent is the only way to distinguish overuse from appropriate care. OBJECTIVE: Our aim was to assess surveillance systemic imaging post-breast cancer treatment in a national sample accounting for scan intent. METHODS: A stage-stratified random sample of 10 women with stage II-III breast cancer in 2006-2007 was selected from each of 1217 Commission on Cancer-accredited facilities, for a total of 10,838 patients. Registrars abstracted scan type (computed tomography [CT], non-breast magnetic resonance imaging, bone scan, positron emission tomography/CT) and intent (cancer-related vs. not, asymptomatic surveillance vs. not) from medical records for 5 years post-diagnosis. Data were merged with each patient's corresponding National Cancer Database record, containing sociodemographic and tumor/treatment information. RESULTS: Of 10,838 women, 30% had one or more, and 12% had two or more, systemic surveillance scans during a 4-year follow-up period. Patients were more likely to receive surveillance imaging in the first follow-up year (lower proportions during subsequent years) and if they had estrogen receptor/progesterone receptor-negative tumors. CONCLUSIONS: Locoregional breast cancer patients undergo asymptomatic systemic imaging during follow-up despite guidelines recommending against it, but at lower rates than previously reported. Providers appear to use factors that confer increased recurrence risk to tailor decisions about systemic surveillance imaging, perhaps reflecting limitations of data on which current guidelines are based. ClinicalTrials.gov Identifier: NCT02171078.

Endovascular Versus Open Revascularization for Peripheral Arterial Disease.

OBJECTIVE: The aim of this study was to determine whether endovascular or open revascularization provides an advantageous approach to symptomatic peripheral arterial disease (PAD) over the longer term. SUMMARY OF BACKGROUND DATA: The optimal revascularization strategy for symptomatic lower extremity PAD is not established. METHODS: We evaluated amputation-free survival, overall survival, and relative rate of subsequent vascular intervention after endovascular or open lower extremity revascularization for propensity-score matched cohorts of Medicare beneficiaries with PAD from 2006 through 2009. RESULTS: Among 14,685 eligible patients, 5928 endovascular and 5928 open revascularization patients were included in matched analysis. Patients undergoing endovascular repair had improved amputation-free survival compared with open repair at 30 days (7.4 vs 8.9%, P = 0.002). This benefit persisted over the long term: At 4 years, 49% of endovascular patients had died or received major amputation compared with 54% of open patients (P < 0.001). An endovascular procedure was associated with a risk-adjusted 16% decreased risk of amputation or death compared with open over the study period (hazard ratio: 0.84; 95% confidence interval, 0.79-0.89; P < 0.001). The amputation-free survival benefit associated with an endovascular revascularization was more pronounced in patients with congestive heart failure or ischemic heart disease than in those without (P = 0.021 for interaction term). The rate of subsequent intervention at 30 days was 7.4% greater for the endovascular vs the open revascularization cohort. At 4 years, this difference remained stable at 8.6%. CONCLUSIONS: Using population-based data, we demonstrate that an endovascular approach is associated with improved amputation-free survival over the long term with only a modest relative increased risk of subsequent intervention.

Trends in the presentation, treatment, and survival of patients with medullary thyroid cancer over the past 30 years.

BACKGROUND: The impact of recent medical advances on disease presentation, extent of operation, and disease-specific survival for patients with medullary thyroid cancer is unclear. METHODS: We used the Surveillance, Epidemiology, and End Results registry to compare trends over 3 time periods, 1983-1992, 1993-2002, and 2003-2012. RESULTS: There were 2,940 patients diagnosed with medullary thyroid cancer between 1983 and 2012. The incidence of medullary thyroid cancer increased during this time period from 0.14 to 0.21 per 100,000 population, and mean age at diagnosis increased from 49.8 to 53.8 (P < .001). The proportion of tumors ≤1 cm also increased from 11.4% in 1983-1992, 19.6% in 1993-2002, to 25.1% in 2003-2012 (P < .001), but stage at diagnosis remained constant (P = .57). In addition, the proportion of patients undergoing a total thyroidectomy and lymph node dissection increased from 58.2% to 76.5% during the study period (P < .001). In the most recent time interval, 5-year, disease-specific survival improved from 86% to 89% in all patients (P < .001) but especially for patients with regional (82% to 91%, P = .003) and distant (40% to 51%, P = .02) disease. CONCLUSION: These data demonstrate that the extent of operation is increasing for patients with medullary thyroid cancer. Disease-specific survival is also improving, primarily in patients with regional and distant disease.

Practice variations in voice treatment selection following vocal fold mucosal resection.

