Steven L. Bernstein

Aims: Unhealthy alcohol use (UAU) and cigarette smoking drive morbidity and mortality among persons with HIV (PWH). Few studies have focused on UAU among PWH receiving tobacco treatment. Methods: Exploratory analysis of A SMART Approach to Treating Tobacco Use Disorder (SMARTTT) trial Stage 1 data, during which participants were randomized to clinical pharmacist-delivered nicotine replacement therapy (NRT) alone or NRT with contingency management (NRT+CM) in HIV clinics from 7/2020-3/2024. Analyses were restricted to participants with baseline AUDIT-C; UAU was defined by AUDIT-C (women=3+/men=4+). Outcomes included visit completion rates, adjusted differences in cigarettes per day (CPD) and abstinence at week 12. Results: Participants (n=314) smoked a mean of 13 CPD and 27% reported UAU at baseline. Participants with UAU were more likely to be younger, Black, healthier, report using cannabis and stimulants and greater reliance on the bus or walking for transportation. Participants with UAU generally had lower visit completion rates. Treatment differences in CPD between NRT+CM and NRT alone at week 12 did not vary by UAU (least squares means UAU: 6.0 vs. 6.7 and no UAU: 6.1 vs. 5.3, respectively; difference in adjusted treatment difference [95% CI]=1.6 [-2.1, 5.3]). Treatment differences in abstinence were also not moderated by UAU (UAU: 18.9% vs. 5.5% and no UAU: 21.7% vs. 10.0%; difference in adjusted difference [95% CI]=1.7% [-14.3%, 17.8%]). Conclusions: Among SMARTTT participants, UAU was common and associated with lower visit completion, without observed effects on smoking outcomes. Future studies should focus on targeting UAU and TUD together to optimize outcomes.

Rationale & Objective: People who live in rural areas with advanced chronic kidney disease (CKD) face well-documented structural barriers to receiving care, yet little is known about how they experience their illness or perceive interactions with their healthcare teams. We aimed to characterize the lived experiences and care perceptions of adults living in rural areas with advanced, pre-dialysis CKD. Study Design: We conducted semi-structured qualitative interviews with patients and care partners. Setting & Participants: We recruited patients with advanced CKD (stages 4–5, not on dialysis) and their care partners from a single hospital-based nephrology clinic in northern New England serving a predominantly rural population. Analytical Approach: We analyzed interview transcripts using participatory Practical Thematic Analysis (PTA), an inductive, stakeholder-engaged approach to qualitative analysis. Results: We interviewed 12 patients and 4 care partners. Four themes were identified: (1) logistical challenges of rural CKD care were pervasive but frequently normalized as an expected feature of rural life; (2) disease progression and future treatments were sources of uncertainty and concern, with expectations about dialysis often shaped by peer accounts rather than clinical discussion; (3) clinical conversations centered on laboratory results and medications, leaving emotional concerns and psychologic challenges unaddressed; and (4) physical symptoms and lifestyle changes were common but frequently attributed to comorbid conditions rather than to CKD. Limitations: Recruitment from a single clinic with a small, racially homogeneous sample limits transferability. While in-person recruitment may have excluded patients with greater transportation barriers, those who attended represent a population navigating substantial access challenges to receive care. Conclusions: Adults living in rural areas with advanced CKD experience logistical, emotional, and informational challenges broadly consistent with those reported in non-rural CKD populations. Patients normalized geographic barriers and did not consistently identify rurality as a source of disadvantage, even as structural barriers persisted. These findings support the development of structured communication approaches in nephrology care that invite discussion of disease trajectory, daily life impacts, and emotional concerns.

Supplementary Figure from Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin

Contingency management (CM), an evidence-based behavioral strategy that rewards positive behavior change including tobacco cessation, is rarely offered to support people with HIV (PWH) who smoke. In this study, we explored perspectives among patients and research staff engaged in a multi-site randomized clinical trial involving clinical pharmacist-delivered CM within HIV clinics. Between February and September 2023, we conducted 1:1 interviews with 12 PWH randomized to receive CM and one focus group with 8 staff (i.e., clinical pharmacists and research coordinators). Qualitative data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework to understand barriers and facilitators related to evidence (perspectives on CM for smoking cessation), context (HIV clinics), and facilitation (promoting effectiveness and sustainability). Regarding evidence, PWH and staff had limited prior experience with CM and supported the use of exhaled carbon monoxide to promote accountability. PWH and staff thought CM was useful in bolstering internal motivation, but differed on ideal target behaviors (i.e., cessation vs. reduction). Regarding context, clinical pharmacist-delivered tobacco treatment within HIV clinics was viewed favorably, with mixed perspectives regarding optimal visit schedules and utility of remote CM. Regarding facilitation, PWH and research staff discussed strategies to increase participant engagement and retention such as incorporating behavioral counseling services. PWH endorsed application of CM beyond smoking cessation and for people without HIV. Future efforts should consider expanding the use of CM to target smoking cessation and related health behaviors and tailoring the intervention to individual needs and goals.

