Assessing the validity of the American Indian Enculturation Scale in Alaska Native adults interested in reducing alcohol use.

The American Indian Enculturation Scale (AIES) was developed for American Indian populations to measure connection to traditional culture, but it has not been evaluated in Alaska Native people. While American Indian and Alaska Native individuals are grouped together, significant differences exist between groups. As a part of a randomized controlled trial for contingency management to reduce alcohol use, 160 Alaska Native adults completed the AIES. The confirmatory factor analysis indicated that a one-factor, 15-item version of the AIES, removing items 1 and 2 and correlating items 8 and 10, was a reliable (15 items; α = 0.896) and valid measure in this sample (χ2 [89] = 155.788, p<.001; CFI = 0.903; TLI = 0.886; RMSEA = 0.068 [90% confidence interval {CI} 0.050-0.086]; p<.001; SRMR = 0.060). The study provides limited evidence of enculturation's structural validity, as measured by the AIES, for Alaska Native adults. Future confirmatory work and potential adaptation is needed to evaluate the empirical utility of the AIES for Alaska Native individuals seeking help to reduce alcohol use.

Patient-Provider Shared Decision-Making, Trust, and Opioid Misuse Among US Veterans Prescribed Long-Term Opioid Therapy for Chronic Pain.

BACKGROUND: Patient-provider shared decision-making is associated with better treatment adherence and pain outcomes in opioid-specific pain management. One possible mechanism through which shared decision-making may impact pain management outcomes is trust in one's prescribing provider. Elucidating relationships between factors that enhance the patient-provider relationship, such as shared decision-making and trust, may reduce risks associated with opioid treatment, such as opioid misuse. OBJECTIVE: The purpose of this study was to investigate the mediating effect of trust in one's prescribing provider on the relationship between shared decision-making and current opioid misuse. DESIGN: A secondary analysis of data from a prospective cohort study of US Veterans (N = 1273) prescribed long-term opioid therapy (LTOT) for chronic non-cancer pain. PARTICIPANTS: Eligibility criteria included being prescribed LTOT, ability to speak and read English, and access to a telephone. Veterans were excluded if they had a cancer diagnosis, received opioid agonist therapy for opioid use disorder, or evidence of pending discontinuation of LTOT. Stratified random sampling was employed to oversample racial and ethnic minorities and women veterans. MAIN MEASURES: Physician Participatory Decision-Making assessed level of patient involvement in medical decision-making, the Trust in Provider Scale assessed interpersonal trust in patient-provider relationships, and the Current Opioid Misuse Measure assessed opioid misuse. KEY RESULTS: Patient-provider shared decision-making had a total significant effect on opioid misuse, in the absence of the mediator (c = - 0.243, p < 0.001), such that higher levels of shared decision-making were associated with lower levels of reported opioid misuse. When trust in provider was added to the mediation model, the indirect effect of shared decision-making on opioid misuse through trust in provider remained significant (c' = - 0.147, p = 0.007). CONCLUSIONS: Shared decision-making is associated with less prescription opioid misuse through the trust that is fostered between patients and providers.

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.

Youth risk profiles and their prediction of distal cannabis and tobacco co-use in the Population Assessment of Tobacco Health (PATH).

Background: Co-use of cannabis and tobacco is common and increases negative behavioral, physical and mental health consequences. This study aimed to describe latent profiles of youth internalizing and externalizing problems, sensation seeking, and family environment in the US and their relationships with substance co-use. Methods: Data come from the Population Assessment of Tobacco Health (PATH). Using latent profile analysis with a distal outcome, we conducted a secondary data analysis examining relationships between latent profiles and the distal outcome of cannabis/tobacco use and co-use one year later. Participants were a nationally representative sample of youth ages 12-17 (N = 13,651). Results: We identified five youth subgroups: (1;11%) Family Risk, (2;32%) Family Protection with Very Low Internalizing, (3;21%) Family Protection with High Youth Risk, (4;24%) Family Protection with Moderate Youth Risk, (5;12%) Family Risk with High Youth Risk. Relationships between group membership and tobacco/cannabis outcomes, one year later, indicated that the least likely tobacco/cannabis users were the Family Protection with Very Low Internalizing class (no lifetime use probability (PR)=0.86, standard error (SE)=0.007; no 30-day use PR = 0.96, SE = 0.004). In contrast, the Family Risk with High Youth Risk class had the highest probability of both co-use (lifetime co-use PR = 0.33; SE = 0.014; 30-day co-use PR = 0.10; SE = 0.010) and single substance use (probability of lifetime single substance use PR = 0.30; SE = 0.013; 30-day single substance use PR = 0.24; SE = 0.014). Conclusions: A "protective but reactive" risk buffering pattern effect of family factors on youth factors was observed in that the lowest rates of co-use were observed in the three classes with family protection. These findings highlight the need for interventions addressing multiple domains and focusing on youth and family risk factors.

Substance use and mental health in pregnant women during the COVID-19 pandemic.

