Background: Infants who survive advanced necrotizing enterocolitis (NEC) at the time of birth are at increased risk of having poor long term physiological and neurodevelopmental growth. The economic implications of the long term morbidity in these children have not been studied to date. This paper compares the long term healthcare costs beyond the initial hospitalization period incurred by medical and surgical NEC survivors with that of matched controls without a diagnosis of NEC during birth hospitalization.Methods: The longitudinal healthcare utilization claim files of infants born between January 2002 and December 2003 and enrolled in the Texas Medicaid fee-for-service program were used for this research. Propensity scoring was used to match infants diagnosed with NEC during birth hospitalization to infants without a diagnosis of NEC on the basis of gender, race, prematurity, extremely low birth weight status and presence of any major birth defects. The Medicaid paid all-inclusive healthcare costs for the period from 6 months to 3 years of age among children in the medical NEC, surgical NEC and matched control groups were evaluated descriptively, and in a generalized linear regression framework in order to model the impact of NEC over time and by birth weight.Results: Two hundred fifty NEC survivors (73 with surgical NEC) and 2,909 matched controls were available for follow-up. Medical NEC infants incurred significantly higher healthcare costs than matched controls between 6–12 months of age (mean incremental cost = US$ 5,112 per infant). No significant difference in healthcare costs between medical NEC infants and matched controls was seen after 12 months. Surgical NEC survivors incurred healthcare costs that were consistently higher than that of matched controls through 36 months of age. The mean incremental healthcare costs of surgical NEC infants compared to matched controls between 6–12, 12–24 and 24–36 months of age were US$ 18,274, 14,067 (p < 0.01) and 8,501 (p = 0.06) per infant per six month period, respectively. These incremental costs were found to vary between sub-groups of infants born with birth weight < 1,000g versus ≥ 1,000g (p < 0.05).Conclusions: The all-inclusive healthcare costs of surgical NEC survivors continued to be substantially higher than that of matched controls through the early childhood development period. These results can have important treatment and policy implications. Further research in this topic is needed.

Background: We have previously shown that an exclusively human milk-based diet is beneficial for extremely premature infants who are at risk for necrotizing enterocolitis (NEC). However, no significant difference in the other primary study endpoint, the length of time on total parenteral nutrition (TPN), was found. The current analysis re-evaluates these data from a different statistical perspective considering the probability or likelihood of needing TPN on any given day rather than the number of days on TPN. This study consisted of 207 premature infants randomized into three groups: one group receiving a control diet of human milk, formula and bovine-based fortifier (“control diet”), and the other two groups receiving only human milk and human milk-based fortifier starting at different times in the enteral feeding process (at feeding volumes of 40 or 100 mL/kg/day; “HM40” and “HM100”, respectively). The counting process Cox proportional hazards survival model was used to determine the likelihood of needing TPN in each group. Results: The two groups on the completely human-based diet had an 11-14 % reduction in the likelihood of needing nutrition via TPN when compared to infants on the control diet (p = 0.0001 and p = 0.001, respectively for the HM40 and HM100 groups, respectively). This was even more pronounced if the initial period of TPN was excluded (p < 0.0001 for both the HM40 and HM100 groups). Conclusions: A completely human milk-based diet significantly reduces the likelihood of TPN use for extremely premature infants when compared to a diet including cow-based products. This likelihood may be reduced even further when the human milk fortifier is initiated earlier in the feeding process. Trial registration: This study was registered at http://www.clinicaltrials.gov reg. # NCT00506584

Introduction: Previous studies have suggested that prescribed cannabidiol (CBD) products may cause elevations in liver tests (LT). This study compared the prevalence of elevated LT in an adult population self-administering CBD with the normal and general adult population prevalences. Materials and Methods: Adults 18–75 years of age across the United States taking CBD orally for a minimum of 30 days were recruited from 12 individual CBD product companies in this decentralized, observational study and sent their standard CBD regimen from the company of their choice. An app-based, 21CFR Part 11 decentralized clinical study platform (ValidCare Study) was used to securely automate consent inclusion/exclusion criteria and collect all the data for this study, including: demographic information, medical history, reasons for taking, dosage, current medications dosage, adverse effects, and efficacy. At the end of 30 days, LTs were obtained. Follow-up LTs were offered to all individuals with elevated alanine transaminase (ALT) values. Results: A total of 28,121 individuals were invited to participate in this study, 1475 enrolled, and 839 (female: 65.3%, male: 34.7%) completed the study. Full-spectrum hemp oil was used by 55.7%, CBD-isolate by 40.5%, and broad spectrum by 3.8%. The mean±SD daily dose of CBD was 50.3+40.7 mg. The prevalence of elevated ALT was 9.1%, aspartate aminotransferase (AST) 4.0%, alkaline phosphatase 1.9%, total bilirubin 1.7%, with 85.5% of the ALT elevations 3× ULN. The prevalence of ALT and AST elevations (9.1% and 4.0%) were not significantly different from known adult general population prevalences (8.9% and 4.9%). There was no significant association between CBD dosage and LT values. Thirty-three individuals with elevated ALT levels had follow-up LT performed with 21 having normal LT, 8 having the same severity of ALT elevation, and 4 having an increase in severity, 1 of which ultimately became normal. Conclusions: Self-medication of CBD does not appear to be associated with an increased prevalence of LT elevation and most of the LT elevations are likely due to the conditions/medications for which the individuals are taking CBD.

