Effectiveness of Biologic Agents Among Hispanic Patients With Metastatic Colorectal Cancer.

BACKGROUND: Randomized clinical trials have defined the survival advantage with the addition of biologic drugs to chemotherapy in patients with metastatic colorectal cancer (mCRC). Under representation of Hispanics contributes to poorly defined outcomes in this group. We aim to determine whether the real-world benefit of biologics extends to Hispanics using a comparative effectiveness research approach. METHODS: This retrospective cohort study included all treatment centers contributing to SEER registry with available claims in the SEER-Medicare linked database (2001-2011) and 2 hospitals (2004-2016) catering to minorities. Metastatic CRC patients were classified as receiving chemotherapy or biochemotherapy (CT plus biologics; if initiated within 3 months of chemotherapy). The primary outcome was overall survival (OS) among the Hispanic patients calculated from time of administration of first dose of chemotherapy to death or last follow-up. A weighted Cox regression model was used to assess differences in survival. RESULTS: We identified 182 Hispanic patients with mCRC from the Patient Entitlement and Diagnosis Summary (PEDSF) file (n = 101) and hospital database (n = 81). Overall, 52% were women and 72% received biologics. The median OS was 11.3 and 17.0 months in chemotherapy and biochemotherapy group, respectively. Biochemotherapy offered a survival benefit compared with chemotherapy alone, with an average hazard rate reduction of 39% (95% CI 6%-60%, p = .0236) using inverse probability of treatment weighting (IPTW) based analysis. CONCLUSION: In this cohort of Hispanic patients with mCRC, biochemotherapy was associated with longer survival. Clinicians may offer biochemotherapy therapy to all patients regardless of race/ethnicity to maximize clinical benefit.

Comparative Effectiveness of Biologic Agents Among Black and White Medicare Patients in the US With Metastatic Colorectal Cancer.

Importance: Randomized clinical trials have defined the survival benefit provided by the addition of biologic drugs to chemotherapy in patients with metastatic colorectal cancer (mCRC). However, Black patients may be underrepresented in trial populations, and outcomes in this group remain poorly defined. Objective: To determine whether the real-world benefit of biologic drugs in Black patients is consistent with the real-world benefit of biologic drugs in White patients using a comparative effectiveness research approach. Design, Setting, and Participants: Population-based retrospective comparative effectiveness analysis of a cohort of patients aged 65 years or older with mCRC diagnosed between 2004 and 2011 who had received at least 1 dose of chemotherapy and had complete Medicare claims data using the Surveillance, Epidemiology, and End Result (SEER)-Medicare linked database. Data were analyzed from August 1, 2020, to March 31, 2021. Interventions: Patient data were classified according to whether patients received chemotherapy (oxaliplatin, irinotecan, and 5-fluorouracil or capecitabine) or biochemotherapy (bevacizumab, cetuximab, panitumumab, ramucirumab, or aflibercept, started within 3 months of chemotherapy). Main Outcomes and Measures: Overall survival (OS) defined as the time from starting chemotherapy to death or last follow-up. A weighted Cox regression model was used to assess differences in survival. Results: A total of 5617 patients with mCRC were identified in the SEER-Medicare linked database, and 4542 patients were included in the main analysis. Of the 5617 patients, 3969 (70.7%) received biologic agents at any point between 2004 and 2011; biologic agent therapy was started within 3 months of chemotherapy in 2894 patients (72.9%). Among 4542 patients with data on race and ethnicity, the median age was 72 years (IQR, 68-78 years), 2365 (52.0%) were female, 3445 (75.8%) had colon as the primary site, 552 (12.2%) were Black patients, and 3990 (87.8%) were White patients. There was no difference in the receipt of 1 (76.7% and 74.8%) vs 2 or more (23.3% and 25.2%: P = .92) lines of therapy, and in the receipt of biologic agents (63.6% vs 64.3% P = .33), among White patients and Black patients, respectively. Biochemotherapy was associated with a significant survival benefit compared with chemotherapy alone in the overall population (biochemotherapy median OS, 17.9 [95% CI, 17.3-18.7] months vs chemotherapy median OS, 8.3 [95% CI, 9.1-9.9] months; P < .001). The survival benefit was similar among White patients (17.8 vs 9 months; average hazard ratio, 0.59; 95% CI, 0.55-0.64; P < .001) and Black patients (18.6 vs 9.9; average hazard ratio, 0.58; 95% CI, 0.47-0.71; P < .001). Conclusions and Relevance: In this comparative effectiveness analysis of a cohort of Medicare recipients with mCRC, biochemotherapy was associated with an improvement in OS with a similar rate of reduction in mortality among Black and White patients. Clinicians may offer biochemotherapy therapy to all patients to maximize clinical benefit, factoring in clinical variables, but not their race.

