Implementation costs of the appraise alcohol brief intervention (ABI) for male remand prisoners: A micro-costing protocol and preliminary findings.

OBJECTIVE: This paper documents the methods used to assess the implementation costs of the APPRAISE alcohol brief intervention (ABI) delivered to male remand prisoners across two study sites in Scotland and North East England. METHOD: We first developed a comprehensive taxonomy of the activities constituting the APPRIASE ABI. Next, data were collected for each activity about the study staff and the subject time spent, in addition to the other resources used and unit costs. RESULTS: From the pilot data collection it was possible to construct a narrative, for both study sites, for how the intervention was delivered and the time required for each activity. The ABI was delivered by Change Grow Live and Humankind intervention staff and staff salaries were obtained from both organizations to calculate the staff delivery costs for each site. Other costs, such as the printing of materials, were estimated based on APPRAISE study records. Due to the ongoing Covid-19 restrictions and limited access to prison resources and staff, there were significant deviations from the initial study protocols. As a result, we document the costs of implementing the ABI as delivered rather than as planned. CONCLUSIONS: This paper provides the first estimates of the implementation costs of an ABI delivered in criminal justice setting in the UK. Although these costs are from a pilot implementation that was heavily impacted by the Covid-19 pandemic, this paper nonetheless provides useful, policy-relevant information on the potential costs of providing ABI to remand prisoners. It also serves as a methodological template, guidance, and proof of concept for future micro-costing studies of ABIs in criminal justice settings.

Neutrophilic Urticarial Dermatosis.

Neutrophilic urticarial dermatosis (NUD) is a rare form of dermatosis that is poorly understood. It was first described by Kieffer and colleagues as an urticarial eruption that is histopathologically characterized by a perivascular and interstitial neutrophilic infiltrate with intense leukocytoclasia and without vasculitis or dermal edema. NUD clinically presents as a chronic or recurrent eruption that consists of nonpruritic macules, papules, or plaques that are pink to reddish and that resolve within 24 hours without residual pigmentation. NUD is often associated with systemic diseases such as Schnitzler syndrome, lupus erythematosus, adult-onset Still's disease, and cryopyrin-associated periodic syndromes.

Estimating Joint Health State Utility Algorithms Under Partial Information.

OBJECTIVES: We explored the performance of existing joint health state utility estimators when data are not available on utilities that isolate single-condition health states excluding any co-occurring condition. METHODS: Using data from the National Epidemiologic Survey on Alcohol and Related Conditions-III, we defined 2 information sets: (1) a full-information set that includes the narrowly defined health state utilities used in most studies that test the performance of joint health state utility estimators, and (2) a limited information set that includes only the more broadly defined health state utilities more commonly available to researchers. We used an example of alcohol use disorder co-occurring with cirrhosis of the liver, depressive disorder, or nicotine use disorder to illustrate our analysis. RESULTS: We found that the performance of joint health state utility estimators is appreciably different under limited information than under full information. Full-information estimators typically overestimate the joint state utility, whereas limited-information estimators underestimate the joint state utility, except for the minimum estimator, which is overestimated in all cases. CONCLUSIONS: Researchers using joint health state utility estimators should understand the information set available to them and use methodological guidance appropriate for that information set. We recommend the minimum estimator under limited information based on its ease of use, consistency (and therefore a predictable direction of bias), and lower root mean squared error.

Alcohol consumption and health-related quality of life in the US during the COVID-19 pandemic: a US national survey.

