Cost-Effectiveness of [99mTc]Tilmanocept Relative to [99mTc]Sulfur Colloid for Sentinel Lymph Node Biopsy in Early Stage Oral Cavity Cancer.

BACKGROUND: Several studies have demonstrated varying rates of efficacy, reliability, and sensitivity of sentinel lymph node biopsy (SLNB) in identifying occult nodal disease for early stage oral cavity squamous cell carcinoma (OCSCC) depending on the radionuclide agent utilized. No head-to-head comparison of cost or clinical outcomes of SLNB when utilizing [99mTc]tilmanocept versus [99mTc]sulfur colloid has been performed. The goal of this study was to develop a decision model to compare the cost-effectiveness of [99mTc]tilmanocept versus [99mTc]sulfur colloid in early stage OCSCC. PATIENTS AND METHODS: A decision model of disease and treatment as a function of SLNB was created. Patients with a negative SLNB entered a Markov model of the natural history of OCSCC parameterized with published data to simulate five states of health and iterated over a 30-year time horizon. Treatment costs and quality-adjusted life-years (QALYs) for each health state were included. The incremental cost-effectiveness ratio (ICER) was then estimated using $100,000 per additional QALY as the threshold for determining cost-effectiveness. RESULTS: The base case cost-effectiveness analysis suggested [99mTc]tilmanocept was more effective than [99mTc]sulfur colloid by 0.12 QALYs (7.06 versus 6.94 QALYs). [99mTc]Tilmanocept was more costly, with a lifetime cost of $84,961 in comparison with $84,264 for sulfur colloid, however, the overall base case ICER was $5859 per additional QALY, well under the threshold for cost-effectiveness. Multiple one-way sensitivity analyses were performed, and demonstrated the model was robust to alternative parameter values. CONCLUSION: Our analysis showed that while [99mTc]tilmanocept is more costly upfront, these costs are worth the additional QALYs gained by the use of [99mTc]tilmanocept.

Correlates of cognition among people with chronic heart failure and insomnia.

PURPOSE: This study aimed to describe cognitive characteristics and their associations with demographic and clinical factors among adults with chronic heart failure (HF) and insomnia. METHODS: We performed a cross-sectional analysis of baseline data from the HeartSleep Study (NCT#02,660,385), a randomized controlled trial designed to evaluate the effects of cognitive-behavioral therapy for insomnia. Demographic characteristics and health history were obtained. We measured sleep characteristics with the Insomnia Severity Index, the PROMIS Sleep Disturbance Questionnaire, and wrist actigraphy. Sleepiness, stress, and quality of life were measured with validated questionnaires. Measures of cognition included frequency of lapses on the psychomotor vigilance test and the PROMIS cognitive abilities scale where ≥ 3 lapses and a score of ≤ 50, respectively, suggested impairment. These variables were combined into a composite score for multivariable analyses. RESULTS: Of a sample that included 187 participants (58% male; mean age 63.1 [SD = 12.7]), 77% had New York Heart Association class I or II HF and 66% had HF with preserved ejection fraction. Common comorbidities were diabetes (35%), hypertension (64%), and sleep apnea (54%). Impaired vigilant attention was associated with non-White race, higher body mass index, less education, and more medical comorbidities. Self-reported cognitive impairment was associated with younger age, higher body mass index, and pulmonary disease. On adjusted analysis, significant risk factors for cognitive impairment included hypertension (OR 1.94), daytime sleepiness (OR 1.09), stress (OR 1.08), and quality of life (OR 0.12). CONCLUSIONS: Impaired cognition is common among people with chronic HF and insomnia and associated with hypertension, daytime sleepiness, stress, and poor quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: Insomnia Self-management in Heart Failure; NCT#02,660,385.

Costs and Resource Utilization of People with Stable Heart Failure and Insomnia: Evidence from a Randomized Trial of Cognitive Behavioral Therapy for Insomnia.