Prediction Model Using Machine Learning for Mortality in Patients with Heart Failure.

Heart Failure (HF) is a major cause of morbidity and mortality in the US. With aging of the US population, the public health burden of HF is enormous. We aimed to develop an ensemble prediction model for 30-day mortality after discharge using machine learning. Using an electronic medical records (EMR) database, all patients with a non-elective HF admission over 10 years (January 2001 - December 2010) within the Montefiore Medical Center (MMC) health system, in the Bronx, New York, were included. We developed an ensemble model for 30-day mortality after discharge and employed discrimination, range of prediction, Brier index and explained variance as metrics in assessing model performance. A total of 7,516 patients were included. The discrimination achieved by the ensemble model was higher 0.83 (95% CI: 0.80 to 0.87) compared to the benchmark model 0.79 (95% CI: 0.75 to 0.84). The ensemble model also exhibited a better range of prediction as well as a favorable profile with respect to the other metrics employed. In conclusion, an ensemble machine learning approach exhibited an improvement in performance compared to the benchmark logistic model in predicting all-cause mortality among HF patients within 30-days of discharge. Machine learning is a promising alternative approach for risk profiling of HF patients, and it enhances individualized patient management.

Noninvasive monitoring of uterine electrical activity among patients with obesity: a new external monitoring device.

BACKGROUND: Tocodynamometry is a common, noninvasive tool used to measure contraction frequency; however, its utility is often limited in patients with obesity. An intrauterine pressure catheter provides a more accurate measurement of uterine contractions but requires ruptured membranes, limiting its utility during early latent labor. Electrical uterine myography has shown promise as a noninvasive contraction monitor with efficacy similar to that of the intrauterine pressure catheter; however, its efficacy has not been widely studied in the obese population. OBJECTIVE: This study aimed to validate the accuracy of electrical uterine myography by comparing it with tocodynamometry and intrauterine pressure catheters among laboring patients with obesity. STUDY DESIGN: This was a prospective observational study from February 2017 to April 2018 of patients with obesity, aged 18 years or older, who were admitted to the labor unit with viable singleton pregnancies and no contraindications for electromyography. Patients were monitored simultaneously with electrical myography and tocodynamometry or intrauterine catheter for more than 30 minutes. Two blinded obstetricians reviewed the tracings. The outcomes of interest were continuous and interpretable tracing, number of contractions, and timing and duration of contractions, interpreted as point estimates and associated 95% confidence intervals. RESULTS: A total of 110 patients were enrolled (65 tocodynamometry, 55 intrauterine catheter). Electrical myography was significantly more interpretable during a 30-minute tracing (P=.001) and detected 39% more contractions than tocodynamometry (P<.0001; 95% confidence interval, 23%-57%), whereas there was no difference in the interpretability of tracings or number of contractions between electrical myography and an intrauterine catheter (P=.16; 95% confidence interval, -0.19 to 1.19). Patients who underwent simultaneous monitoring preferred the electrical myography device over tocodynamometry. CONCLUSION: Electrical uterine myography is superior to tocodynamometry in the detection of intrapartum uterine contraction monitoring and comparable with internal contraction monitoring.

Racial Diversity Among Histology of Renal Cell Carcinoma at an Urban Medical Center.