BACKGROUND: Alcohol consumption has changed during the COVID-19 pandemic yet the impacts on alcohol-related outcomes, and specifically health-related quality of life, are not completely known. Our objective was to assess the association between alcohol consumption and health-related quality of life (HRQOL) during the COVID-19 pandemic. METHOD: We conducted an on-line/telephone survey of three cross-sectional samples of US adults during a nine-month stretch of the pandemic, from August 2020 through April 2021, collecting data on drinking-current quantity/frequency and change since prior to pandemic, HRQOL (using the SF-6D), and perceived impact of the pandemic on respondents' lives-overall impact and disruptions across various dimensions (job loss, school closures, social isolation, loss of income). We pooled the data from the three administrations and applied survey weights to reflect the US population. We described drinking behavior and pandemic impact, and regressed HRQOL on alcohol consumption risk level (per World Health Organization categories), change in drinking since pre-pandemic, and pandemic impact using weighted least squares, controlling for respondents' demographic characteristics. We tested the significance of categorical variables using Wald tests at a p-value of 0.05. RESULTS: Among 3,125 respondents, weighted to reflect the US population, 68% reported drinking during the pandemic and 40% reported a change in drinking from pre-pandemic level (either increased or decreased). Mean HRQOL among our sample was 0.721 (SD 0.003). Any change in drinking from pre-pandemic level was independently associated with significantly lower HRQOL compared to never drinking (pre or during pandemic), from - 0.0251 points for decreased/stopped drinking to -0.0406 points for increased drinking (combined levels' Wald test F = 10.62, p < 0.0000). COVID-19 pandemic related impacts/disruptions were associated with HRQOL decrements ranging from - 0.0834 to -0.1340 (Wald test F = 64.34, p < 0.0000). CONCLUSION: The US population HRQOL was substantially lower during the pandemic than reported a decade earlier (mean = 0.79 in 2012-13). While pandemic-related impacts and disruptions may explain a large part of this decrement, changes in drinking-and the associated implications of such changes-might also play a role. Both individuals who reduced their drinking during the pandemic and those who increased consumption may be at risk of poor HRQOL.

The COVID-19 pandemic has precipitated changes in drinking that may be positive or negative depending on who is affected and how. We conducted a survey of over 3,000 adults in the US during the middle of the pandemic to understand drinking and quality of life. We found that US adults' quality of life was worse during the pandemic than in prior years, and people who either increased or decreased the amount that they drank were particularly worse-off. People who reported being severely impacted by the pandemic, however, were also much worse-off in terms of quality of life, and actually more so than people whose drinking habits changed. We need to pay attention to how drinking is connected to stressful events such as the pandemic, and make sure to attend to people who change their drinking in either direction as this may indicate underlying problems.

Understanding eligibility creep in psoriasis assessments: a survey study.

Psoriasis severity assessments for clinical trial entry may be unintentionally overestimated, especially if trial eligibility is chiefly dependent on rating of disease severity. When this results in patients with less severe phenotypes joining clinical trials it is referred to as eligibility creep. We investigated the potential impact of psychosocial incentives on psoriasis lesion severity grading. A survey was constructed and disseminated through Amazon Mechanical Turk. Participants completed two vignette-style questions prompted with a randomly allocated psychosocial incentive. Questions required participants to grade and select psoriasis lesion pictures for a fictional trial. Participants also decided whether or not to schedule re-evaluation of patients deemed ineligible at initial visit. There were 646 participants. There was no significant difference in number of total lesions selected for study inclusion between incentive groups (Kruskal-Wallis, P=0.30). In general, participants completing empathy and professional uncertainty incentives selected the most and least number of lesion pictures for trial inclusion, respectively. Participants prompted with empathy incentives had significantly greater rates of choosing to schedule a follow-up visit for ineligible patients compared to participants prompted with other incentives (69.7% versus 59.1%, Chi square P=0.046). Situations evoking empathy may contribute to eligibility creep.

Health Utility of Drinkers' Family Members: A Secondary Analysis of a US Population Data Set.

Background. Problematic alcohol use is known to harm individuals surrounding the drinker. This study described the health utility of people who reported having a family member(s) whom they perceived as a "problem drinker."Methods. We conducted a secondary analysis of the US National Epidemiologic Survey of Alcohol and Related Conditions Wave 3 (NESARC-III, 2012-13) data to estimate the independent associations of a family member's problem drinking on the respondent's health utility, also known as health-related quality of life, assessed via the SF-6D. Participants included 29,159 noninstitutionalized adults, of whom 21,808 reported perceiving a family member or members as having a drinking problem at any point in that person's life. Respondent drinking was assessed via self-report and diagnostic interview. We used population-weighted multivariate regression to estimate disutility. Results. After adjusting for the respondent's own alcohol consumption, alcohol use disorder (AUD), family structure, and sociodemographic characteristics, the mean decrement in SF-6D score associated with perceiving a family member as a problem drinker ranged from 0.033 (P < 0.001) for a spouse/partner to 0.023 (P < 0.001) for a grandparent, sibling, aunt, or uncle. The mean decrement in SF-6D score from having AUD oneself was 0.039 (P < 0.001). Conclusions. Perceived problem drinking within one's family is associated with statistically significant losses in health utility, the magnitude of which is dependent on relationship type. The adverse consequences associated with problem drinking in the family may rival having AUD oneself. Implications. Family-oriented approaches to AUD interventions may confer outsize benefits, especially if focused on the spouse or partner. Economic evaluation of alcohol misuse could be made more accurate through the inclusion of family spillover effects. Highlights: Spillover effects from problem drinking in the family vary by relationship type.One's perception of their spouse or child as having a drinking problem is associated with a utility decrement of equal magnitude to having alcohol use disorder oneself.Medical decision makers should consider the outsize effects of family spillovers in treatment decisions in the context of alcohol consumption, particularly among spouses and children of problem drinkers.Economic evaluation should consider how to incorporate family spillover effects from problem drinking in alcohol-related models.