Introduction: Tobacco contributes to the leading causes of morbidity and mortality among persons with human immunodeficiency virus (PWHs). Nonetheless, medications for tobacco use disorder are widely underused, particularly among PWHs. We sought to characterize the extent to which insurance barriers impacted access to medications for tobacco use disorder and, in comparison, to access to antiretroviral therapy (ART). Methods: This is a secondary analysis of data on individuals enrolled in a randomized clinical trial to address tobacco use involving nicotine replacement therapy and, for some, additionally, varenicline or bupropion. Medication prescriptions are transmitted electronically from the clinic to neighborhood pharmacies. Data sources included participant assessments and intervention visit tracking forms. Results: Of 93 participants enrolled from September 2020 to July 2021, 20 (22%) were unable to fill or had difficulty filling their nicotine replacement therapy (NRT) prescriptions because of insurance barriers. These fell into 2 broad categories: enrollment in a publicly insured managed care plan in which the pharmacy benefit manager excluded nonprescription NRT and lack of understanding by the pharmacy of the scope of coverage. Of these 20 participants, 5 (25%) were unable to obtain medications at all, and 3 of these participants dropped out of the study. One additional participant paid out-of-pocket to obtain NRT. No participant was denied coverage of ART, bupropion, or varenicline. Conclusions: Gaps in insurance coverage may result in PWHs receiving ART without simultaneous medical management of their tobacco use. This may undermine the efficacy of antivirals. Mandated insurance coverage of nonprescription NRT may improve the health of PWHs who smoke.

Introduction The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes. Methods and analysis This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial. Ethics and dissemination Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications. Trial registration number NCT04959279; Pre-results.

Conceptualizing tobacco dependence as a chronic relapsing condition suggests the need to use analytic strategies that reflect that premise. However, clinical trials for smoking cessation typically define the primary endpoint as a measure of abstinence at a single timepoint distal to the intervention, typically 3–12 months. This reinforces the concept of tobacco outcomes as a dichotomous state—one is, or is not, abstinent. Fortunately, there are several approaches available to handle longitudinal data that reflect the relapsing and remitting nature of tobacco use during treatment studies. In this paper, sponsored by the Society for Research on Nicotine and Tobacco’s Treatment Research Network, we present an introductory overview of these techniques and their application in smoking cessation clinical trials. Topics discussed include models to examine abstinence outcomes (eg, trajectory models of abstinence, models for transitions in smoking behavior, models for time to event), models that examine reductions in tobacco use, and models to examine joint outcomes (eg, examining changes in the use of more than one tobacco product). Finally, we discuss three additional relevant topics (ie, heterogeneity of effects, handling missing data, and power and sample size) and provide summary information about the type of model that can be used based on the type of data collected and the focus of the study. We encourage investigators to familiarize themselves with these techniques and use them in the analysis of data from clinical trials of smoking cessation treatment. Implications Clinical trials of tobacco dependence treatment typically measure abstinence 3–12 months after participant enrollment. However, because smoking is a chronic relapsing condition, these measures of intervention success may not accurately reflect the common trajectories of tobacco abstinence and relapse. Several analytical techniques facilitate this type of outcome modeling. This paper is meant to be an introduction to these concepts and techniques to the global nicotine and tobacco research community including which techniques can be used for different research questions with visual summaries of which types of models can be used for different types of data and research questions.

Qualitative research methods explore and provide deep contextual understanding of real world issues, including people’s beliefs, perspectives, and experiences. Whether through analysis of interviews, focus groups, structured observation, or multimedia data, qualitative methods offer unique insights in applied health services research that other approaches cannot deliver. However, many clinicians and researchers hesitate to use these methods, or might not use them effectively, which can leave relevant areas of inquiry inadequately explored. Thematic analysis is one of the most common and flexible methods to examine qualitative data collected in health services research. This article offers practical thematic analysis as a step-by-step approach to qualitative analysis for health services researchers, with a focus on accessibility for patients, care partners, clinicians, and others new to thematic analysis. Along with detailed instructions covering three steps of reading, coding, and theming, the article includes additional novel and practical guidance on how to draft effective codes, conduct a thematic analysis session, and develop meaningful themes. This approach aims to improve consistency and rigor in thematic analysis, while also making this method more accessible for multidisciplinary research teams.