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1.
Am J Emerg Med ; 86: 11-20, 2024 Sep 14.
Article in English | MEDLINE | ID: mdl-39305696

ABSTRACT

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.

2.
JAMA Netw Open ; 7(7): e2422281, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-39012634

ABSTRACT

Importance: Acute urinary retention (UR) is common, yet variations in diagnosis and management can lead to inappropriate catheterization and harm. Objective: To develop an algorithm for screening and management of UR among adult inpatients. Design, Setting, and Participants: In this mixed-methods study using the RAND/UCLA Appropriateness Method and qualitative interviews, an 11-member multidisciplinary expert panel of nurses and physicians from across the US used a formal multi-round process from March to May 2015 to rate 107 clinical scenarios involving diagnosis and management of adult UR in postoperative and medical inpatients. The panel ratings informed the first algorithm draft. Semistructured interviews were conducted from October 2020 to May 2021 with 33 frontline clinicians-nurses and surgeons from 5 Michigan hospitals-to gather feedback and inform algorithm refinements. Main Outcomes and Measures: Panelists categorized scenarios assessing when to use bladder scanners, catheterization at various scanned bladder volumes, and choice of catheterization modalities as appropriate, inappropriate, or uncertain. Next, qualitative methods were used to understand the perceived need, usability, and potential algorithm uses. Results: The 11-member expert panel (10 men and 1 woman) used the RAND/UCLA Appropriateness Method to develop a UR algorithm including the following: (1) bladder scanners were preferred over catheterization for UR diagnosis in symptomatic patients or starting as soon as 3 hours since last void if asymptomatic, (2) bladder scanner volumes appropriate to prompt catheterization were 300 mL or greater in symptomatic patients and 500 mL or greater in asymptomatic patients, and (3) intermittent was preferred to indwelling catheterization for managing lower bladder volumes. Interview findings were organized into 3 domains (perceived need, feedback on algorithm, and implementation suggestions). The 33 frontline clinicians (9 men and 24 women) who reviewed the algorithm reported that an evidence-based protocol (1) was needed and could be helpful to clinicians, (2) should be simple and graphically appealing to improve rapid clinician review, and (3) should be integrated within the electronic medical record and prominently displayed in hospital units to increase awareness. The draft algorithm was iteratively refined based on stakeholder feedback. Conclusions and Relevance: In this study using a systematic, multidisciplinary, evidence- and expert opinion-based approach, a UR evaluation and catheterization algorithm was developed to improve patient safety by increasing appropriate use of bladder scanners and catheterization. This algorithm addresses the need for practical guidance to manage UR among adult inpatients.


Subject(s)
Algorithms , Urinary Catheterization , Urinary Retention , Humans , Urinary Retention/therapy , Urinary Catheterization/methods , Male , Female , Adult , Inpatients/statistics & numerical data , Middle Aged , Qualitative Research
3.
Front Health Serv ; 4: 1326777, 2024.
Article in English | MEDLINE | ID: mdl-39036464

ABSTRACT

Background: Rural healthcare has unique characteristics that affect the dissemination and implementation of evidence-based interventions. Numerous theories, models, and frameworks have been developed to guide implementation of healthcare interventions, though not specific to rural healthcare. The present scoping review sought to identify the theories, models, and frameworks most frequently applied to rural health and propose an approach to rural health research that harnesses selected constructs from these theories, models, and frameworks. This resulting synthesis can serve as a guide to researchers, policy makers, and clinicians seeking to employ commonly used theories, models, and frameworks to rural health. Methods: We used the Scopus abstract indexing service to identify peer-reviewed literature citing one or more of theories, models, or frameworks used in dissemination and implementation research and including the word "rural" in the Title, Abstract, or Keywords. We screened the remaining titles and abstracts to ensure articles met additional inclusion criteria. We conducted a full review of the resulting 172 articles to ensure they identified one or more discrete theory, model, or framework applied to research or quality improvement projects. We extracted the theories, models, and frameworks and categorized these as process models, determinant frameworks, classic theories, or evaluation frameworks. Results: We retained 61 articles of which 28 used RE-AIM, 11 used Community-Based Participatory Research (CBPR) framework, eight used the Consolidated Framework for Implementation Research (CFIR), and six used the integrated-Promoting Action on Research Implementation in Health Services (iPARIHS). Additional theories, models, and frameworks were cited in three or fewer reports in the literature. The 14 theories, models, and frameworks cited in the literature were categorized as seven process models, four determinant frameworks, one evaluation framework, and one classic theory. Conclusions: The RE-AIM framework was the most frequently cited framework in the rural health literature, followed by CBPR, CFIR, and iPARIHS. A notable advantage of RE-AIM in rural healthcare settings is the focus on reach as a specified outcome, given the challenges of engaging a geographically diffuse and often isolated population. We present a rationale for combining the strengths of these theories, models, and frameworks to guide a research agenda specific to rural healthcare research. Systematic Review Registration: https://osf.io/fn2cd/.