Reassurance Techniques Do Not Significantly Impact Confidence in Biosimilars for Psoriasis: A Survey of a Convenience Sample of Individuals with Self-Identified Psoriasis.

INTRODUCTION: Biosimilars are underutilized, and negative perceptions may hinder their acceptance by patients. Psychologic interventions have not been extensively studied in the context of alleviating biosimilar hesitancy. The objective of this study was to assess the effectiveness of psychologic interventions on biosimilar confidence. METHODS: Following institutional review board (IRB) approval, 1285 subjects with self-reported psoriasis were recruited using Amazon Mechanical Turk, an online crowdsourcing platform. Participants were randomized to one of ten groups. Group A started with a hypothetical bio-originator; group B started with a hypothetical biosimilar. The remaining groups were provided a hypothetical scenario in which they were switching to a biosimilar after achieving great results with a bio-originator, and were randomized to receive either no reassurance (group C) or one of the following psychologic interventions: reassurance of comparable effectiveness (group D), an illustration implying comparable effectiveness (group E), anecdote of great results obtained in "other psoriasis patients" (group F), anecdote of great results obtained in another psoriasis patient "a lot like you" (group G), reassurance of the rigorous evaluation process to gain Food and Drug Administration (FDA) approval (group H), engagement in a task designed to facilitate recognition of biosimilars' comparability through answering multiple choice (group I) or free response questions (group J). Confidence levels were assessed using six-point Likert scales and analyzed using one-way analysis of variance (ANOVA) and two-group t-tests. RESULTS: While no statistically significant differences were detected, illustrations implying comparability (mean 4.19), explanations of the rigorous process to gain FDA approval (mean 4.21), testimonials of treatment success in another psoriasis patient "a lot like you" (mean 4.07) and "other psoriasis patients" (mean 4.01), and engagement with multiple choice (mean 4.02) and free response answers (mean 4.08) improved biosimilar confidence compared with the biosimilar switch control group (mean 3.96). CONCLUSION: Identifying highly impactful methods of improving biosimilar confidence remains a challenge.

Association of opioid utilization management with prescribing and overdose.

OBJECTIVES: Deaths from prescription opioids have reached epidemic levels in the United States, yet little is known about how insurers' coverage policies may affect rates of fatal and nonfatal overdose among individuals filling an opioid prescription. STUDY DESIGN: Retrospective cohort study using 2010-2016 Medicare claims data for beneficiaries with 1 or more filled prescriptions for a Schedule II opioid. METHODS: Outcomes were opioid volume dispensed in morphine milligram equivalents (MME), number of days supplied, and number of pills dispensed on each prescription and emergency department or inpatient stay associated with an opioid overdose during a prescription or within 7 days of the end of the prescription. RESULTS: A total of 7.03 million prescriptions for Schedule II opioids were dispensed over 1.87 million Part D beneficiary-years. The 7.03 million opioid prescriptions were associated with 8.5 opioid overdoses per 10,000 prescriptions. Prior authorization was associated with larger opioid volumes per prescription (103.6 MME; 95% CI, 36.2-171.0). Step therapy was associated with a greater number of days supplied (0.62 days; 95% CI, 0.10-1.13) and more pills dispensed (6.12 pills; 95% CI, 2.17-10.1). Quantity limits were associated with smaller opioid volumes (24.3 MME; 95% CI, 12.3-36.3) and fewer pills dispensed (2.35 pills; 95% CI, 1.77-2.93). In adjusted models, beneficiaries filling an opioid requiring prior authorization experienced 3.3 fewer overdoses per 10,000 prescriptions (95% CI, 0.41-6.2). CONCLUSIONS: Opioid utilization management among these beneficiaries was associated with mixed effects on opioid prescribing, and prior authorization was associated with a decreased likelihood of subsequent overdose. Further work exploring the impact of utilization management and insurer policies is needed.

