Participant recruitment and retention from vulnerable populations in clinical trials is a matter of trust.

Clinical research sites can struggle with recruiting and retaining vulnerable populations. Vulnerable research participants often have significant trauma histories making traditional approaches to recruitment and retention tenuous. Due to these difficulties, vulnerable populations are often intentionally excluded from clinical research due to the additional time and work involved. While it is important to provide protections for any participant that has decreased autonomy or increased susceptibility to coercion, it is equally important to assure that individuals in vulnerable populations have access to any clinical research that might pertain to them. In addition, the new trends in the drug development industry including early-stage development, risk-identification, preventative care, and disease spread modeling are likely to include health disparate patient populations that have increased probability of vulnerability. In this article we discuss the roots of many vulnerabilities and how to foster trust for more effective recruitment and retention of vulnerable populations.

Inclusion of Positive Self-reporting by Mothers of Substance Exposed Neonates Increases the Predictability of NAS Severity Over Toxicology Alone.

OBJECTIVES: The rise in opioid use among pregnant women has resulted in an increase in the incidence of neonatal abstinence syndrome (NAS). Despite the focus on opioid use, prenatal polysubstance exposure is often associated with NAS diagnosis and severity. Drug toxicology screens such as urine drug screens and umbilical cord toxicology are dependent upon the substance, timing, frequency, and dose to detect substances present and can underestimate the neonatal exposure. The aim of this study was to identify the predictability of the consequences of prenatal polysubstance exposure versus opioid only exposure based on toxicology and toxicology plus self-report. METHODS: Neonates > 35 weeks gestation with prenatal opioid exposure were included in this retrospective data analysis. NAS was identified using maternal urine drug screen (UDS) toxicology, self-reported exposure during pregnancy, and neonatal toxicology. Analysis was conducted using Stata 15.1 utilizing McNemar's test, chi-square for categorical outcomes, and Wilcoxon test for numerical outcomes. RESULTS: A statistically significant difference in length of stay and length of treatment with poly-exposed neonates was observed when maternal self-report was considered with toxicology, but not with toxicology alone. This trend was observed for cumulative hospital length of stay as well as length and dose of treatment. CONCLUSIONS FOR PRACTICE: The findings in this report demonstrate that self-report is important for identifying substance of exposure. Three substances in particular that often require a change in treatment paradigm went undetected by toxicology were Gabapentin (20.9% of the population), Heroin (20.5% of the population), and Benzodiazepines (8.5% of the population). A healthy rapport with patients is often critical to effective clinical practice. Women with substance use disorder anticipate negative reactions from healthcare providers. Empathetic interview techniques to facilitate accurate disclosure may be more important to the treatment of the exposed neonate.

Abnormal Presentation of Hypoxic Ischemic Encephalopathy Attributed to Polysubstance Exposure.

BACKGROUND With the increasing prevalence of substance use in pregnancy, the rates of neonatal abstinence syndrome (NAS) are dramatically increasing. There is little information on the use of multiple substances in adults, even less so of polysubstance abuse during pregnancy and the consequences for the fetus as well as the mother. CASE REPORT A newborn male born at 35 weeks presented post-delivery with hips bilaterally dislocated and hyperflexed. The patient's legs fully extended and their shoulders were bilaterally mid-flexed with arms fully extended. This neonate was also reported to have bilateral hearing and vision loss as well as NAS symptoms of high-pitched crying and respiratory distress. During pregnancy the mother in this case study admitted to using buprenorphine, benzodiazepines, gabapentin, and heroin. The consequences of using this combination has not been well studied in pregnancy. CONCLUSIONS The presented case had severe complications, likely due to maternal polysubstance use and poor prenatal care in pregnancy. Clonidine was used to control the NAS symptoms, ranitidine was used to treat the gastroesophageal reflux, and glycopyrronium bromide was used for the neonate's excessive secretions. After delivery, the patient was placed on a nasal noninvasive cannula for respiratory distress and was transferred to a different hospital for treatment of the more serious comorbid conditions.