4.
J Cosmet Dermatol ; 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-39037906

ABSTRACT

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 HACON and HALYF. PATIENTS/METHODS: Female subjects intending to undergo cheek augmentation were treated according to primary need for treatment-HACON for contouring or HALYF 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 HACON or HALYF 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.

5.
Jt Comm J Qual Patient Saf ; 50(8): 591-600, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38762387

ABSTRACT

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.


Subject(s)
Catheter-Related Infections , Catheterization, Peripheral , Quality Improvement , Female , Humans , Male , Middle Aged , Catheter Obstruction , Catheter-Related Infections/prevention & control , Catheter-Related Infections/economics , Catheterization, Central Venous/economics , Catheterization, Central Venous/adverse effects , Catheterization, Peripheral/economics , Catheterization, Peripheral/adverse effects , Cost-Effectiveness Analysis , Quality Improvement/organization & administration , Quality Improvement/economics , Venous Thromboembolism/prevention & control , Venous Thromboembolism/economics
6.
J Addict Med ; 18(4): 404-407, 2024.
Article in English | MEDLINE | ID: mdl-38606851

ABSTRACT

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.


Subject(s)
Antiviral Agents , HIV Infections , Insurance Coverage , Tobacco Use Cessation Devices , Humans , Male , Female , Tobacco Use Cessation Devices/economics , Tobacco Use Cessation Devices/statistics & numerical data , Insurance Coverage/statistics & numerical data , HIV Infections/drug therapy , Middle Aged , Adult , Antiviral Agents/therapeutic use , Antiviral Agents/economics , Varenicline/therapeutic use , Bupropion/therapeutic use , Health Services Accessibility/statistics & numerical data , Smoking Cessation Agents/therapeutic use , Tobacco Use Disorder/drug therapy , Nicotine Replacement Therapy
7.
Implement Sci ; 19(1): 23, 2024 Mar 04.
Article in English | MEDLINE | ID: mdl-38439076

ABSTRACT

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.


Subject(s)
Health Equity , Patient Discharge , Humans , Anti-Bacterial Agents/therapeutic use , Hospitals , Knowledge , Randomized Controlled Trials as Topic
8.
JAMA Intern Med ; 184(5): 548-556, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38526476

ABSTRACT

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.


Subject(s)
Anti-Bacterial Agents , Community-Acquired Infections , Hospitalization , Pneumonia , Humans , Female , Male , Aged , Community-Acquired Infections/diagnosis , Community-Acquired Infections/drug therapy , Middle Aged , Pneumonia/diagnosis , Pneumonia/drug therapy , Hospitalization/statistics & numerical data , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/adverse effects , Prospective Studies , Risk Factors , Michigan/epidemiology , Aged, 80 and over , Patient Readmission/statistics & numerical data
9.
Clin Infect Dis ; 78(6): 1403-1411, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38298158

ABSTRACT

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.


Subject(s)
Community-Acquired Infections , Patient Safety , Urinary Tract Infections , Humans , Urinary Tract Infections/diagnosis , Community-Acquired Infections/diagnosis , Male , Female , Middle Aged , Reproducibility of Results , Aged , Michigan , Pneumonia/diagnosis , Diagnostic Errors/statistics & numerical data , Anti-Bacterial Agents/therapeutic use , Adult
10.
BMJ Open ; 14(2): e082834, 2024 Feb 19.
Article in English | MEDLINE | ID: mdl-38373857

ABSTRACT

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.


