Cost-Effectiveness of Smoking Cessation Approaches in Emergency Departments.

INTRODUCTION: Americans of lower SES use tobacco products at disproportionately high rates and are over-represented as patients of emergency departments. Accordingly, emergency department visits are an ideal time to initiate tobacco treatment and aftercare for this vulnerable and understudied population. This research estimates the costs per quit of emergency department smoking-cessation interventions and compares them with those of other approaches. METHODS: Previously published research described the effectiveness of 2 multicomponent smoking cessation interventions, including brief negotiated interviewing, nicotine replacement therapy, quitline referral, and follow-up communication. Study 1 (collected in 2010-2012) only analyzed the combined interventions. Study 2 (collected in 2017-2019) analyzed the intervention components independently. Costs per participant and per quit were estimated separately, under distinct intervention with dedicated staff and intervention with repurposed staff assumptions. The distinction concerns whether the intervention used dedicated staff for delivery or whether time from existing staff was repurposed for intervention if available. RESULTS: Data were analyzed in 2021-2022. In the first study, the cost per participant was $860 (2018 dollars), and the cost per quit was $11,814 (95% CI=$7,641, $25,423) (dedicated) and $227 per participant and $3,121 per quit (95% CI=$1,910, $7,012) (repurposed). In Study 2, the combined effect of brief negotiated interviewing, nicotine replacement therapy, and quitline cost $808 per participant and $6,100 per quit (dedicated) (95% CI=$4,043, $12,274) and $221 per participant and $1,669 per quit (95% CI=$1,052, $3,531) (repurposed). CONCLUSIONS: Costs varied considerably per method used but were comparable with those of other smoking cessation interventions.

Racial and Ethnic Differences in Internal Medicine Residency Assessments.

Importance: Previous studies have demonstrated racial and ethnic inequities in medical student assessments, awards, and faculty promotions at academic medical centers. Few data exist about similar racial and ethnic disparities at the level of graduate medical education. Objective: To examine the association between race and ethnicity and performance assessments among a national cohort of internal medicine residents. Design, Setting, and Participants: This retrospective cohort study evaluated assessments of performance for 9026 internal medicine residents from the graduating classes of 2016 and 2017 at Accreditation Council of Graduate Medical Education (ACGME)-accredited internal medicine residency programs in the US. Analyses were conducted between July 1, 2020, and June 31, 2022. Main Outcomes and Measures: The primary outcome was midyear and year-end total ACGME Milestone scores for underrepresented in medicine (URiM [Hispanic only; non-Hispanic American Indian, Alaska Native, or Native Hawaiian/Pacific Islander only; or non-Hispanic Black/African American]) and Asian residents compared with White residents as determined by their Clinical Competency Committees and residency program directors. Differences in scores between Asian and URiM residents compared with White residents were also compared for each of the 6 competency domains as supportive outcomes. Results: The study cohort included 9026 residents from 305 internal medicine residency programs. Of these residents, 3994 (44.2%) were female, 3258 (36.1%) were Asian, 1216 (13.5%) were URiM, and 4552 (50.4%) were White. In the fully adjusted model, no difference was found in the initial midyear total Milestone scores between URiM and White residents, but there was a difference between Asian and White residents, which favored White residents (mean [SD] difference in scores for Asian residents: -1.27 [0.38]; P < .001). In the second year of training, White residents received increasingly higher scores relative to URiM and Asian residents. These racial disparities peaked in postgraduate year (PGY) 2 (mean [SD] difference in scores for URiM residents, -2.54 [0.38]; P < .001; mean [SD] difference in scores for Asian residents, -1.9 [0.27]; P < .001). By the final year 3 assessment, the gap between White and Asian and URiM residents' scores narrowed, and no racial or ethnic differences were found. Trends in racial and ethnic differences among the 6 competency domains mirrored total Milestone scores, with differences peaking in PGY2 and then decreasing in PGY3 such that parity in assessment was reached in all competency domains by the end of training. Conclusions and Relevance: In this cohort study, URiM and Asian internal medicine residents received lower ratings on performance assessments than their White peers during the first and second years of training, which may reflect racial bias in assessment. This disparity in assessment may limit opportunities for physicians from minoritized racial and ethnic groups and hinder physician workforce diversity.

D-CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System-Based Versus Community-Based Dementia Care Versus Usual Dementia Care.

BACKGROUND/OBJECTIVES: Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown. DESIGN: Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad. SETTING: Four clinical trial sites (CTSs) based in academic and clinical health systems. PARTICIPANTS: A total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers. INTERVENTIONS: Eighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline. MEASUREMENTS: Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales. SECONDARY OUTCOMES: NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims. RESULTS: The results will be reported in the spring of 2024. CONCLUSION: D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.

Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.

We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.

Interrupted Time Series of User-centered Clinical Decision Support Implementation for Emergency Department-initiated Buprenorphine for Opioid Use Disorder.

OBJECTIVES: Adoption of emergency department (ED) initiation of buprenorphine (BUP) for opioid use disorder (OUD) into routine emergency care has been slow, partly due to clinicians' unfamiliarity with this practice and perceptions that it is complicated and time-consuming. To address these barriers and guide emergency clinicians through the process of BUP initiation, we implemented a user-centered computerized clinical decision support system (CDS). This study was conducted to assess the feasibility of implementation and to evaluate the preliminary efficacy of the intervention to increase the rate of ED-initiated BUP. METHODS: An interrupted time series study was conducted in an urban, academic ED from April 2018 to February 2019 (preimplementation phase), March 2019 to August 2019 (implementation phase), and September 2019 to December 2019 (maintenance phase) to study the effect of the intervention on adult ED patients identified by a validated electronic health record (EHR)-based computable phenotype consisting of structured data consistent with potential cases of OUD who would benefit from BUP treatment. The intervention offers flexible CDS for identification of OUD, assessment of opioid withdrawal, and motivation of readiness to start treatment and automates EHR activities related to ED initiation of BUP (including documentation, orders, prescribing, and referral). The primary outcome was the rate of ED-initiated BUP. Secondary outcomes were launch of the intervention, prescription for naloxone at ED discharge, and referral for ongoing addiction treatment. RESULTS: Of the 141,041 unique patients presenting to the ED over the preimplementation and implementation phases (i.e., the phases used in primary analysis), 906 (574 preimplementation and 332 implementation) met OUD phenotype and inclusion criteria. The rate of BUP initiation increased from 3.5% (20/574) in the preimplementation phase to 6.6% (22/332) in the implementation phase (p = 0.03). After the temporal trend of the number of physician's with X-waiver training and other covariates were adjusted for, the relative risk of BUP initiation rate was 2.73 (95% confidence interval [CI] = 0.62 to 12.0, p = 0.18). Similarly, the number of unique attendings who initiated BUP increased modestly 7/53 (13.0%) to 13/57 (22.8%, p = 0.10) after offering just-in-time training during the implementation period. The rate of naloxone prescribed at discharge also increased (6.5% preimplementation and 11.5% implementation; p < 0.01). The intervention received a system usability scale score of 82.0 (95% CI = 76.7 to 87.2). CONCLUSION: Implementation of user-centered CDS at a single ED was feasible, acceptable, and associated with increased rates of ED-initiated BUP and naloxone prescribing in patients with OUD and a doubling of the number of unique physicians adopting the practice. We have implemented this intervention across several health systems in an ongoing trial to assess its effectiveness, scalability, and generalizability.

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

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

"To Err Is Human" but Disclosure Must be Taught: A Simulation-Based Assessment Study.

INTRODUCTION: Although error disclosure is critical in promoting safety and patient-centered care, physicians are inconsistently trained in its practice, and few objective methods to assess competence exist. We used an immersive simulation scenario to determine whether providers with varying levels of clinical experience adhere to the disclosure safe practice guidelines when exposed to a serious adverse event simulation scenario. METHODS: This was a prospective cohort study with medical students, junior emergency medicine (EM) residents (PGY 1-2), senior EM residents (PGY 3-4), and attending EM physicians participating in a simulated case in which a scripted medication overdose resulted in an adverse event. Each scenario was videotaped and scored by two expert raters based on a 6-component, 21-point disclosure assessment instrument. RESULTS: There were 12 participants in each study group (N = 48). There was good interrater reliability (κ = 0.70). Total scores improved significantly as the level of training increased: medical student = 10.3 (2.7), PGY 1-2 = 12.3 (6.2), PGY 3-4 = 13.7 (3.2), and attending physicians = 12.8 (3.7) (P = 0.03). Seventy-five percent of participants did not address preventing recurrence of the error. Fifty-six percent offered no apology or only offered it with prompting from the patient; only 23% offered an apology with the initial disclosure. CONCLUSIONS: We demonstrated suboptimal adherence to best practices guidelines for error disclosure when providers are assessed in an immersive simulation setting. Despite a correlation in performance of medical error disclosure with increased physician experience, this study suggests that healthcare providers may need additional training to comply with safe practice guidelines for disclosure of unanticipated adverse events.

Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy.

BACKGROUND: Tobacco dependence remains the leading preventable cause of death in the developed world. Smokers are disproportionately from lower socioeconomic groups, and may use the hospital emergency department (ED) as an important source of care. A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit, but the independent contributions of those components is unknown. METHODS: This is a full-factorial (16-arm) randomized trial in a busy hospital ED of 4 tobacco dependence interventions: brief motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program. The trial utilizes the Multiphase Optimization Strategy (MOST) and a novel mixed methods analytic design to assess clinical efficacy, cost effectiveness, and qualitative participant feedback. The primary endpoint is tobacco abstinence at 3months, verified by participants' exhaled carbon monoxide. RESULTS: Study enrollment began in February 2017. As of April 2017, 52 of 1056 planned participants (4.9%) were enrolled. Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence are completed at the 3-month follow-up. Efficacy and cost effectiveness analyses will be conducted after follow-up is completed. DISCUSSION: The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients. The efficacy of this combination can then be tested in a subsequent confirmatory trial. Our approach incorporates qualitative feedback from study participants in evaluating which intervention components will be tested in the future trial. TRIAL REGISTRATION: Trial (NCT02896400) registered in ClinicalTrials.gov on September 6, 2016.

Behavioral and Environmental Explanations of Elevated Blood Lead Levels in Immigrant Children and Children of Immigrants.

Immigrant/refugee children sometimes have substantially higher blood lead levels (BLLs) than US-born children in similar environments. We try to understand why, by exploring the relationship between immigration status of mother and the BLLs of US-born children. We compared BLLs of children born in Michigan to immigrant and non-immigrant parents, using the Michigan database of BLL tests for 2002-2005, which includes the child's race, Medicaid eligibility and address. We added census data on socio-demographic/housing characteristics of the child's block group, and information about parents. Low parental education, single parent households, mothers' smoking and drinking, all increase the child's BLL. However, immigrant parents had fewer characteristics associated with high BLL than US born parents, and their children had lower BLLs than children of US-born mothers. Our findings suggest that prior findings of higher BLLs among immigrant/refugee children probably result from them starting life in high-lead environments.

Chest pain syndromes are associated with high rates of recidivism and costs in young United States Veterans.

BACKGROUND: Recurrent chest pain is common in patients with and without coronary artery disease. The prevalence and burden of these symptoms on healthcare is unknown. OBJECTIVES: To compare chest pain return visits (recidivism) in patients with unexplained chest pain (UCP) against reference group of patients with coronary artery disease (CAD) and estimate the annual cost of recurrent chest pain. METHODS: In a retrospective cohort study, a Veteran Affairs (VA) administrative and clinical database of Veterans who were deployed to or served in support of the wars in Iraq or Afghanistan was queried for first disease specific ICD-9 code to form two cohorts (UCP or CAD). Patients were followed between 09/2001-09/2010 for the first and cumulative return visits for UCP or cardiac pain (ACS or angina) to clinic, emergency department or admission; or for all-cause death. Time to return was analyzed using Cox regression and negative binomial models and adjusted for age, gender, race, marital status, and risk factors (hypertension, hyperlipidemia, diabetes, smoking and obesity). Direct total costs included inpatient, outpatient and fee basis (non-VA) costs. RESULTS: Of 749,036 patients, 20,521 had UCP and 5303 had CAD. UCP patients were young and had a lower burden of risk factors than CAD cohort (p < .01). Yet, these patients were likely to return earlier with any chest pain (adjusted Hazard Ratio [aHR] = 1.76; 95 % CI 1.65-1.88); or unexplained chest pain than CAD patients (aHR: 1.89; 95 % CI 1.77-2.01). UCP patients were also likely to return more frequently for any chest pain (aRate Ratio = 1.54; 95 % CI 1.43-1.64) or UCP than CAD patients (aRR =2.63; 95 % CI 2.43-2.87). Per 100 patients, the 1-year cumulative returns were 37 visits for reference group and 45 visits for UCP cohort. The annual costs for chest pain averaged $69,009 for CAD and $57,336 for UCP patients (log geometric mean ratio=1.25; 95 % CI 1.18-1.32). CONCLUSION: Chest pain recidivism is common and costly even in patients without known CAD. We need evidence-based guidelines for these patients to minimize returns.

New media use by patients who are homeless: the potential of mHealth to build connectivity.