OBJECTIVES/HYPOTHESIS: To characterize initial voice treatment selection following vocal fold mucosal resection in a Medicare population. STUDY DESIGN: Retrospective analysis of a large, nationally representative Medicare claims database. METHODS: Patients with > 12 months of continuous Medicare coverage who underwent a leukoplakia- or cancer-related vocal fold mucosal resection (index) procedure during calendar years 2004 to 2009 were studied. The primary outcome of interest was receipt of initial voice treatment (thyroplasty, vocal fold injection, or speech therapy) following the index procedure. We evaluated the cumulative incidence of each postindex treatment type, treating the other treatment types as competing risks, and further evaluated postindex treatment utilization using the proportional hazards model for the subdistribution of a competing risk. Patient age, sex, and Medicaid eligibility were used as predictors. RESULTS: A total of 2,041 patients underwent 2,427 index procedures during the study period. In 14% of cases, an initial voice treatment event was identified. Women were significantly less likely to receive surgical or behavioral treatment compared to men. From age 65 to 75 years, the likelihood of undergoing surgical treatment increased significantly with each 5-year age increase; after age 75 years, the likelihood of undergoing either surgical or behavioral treatment decreased significantly every 5 years. Patients with low socioeconomic status were significantly less likely to undergo speech therapy. CONCLUSION: The majority of Medicare patients do not undergo voice treatment following vocal fold mucosal resection. Further, the treatments analyzed here appear disproportionally utilized based on patient sex, age, and socioeconomic status. Additional research is needed to determine whether these observations reflect clinically explainable differences or disparities in care. LEVEL OF EVIDENCE: 2c. Laryngoscope, 126:2505-2512, 2016.

Trajectories and Prognosis of Older Patients Who Have Prolonged Mechanical Ventilation After High-Risk Surgery.

OBJECTIVES: Surgical patients often receive routine postoperative mechanical ventilation with excellent outcomes. However, older patients who receive prolonged mechanical ventilation may have a significantly different long-term trajectory not fully captured in 30-day postoperative metrics. The objective of this study is to describe patterns of mortality and hospitalization for Medicare beneficiaries 66 years old and older who have major surgery with and without prolonged mechanical ventilation. DESIGN: Retrospective cohort study. SETTING: Hospitals throughout the United States. PATIENTS: Five percent random national sample of elderly Medicare beneficiaries (age ≥ 66 yr) who underwent 1 of 227 operations previously defined as high risk during an inpatient stay at an acute care hospital between January 1, 2005, and November 30, 2009. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We identified 117,917 episodes for older patients who had high-risk surgery; 4% received prolonged mechanical ventilation during the hospitalization. Patients who received prolonged mechanical ventilation had higher 1-year mortality rate than patients who did not have prolonged ventilation (64% [95% CI, 62-65%] vs 17% [95% CI, 16.4-16.9%]). Thirty-day survivors who received prolonged mechanical ventilation had a 1-year mortality rate of 47% (95% CI, 45-48%). Thirty-day survivors who did not receive prolonged ventilation were more likely to be discharged home than patients who received prolonged ventilation 71% versus 10%. Patients who received prolonged ventilation and were not discharged by postoperative day 30 had a substantially increased 1-year mortality (adjusted hazard ratio, 4.39 [95% CI, 3.29-5.85]) compared with patients discharged home by day 30. Hospitalized 30-day survivors who received prolonged mechanical ventilation and died within 6 months of their index procedure spent the majority of their remaining days hospitalized. CONCLUSIONS: Older patients who require prolonged mechanical ventilation after high-risk surgery and survive 30 days have a significant 1-year risk of mortality and high burdens of treatment. This difficult trajectory should be considered in surgical decision making and has important implications for surgeons, intensivists, and patients.

Disparities in Utilization of Jaw Surgery for Treatment of Sleep Apnea: A Nationwide Analysis.

BACKGROUND: Maxillomandibular advancement has been shown to be one of the most effective operations for management of severe obstructive sleep apnea, yet pharyngeal surgery is more commonly performed. The goal of this study was to identify socioeconomic factors associated with this phenomenon. METHODS: Patients aged 14 or older with a primary hospital diagnosis of sleep apnea were identified using the National Inpatient Sample from 2005 to 2012. ICD9 codes were used to determine whether a pharyngeal or jaw procedure was performed. Patient demographics, comorbidities, and complications were compared. RESULTS: Among 6316 sleep surgeries, 5964 (94.4%) were pharyngeal and 352 (5.6%) were jaw procedures. Women were significantly more likely to receive jaw surgery than men (odds ratio [OR] = 1.68, P = 0.0007). African Americans (OR = 0.19, P < 0.0001), Hispanics (OR = 0.42, P = 0.0009), Asians (OR = 0.41, P = 0.0009), and other non-Caucasians (OR = 0.19, P = 0.0008) had a significantly lower odds of receiving jaw surgery than Caucasians. Patients falling into lower-income brackets (OR = 0.39 and 0.57, P = 0.02 and 0.04) and patients with Medicare compared with private or Health Maintenance Organization insurance (OR = 0.46, P = 0.008) also had significantly decreased odds of undergoing jaw surgery. Comorbidities were similar between surgical groups, and there were no significant differences in bleeding, infection, or cardiopulmonary complications. CONCLUSIONS: We identified no significant difference in complication rates between pharyngeal and jaw procedures. Nonetheless, African American, Hispanic, and Asian patients, in addition to lower-income patients and patients with Medicare, had a significantly lower odds of receiving jaw surgery. Awareness of these disparities may help guide efforts to improve patients' surgical options for sleep apnea.

