An Introduction and Practical Guide to Strategies for Analyzing Longitudinal Data in Clinical Trials of Smoking Cessation Treatment: Beyond Dichotomous Point-Prevalence Outcomes.

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.

Impact of Nicotine Replacement Therapy on Breast Surgery Outcomes.

BACKGROUND: Smoking cessation therapy, including nicotine replacement therapy (NRT), is used perioperatively to assist patients to reduce their tobacco smoke intake and consequently decrease their risk of smoking-associated complications. There are, however, theoretical concerns that nicotine-induced peripheral vasoconstriction could impair wound healing. This study investigated the effect of NRT on postoperative outcomes in patients undergoing breast surgery. METHODS: A retrospective chart review of patients undergoing breast surgery within the Yale New Haven Health System from the years 2014 to 2020 was performed. Documented smoking status within 6 months before surgery, use or prescription of NRT, type of surgery, and surgical complications of infection, wound dehiscence, tissue necrosis, hematoma, seroma, fat necrosis, and return to operating room within 30 days were recorded. Demographic and complication data were compared between patients with NRT usage and those without using t-tests and chi-square analyses. Multivariable logistic regression models were created to predict the effect of NRT usage on the occurrence of any complication. RESULTS: A total of 613 breast procedures met inclusion criteria, of which 105 (17.2%) had documented NRT use. The NRT cohort and the non-NRT cohort were well balanced with respect to demographics and procedural variables. Upon multivariable modeling for risk of any surgical complication, NRT was not a significant predictor (odds ratio [OR]: 1.199, p = 0.607 and OR: 0.974, p = 0.912, respectively), whereas procedure type, increased body mass index, and increased age were. CONCLUSION: NRT use was not associated with an increased risk of postoperative complications compared with not using NRT as part of smoking cessation therapy prior to operation.

The Relationship of COVID-19 Vaccination with Mortality Among 86,732 Hospitalized Patients: Subpopulations, Patient Factors, and Changes over Time.

BACKGROUND: Information on COVID-19 vaccination effects on mortality among patients hospitalized with COVID-19 could inform vaccination outreach efforts and increase understanding of patient risk. OBJECTIVE: Determine the associations of vaccination status with mortality in adult patients hospitalized with COVID-19. DESIGN: This retrospective cohort study assessed the characteristics and mortality rates of adult patients hospitalized with COVID-19 across 21 healthcare systems in the USA from January 1, 2021, to January 31, 2022. PARTICIPANTS: Adult patients admitted to participating hospitals who had COVID-19 diagnoses and/or positive PCR tests and completed their hospital stay via discharge or death. MAIN MEASURE: In-hospital mortality vs. discharge (outcome) and patient age, sex, race, ethnicity, BMI, insurance status, comorbidities, and vaccination status extracted from the electronic health record (EHR). KEY RESULTS: Of 86,732 adult patients hospitalized with COVID-19, 45,082 (52%) were female, mean age was 60 years, 20,800 (24%) were Black, and 22,792 (26.3%) had one or more COVID-19 vaccinations. Statistically adjusted mortality rates for unvaccinated and vaccinated patients were 8.3% (95% CI, 8.1-8.5) and 5.1% (95% CI, 4.8-5.4) respectively (7.9% vs. 4.5% with no immune compromise). Vaccination was associated with especially large reductions in mortality for obese (OR = 0.67; 95% CI 0.56-0.80) and severely obese (OR = 0.52; 95% CI, 0.41-0.67) patients and for older patients (OR = 0.99; 95% CI, 0.98-0.99). Mortality likelihood was higher later in the study period (August 2021-January 31, 2022) than earlier (January 1, 2021-July 30, 2021) (OR = 1.10; 95% CI = 1.04-1.17) and increased significantly for vaccinated patients from 4.6% (95% CI, 3.9-5.2%) to 6.5% (95% CI, 6.2-6.9%). CONCLUSIONS: Patients vaccinated for COVID-19 had reduced mortality, especially for obese/severely obese and older individuals. Vaccination's protective effect against mortality declined over time and hospitalized obese and older individuals may derive especially great benefit from prior vaccination against SARS-CoV-2.