BACKGROUND: Patients experiencing homelessness represent a disproportionate share of emergency department (ED) visits due to poor access to primary care and high levels of unmet health care needs. This is in part due to the difficulty of communicating and following up with patients who are experiencing homelessness. OBJECTIVE: To determine the prevalence and types of "new media" use among ED patients who experience homelessness. METHODS: This was a cross-sectional observational study with sequential enrolling of patients from three emergency departments 24/7 for 6 weeks. In total, 5788 ED patients were enrolled, of whom 249 experienced homelessness. Analyses included descriptive statistics, and unadjusted and adjusted odds ratios. RESULTS: 70.7% (176/249) of patients experiencing homelessness own cell phones compared to 85.90% (4758/5539) of patients in stable housing (P=.001) with the former more likely to own Androids, 70% (53/76) versus 43.89% (1064/2424), and the latter more likely to have iPhones, 44.55% (1080/2424) versus 17% (13/76) (P=.001). There is no significant difference in new media use, modality, or frequency for both groups; however, there is a difference in contract plan with 50.02% (2380/4758) of stably housed patients having unlimited minutes versus 37.5% (66/176) of homeless patients. 19.78% (941/4758) of patients in stable housing have pay-as-you-go plans versus 33.0% (58/176) of homeless patients (P=.001). Patients experiencing homelessness are more likely to want health information on alcohol/substance abuse, mental health, domestic violence, pregnancy and smoking cessation. CONCLUSIONS: This study is unique in its characterization of new media ownership and use among ED patients experiencing homelessness. New media is a powerful tool to connect patients experiencing homelessness to health care.

Point-of-care focused cardiac ultrasound for the assessment of thoracic aortic dimensions, dilation, and aneurysmal disease.

OBJECTIVES: Thoracic aortic aneurysm and thoracic aortic dissection are related and potentially deadly diseases that present with nonspecific symptoms. Transthoracic echocardiography (TTE) may detect thoracic aortic pathology and is being increasingly performed by the emergency physician at the bedside; however, the accuracy of point-of-care (POC) focused cardiac ultrasound (FOCUS) for thoracic aortic aneurysm and thoracic aortic dissection has not been studied. The objective of this pilot study was to explore the agreement, sensitivity, and specificity of FOCUS for thoracic aortic dimensions, dilation, and aneurysm compared with CT angiography (CTA) as the reference standard. METHODS: This study was a retrospective pilot analysis of image and chart data on consecutive patients presenting to an urban, academic emergency department (ED) between January 2008 and June 2010, who had both a FOCUS and a CTA for suspicion of thoracic aorta pathology. Thoracic aorta dimensions were measured from recordings by three ultrasound-trained emergency physicians blinded to any initial FOCUS and CTA results. CTA measurements were obtained by a radiologist blinded to the FOCUS results. Using cutoffs of 40 and 45 mm, we calculated the sensitivity and specificity of FOCUS for aortic dilation and aneurysm with the largest measurement on CT as the reference standard. Bland-Altman plots with 95% limits of agreement were used to demonstrate agreement for aortic measurements, kappa statistics to assess the degree of agreement between tests for aortic dilation, and intraclass correlation for interobserver and intraobserver variability. RESULTS: Ninety-two patients underwent both FOCUS and CTA during the study period. Ten FOCUS studies had inadequate visualization for all measurements areas. Eighty-two patients were included in the final analysis. Mean (±SD) age was 58.1 (±16.6) years and 58.5% were male. Sensitivity, specificity, and the observed kappa value (95% confidence interval [CI]) between FOCUS and CTA for the presence of aortic dilation at the 40-mm cutoff were 0.77 (95% CI = 0.58 to 0.98), 0.95 (95% CI = 0.84 to 0.99), and 0.74 (95% CI = 0.58 to 0.90), respectively. The mean difference (95% limits of agreement) for the Bland-Altman plots was 0.6 mm (-5.3 to 6.5) for the sinuses of Valsalva, 4 mm (-2.7 to 10.7) for the sinotubular junction, 1.5 mm (-5.8 to 8.8) for the ascending aorta, and 2.2 mm (-5.9 to 10.3) for the descending aorta. CONCLUSIONS: In this retrospective pilot study, FOCUS demonstrated good agreement with CTA measurements of maximal thoracic aortic diameter. FOCUS appears to be specific for aortic dilation and aneurysm when compared to CTA, but requires further prospective study.

Renal ultrasonography in the evaluation of acute kidney injury: developing a risk stratification framework.

