Econometric Issues in Prospective Economic Evaluations Alongside Clinical Trials: Combining the Nonparametric Bootstrap With Methods That Address Missing Data.

Prospective economic evaluations conducted alongside clinical trials have become an increasingly popular approach in evaluating the cost-effectiveness of a public health initiative or treatment intervention. These types of economic studies provide improved internal validity and accuracy of cost and effectiveness estimates of health interventions and, compared with simulation or decision-analytic models, have the advantage of jointly observing health and economics outcomes of trial participants. However, missing data due to incomplete response or patient attrition, and sampling uncertainty are common concerns in econometric analysis of clinical trials. Missing data are a particular problem for comparative effectiveness trials of substance use disorder interventions. Multiple imputation and inverse probability weighting are 2 widely recommended methods to address missing data bias, and the nonparametric bootstrap is recommended to address uncertainty in predicted mean cost and effectiveness between trial interventions. Although these methods have been studied extensively by themselves, little is known about how to appropriately combine them and about the potential pitfalls and advantages of different approaches. We provide a review of statistical methods used in 29 economic evaluations of substance use disorder intervention identified from 4 published systematic reviews and a targeted search of the literature. We evaluate how each study addressed missing data bias, whether the recommended nonparametric bootstrap was used, how these 2 methods were combined, and conclude with recommendations for future research.

Sensitivity and specificity of pupillary light reflex measures for ASD using monocular pupillometry.

INTRODUCTION: Automated hand-held pupillometry demonstrates precision accuracy, offering promise for augmenting ASD screening. METHODS: Monocular pupillometry was examined in children and adolescents (36 ASD; 24 TD). Multiple logistic regression and receiver operating characteristic analysis assessed PLR metrics and diagnostic status. RESULTS: Constriction time (Ct1) (ASD: M = 0.69, SD = 0.21; TD: M = 0.82, SD = 0.18; t(58 = 2.37; p = 0.02) and return to baseline (RTB T75) (ASD: M = 2.93, SD = 1.21; TD: M = 2.32, SD = 1.08; t(58) = - 2.03; p = 0.04) predicted ASD (ß = - 1.31, OR = 0.27; RTB T75, ß = 0.156, OR = 1.162). Sensitivity = 74.8%, when RTB ≥ 1.83 s and 69.4% when Ct1 = 0.785 s. CONCLUSION: Findings suggest monocular pupillometry captures differences detecting ASD.

Supporting perinatal individuals with opioid use disorder and their newborns experiencing neonatal abstinence syndrome: impressions from patients and healthcare providers.

Background: Facilitating maternal-newborn involvement and care is critical for improving outcomes for perinatal individuals receiving opioid agonist therapy (OAT) and newborns experiencing Neonatal Abstinence Syndrome (NAS). Comprehensive education strategies are needed to prepare pregnant individuals receiving OAT for navigating the perinatal period.Objectives: Identify facilitators to successful care of perinatal individuals receiving OAT and newborns experiencing NAS via interviews with perinatal individuals and healthcare providers. The goal of identifying this information is to inform a future educational tool development.Methods: Ten perinatal individuals receiving OAT and ten healthcare providers participated in interviews conducted via phone or video conference using semi-structured, open-ended questions. Data were analyzed separately for the two groups and later merged across samples using a qualitative descriptive content analysis approach to identify themes.Results: Under the overarching theme of empowerment to improve outcomes for perinatal women, four themes arose from perinatal and provider interviews: 1) Preparation for Child Protective Services (CPS) involvement, 2) Healthcare providers shape experience through stigma and support 3) Caring for newborns with NAS, and 4) Managing health and resources during postpartum.Conclusion: Perinatal participants emphasized the importance of self-advocacy while navigating healthcare and social systems. Providers highlighted the importance of communicating expectations to empower patients. Education is needed for pregnant individuals receiving OAT on what to expect during pregnancy and postpartum, as well as for providers to help them optimally support their perinatal patients receiving OAT.

Association of Acute Kidney Injury with Cardiovascular Events and Death in Systolic Blood Pressure Intervention Trial.

