Importance:There is a lack of robust strategies to reduce cigarette smoking among people with HIV. Objective:To identify optimal adaptive treatment strategies involving clinical pharmacist-delivered medications for tobacco use disorder and contingency management (CM) for smoking reduction among people with HIV. Design, Setting, and Participants:From July 27, 2020, through March 28, 2024, using a sequential multiple-assignment randomized clinical trial, people with HIV who smoked cigarettes were recruited and randomized 1:1 to nicotine replacement therapy (NRT) with or without CM (stage 1). After 12 weeks of treatment (stage 2), individuals with confirmed abstinence continued stage 1 treatment; individuals without confirmed abstinence were rerandomized to switch to oral medications for tobacco use disorder or to intensified CM. Interventions were delivered by clinical pharmacists in HIV clinics across 24 weeks. Interventions:Stage 1 included NRT with or without CM (rewards for confirmed abstinence). Stage 2 included either a switch to varenicline or bupropion or intensification to more rewards for abstinence. Each stage involved 5 clinical pharmacist visits. Main Outcomes and Measures:The primary outcome was cigarettes per day (CPD), and the secondary outcome was 7-day confirmed abstinence at 12 and 24 weeks with imputation. Analyses were conducted using intention-to-treat principles. Results:In total, 323 participants (181 [56.0%] male at birth; 317 [72.5%] Black or African American; mean [SD] age, 55.1 [10.7] years) smoked a mean (SD) of 12.8 (7.2) CPD at baseline. At 12 weeks, participants in the NRT plus CM (least-squares mean [LSM], 4.9 [97.5% CI, 3.5-6.2] CPD) and NRT (LSM, 5.2 [97.5% CI, 3.9-6.5] CPD) groups smoked similar numbers of CPD (adjusted LSM difference, -0.3 [97.5% CI, -1.9 to 1.3]; P = .66). Abstinence was greater at 12 weeks in the NRT plus CM group (36 of 160 [22.5%]) compared with the NRT group (16 of 163 [9.8%]) (adjusted odds ratio [AOR], 2.70 [99.0% CI, 1.19-6.14]; P = .002). Among participants without week 12 abstinence, the effect of intensifying vs switching on week 24 CPD varied by stage 1 treatment. Intensifying was better among individuals starting with NRT alone (adjusted LSM difference, -3.8 [97.5% CI, -6.0 to -1.5] CPD; P < .001) but not among individuals initially receiving NRT plus CM (adjusted LSM difference, 0.3 [97.5% CI, -2.1 to 2.6] CPD; P = .80). Abstinence at 24 weeks was similar among individuals in intensified vs switched groups regardless of stage 1 treatment (AOR, 1.5 [99% CI, 0.4-4.2]; P = .37; P = .85 for interaction). Overall, 24-week CPD was lowest with the adaptive treatment strategy involving NRT followed by NRT plus CM (eg, LSM, 2.6 [99% CI, 1.1-4.1] CPD vs 4.2 [99% CI, 2.6-5.9] CPD for NRT plus CM followed by NRT plus CM intensified), and abstinence was highest for the NRT plus CM followed by the intensified strategy (eg, LSM, 30.0% [99% CI, 16.2%-48.7%] vs 12.8% [99% CI, 5.2%-28.3%] for NRT followed by NRT plus CM intensified). Conclusions and Relevance:In this randomized clinical trial of people with HIV who smoked cigarettes, CM was an effective adjunct to clinical pharmacist-delivered NRT for improving tobacco-related outcomes. Optimal timing to add CM differed based on treatment goals. Trial Registration:ClinicalTrials.gov Identifier: NCT04490057.