OBJECTIVE The study objective was to evaluate how the use of a pervasive blood glucose monitoring (BGM) technology relates to glycemic control, report of self-care behavior, and emotional response to BGM of children with type 1 diabetes and their parents. RESEARCH DESIGN AND METHODS Forty-eight children aged less than 12 years (mean 8.8 years) with type 1 diabetes were randomly assigned to one of two study groups, a control group (conventional care without technology) or an experimental group (conventional care with technology), and followed for 12 months. Families in the experimental group were given the Automated Diabetes Management System (ADMS), which automatically collects blood glucose (BG) values and sends to parent(s) a 21-day BG trending report via e-mail each night. Measures of glycemic control (HbA_1c) were collected at baseline and at quarterly diabetes clinic visits; BGM effect and diabetes self-care behavior measures were obtained at the baseline, 6-month, and 12-month visits. RESULTS Children in the experimental group had significantly (P = 0.01) lower HbA_1c at 12 months (7.44 ± 0.94, −0.35 from baseline) than controls (8.31 ± 1.24, +0.15 from baseline). Improvement in HbA_1c was more profound in families using the ADMS more frequently. In addition, in these families, parents showed a significant improvement in BGM effect (P = 0.03) and children became more meticulous in diabetes self-care (P = 0.04). Children in both experimental and control groups experienced no change in their emotional response to BGM. CONCLUSIONS Using the ADMS 1–3 times/week may help children with type 1 diabetes improve glycemic control and gain diabetes self-management skills, as well as improve the BGM effect of parents.

Parkinson’s disease, the second most common neurodegenerative disease, is diagnostically defined by motor impairments, but also includes often under-recognized impairments in cognition, mood, sleep, and the autonomic nervous system. These problems can severely affect individuals’ quality of life. In our prior research, we have developed indicators to measure the quality of care delivered to patients with Parkinson’s disease, and we identified gaps in delivering evidence-based treatments for this population. Effective strategies to close these gaps are needed to improve patient quality of life. Building on prior research we developed a multi-faceted proactive implementation program called Care Coordination for Health Promotion and Activities in Parkinson’s Disease (CHAPS). To be eligible, patients had to have at least two visits with a primary diagnosis of idiopathic Parkinson’s disease (ICD-9 code: 332.0) at one of five Veterans Affairs Medical Centers in the southwestern United States from 2010 to 2014. The program consists of telephone assessments, evidence-based protocols, and tools to enhance patient self-management, care planning, and coordination of care across providers, including an electronic database to support and track coordination of care. Our mixed-methods study employs a randomized, controlled trial design to test whether the CHAPS intervention improves performance in 38 quality measures among an analytic sample of 346 patients. The 38 quality measures are categorized into overarching areas of communication, education, and continuity; regulatory reporting; diagnosis; periodic assessment; medication use; management of motor and non-motor symptoms; use of non-pharmacological approaches and therapies; palliative care; and health maintenance. Secondary outcomes are patient health-related quality of life, self-efficacy, and perceptions of care quality. We are also evaluating the extent of the CHAPS Program implementation and measuring program costs and impacts on health services utilization, in order to perform a analysis of the CHAPS program from the perspective of the Veterans Health Administration (VA). Outcomes are assessed by interviewer-administered surveys collected at baseline and at 6, 12, and 18 months, and by medical record chart abstractions. Analyses will be intention-to-treat. The CHAPS Program is poised for dissemination within the VA National Parkinson’s Disease Research, Education, and Clinical Center Consortium if demonstrated efficacious. ClinicalTrials.gov NCT01532986 ; registered on January 13, 2012.