BACKGROUND: Non-Hispanic blacks (NHB) with renal cell carcinoma (RCC) are more likely to have papillary RCC (pRCC) than non-Hispanic whites (NHW). Data on histologic subtypes in RCC in Hispanics (H) are also sparse. Previous studies have shown that pRCC is more prevalent in NHB than in NHW, but they analyzed predominantly NHW populations. The Montefiore-Einstein Center for Cancer Care (MECC) serves a predominantly NHB and H population in the Bronx, NY. We investigated histologic subtype specific associations with established RCC risk factors in this population. PATIENTS AND METHODS: The MECC tumor registry was used to identify patients ≥ 18 years of age treated with partial or radical nephrectomy between January 2000 and December 2015. An institutional software program and individual chart review were used to obtain demographic data (including self-reported race, age, and sex), pathology data, and RCC risk factors (hypertension, diabetes, renal function, weight). Data were modeled by multinomial logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: A total of 1010 RCC cases were identified. Of these, 232 (23.0%) occurred in NHW, 383 (37.9%) NHB, 181 (17.9%) H, and 214 (21.2%) other. A total of 530 cases (52.5%) were clear cell (ccRCC) histology, 257 (25.4%) pRCC, 100 (9.9%) chromophobe (cRCC), and 123 (12.2%) other. Individuals with pRCC compared to ccRCC were more likely to be NHB than NHW (OR, 4.41; 95% CI, 2.81-6.93) but were less likely to be female (OR, 0.50; 95% CI, 0.35-0.72). Individuals with pRCC were also less likely to be H than NHW (OR, 0.52; 95% CI, 0.27-0.99). Patients with cRCC were also more likely to be NHB than NHW (OR, 2.23; 95% CI, 1.06-4.67). CONCLUSION: In the MECC data set, histology of RCC varies by race, confirming earlier reports that non-ccRCC is more common in NHB than NHW. We also report that pRCC is less common in H than NHW.

Associations between immediate postpartum long-acting reversible contraception and short interpregnancy intervals.

OBJECTIVE: We aimed to evaluate the rates of short interpregnancy interval pregnancies and deliveries among women who receive immediate postpartum LARC. STUDY DESIGN: We conducted a retrospective cohort study of all women who delivered at Montefiore Medical Center between January 2015 and June 2016 (N = 9561). In this cohort, we identified all repeat deliveries and pregnancies within 18 months of the initial delivery. Using logistic regression models, we compared rates of short interpregnancy interval delivery and pregnancy among recipients of an immediate postpartum IUD, immediate postpartum implant, and no immediate postpartum LARC, adjusting for covariates including patient age, mode of delivery, socioeconomic status, and race. RESULTS: In our cohort, 12.9% of patients received immediate postpartum LARC. The rates of short interpregnancy interval delivery were 3.3% (N = 259/7833) among patients who did not receive immediate postpartum LARC, 1% (N = 6/595) among immediate postpartum IUD recipients, and 0.4% (N = 2/562) among immediate postpartum implant recipients. The rates of short interpregnancy interval pregnancy were 13.8% (N = 1082/7833) among patients who did not receive immediate postpartum LARC, 7.4% (N = 44/595) among immediate postpartum IUD recipients, and 5.2% (N = 29/562) among immediate postpartum implant recipients. Both recipients of immediate postpartum IUDs and immediate postpartum implants had lower rates of short interpregnancy interval delivery and pregnancy compared to patients who did not receive immediate postpartum LARC. CONCLUSIONS: This study confirms that women who received immediate postpartum IUDs and implants have lower rates of short interpregnancy interval pregnancies. IMPLICATIONS: Making immediate postpartum LARC widely available is a promising public health approach to help women achieve a longer interpregnancy interval.

The impact of menstrual hygiene management on adolescent health: The effect of Go! pads on rate of urinary tract infection in adolescent females in Kibogora, Rwanda.