BACKGROUND:There remains equipoise regarding the benefit of empiric azithromycin with beta-lactam therapy in patients hospitalized with non-severe CAP. METHODS:We performed a target trial emulation using a propensity-weighted cohort from 68 hospitals in Michigan. Adult patients hospitalized with non-severe CAP receiving beta-lactam antimicrobial therapy with or without azithromycin were included. CAP was defined by ICD-10 discharge diagnosis code of pneumonia and >2 signs/symptoms of pneumonia with radiographic findings. Patients with severe CAP, risk factors for multi-drug-resistant organisms, a macrolide allergy, or who received non-standard CAP treatment, doxycycline, an alternative macrolide, or a fluroquinolone were excluded. Time zero was encounter start. The primary outcome was time (days) to clinical stability. Secondary outcomes included composite 30-day mortality and rehospitalization, ICU transfer, and antibiotic duration. RESULTS:Of 66,657 patients hospitalized for CAP between September 2015 and July 2024, 28.5% (19,010) met inclusion criteria, of whom 93.8% (17,822/19,010) received empiric azithromycin. After IPTW, there was no difference in time to clinical stability between those receiving and not receiving empiric azithromycin (3 [IQR 3-4] vs 3 days [IQR 3-4], aHR 1.00 [0.96-1.05], p=.91). Empiric azithromycin was associated with lower composite 30-day mortality and rehospitalization (10.8% vs. 15.1%, aHR 0.73 [0.62-0.87], p=0.0004). There were no differences in ICU transfer (0.9% vs 1.4%; aHR 0.85 [0.48-1.49], p=.57), or total antibiotic duration (6 [IQR 5-8] vs. 7 [IQR 5-9] days, p=.23). CONCLUSION:Adding azithromycin to beta-lactam therapy in patients hospitalized with non-severe CAP was not associated with time to clinical stability but was associated with lower composite 30-day mortality and rehospitalization.

Patients with cancer frequently visit the emergency department (ED) and are at high risk for hospitalization due to severe illness from cancer progression or treatment side effects. With an aging population and rising cancer incidence rates worldwide, it is crucial to understand how EDs and other acute care venues manage oncologic emergencies. Insights from other nations and health systems may inform resources necessary for optimal ED management and novel care delivery pathways. We described clinical management of oncologic emergencies and their contribution to ED visits and hospitalizations worldwide. We performed a systematic review of peer-reviewed original research studies published in the English language between January 1st, 2003, to December 31st, 2022, garnered from PubMed, Web of Science, and EMBASE. We included all studies investigating adult (≥ 18 years) cancer patients with emergency visits. We examined chief complaints or predictors of ED use that explicitly defined oncologic emergencies. The search strategy yielded 49 articles addressing cancer-related emergency visits. Most publications reported single-site studies (n = 34/49), with approximately even distribution across clinical settings- ED (n = 22/49) and acute care hospital/ICU (n = 27/49). The number of patient observations varied widely among the published studies (range: 9 – 87,555 patients), with most studies not specifying the cancer type (n = 33/49), stage (n = 41/49), or treatment type (n = 36/49). Most studies (n = 31/49) examined patients aged ≥ 60 years. Infection was the most common oncologic emergency documented (n = 22/49), followed by pain (n = 20/49), dyspnea (n = 19/49), and gastrointestinal (GI) symptoms (n = 17/49). Interventions within the ED or hospital ranged from pharmacological management with opioids (n = 11/49), antibiotics (n = 9/49), corticosteroids (n = 5/49), and invasive procedures (e.g., palliative stenting; n = 13/49) or surgical interventions (n = 2/49). Limited research specifically addresses oncologic emergencies despite the international prevalence of ED presentations among cancer patients. Patients with cancer presenting to the ED appear to have a variety of complaints which could result from their cancers and thus may require tailored diagnostic and intervention pathways to provide optimal acute care. Further acute geriatric oncology research may clarify the optimal management strategies to improve the outcomes for this vulnerable patient population.

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.

