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Item ACMT Position Statement: Determining Brain Death in Adults After Drug Overdose(Springer Nature, 2017-09) Neavyn, Mark J.; Stolbach, Andrew; Greer, David M.; Nelson, Lewis S.; Smith, Silas W.; Brent, Jeffrey; Tormoehlen, Laura M.; Neurology, School of MedicineItem Barriers impacting the POINT pragmatic trial: the unavoidable overlap between research and intervention procedures in “real-world” research(BMC, 2021-02-04) Dir, Allyson L.; Watson, Dennis P.; Zhiss, Matthew; Taylor, Lisa; Bray, Bethany C.; McGuire, Alan; Psychiatry, School of MedicineBackground: This manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching intervention for linking patients with opioid use disorder to evidence-based treatment. The research team has encountered a number of challenges related to the "real-world" study setting since the trial began. Using an implementation science lens, we sought to identify and describe barriers impacting both the intervention and research protocols of the POINT study, which are often intertwined in pragmatic trials due to the focus on external validity. Method: Qualitative data were collected from 3 peer recovery coaches, 2 peer recovery coach supervisors, and 3 members of the research team. Questions and deductive qualitative analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Results: Nine unique barriers were noted, with 5 of these barriers impacting intervention and research protocol implementation simultaneously. These simultaneous barriers were timing of intervention delivery, ineffective communication with emergency department staff, lack of privacy in the emergency department, the fast-paced emergency department setting, and patient's limited resources. Together, these barriers represent the intervention characteristics, inner setting, and outer setting domains of the CFIR. Conclusion: Results highlight the utility of employing an implementation science framework to assess implementation issues in pragmatic trials and how this approach might be used as a quality assurance mechanism given the considerable overlap that exists between research and intervention protocols in real-world trial settings. Previously undocumented changes to the trial design that have been made as a result of the identified barriers are discussed.Item Comparing Practices Used in Overdose Fatality Review Teams to Recommended Implementation Guidelines(Wolters Kluwer, 2022) Ray, Bradley; Bailey, Katie; Dunnigan, Megan; Aalsma, Matthew C.; Bell, Lauren; O’Brien, Mallory; Pediatrics, School of MedicineObjectives: Overdose fatality review teams are a public health and public safety collaboration that reviews fatality cases using a multidisciplinary team to provide recommendations for overdose prevention. No research exists on the case review practices currently being used in these programs. Design: We administered a cross-sectional survey measuring case review practices and perceptions to a convenience sample of overdose fatality review teams. Setting: We administered the online survey to participants at a national virtual forum on overdose fatality review. Participants: In this study, we examined 30 county-level overdose fatality review teams from 6 states who completed the survey. Main outcome measures: We developed measures of case review practices from an overdose fatality review implementation guide. We provided descriptive statistics on the survey items used to measure these practices and examined how practice uptake varied by overdose fatality review team characteristics. Results: Most overdose fatality review teams had adequate representation and membership, but none adhered to all of the practices measured from the implementation guide. The largest gap was in perceived effectiveness and implementation of case review recommendations. In addition, teams that had been reviewing cases for longer reported more adherence to recommended practices. Conclusions: Overdose fatality case review is a collaboration between local public health and public safety agencies that holds great promise. However, these teams will require additional training and technical assistance with local community support to ensure that recommendations are actionable.Item Correction to: The Toxicology Investigators Consortium Case Registry-The 2017 Annual Report(Springer, 2018-12) Farrugia, Lynn A.; Rhyee, Sean H.; Campleman, Sharan L.; Judge, Bryan; Kao, Louise; Pizon, Anthony; Porter, Lauren; Riederer, Anne M.; Wiegand, Timothy; Calello, Diane P.; Wax, Paul M.; Brent, Jeffrey; On behalf of of the Toxicology Investigators Consortium (ToxIC) Study Group; Medicine, School of MedicineThe Toxicology Investigators Consortium (ToxIC) Case Registry was established by the American College of Medical Toxicology in 2010. The Registry collects data from participating sites with the agreement that all bedside medical toxicology consultations will be entered. The objective of this eighth annual report is to summarize the Registry's 2017 data and activity with its additional 7577 cases. Cases were identified for inclusion in this report by a query of the ToxIC database for any case entered from 1 January to 31 December 2017. Detailed data was collected from these cases and aggregated to provide information which includes demographics (e.g., age, gender, race, ethnicity), reason for medical toxicology evaluation (e.g., intentional pharmaceutical exposure, envenomation, withdrawal from a substance), agent and agent class, clinical signs and symptoms (e.g., vital sign abnormalities, organ system dysfunction), treatments and antidotes administered, fatality, and life support withdrawal data. Females