OBJECTIVES: Nearly half of patients with chronic heart failure (HF) report insomnia symptoms. The purpose of this study was to examine the impact of CBT-I versus HF self-management on healthcare costs and resource utilization among patients with stable chronic HF who participated in a clinical trial of the effects of CBT-I compared to HF self-management education (attention control) over 1 year. METHODS: We measured resource utilization as self-reported (medical record review) physician office visits, emergency department visits, and inpatient admissions at 3-month intervals for 1 year after enrollment. Costs were estimated by applying price weights to visits and adding self-reported out-of-pocket and indirect costs. Univariate comparisons were made of resource utilization and costs between CBT-I and the HF self-management group. A generalized linear model (GLM) was used to model costs, controlling for covariates. RESULTS: The sample included 150 patients [79 CBT-I; 71 self-management (M age = 62 + 13 years)]. The CBT-I group had 4.2 inpatient hospitalizations vs 4.6 for the self-management group (p = .40). There were 13.1 outpatient visits, in the CBT-I compared with 15.4 outpatient visits (p-value range 0.39-0.81) for the self-management group. Total costs were not significantly different in univariate or ($7,813 CBT-I vs. $7,538 self-management), p = .96) or multivariable analyses. CONCLUSIONS: Among patients with both HF and insomnia, CBT-I and HF self-management were associated with similar resource utilization and total costs. Additional research is needed to estimate the value of CBT-I relative to usual care and other treatments for insomnia in patients with HF.

Symptom Cluster Profiles Among Adults with Insomnia and Heart Failure.

OBJECTIVE/BACKGROUND: Both heart failure (HF) and insomnia are associated with high symptom burden that may be manifested in clustered symptoms. To date, studies of insomnia have focused only on its association with single symptoms. The purposes of this study were to: (1) describe daytime symptom cluster profiles in adults with insomnia and chronic HF; and (2) determine the associations between demographic and clinical characteristics, insomnia and sleep characteristics and membership in symptom cluster profiles. PARTICIPANTS: One hundred and ninety-five participants [M age 63.0 (SD12.8); 84 (43.1%) male; 148 (75.9%) New York Heart Association Class I/II] from the HeartSleep study (NCT0266038), a randomized controlled trial of the sustained effects of cognitive behavioral therapy for insomnia (CBT-I). METHODS: We analyzed baseline data, including daytime symptoms (fatigue, pain, anxiety, depression, dyspnea, sleepiness) and insomnia (Insomnia Severity Index), and sleep characteristics (Pittsburgh Sleep Quality Index, wrist actigraphy). We conducted latent class analysis to identify symptom cluster profiles, bivariate associations, and multinomial regression. RESULTS: We identified three daytime symptom cluster profiles, physical (N = 73 participants; 37.4%), emotional (N = 12; 5.6%), and all-high symptoms (N = 111; 56.4%). Body mass index, beta blockers, and insomnia severity were independently associated with membership in the all-high symptom profile, compared with the other symptom profile groups. CONCLUSIONS: Higher symptom burden is associated with more severe insomnia in people with stable HF. There is a need to understand whether treatment of insomnia improves symptom burden as reflected in transition from symptom cluster profiles reflecting higher to lower symptom burden.

Potential Early Markers for Breast Cancer: A Proteomic Approach Comparing Saliva and Serum Samples in a Pilot Study.

Breast cancer is the second leading cause of death for women in the United States, and early detection could offer patients the opportunity to receive early intervention. The current methods of diagnosis rely on mammograms and have relatively high rates of false positivity, causing anxiety in patients. We sought to identify protein markers in saliva and serum for early detection of breast cancer. A rigorous analysis was performed for individual saliva and serum samples from women without breast disease, and women diagnosed with benign or malignant breast disease, using isobaric tags for relative and absolute quantitation (iTRAQ) technique, and employing a random effects model. A total of 591 and 371 proteins were identified in saliva and serum samples from the same individuals, respectively. The differentially expressed proteins were mainly involved in exocytosis, secretion, immune response, neutrophil-mediated immunity and cytokine-mediated signaling pathway. Using a network biology approach, significantly expressed proteins in both biological fluids were evaluated for protein-protein interaction networks and further analyzed for these being potential biomarkers in breast cancer diagnosis and prognosis. Our systems approach illustrates a feasible platform for investigating the responsive proteomic profile in benign and malignant breast disease using saliva and serum from the same women.