ImportanceLittle is known about the safety of midline catheters vs peripherally inserted central catheters (PICCs) for outpatient parenteral antimicrobial therapy (OPAT).ObjectiveTo compare outcomes from midline catheters vs PICCs for OPAT.Design, Setting, and ParticipantsThis retrospective cohort study included patients who received antimicrobial therapy through a midline catheter or PICC between January 2017 and November 2023 across 69 Michigan hospitals. Because peripherally compatible OPAT was the indication of interest, vancomycin therapy was excluded. Data were analyzed from April to June 2024.ExposuresInsertion of a midline catheter or PICC for OPAT following hospitalization.Main Outcomes and MeasuresThe primary outcome was major device complications (ie, catheter-related bloodstream infection or catheter-related venous thromboembolism). Secondary outcomes included minor device complications (eg, catheter dislodgement, occlusion, tip migration, infiltration, superficial thrombophlebitis, or exit site concerns) and device failure, defined as catheter removal following device complication. Cox proportional hazards regression models were fit to device type and outcomes, adjusting for patient and device confounders and device dwell.ResultsOf 2824 included patients, 1487 (53.5%) were male, and the median (IQR) age was 66.8 (55.9-77.1) years. Of 2824 devices placed for OPAT, 1999 (70.8%) were midline catheters and 825 (29.2%) were PICCs. The median (IQR) dwell time was 12 (8-17) days for midline catheters and 19 (12-27) days for PICCs (P < .001). A major device complication occurred in 44 patients (1.6%) overall, including 16 (0.8%) with midline catheters and 28 (3.4%) with PICCs (P < .001). OPAT delivered via midline catheters was associated with a lower risk of major complications vs PICCs (adjusted hazard ratio [aHR], 0.46; 95% CI, 0.23-0.91). Risks of minor complications and device failure were similar across device types (minor complications: 206 of 1999 [10.3%] vs 114 of 825 [13.8%]; aHR, 1.07; 95% CI, 0.83-1.38; device failure: 191 of 1999 [9.6%] vs 100 of 825 [12.1%]; aHR, 1.26; 95% CI, 0.96-1.65). For device dwell of 14 or fewer days, midline catheters were associated with a lower risk of major complications (12 of 1324 [0.9%] vs 16 of 304 [5.3%]; aHR, 0.29; 95% CI, 0.12-0.68) and similar risk of failure (151 of 1324 [11.4%] vs 52 of 304 [17.1%]; aHR, 0.79; 95% CI, 0.56-1.12) vs PICCs. For dwell longer than 14 days, no significant difference in rates of major complications (4 of 675 [0.6%] vs 12 of 521 [2.3%]; aHR, 0.42; 95% CI, 0.13-1.40) or device failure (40 of 675 [5.9%] vs 48 of 521 [9.2%]; aHR, 1.02; 95% CI, 0.64-1.61) were observed.Conclusions and RelevanceIn this study, midline catheters appeared to be safe alternatives to PICCs for OPAT, particularly if infusions were planned for 14 or fewer days.

Importance Agitation events are increasing in emergency departments (EDs), exacerbating safety risks for patients and clinicians. A wide range of clinical etiologies and behavioral patterns in the emergency setting make agitation prediction difficult in this setting. Objective To develop, train, and validate an agitation-specific prediction model based on a large, diverse set of past ED visit data. Design, Setting, and Participants This cohort study included electronic health record data collected from 9 ED sites within a large, urban health system in the Northeast US. All ED visits featuring patients aged 18 years or older from January 1, 2015, to December 31, 2022, were included in the analysis and modeling. Data analysis occurred between May 2023 and September 2024. Exposures Variables that served as potential exposures of interest, encompassing demographic information, patient history, initial vital signs, visit information, mode of arrival, and health services utilization. Main Outcomes and Measures The primary outcome of agitation was defined as the presence of an intramuscular chemical sedation and/or violent physical restraint order during an ED visit. A clinical model was developed to identify risk factors that predict agitation development during an ED visit prior to symptom onset. Model performance was measured using area under the receiver operating characteristic curve (AUROC) and area under the precision recall curve (PR-AUC). Results The final cohort comprised 3 048 780 visits. The cohort had a mean (SD) age of 50.2 (20.4) years, with 54.7% visits among female patients. The final artificial intelligence model used 50 predictors for the primary outcome of predicting agitation events. The model achieved an AUROC of 0.94 (95% CI, 0.93-0.94) and a PR-AUC of 0.41 (95% CI, 0.40-0.42) in cross-validation, indicating good discriminative ability. Calibration of the model was evaluated and demonstrated robustness across the range of predicted probabilities. The top predictors in the final model included factors such as number of past ED visits, initial vital signs, medical history, chief concern, and number of previous sedation and restraint events. Conclusions and Relevance Using a cross-sectional cohort of ED visits across 9 hospitals, the prediction model included factors for detecting risk of agitation that demonstrated high accuracy and applicability across diverse patient populations. These results suggest that clinical application of the model may enhance patient-centered care through preemptive deescalation and prevention of agitation.

