The first 20 months of the COVID-19 pandemic: Mortality, intubation and ICU rates among 104,590 patients hospitalized at 21 United States health systems.

MAIN OBJECTIVE: There is limited information on how patient outcomes have changed during the COVID-19 pandemic. This study characterizes changes in mortality, intubation, and ICU admission rates during the first 20 months of the pandemic. STUDY DESIGN AND METHODS: University of Wisconsin researchers collected and harmonized electronic health record data from 1.1 million COVID-19 patients across 21 United States health systems from February 2020 through September 2021. The analysis comprised data from 104,590 adult hospitalized COVID-19 patients. Inclusion criteria for the analysis were: (1) age 18 years or older; (2) COVID-19 ICD-10 diagnosis during hospitalization and/or a positive COVID-19 PCR test in a 14-day window (+/- 7 days of hospital admission); and (3) health system contact prior to COVID-19 hospitalization. Outcomes assessed were: (1) mortality (primary), (2) endotracheal intubation, and (3) ICU admission. RESULTS AND SIGNIFICANCE: The 104,590 hospitalized participants had a mean age of 61.7 years and were 50.4% female, 24% Black, and 56.8% White. Overall risk-standardized mortality (adjusted for age, sex, race, ethnicity, body mass index, insurance status and medical comorbidities) declined from 16% of hospitalized COVID-19 patients (95% CI: 16% to 17%) early in the pandemic (February-April 2020) to 9% (CI: 9% to 10%) later (July-September 2021). Among subpopulations, males (vs. females), those on Medicare (vs. those on commercial insurance), the severely obese (vs. normal weight), and those aged 60 and older (vs. younger individuals) had especially high mortality rates both early and late in the pandemic. ICU admission and intubation rates also declined across these 20 months. CONCLUSIONS: Mortality, intubation, and ICU admission rates improved markedly over the first 20 months of the pandemic among adult hospitalized COVID-19 patients although gains varied by subpopulation. These data provide important information on the course of COVID-19 and identify hospitalized patient groups at heightened risk for negative outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04506528 (https://clinicaltrials.gov/ct2/show/NCT04506528).

A new statistical model for longitudinal ecological momentary assessment data on dual use of electronic and combustible cigarettes.

Background: Existing studies of dual use of electronic and combustible cigarettes either collected longitudinal data with long gaps in between waves or conducted ecological momentary assessment (EMA) over a short period of time. In recent years, the measurement burst design that embeds an EMA protocol in each wave assessment of a traditional longitudinal study has become more popular and yet conventional generalized linear mixed models (GLMM) have important limitations for handling data from this design.Objectives: This study proposed a new statistical method to analyze data from the measurement burst design.Methods: This new statistical method was designed to model the short-term (within-wave) as well as long-term (between-wave) changes and was validated by a simulation study. Secondary analysis was conducted to analyze data from 205 dual users (52% male) and 146 exclusive smokers (50% male) who participated in a recent study using the measurement burst design.Results: The simulation study shows that the proposed method can handle the gap between waves well and is also robust to nonlinear changes across waves. Although no short-term change in smoking was found, dual users reported a long-term reduction in cigarette use that was more rapid compared to exclusive smokers (߈=-0.0127,p=.0167). Vaping more was associated with smoking less (߈=-0.0058,p=.0054).Conclusion: The proposed method is highly applicable as it can be easily implemented by substance use researchers and the results can be straightforwardly interpreted. The results suggest that e-cigarette use may play a role in promoting a long-term reduction in smoking among dual users.

Understanding contexts of smoking and vaping among dual users: analysis of ecological momentary assessment data.

