Multivariate framework of the Brief Questionnaire of Smoking Urges.

We conducted an investigation of the 10-item Brief Questionnaire of Smoking Urges (QSU-Brief) to confirm its hypothesized two-factor structure and to assess the validity and reliability of its total score and these factors. Data were obtained from a 7-week clinical trial on smoking cessation (N=626). The hypothesized two-factor structure of the QSU-Brief was supported by fit indexes (>0.90) from a confirmatory factor analysis at each of three relevant time points (baseline, Week 2, Week 4). Corresponding values of Cronbach's alpha were acceptable (>0.75) on the Total Craving Score and on Factors 1 and 2. This research supports the validity and reliability of the instrument and confirms the proposed two-dimensional structure of self-reported craving as measured by the QSU-Brief.

Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire.

We examined the validity and reliability of the modified Cigarette Evaluation Questionnaire (mCEQ) that assesses the degree to which subjects experience the reinforcing effects of smoking. Data came from three phase II clinical trials (n=626, n=627, n=312) on varenicline for smoking cessation. Comparative fit indexes and non-normed fit indexes from a confirmatory factor analysis exceeded 0.90. Cronbach's alpha for internal consistency reliability exceeded 0.70 for the Smoking Satisfaction domain and the Psychological Reward domain but was less than 0.70 for the Aversion domain; test-retest reliability generally exceeded 0.70 on the three multi-item domains and two single items. The validity and, in general, the reliability of the postulated multidimensional framework of the mCEQ are confirmed and supported by the analyses of three independent studies, with multi-item domains on Smoking Satisfaction (satisfying, taste good, enjoy smoking), Psychological Reward (calm down, more awake, less irritable, help concentrate, reduce hunger), and Aversion (dizziness, nauseous), as well as the single-item assessment on Enjoyment of Respiratory Tract Sensations and on Craving Reduction.

Revealing the multidimensional framework of the Minnesota nicotine withdrawal scale.

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.

Safety of cetirizine in infants 6 to 11 months of age: a randomized, double-blind, placebo-controlled study.

BACKGROUND: H(1)-antihistamines are widely used for symptom relief in allergic disorders in infants and children; however, there are few prospective, randomized, double-blind, controlled studies of these medications in young children, and to date, no such studies have been conducted in infants. OBJECTIVE: This prospective, randomized, parallel-group, double-blind, placebo-controlled study was designed to evaluate the safety of the H(1)-antihistamine cetirizine, particularly with regard to central nervous system and cardiac effects, in infants age 6 to 11 months, inclusive. METHODS: Infants who met the entry criteria for age and had a history of treatment with an H(1)-antihistamine for an allergic or other disorder were randomized to receive 0.25 mg/kg cetirizine orally or matching placebo twice daily orally for 1 week. RESULTS: The mean daily dose in cetirizine-treated infants was 4.5 +/- 0.7 mg (SD). No differences in all-cause or treatment-related adverse events were observed between the cetirizine- and placebo-treated groups. A trend was observed toward fewer adverse events and sleep-related disturbances in the cetirizine group compared with the placebo group. No prolongation in the linear corrected QT interval was observed in cetirizine-treated infants compared with either baseline values or with values in placebo-treated infants. CONCLUSIONS: We have documented the safety of cetirizine in this short-term investigation, the first randomized, double-blind, placebo-controlled study of any H(1)-antihistamine in infants. Additional prospective, randomized, double-blind, placebo-controlled, long-term studies of cetirizine and other H(1)-antihistamines are needed in this population.

The health-related quality of life effects of once-daily cetirizine HCl syrup in children with seasonal allergic rhinitis.

Seasonal allergic rhinitis (SAR) can adversely impact children's physical, psychological, and social functioning and well-being, that is, their health-related quality of life (HRQL). This study assessed HRQL in children 6 to 11 years treated with cetirizine HCl syrup, while concurrently assessing symptomatic relief and safety. In an open-label, non-comparative study, 544 children from 124 centers in the United States were instructed to take cetirizine HCl syrup (10 cc of 1 mg/mL) each evening for 4 weeks. Children experienced statistically significant improvements in HRQL with significant reductions in mean symptom score (p < 0.001) during the treatment period. Results were consistent across age groups (6-7, 8-9, 10-11 years). These results suggest that the symptomatic relief and tolerability profile of cetirizine HC1 syrup daily translates into improvements in the HRQL of children with SAR. This 4-week open label study is among the first to evaluate the effect of antihistamine treatment on HRQL outcomes in children.

Comprehensive evaluation of cetirizine in the management of seasonal allergic rhinitis: impact on symptoms, quality of life, productivity, and activity impairment.

Improvement in patient daily functioning and well-being resulting from disease-related symptom relief is increasingly viewed as a clinically relevant therapeutic outcome. The objective of this study was to evaluate the health-related quality of life (HRQL) effects, safety and efficacy of cetirizine in the treatment of seasonal allergic rhinitis, and impact on self-reported work/school-related productivity and activity impairment (WPAI). This was a double-blind, placebo-controlled, parallel-group study. Adult patients (n = 865) were randomized to daily treatment for 2 weeks with cetirizine or placebo. Patient disease-specific HRQL and WPAI were assessed at baseline and weeks 1 and 2 of treatment using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Allergy-Specific Work Productivity and Activity Impairment (WPAI-AS) Instrument, respectively. Treatment with cetirizine resulted in greater (p < 0.001) improvement in overall RQLQ and individual domain scores (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional), as compared with placebo. Cetirizine therapy produced a 28.9% mean reduction in total symptom severity complex (TSSC) score versus 12.7% with placebo at study end. Work/school productivity and activity impairment were significantly (p < 0.001) decreased from baseline for cetirizine-treated patients compared with placebo. The incidence of treatment-related side effects was similar between groups. Cetirizine provides safe and effective symptomatic relief in adults with SAR while significantly improving HRQL and providing a positive impact on work/school-related productivity and activity impairment. These results provide a more comprehensive assessment of cetirizine, indicating that its benefits extend beyond conventional measures of clinical outcome.