OBJECTIVES: We examined the prevalence of substance use as a coping mechanism and identified relationships between maternal mental health over time and use of substances to cope during the Coronavirus Disease 2019 (COVID-19) pandemic among pregnant women in the U.S.A. METHODS: Self-reported repeated measures from 83 pregnant women were collected online in April 2020 and May 2020. Women retrospectively reported their mental/emotional health before the pandemic, as well as depression, stress, and substance use as a result of the pandemic at both time points. Linear regression measured cross-sectional and longitudinal associations between mental health and substance use. RESULTS: Pre-COVID-19 reports of poorer mental/emotional health (b = 0.46) were significantly (p < .05) associated with number of substances used to cope with the pandemic. Elevated stress (b = 0.35) and depressive symptoms (b = 0.27) and poorer mental/emotional health (b = 0.14) in April were also significantly related to higher numbers of substances used in May (p < .05). CONCLUSION: Pregnant women's psychological well-being may be a readily measured indicator substance use risk during crises such as the COVID-19 pandemic. Interventions addressing increased stress and depression may also mitigate the emergence of greater substance use among pregnant women.

Crossover associations of alcohol and smoking, craving and biochemically verified alcohol and nicotine use in heavy drinking smokers.

This study examined associations between drinking and smoking prior to treatment (biochemically measured at baseline), alcohol and tobacco craving, and biochemical alcohol and tobacco use during the analog trial period. We conducted a secondary data analysis of a randomized clinical analog trial where participants with a Diagnostic and Statistical Manual, Fourth Edition Text Revision (DSM-IV-TR) diagnosis of alcohol dependence, abuse or reported heavy drinking, with a co-occurring DSM-IV-TR diagnosis of nicotine dependence, abuse or reported heavy use, who were not seeking treatment were recruited. A generalized estimation equation model for longitudinal binary outcomes was created (N = 34) to determine the predictive effects of baseline tobacco use, alcohol craving, and tobacco craving on alcohol use over the 4 weeks of the trial. Baseline smoking was significantly (*p < 0.05) associated with drinking over time [odds ratio (OR) = 3.09*], while baseline drinking was associated with smoking (OR = 4.17*). Baseline alcohol and tobacco craving were positively associated with smoking over time (OR = 3.21* and OR = 1.92*, respectively) but were negatively associated with alcohol use over time (OR = 0.79* and OR = 0.57*, respectively). Heavier use of either tobacco or alcohol preceding treatment may require more intensive interventions in order to reduce tobacco and alcohol use. Future trials designed to address mechanisms of behavior change in the context of novel treatments could promote a better understanding of the cross-rewarding effects related to the co-use of these substances and lead to the development of more integrated and appropriately intense treatments for individuals with concomitant tobacco and alcohol use disorders.

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.

Decreases in smoking during treatment for methamphetamine-use disorders: preliminary evidence.

Despite high rates of smoking (70-90%) and the severely negative impact of smoking on physical and mental health, only 12% of individuals receiving stimulant-use disorder treatment also receive smoking-cessation treatment. The aim of this investigation was to examine the effect of a contingency management (CM) intervention targeting methamphetamine (MA) use on cigarette smoking. Sixty-one adults with MA-use disorders who were smokers were assigned to CM or standard psychosocial treatment. Rates of smoking-negative breath samples (carbon monoxide <3 ppm) were compared between the two groups while controlling for baseline carbon monoxide level, marijuana use, MA use, and time. This subgroup of mostly male (59%) participants included 44 participants in the CM group and 17 participants in the standard psychosocial treatment. Tobacco smoking participants who received CM targeting MA use were 140% (odds ratio: 2.395; 95% confidence interval: 1.073-5.346) more likely to submit a smoking-negative breath sample relative to standard psychosocial treatment during the treatment period, holding constant several other prespecified covariates. This study provides evidence that a behavioral treatment for MA use results in reductions in cigarette smoking in adults with MA-use disorder.

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.

Sex differences in opioid use and medical issues during buprenorphine/naloxone treatment.

BACKGROUND: There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive samples was found during treatment for men, but not women. In order to inform sex-based approaches to improve treatment outcomes, research is needed to determine if opioid use, and predictors of opioid use, differs between men and women during treatment. OBJECTIVES: To test for sex differences in opioid use during a buprenorphine/naloxone clinical trial and determine if sex differences exist in the associations between addiction-related problem areas and opioid use over the course of the trial. METHOD: This secondary data analysis of the National Drug Abuse Treatment Clinical Trials Network (CTN) 0003 examined sex differences (men = 347, women = 169) in opioid-positive samples in a randomized clinical trial comparing 7-day vs. 28-day buprenorphine/naloxone tapering strategies. Addiction-related problem areas were defined by Addiction Severity-Lite (ASI-L) domain composite scores. RESULTS: Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial (B = .33, p = .01) and medical issues were positively related to submitting an opioid-positive sample during treatment for women (B = 1.67, p = .01). No ASI-L domain composite score was associated with opioid-positive samples during treatment for men. CONCLUSION: Women were more likely than men to use opioids during the course of the buprenorphine/naloxone clinical trial, and medical issues predicted opioid use during treatment for women but not men. Complementary treatment for medical problems during opioid replacement therapy may benefit women.