OBJECTIVE: To determine the rates of urinary tract infection (UTI) in adolescent users of menstrual pads versus non-users in a rural area of Rwanda. METHODS: An interventional prospective cohort study was conducted at four secondary schools in the Western Province of Rwanda from May 12, 2017 to October 20, 2017. Inclusion criteria were female students aged 18-24 who were menstruating and volunteered to participate in the study. In total, 240 adolescent participants were assigned to two cohorts; 120 received menstrual pads for 6 months and the other 120 did not use pads. Baseline symptoms and urine cultures were obtained. Symptoms and methods of menstrual hygiene management were assessed and urine cultures were obtained every 2 months. The primary outcome was the presence of UTI diagnosed by positive urine culture. Secondary outcomes were symptoms of UTI, vulvovaginal symptoms, sexual activity, dyspareunia, and self-reported sexually transmitted infection. Generalized estimating equations with nesting were used to assess associations of pad use with study outcomes. RESULTS: A total of 209 participants completed the study. There was no difference in rates of positive urine culture. A decreased odds of vulvovaginal symptoms was found in self-reported "always" versus "never" pad users (odds ratio [OR] 0.64, 95% confidence interval [CI] 0.43-0.96; P=0.031). CONCLUSIONS: Despite not finding any difference in rates of UTI, the present study showed a decreased rate of vulvovaginal symptoms in users of menstrual pads. Further research investigating rates of genital infections in this population is thus necessary.

Prevalence and Predictors of Deep Vein Thrombosis in Critically Ill Medical Patients Who Underwent Diagnostic Duplex Ultrasonography.

INTRODUCTION: Deep vein thrombosis (DVT) is a recognized but preventable cause of morbidity and mortality in the medical intensive care unit (MICU). We examined the prevalence and risk factors for DVT in MICU patients who underwent diagnostic venous duplex ultrasonography (DUS) and the potential effect on clinical outcomes. METHODS: This is a retrospective study examining prevalence of DVT in 678 consecutive patients admitted to a tertiary care level academic MICU from July 2014 to 2015. Patients who underwent diagnostic DUS were included. Potential conditions of interest were mechanical ventilation, hemodialysis, sepsis, Sequential Organ Failure Assessment (SOFA) scores, central venous catheters, prior DVT, and malignancy. Primary outcomes were pulmonary embolism, ICU length of stay, and mortality. Additionally, means of thromboprophylaxis was compared between the groups. Multivariable logistic regression analysis was utilized to determine predictors of DVT occurrence. RESULTS: Of the 678 patients, 243 (36%) patients underwent DUS to evaluate for DVT. The prevalence of DVT was 16% (38) among tested patients, and a prior history of DVT was associated with DVT prevalence (P < .01). Between cases and controls, there were no significant differences in central venous catheters, mechanical ventilation, hemodialysis, sepsis, SOFA scores, malignancy, and recent surgery. Patients receiving chemical prophylaxis had fewer DVTs compared to persons with no prophylaxis (14% vs 29%; P = .01) and persons with dual chemical and mechanical prophylaxis (P = 0.1). Fourteen percent of patients tested had documented DVT while on chemoprophylaxis. There were no significant differences in ICU length of stay (P = .35) or mortality (P = .34). CONCLUSIONS: Despite the appropriate use of universal thromboprophylaxis, critically ill nonsurgical patients still demonstrated high rates of DVT. A history of DVT was the sole predictor for development of proximal DVT on DUS testing. Dual chemical and mechanical prophylaxis does not appear to be superior to single-chemical prophylaxis in DVT prevention in this population.

The Neutrophil-to-Lymphocyte Ratio is a Prognostic Biomarker in An Ethnically Diverse Patient Population with Advanced Pancreatic Cancer.