AIMS: To understand dual users' cigarette and e-cigarette use patterns, including the contexts in which they vape versus smoke and to understand how environmental and internal contexts and smoking patterns differ between dual users and exclusive smokers. DESIGN: Longitudinal observational trial. SETTING: Research center in Wisconsin, USA. PARTICIPANTS: Adult dual users (n = 162) and adults who exclusively smoked (n = 143), with no plans to quit smoking or vaping in the next 30 days. MEASUREMENTS: Participants carried smartphones for 2 weeks at baseline to record each use event for the two products and report on the context of their product use. The percentage of mornings where participants vaped first versus smoked were used to compute e-cigarette dependence. FINDINGS: Hierarchical linear regression models with random slopes and intercepts examined the within- and between-subject effects of context on the likelihood of vaping (versus smoking); significant fixed effects were tested for moderation by e-cigarette dependence. Dual users reported significantly more puffs/cigarette [mean = 13.1, standard deviation (SD) = 10.2] than puffs/vape event (mean = 11.7, SD = 11.5; P = 0.01). E-cigarette dependence moderated the influence of social cues (t-ratio = 2.4, P = 0.02) and smoking restrictions (t-ratio = 3.1, P = 0.003) on the likelihood of vaping versus smoking [odds ratio (OR) = 2.30, P = 0.02]. Context was more related to which product was used in those of low versus higher e-cigarette dependence. Reports of strong cravings to smoke and positive expectancies for cigarettes were associated with a reduced likelihood of vaping, whereas strong cravings to vape and positive vaping expectancies were related to increased likelihood of vaping. CONCLUSIONS: Among dual users of cigarettes and e-cigarettes with no motivation to quit, vaping appears to be related to internal cues and more highly linked with social contexts and smoking restrictions (i.e. under stronger external stimulus control) among those with low to moderate e-cigarette dependence compared with high e-cigarette dependence. These findings illustrate the importance of contextual factors in tobacco product use among dual users with the influence of context being reduced at high levels of e-cigarette dependence.

Dual Users Compared to Smokers: Demographics, Dependence, and Biomarkers.

INTRODUCTION: The availability of electronic cigarettes (e-cigarettes) has profoundly changed the tobacco product landscape. In the United States, almost 6 million adults use both combustible and e-cigarettes (ie, dual users). The goal of this study was to understand how smokers and dual users differ in terms of demographics, cigarette dependence, and exposure to carcinogens. METHODS: An observational cohort (smokers, n = 166, ≥5 cigarettes/day for 6 months and no e-cigarette use in 3 months; dual users, n = 256, smoked daily for 3 months and used e-cigarettes at least once/week for the past 3 months) completed baseline assessments of demographics, tobacco use, and dependence. They also provided breath samples for carbon monoxide (CO) assay and urine samples for cotinine, 3-hydroxycotinine, and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) assays. RESULTS: Compared to smokers, dual users (mean e-cigarette use = 5.5 days/week [SD = 1.9]) were significantly younger and more likely to be white, have more education, report a history of psychiatric co-morbidity, and smoke fewer cigarettes per day. There were no differences in CO, cotinine, or 3-hydroxycotinine levels; however, dual users had significantly lower levels of NNAL than did smokers. Most smokers and dual users had no plans to quit smoking within the next year; 91% of dual users planned to continue using e-cigarettes for at least the next year. CONCLUSIONS: In this community sample, dual users are supplementing their smoking with e-cigarette use. Dual users, versus smokers, smoked fewer cigarettes per day and delayed their first cigarette of the day, but did not differ in quitting intentions. IMPLICATIONS: This comparison of a community sample of established dual users and exclusive smokers addresses key questions of dependence and health risks of dual use in real-world settings. Dual users were more likely to be white, younger, have more than a high school education and have a psychiatric history. Dual users also smoked significantly fewer cigarettes and had lower levels of NNAL (a carcinogen), but they did not differ from exclusive smokers in CO or cotinine levels, suggesting that they supplemented their nicotine intake via e-cigarettes.

Perceptions and influences of a state prison smoking ban.

