Impact of insurance and neighborhood socioeconomic status on clinical outcomes in therapeutic clinical trials for breast cancer.

The objective of this study was to evaluate the impact of insurance and neighborhood SES (nSES) on chemotherapy completion and overall mortality among participants in breast cancer clinical trials. The data sources for this study were two adjuvant breast cancer trials (ECOG E1199 and E5103) collectively including 9790 women. Insurance status at trial registration was categorized into private, government (Medicaid, Medicare, and other government type insurance), and self-pay. An Agency for Healthcare Research Quality (AHRQ) nSES index was calculated using residential zip codes linked to county level data on occupation, income, poverty, wealth, education, and crowding. Logistic regression and Cox Proportional Hazard models estimated odds ratios (OR) for chemotherapy treatment completion and hazard ratios (HR) for mortality, respectively, for insurance status and nSES. The models adjusted for: race, age, tumor size, nodal status, hormone receptor status, and primary surgery. The majority of patients had private insurance at trial registration: E1199: 85.6% (4154/4854) and E5103: 82.4% (3987/4836); median SES index was 53.8 (range: 41.8-66.8) and 54.1 (range: 44.5-66.1), respectively. Patients with government insurance were less likely to complete chemotherapy treatment (E1199 OR (95%CI): 0.73 (0.57-0.94); E5103 0.76 (0.64-0.91)) and had an increased risk of death (E1199 HR (95%CI): 1.44 (1.22-1.70); E5103 1.29 (1.06-1.58)) compared to the privately insured patients. There was no association between nSES and chemotherapy completion or overall mortality. Patients with government insurance at trial registration appeared to face barriers in chemotherapy completion and had a higher overall mortality compared to their privately insured counterparts.

A structured pathway for accelerated postoperative recovery reduces hospital stay and cost of care following microvascular breast reconstruction without increased complications.

INTRODUCTION: Accelerated recovery protocols have proved effective in many surgical procedures but are infrequently applied in breast reconstruction. In this study, we evaluate the impact of a structured pathway for accelerated postoperative recovery in patients undergoing microvascular breast reconstruction at a high-volume center. METHODS: We describe our care pathway for patients undergoing deep inferior epigastric artery perforator (DIEP) flap breast reconstruction at our center. We compared length of stay (LOS), complication rates, readmission rates, and cost of inpatient care before (pre-protocol (Pre-P)) and after (post-protocol (Post-P)) the implementation of the protocol. RESULTS: Patients in the Post-P group (n = 198) had a significant reduction in mean LOS as compared to those in the Pre-P (n = 183) group (3.6 +/- 0.85 vs. 4.7 +/-1.04 days, p = 0.006). There was no significant difference in the rates of major (Pre-P 16.9% vs. Post-P 14.7%, p = 0.71) or minor (Pre-P 21.3% vs. 17.1%, p = 0.22) postoperative complications between groups. The readmission rates were also similar (Pre-P 6.5% vs. Post-P 4.5, p = 0.69). Implementation of the protocol resulted in a significant reduction in the mean cost of in-patient care. CONCLUSION: A simple protocol for accelerated and streamlined postoperative recovery effectively reduces LOS and patient care costs following DIEP flap breast reconstruction without compromising patient safety.

Predicting complications in immediate microvascular breast reconstruction: Validity of the breast reconstruction assessment (BRA) surgical risk calculator.

BACKGROUND: The Breast Reconstruction Assessment (BRA)-score is a disease-specific risk calculator that estimates the likelihood of postoperative complications in an individual patient. The tool has not been previously externally validated in microvascular breast reconstruction. The purpose of this study was to evaluate the efficacy of the calculator in patients who underwent microvascular reconstruction at a single specialist institution. METHODS: Data from 415 patients who had immediate microvascular breast reconstruction were entered into the calculator. The predicted and observed rates of surgical complications, medical complications, reoperation, and total or partial flap failure were compared. The accuracy of the calculator was assessed using statistical measures of calibration and discrimination. RESULTS: The calculator accurately predicted the proportion of patients who would experience surgical complications and reoperations but overestimated the rates of medical complications and flap failures. The C-statistics were low for all four prediction models (0.49-0.59), suggesting weak discriminatory power, and the Brier scores were relatively high (0.09-0.44), indicating poor correlation between predicted and actual probability of complications. CONCLUSION: These results suggest that the BRA score cannot accurately identify patients at risk for complications following immediate microvascular breast reconstruction at our institution.

A cost-effectiveness analysis of DIEP vs free MS-TRAM flap for microsurgical breast reconstruction.