RATIONALE AND OBJECTIVE: In the Systolic Blood Pressure Intervention Trial, the possible relationships between acute kidney injury (AKI) and risk of major cardiovascular events and death are not known. STUDY DESIGN: Post hoc analysis of a multicenter, randomized, controlled, open-label clinical trial. SETTING AND PARTICIPANTS: Hypertensive adults without diabetes who were ≥50 years of age with prior cardiovascular disease, chronic kidney disease (CKD), 10-year Framingham risk score > 15%, or age > 75 years were assigned to a systolic blood pressure target of < 120 mm Hg (intensive) or < 140 mm Hg (standard). PREDICTOR: AKI episodes. OUTCOMES: The primary outcome was a composite of myocardial infarction, acute coronary syndrome, stroke, decompensated heart failure, or cardiovascular death. The secondary outcome was death from any cause. Analytical Approach: AKI was defined using the Kidney Disease: Improving Global Outcomes modified criteria based solely upon serum creatinine. AKI episodes were identified by serious adverse events or emergency room visits. Cox proportional hazards models assessed the risk for the primary and secondary outcomes by AKI status. RESULTS: Participants were 68 ± 9 years of age, 36% women (3,332/9,361), and 30% Black race (2,802/9,361), and 17% (1,562/9,361) with cardiovascular disease. Systolic blood pressure was 140 ± 16 mm Hg at study entry. AKI occurred in 4.4% (204/4,678) and 2.6% (120/4,683) in the intensive and standard treatment groups respectively (p < 0.001). Those who experienced AKI had higher risk of cardiovascular events (hazard ratio [HR] 1.52, 95% CI 1.05-2.20, p = 0.026) and death from any cause (HR 2.33, 95% CI 1.56-3.48, p < 0.001) controlling for age, sex, race, baseline systolic blood pressure, body mass index, number of antihypertensive medications, cardiovascular disease and CKD status, hypotensive episodes, and treatment assignment. LIMITATIONS: The study was not prospectively designed to determine relationships between AKI, cardiovascular events, and death. CONCLUSIONS: Among older adults with hypertension at high cardiovascular risk, intensive treatment of blood pressure independently increased risk of AKI, which substantially raised risks of major cardiovascular events and death.

Rationale and design of a multicenter Chronic Kidney Disease (CKD) and at-risk for CKD electronic health records-based registry: CURE-CKD.

BACKGROUND: Chronic kidney disease (CKD) is a global public health problem, exhibiting sharp increases in incidence, prevalence, and attributable morbidity and mortality. There is a critical need to better understand the demographics, clinical characteristics, and key risk factors for CKD; and to develop platforms for testing novel interventions to improve modifiable risk factors, particularly for the CKD patients with a rapid decline in kidney function. METHODS: We describe a novel collaboration between two large healthcare systems (Providence St. Joseph Health and University of California, Los Angeles Health) supported by leadership from both institutions, which was created to develop harmonized cohorts of patients with CKD or those at increased risk for CKD (hypertension/HTN, diabetes/DM, pre-diabetes) from electronic health record data. RESULTS: The combined repository of candidate records included more than 3.3 million patients with at least a single qualifying measure for CKD and/or at-risk for CKD. The CURE-CKD registry includes over 2.6 million patients with and/or at-risk for CKD identified by stricter guide-line based criteria using a combination of administrative encounter codes, physical examinations, laboratory values and medication use. Notably, data based on race/ethnicity and geography in part, will enable robust analyses to study traditionally disadvantaged or marginalized patients not typically included in clinical trials. DISCUSSION: CURE-CKD project is a unique multidisciplinary collaboration between nephrologists, endocrinologists, primary care physicians with health services research skills, health economists, and those with expertise in statistics, bio-informatics and machine learning. The CURE-CKD registry uses curated observations from real-world settings across two large healthcare systems and has great potential to provide important contributions for healthcare and for improving clinical outcomes in patients with and at-risk for CKD.

Dentists' attitudes towards chairside medical conditions screening in a dental setting in Saudi Arabia: an exploratory cross-sectional Study.