SBIRT administered by mental health counselors for hospitalized adults with substance misuse or disordered use: Evaluating hospital utilization and costs.

OBJECTIVE: We analyzed the association of Screening, Brief Intervention, and Referral to Treatment (SBIRT) with hospitalizations, emergency department (ED) visits, and related costs, when administered to inpatients with substance misuse or disordered use by professional mental health counselors. METHODS: Our study used retrospective program and health records data and a difference-in-differences design with propensity score covariates. The study population consisted of hospital inpatients admitted to integrated care services staffed by physicians, nurses, and mental health counselors. The intervention group consisted of patients selected for intervention based on substance use history and receiving SBIRT (n = 1577). Patients selected for intervention but discharged before SBIRT administration (n = 618) formed the comparison group. The outcome variables were hospitalization and ED visits costs and counts. Costs of hospitalizations and ED visits were combined to allow sufficient data for analysis, with counts treated similarly. Patient-level variables were substance use type and substance use severity. A cluster variable was inpatient clinical service. Zero-censored and two-part logistic and generalized linear models with robust standard errors tested the association of SBIRT interventions with the outcomes. RESULTS: For the full study population of patients using alcohol, illicit drugs, or both, SBIRT administered by mental health counselors was not associated with changes in hospitalizations and ED visits. For patients with alcohol misuse or disordered use, SBIRT by mental health counselors was associated an odds ratio of 0.32 (p < .001) of having subsequent hospitalizations or ED visits. For patients with alcohol use who did return as hospital inpatients or to the ED, SBIRT by counselors was associated with a reduction in costs of $2547 per patient (p < .001) and with an incidence rate ratio of 0.57 for counts (p = .003). CONCLUSION: Our results suggest that professional mental health counselors on inpatient integrated care teams may provide SBIRT effectively for patients with misuse and disordered use of alcohol, reducing the likelihood of future healthcare utilization and costs.

The "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) Core Outcome Set: International Consensus on Outcomes to Measure in Efficacy and Effectiveness Trials of Alcohol Brief Interventions.

OBJECTIVE: The purpose of this study was to report the "Outcome Reporting in Brief Intervention Trials: Alcohol" (ORBITAL) recommended core outcome set (COS) to improve efficacy and effectiveness trials/evaluations for alcohol brief interventions (ABIs). METHOD: A systematic review identified 2,641 outcomes in 401 ABI articles measured by 1,560 different approaches. These outcomes were classified into outcome categories, and 150 participants from 19 countries participated in a two-round e-Delphi outcome prioritization exercise. This process prioritized 15 of 93 outcome categories for discussion at a consensus meeting of key stakeholders to decide the COS. A psychometric evaluation determined how to measure the outcomes. RESULTS: Ten outcomes were voted into the COS at the consensus meeting: (a) typical frequency, (b) typical quantity, (c) frequency of heavy episodic drinking, (d) combined consumption measure summarizing alcohol use, (e) hazardous or harmful drinking (average consumption), (f) standard drinks consumed in the past week (recent, current consumption), (g) alcohol-related consequences, (h) alcohol-related injury, (i) use of emergency health care services (impact of alcohol use), and (j) quality of life. CONCLUSIONS: The ORBITAL COS is an international consensus standard for future ABI trials and evaluations. It can improve the synthesis of new findings, reduce redundant/selective reporting (i.e., reporting only some, usually significant outcomes), improve between-study comparisons, and enhance the relevance of trial and evaluation findings to decision makers. The COS is the recommended minimum and does not exclude other, additional outcomes.

The effect of physician appearance on patient perceptions of treatment plans.

The presentation of a physician's clothing and themselves is an important part of the physician-patient interaction. Physician attire can impact patient satisfaction and trust in their physician. We sought to discover the influence physician attire may have on patients' comfort level with proposed treatment plans, which could influence treatment adherence. We surveyed 495 subjects to better understand the relationship between physician attire and patients' perceptions of treatment plans. We found subjects' comfort level in proposed treatment plans was not significantly affected by physician attire. This finding suggests physician attire may not be as important when considering the potential effect on treatment adherence.

Assessing the utility of the decoy effect on biologic treatment preference.