BACKGROUND AND OBJECTIVES: The deep inferior epigastric perforator (DIEP) flap may be associated with less long-term donor-site morbidity compared with free muscle-sparing transverse rectus abdominis myocutaneous flap (MS-TRAM) flap. However, DIEP flaps may have longer operative time and higher rates of acute postoperative complications. We performed a cost-effectiveness analysis (CEA) that compared the long-term costs and patient-reported outcomes between the two flaps. METHODS: A retrospective cohort of women who received free MS-TRAM or DIEP flap reconstruction between January 2008 and December 2012, with a minimum of 2-year follow-up, were recruited. Cost data of the primary reconstruction and any subsequent hospitalization due to complications from the reconstruction within 2 years were obtained. Each patient received a BREAST-Q questionnaire at 2 years post-reconstruction. RESULTS: In total, 227 patients (180 DIEP, 47 free MS-TRAM) were included. DIEP patients had significantly fewer abdominal hernia (P = 0.04). The adjusted-incremental cost-effectiveness ratios found that DIEP flap was more cost-effective to free MS-TRAM flap in the domains of "Physical Well-Being of the Abdomen" and "Satisfaction with Outcome." CONCLUSIONS: DIEP flap is the more cost-effective method of autologous breast reconstruction in the long-term compared with free MS-TRAM flap with respect to patient-reported abdominal well-being and overall satisfaction with the outcome.

Preoperative Computed Tomographic Angiogram Measurement of Abdominal Muscles Is a Valuable Risk Assessment for Bulge Formation after Microsurgical Abdominal Free Flap Breast Reconstruction.

BACKGROUND: A major shortcoming associated with abdominal tissue breast reconstruction is long-term abdominal wall morbidity. Although abdominal muscle size on computed tomographic angiography has been correlated with morbidity following many abdominal operations, it has not been studied for breast reconstruction. Therefore, the authors evaluated the association between preoperative computed tomography angiography-derived measurements of abdominal core muscles and postoperative abdominal wall morbidity after abdominal tissue breast reconstruction. METHODS: In this retrospective matched case-control study of women who underwent microsurgical abdominal flap breast reconstruction at one institution between January 2011 and June 2015, the authors evaluated all cases of postoperative bulge/hernia, matched by type of abdominal flap and body mass index in a ratio of 1:2 to controls without bulge/hernia. The authors obtained morphometric measurements of abdominal core muscles on preoperative computed tomographic angiographs. Using univariable and multivariable logistic regressions, the authors examined the effects of clinical risk factors and computed tomographic angiography morphometric measurements on postoperative bulge/hernia formation. RESULTS: Of the 589 patients who underwent abdominal free flap breast reconstruction, symptomatic bulges/hernias were identified in 35 patients (5.9 percent). When compared to the 70 matched controls, multivariable analysis showed that decreased area of rectus abdominis muscle (OR, 0.18; p < 0.01) and increased inter-rectus abdominis distance (OR, 1.14; p < 0.01) on computed tomographic angiography were significant risk factors associated with postoperative bulge/hernia. CONCLUSION: Preoperative computed tomographic angiography allows objective measurements of the patient's abdominal muscle anatomy that provide valuable prognostic information on the risk of bulge/hernia formation following abdominally based microsurgical breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Integrating omic technologies into aquatic ecological risk assessment and environmental monitoring: hurdles, achievements, and future outlook.

BACKGROUND: In this commentary we present the findings from an international consortium on fish toxicogenomics sponsored by the U.K. Natural Environment Research Council (Fish Toxicogenomics-Moving into Regulation and Monitoring, held 21-23 April 2008 at the Pacific Environmental Science Centre, Vancouver, BC, Canada). OBJECTIVES: The consortium from government agencies, academia, and industry addressed three topics: progress in ecotoxicogenomics, regulatory perspectives on roadblocks for practical implementation of toxicogenomics into risk assessment, and dealing with variability in data sets. DISCUSSION: Participants noted that examples of successful application of omic technologies have been identified, but critical studies are needed to relate molecular changes to ecological adverse outcome. Participants made recommendations for the management of technical and biological variation. They also stressed the need for enhanced interdisciplinary training and communication as well as considerable investment into the generation and curation of appropriate reference omic data. CONCLUSIONS: The participants concluded that, although there are hurdles to pass on the road to regulatory acceptance, omics technologies are already useful for elucidating modes of action of toxicants and can contribute to the risk assessment process as part of a weight-of-evidence approach.