Cost-Effectiveness of Preoperative Spinal Imaging Before Total Hip Arthroplasty.

BACKGROUND: The risk of instability, dislocation, and revision following total hip arthroplasty (THA) is increased in patients with abnormal spinopelvic mobility. Seated and standing lateral lumbar spine imaging can identify patients with stiff/hypermobile spine (SHS) to guide interventions such as changes in acetabular cup placement or use of a dual-mobility hip construct aimed at reducing dislocation risk. METHODS: A Markov decision model was created to compare routine preoperative spinal imaging (PSI) to no screening in patients with and without SHS. Screened patients with SHS were assumed to receive dual-mobility hardware while those without SHS and nonscreened patients were assumed to receive conventional THA. Cost-effectiveness was determined by estimating the incremental cost-effectiveness ratio. Effectiveness measured as quality-adjusted life years (QALYs), with $100,000 per additional QALY as the threshold for cost-effectiveness. Sensitivity analyses were performed to determine the robustness of the base-case result. RESULTS: The screening strategy with PSI had a lifetime cost of $12,515 and QALY gains of 16.91 compared with no-screening ($13,331 and 16.77). The PSI strategy reached cost-effectiveness at 5 years and was dominant (ie, less costly and more effective) at 11 years following THA. In sensitivity analyses, PSI remained the dominant strategy if prevalence of SHS was >1.9%, the cost of PSI was <$925, and the cost of dual-mobility hardware exceeded the cost of conventional hardware by <$2850. CONCLUSION: Screening patients for SHS prior to THA with PSI is both less costly and more effective and should be considered as part of standard presurgical workup.

Day-to-day Relationships between Physical Activity and Sleep Characteristics among People with Heart Failure and Insomnia.

OBJECTIVE: Examine the bidirectional relationships between within-person day-to-day fluctuations in physical activity (PA) and sleep characteristics among people with heart failure (HF) and insomnia. PARTICIPANTS: Ninety-seven community-dwelling adults [median age 61.9 (interquartile range 55.3,70.9) years, female 41%] with stable HF and insomnia (insomnia severity index >7). METHODS: This sub-study longitudinally analyzed 15 consecutive days and nights of wrist actigraphy recordings, that were collected for baseline data prior to participation in a randomized controlled trial of cognitive behavioral therapy for insomnia. We used two-level mixed models of within- (daily) and between-participants variation to predict daytime PA counts/minutes from sleep variables (total sleep time, sleep efficiency) and predict sleep variables from PA. RESULTS: PA counts/minutes were low compared to prior cohorts that did not have HF (209 (166,259)) and negatively associated with NYHA class (standardized coefficient ßs = -0.14, p < .01), age (ßs = -0.13, p = .01), comorbidities (ßs = -0.19, p < .01), and body mass index (ßs = -0.12, p = .04). After adjustment for all significant covariates, the within-participant association of total sleep time with next-day PA was estimated to be positive among participants with NYHA class II-IV HF (ßs = 0.09, p = .01), while the within-participant association of PA with same-night total sleep time was estimated to be positive among participants aged ≥60 years (ßs = 0.10, p = .03). CONCLUSIONS: Depending upon age and HF class, daytime PA was associated with longer same-night sleep and/or longer sleep was associated with greater next-day PA. Among those with more advanced HF, realistic sleep improvements were associated with clinically meaningful PA gains the next day.

The Association of Race, Sex, and Insurance With Transfer From Adult to Pediatric Trauma Centers.