Subject(s)
Decision Support Systems, Clinical , Adult , Humans , Research Design , Informed Consent , Emergency Service, Hospital , Randomized Controlled Trials as Topic
11.
Cells ; 13(3)2024 Jan 23.
Article in English | MEDLINE | ID: mdl-38334594

ABSTRACT

We evaluated whether inhibiting sterile alpha and (Toll/interleukin receptor (TIR)) motif-containing 1 (SARM1) activity protects retinal ganglion cells (RGCs) following ischemic axonopathy (rodent nonarteritic anterior ischemic optic neuropathy: rNAION) by itself and combined with ciliary neurotrophic factor (CNTF). Genetically modified SARM1(-) rats were rNAION-induced in one eye and compared against equivalently induced wild-type animals of the same background. Optic nerve (ON) diameters were quantified using optical coherence tomography (SD-OCT). RGCs were quantified 30 d post-induction using retinal stereology for Brn3a(+) nuclei. ON sections were analyzed by TEM and immunohistochemistry. SARM1(-)(-) and WT animals were then bilaterally sequentially rNAION-induced. One eye received intravitreal vehicle injection following induction; the contralateral side received CNTF and was analyzed 30 d post-induction. Inhibiting SARM1 activity suppressed axonal collapse following ischemic axonopathy. SARM1(-) animals significantly reduced RGC loss, compared with WT animals (49.4 ± 6.8% RGC loss in SARM1(-) vs. 63.6 ± 3.2% sem RGC loss in WT; Mann-Whitney one-tailed U-test, (p = 0.049)). IVT-CNTF treatment vs. IVT-vehicle in SARM1(-) animals further reduced RGC loss by 24% at 30 d post-induction, but CNTF did not, by itself, improve long-term RGC survival in WT animals compared with vehicle (Mann-Whitney one-tailed t-test; p = 0.033). While inhibiting SARM1 activity is itself neuroprotective, combining SARM1 inhibition and CNTF treatment generated a long-term, synergistic neuroprotective effect in ischemic neuropathy. Combinatorial treatments for NAION utilizing independent neuroprotective mechanisms may thus provide a greater effect than individual treatment modalities.


Subject(s)
Optic Neuropathy, Ischemic , Retinal Ganglion Cells , Animals , Rats , Animals, Wild , Ciliary Neurotrophic Factor , Retina , Rodentia
12.
Nicotine Tob Res ; 26(7): 796-805, 2024 Jun 21.
Article in English | MEDLINE | ID: mdl-38214037

ABSTRACT

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.


Subject(s)
Clinical Trials as Topic , Smoking Cessation , Smoking Cessation/methods , Humans , Longitudinal Studies , Tobacco Use Disorder/therapy , Treatment Outcome , Prevalence
13.
J Reconstr Microsurg ; 40(3): 239-244, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37467771

ABSTRACT

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.


Subject(s)
Breast Neoplasms , Smoking Cessation , Humans , Female , Smoking Cessation/methods , Nicotinic Agonists , Nicotine Replacement Therapy , Retrospective Studies , Tobacco Use Cessation Devices , Smoking Prevention , Postoperative Complications
14.
Clin Infect Dis ; 2023 Dec 06.
Article in English | MEDLINE | ID: mdl-38059532

ABSTRACT

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=0.001), considered valuable team members (p=0.001), comfortable recommending antibiotic changes (p=0.02). Based on mixed-methods analysis, hospitals with low antibiotic overuse had four distinguishing characteristics: a) robust knowledge of and access to antibiotic stewardship guidance, b) high quality clinical pharmacist-physician relationships, c) tools and infrastructure to support stewardship, and d) highly engaged Infectious Diseases physicians who advocated stewardship principles. CONCLUSION: This mixed-method study demonstrates the importance of organizational context for high performance in stewardship and suggests improving antimicrobial stewardship requires attention to knowledge, interactions, and relationships between clinical teams and infrastructure that supports stewardship and team interactions.

