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Pulmonary and Cardiac Smoking-Related History Improves Abstinence Rates in an Urban, Socioeconomically Disadvantaged Patient Population

Khera, Zain; Illenberger, Nicholas; Sherman, Scott E
BACKGROUND:Tobacco use continues to take the lives of many, and targeted interventions can counter this health burden. One possible target population is patients who have had a smoking-related diagnosis, as they may have a greater drive to quit. OBJECTIVE:To assess whether patients with previous cardiac or pulmonary conditions directly attributable to smoking have greater rates of abstinence post-discharge from hospitalization in the CHART-NY trial. DESIGN/METHODS:CHART-NY was a randomized comparative effectiveness trial comparing a more intensive versus a less intensive smoking cessation intervention after hospital discharge. We divided the 1618 CHART-NY participants into a smoking-related history group of 597 and a nonsmoking-related history group of 1021 based on cardiac or pulmonary conditions in a retrospective chart review. We conducted chi-squared analyses on baseline characteristics. Using follow-up survey data, we conducted chi-squared analyses on abstinence outcomes and made logistic regression models for the predictive value of smoking-related conditions on abstinence. PARTICIPANTS/METHODS:A total of 1059 and 1084 participants in CHART-NY who completed both 2- and 6-month follow-up surveys respectively. MAIN MEASURES/METHODS:Self-reported 30-day abstinence at 2- and 6-month follow-up and survey data for baseline characteristics. KEY RESULTS/RESULTS:Those abstinent at 6-month follow-up were more likely to have a smoking-attributable history (OR = 1.40, 95% CI 1.09-1.81). When stratified based on intervention, only the intensive counseling group was significant (OR = 1.53, 95% CI 1.08-2.17). The regression model using a smoking-related comorbidity score was significant at 6 months (OR = 1.29, p = 0.03), and the multivariate logistic regression model analyzing each smoking-related condition separately demonstrated significance for myocardial infarction at 6 months (OR = 1.66, p = 0.03). CONCLUSIONS:People who smoke who have experienced smoking-related conditions may be more likely to benefit from smoking cessation interventions, especially intensive telephone-based counseling. Multiple conditions had an additive effect in predicting long-term abstinence after intervention, and myocardial infarction had the greatest predictive value.
PMID: 39358497
ISSN: 1525-1497
CID: 5803272

Rationale and Design for the BLOCK-SAH Study (Pterygopalatine Fossa Block as an Opioid-Sparing Treatment for Acute Headache in Aneurysmal Subarachnoid Hemorrhage): A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial with a Sequential Parallel Comparison Design

Busl, Katharina M; Smith, Cameron R; Troxel, Andrea B; Fava, Maurizio; Illenberger, Nicholas; Pop, Ralisa; Yang, Wenqing; Frota, Luciola Martins; Gao, Hanzhi; Shan, Guogen; Hoh, Brian L; Maciel, Carolina B; ,
BACKGROUND:Acute post-subarachnoid hemorrhage (SAH) headaches are common and severe. Management strategies for post-SAH headaches are limited, with heavy reliance on opioids, and pain control is overall poor. Pterygopalatine fossa (PPF) nerve blocks have shown promising results in treatment of acute headache, including our preliminary and published experience with PPF-blocks for refractory post-SAH headache during hospitalization. The BLOCK-SAH trial was designed to assess the efficacy and safety of bilateral PPF-blocks in awake patients with severe headaches from aneurysmal SAH who require opioids for pain control and are able to verbalize pain scores. METHODS:BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial using the sequential parallel comparison design (SPCD), followed by an open-label phase. RESULTS:Across 12 sites in the United States, 195 eligible study participants will be randomized into three groups to receive bilateral active or placebo PPF-injections for 2 consecutive days with periprocedural monitoring of intracranial arterial mean flow velocities with transcranial Doppler, according to SPCD (group 1: active block followed by placebo; group 2: placebo followed by active block; group 3: placebo followed by placebo). PPF-injections will be delivered under ultrasound guidance and will comprise 5-mL injectates of 20 mg of ropivacaine plus 4 mg of dexamethasone (active PPF-block) or saline solution (placebo PPF-injection). CONCLUSIONS:The trial has a primary efficacy end point (oral morphine equivalent/day use within 24 h after each PPF-injection), a primary safety end point (incidence of radiographic vasospasm at 48 h from first PPF-injection), and a primary tolerability end point (rate of acceptance of second PPF-injection following the first PPF-injection). BLOCK-SAH will inform the design of a phase III trial to establish the efficacy of PPF-block, accounting for different headache phenotypes.
PMID: 39138719
ISSN: 1556-0961
CID: 5726832