Background: Patients can have different reasons for seeking cheek augmentation; while some are in need of volume augmentation, others may request projection and lifting. A treatment guide can be useful for treating clinicians in choosing the most suitable product. Aims: This 8-week, multicenter study was conducted to evaluate the effectiveness and safety of cheek augmentation using a treatment guide to choose between study products HA(CON) and HA(LYF). Patients/Methods: FFemale subjects intending to undergo cheek augmentation were treated according to primary need for treatment-HA(CON) for contouring or HA(LYF) for projection. Treatments were performed according to approved labels. Assessments included Global Aesthetic Improvement Scale (GAIS) evaluations, subject satisfaction, subject-perceived age (FACE-Q), naturalness of facial expressions, 3D imaging analysis, and safety assessments. Results: All subjects (n = 60) were assessed as aesthetically improved by the investigators 4 and 8 weeks after last injection. For all subjects, contouring or projection was achieved as planned with natural-looking results. Subject satisfaction was high in both study groups. Volume change of the cheek area was statistically significant from baseline to Week 4 (p < 0.001), in both treatment groups and on both sides of the face. Overall, treatments were well tolerated with mainly mild adverse events related to treatment. Conclusions: The proposed guide for product selection of HA(CON) or HA(LYF) for treatment of the cheek area was useful to achieve the primary treatment goal for both products. Treatments were well tolerated and associated with improved aesthetic appearance of the cheeks as well as high subject satisfaction.

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.

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.

Background Inappropriate diagnosis of infections results in antibiotic overuse and may delay diagnosis of underlying conditions. Here we describe the development and characteristics of 2 safety measures of inappropriate diagnosis of urinary tract infection (UTI) and community-acquired pneumonia (CAP), the most common inpatient infections on general medicine services. Methods Measures were developed from guidelines and literature and adapted based on data from patients hospitalized with UTI and CAP in 49 Michigan hospitals and feedback from end-users, a technical expert panel (TEP), and a patient focus group. Each measure was assessed for reliability, validity, feasibility, and usability. Results Two measures, now endorsed by the National Quality Forum (NQF), were developed. Measure reliability (derived from 24 483 patients) was excellent (0.90 for UTI; 0.91 for CAP). Both measures had strong validity demonstrated through (a) face validity by hospital users, the TEPs, and patient focus group, (b) implicit case review (ĸ 0.72 for UTI; ĸ 0.72 for CAP), and (c) rare case misclassification (4% for UTI; 0% for CAP) due to data errors (<2% for UTI; 6.3% for CAP). Measure implementation through hospital peer comparison in Michigan hospitals (2017 to 2020) demonstrated significant decreases in inappropriate diagnosis of UTI and CAP (37% and 32%, respectively, P < .001), supporting usability. Conclusions We developed highly reliable, valid, and usable measures of inappropriate diagnosis of UTI and CAP for hospitalized patients. Hospitals seeking to improve diagnostic safety, antibiotic use, and patient care should consider using these measures to reduce inappropriate diagnosis of CAP and UTI.

BACKGROUND:The COVID-19 pandemic was managed in part by the rapid development of vaccines, diagnostics, and therapeutics including antiviral agents and advances in emergency airway and ventilatory management. The impact of these therapeutic advances on clinically pertinent metrics of emergency care have not been well-studied. METHODS:We abstracted data from emergency department (ED) visits made to 21 US health systems during the first two years of the pandemic, from February 1, 2020 to January 31, 2022. These health systems were participants in the NIH-supported COVID EHR Cohort, in which the University of Wisconsin served as the coordinating site. Limited patient-level data files were submitted monthly. Data elements included demographic and clinical variables, as well as standard measures of ED outcomes including 72-h returns, 72-h returns leading to readmission, and in-hospital mortality. Multivariable models were fitted to identify correlates of each of the dependent variables. A test for trend was used to detect changes in outcomes over time. RESULTS:During the two-year period, 150,357 individuals aged 18 years or older visited the ED. The median age was 45.4 years (IQR 27), 58.1 % were female, 49 % were White, 18.3 % Hispanic/Latino, and 45 % were publicly insured or uninsured. The prevalence of 72-h ED returns, readmissions, and in-hospital mortality significantly declined across the two-year period. SARS-CoV-2 vaccination was associated with reduced ED returns and mortality. Therapeutic agents were associated with increased mortality risk but were likely confounded by unmeasured covariates. CONCLUSIONS:Operational and clinical outcomes of ED-based treatment of individuals with COVID-19 improved in the first two years of the pandemic. This improvement is likely multifactorial and includes the development and deployment of SARS-CoV-2-specific vaccines, therapeutic agents, and improved healthcare delivery in the ED and elsewhere addressing management of airway and ventilatory status, as well as increased innate immunity in the general population.