PURPOSE: The neutrophil-to-lymphocyte ratio (NLR) is associated with decreased overall survival in patients with pancreatic adenocarcinoma (PAC) in studies including few minority patients. We investigated the association between NLR and survival in patients with advanced PAC in an ethnically diverse population. METHODS: We retrospectively evaluated 226 patients with advanced PAC treated at Montefiore Medical Center between 2006 and 2015. Adjusted Cox proportion hazard regression models were utilized to derive effect estimates for survival duration. RESULTS: Patients with a NLR ≤ 5 (126 patients, median age 66 years) were more likely to be non-Hispanic Black (30.8% vs. 20%), while patients with a NLR > 5 (70 patients, median age 66 years) were more likely to be non-Hispanic White (21.4% vs. 12.2%) or Hispanic (44.3% vs. 34%). A NLR > 5 compared with a NLR ≤ 5 was significantly associated with a worse overall survival when adjusted for a priori and exploratory variables from the univariate analysis (median survival 7.4 vs. 12 months, HR 1.650, 95% CI 1.139, 2.390). CONCLUSIONS: In an ethnically diverse population, elevated NLR is an independent marker of poor prognosis and a potentially valuable factor in driving therapeutic decisions and defining prognosis for patients in the locally advanced or metastatic for PAC setting, meriting investigation in prospective clinical trials.

Enhanced recovery after surgery at cesarean delivery to reduce postoperative length of stay: a randomized controlled trial.

OBJECTIVE: Our objective was to determine whether an enhanced recovery after surgery pathway at the time of cesarean birth would permit a reduction in postoperative length of stay and improve postoperative patient satisfaction compared to standard perioperative care. MATERIALS AND METHODS: Patients undergoing nonemergent cesarean delivery at ≥37 weeks of gestation were randomized to enhanced recovery after surgery or standard care. Enhanced recovery after surgery involved multiple evidence-based interventions bundled into 1 protocol. The primary outcome was discharge on postoperative day 2. Secondary outcome variables included pain medication requirements, breastfeeding rates, and various measures of patient satisfaction. RESULTS: From September 27, 2017, to May 2, 2018, a total of 58 women were randomized to enhanced recovery after surgery and 60 women to standard care. The groups were similar in medical comorbidities and in demographic and perioperative characteristics. Enhanced recovery after surgery was not associated with a significantly increased rate of postoperative day 2 discharges when compared with standard care (8.6% vs 3.3%, respectively; odds ratio, 2.74; 95% confidence interval, 0.51-14.70), but it was associated with a significantly reduced postoperative length of stay when compared with standard care, with a median length of stay of 73.5 hours (interquartile range, 71.08-76.62) vs 75.5 hours (interquartile range, 72.86-76.84) from surgery, difference in median length of stay (-1.92; 95% confidence interval, -3.80 to -0.29). Enhanced recovery after surgery was not associated with a reduction in postoperative narcotic use (117.16 ± 54.17 vs 119.38 ± 47.98 morphine milligram equivalents; mean difference, -2.22; 95% confidence interval, -20.86 to 16.42). More subjects randomized to the enhanced recovery after surgery protocol reported breastfeeding at discharge (67.2% vs 48.3%; P = .046). When patients were surveyed 6 weeks postpartum, those in the enhanced recovery after surgery group were more likely to feel that their expectations were met and that they had achieved their postoperative milestones earlier, and to report continued breastfeeding. CONCLUSION: Enhanced recovery after surgery at cesarean delivery was not associated with an increase in the number of women discharged on postoperative day 2, but that may have been related to factors other than patients' medical readiness for discharge. Evidence that enhanced recovery after surgery at cesarean delivery may have the potential to improve outcomes such as day of discharge is suggested by the observed reduction in overall postoperative length of stay, improved patient satisfaction, and an increase in breastfeeding rates. Even better results may accrue with more provider and patient experience with enhanced recovery after surgery.

Excision repair cross-complementing group-1 (ERCC1) induction kinetics and polymorphism are markers of inferior outcome in patients with colorectal cancer treated with oxaliplatin.