Prison smoking bans are increasingly common. It is important to consider how those who are incarcerated respond to these bans and to the subsequent development of contraband tobacco markets. Since there are high rates of smoking in individuals who become incarcerated, along with high rates of chronic illnesses that are exacerbated by smoking, it is critical to examine whether there are health promoting changes in perceptions of and intentions toward smoking and other health behaviors that can be maintained on release to the community. Interviews with incarcerated men experiencing a prison smoking ban revealed their responses to being smoke-free, reactions to the presence of contraband smoking, and the influences of this experience on their intentions to smoke following release.

The multiphase optimization strategy for engineering effective tobacco use interventions.

The multiphase optimization strategy (MOST) is a new methodological approach for building, optimizing, and evaluating multicomponent interventions. Conceptually rooted in engineering, MOST emphasizes efficiency and careful management of resources to move intervention science forward steadily and incrementally. MOST can be used to guide the evaluation of research evidence, develop an optimal intervention (the best set of intervention components), and enhance the translation of research findings, particularly type II translation. This article uses an ongoing study to illustrate the application of MOST in the evaluation of diverse intervention components derived from the phase-based framework reviewed in the companion article by Baker et al. (Ann Behav Med, in press, 2011). The article also discusses considerations, challenges, and potential benefits associated with using MOST and similar principled approaches to improving intervention efficacy, effectiveness, and cost-effectiveness. The applicability of this methodology may extend beyond smoking cessation to the development of behavioral interventions for other chronic health challenges.

An Ecological Momentary Assessment analysis of relations among coping, affect and smoking during a quit attempt.

AIMS: This study used Ecological Momentary Assessment (EMA) data from smokers trying to quit to assess relations among coping, positive affect, negative affect and smoking. The effects of stress coping on affect and smoking were examined. DESIGN: Data from a randomized clinical trial of smoking cessation treatments were submitted to multi-level modeling to test the effects of coping with stressful events on subsequent affect and smoking. SETTING: Center for Tobacco Research and Intervention, Madison, Wisconsin. PARTICIPANTS: A total of 372 adult daily smokers who reported at least one stressful event and coping episode and provided post-quit data. MEASUREMENTS: Participants' smoking, coping and affect were assessed in near real time with multiple EMA reports using electronic diaries pre- and post-quit. FINDINGS: Multi-level models indicated that a single coping episode did not predict a change in smoking risk over the next 4 or 48 hours, but coping in men was associated with concurrent reports of increased smoking. Coping predicted improved positive and negative affect reported within 4 hours of coping, but these affective gains did not predict reduced likelihood of later smoking. Pre-quit coping frequency and gender moderated post-quit stress coping relations with later positive affect. Men and those with greater pre-quit coping frequency reported greater gains in positive affect following post-quit coping. CONCLUSIONS: Coping responses early in a quit attempt may help smokers trying to quit feel better, but may not help them stay smoke-free.

Gender, race, and education differences in abstinence rates among participants in two randomized smoking cessation trials.

INTRODUCTION: Smoking is the leading preventable cause of morbidity and mortality in the United States, but this burden is not distributed equally among smokers. Women, Blacks, and people with low socioeconomic status are especially vulnerable to the health risks of smoking and are less likely to quit. METHODS: This research examined cessation rates and treatment response among 2,850 participants (57.2% women, 11.7% Blacks, and 9.0% with less than a high school education) from two large cessation trials evaluating: nicotine patch, nicotine lozenge, bupropion, bupropion + lozenge, and nicotine patch + lozenge. RESULTS: Results revealed that women, Blacks, and smokers with less education were less likely to quit smoking successfully than men, Whites, and smokers with more education, respectively. Women did not appear to benefit more from bupropion than from nicotine replacement therapy, but women and smokers with less education benefited more from combination pharmacotherapy than from monotherapy. DISCUSSION: Women, Blacks, and smokers with less education are at elevated risk for cessation failure, and research is needed to understand this risk and develop pharmacological and psychosocial interventions to improve their long-term cessation rates.