Successful Optimization of Tobacco Dependence Treatment in the Emergency Department: A Randomized Controlled Trial Using the Multiphase Optimization Strategy.

STUDY OBJECTIVE: Tobacco dependence treatment initiated in the hospital emergency department (ED) is effective. However, trials typically use multicomponent interventions, making it difficult to distinguish specific components that are effective. In addition, interactions between components cannot be assessed. The Multiphase Optimization Strategy allows investigators to identify these effects. METHODS: We conducted a full-factorial, 24 or 16-condition optimization trial in a busy hospital ED to examine the performance of 4 tobacco dependence interventions: a brief negotiation interview; 6 weeks of nicotine replacement therapy with the first dose delivered in the ED; active referral to a telephone quitline; and enrollment in SmokefreeTXT, a free short-messaging service program. Study data were analyzed with a novel mixed methods approach to assess clinical efficacy, cost-effectiveness, and qualitative participant feedback. The primary endpoint was tobacco abstinence at 3 months, verified by exhaled carbon monoxide using a Bedfont Micro+ Smokerlyzer. RESULTS: Between February 2017 and May 2019, we enrolled 1,056 adult smokers visiting the ED. Odd ratios (95% confidence intervals) from the primary analysis of biochemically confirmed abstinence rates at 3 months for each intervention, versus control, were: brief negotiation interview, 1.8 (1.1, 2.8); nicotine replacement therapy, 2.1 (1.3, 3.2); quitline, 1.4 (0.9, 2.2); SmokefreeTXT, 1.1 (0.7, 1.7). There were no statistically significant interactions among components. Economic and qualitative analyses are in progress. CONCLUSION: The brief negotiation interview and nicotine replacement therapy were efficacious. This study is the first to identify components of ED-initiated tobacco dependence treatment that are individually effective. Future work will address the scalability of the brief negotiation interview and nicotine replacement therapy by offering provider-delivered brief negotiation interviews and nicotine replacement therapy prescriptions.

National Institute on Drug Abuse Clinical Trials Network Meeting Report: Advancing Emergency Department Initiation of Buprenorphine for Opioid Use Disorder.

Opioid use disorder and opioid overdose deaths are a major public health crisis, yet highly effective evidence-based treatments are available that reduce morbidity and mortality. One such treatment, buprenorphine, can be initiated in the emergency department (ED). Despite evidence of efficacy and effectiveness for ED-initiated buprenorphine, universal uptake remains elusive. On November 15 and 16, 2021, the National Institute on Drug Abuse Clinical Trials Network convened a meeting of partners, experts, and federal officers to identify research priorities and knowledge gaps for ED-initiated buprenorphine. Meeting participants identified research and knowledge gaps in 8 categories, including ED staff and peer-based interventions; out-of-hospital buprenorphine initiation; buprenorphine dosing and formulations; linkage to care; strategies for scaling ED-initiated buprenorphine; the effect of ancillary technology-based interventions; quality measures; and economic considerations. Additional research and implementation strategies are needed to enhance adoption into standard emergency care and improve patient outcomes.

A Secondary Analysis of a Preliminary Contingency Management Intervention for Presurgical Cancer Patients: Evaluating Individual Participant Data.

INTRODUCTION: Contingency management (CM) interventions deliver monetary reinforcers contingent upon biochemically verified abstinence from smoking. CM has been found to be effective, however, individual participant, analyses are warranted to further elucidate how individual-level behavior patterns vary during the intervention period, both within and across treatment groups. AIMS AND METHODS: This is a secondary analysis of a randomized controlled pilot trial of presurgical cancer patients who smoke (RCT N = 40). All participants were current everyday smokers and were enrolled in cessation counseling, offered nicotine replacement therapy, and submitted breath CO testing 3 times per week for 2-5 weeks. Participants randomized to CM received monetary reinforcers for breath CO ≤6 ppm on an escalating schedule of reinforcement with a reset for positive samples. Sufficient breath CO data exist for 28 participants (CM = 14; monitoring only [MO] = 14). Effect size was calculated for differences in negative CO tests. Time to first negative test was tested using survival analysis. Fisher's exact test was used to assess relapse. RESULTS: The CM group achieved abstinence more quickly (p < .05), had a lower percentage of positive tests (h = 0.80), and experienced fewer lapses following abstinence (p = .00). While 11 of 14 participants in the CM group achieved and sustained abstinence by their third breath test, this was only true for 2 of the 14 MO participants. CONCLUSIONS: Those in CM achieved abstinence quicker and with fewer lapses than those engaged in MO speaking to the efficacy of the schedule of financial reinforcement. This is particularly important within presurgical populations given the potential benefits to postoperative cardiovascular and wound infection risk. IMPLICATIONS: While the efficacy of CM as an intervention is well established, this secondary analysis provides insight into the individual behavior patterns underlying successful abstinence. Those assigned to CM were not only more likely to achieve abstinence, but did so more quickly and with fewer instances of relapse. This is of particular importance to those scheduled for surgery where achieving abstinence as early as possible impacts on the risk of postoperative complications. CM interventions may be particularly well suited for critical windows in which timely and sustained abstinence is advantageous.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Proposing a Model of Proactive Outreach to Advance Clinical Research and Care Delivery for Patients Who Use Tobacco.