were involved in 50.4% of cases. Transgender demographic information collection was initiated in 2017 to better represent the population and there were 36 cases involving transgender patients. Adults aged 19-65 were the most commonly reported age group. Non-opioid analgesics were the most commonly reported agent class, with acetaminophen again the most common agent reported. There were 93 fatalities reported in 2017. Treatment interventions were frequently reported with 30.6% receiving specific antidotal therapy. Major trends in demographics and exposure characteristics remained similar to past years' reports. While treatment interventions were commonly required, fatalities were rare.Item Effectiveness and implementability of state-level naloxone access policies: Expert consensus from an online modified-Delphi process(Elsevier, 2021) Smart, Rosanna; Grant, Sean; Social and Behavioral Sciences, School of Public HealthBackground: Naloxone distribution, a key global strategy to prevent fatal opioid overdose, has been a recent target of legislation in the U.S., but there is insufficient empirical evidence from causal inference methods to identify which components of these policies successfully reduce opioid-related harms. This study aimed to examine expert consensus on the effectiveness and implementability of various state-level naloxone policies. Methods: We used the online ExpertLens platform to conduct a three-round modified-Delphi process with a purposive sample of 46 key stakeholders (advocates, healthcare providers, human/social service practitioners, policymakers, and researchers) with naloxone policy expertise. The Effectiveness Panel (n = 24) rated average effects of 15 types of policies on naloxone pharmacy distribution, opioid use disorder (OUD) prevalence, nonfatal opioid-related overdoses, and opioid-related overdose mortality. The Implementation Panel (n = 22) rated the same policies on acceptability, feasibility, affordability, and equitability. We compared ratings across policies using medians and inter-percentile ranges, with consensus measured using the RAND/UCLA Appropriateness Method Inter-Percentile Range Adjusted for Symmetry technique. Results: Experts reached consensus on all items. Except for liability protections and required provision of education or training, experts perceived all policies to generate moderate-to-large increases in naloxone pharmacy distribution. However, only three policies were expected to yield substantive decreases on fatal overdose: statewide standing/protocol order, over-the-counter supply, and statewide "free naloxone." Of these, experts rated only statewide standing/protocol orders as highly affordable and equitable, and unlikely to generate meaningful population-level effects on OUD or nonfatal opioid-related overdose. Across all policies, experts rated naloxone prescribing mandates relatively lower in acceptability, feasibility, affordability, and equitability. Conclusion: Experts believe statewide standing/protocol orders are an effective, implementable, and equitable policy for addressing opioid-related overdose mortality. While experts believe many other broad policies are effective in reducing opioid-related harms, they also believe these policies face implementation challenges related to cost and reaching vulnerable populations.Item Erratum to: Examining Fatal Opioid Overdoses in Marion County, Indiana(Springer-Verlag, 2017-04) Ray, Bradley; Quinet, Kenna; Dickinson, Timothy; Watson, Dennis P.; Ballew, Alfarena; School of Public and Environmental AffairsItem Evaluation of an emergency department-based opioid overdose survivor intervention: Difference-in-difference analysis of electronic health record data to assess key outcomes(Elsevier, 2021) Watson, Dennis P.; Weathers, Tess; McGuire, Alan; Cohen, Alex; Huynh, Philip; Bowes, Clay; O’Donnell, Daniel; Brucker, Krista; Gupta, Sumedha; Social and Behavioral Sciences, School of Public HealthBackground: In recent years, a number of emergency department (ED)-based interventions have been developed to provide supports and/or treatment linkage for people who use opioids. However, there is limited research supporting the effectiveness of the majority of these interventions. Project POINT is an ED-based intervention aimed at providing opioid overdose survivors with naloxone and recovery supports and connecting them to evidence-based medications for opioid use disorder (MOUD). An evaluation of POINT was conducted. Methods: A difference-in-difference analysis of electronic health record data was completed to understand the difference in outcomes for patients admitted to the ED when a POINT staff member was working versus times when they were not. The observation window was January 1, 2012 to July 6, 2019, which included N = 1462 unique individuals, of which 802 were in the POINT arm. Outcomes of focus include MOUD opioid prescriptions dispensed, active non-MOUD opioid prescriptions dispensed, naloxone access, and drug poisonings. Results: The POINT arm had a significant increase in MOUD prescriptions dispensed, non-MOUD prescriptions dispensed, and naloxone access (all p-values < 0.001). There was no significant effect related to subsequent drug poisoning-related hospital admissions. Conclusions: The results support the assertion that POINT is meeting its two primary goals related to increasing naloxone access and connecting patients to MOUD. Generalization of these results is limited; however, the evaluation contributes to a nascent area of research and can serve a foundation for future work.Item Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?