OBJECTIVE: Our objective was to investigate whether racial/ethnic-based or payer-based disparities existed in the transfer practices of pediatric trauma patients from adult trauma center (ATC) to pediatric trauma center (PTC) in Pennsylvania. METHODS: Data on trauma patients aged 14 years or less initially evaluated at level I and II ATC were obtained from the Pennsylvania Trauma Outcome Study (2008-2012) (n = 3446). Generalized estimating equations regression analyses were used to evaluate predictors of subsequent transfer controlling for confounders and clustering. Recent literature has described racial and socioeconomic disparities in outcomes such as mortality after trauma; it is unknown whether these factors also influence the likelihood of subsequent interfacility transfer between ATC and PTC. RESULTS: Patients identified as nonwhite comprised 36.1% of the study population. Those without insurance comprised 9.9% of the population. There were 2790 patients (77.4%) who were subsequently transferred. Nonwhite race (odds ratio [OR], 4.3), female sex (OR, 1.3), and lack of insurance (OR, 2.3) were associated with interfacility transfer. Additional factors were identified influencing likelihood of transfer (increased odds: younger age, intubated status, cranial, orthopedic, and solid organ injury; decreased odds: operative intervention at the initial trauma center) (P < 0.05 for all). CONCLUSIONS: Although we assume that a desire for specialized care is the primary reason for transfer of injured children to PTCs, our analysis demonstrates that race, female sex, and lack of insurance are also associated with transfers from ATCs to PTCs for children younger than 15 years in Pennsylvania. Further research is needed to understand the basis of these health care disparities and their impact.

Outcomes after ruptured abdominal aortic aneurysm repair in the era of centralized care.

OBJECTIVE: Little is known about the relationship between case volume and patient outcomes of those treated for ruptured abdominal aortic aneurysm (rAAA) after either endovascular aneurysm repair (EVAR) or open aneurysm repair (OAR). This study evaluated the impact of hospital case volume on outcomes after rAAA. METHODS: Patients with rAAA were identified in the Society for Vascular Surgery Vascular Quality Initiative database from 2003 to 2017, excluding patients from years in which a limited number of hospitals were included (2003-2009, 2017). Patients were stratified according to type of aneurysm repair and further stratified according to aortic surgical volume of the treating facility. Univariate and multivariable analyses were performed. RESULTS: Between 2010 and 2016, of 2895 patients who presented emergently with rAAA, 1246 underwent ruptured OAR (rOAR) and 1649 underwent ruptured EVAR (rEVAR). Before adjustment for demographics, comorbidities, and clinical characteristics, there were no differences in 1-year patient survival based on hospital OAR or EVAR volumes among patients undergoing rOAR or rEVAR. After adjustment for confounding variables, patients treated with rOAR at the highest volume OAR hospitals had a 33% lower hazard of mortality at 1 year relative to patients treated with rOAR at the lowest volume OAR hospitals. Preoperative interfacility transfer was associated with a 27% lower hazard of mortality after rOAR. There was no significant difference in hazard of mortality among patients undergoing rEVAR when they were stratified according to hospital EVAR volumes after adjustment for all other covariates. CONCLUSIONS: Outcomes after rAAA repair are associated with hospital volume among patients undergoing rOAR but not among patients undergoing rEVAR. Thus, centralization of care may have an important impact on outcomes when OAR is indicated, suggesting a benefit for preoperative interfacility transfer of care when it is feasible.

One-Year Postpartum Mental Health Outcomes of Mothers of Infants with Neonatal Abstinence Syndrome.