Background Antibiotic overuse at hospital discharge is common, costly, and harmful. While discharge-specific antibiotic stewardship interventions are effective, they are resource-intensive and often infeasible for hospitals with resource constraints. This weakness impacts generalizability of stewardship interventions and has health equity implications as not all patients have access to the benefits of stewardship based on where they receive care. There may be different pathways to improve discharge antibiotic prescribing that vary widely in feasibility. Supporting hospitals in selecting interventions tailored to their context may be an effective approach to feasibly reduce antibiotic overuse at discharge across diverse hospitals. The objective of this study is to evaluate the effectiveness of the Reducing Overuse of Antibiotics at Discharge Home multicomponent implementation strategy (“ROAD Home”) on antibiotic overuse at discharge for community-acquired pneumonia and urinary tract infection. Methods This 4-year two-arm parallel cluster-randomized trial will include three phases: baseline (23 months), intervention (12 months), and postintervention (12 months). Forty hospitals recruited from the Michigan Hospital Medicine Safety Consortium will undergo covariate-constrained randomization with half randomized to the ROAD Home implementation strategy and half to a “stewardship as usual” control. ROAD Home is informed by the integrated-Promoting Action on Research Implementation in Health Services Framework and includes (1) a baseline needs assessment to create a tailored suite of potential stewardship interventions, (2) supported decision-making in selecting interventions to implement, and (3) external facilitation following an implementation blueprint. The primary outcome is baseline-adjusted days of antibiotic overuse at discharge. Secondary outcomes include 30-day patient outcomes and antibiotic-associated adverse events. A mixed-methods concurrent process evaluation will identify contextual factors influencing the implementation of tailored interventions, and assess implementation outcomes including acceptability, feasibility, fidelity, and sustainment. Discussion Reducing antibiotic overuse at discharge across hospitals with varied resources requires tailoring of interventions. This trial will assess whether a multicomponent implementation strategy that supports hospitals in selecting evidence-based stewardship interventions tailored to local context leads to reduced overuse of antibiotics at discharge. Knowledge gained during this study could inform future efforts to implement stewardship in diverse hospitals and promote equity in access to the benefits of quality improvement initiatives. Trial registration Clinicaltrials.gov NCT06106204 on 10/30/23

Importance:Little is known about incidence of, risk factors for, and harms associated with inappropriate diagnosis of community-acquired pneumonia (CAP). Objective:To characterize inappropriate diagnosis of CAP in hospitalized patients. Design, Setting, and Participants:This prospective cohort study, including medical record review and patient telephone calls, took place across 48 Michigan hospitals. Trained abstractors retrospectively assessed hospitalized patients treated for CAP between July 1, 2017, and March 31, 2020. Patients were eligible for inclusion if they were adults admitted to general care with a discharge diagnostic code of pneumonia who received antibiotics on day 1 or 2 of hospitalization. Data were analyzed from February to December 2023. Main Outcomes and Measures:Inappropriate diagnosis of CAP was defined using a National Quality Forum-endorsed metric as CAP-directed antibiotic therapy in patients with fewer than 2 signs or symptoms of CAP or negative chest imaging. Risk factors for inappropriate diagnosis were assessed and, for those inappropriately diagnosed, 30-day composite outcomes (mortality, readmission, emergency department visit, Clostridioides difficile infection, and antibiotic-associated adverse events) were documented and stratified by full course (>3 days) vs brief (≤3 days) antibiotic treatment using generalized estimating equation models adjusting for confounders and propensity for treatment. Results:Of the 17 290 hospitalized patients treated for CAP, 2079 (12.0%) met criteria for inappropriate diagnosis (median [IQR] age, 71.8 [60.1-82.8] years; 1045 [50.3%] female), of whom 1821 (87.6%) received full antibiotic courses. Compared with patients with CAP, patients inappropriately diagnosed were older (adjusted odds ratio [AOR], 1.08; 95% CI, 1.05-1.11 per decade) and more likely to have dementia (AOR, 1.79; 95% CI, 1.55-2.08) or altered mental status on presentation (AOR, 1.75; 95% CI, 1.39-2.19). Among those inappropriately diagnosed, 30-day composite outcomes for full vs brief treatment did not differ (25.8% vs 25.6%; AOR, 0.98; 95% CI, 0.79-1.23). Full vs brief duration of antibiotic treatment among patients was associated with antibiotic-associated adverse events (31 of 1821 [2.1%] vs 1 of 258 [0.4%]; P = .03). Conclusions and Relevance:In this cohort study, inappropriate diagnosis of CAP among hospitalized adults was common, particularly among older adults, those with dementia, and those presenting with altered mental status. Full-course antibiotic treatment of those inappropriately diagnosed with CAP may be harmful.