15.
AEM Educ Train ; 7(6): e10919, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38037629

ABSTRACT

Emergency physicians (EPs) are well positioned to perform medical research. EPs are exposed to a wide range of disease types, medical specialties, and treatment modalities. Furthermore, emergency medicine (EM) serves as the safety net for the U.S. health care system. The diverse exposure provides a vast opportunity for EP to perform many worthwhile research projects. Yet, EM has historically had the lowest amount of funding and a lower number of National Institutes of Health-funded research projects. Many suggest the etiology is a "leaky" educational pipeline with loss of many potential physician-scientists over the training and development course. Current research training options for the EM physician-scientist includes MD-PhD, 4-year EM residency program and postresidency fellowships. While each has its advantages and disadvantages, we describe an additional educational alternative of EM physician-scientists, which we have named the integrated-dedicated research period within an EM residency. We describe the features of these programs and preliminary results from the graduates and current trainees.

16.
J Hosp Med ; 18(11): 969-977, 2023 11.
Article in English | MEDLINE | ID: mdl-37771294

ABSTRACT

BACKGROUND: Midline catheters (midlines) are increasingly used in patients with advanced chronic kidney disease (CKD). OBJECTIVE: This study describes current practice and acute complications associated with midlines in CKD patients. DESIGNS, SETTING, AND PARTICIPANTS: Trained abstractors at 66 hospitals from the Michigan Hospital Medicine Safety (HMS) Consortium collected data on a sample of patients who received a midline during hospitalization. Patients were classified as having advanced CKD if their estimated glomerular filtration rate was <45 mL/min/1.73 m2 . MAIN OUTCOME AND MEASURES: Midline recipients with advanced CKD were compared to those without advanced CKD by patient, provider, and device characteristics, and by the occurrence of acute complications including major (e.g., upper extremity deep vein thrombosis [UE-DVT] and catheter-related bloodstream infection [CRBSI]) or minor (e.g., catheter occlusion, catheter dislodgement, infiltration, superficial thrombophlebitis, and leaking at insertion site) events. Multivariable mixed effects logistic regression was used to evaluate the association between catheter-related complications and stage of CKD. RESULTS: Of 21,415 midline recipients, 5272 (24.6%) had advanced CKD, while 16,143 (75.4%) did not. Most midlines were single lumen (90.5%) and remained in place for a median of 6 days. A major or minor midline complication occurred in 804 (15.3%) patients with and 2239 (14.4%) patients without advanced CKD (adjusted odds ratios = 1.04; 95% confidence interval: 0.94-1.14). Among patients with advanced CKD, CRBSI occurred in 13 patients (0.2%) and UE-DVT occurred in 65 patients (1.2%). The proportion of advanced CKD among midline recipients and the frequency of midline-related complications varied across hospitals (interquartile range [IQR] = 19.2% to 29.8% [median = 25.0%] and IQR = 11.0%-18.9% [median = 15.4%], respectively).


Subject(s)
Catheterization, Central Venous , Renal Insufficiency, Chronic , Thrombophlebitis , Humans , Catheterization, Central Venous/adverse effects , Catheters , Patients , Postoperative Complications/etiology
17.
JAMA Intern Med ; 183(9): 933-941, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37428491