BACKGROUND: Screening for medical conditions (MCs) of public health importance is a first step in disease prevention and control. Prior studies in the United States found oral health care providers (OHCPS) embrace screening for increased risk of medical conditions in the dental setting. Our objectives were to assess Saudi Arabian (SA) dentist's attitudes, willingness and perceived barriers towards implementing screening for MCs into their dental practices. METHODS: A self-administered, 5-point Likert Scale (1 = very important/willing to 5 = very unimportant/unwilling) questionnaire was given to a convenience sample of 190 practicing dentists. Friedman nonparametric analysis of variance was used to compare responses within each question. RESULTS: Of the 143 responding dentists the mean age was 31 years; 102 (71%) were men. The majority felt it was important for a dentist to screen for cardiovascular disease (98.6%), hypertension (97.9%), diabetes (97.9%), human immunodeficiency virus (HIV) (97.9%), and hepatitis C virus (98.6%). Respondents were willing to refer a patient to a physician (97.9%); send samples to an outside laboratory (96.1%); conduct screening that yields immediate results (96.2%); and discuss results immediately with the patient (93.7%). Respondents were willing to measure/collect blood pressure (67.2%); weight and height (63.7%); and finger stick blood (54.6%). The whole responding dentists (100%) reported time as an important barrier. Respondents were significantly more willing to refer a patient for consultation than send samples to an outside laboratory (mean ranks: 2.32, 2.81, P < 0.001); significantly more willing to measure blood pressure than take oral fluids for salivary diagnostics (mean ranks 2.22, 2.75, p = 0.003). Insurance was significantly (P < 0.05) less important barrier than time, cost, patients' willingness or liability (mean ranks 3.56, 2.63, 3.00, 2.79, 3.02, respectively). CONCLUSIONS: The majority of dentists in this study reported positive attitudes towards and willingness to perform medical screenings in their practice. Time was an important factor.

Pilot investigation: randomized-controlled analog trial for alcohol and tobacco smoking co-addiction using contingency management.

Contingency management (CM) is associated with decreases in off-target drug and alcohol use during primary target treatment. The primary hypothesis for this trial was that targeting alcohol use or tobacco smoking would yield increased abstinence in the opposite, nontargeted drug. We used a 2 [CM vs. noncontingent control (NC) for alcohol]×2 (CM vs. NC for smoking tobacco) factorial design, with alcohol intake (through urinary ethyl glucuronide) and tobacco smoking (through urinary cotinine) as the primary outcomes. Thirty-four heavy-drinking smokers were randomized into one of four groups, wherein they received CM, or equivalent NC reinforcement, for alcohol abstinence, smoking abstinence, both drugs, or neither drug. The CM for alcohol and tobacco group had only two participants and therefore was not included in analysis. Compared with the NC for alcohol and tobacco smoking group, both the CM for the tobacco smoking group [odds ratio (OR)=12.03; 95% confidence interval (CI): 1.50-96.31] and the CM for the alcohol group (OR=37.55; 95% CI: 4.86-290.17) submitted significantly more tobacco-abstinent urinalyses. Similarly, compared with the NC for the alcohol and tobacco group, both the CM for smoking (OR=2.57; 95% CI: 1.00-6.60) and the CM for alcohol groups (OR=3.96; 95% CI: 1.47-10.62) submitted significantly more alcohol-abstinent urinalyses. These data indicate cross-over effects of CM on indirect treatment targets. Although this is a pilot investigation, it could help to inform the design of novel treatments for alcohol and tobacco co-addiction.

Contingency management intervention targeting co-addiction of alcohol and drugs among American Indian adults: Design, methodology, and baseline data.

BACKGROUND/AIMS: American Indian adults have some of the highest alcohol abstinence rates compared to the overall US population. Despite this, many American Indian people are more likely to concurrently use alcohol and illicit drugs and are less likely to participate and remain in outpatient treatment for alcohol and other drug use compared to the general US population. There is limited knowledge about effective interventions targeting alcohol and drug co-addiction among American Indian adults. Contingency management is a behavioral intervention designed to increase drug abstinence by offering monetary incentives in exchange for drug and alcohol negative urine samples. We aim to evaluate and describe a culturally tailored contingency management intervention to increase alcohol and other drug abstinence among American Indian adults residing in a Northern Plains reservation. METHODS: This 2 × 2 factorial, randomized controlled trial currently includes 114 American Indian adults with alcohol and/or drug dependence who are seeking treatment. Participants were randomized into one of four groups that received (1) contingency management for alcohol, (2) contingency management for other drug, (3) contingency management for both substances, or (4) no contingency management for either substance. We present descriptive, baseline data to characterize the sample and describe the modified contingency management approach that is specific to the community wherein this trial was being conducted. RESULTS: The sample is 49.1% male, with an average age of 35.8 years (standard deviation = 10.4 years). At baseline, 43.0% of the sample tested positive for ethyl glucuronide, 50.9% of participants self-reported methamphetamine as their most used drug, 36.8% self-reported cannabis, and 12.3% self-reported prescription opiates as their most used drug. Among randomized participants, 47.4% tested positive for cannabis, 28.1% tested positive for methamphetamine, 16.7% tested positive for amphetamines, and 2.1% tested positive for opiates. CONCLUSION: This is the first study to examine a culturally tailored contingency management intervention targeting co-addiction of two substances among American Indian adults. By establishing a tribal-university partnership to adapt, implement, and evaluate contingency management, we will increase the literature on evidence-based addiction treatments and research, while improving trust for addiction interventions among American Indian communities through ongoing collaboration. Moreover, results have implications for the use of contingency management as an intervention for co-addiction in any population.

