Policy perceptions of US state public health and child and family services regarding maternal opioid use and neonatal exposure

Objective To explore how state legislatures and departments of health are responding to the public health and economic issues of increases in opioid use disorder and the impact on pregnant women and infants. Design The design was a non-experimental descriptive study using a mixed methods survey research approach. Setting Electronic and telephone survey of individuals from state departments of health associated with departments of behavioral health and substance use, or child and family services. Participants Fifty-two respondents employed by individual state departments of health and child and family services. Methods Univariate analysis and frequency distribution of ordinal variables was completed. Thematic analysis was used to analyze free text questions and identify themes. Results All states reported recent changes or plans to address the problem of opioid misuse in their state. Many respondents feel their state continues to lack adequate services for treatment. Some states are exploring unique methods for addressing this in a safe and timely fashion, such as moving medication-assisted treatment to primary care and expanding licensure to Primary Care Physicians (PCPs) and nurse practitioners. Conclusions Our findings demonstrate an increased commitment throughout the United States to enhance access to clinically appropriate treatment of substance use disorder particularly during pregnancy, consider unique methods for addressing the problem of opioid dependency, and increase education and primary prevention programs

Experience of Maternal Narcotics Users with Fetal and Infant Loss throughout the Infant Life Cycle

poster abstractObjective: Fetal or infant loss is a painful and traumatic experience for all mothers. Literature, however, has been limited in describing maternal experience from pregnancy to the time when a baby dies. This study explored the experience of mothers using prescribed or illicit opioids and encountering fetal or infant loss. Design: A qualitative approach using a reflexive iteration process was used to identify maternal experience across an infant’s life cycle. Participants: Eleven mothers (mostly white, single, less than a high school education) with a history of using prescribed or illicit opioids participated in the semi-structured telephone or in person maternal interview portion of the Fetal and Infant Mortality Review in a Midwest county. Methods: Interview transcripts were first coded. Codes with similar meaning were grouped into categories. Categories sharing similar features were collapsed into common themes. Each phase of analysis was performed and checked by three investigators. Results: Four common themes were identified throughout the entire life cycle of the infant: not being heard, dealing with medical complications, reproductive health, and grief, guilt and bereavement. Mothers perceived that their needs and concerns were not carefully attended to by care providers. They were overwhelmed by medical information about pregnancy and infant complications. Participants did not plan for the pregnancy or use contraception prior to the pregnancy but did use contraception in the post-partum period. Many mothers struggled with grief and loss. Additional themes included care needs for substance use and mental health and taking action and making decisions for the baby’s life. Conclusions: The findings suggest women experiencing opioid use have education and care needs when dealing with fetal/infant loss. When developing interventions for these women, clear communication about medical complications, emotional and bereavement support, and services to help these women prevent unplanned pregnancy are needed

Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden

Clinical validation of a next-generation sequencing-based multi-cancer early detection "liquid biopsy" blood test in over 1,000 dogs using an independent testing set: The CANcer Detection in Dogs (CANDiD) study.

Cancer is the leading cause of death in dogs, yet there are no established screening paradigms for early detection. Liquid biopsy methods that interrogate cancer-derived genomic alterations in cell-free DNA in blood are being adopted for multi-cancer early detection in human medicine and are now available for veterinary use. The CANcer Detection in Dogs (CANDiD) study is an international, multi-center clinical study designed to validate the performance of a novel multi-cancer early detection "liquid biopsy" test developed for noninvasive detection and characterization of cancer in dogs using next-generation sequencing (NGS) of blood-derived DNA; study results are reported here. In total, 1,358 cancer-diagnosed and presumably cancer-free dogs were enrolled in the study, representing the range of breeds, weights, ages, and cancer types seen in routine clinical practice; 1,100 subjects met inclusion criteria for analysis and were used in the validation of the test. Overall, the liquid biopsy test demonstrated a 54.7% (95% CI: 49.3-60.0%) sensitivity and a 98.5% (95% CI: 97.0-99.3%) specificity. For three of the most aggressive canine cancers (lymphoma, hemangiosarcoma, osteosarcoma), the detection rate was 85.4% (95% CI: 78.4-90.9%); and for eight of the most common canine cancers (lymphoma, hemangiosarcoma, osteosarcoma, soft tissue sarcoma, mast cell tumor, mammary gland carcinoma, anal sac adenocarcinoma, malignant melanoma), the detection rate was 61.9% (95% CI: 55.3-68.1%). The test detected cancer signal in patients representing 30 distinct cancer types and provided a Cancer Signal Origin prediction for a subset of patients with hematological malignancies. Furthermore, the test accurately detected cancer signal in four presumably cancer-free subjects before the onset of clinical signs, further supporting the utility of liquid biopsy as an early detection test. Taken together, these findings demonstrate that NGS-based liquid biopsy can offer a novel option for noninvasive multi-cancer detection in dogs