Background: Quality improvement (QI) programs require significant financial investment. The authors evaluated the cost-effectiveness of a physician-led, performance-incentivized, QI intervention that increased appropriate peripherally inserted central catheter (PICC) use. Methods: The authors used an economic evaluation from a health care sector perspective. Implementation costs included incentive payments to hospitals and costs for data abstractors and the coordinating center. Effectiveness was calculated from propensity score-matched observations across two time periods for complications (venous thromboembolism [VTE], central line-associated bloodstream infection [CLABSI], and catheter occlusion): preintervention period (January 2015 through December 2016) and intervention period (January 2017 through December 2021). Cost-effectiveness was presented as the cost-offset per averted complication, reflecting the health care costs avoided due to having lower complication rates. Results: Across 35 hospitals, this study sampled 17,418 PICCs placed preintervention and 26,004 placed during the intervention period. PICC complications decreased significantly following the intervention. CLABSIs decreased from 2.1% to 1.5%, VTEs from 3.2% to 2.3%, and catheter occlusions from 10.8% to 7.0% (all p < 0.01). Estimated number of complications prevented included 871 CLABSIs, 2,535 VTEs, and 8,743 catheter occlusions. Project implementation costs were $31.8 million, and the cost-offset related to avoided complications was $64.4 million. Each participating hospital averaged $932,073 in cost-offset over seven years, and the average cost-offset per complication averted was $2,614 (95% CI [confidence interval] $2,314-$3,003). Conclusion: A large-scale, multihospital QI initiative to improve appropriate PICC use yielded substantial return on investment from cost-offset of prevented complications.

Background Despite antibiotic stewardship programs existing in most acute care hospitals, there continues to be variation in appropriate antibiotic use. While existing research examines individual prescriber behavior, contextual reasons for variation are poorly understood.Methods We conducted an explanatory, sequential mixed-methods study of a purposeful sample of 7 hospitals with varying discharge antibiotic overuse. For each hospital, we conducted surveys, document analysis, and semi-structured interviews with antibiotic stewardship and clinical stakeholders. Data were analyzed separately and mixed during the interpretation phase, where each hospital was examined as a case, with findings organized across cases using a strengths, weaknesses, opportunities, and threats framework to identify factors accounting for differences in antibiotic overuse across hospitals.Results Surveys included 85 respondents. Interviews included 90 respondents (31 hospitalists, 33 clinical pharmacists, 14 stewardship leaders, 12 hospital leaders). On surveys, clinical pharmacists at hospitals with lower antibiotic overuse were more likely to report feeling: respected by hospitalist colleagues (P = .001), considered valuable team members (P = .001), and comfortable recommending antibiotic changes (P = .02). Based on mixed-methods analysis, hospitals with low antibiotic overuse had 4 distinguishing characteristics: (1) robust knowledge of and access to antibiotic stewardship guidance; (2) high-quality clinical pharmacist-physician relationships; (3) tools and infrastructure to support stewardship; and (4) highly engaged infectious diseases physicians who advocated stewardship principles.Conclusions This mixed-methods study demonstrates the importance of organizational context for high performance in stewardship and suggests that improving antimicrobial stewardship requires attention to knowledge, interactions, and relationships between clinical teams and infrastructure that supports stewardship and team interactions. In this mixed-methods study, hospitals with low antibiotic overuse had 4 distinguishing characteristics: robust knowledge of antibiotic stewardship, quality clinical pharmacist-physician relationships, tools and infrastructure to support stewardship, and highly engaged infectious diseases physicians who advocated for stewardship principles.

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.