BACKGROUND: ERCC1, a component of nucleotide excision repair pathway, is known to repair DNA breaks induced by platinum drugs. We sought to ascertain if ERCC1 expression dynamics and a single nucleotide polymorphism (SNP) rs11615 are biomarkers of sensitivity to oxaliplatin therapy in patients with colorectal cancer (CRC). METHODS: Western blot and qPCR for ERCC1 expression was performed from PBMCs isolated from patients receiving oxaliplatin-based therapy at specified timepoints. DNA was also isolated from 59 biorepository specimens for SNP analysis. Clinical benefit was determined using progression free survival (PFS) for metastatic CRC. RESULTS: ERCC1 was induced in PBMC in response to oxaliplatin in 13/25 patients with mCRC (52%). Median PFS with ERCC1 induction was 190d compared to 237d in non-induced patients (HR 2.35, CI 1.005-5.479; p=0.0182). ERCC1 rs11615 SNP analysis revealed that 43.3% harbored C/C, 41.2%-T/C and 15.5%-T/T genotype. Median PFS was significantly lower with C/C or T/C (211 and 196d) compared to T/T (590d; p=0.0310). CONCLUSIONS: ERCC1 was induced in a sub-population of patients undergoing oxaliplatin treatment, which was associated with poorer outcome, suggesting this could serve as a marker of oxaliplatin response. C/C or C/T genotype in ERCC1 rs11615 locus decreased benefit from oxaliplatin.

Noninvasive Measures of Pulsatility and Blood Pressure During Continuous-Flow Left Ventricular Assist Device Support.

The reliability and validity of a palpable pulse and other noninvasive measures of pulsatility in patients on continuous-flow (CF) left ventricular assist device (LVAD) support have not been rigorously evaluated. We prospectively enrolled 23 patients who had CF-LVAD and an arterial catheter for blood pressure (BP) monitoring. Pulse pressure (PP) via the arterial line was compared with three noninvasive measures of pulsatility: presence of a palpable pulse, pulsatility index (PI), and aortic valve opening (AVO). In addition, the relationship between Doppler BP (DopBP) and arterial line pressures was evaluated. The study group comprised 30% females, 73% nonischemic cardiomyopathy, 87% axial flow device (HeartMate II [HMII]), and 13% centrifugal flow device (HeartWare ventricular assist device [HVAD]) support. Among four practitioners, the interobserver agreement for the presence of a palpable pulse was moderate (k = 0.41; 95% CI, 0.28-0.60). If the PP was ≥15 mm Hg, a radial pulse was palpated 82% of the time, whereas when the PP was <15 mm Hg, a radial pulse was palpated only 35% of the time. In subjects with a palpable pulse, there was a strong correlation between DopBP and systolic BP (SBP) (r = 0.94; 95% CI, 0.82-0.99), whereas the correlation between DopBP and mean arterial pressure (MAP) was much weaker (r = 0.42; 95% CI, 0.19-0.96). In subjects without a palpable pulse, there was a strong correlation between both the DopBP and SBP (r = 0.94; 95% CI, 0.80-1.0) and DopBP and MAP (r = 0.87; 95% CI, 0.77-1.00). Finally, PP was significantly associated with PI (odds ratio [OR], 0.3; 95% CI, 0.14-0.45; p = 0.0002) but not AVO (OR, 1.41: 95% CI, 0.70-2.83; p = 0.33). The presence of a palpable pulse has good interobserver agreement and allows for dichotomization of the DopBP to reflect the SBP in its presence and the MAP in its absence. This simple measure should be incorporated into BP management algorithms for CF-LVADs. The PI shows a modest correlation to PP.

Design and Validation of a Peer-Teacher-Based Musculoskeletal Ultrasound Curriculum.