Homelessness predicts attrition but not alcohol abstinence in outpatients experiencing co-occurring alcohol dependence and serious mental illness.

BACKGROUND: Adults experiencing homelessness and serious mental illnesses (SMI) are at an increased risk of poor mental health and treatment outcomes compared with stably housed adults with SMI. The additional issue of alcohol misuse further complicates the difficulties of those living with homelessness and SMI. In this secondary data analysis, the authors investigated the impact of homelessness on attrition and alcohol use in a contingency management (CM) intervention that rewarded alcohol abstinence in outpatients with SMI. METHODS: The associations between housing status and attrition and alcohol abstinence during treatment, as assessed by ethyl glucuronide (EtG) urine tests, were evaluated in 79 adults diagnosed with alcohol dependence and SMI. RESULTS: Thirty-nine percent (n = 31) of participants reported being homeless at baseline. Individuals who were homeless were more likely to drop out of CM (n = 10, 62.5%) than those who were housed (n = 4, 16.7%), χ2(1) = 8.86, P < .05. Homelessness was not associated with attrition in the noncontingent control group. Accounting for treatment group and prerandomization EtG levels, neither the effect of housing status nor the interaction of housing status and group were associated with EtG-assessed alcohol abstinence during treatment. CONCLUSIONS: Individuals experiencing homelessness and co-occurring alcohol dependence and SMI receiving CM had higher rates of attrition, relative to those who were housed. Homelessness was not associated with differences in biologically assessed alcohol abstinence.

Association of Serum Amyloid A with Kidney Outcomes and All-Cause Mortality in American Indians with Type 2 Diabetes.

BACKGROUND: Serum amyloid A (SAA) induces inflammation and apoptosis in kidney cells and is found to be causing the pathologic changes that are associated with diabetic kidney disease (DKD). Higher serum SAA concentrations were previously associated with increased risk of end-stage renal disease (ESRD) and death in persons with type 2 diabetes and advanced DKD. We explored the prognostic value of SAA in American Indians with type 2 diabetes without DKD or with early DKD. METHODS: SAA concentration was measured in serum samples obtained at the start of follow-up. Multivariate proportional hazards models were employed to examine the magnitude of the risk of ESRD or death across tertiles of SAA concentration after adjustment for traditional risk factors. The C statistic was used to assess the additional predictive value of SAA relative to traditional risk factors. RESULTS: Of 256 participants (mean ± SD glomerular filtration rate [iothalamate] = 148 ± 45 mL/min, and median [interquartile range] urine albumin/creatinine = 39 [14-221] mg/g), 76 developed ESRD and 125 died during a median follow-up period of 15.2 and 15.7 years, respectively. After multivariable proportional hazards regression, participants in the 2 highest SAA tertiles together exhibited a 53% lower risk of ESRD (hazard ratio [HR] 0.47, 95% CI 0.29-0.78), and a 30% lower risk of death (HR 0.70, 95% CI 0.48-1.02), compared with participants in the lowest SAA tertile, although the lower risk of death was not statistically significant. Addition of SAA to the ESRD model increased the C statistic from 0.814 to 0.815 (p = 0.005). CONCLUSIONS: Higher circulating SAA concentration is associated with a reduced risk of ESRD in American Indians with type 2 diabetes.

Mobile Medication Adherence Platform for Buprenorphine (MAP4BUP): A Phase I feasibility, usability and efficacy pilot randomized clinical trial.