BACKGROUND: In adult inpatients with acute kidney injury (AKI), clinicians routinely order a renal ultrasonography (RUS) study. It is unclear how often this test provides clinically useful information. METHODS: Cross-sectional study, including derivation and validation samples, of 997 US adults admitted to Yale-New Haven Hospital from January 2005 to May 2009, who were diagnosed as having AKI and who underwent RUS to evaluate elevated creatinine level. Pregnant women, renal transplant recipients, and patients with recently diagnosed hydronephrosis (HN) were excluded. Demographic and clinical characteristics were abstracted from the medical records. A multivariable logistic regression model was developed to create risk strata for HN and HN requiring an intervention (HNRI); a separate sample was used for validation. The frequency of incidental findings on RUS was assessed for each stratum. RESULTS: In a derivation sample of 200 patients, 7 factors were found to be associated with HN: history of HN; recurrent urinary tract infections; diagnosis consistent with obstruction; nonblack race; and absence of the following: exposure to nephrotoxic medications, congestive heart failure, or prerenal AKI. Among 797 patients in the validation sample (mean age, 65.6 years), 10.6% had HN and 3.3% had HNRI. Of 223 patients in the low-risk group, 7 (3.1%) had HN and 1 (0.4%) had HNRI (223 patients needed to be screened to find 1 case of HNRI). In this group, there were 0 incidental findings on RUS unknown to the clinical team. In the higher-risk group, 15.7% had HN and 4.7% had HNRI. CONCLUSION: In adult inpatients with AKI, specific factors can identify patients unlikely to have HN or HNRI on RUS.

Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

BACKGROUND: Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. OBJECTIVE: We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. DESIGN: Randomized controlled trial. PARTICIPANTS: All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. MEASUREMENTS: Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. RESULTS: A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. CONCLUSIONS: A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

Socioeconomic predictors of weight loss after laparoscopic Roux-Y gastric bypass.

INTRODUCTION: Successful weight loss after laparoscopic Roux-Y gastric bypass (LRYGB) hinges on many elements including neurohormonal, anatomical, and postoperative behavioral changes. To date, the effects of socioeconomic factors have been inadequately studied. We examine several components of socioeconomic status and its relationship to weight loss after LRYGB. METHODS: Between August 2002 and July 2006, 405 LRYGB were performed by a single surgeon. Patient demographics were entered into a longitudinal, prospective database. At 1-year follow-up, 309 patients were available for analysis. Regional median household income (RMAHI) and primary insurance carrier were used as surrogates for preoperative socioeconomic status. Analysis of covariance (ANCOVA) test was used for statistical analysis. According to RMAHI, we divided the patients into three groups: US $20,001-40,000 (group A, n = 67), US $40,001-60,000 (group B, n = 153), and more than US $60,000 (group C, n = 89). Initial body mass index (BMI) was 52.76 +/- 1.01, 51.28 +/- 0.67, and 48.87 +/- 0.94 kg/m2, respectively. Additionally, patients were divided according to private insurance or state-based insurance. A total of 274 patients had private insurance, with an initial mean BMI of 50.6 kg/m2, and 35 patients had state-based insurance, with an initial BMI of 53.0 kg/m2. RESULTS: After 1 year, weight loss in groups A, B and C was 110.6 +/- 4.3, 110.0 +/- 2.5, and 103.9 +/- 3.6 lb with BMI decrease of 17.7 +/- 0.6, 17.7 +/- 0.4, and 16.9 +/- 0.6 kg/m2, respectively. Weight loss in the private insurance group was 49.2 +/- 0.9 kg compared with 50.2 +/- 2.3 kg in the state-based group with BMI decrease of 17.4 +/- 0.3 and 18.4 +/- 0.8 kg/m2, respectively. There were no statistical significances in the effect of socioeconomic status, median household income, and insurance carrier on postoperative weight loss. CONCLUSION: With appropriate patient selection, the socioeconomic status of patients undergoing LRYGB does not affect postoperative weight loss.

Methodological issues in design and analysis of a matched case-control study of a vaccine's effectiveness.

OBJECTIVE: Case-control studies of the effectiveness of a vaccine are useful to answer important questions, such as the effectiveness of a vaccine over time, that usually are not addressed by prelicensure clinical trials of the vaccine's efficacy. This report describes methodological issues related to design and analysis that were used to determine the effects of time since vaccination and age at the time of vaccination. STUDY DESIGN AND SETTING: A matched case-control study of the effectiveness of varicella vaccine was conducted. RESULTS: Sampling procedures and conditional logistic regression models including interaction terms are described. CONCLUSION: Use of these methods will allow investigators to assess the effects of a wide range of variables, such as time since vaccination and age at the time of vaccination, on the effectiveness of a vaccine.