ABSTRACT

Importance: Hospitalized patients with asymptomatic bacteriuria (ASB) often receive unnecessary antibiotic treatment, which increases antibiotic resistance and adverse events. Objective: To determine whether diagnostic stewardship (avoiding unnecessary urine cultures) or antibiotic stewardship (reducing unnecessary antibiotic treatment after an unnecessary culture) is associated with better outcomes in reducing antibiotic use for ASB. Design, Setting, and Participants: This 3-year, prospective quality improvement study included hospitalized general care medicine patients with a positive urine culture among 46 hospitals participating in a collaborative quality initiative, the Michigan Hospital Medicine Safety Consortium. Data were collected from July 1, 2017, through March 31, 2020, and analyzed from February to October 2022. Exposure: Participation in the Michigan Hospital Medicine Safety Consortium with antibiotic and diagnostic stewardship strategies at hospital discretion. Main Outcomes and Measures: Overall improvement in ASB-related antibiotic use was estimated as change in percentage of patients treated with antibiotics who had ASB. Effect of diagnostic stewardship was estimated as change in percentage of patients with a positive urine culture who had ASB. Effect of antibiotic stewardship was estimated as change in percentage of patients with ASB who received antibiotics and antibiotic duration. Results: Of the 14 572 patients with a positive urine culture included in the study (median [IQR] age, 75.8 [64.2-85.1] years; 70.5% female); 28.4% (n = 4134) had ASB, of whom 76.8% (n = 3175) received antibiotics. Over the study period, the percentage of patients treated with antibiotics who had ASB (overall ASB-related antibiotic use) declined from 29.1% (95% CI, 26.2%-32.2%) to 17.1% (95% CI, 14.3%-20.2%) (adjusted odds ratio [aOR], 0.94 per quarter; 95% CI, 0.92-0.96). The percentage of patients with a positive urine culture who had ASB (diagnostic stewardship metric) declined from 34.1% (95% CI, 31.0%-37.3%) to 22.5% (95% CI, 19.7%-25.6%) (aOR, 0.95 per quarter; 95% CI, 0.93-0.97). The percentage of patients with ASB who received antibiotics (antibiotic stewardship metric) remained stable, from 82.0% (95% CI, 77.7%-85.6%) to 76.3% (95% CI, 68.5%-82.6%) (aOR, 0.97 per quarter; 95% CI, 0.94-1.01), as did adjusted mean antibiotic duration, from 6.38 (95% CI, 6.00-6.78) days to 5.93 (95% CI, 5.54-6.35) days (adjusted incidence rate ratio, 0.99 per quarter; 95% CI, 0.99-1.00). Conclusions and Relevance: This quality improvement study showed that over 3 years, ASB-related antibiotic use decreased and was associated with a decline in unnecessary urine cultures. Hospitals should prioritize reducing unnecessary urine cultures (ie, diagnostic stewardship) to reduce antibiotic treatment related to ASB.


Subject(s)
Bacteriuria , Humans , Female , Aged , Male , Bacteriuria/diagnosis , Bacteriuria/drug therapy , Anti-Bacterial Agents/therapeutic use , Prospective Studies , Urinalysis , Michigan
19.
J Pain Res ; 16: 2321-2330, 2023.
Article in English | MEDLINE | ID: mdl-37456356

ABSTRACT

Purpose: About 5-8 million US patients take long-term opioid therapy for chronic pain. In the context of policies and guidelines instituted to reduce inappropriate opioid prescribing, abrupt discontinuations in opioid prescriptions have increased and many primary care clinics will not prescribe opioids for new patients, reducing access to care. This may result in uncontrolled pain and other negative outcomes, such as transition to illicit opioids. The objective of this study was to generate policy, intervention, and research recommendations to improve access to care for these patients. Participants and Methods: We conducted a RAND/UCLA Modified Delphi, consisting of workshops, background videos and reading materials, and moderated web-based panel discussions held September 2020-January 2021. The panel consisted of 24 individuals from across Michigan, identified via expert nomination and snowball recruitment, including clinical providers, health science researchers, state-level policymakers and regulators, care coordination experts, patient advocates, payor representatives, and community and public health experts. The panel proposed intervention, policy, and research recommendations, scored the feasibility, impact, and importance of each on a 9-point scale, and ranked all recommendations by implementation priority. Results: The panel produced 11 final recommendations across three themes: reimbursement reform, provider education, and reducing racial inequities in care. The 3 reimbursement-focused recommendations were highest ranked (theme average = 4.2/11), including the two top-ranked recommendations: increasing reimbursement for time needed to treat complex chronic pain (ranked #1/11) and bundling payment for multimodal pain care (#2/11). Four provider education recommendations ranked slightly lower (theme average = 6.2/11) and included clarifying the spectrum of opioid dependence and training providers on multimodal treatments. Four recommendations addressed racial inequities (theme average = 7.2/11), such as standardizing pain management protocols to reduce treatment disparities. Conclusion: Panelists indicated reimbursement should incentivize traditionally lower-paying evidence-based pain care, but multiple strategies may be needed to meaningfully expand access.

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