BACKGROUND/AIM: Poor medication adherence is one of the main barriers to the long-term efficacy of buprenorphine/naloxone (BUP/NAL). The aims of this pilot investigation were to examine if a Bluetooth-enabled pill cap and mobile application is a feasible, usable tool for increasing BUP/NAL adherence among people with an opioid use disorder. METHODS: This pilot randomized clinical trial (RCT; total n = 41) lasted 12 weeks and was conducted in two office-based BUP/NAL provider locations in Spokane, WA and Coeur d'Alene, ID from January 2020 to September of 2021 with an 11-month gap due to COVID-19. Patients receiving BUP/NAL who consented to participate were randomized to receive the pill cap device (PLY group; n = 19) or a service as usual (SAU group; n = 22) group that included an identical but inactive cap for their bottle. The PLY group received reminders via text and voice, and the support of a "helper" (e.g., friend) to monitor pill cap openings. RESULTS: Most participants in PLY group found the device both feasible (92.86 %) and usable (78.57 %). Most participants liked using the device (92.86 %) and were satisfied with the device (85.71 %). While not statistically different from one another, medication adherence per the Medication Possession Ratio was 75 % in the SAU group and 84 % in the PLY group. Pill cap openings were significantly higher in the PLY group with an average of 91.8 openings versus the SAU group's average of 56.7 (p < 0.05). CONCLUSION: The devices was feasible, usable, and patients had high levels of satisfaction. The device was associated with increased pill openings.

How Media Literacy, Trust of Experts and Flu Vaccine Behaviors Associated with COVID-19 Vaccine Intentions.

PURPOSE: To assess how previous experiences and new information contributed to COVID-19 vaccine intentions. DESIGN: Online survey (N = 1264) with quality checks. SETTING: Cross-sectional U.S. survey fielded June 22-July 18, 2020. SAMPLE: U.S. residents 18+; quotas reflecting U.S. Census, limited to English speakers participating in internet panels. MEASURES: Media literacy for news content and sources, COVID-19 knowledge; perceived usefulness of health experts; if received flu vaccine in past 12 months; vaccine willingness scale; demographics. ANALYSIS: Structural equation modelling. RESULTS: Perceived usefulness of health experts (b = .422, P < .001) and media literacy (b = .162, P < .003) predicted most variance in vaccine intentions (R-squared=31.5%). A significant interaction (b = .163, P < .001) between knowledge (b = -.132, P = .052) and getting flu shot (b = .185, P < .001) predicted additional 3.5% of the variance in future vaccine intentions. An increase in knowledge of COVID-19 associated with a decrease in vaccine intention among those declining the flu shot. CONCLUSION: The interaction result suggests COVID-19 knowledge had a positive association with vaccine intention for flu shot recipients but a counter-productive association for those declining it. Media literacy and trust in health experts provided strong counterbalancing influences. Survey-based findings are correlational; thus, predictions are based on theory. Future research should study these relationships with panel data or experimental designs.

Exploring the mediating role of baseline urinalysis results on demographic characteristics and stimulant use disorder treatment outcomes.

INTRODUCTION: Baseline stimulant urinalysis (UA) is one of the most reliable predictors of stimulant use disorder treatment outcomes. Yet we know little about the role of baseline stimulant UA mediating the effects of different baseline characteristics on treatment outcomes. OBJECTIVES: This study aimed to explore the potential mediating role of baseline stimulant UA results on the relationship between baseline characteristics and total number of stimulant negative UAs submitted during treatment. METHODS: The study team conducted analyses on data from a multisite randomized clinical trial of contingency management (CM) targeting stimulant use among individuals enrolled in methadone maintenance treatment programs (n = 394). Baseline characteristics included trial arm, education, race, sex, age, and Addiction Severity Index (ASI) composite measures. Baseline stimulant UA was the mediator and total number of stimulant negative UAs provided during treatment was the primary outcome variable. RESULTS: The baseline characteristics of sex (OR = 1.85), ASI drug (OR = 0.01) and psychiatric (OR = 6.20) composites were directly associated with the baseline stimulant UA result (p < 0.05 for all). Baseline stimulant UA result (B = -8.24), trial arm (B = -2.55), ASI drug composite (B = -8.38) and education (B = -1.95) were directly associated with the total number of negative UAs submitted (p < 0.05 for all). The evaluation of indirect effects of baseline characteristics on the primary outcome through baseline stimulant UA revealed significant mediated effects for the ASI drug composite (B = -5.50) and age (B = -0.05; p < 0.05 for both). CONCLUSIONS: Baseline stimulant UA is a strong predictor of stimulant use treatment outcomes and mediates the association of some baseline characteristics and a stimulant use treatment outcome.

