Hathcock, Matthew

Abstract BackgroundTraditional prenatal care includes up to 13 in person office visits, and the cost of this care is not well-described. Alternative models are being explored to better meet the needs of patients and providers. OB Nest is a telemedicine-enhanced program with a reduced frequency of in-person prenatal visits. The cost implications of connected care services added to prenatal care packages are unclear.MethodsUsing data from the OB Nest randomized, controlled trial we analyzed the provider and staff time associated with prenatal care in the traditional and OB Nest models. Fewer visits were required for OB Nest, but given the compensatory increase in connected care activity and supplies, the actual cost difference is not known.Nursing and provider staff time was prospectively recorded for all patients enrolled in the OB Nest clinical trial. Published 2015 national wages for healthcare workers were used to calculate the actual labor cost of providing either traditional or OB Nest prenatal care in 2015 US dollars. Overhead expenses and opportunity costs were not considered.ResultsTotal provider cost was decreased caring for the OB Nest participants, but nursing cost was increased. OB Nest care required an average of 160.8 (+/- 45.0) minutes provider time and 87.8 (+/- 25.1) minutes nursing time, compared to 215.0 (+/- 71.6) and 99.6 (+/- 29.7) minutes for traditional prenatal care (P<0.01). This translated into decreased provider cost and increased nursing cost (P<0.01). Supply costs increased, travel costs declined, and overhead costs declined in the OB Nest model. ConclusionsIn this trial, labor cost for OB Nest prenatal care was 34% higher than for traditional prenatal care. The increased cost is largely attributable to additional nursing connected care time, and in some practice settings may be offset by decreased overhead costs and increased provider billing opportunities. Future efforts will be focused on development of digital solutions for some routine nursing tasks to decrease the overall cost of the model. Trial Registrations: ClinicalTrials.gov Identifier: NCT02082275

Magnesium is an essential element that is involved in the regulation of cell growth, division and differentiation. Epidemiologic studies have demonstrated that a diet poor in magnesium is associated with an increased risk of developing cancer. There are few studies investigating whether magnesium deficiency is associated with a poor prognosis in lymphomas. The recent discovery of X-linked immunodeficiency with magnesium defect, Epstein-Barr virus, and neoplasia (XMEN) disease, suggests a role of magnesium in the development of hematologic malignancies and lymphocyte function. Furthermore, a recently published study found that hypomagnesemia prior to chemotherapy is associated with inferior overall survival (OS) in patients with Burkitt Lymphoma. We hypothesized that low magnesium levels prior to autologous hematopoietic stem cell transplant (AHSCT) may lead to inferior outcomes via impaired lymphocyte recovery. We evaluated whether low serum magnesium levels were associated with inferior survival in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who underwent autologous hematopoietic stem cell transplant (AHSCT) between January 1998 and May 2020 using a retrospective study design. We cross-referenced our search with patients who had a magnesium level as part of their pre-transplant workup between 7 and 28 days prior to their first transplant. Two-sided Wilcoxon rank sum test and Chi square/Fischer's exact test were used to compare the continuous and categorical variables, respectively. Kaplan-Meier and log-rank tests were used to perform all time to event analysis. Hazard ratios (HR) with confidence intervals (CI) were calculated using Cox-proportional hazards. Our study included 581 patients of which 82 (14.1%) had hypomagnesemia (magnesium &lt; 1.7 mg/dL) prior to AHSCT. Our study found that hypomagnesemia was associated with inferior OS and event-free survival (EFS) defined as re-transplant, relapse or death, compared to those with a normal magnesium level; median OS: 7.3 years (95% CI: 2.91 - upper limit not estimable) versus 9.7 years (95% CI: 6.92 - 12.3 years), p=0.0041; and median EFS: 3.9 years (95% CI: 1.63 - 8.98 years) versus 6.29 years (95% CI: 4.73 - 8.95 years), p = 0.016 respectively(B). Higher serum magnesium (HR 0.199 per doubling, 95% CI 0.078 - 0.503; p&lt;0.001) and higher albumin (HR 0.090 per doubling, 95% CI 0.021 - 0.394; p=0.001) were associated with lower mortality rates, and higher creatinine (HR 1.669 per doubling, 95% CI 1.03 - 2.52; p=0.04) was associated with greater mortality up to 1 year post-transplantation. In a multivariate Cox regression excluding albumin, hypomagnesemia (p &lt; 0.001) and elevated creatinine (p = 0.038) were independent predictors of poor overall survival(A). There was no significant difference between day 15 absolute lymphocyte count between patients with normal magnesium levels and low serum magnesium levels prior to their conditioning regimen. Although we hypothesized that we would find a significant difference between 15 day absolute lymphocyte count recovery and hypomagnesemia, this was not apparent. However, magnesium is an important nutrient for immune function and immune recovery is important after the bone marrow is restored post ablative therapy. Thus, low serum magnesium levels may lead to impaired OS and EFS via impaired lymphocyte function. In vitro studies will be necessary to understand this mechanism further. Magnesium may simply be a marker of illness and replacement of magnesium may not improve outcomes. However, further investigations are needed to determine whether outcomes would improve with replacement of magnesium in patients with hypomagnesemia, which our study did not address. Overall, our preliminary data suggests that hypomagnesemia is an independent prognostic factor and predictor of inferior OS and EFS in this cohort of patients. Figure Disclosures Ansell: ADC Therapeutics:Research Funding;AI Therapeutics:Research Funding;Trillium:Research Funding;Affimed:Research Funding;Regeneron:Research Funding;Seattle Genetics:Research Funding;Bristol Myers Squibb:Research Funding;Takeda:Research Funding.Witzig:Spectrum:Consultancy;Celgene:Consultancy, Research Funding;Immune Design:Research Funding;Karyopharm Therapeutics:Research Funding;Acerta:Research Funding;Incyte:Consultancy;AbbVie:Consultancy;MorphSys:Consultancy.