(Springer, 2021) Baum, Regan A.; Woolum, Jordan A.; Bailey, Abby M.; Howell, Molly M.; Weant, Kyle A.; Geraghty, LeeAnn; Mohan, Sanjay; Webb, Ashley N.; Su, Mark K.; Akpunonu, Peter; Medicine, School of MedicineIntroduction: Acetaminophen is a commonly used analgesic and antipyretic, with the potential to cause significant injury when ingested in toxic amounts. Although the antidote n-acetylcysteine (NAC) is available, evidence supporting dose recommendations for patients weighing over 100 kg are lacking. We performed a retrospective, multi-center analysis to determine if a capped NAC dosing scheme is similar to a non-capped dosing scheme in patients weighing over 100 kg. Methods: Between January 2009 and January 2016, we identified patients presenting to 12 different centers who were evaluated for acetaminophen poisoning treatment. Patients must have weighed greater than 100 kg and were evaluated and identified as needing treatment for acetaminophen-related poisoning with NAC. The primary outcome was occurrence of hepatic injury, defined as an AST or ALT ≥ 100 IU/L. Secondary endpoints included number of drug-related adverse events, occurrence of hepatotoxicity, cumulative NAC dose, regimen cost, length of hospital and intensive care unit stays, and in-hospital mortality. Results: There were 83 patients identified as meeting the pre-specified inclusion and exclusion criteria. A capped NAC dosing scheme resulted in no difference in hepatic injury when compared to a non-capped regimen (49.4% vs 50%, p = 1.000). The capped dosage regimen was associated with a lower cumulative dose (285.2 mg/kg vs 304.6 mg/kg, p < 0.001) and cost. No other statistically significant differences were identified among the secondary endpoints. Conclusion: A capped NAC dosing scheme was not associated with higher rates of hepatic injury or hepatotoxicity in obese patients in the setting of acetaminophen poisoning when compared to a non-capped regimen. Further research is needed to verify these results.Item Examining Fatal Opioid Overdoses in Marion County, Indiana(Springer, 2017-04-01) Ray, Bradley; Quinet, Kenna; Dickinson, Timothy; Watson, Dennis P.; Ballew, Alfarena; School of Public and Environmental AffairsDrug-related overdoses are now the leading injury-related death in the USA, and many of these deaths are associated with illicit opioids and prescription opiate pain medication. This study uses multiple sources of data to examine accidental opioid overdoses across 6 years, 2010 through 2015, in Marion County, IN, an urban jurisdiction in the USA. The primary sources of data are toxicology reports from the county coroner, which reveal that during this period, the most commonly detected opioid substance was heroin. During the study period, 918 deaths involved heroin, and there were significant increases in accidental overdose deaths involving both heroin and fentanyl. In order to disentangle the nature and source of opioid overdose deaths, we also examine data from Indiana’s prescription drug monitoring program and the law enforcement forensic services agency. Results suggest that there have been decreases in the number of opiate prescriptions dispensed and increases in law enforcement detection of both heroin and fentanyl. Consistent with recent literature, we suggest that increased regulation of prescription opiates reduced the likelihood of overdoses from these substances, but might have also had an iatrogenic effect of increasing deaths from heroin and fentanyl. We discuss several policy implications and recommendations for Indiana.Item Expert views on state-level naloxone access laws: a qualitative analysis of an online modified-Delphi process(BMC, 2022-06-08) Grant, Sean; Smart, Rosanna; Social and Behavioral Sciences, School of Public HealthBackground: Expanding availability to naloxone is a core harm reduction strategy in efforts to address the opioid epidemic. In the US, state-level legislation is a prominent mechanism to expand naloxone availability through various venues, such as community pharmacies. This qualitative study aimed to identify and summarize the views of experts on state-level naloxone access laws. Methods: We conducted a three-round modified-Delphi process using the online ExpertLens platform. Participants included 46 key stakeholders representing various groups (advocates, healthcare providers, human/social service practitioners, policymakers, and researchers) with expertise naloxone access laws. Participants commented on the effectiveness and implementability of 15 state-level naloxone access laws (NALs). We thematically analyzed participant comments to summarize views on NALs overall and specific types of NAL. Results: Participants commented that the effectiveness of NALs in reducing opioid-related mortality depends on their ability to make sustained, significant impacts on population-level naloxone availability. Participants generally believed that increased naloxone availability does not have appreciable negative impacts on the prevalence of opioid misuse, opioid use disorder (OUD), and non-fatal opioid overdoses. Implementation barriers include stigma among the general public, affordability of naloxone, and reliance on an inequitable healthcare system. Conclusions: Experts believe NALs that significantly increase naloxone access are associated with less overdose mortality without risking substantial unintended public health outcomes. To maximize impacts, high-value NALs should explicitly counter existing healthcare system inequities, address stigmatization of opioid use and naloxone, maintain reasonable prices for purchasing naloxone, and target settings beyond community pharmacies to distribute naloxone.
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