There are evidence-based treatments for tobacco dependence, but inequities exist in the access to and reach of these treatments. Traditional models of tobacco treatment delivery are "reactive" and typically provide treatment only to patients who are highly motivated to quit and seek out tobacco treatment. Newer models involve "proactive" outreach, with benefits that include increasing access to tobacco treatment, prompting quit attempts among patients with low motivation, addressing health disparities, and improving population-level quit rates. However, the definition of "proactive" is not clear, and adoption has been slow. This commentary introduces a comprehensive yet flexible model of proactive outreach and describes how proactive outreach can optimize clinical research and care delivery in these domains: (1) identifying the population, (2) offering treatment, and (3) delivering treatment. Dimensions relevant to each domain are the intensity of proactive outreach (low to high) and the extent to which proactive outreach activities rely on human interaction or are facilitated by information technology (IT). Adoption of the proposed proactive outreach model could improve the precision and rigor with which tobacco cessation research and tobacco treatment programs report data, which could have a positive effect on care delivery and patient outcomes.

Design and Implementation of an Agitation Code Response Team in the Emergency Department.

STUDY OBJECTIVE: Agitation, defined as excessive psychomotor activity leading to violent and aggressive behavior, is becoming more prevalent in the emergency department (ED) amidst a strained behavioral health system. Team-based interventions have demonstrated promise in promoting de-escalation, with the hope of minimizing the need for invasive techniques, like physical restraints. This study aimed to evaluate an interprofessional code response team intervention to manage agitation in the ED with the goal of decreasing physical restraint use. METHODS: This quality improvement study occurred over 3 phases, representing stepwise rollout of the intervention: (1) preimplementation (phase I) to establish baseline outcome rates; (2) design and administrative support (phase II) to conduct training and protocol design; and (3) implementation (phase III) of the code response team. An interrupted time-series analysis was used to compare trends between phases to evaluate the primary outcome of physical restraint orders occurring during the study period. RESULTS: Within the 634,578 ED visits over a 5-year period, restraint use significantly declined sequentially over the 3 phases (1.1%, 0.9%, and 0.8%, absolute change -0.3% between phases I and III, 95% confidence interval [CI] -0.4% to 0.3%), which corresponded to a 27.3% proportionate decrease in restraint rates between phases I and III. For the interrupted time-series analysis, there was a significantly decreasing slope in biweekly restraints in phase II compared to phase I (slope, -0.05 restraints per 1,000 ED visits per 2-week period, 95% CI -0.07 to -0.03), which was sustained in an incremental fashion in phase III (slope, -0.05, 95% CI -0.07 to -0.02). CONCLUSION: With the implementation of a structured agitation code response team intervention combined with design and administrative support, a decreased rate of physical restraint use occurred over a 5-year period. Results suggest that investment in organizational change, along with interprofessional collaboration during the management of agitated patients in the ED, can lead to sustained reductions in the use of an invasive and potentially harmful measure on patients.

Advances in clinical trials methodology: Intervention optimization approaches in emergency medicine.