AbstractBackgroundResilience represents the capacity to adapt to adversity. Resilience can improve following behavioral interventions. We examined lung transplant candidates’ resilience as a novel predictor using the Connor‐Davidson Resilience Scale (RISC‐10).MethodsWaitlisted candidates at six centers were mailed questionnaires from 9/16/2015 to 10/1/2019. Follow‐up surveys were collected annually and post‐transplant. Outcomes were recorded through February 17, 2020. Primary outcome was pre‐transplant death/delisting. Analyses included t test or chi‐square for group comparisons, Pearson's correlation coefficients for strength of relationships, and Cox proportional‐hazard models to evaluate associations with outcomes, adjusting for age, sex, and mood.ResultsParticipation was 55.3% (N = 199). Baseline RISC‐10 averaged 32.0 ± 5.6 and did not differ by demographics, primary transplant diagnosis, or disease severity markers. RISC‐10 did not correlate to the commonly utilized Psychosocial Assessment of Candidates for Transplant [PACT] or Stanford Integrated Psychosocial Assessment for Transplantation [SIPAT] tools. Scores < 26.3 (representing > 1 standard deviation below population average) occurred in 16% and were associated with pre‐transplant death or delisting, adjusted Hazard Ratio of 2.60 (95% Confidence Interval 1.23‐5.77; P = .01).ConclusionOne in six lung candidates had low resilience, predicting increased pre‐transplant death/delisting. RISC‐10 did not correlate with PACT or SIPAT; resilience may represent a novel risk factor.

Abstract The importance of fetal placental macrophages (Hofbauer cell [HCs]) is underscored by their appearance 18 d postconception and maintenance through term; however, how human HCs evolve during healthy pregnancy and how microenvironment and ontogeny impact phenotype and function remain unknown. In this study, we comprehensively classify human HCs ex vivo, interrogate phenotypic plasticity, and characterize antiviral immune responses through gestation. Activated HCs were abundant in early pregnancy and decreased by term; molecular signatures emphasize inflammatory phenotypes early in gestation. Frequency of HCs with regulatory phenotypes remained high through term. Furthermore, term HCs exhibited blunted responses to stimulation, indicating reduced plasticity. IFN-λ1 is a key placental IFN that appeared less protective than IFN-α, suggesting a potential weakness in antiviral immunity. Ligand-specific responses were temporally regulated: we noted an absence of inflammatory mediators and reduced antiviral gene transcription following RIG-I activation at term despite all HCs producing inflammatory mediators following IFN-γ plus LPS stimulation. Collectively, we demonstrate sequential, evolving immunity as part of the natural history of HCs through gestation.

Background. Sepsis is a leading cause of mortality and morbidity in neonates, with group B streptococcus (GBS) remaining the most frequent pathogen isolated from term infants. Surveillance data showed that the majority of cases of early-onset GBS disease were neonates born to women who either received no or suboptimal intrapartum antibiotic prophylaxis with a notable portion of those women having a missed opportunity to receive ≥4 hours of chemoprophylaxis. Women planning delivery by cesarean section who present in labor or rupture of membranes prior to their scheduled surgery are unlikely to receive optimal GBS chemoprophylaxis and thus their neonates are at risk of having sepsis. Materials and Methods. A retrospective cohort study of women-infant dyads was extracted from the Consortium on Safe Labor dataset. Women who had an unlabored cesarean section at ≥37+0 week gestation were selected and divided into four groups based on GBS status and timing of cesarean section with respect to onset of labor or rupture of membranes. The rate of neonatal sepsis and the patterns of intrapartum antibiotic chemoprophylaxis were determined. Results. The sepsis rate (4.5%) among neonates of GBS-colonized women having their unlabored cesarean section after onset of labor or rupture of membranes was significantly higher than that in any other group in this study. In this group, 9.4% of women received chemoprophylaxis for ≥4 hours, while 31% had a missed opportunity to receive ≥4 hours of chemoprophylaxis. Conclusion. This study suggests that neonates of GBS-colonized women having a planned cesarean section after onset of labor or rupture of membranes are at increased risk of having a sepsis diagnosis. This finding suggest the need for additional studies to assess the risk of sepsis among neonates of women in this group.