Generalized Propensity Score Methods to Assess CKD-Associated Physiologic Factors and Risk of Kidney Failure in the Chronic Renal Insufficiency Cohort (CRIC) Study

Scialla, Julia J; Mallawaarachchi, Indika; Illenberger, Nicholas; Brookhart, M Alan; Isakova, Tamara; Mitra, Nandita; Ma, Jennie Z; ,
Epidemiologic studies have identified many biochemical risk factors for chronic kidney disease (CKD) progression that are correlates of kidney function, termed here 'CKD-associated physiologic factors'. Uncertainty remains if these factors are risk factors or risk markers accounting for aspects of kidney function not otherwise captured. We aimed to use flexible machine learning, a dynamic covariate history including kidney function informative markers, and generalized propensity score (GPS) weighting, to better control confounding for such exposures. We studied 3,052 adults with CKD in the Chronic Renal Insufficiency Cohort Study. We established a 2-year run-in period and assembled 90 variables that characterize variability and trends of selected CKD-associated physiologic factors and confounders. Using SuperLearner, we created a GPS for each CKD-associated physiologic factor and performed GPS-weighted Cox regressions. For context, we also evaluated results from traditional multivariable Cox proportional hazards models as in prior studies. Similar to traditional approaches, bicarbonate, calcium, potassium, hemoglobin, and PTH were each associated with risk of kidney failure using GPS weighting. The GPS approach detected non-linear associations in many factors, some of which were not detected with traditional models. We conclude that many associations between CKD-associated physiologic factors and kidney outcomes remain strong after GPS weighting.
PMID: 39198916
ISSN: 1476-6256
CID: 5729812

Comparing Veterans Preferences and Barriers for Video Visit Utilization Versus In-Person Visits: a Survey of Two VA Centers [Letter]

El-Shahawy, Omar; Nicholson, Andrew; Illenberger, Nicholas; Altshuler, Lisa; Dembitzer, Anne; Krebs, Paul; Jay, Melanie
PMID: 38252249
ISSN: 1525-1497
CID: 5624682

A Cluster-Randomized Study of Technology-Assisted Health Coaching for Weight Management in Primary Care

Jay, Melanie R; Wittleder, Sandra; Vandyousefi, Sarvenaz; Illenberger, Nicholas; Nicholson, Andrew; Sweat, Victoria; Meissner, Paul; Angelotti, Gina; Ruan, Andrea; Wong, Laura; Aguilar, Adrian D; Orstad, Stephanie L; Sherman, Scott; Armijos, Evelyn; Belli, Hayley; Wylie-Rosett, Judith
PURPOSE/OBJECTIVE:We undertook a trial to test the efficacy of a technology-assisted health coaching intervention for weight management, called Goals for Eating and Moving (GEM), within primary care. METHODS:). The primary outcome (weight change at 12 months) and exploratory outcomes (eg, program attendance, diet, physical activity) were analyzed according to intention to treat. RESULTS:= .48). There were no statistically significant differences in secondary outcomes. Exploratory analyses showed that the GEM arm had a greater change than the EUC arm in mean number of weekly minutes of moderate to vigorous physical activity other than walking, a finding that may warrant further exploration. CONCLUSIONS:The GEM intervention did not achieve clinically important weight loss in primary care. Although this was a negative study possibly affected by health system resource limitations and disruptions, its findings can guide the development of similar interventions. Future studies could explore the efficacy of higher-intensity interventions and interventions that include medication and bariatric surgery options, in addition to lifestyle modification.
PMCID:11419716
PMID: 39313341
ISSN: 1544-1717
CID: 5738742