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.

Pretreatment ethyl glucuronide levels predict response to a contingency management intervention for alcohol use disorders among adults with serious mental illness.

BACKGROUND AND OBJECTIVES: This study investigated if pretreatment ethyl glucuronide (EtG) levels corresponding to light (100 ng/mL), heavy (500 ng/mL), and very heavy (1,000 ng/mL) drinking predicted longest duration of alcohol abstinence (LDA) and proportion of EtG-negative urine tests in outpatients receiving a 12-week EtG-based contingency management (CM) intervention for alcohol dependence. METHODS: Participants were 40 adults diagnosed with alcohol use disorders and serious mental illness who submitted up to 12 urine samples for EtG analysis during a 4-week observation period and were then randomized to 12-weeks of CM for alcohol abstinence and addiction treatment attendance. Alcohol use outcomes during CM as assessed by EtG and self-report were compared across those who did and did not attain a pre-treatment average EtG level of 500 ng/mL-a level that equates to frequent heavy drinking. RESULTS: Only the 500 ng/mL cutoff was associated with significant differences in LDA and proportion of EtG-negative samples during CM. Those with a pre-treatment EtG < 500 ng/mL attained a LDA 2.3 (alcohol) to 2.9 (drugs) weeks longer than pre-treatment heavy drinkers. DISCUSSION AND CONCLUSIONS: The EtG biomarker can be used to determine who will respond to a CM intervention for alcohol use disorders and could inform future trials that are designed to be tailored to individual patients. SCIENTIFIC SIGNIFICANCE: Results suggest pre-treatment EtG cutoffs equivalent to heavy and very heavy drinking predict outcomes in CM. (Am J Addict 2017;26:673-675).

A Randomized Controlled Trial of a Citywide Emergency Department Care-Coordination Program to Reduce Prescription Opioid-Related Visits: An Economic Evaluation.

BACKGROUND: Care provided in the emergency department (ED) can cost up to five times as much as care received for comparable diagnoses in alternative settings. Small groups of patients, many of whom suffer from an opioid use disorder, often account for a large proportion of total ED visits. We recently conducted, and demonstrated the effectiveness of, the first randomized controlled trial of a citywide ED care-coordination program intending to reduce prescription-opioid-related ED visits. All EDs in the metropolitan study area were connected to a Web-based information exchange system. OBJECTIVE: The objective of this article was to perform an economic evaluation of the 12-month trial from a third-party-payer perspective. METHODS: We modeled the person-period monthly for the 12-month observation period, and estimated total treatment costs and return on investment (ROI) with regard to cost offsets, over time, for all visits where the patient was admitted to and discharged from the ED. RESULTS: By the end of month 4, the mean cumulative cost differential was significantly lower for intervention relative to treatment-as-usual participants (-$1370; p = 0.03); this figure climbed to -$3200 (p = 0.02) by the end of month 12. The ROI trended upward throughout the observation period, but failed to reach statistical significance by the end of month 12 (ROI = 3.39, p = 0.07). CONCLUSION: The intervention produced significant cost offsets by the end of month 4, which continued to accumulate throughout the trial; however, ROI was not significant. Because the per-patient administrative costs of the program are incurred at the time of enrollment, our results highlight the importance of future studies that are able to follow participants for a period beyond 12 months to more accurately estimate the program's ROI.

Medication Intervention for Chronic Kidney Disease Patients Transitioning from Hospital to Home: Study Design and Baseline Characteristics.

BACKGROUND: The hospital readmission rate in the population with chronic kidney disease (CKD) is high and strategies to reduce this risk are urgently needed. METHODS: The CKD-Medication Intervention Trial (CKD-MIT; www.clinicaltrials.gov; NCTO1459770) is a single-blind (investigators), randomized, clinical trial conducted at Providence Health Care in Spokane, Washington. Study participants are hospitalized patients with CKD stages 3-5 (not treated with kidney replacement therapy) and acute illness. The study intervention is a pharmacist-led, home-based, medication management intervention delivered within 7 days after hospital discharge. The primary outcome is a composite of hospital readmissions and visits to emergency departments and urgent care centers for 90 days following hospital discharge. Secondary outcomes are achievements of guideline-based targets for CKD risk factors and complications. RESULTS: Enrollment began in February 2012 and ended in May 2015. At baseline, the age of participants was 69 ± 11 years (mean ± SD), 50% (77 of 155) were women, 83% (117 of 141) had hypertension and 56% (79 of 141) had diabetes. At baseline, the estimated glomerular filtration rate was 41 ± 14 ml/min/1.73 m2 and urine albumin-to-creatinine ratio was 43 mg/g (interquartile range 8-528 mg/g). The most frequent diagnosis category for the index hospital admission was cardiovascular diseases at 34% (53 of 155), but the most common single diagnosis for admission was community-acquired acute kidney injury at 10% (16 of 155). CONCLUSION: Participants in CKD-MIT are typical of acutely ill hospitalized patients with CKD. A medication management intervention after hospital discharge is under study to reduce post-hospitalization acute care utilization and to improve CKD management.