The classical two-arm randomized clinical trial (RCT) is designed to test the efficacy or effectiveness of an intervention, which may consist of one or more components. However, this approach does not enable the investigator to obtain information that is important in intervention development, such as which individual components of the intervention are efficacious, which are not and possibly should be removed, and whether any components interact. The Multiphase Optimization Strategy (MOST) is a new framework for development, optimization, and evaluation of interventions. MOST includes the RCT for purposes of evaluation, but inserts a phase of research before the RCT aimed at intervention optimization. The optimization phase requires one or more separate trials similar in scope to an RCT, but employing a different experimental design. The design of the optimization trial is selected strategically so as to maximize the amount of scientific information gained using the available resources. One consideration in selecting this experimental design is the type of intervention to be optimized. If a fixed intervention, i.e. one in which the same intervention content and intensity is provided to all participants, is to be optimized, a factorial experiment is often appropriate. If an adaptive intervention, i.e. one in which intervention content or intensity is varied in a principled manner, is to be optimized, a sequential multiple-assignment randomized trial (SMART) is often a good choice. The objective of this article is to describe MOST and the scientific rationale for its use; describe two current applications of MOST in emergency medicine research, one using a factorial experiment and the other using a SMART; and discuss funding strategies and potential future applications in studying the care of individuals with acute illness, injury, or behavioral disorders.

Neuroprotection and Neuroregeneration Strategies Using the rNAION Model: Theory, Histology, Problems, Results and Analytical Approaches.

Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common cause of sudden optic nerve (ON)-related vision loss in humans. Study of this disease has been limited by the lack of available tissue and difficulties in evaluating both treatments and the window of effectiveness after symptom onset. The rodent nonarteritic anterior ischemic optic neuropathy model (rNAION) closely resembles clinical NAION in its pathophysiological changes and physiological responses. The rNAION model enables analysis of the specific responses to sudden ischemic axonopathy and effectiveness of potential treatments. However, there are anatomic and genetic differences between human and rodent ON, and the inducing factors for the disease and the model are different. These variables can result in marked differences in lesion development between the two species, as well as in the possible responses to various treatments. These caveats are discussed in the current article, as well as some of the species-associated differences that may be related to ischemic lesion severity and responses.

A Preoperative Contingency Management Intervention for Smoking Abstinence in Cancer Patients: A Preliminary Randomized Controlled Trial.

INTRODUCTION: The purpose of this study was to evaluate a pilot preoperative contingency management (CM) intervention for smoking abstinence. AIMS AND METHODS: This multisite pilot study was conducted at two cancer center-based tobacco treatment programs. Participants who were smoking, diagnosed with or suspected to have any type of operable cancer, and had a surgical procedure scheduled in the next 10 days to 5 weeks (N = 40) were randomized to receive standard care plus monitoring only (MO) or CM prior to surgery. All patients received breath carbon monoxide (CO) tests 3 times per week, nicotine patches, and counseling. The CM group also earned payments for self-reported smoking abstinence confirmed by CO breath test ≤6 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Seven-day point prevalence abstinence rates on the day of surgery and at 3-month follow-up were compared between groups using repeated measures log-linear regression models utilizing generalized estimating equations. Participants lost to follow-up are assumed to have returned to smoking. RESULTS: The sample was 50% female and 75% White. In covariate adjusted models, patients in the CM group had a greater probability of reported abstinence. On the day of surgery (end of treatment), 52% of CM patients were abstinent compared with 16% of patients in MO (risk ratio = 3.2 [1.1-9.3]; p = .03). At the 3-month follow-up, 43% of CM patients were abstinent compared with 5% in MO (risk ratio = 8.4 [1.5-48.3]; p = .02). CONCLUSIONS: Providing monetary incentives contingent on abstinence prior to cancer surgery may produce significant improvements in smoking abstinence rates relative to breath CO MO. IMPLICATIONS: In this pilot preoperative CM intervention for smoking abstinence, patients receiving a CM intervention prior to cancer surgery had a greater probability of smoking abstinence at the end of treatment compared with a breath MO group (52% vs. 16%, respectively). Thus, providing monetary incentives contingent on abstinence may produce significant improvements in smoking abstinence rates prior to cancer surgery relative to breath CO monitoring.

The United States National Cancer Institute's Coordinated Research Effort on Tobacco Use as a Major Cause of Morbidity and Mortality among People with HIV.

