Elizabeth Merikle

Revealing the multidimensional framework of the Minnesota nicotine withdrawal scale.

ABSTRACT Objectives: The version of the Minnesota Nicotine Withdrawal Scale (MNWS) under consideration consists of nine items. No psychometric analyses of this version have been published. The objectives of this investigation were to perform a factor analysis and to further assess the psychometric properties of the MNWS. Research design and methods: Data came from three Phase II clinical trials on varenicline, developed for smoking cessation, in a sample of smokers. Exploratory factor analysis was used to examine the structure of the MNWS in the first completed study ( n = 626) over various time periods. The postulated factor structure was then tested in a set of confirmatory analyses conducted on two subsequent studies ( n = 627, n = 312). The proposed structure was further evaluated through construct validity and reliability analyses. Main outcome measures: The nine items of the MNWS included the following: urge to smoke (craving); depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; and difficulty staying asleep. Each item was rated by a subject on an ordinal scale from 0 (not at all) to 4 (extreme). Results: Scree plots and rotated factor patterns from the exploratory factor analyses revealed two multi-item domains – Negative Affect with four items and Insomnia with two items – and three individual items (Craving, Restlessness, Increased Appetite). Confirmatory factor analyses supported the structure with fit indexes exceeding 0.90. The multidimensional framework of the MNWS correlated as expected with health status, depicted an expected course of withdrawal symptoms over time, predicted the sensitivity of withdrawal symptoms on subsequent cessation, and produced internal reliability estimates above 0.70. Conclusions: Evidence is obtained to support the validity and reliability of the multidimensional structure of the nine-item MNWS. The data suggest that the MNWS has individual constructs on Negative Affect (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating), Insomnia (difficulty going to sleep; difficulty staying asleep), Craving, Restlessness, and Increased Appetite. As such, analyzing each construct separately would strengthen the analysis of the popular MNWS.

Baseline prediction of 7-month cocaine abstinence for cocaine dependence patients

A broad range of baseline subject variables was evaluated to identify predictors of 7-month cocaine use for 160 lower socioeconomic cocaine dependent male veteran patients participating in either an intensive 1-month day hospital (DH; n=90) or a 1-month inpatient (INP; n=70) treatment program. The baseline measures included sociodemographic variables, the seven Addiction Severity Index composite scores, cocaine urine toxicology, craving, the SCL-90 total score, and lifetime psychiatric diagnoses. Since a proportion of subjects who reported no use at follow-up had positive urines, both liberal and conservative data estimation strategies were employed for subjects without urine toxicology data at follow-up who had reported no use (21% of subjects). Analyses were done separately for the DH and INP subjects. Under the conservative definition of cocaine abstinence/use, univariate correlations of predictor variables with 7-month cocaine use revealed no statistically significant relationships. Under the liberal definition of cocaine abstinence/use, only one variable, greater severity of alcohol problems at intake predicted cocaine abstinence at outcome. Because of the inability to predict treatment success, originally planned logistic regression analyses were not undertaken. The findings point to the difficulty of predicting long-term outcomes in cocaine dependent patients based on baseline information and to the importance of obtaining objective data on cocaine use.

A Retrospective Analysis of the Prevalence and Treatment of Hypertension and Dyslipidemia in Southwestern Ontario, Canada

BACKGROUND Previous evaluations of the Southwestern Ontario (SSWO) cohort have reported that hypertension (HTN) and dyslipidemia (DYS) are undertreated illnesses; however, concomitant treatment is unknown. OBJECTIVES The objectives of this study were to assess the prevalence and associated treatment of HTN and DYS in primary health care in SWO and to identify care gaps across subpopulations. METHODS In this retrospective cohort analysis, chart-abstracted medical records of patients aged>or=118 years with a clinical diagnosis of HTN, DYS, or both and the clinical practice records of primary health care facilities in London, Ontario, Canada, and the surrounding area were conducted between April and December 2000; longitudinal updates were performed quarterly until December 2004. Chart-abstracted information included demographics, lifestyle (eg, diet, exercise), cardiovascular disease indicators, complete morbidity profile, and drug treatments and effects. RESULTS The medical records of 46,322 patients who received medical care and the clinical practice records of 37 primary health care facilities (where the patients received treatment) in London, Ontario, Canada, and the surrounding area were included in this study. Our analyses found that the prevalence of HTN (17.66%) was greater than that of DYS (12.33%); with comorbid HTN and DYS found in 8.0% of the population. Most hypertensive patients were not dyslipidemic (54.88%), but more than half of dyslipidemic patients had comorbid HTN (64.99%). Significant differences in prevalence among the sex, age, and comorbid subgroups were found. HTN was higher among females than males (P<0.001) but lower among female smokers than male smokers (P<0.001). Patients aged >55 years were much more likely to be hypertensive, dyslipidemic, or both compared with those aged <55 years (P<0.009), except among those patients with a family history of coronary heart disease (CHD). Additionally, a steady increase in HTN and DYS prevalence with age by decade until 75 years of age, after which the rates dropped off, was observed. Most patients were untreated for HTN (66.00%) or DYS (80.00%) unless both conditions were present (35.00% untreated for HTN; 39.00% untreated for DYS). Among patients with comorbid HTN and DYS, the order of diagnosis had a significant effect on treatment level. The presence of other comorbidities (eg, family history of CHD) resulted in higher treatment and control rates. Control levels were generally poor, with 7.0% among patients with DYS, 15.00% among patients with HTN, and 17.00% among patients with both conditions. CONCLUSIONS Treatment patterns of HTN and DYS in practice settings are not in alignment with current guidelines in this cohort. Pharmacologic treatment of HTN and DYS is underprescribed. Patients most likely to receive treatment have comorbidities, but even in those high-risk groups, treatment levels are low and recommended control levels even lower.