INTRODUCTION: Women with substance use disorders have high incidences of psychiatric and mood disorders, which may affect their ability to cope with an infant with neonatal abstinence syndrome (NAS), particularly one with a protracted NICU course, exacerbating symptoms of mental health disorders. We examined the incidence of mental health diagnoses in the first 12 postpartum months in mothers of an NAS infant compared to mothers of an infant without NAS. METHODS: In this retrospective, cohort study, data were extracted from MarketScan® database (2005-2013). NAS newborns were identified using ICD-9 codes. Each mother of an NAS newborn was matched to a mother of a newborn without NAS on age at delivery, birth year, gestational age, NICU stay and maternal mental health diagnoses in the 9 months prior to delivery. Primary outcomes were claims for major depression, postpartum depression, anxiety, adjustment reaction, post-traumatic stress disorder, and suicidal ideation. RESULTS: 338 mother-infant pairs met all inclusion/exclusion criteria and were matched 1-to-1 with controls. 245 (73%) of the NAS infants had a NICU admission. Median length of stay for these infants was 10 days compared to 3 days for infants with no NICU admission (p < 0.001). Mothers of NAS infants were more likely to have claims for major depression (33% vs. 15%, p < 0.01), postpartum depression (7% vs. 3%, p = 0.04), and anxiety (27% vs. 13%, p < 0.01). CONCLUSION: Mothers of infants with NAS have a higher incidence of mental health diagnoses in the first 12 months postpartum compared to mothers of infants without NAS.

Emergent Colon Resections: Does Surgeon Specialization Influence Outcomes?

BACKGROUND: Relationships between high-volume surgeons and improved postoperative outcomes have been well documented. Colorectal procedures are often performed by general surgeons, particularly in emergent settings, and may form a large component of their practice. The influence of subspecialized training on outcomes after emergent colon surgery, however, is not well described. OBJECTIVE: The purpose of this study was to determine whether subspecialty training in colorectal surgery is associated with differences in postoperative outcomes after emergency colectomy. DESIGN: This was a retrospective cohort study. SETTINGS: Three tertiary care hospitals participating in the National Surgical Quality Improvement Project were included. PATIENTS: Patients undergoing emergent colon resections were identified at each institution and stratified by involvement of either a colorectal surgeon or a general or acute care surgeon. MAIN OUTCOME MEASURES: Propensity score matching was used to isolate the effect of surgeon specialty on the primary outcomes, including postoperative morbidity, mortality, length of stay, and the need for unplanned major reoperation, in comparable cohorts of patients. RESULTS: A total of 889 cases were identified, including 592 by colorectal and 297 by general/acute care surgeons. After propensity score matching, cases performed by colorectal surgeons were associated with significantly lower rates of 30-day mortality (6.7% vs 16.4%; p = 0.001), postoperative morbidity (45.0% vs 56.7%; p = 0.009), and unplanned major reoperation (9.7% vs 16.4%; p = 0.04). In addition, length of stay was ≈4.4 days longer among patients undergoing surgery by general/acute care surgeons (p < 0.001). LIMITATIONS: This study was limited by its retrospective design, with potential selection bias attributed to referral patterns. CONCLUSIONS: After controlling for underlying disease states and illness severity, emergent colon resections performed by colorectal surgeons were associated with significantly lower rates of postoperative morbidity and mortality when compared with noncolorectal surgeons. These findings may have implications for referral patterns for institutions. See Video Abstract at http://links.lww.com/DCR/A767.

Thirty-day Readmission Rates for Carotid Endarterectomy Versus Carotid Artery Stenting.

BACKGROUND: Because of the emergence of readmission-related Medicare penalties, efforts are being made to identify and reduce patient readmissions. The purpose of this study was to compare rates and risk factors for 30-d readmission and hospital length of stay (LOS) after carotid endarterectomy (CEA) and carotid artery stenting (CAS) among patients treated for carotid artery stenosis in Pennsylvania. MATERIALS AND METHODS: Data were from the Pennsylvania Health Care Cost Containment Council (PHC4). We identified 15,966 patients who underwent CEA (n = 13,557) or CAS (n = 2409) in Pennsylvania between 2011 and 2014. Logistic regression was used to determine risk factors for 30-d readmission, whereas linear regression was used to model factors influencing LOS. Propensity score analysis was used to control for imbalanced covariates between procedures. RESULTS: Thirty-day readmission rates in Pennsylvania after CEA and CAS for carotid artery stenosis were similar (9.8% and 9.6%, respectively; P = 0.794). Not home discharge destination, Charlson comorbidity index ≥2, and LOS >1 d were all significantly associated with readmission risk. Procedure type (CEA or CAS) did not significantly influence risk. A significant difference in LOS was found between CEA and CAS, but the magnitude of the difference was small (2.38 for CAS versus 2.59 for CEA; P = 0.007). Black race, urgent and emergent cases, and not home discharges significantly increased LOS by notable amounts (1, 1.5, 3.9, and 1.9 d, respectively). CONCLUSIONS: Carotid artery stenosis patients in Pennsylvania undergoing CEA or CAS had similar 30-d readmission rates. Although LOS was significantly different, the magnitude of the difference was not large.