The use of antiretroviral therapy for people with HIV (PWH) has improved life expectancy. However, PWH now lose more life-years to tobacco use than to HIV infection. Unfortunately, PWH smoke at higher rates and have more difficulty maintaining abstinence than the general population, compounding their risk for chronic disease. In this Commentary, we describe a United States National Cancer Institute-led initiative to address the relative lack of research focused on developing, testing, and implementing smoking cessation interventions for PWH. This initiative supports seven clinical trials designed to systematically test and/or develop and test adaptations of evidence-based smoking cessation interventions for PWH (eg, combination of behavioral and pharmacological). We summarize each project, including setting/recruitment sites, inclusion/exclusion criteria, interventions being tested, and outcomes. This initiative provides critical opportunities for collaboration and data harmonization across projects. The knowledge gained will inform strategies to assist PWH to promote and maintain abstinence, and ensure that these efforts are adaptable and scalable, thereby addressing one of the major threats to the health of PWH. Reducing smoking behavior may be particularly important during the COVID-19 pandemic given that smokers who become infected with SARS-CoV-2 may be at risk for more severe disease. IMPLICATIONS: This Commentary describes a National Cancer Institute-led initiative to advance the science and practice of treating tobacco use among PWH, which is now responsible for more life years lost than HIV. We describe the scope of the problem, the objectives of the initiative, and a summary of the seven funded studies. Harmonization of data across projects will provide information related to treatment mediators and moderators that was not previously possible. Stakeholders interested in tobacco cessation, including researchers, clinicians and public health officials, should be aware of this initiative and the evidence-base it will generate to advance tobacco treatment among this high-risk population.

Cancer pain management in the emergency department: a multicenter prospective observational trial of the Comprehensive Oncologic Emergencies Research Network (CONCERN).

PURPOSE: Many patients with cancer seek care for pain in the emergency department (ED). Prospective research on cancer pain in this setting has historically been insufficient. We conducted this study to describe the reported pain among cancer patients presenting to the ED, how pain is managed, and how pain may be associated with clinical outcomes. METHODS: We conducted a multicenter cohort study on adult patients with active cancer presenting to 18 EDs in the USA. We reported pain scores, response to medication, and analgesic utilization. We estimated the associations between pain severity, medication utilization, and the following outcomes: 30-day mortality, 30-day hospital readmission, and ED disposition. RESULTS: The study population included 1075 participants. Those who received an opioid in the ED were more likely to be admitted to the hospital and were more likely to be readmitted within 30 days (OR 1.4 (95% CI: 1.11, 1.88) and OR 1.56 (95% CI: 1.17, 2.07)), respectively. Severe pain at ED presentation was associated with increased 30-day mortality (OR 2.30, 95% CI: 1.05, 5.02), though this risk was attenuated when adjusting for clinical factors (most notably functional status). CONCLUSIONS: Patients with severe pain had a higher risk of mortality, which was attenuated when correcting for clinical characteristics. Those patients who required opioid analgesics in the ED were more likely to require admission and were more at risk of 30-day hospital readmission. Future efforts should focus on these at-risk groups, who may benefit from additional services including palliative care, hospice, or home-health services.

Emergency department monitor alarms rarely change clinical management: An observational study.

STUDY OBJECTIVE: Monitor alarms are prevalent in the ED. Continuous electronic monitoring of patients' vital signs may alert staff to physiologic decompensation. However, repeated false alarms may lead to desensitization of staff to alarms. Mitigating this could involve prioritizing the most clinically-important alarms. There are, however, little data on which ED monitor alarms are clinical meaningful. We evaluated whether and which ED monitor alarms led to observable changes in patients' ED care. METHODS: This prospective, observational study was conducted in an urban, academic ED. An ED physician completed 53 h of observation, recording patient characteristics, alarm type, staff response, whether the alarm was likely real or false, and whether it changed clinical management. The primary outcome was whether the alarm led to an observable change in patient management. Secondary outcomes included the type of alarms and staff responses to alarms. RESULTS: There were 1049 alarms associated with 146 patients, for a median of 18 alarms per hour of observation. The median number of alarms per patient was 4 (interquartile range 2-8). Alarms changed clinical management in 8 out of 1049 observed alarms (0.8%, 95% CI, 0.3%, 1.3%) in 5 out of the 146 patients (3%, 95% CI, 0.2%, 5.8%). Staff did not observably respond to most alarms (63%). CONCLUSION: Most ED monitor alarms did not observably affect patient care. Efforts at improving the clinical significance of alarms could focus on widening alarm thresholds, customizing alarms parameters for patients' clinical status, and on utilizing monitoring more selectively.