Investigating Secondary Alcohol Outcomes in a Contingency Management Intervention among American Indian and Alaska Native Adults.

OBJECTIVE: The aim of the study is to investigate clinically meaningful, secondary outcomes in a randomized trial of a culturally adapted contingency management (CM) intervention for alcohol use in 3 diverse American Indian and Alaska Native communities. METHODS: Three American Indian and Alaska Native communities located in the Northern Plains, Alaska, and the Inland Northwest were partnering sites. A total of 158 individuals were randomized to either a 12-week CM intervention or a noncontingent (NC) control group. The CM group received reinforcers for providing alcohol-negative ethyl glucuronide (EtG < 150 ng/mL) urine samples, while the NC group received reinforcers unconditionally. Outcomes included EtG as a continuous measure (range, 0-2,000 ng/mL), EtG > 499 ng/mL (a measure of higher levels of recent alcohol use), longest duration of abstinence, and time-to-first alcohol-positive EtG during the trial. Generalized estimating equations along with Cox proportional hazard and negative binomial regressions were used. RESULTS: Participants randomized to the CM group had lower mean EtG levels (-241.9 ng/mL; 95% confidence interval [CI], -379.0 to -104.8 ng/mL) and 45.7% lower odds (95% CI, 0.31 to 0.95) of providing an EtG sample indicating higher levels of alcohol use during the intervention. Longest duration of abstinence was 43% longer for the CM group than the NC group (95% CI, 1.0 to 1.9). Risk of time-to-first drink during treatment did not differ significantly. CONCLUSIONS: These secondary outcome analyses provide evidence that CM is associated with reductions in alcohol use and longer durations of abstinence (as assessed by EtG), both clinically meaningful endpoints and analyses that differ from the primary study outcome.

Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder.

Alcohol Use Disorder (AUD) is the most prevalent substance use disorder in the United States and is directly related to 5% of all annually reported deaths worldwide. Contingency Management (CM) is among the most effective interventions for AUD, with recent technological advancements allowing CM to be provided remotely. Objective: To evaluate the feasibility and acceptability of a mobile Automated Reinforcement Management System (ARMS) designed to provide CM for AUD remotely. Methods: Twelve participants with mild or moderate AUD were exposed to ARMS in a A-B-A within-subject experimental design where they were required to submit three breathalyzer samples per day. During the B phase participants could earned rewards with monetary value for submitting negative samples. Feasibility was determined by the proportion of samples submitted and retention in the study and acceptability was based on participants self-reported experience. Results: The mean number of samples submitted per day was 2.02 out of 3. The proportion of samples submitted in each phase was 81.5%, 69.4% and 49.4%, respectively. Participants were retained for a mean of 7.5 (SD=1.1) out of 8 weeks with 10 participants (83.3%) completing the study. All participants found the app easy to use and stated it helped them reduce their alcohol use. Eleven (91.7%) would recommend the app as an adjunct to AUD treatment. Preliminary indicators of efficacy are also presented. Conclusions: ARMS has shown to be feasible and well accepted. If shown effective, ARMS can serve as an adjunctive treatment for AUD.

Validation of the quantification of phosphatidylethanol 16:0/18:1 concentrations in TASSO-M20 devices.

BACKGROUND: Phosphatidylethanol 16:0/18:1 (PEth), found in whole blood, is a biomarker for alcohol consumption with high sensitivity, specificity, and a long detection window. The TASSO-M20 device is used to self-collect capillary blood from the upper arm and has advantages over finger stick methods. The purpose of this study was to (1) validate PEth measurement using the TASSO-M20 device, (2) describe the TASSO-M20 for blood self-collection during a virtual intervention, and (3) characterize PEth, urinary ethyl glucuronide (uEtG) and self-reported alcohol in a single participant over time. METHODS: PEth levels in blood samples dried on TASSO-M20 plugs were compared to those in (1) liquid whole blood (N = 14) and (2) dried blood spot cards (DBS; N = 23). Additionally, the self-reported drinking, positive or negative uEtG results (dip card cutoff ≥300 ng/mL), and observed self-collection of blood with TASSO-M20 devices for PEth levels were obtained over time during virtual interviews of a single contingency management participant. High-performance liquid chromatography with tandem mass spectrometry detection was used to measure PEth levels for both preparations. RESULTS: PEth concentrations from dried blood on TASSO-M20 plugs and liquid whole blood were correlated (0 to 1700 ng/mL; N = 14; r2  = 0.988; slope = 0.951) and in a subgroup of samples with lower concentrations (N = 7; 0 to 200 ng/mL; r2  = 0.944, slope = 0.816). PEth concentrations from dried blood on TASSO-M20 plugs and DBS were correlated (0 to 2200 ng/mL; N = 23; r2  = 0.927; slope = 0.667) and in a subgroup of samples with lower concentrations (N = 16; 0 to 180 ng/mL; r2  = 0.978, slope = 0.749). Results of the contingency management participant indicate that changes in PEth levels (TASSO-M20) and uEtG concentrations were consistent with each other and with changes in self-reported alcohol use. CONCLUSIONS: Our data support the utility, accuracy, and feasibility of using the TASSO-M20 device for blood self-collection during a virtual study. The TASSO-M20 device had multiple advantages over the typical finger stick method, including consistent blood collection, participant acceptability, and less discomfort as indicated by acceptability interviews.