RATIONALE AND OBJECTIVES: To design and validate a peer-teacher based musculoskeletal ultrasound curriculum for radiology residents. MATERIALS AND METHODS: A musculoskeletal ultrasound curriculum with hands-on scanning workshops was designed for radiology residents. Prior to the workshops, several residents received 3 hours of hands-on training in ultrasound scanning technique which was overseen by an attending musculoskeletal radiologist; these "peer teachers" then led small-group hands-on scanning during the workshops. Participants performed diagnostic ultrasound examinations at the conclusion of the workshops to assess skill acquisition and 2 months following the workshops to quantify skill retention. Participants also completed surveys to determine confidence in performing musculoskeletal ultrasound examinations. Median scores and interquartile range (25-75%) were calculated, and t test was used to compare results. RESULTS: Thirty seven residents from all years of training and six senior resident or fellow peer teachers participated in four workshops. Diagnostic ultrasound images were obtained in 100% at the conclusion of the workshop and in 79% 2 months later. Prior to the workshops, residents reported low level of musculoskeletal ultrasound knowledge (median 2, interquartile ranges 1-2), and low confidence in performing (1, 1-2) and interpreting (1, 1-2) musculoskeletal ultrasound examinations. There was a significant increase in knowledge (3, 3-4) and confidence performing (3, 3-4) and interpreting (3, 3-4) studies following the workshops (p < 0.001 for all comparisons). CONCLUSION: Hands-on musculoskeletal ultrasound workshops, utilizing a peer teacher led small group format is an effective method of teaching scanning skills to residents. There was excellent skill acquisition, good skill retention, and significant increase in confidence performing and interpreting these studies following completion of the curriculum.

The impact of using donor sperm in assisted reproductive technology cycles on perinatal outcomes.

OBJECTIVE: To assess the impact of using donor sperm in assisted reproductive technology (ART) cycles on perinatal outcomes. DESIGN: Historical cohort study. SETTING: US national database from the Society of Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) from 2012 to 2013. PATIENT(S): Patients undergoing the first fresh autologous ART cycle using either donor or partner sperm. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Miscarriage, preterm birth, low birthweight rates. RESULTS: A total of 134,710 fresh autologous ART cycles were evaluated from the SART CORS database. Following exclusion criteria and after restricting to the first cycle, 2,123 donor sperm and 42,799 partner sperm ART cycles were included in the final analyses. After adjusting for all confounding variables (including maternal age, race, body mass index, smoking status, gravidity, history of preterm birth, highest follicle stimulating hormone count, blastocyst transfer percentage, total embryo transferred, and etiology of infertility), no statistically significant differences in miscarriage rates, preterm births, very preterm births, low birthweight, and very low birthweight were observed. Birthweight was significantly lower in the partner sperm group than in the donor sperm group (3,292 ± 601 and 3,233 ± 592 g in donor and partner sperm groups, respectively, adjusted P value 0.003); however, this small absolute difference (adjusted effect estimate 42 g, 95% CI 14.7-70.9) does not carry clinical significance. CONCLUSIONS: The use of donor sperm in fresh autologous ART cycles was not associated with increased miscarriage, preterm births, or low birthweights, as compared to cycles using partner sperm. This information can be used in patient counseling to reassure patients using donor sperm in ART cycles.

Comparative Effectiveness Research: The Impact of Biologic Agents in Ethnic Minorities With Metastatic Colorectal Cancer.

BACKGROUND: Biologic agents have improved the outcomes of patients with metastatic colorectal cancer (mCRC). However, the clinical trials included a predominately white population (85%), with Hispanic and black patients underrepresented. Thus, the real world benefit for the latter remains unknown. Comparative effectiveness research is a tool allowing for this exploration. PATIENTS AND METHODS: The demographic and clinical characteristics of patients treated for mCRC from 2000 to 2011 were extracted from the medical records of Montefiore Medical Center. A semiparametric accelerated failure time model was used to assess the survival differences between patients receiving chemotherapy (CT) alone versus CT plus biologic agents (CBT). RESULTS: Of the 290 patients (black, 45.9%; Hispanic, 26.2%; and white, 27.9%), 53.8% received biologic agents. The median overall survival was 15.2 months in the CT-alone group and 25.6 months in CBT group (P = .004). On univariate analysis, a lower number of metastatic sites, carcinoembryonic antigen < 41 ng/mL, and more lines of CT were associated with improved overall survival. In a propensity score-based analysis of the entire cohort, CBT offered a survival benefit compared with CT alone (increased median survival, 1.44-fold; 95% confidence interval [CI], 1.11-1.86; P = .038). The results of the subgroup analysis suggested a survival benefit for white patients (2.01; 95% CI, 1.26-3.23; P = .031) but not for Hispanic (1.42; 95% CI, 0.91-2.20; P = .370) or black (1.12; 95% CI, 0.76-1.66; P = .596) patients. CONCLUSION: In the present cohort, CBT was associated with longer survival, with the effect mainly driven by the outcomes for white patients, with black patients not appearing to benefit. These data are provocative and warrant further confirmation. Efforts to increase ethnic minority patients' enrollment in clinical trials is required to prospectively define the benefit from novel therapies.