A Cost Comparison Between Mohs Micrographic Surgery and Conventional Excision for the Treatment of Head and Neck Melanomas In Situ and Thin Melanomas

Nugent, Shannon T; Cheng, Brian; Illenberger, Nicholas; Wu, Yaxin; Russell, Louise B; Miller, Christopher J; Zullo, Shannon W; Perz, Allison; Fix, William C; Etzkorn, Jeremy R; Sobanko, Joseph F
BACKGROUND:Variation in operative setting and surgical technique exists when treating specialty site melanomas. There are limited data comparing costs among surgical modalities. OBJECTIVE:To evaluate the costs of head and neck melanoma surgery performed with Mohs micrographic surgery or conventional excision in the operating room or office-based settings. METHODS:A retrospective cohort study was performed on patients aged 18 years and older with surgically treated head and neck melanoma in 2 cohorts, an institutional cohort and an insurance claims cohort, for the years 2008-2019. The primary outcome was total cost of care for a surgical encounter, provided in the form of insurance reimbursement data. A generalized linear model was used to adjust for covariates affecting differences between treatment groups. RESULTS:In the institutional and insurance claims cohorts, average adjusted treatment cost was highest in the conventional excision-operating room treatment group, followed by the Mohs surgery and conventional excision-office setting ( p < .001). CONCLUSION:These data demonstrate the important economic role the office-based setting has for head and neck melanoma surgery. This study allows cutaneous oncologic surgeons to better understand the costs of care involved in head and neck melanoma treatment. Cost awareness is important for shared decision-making discussions with patients.
PMID: 36877120
ISSN: 1524-4725
CID: 5605152

Identifying optimally cost-effective dynamic treatment regimes with a Q-learning approach

Illenberger, Nicholas; Spieker, Andrew J.; Mitra, Nandita
Health policy decisions regarding patient treatment strategies require consideration of both treatment effectiveness and cost. We propose a two-step approach for identifying an optimally cost-effective and interpretable dynamic treatment regime. First, we develop a combined Q-learning and policy-search approach to estimate optimal list-based regimes under a constraint on expected treatment costs. Second, we propose an iterative procedure to select an optimally cost-effective regime from a set of candidate regimes corresponding to different cost constraints. Our approach can estimate optimal regimes in the presence of time-varying confounding, censoring, and correlated outcomes. Through simulation studies, we examine the operating characteristics of our approach under flexible modelling approaches. We also apply our methodology to identify optimally cost-effective treatment strategies for assigning adjuvant therapies to endometrial cancer patients.
SCOPUS:85180579863
ISSN: 0035-9254
CID: 5630712

Incidence of Timely Outpatient Follow-Up Care After Emergency Department Encounters for Acute Heart Failure

Kilaru, Austin S; Illenberger, Nicholas; Meisel, Zachary F; Groeneveld, Peter W; Liu, Manqing; Mondal, Angira; Mitra, Nandita; Merchant, Raina M
BACKGROUND:Patients who are discharged from the emergency department (ED) after an encounter for acute heart failure are at high risk for return hospitalization. These patients may benefit from timely outpatient follow-up care to reassess volume status, adjust medications, and reinforce self-care strategies. This study examines the incidence of outpatient follow-up care after ED encounters for acute heart failure and describes patient characteristics associated with obtaining timely follow-up care. METHODS:We conducted a retrospective cohort study using an administrative claims database for a large US commercial insurer, from January 1, 2012 to June 30, 2019. Participants included adult patients discharged from the ED with principal diagnosis of acute heart failure. The primary outcome was obtaining an in-person outpatient clinic visit for heart failure within 30 days. We also examined the competing risk of all-cause hospitalization within 30 days and without an intervening outpatient clinic visit. We estimated competing risk regression models to identify patient characteristics associated with obtaining outpatient follow-up and report cause-specific hazard ratios. RESULTS:The cohort included 52 732 patients, with mean age of 73.9 years (95% CI, 73.8-74.0) and 27 395 (52.0% [95% CI, 51.5-52.4]) female patients. Within 30 days of the ED encounter, 12 279 (23.2%) patients attended an outpatient clinic visit for heart failure, with 8382 (15.9%) patients hospitalized before they could obtain an outpatient clinic visit. In the adjusted analysis, patients that were younger, women, reporting non-Hispanic Black race, and had fewer previous clinic visits were less likely to obtain outpatient follow-up care. CONCLUSIONS:Few patients obtain timely outpatient follow-up after ED visits for heart failure, although nearly 20% require hospitalization within 30 days. Improved transitions following discharge from the ED may represent an opportunity to improve outcomes for patients with acute heart failure.
PMCID:9489651
PMID: 36073354
ISSN: 1941-7705
CID: 5335032