Physical Restraint Use in Adult Patients Presenting to a General Emergency Department.

STUDY OBJECTIVE: The prevalence of agitation among emergency department (ED) patients is increasing. Physical restraints are routinely used to prevent self-harm and to protect staff, but are associated with serious safety risks. To date, characterization of physical restraint use in the emergency setting has been limited. We thus aim to describe restraint patterns in the general ED to guide future investigation in the management of behavioral disorders. METHODS: We conducted a cross-sectional study of adult patients presenting to 5 adult EDs within a large regional health system for 2013 to 2015, and with a physical restraint order during their visit. We undertook descriptive analyses and cluster analysis to determine unique meaningful groups within our sample. RESULTS: In 956,153 total ED visits, 4,661 patients (0.5%) had associated restraint orders, representing 3,739 unique patients. The median age was 47 years (interquartile range 32 to 59 years), 66.7% of patients were men, 61.9% had a psychiatric history, and 91.1% arrived by ambulance. For chief complaints, 33.7% were alcohol or drug use, 45.4% medical, 12.3% psychiatric, and 8.5% trauma. Cluster analysis identified 2 distinct cohorts. A younger, predominantly male population presented with alcohol or drug use, whereas an older group arrived with medical complaints. CONCLUSION: Our data found strong association of alcohol or drug use with physical restraints and identified a unique elderly population with behavioral disturbances in the ED. Further characterization of causal links and safer practices to manage agitation for these vulnerable populations are needed.

Considering Systemic Barriers to Treating Tobacco Use in Clinical Settings in the United States.

The Comorbidity Workgroup of the Tobacco Treatment Research Network, within the Society for Research on Nicotine and Tobacco, previously highlighted the need to provide tobacco treatment to patients diagnosed with comorbid physical and mental health conditions. Yet, systemic barriers in the United States health care system prevent many patients who present for medical treatment from getting the evidence-based tobacco treatment that they need. The identified barriers include insufficient training in the epidemiologic impact of tobacco use, related disorders, and pharmacological and behavioral treatment approaches; misunderstanding among clinicians about the effectiveness of tobacco treatment; lack of therapeutic support from clinical staff; insufficient use of health information technology to improve tobacco use identification and treatment; and limited time and reimbursement for clinicians to provide treatment. We highlight three vignettes demonstrating the complexities of practical barriers at the health care system level. We consider each of the barriers in turn and discuss evidence-based strategies that could be implemented in the clinical care of patients with comorbid conditions. In addition, in the absence of compelling data to guide implementation approaches, we offer suggestions for potential strategies and avenues for future research. Implications: Three vignettes highlighted in this article illustrate some systemic barriers to providing tobacco treatment for patients being treated for comorbid conditions. We explore the barriers to tobacco treatment and offer suggestions for changes in training, health care systems, clinical workflow, and payment systems that could enhance the reach and the quality of tobacco treatment within the US health care system.

Characteristics and Severity of Agitation Associated With Use of Sedatives and Restraints in the Emergency Department.

BACKGROUND: Agitated patients frequently present to emergency departments, but limited evidence exists regarding clinical decisions to use chemical sedatives and physical restraints. OBJECTIVE: We examined attributes and levels of agitation impacting thresholds for sedative and restraint use in the emergency setting. METHODS: This was a secondary study focusing on agitation characteristics within a prospective observational study of agitated patients in the emergency department at an urban, tertiary referral center. We recorded scores on 3 validated agitation scales: the Agitated Behavior Scale, the Overt Aggression Scale, and the Severity Scale. Consecutive patients requiring security presence or scoring ≥1 on an agitation scale were enrolled during randomized 8-h blocks. RESULTS: Ninety-five agitation events on unique patients were observed. The median age was 42 years, and 62.1% were male. Highest frequency triage chief complaints were alcohol/drug use (37.9%) and psychiatric (23.2%). Most events (73.7%) were associated with sedative or restraint use. Factors related to treatment course or interactions with staff were commonly cited (56.8%) as the primary etiology for agitation. A logistic regression model found no association between demographics and odds of sedative/restraint use. Overt Aggression Scale scores were associated with significantly higher odds of sedative use (adjusted odds ratio [AOR] 1.62 [range 1.13-2.32]), while Severity Scale scores had significantly higher odds of restraint use (AOR 1.39 [range 1.12-1.73]) but significantly lower odds of sedative use (AOR 0.79 [range 0.64-0.98]). CONCLUSION: External factors may be important targets for behavioral techniques in agitation management. Further study of the Severity Scale scale may allow for earlier detection of agitation and identify causal links between agitation severity and use of sedatives and restraints.