Geo-spatial risk factor analysis for drug overdose death in South Florida from 2014 to 2019, and the independent contribution of social determinants of health.

PURPOSE: The physical environment and social determinants of health have been shown to influence health behaviors including drug use and fatal drug overdose. The current research examines the effects of the built environment, social determinants of health measures and aggregated risk from the built environment at neighborhood-level on drug overdose death locations in Miami-Dade County, Florida. METHODS: Risk Terrain Modeling (RTM) was used to assess the place features risk factors that significantly increase the risk of drug overdose death spatially in Miami-Dade County ZIP Code Tabulation Areas, Florida from 2014 to 2019. An aggregated neighborhood risk of fatal drug overdose measure was developed by averaging the risk per grid cell from the RTM within census block groups each year. Six logistic and zero-inflated regression models were built to examine the effects of three indices of incident-specific social determinants of health (IS-SDH) measures and aggregated risk measures separately, and simultaneously on drug overdose death locations each year. RESULTS: Seven place features including parks, bus stops, restaurants and grocery stores were significantly related to the occurrence of fatal drug overdoses. When examined separately, one or more indices of the IS-SDH were significant covariates of drug overdose locations in some years. When examined simultaneously, the three indices of the IS-SDH and aggregated risk of fatal drug overdose measure could be all significant in certain years. CONCLUSIONS: The patterns of high-risk areas and place features identified from the RTM related to drug overdose deaths may be used to inform the placement of treatment and prevention resources. A multi-factor approach that combines an aggregated neighborhood risk measure reflecting the risk from the built environment and the incident-specific social determinants of health measures can be used to identify the drug overdose death locations in certain years.

Assessing Clinically Significant Cognitive Impairment Using the NIH Toolbox in Individuals with Co-occurring Serious Mental Illness and Alcohol Use Disorder.

OBJECTIVE: Serious mental illnesses (SMI) and alcohol use disorder (AUD) co-occurrence (SMI-AUD) is common, yet little is known about the prevalence and risk factors of cognitive impairment for this population. We used the National Institutes of Health (NIH) Toolbox to identify clinically significant cognitive impairment (CSCI), describe the cognitive profile, and investigate whether psychiatric and AUD severity measures are associated with CSCI in individuals with SMI-AUD. METHODS: CSCI was defined as 2 or more fully corrected fluid subtest T scores below a set threshold based on an individual's crystalized composite score. Psychiatric severity measures included the Structured Clinical Interview for DSM-V (SCID-5) for SMI diagnosis and the Positive and Negative Syndrome Scale. AUD severity measures included the SCID-5 for AUD symptom severity score, years of alcohol use, and urine ethyl glucuronide levels. A multivariable logistic regression was used to investigate the adjusted effects of each variable on the probability of CSCI. RESULTS: Forty-one percent (N = 55/135) of our sample had CSCI compared with the base rate of 15% from the NIH Toolbox normative sample. Subtests measuring executive function most frequently contributed to meeting criteria for CSCI (Flanker and Dimensional Change Card Sort). A history of head injury ( P = 0.033), increased AUD symptom severity score ( P = 0.007) and increased negative symptom severity score ( P = 0.027) were associated with CSCI. CONCLUSIONS: Cognition should be considered in the treatment of people with SMI-AUD, particularly in those with history of brain injury, higher AUD symptom severity, and/or negative symptom severity.

Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability.