Determinants of treatment in patients with stage IV renal cell carcinoma.

BACKGROUND: Advances in systemic targeted therapies afford treatment opportunities in patients with metastatic renal cell carcinoma (RCC). Elderly patients with metastatic RCC present a subpopulation for consideration owing to competing causes of mortality and benefits seen with new therapeutic agents. We investigate treatment patterns for elderly patients with stage IV RCC and determine factors associated with not receiving treatment. METHODS: The Surveillance Epidemiology and End Results (SEER) Medicare linked data set contained 949 stage IV RCC patients over age 65 diagnosed between 2007 and 2011. Treatment approach was modeled using multinomial logistic regression. Landmark analysis at 6 months accounted for early death as a potential explanation for no treatment. RESULTS: Of the 949 patients with stage IV RCC, 26.2% received surgery and 34.1% received systemic therapy within 6 months of diagnosis. Among our entire cohort, over half (51.2%) had no evidence of receiving surgery or systemic therapy. Among the 447 patients who survived at least 6 months, 26.6% did not receive treatment during this time. Older patients and those with a higher Charlson Comorbidity Index (CCI) had lower odds of being treated with surgery, systemic therapy, or both. Conversely, married patients had higher odds of receiving these therapies. These associations were largely sustained in the 6-month landmark analyses. CONCLUSIONS: Elderly patients with metastatic RCC present a unique subpopulation for consideration owing to competing causes of mortality. Many elderly patients with stage IV RCC did not receive surgery or systemic therapy up to 6 months from diagnosis. Several clinical and demographic factors were associated with this observation. Further investigation is needed to understand the rationale underlying the underutilization of systemic therapy in elderly patients.

Morbidity after tonsillectomy in children with autism spectrum disorders.

OBJECTIVES: As the incidence of autism spectrum disorder (ASD) increases, otolaryngologists are more likely to encounter patients from this population during tonsillectomy. The purpose of this study was to examine whether outcomes differ between pediatric patients with and without ASD in a national cohort of children undergoing tonsillectomy. Understanding these differences may be used to inform future approaches to improve clinical outcomes and healthcare costs. METHODS: Data for this study were obtained from the Kids Inpatient Database (KID) of the Healthcare Cost Utilization Project. We studied pediatric patients who underwent tonsillectomy during 2003, 2006, 2009, and 2012. Tonsillectomy was identified using ICD-9-CM diagnosis codes 28.2 (tonsillectomy without adenoidectomy) and 28.3 (tonsillectomy with adenoidectomy). ASD was identified using ICD-9-CM diagnosis code 299 (autism). Outcomes including complications, length of hospital stay, and total hospitalization costs. Analyses were performed using multivariable models. Propensity score matching was used to control for covariate imbalance between patients with and without ASD. RESULTS: In our sample of 27,040 patients, 322 (1.2%) had a diagnosis of ASD. After controlling for potential confounders, multivariable modeling suggested patients with ASD had a shorter LOS of 0.50 days (p < 0.0001), were less likely to experience complications (odds ratio 0.57, p = 0.001), and had lower associated costs of $1308 less (p < 0.0001). Propensity score matching confirmed the findings of the multivariable modeling. CONCLUSION: Although ASD alone does not appear to confer additional costs or morbidity, differences between children with and without ASD suggest the need for providers to address patients with ASD uniquely.