BACKGROUND: Many patients struggle with choosing and adhering to biologics. Psychological approaches (e.g. decoy effect) may impact patients' choices when selecting a biologic. OBJECTIVE: Assess whether decoy options influence choice between injectable treatment options. METHODS: Following IRB approval, 750 subjects >18 years were recruited through MTurk. Subjects were randomized in a 1:1:1 ratio into the following groups: 1) baseline comparison between a more effective, weekly injection and a less effective, every-three-month injection; 2) baseline with a decoy inferior to the weekly injection; 3) baseline with a decoy inferior to the every-three-month injection. Treatment preference was self-reported and compared using chi-square tests. RESULTS: Sixty-six percent of subjects preferred the weekly injection versus 34% for the every-three-month injection (group 1). There was a 4% increase in the number of subjects who preferred the weekly injection (70%; group 2; P=0.34) and a 3% increase for the every-three-month injection (37%) when a decoy inferior to them was included (group 3; P=0.56). CONCLUSION: Psychological approaches can be used to enhance treatment initiation and adherence. However, the decoy effect did not appear to have a significant impact in this study. Patients' preferences for efficacy versus frequency of injection may be rather fixed.

A two-arm parallel-group individually randomised prison pilot study of a male remand alcohol intervention for self-efficacy enhancement: the APPRAISE study protocol.

INTRODUCTION: The prevalence of at-risk drinking is far higher among those in contact with the criminal justice system (73%) than the general population (35%). However, there is little evidence on the effectiveness of alcohol brief interventions (ABIs) in reducing risky drinking among those in the criminal justice system, including the prison system and, in particular, those on remand. Building on earlier work, A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement (APPRAISE) is a pilot study designed to assess the feasibility and acceptability of an ABI, delivered to male prisoners on remand. The findings of APPRAISE should provide the information required to design a future definitive randomised controlled trial (RCT). METHODS AND ANALYSIS: APPRAISE will use mixed methods, with two linked phases, across two prisons in the UK, recruiting 180 adult men on remand: 90 from Scotland and 90 from England. Phase I will involve a two-arm, parallel-group, individually randomised pilot study. The pilot evaluation will provide data on the likely impact of A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement (APPRAISE), which will be used to inform a future definitive multicentre RCT. Phase II will be a process evaluation assessing how the ABI has been implemented to explore the change mechanisms underpinning the ABI (figure 1) and to assess the context within which the ABI is delivered. ETHICS AND DISSEMINATION: The APPRAISE protocol has been approved by the East of Scotland Research Ethics Committee (19/ES/0068), National Offender Management System (2019-240), Health Board Research and Development (2019/0268), Scottish Prison Service research and ethics committee, and by the University of Edinburgh's internal ethics department. The findings will be disseminated via peer-reviewed journal publications, presentations at local, national and international conferences, infographics and shared with relevant stakeholders through meetings and events. TRIAL REGISTRATION NUMBER: ISRCTN27417180.

A Scoping Review of Economic Evaluations of Workplace Wellness Programs.

OBJECTIVE: Debates about the effectiveness of workplace wellness programs (WWPs) call for a review of the evidence for return on investment (ROI) of WWPs. We examined literature on the heterogeneity in methods used in the ROI of WWPs to show how this heterogeneity may affect conclusions and inferences about ROI. METHODS: We conducted a scoping review using systematic review methods and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We reviewed PubMed, EconLit, Proquest Central, and Scopus databases for published articles. We included articles that (1) were published before December 20, 2019, when our last search was conducted, and (2) met our inclusion criteria that were based on target population, target intervention, evaluation method, and ROI as the main outcome. RESULTS: We identified 47 peer-reviewed articles from the selected databases that met our inclusion criteria. We explored the effect of study characteristics on ROI estimates. Thirty-one articles had ROI measures. Studies with costs of presenteeism had the lowest ROI estimates compared with other cost combinations associated with health care and absenteeism. Studies with components of disease management produced higher ROI than programs with components of wellness. We found a positive relationship between ROI and program length and a negative relationship between ROI and conflict of interest. Evaluations in small companies (≤500 employees) were associated with lower ROI estimates than evaluations in large companies (>500 employees). Studies with lower reporting quality scores, including studies that were missing information on statistical inference, had lower ROI estimates. Higher methodologic quality was associated with lower ROI estimates. CONCLUSION: This review provides recommendations that can improve the methodologic quality of studies to validate the ROI and public health effects of WWPs.