A regression framework for a probabilistic measure of cost-effectiveness

Illenberger, Nicholas; Mitra, Nandita; Spieker, Andrew J
To make informed health policy decisions regarding a treatment, we must consider both its cost and its clinical effectiveness. In past work, we introduced the net benefit separation (NBS) as a novel measure of cost-effectiveness. The NBS is a probabilistic measure that characterizes the extent to which a treated patient will be more likely to experience benefit as compared to an untreated patient. Due to variation in treatment response across patients, uncovering factors that influence cost-effectiveness can assist policy makers in population-level decisions regarding resource allocation. In this paper, we introduce a regression framework for NBS in order to estimate covariate-specific NBS and find determinants of variation in NBS. Our approach is able to accommodate informative cost censoring through inverse probability weighting techniques, and addresses confounding through a semiparametric standardization procedure. Through simulations, we show that NBS regression performs well in a variety of common scenarios. We apply our proposed regression procedure to a realistic simulated data set as an illustration of how our approach could be used to investigate the association between cancer stage, comorbidities and cost-effectiveness when comparing adjuvant radiation therapy and chemotherapy in post-hysterectomy endometrial cancer patients.
PMID: 35460149
ISSN: 1099-1050
CID: 5271112

Changes in Supplemental Nutrition Assistance Program Policies and Diabetes Prevalence: Analysis of Behavioral Risk Factor Surveillance System Data From 2004 to 2014

Khatana, Sameed Ahmed M; Illenberger, Nicholas; Werner, Rachel M; Groeneveld, Peter W; Mitra, Nandita
OBJECTIVE:Food insecurity is associated with diabetes. The Supplemental Nutrition Assistance Program (SNAP) is the largest U.S. government food assistance program. Whether such programs impact diabetes trends is unclear. The objective of this study was to evaluate the association between changes in state-level policies affecting SNAP participation and county-level diabetes prevalence. RESEARCH DESIGN AND METHODS:We evaluated the association between change in county-level diabetes prevalence and changes in the U.S. Department of Agriculture SNAP policy index-a measure of adoption of state-level policies associated with increased SNAP participation (higher value indicating adoption of more policies associated with increased SNAP participation; range 1-10)-from 2004 to 2014 using g-computation, a robust causal inference methodology. The study included all U.S. counties with diabetes prevalence data available from the Centers for Disease Control and Prevention's U.S. Diabetes Surveillance System. RESULTS:The study included 3,135 of 3,143 U.S. counties. Mean diabetes prevalence increased from 7.3% (SD 1.3) in 2004 to 9.1% (SD 1.8) in 2014. The mean SNAP policy index increased from 6.4 (SD 0.9) to 8.2 (SD 0.6) in 2014. After accounting for changes in demographic-, economic-, and health care-related variables and the baseline SNAP policy index, a 1-point absolute increase in the SNAP policy index between 2004 and 2014 was associated with a 0.050 (95% CI 0.042-0.057) percentage point lower diabetes prevalence per year. CONCLUSIONS:State policies aimed at increasing SNAP participation were independently associated with a lower rise in diabetes prevalence between 2004 and 2014.
PMCID:8669531
PMID: 34607835
ISSN: 1935-5548
CID: 5271092