Increased risk of stroke and mortality following new-onset atrial fibrillation during hospitalization.

AIMS: The outcome of patients who develop new-onset atrial fibrillation (AF) during hospitalization is unknown, and the management of this patient population is not specifically addressed by current guidelines. We investigated the incidence of death and inhospital stroke among a large cohort of hospitalized inpatients who developed new-onset AF. METHODS AND RESULTS: All patients ≥50 years of age admitted to a tertiary academic medical centre (20 April 2005 to 31 December 2011; n = 84 919) were studied. Demographic variables were compared among patients categorized as having new-onset, pre-existing, or no AF. A propensity-matched analysis was employed to compare outcomes by generalized estimating equations. Primary endpoints were all-cause 30-day and 1-year mortality and inhospital stroke. New-onset AF occurred in 1749 (2.1%) hospitalized patients. Among patients with new-onset AF, mortality at 30 days and 1 year was higher compared with patients without AF (at 30 days: OR 2.28, 95% CI 1.72-3.02, P < 0.0001; at 1 year: RR 1.53, 95% CI 1.36-1.73, P < 0.0001), and compared with patients with pre-existing AF at 30 days (OR 1.52, 95% CI 1.06-2.17, P = 0.02) -an effect that persisted as non-significant trend at 1 year (RR 1.14, 95% CI 0.98-1.34, P = 0.09). Risk of inhospital stroke was higher in patients with new-onset AF compared with patients without AF (OR 4.53, 95% CI 1.36-15.11, P = 0.02). Among patients with new-onset AF, the CHA2DS2-Vasc score correlated with incidence of inhospital stroke. CONCLUSION: New-onset AF among hospitalized inpatients is independently associated with an increased incidence of stroke and mortality.

Effect of Electronic Cigarette Use on the Urge-to-Cough Sensation.

INTRODUCTION: Electronic cigarettes (e-cigs) have attained common usage worldwide, yet knowledge of their physiological effects remains minimal. The aim of this study was to evaluate the effect of a single exposure to e-cig vapor on the urge-to-cough (UTC) threshold and C5. METHODS: Seventeen healthy nonsmokers underwent C5 measurement employing capsaicin cough challenge at baseline, 15 minutes, and 24 hours after e-cig exposure (30 puffs 30 seconds apart). The endpoint of cough challenge is C5, the concentration of capsaicin inducing five or more coughs. The UTC threshold (Cu) is defined as the lowest concentration of capsaicin inducing UTC without an associated motor cough. RESULTS: The Cu and C5 were significantly inhibited (Cu and C5 increased) 15 minutes after e-cig use. Mean log Cu rose from -0.035±0.08 (SEM) to 0.21±0.12 (P = .005). Mean log C5 increased from 0.60±0.11 to 0.92±0.16 (P = .001). By 24 hours after e-cig exposure, Cu and C5 had returned to baseline levels. CONCLUSIONS: A single session of e-cig use, approximating nicotine exposure of one tobacco cigarette, induces significant inhibition of the Cu, as well as C5. Previous studies implicate nicotine as the agent responsible for suppression of C5, and we hypothesize a similar role for nicotine in the suppression of the Cu. Given our observation of the effect of a single e-cig exposure, studies of the respiratory physiologic implications of repeated or chronic e-cig use are warranted. IMPLICATIONS: This is the first study to demonstrate that a single exposure to an e-cig significantly inhibits the Cu as measured by capsaicin cough challenge testing. These findings add to the growing body of evidence that e-cig vapor is not a physiologically benign substance, and support further investigation of the effects of repeated or chronic use of e-cigs on cough sensitivity and other respiratory parameters.