Predictors of surgical site infection after hospital discharge in patients undergoing major vascular surgery.

OBJECTIVE: Surgical site infection (SSI) is one of the most common postoperative complications after vascular reconstruction, producing significant morbidity and hospital readmission. In contrast to SSI that develops while patients are still hospitalized, little is known about the cohort of patients who develop SSI after discharge. In this study, we explore the factors that lead to postdischarge SSI, investigate the differences between risk factors for in-hospital vs postdischarge SSI, and develop a scoring system to identify patients who might benefit from postdischarge monitoring of their wounds. METHODS: Patients who underwent major vascular surgery from 2005 to 2012 for aneurysm and lower extremity occlusive disease were identified from the American College of Surgeons National Surgical Quality Improvement Program Participant Use Files. Patients were categorized as having no SSI, in-hospital SSI, or SSI after hospital discharge. Predictors of postdischarge SSI were determined by multivariable logistic regression and internally validated by bootstrap resampling. Risk scores were assigned to all significant variables in the model. Summative risk scores were collapsed into quartile-based ordinal categories and defined as low, low/moderate, moderate/high, and high risk. Multivariable logistic regression was used to determine predictors of in-hospital SSI. RESULTS: Of the 49,817 patients who underwent major vascular surgery, 4449 (8.9%) were diagnosed with SSI (2.1% in-hospital SSI; 6.9% postdischarge SSI). By multivariable analysis, factors significantly associated with increased odds of postdischarge SSI include female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, neurologic disease, prolonged operative time >4 hours, American Society of Anesthesiology class 4 or 5, lower extremity revascularization or aortoiliac procedure, and groin anastomosis. The model exhibited moderate discrimination (bias-corrected C statistic, 0.691) and excellent internal calibration. The postdischarge SSI rate was 2.1% for low-risk patients, 5.1% for low/moderate-risk patients, 7.8% for moderate/high-risk patients, and 14% for high-risk patients. In a comparative analysis, comorbidities were the primary driver of postdischarge SSI, whereas in-hospital factors (operative time, emergency case status) and complications predicted in-hospital SSI. CONCLUSIONS: The majority of SSIs after major vascular surgery develop following hospital discharge. We have created a scoring system that can select a cohort of patients at high risk for SSI after discharge. These patients can be targeted for transitional care efforts focused on early detection and treatment with the goal of reducing morbidity and preventing readmission secondary to SSI.

Clinical and socioeconomic factors influence treatment decisions in Graves' disease.

BACKGROUND: Definitive treatment of Graves' disease includes radioactive iodine (RAI) and thyroidectomy, but utilization varies. We hypothesize that, in addition to clinical reasons, there are socioeconomic factors that influence whether a patient undergoes thyroidectomy or RAI. METHODS: Patients treated for Graves' disease between August 2007 and September 2013 at our university hospital were included. A comparative analysis of clinical and socioeconomic factors was completed. RESULTS: Of 427 patients, 300 (70 %) underwent RAI, whereas 127 (30 %) underwent surgery. Multiple factors were associated with surgery: younger age (mean 36 vs. 41 years, p < 0.01), female gender (33 vs. 19 % males, p = 0.01), black race (56 vs. 28 % nonblack, p < 0.01), Medicaid or uninsured (43 vs. 27 % private insurance or Medicare, p < 0.01), ophthalmopathy (38 vs. 26 %, p < 0.01), goiter (35 vs. 23 %, p < 0.01), and lowest quartile of median household income (38 vs. 27 % upper three quartiles, p = 0.03). Thyroidectomy increased annually, with 52 % undergoing surgery during the final year (p < 0.01). Adjusting for confounding, younger age (odds ratio [OR] 1.04; 95 % confidence interval [CI] 1.02, 1.05), female gender (OR 2.06; 95 % CI 1.06, 4.01), ophthalmopathy (OR 2.35; 95 % CI 1.40, 3.96), and later year of treatment (OR 1.66; 95 % CI 1.41, 1.95) remained significantly associated with surgery. CONCLUSIONS: Surgery has now become the primary treatment modality of choice for Graves' disease at our institution. Clinical factors are the main drivers behind treatment choice, but patients with lower SES are more likely to have clinical features best treated with surgery, underlying the importance of improving access to quality surgical care for all patients.