Changes in Health Care Costs Before and After Smoking Cessation

Previous research on health care costs among former smokers suggests that quitters incur greater health care costs for up to 4 years after cessation compared with continuing smokers. However, little is known about the relationship between health care costs and utilization in the periods before as well as after cessation. The present study used a retrospective cohort design with automated health plan and primary data to examine the health care costs and clinical experiences before and after smoking cessation among former smokers compared with a sample of continuing smokers. Subjects were a random sample of adults (aged 25 and older) whose smoking status was identified by a physician during a primary care visit to the Group Health Cooperative (GHC), a nonprofit, integrated health care delivery system in western Washington state. Total direct health care costs among former smokers began to rise in the quarter prior to cessation and were significantly greater (p < .001) than those of continuing smokers in the quarter immediately following cessation. This difference dissipated within one quarter following cessation. We replicated the postquit cost spike among former smokers found by other research and showed that this spike dissipated within the first year postquit. Smoking cessation did not result in sustained cost increases among former smokers.

Economic evaluation of high-dose (80 mg/day) atorvastatin treatment compared with standard-dose (20 mg/day to 40 mg/day) simvastatin treatment in Canada based on the Incremental Decrease in End-Points Through Aggressive Lipid-Lowering (IDEAL) trial

BACKGROUND The Incremental Decrease in End-Points Through Aggressive Lipid-Lowering (IDEAL) trial demonstrated incremental cardiovascular benefit of treatment with high-dose atorvastatin (80 mg/ day) versus standard-dose simvastatin (20 mg/day to 40 mg/day) in 8888 patients with a previous myocardial infarction (MI) over a median follow-up period of 4.8 years. OBJECTIVES To assess the cost-effectiveness of high-dose atorvastatin versus standard-dose simvastatin treatment in patients with a history of MI from a Canadian societal perspective. METHODS In a within-trial analysis, end point-related events, resources used and productivity losses occurring during the IDEAL trial were aggregated by treatment arm on an intention-to-treat basis to calculate the incremental cost per event avoided. Additionally, quality-adjusted survival was projected using a lifetime Markov model. Transition probabilities, workdays lost, use of study medication and cardiovascular hospitalization rates were based on IDEAL trial data. Hospitalization, study medication and productivity costs were included. Probabilistic and deterministic sensitivity analyses were performed. RESULTS Compared with standard-dose simvastatin, atorvastatin 80 mg led to 0.099 fewer events per patient and cost savings over 4.8 years of treatment. Over a lifetime horizon, atorvastatin 80 mg led to 0.023 qualityadjusted life years (QALYs) gained per patient at an incremental cost of

Day treatment for cocaine dependence: Incremental utility over outpatient counseling and voucher incentives

26,795/QALY gained. The incremental cost-effectiveness ratio remained below

A model for assessing the cost-effectiveness of atorvastatin and simvastatin in achieving Canadian low-density lipoprotein cholesterol targets.

50,000/QALY in 78% of 1000 simulations. Exclusion of indirect costs resulted in an incremental cost-effectiveness ratio of

Cost-Effectiveness of Atorvastatin in the Primary Prevention of Major Cardiovascular Events in Patients with Type 2 Diabetes in Canada

38,834/QALY. Results were relatively sensitive to baseline age, but robust with respect to sex, baseline low-density lipoprotein cholesterol levels, diabetes status and hospitalization costs. CONCLUSION From a Canadian societal perspective, high-dose atorvastatin is cost-effective compared with standard-dose simvastatin in patients with a previous MI.

Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire

Urban, poor, crack cocaine-dependent clients were randomly assigned to outpatient addiction counseling (n=39) or day treatment (n=40). Participants in both conditions received equivalent individual cognitive-behavioral counseling and earned equivalent payment vouchers for providing cocaine-negative urine samples. However, day treatment participants attended significantly more psychoeducational and recreational groups and received two meals per day. Prior to random assignment, more participants expressed a preference for day treatment and participants were more likely to return for an initial appointment following assignment to day treatment. However, no significant between-groups differences in tenure or abstinence were detected during the 3-month course of treatment. These null findings were attributable to an absence of a dose-response effect for the group interventions in the day treatment condition. In addition, there may have been a ceiling effect from the vouchers, which masked the influence of the additional day treatment components.

Factors accounting for cocaine use two years following initiation of continuing care

BACKGROUND Elevated low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor for cardiovascular (CV) disease. Statins differ in their LDL-C-lowering effects and acquisition costs. Atorvastatin and simvastatin are the 2 most commonly used statins in Canada. OBJECTIVE This analysis compared the cost-effectiveness of atorvastatin and generic simvastatin in terms of annual drug cost per patient treated to Canadian LDL-C targets. It was conducted from the perspective of the Canadian provincial drug-reimbursement plans. METHODS A hypothetical cohort of 1000 dyslipidemic patients was assigned baseline LDL-C serum concentrations and levels of risk for CV disease based on Canadian population data. Canadian data on statin dosing were combined with efficacy data from a published meta-analysis to determine the proportion of patients who would be expected to achieve LDL-C targets after treatment with atorvastatin or generic simvastatin. Statin acquisition costs were obtained from Ontario and Quebec and reported in 2005 Canadian dollars. The sensitivity of the model to changes in drug costs, effectiveness, and persistence with treatment was tested. RESULTS The model predicted that more patients would reach the LDL-C target with atorvastatin than with simvastatin (73% vs 57%, respectively). The mean annual drug cost per patient treated to target was