Validation of the Emergency Severity Index (Version 4) for the Triage of Adult Emergency Department Patients With Active Cancer.

BACKGROUND: Patients with active cancer account for a growing percentage of all emergency department (ED) visits and have a unique set of risks related to their disease and its treatments. Effective triage for this population is fundamental to facilitating their emergency care. OBJECTIVES: We evaluated the validity of the Emergency Severity Index (ESI; version 4) triage tool to predict ED-relevant outcomes among adult patients with active cancer. METHODS: We conducted a prespecified analysis of the observational cohort established by the National Cancer Institute-supported Comprehensive Oncologic Emergencies Research Network's multicenter (18 sites) study of ED visits by patients with active cancer (N = 1075). We used a series of χ2 tests for independence to relate ESI scores with 1) disposition, 2) ED resource use, 3) hospital length of stay, and 4) 30-day mortality. RESULTS: Among the 1008 subjects included in this analysis, the ESI distribution skewed heavily toward high acuity (>95% of subjects had an ESI level of 1, 2, or 3). ESI was significantly associated with patient disposition and ED resource use (p values < 0.05). No significant associations were observed between ESI and the non-ED based outcomes of hospital length of stay or 30-day mortality. CONCLUSION: ESI scores among ED patients with active cancer indicate higher acuity than the general ED population and are predictive of disposition and ED resource use. These findings show that the ESI is a valid triage tool for use in this population for outcomes directly relevant to ED care.

Impact of Cost Display on Ordering Patterns for Hospital Laboratory and Imaging Services.

BACKGROUND: Physicians "purchase" many health care services on behalf of patients yet remain largely unaware of the costs of these services. Electronic health record (EHR) cost displays may facilitate cost-conscious ordering of health services. OBJECTIVE: To determine whether displaying hospital lab and imaging order costs is associated with changes in the number and costs of orders placed. DESIGN: Quasi-experimental study. PARTICIPANTS: All patients with inpatient or observation encounters across a multi-site health system from April 2013 to October 2015. INTERVENTION: Display of order costs, based on Medicare fee schedules, in the EHR for 1032 lab tests and 1329 imaging tests. MAIN MEASURES: Outcomes for both lab and imaging orders were (1) whether an order was placed during a hospital encounter, (2) whether an order was placed on a given patient-day, (3) number of orders placed per patient-day, and (4) cost of orders placed per patient-day. KEY RESULTS: During the lab and imaging study periods, there were 248,214 and 258,267 encounters, respectively. Cost display implementation was associated with a decreased odds of any lab or imaging being ordered during the encounter (lab adjusted odds ratio [AOR] = 0.97, p = .01; imaging AOR = 0.97, p < .001), a decreased odds of any lab or imaging being ordered on a given patient-day (lab AOR = 0.95, p < .001; imaging AOR = 0.97, p < .001), a decreased number of lab or imaging orders on patient-days with orders (lab adjusted count ratio = 0.93, p < .001; imaging adjusted count ratio = 0.98, p < .001), and a decreased cost of lab orders and increased cost of imaging orders on patient-days with orders (lab adjusted cost ratio = 0.93, p < .001; imaging adjusted cost ratio = 1.02, p = .003). Overall, the intervention was associated with an 8.5 and 1.7% reduction in lab and imaging costs per patient-day, respectively. CONCLUSIONS: Displaying costs within EHR ordering screens was associated with decreases in the number and costs of lab and imaging orders.