BACKGROUND: Opioid use disorders impact the health and well-being of millions of Americans. Buprenorphine and naloxone (BUP and NAL) can reduce opioid overdose deaths, decrease misuse, and improve quality of life. Unfortunately, poor medication adherence is a primary barrier to the long-term efficacy of BUP and NAL. OBJECTIVE: We aimed to examine patient feedback on current and potential features of a Bluetooth-enabled pill bottle cap and associated mobile app for patients prescribed BUP and NAL for an opioid use disorder, and to solicit recommendations for improvement to effectively and appropriately tailor the technology for people in treatment for opioid use disorder. METHODS: A convenience sample of patients at an opioid use disorder outpatient clinic were asked about medication adherence, opioid cravings, experience with technology, motivation for treatment, and their existent support system through a brief e-survey. Patients also provided detailed feedback on current features and features being considered for inclusion in a technology designed to increase medication adherence (eg, inclusion of a personal motivational factor, craving and stress tracking, incentives, and web-based coaching). Participants were asked to provide suggestions for improvement and considerations specifically applicable to people in treatment for opioid use disorder with BUP and NAL. RESULTS: Twenty people with an opioid use disorder who were prescribed BUP and NAL participated (mean age 34, SD 8.67 years; 65% female; 80% White). Participants selected the most useful, second-most useful, and least useful features presented; 42.1% of them indicated that motivational reminders would be most useful, followed by craving and stress tracking (26.3%) and web-based support forums (21.1%). Every participant indicated that they had at least 1 strong motivating factor for staying in treatment, and half (n=10) indicated children as that factor. All participants indicated that they had, at some point in their lives, the most extreme craving a person could have; however, 42.1% indicated that they had no cravings in the last month. Most respondents (73.7%) stated that tracking cravings would be helpful. Most respondents (84.2%) also indicated that they believed reinforcers or prizes would help them achieve their treatment goals. Additionally, 94.7% of respondents approved of adherence tracking to accommodate this feature using smart packaging, and 78.9% of them approved of selfie videos of them taking their medication. CONCLUSIONS: Engaging patients taking treatment for opioid use disorder with BUP and NAL allowed us to identify preferences and considerations that are unique to this treatment area. As the technology developer of the pill cap and associated mobile app is able to take into consideration or integrate these preferences and suggestions, the smart cap and associated mobile app will become tailored to this population and more useful for them, which may encourage patient use of the smart cap and associated mobile app.

Automated Reinforcement Management System (ARMS): focused phase I provider feedback.

BACKGROUND: Alcohol use increases risk for morbidity and mortality and is associated with over 3 million annual deaths worldwide. Contingency Management (CM) is one of the most effective interventions for substance use disorders, and has recently been coupled with technologies to promote novel treatments for alcohol use disorders (AUD). Leveraging these technological advances, we are developing the Automated Reinforcement Management System (ARMS), an integrated CM system designed to enable CM treatment as a component of a digital therapeutic or adjunct therapy remotely to anyone with a smartphone. OBJECTIVE: To collect detailed provider feedback on ARMS and determine the need for modifications to make the system most feasible, acceptable, and useful to providers. METHODS: Seven providers completed one-hour structured interviews/focus groups wherein we described the ARMS system and its application to clinical care. Providers viewed screen shots of the ARMS provider facing and patient facing systems. Providers gave feedback on their current AUD treatment practices, preferences for the functionality and appearance of the system, preferences for receipt of information on their patients, why they and their patients would or would not use the system, suggestions for improvement, and the proposed intervention overall. To analyze the qualitative data gathered, we used a qualitative descriptive approach with content analysis methods. RESULTS: The overarching theme of Individualized Treatment emerged throughout the interviews. This sentiment supports use of ARMS, as it is intended to supplement provider communication and intervention as an adjunctive and customizable tool with the ability to reach rural patients, not a stand-alone option. Themes of Accountability and Objective Assessment arose during discussions of why people would use the system. Themes within provider obstacles included, Information Overload and Clinical Relevance, and in patient obstacles, Sustained Engagement and Security Concerns. Two themes emerged regarding suggestions for improvement: Increasing Accessibility and Bi-directional Communication. DISCUSSION: Themes from provider input are being used to modify ARMS to make it more user friendly, time saving, and relevant to treatment of AUD. If successful, ARMS will provide effective, individualized-digital therapeutic for those needing adjunctive treatment or those living in rural remote areas needing better connected care.