Perioperative thrombotic complications associated with pediatric liver transplantation: a UNOS database evaluation.

BACKGROUND: This retrospective UNOS database evaluation analyzes the prevalence of preoperative portal vein thromboses (PVT), and postoperative thromboses leading to graft failure in pediatric patients undergoing liver transplantation (LT). METHODS: The evaluation was performed in three age groups: I (0-5), II (6-11), III (12-18) years old. Factors predictive of pre- and postoperative thromboses were analyzed. RESULTS: Between 2000 and 2015, 8982 pediatric LT were performed in the US. Of those, 390 patients had preoperative PVT (4.3%), and 396 (4.4%) had postoperative thromboses. The prevalence of both types of thromboses was less in Group III than in the other two groups (3.20% vs 4.65%, p = 0.007 and 1.73% vs. 5.13%, p < 0.001, respectively). The prevalence of postoperative thromboses was significantly higher in Group I than in the other two groups (5.49% vs. 2.51%, p < 0.001). Preoperative PVT was independently associated with postoperative thromboses (OR = 1.7, p = 0.02). Children less than 5 years of age were more likely to develop postoperative thromboses leading to graft failure (OR = 2.9, p < 0.001). CONCLUSION: Younger children undergoing LT are prone to pre-and postoperative thrombotic complications. Preoperative PVT at the time of transplantation was independently associated with postoperative thromboses. Perioperative antithrombotic therapy should be considered in pediatric patients undergoing LT.

Truven Health Analytics MarketScan Databases for Clinical Research in Colon and Rectal Surgery.

The MarketScan databases are a family of administrative claims databases that contain data on inpatient and outpatient claims, outpatient prescription claims, clinical utilization records, and healthcare expenditures. The three main databases available for use are each composed of a convenience sample for one of the following patient populations: (1) patients with employer-based health insurance from contributing employers, (2) Medicare beneficiaries who possess supplemental insurance paid by their employers, and (3) patients with Medicaid in one of eleven participating states. Eleven supplemental databases are available, which are utilized to overcome the limited clinical data available in the core MarketScan databases. There are several limitations to this database, primarily related to the fact that individuals or their family members within two of the core databases mandatorily possess some form of employer-based health insurance, which prevents the dataset from being nationally representative. Nonetheless, this database provides detailed and rigorously maintained claims data to identify healthcare utilization patterns among this cohort of patients.

Prognostic Significance of Tumor Deposits in Stage III Colon Cancer.

BACKGROUND: The American Joint Committee on Cancer includes extranodal tumor deposits in the tumor-node-metastasis classification of colon cancer. However, it is unclear how tumor deposits compare with lymph node metastases in prognostic significance. This study evaluated the survival impact of tumor deposits relative to lymph node metastases in stage III colon cancer. METHODS: The US National Cancer Database (2010-2012) was reviewed for resectable stage III adenocarcinoma of the colon, and stratified by presence of tumor deposits and lymph node metastases. Univariate and multivariate survival analyses were performed. RESULTS: Of 6424, 10.1% had both tumor deposits and lymph node metastases [5-year survival (5YS) 40.2%], 2.5% had tumor deposits alone (5YS 68.1%), and 87.4% had lymph node metastases alone (5YS 55.4%). Patients with lymph node metastases alone tended to have a greater number of lymph nodes retrieved (20.9 versus 18.8, p = 0.0126) and were more likely to receive adjuvant therapy (66.9 vs 58.0%, p = 0.003) than those with only tumor deposits. Patients with both had significantly worse survival at all T stages (p < 0.05, all). There was no significant difference in survival between tumor deposits alone and lymph node metastases alone at any T stage (p > 0.8, all). After controlling for patient, disease, and treatment characteristics, patients with tumor deposits alone [hazard ratio (HR) 0.56, p = 0.001] or only lymph node metastases (HR 0.64, p < 0.001) were associated with improved survival relative to patients with both. CONCLUSIONS: Concomitant presence of tumor deposits and lymph node invasion carries poor prognostic significance. Tumor deposits alone appear to have prognostic implications similar to lymph node invasion alone.