Objective: A retrospective cohort study was performed to evaluate whether birthweight was less among infants of women taking amphetamine–dextroamphetamine during pregnancy at our academic institution. Method: We identified mother–infant pairs with documented exposure to amphetamine–dextroamphetamine in pregnancy from 2005 through 2015. Patients were matched 2:1 with unexposed controls. Charts were reviewed for known causes of intrauterine growth restriction. Analysis of birthweight used generalized estimating equation blocking on matching. Medical histories were analyzed with χ 2 test or Fisher’s exact test. Results: We identified 53 exposed mother–infant pairs. The difference in mean birthweight of infants exposed to amphetamine–dextroamphetamine versus those not exposed was 26.9 g, which is not significant (95% confidence interval [CI] = [−141, 195 g]; p = .75). A significant difference was noted for exposed versus unexposed mothers for comorbid psychiatric illness and history of substance abuse ( p < .001). Conclusion: With a limited sample size, our study suggests no significant difference in birthweight.

Purpose The Mayo Clinic Biobank was established to provide a large group of patients from which comparison groups (ie, controls) could be selected for case–control studies, to create a prospective cohort with sufficient power for common outcomes and to support electronic health record (EHR) studies. Participants A total of 56 862 participants enrolled (21% response rate) into the Mayo Clinic Biobank from Rochester, Minnesota (77%, n=43 836), Jacksonville, Florida (18%, n=10 368) and La Crosse, Wisconsin (5%, n=2658). Participants were all Mayo Clinic patients, 18 years of age or older and US residents. Findings to date Overall, 43% of participants were 65 years of age or older and female participants were more frequent (59%) than males at all sites. Most participants resided in the Upper Midwest regions of the USA (Minnesota, Iowa, Illinois or Wisconsin), Florida or Georgia. Self-reported race among Biobank participants was 90% white. Here we provide examples of the types of studies that have successfully utilised the resource, including (1) investigations of the population itself, (2) provision of controls for case–control studies, (3) genotype-driven research, (4) EHR-based research and (5) prospective recruitment to other studies. Over 270 projects have been approved to date to access Biobank data and/or samples; over 200 000 sample aliquots have been approved for distribution. Future plans The data and samples in the Mayo Clinic Biobank can be used for various types of epidemiological and clinical studies, especially in the setting of case–control studies for which the Biobank samples serve as control samples. We are planning cohort studies with additional follow-up and acquisition of genetic information on a large scale.

Background: DNA biobanks frequently obtain broad permissions from sample donors, who agree to allow their biospecimens to be used for a variety of future purposes. A limitation of this approach is that it may not be possible to discuss or anticipate all potential uses of biospecimens at the time patient consent is obtained. We surveyed biobank participants to clarify their views regarding the need to be informed about research involving whole genome sequencing (WGS). Methods: We invited 1200 participants in the Mayo Clinic Biobank to complete a survey inquiring about their support for WGS; their interest in being recontacted before WGS of their biospecimens; whether they would consent to WGS if asked; and the acceptability of proceeding with WGS if sample donors could not be reached. Results: Six hundred eighty-seven biobank participants returned completed surveys (57% response). More than 96% of biobank participants were supportive of WGS and would give permission for WGS of their sample, if asked. Nonetheless, 61% of biobank participants felt they should be recontacted before WGS was done. Participants were divided regarding the permissibility of conducting WGS if efforts to recontact sample donors were unsuccessful. Discussion: Our findings highlight a potential discrepancy between the broad permissions granted by biobank participants at the time they donated biospecimens and their views about the application of WGS to their samples. Biobank participants appear to value the ability to confirm their commitment to genetic research when the studies in question involve WGS, a technological capacity they may not have anticipated at the time they donated their biospecimens. Efforts to reevaluate biobank participants' views about the acceptability of new technologies may help to ensure alignment of participants' current beliefs and research applications that would have been difficult to anticipate at the time biospecimens were collected.