Increased Postoperative Morbidity Associated With Prolonged Laparoscopic Colorectal Resections Is Not Increased by Resident Involvement.

BACKGROUND: Although longer operative times are associated with increased postoperative morbidity, the influence of surgical residents on this association is unclear. OBJECTIVE: The purpose of this study was to evaluate whether morbidity associated with operative times in laparoscopic colorectal surgery is increased by resident training. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted using a national database. PATIENTS: Laparoscopic ileocolectomies, partial colectomies, and low anterior resections were identified in the National Surgical Quality Improvement Project (2005-2012). This cohort was stratified by the presence of resident involvement (postgraduate clinical year ≤5) and then divided into tertiles of operative time (low, medium, and high), allowing comparisons of cases by duration with resident involvement with cases of similar length without resident involvement. MAIN OUTCOME MEASURES: Postoperative morbidity (infectious and noninfectious), length of hospital stay, and unplanned reoperations were the primary study outcomes. RESULTS: A total of 20,785 procedures were identified. In aggregate, prolonged operative time was associated with both infectious (OR = 1.49, p < 0.001 with residents; OR = 1.38, p < 0.001 without residents) and noninfectious complications (OR = 1.51, p < 0.001 with residents; OR = 1.48, p < 0.001 without residents) when compared with short cases without residents. Longer hospital stay was observed both within the highest (additional 1.2 days (p < 0.001) with residents; 1.1 days (p < 0.001) without residents) and middle (additional 0.4 days (p < 0.001) with residents; 0.4 days (p = 0.001) without residents) tertiles of operative time. Within the highest tertile of operative length, there was no statistically significant difference in complication rates between cases with and without resident participation. LIMITATIONS: The study was limited by its retrospective design and inability to define the complexity of case and extent of resident involvement. CONCLUSIONS: Although longer operative times confer increased postoperative morbidity, there was no significant difference in complication rates within the highest tertile between cases with and without resident participation. Resident involvement does not appear to add to the risk of morbidity associated with longer and more complicated surgeries. See Video Abstract at http://links.lww.com/DCR/A440.

Pregnancy after a melanoma diagnosis in women in the United States.

BACKGROUND: Melanoma is the third most common cancer in women aged 18-39 years. Medical literature recommends that women wait for at least 2 years before becoming pregnant, yet few studies have examined pregnancy after melanoma. Our aims were to investigate the pregnancy rate after a melanoma diagnosis and the relationship between melanoma treatment and subsequent pregnancy. METHODS: We studied women with a melanoma diagnosis in the Truven Health MarketScan database. Women with a melanoma diagnosis were matched 1:1 to women with no melanoma diagnosis to compare pregnancy rates between groups. For women with melanoma, Cox models were fitted for rates of pregnancy overall, pregnancy if postsurgical treatment was received, and for treatment after pregnancy. RESULTS: The sample included 11,801 women aged 18-40 years with melanoma, who were not pregnant on the index date. These women had a higher rate of pregnancy within 2 years compared to matched controls (15.8% versus 13.6%, P < 0.001). For 0-9 months after diagnosis, women who received postsurgical treatment had a 74% lower probability of becoming pregnant (hazard ratio = 0.26, P = 0.003). Rates of treatment received after pregnancy were not significantly different (hazard ratio = 0.68, P = 0.23). CONCLUSIONS: Our study is the largest review of postmelanoma pregnancy in the United States. After a melanoma diagnosis, women had a slightly higher rate of pregnancy than matched controls, indicating that women are not delaying pregnancy. However, women who received advanced treatment for melanoma had a lower rate of pregnancy than untreated women. Women who became pregnant after a melanoma diagnosis did not have an increased risk of requiring subsequent treatment for melanoma.