Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum Scale.

This study examined the reliability and validity of a new measure for evaluating symptoms in patients with chronic obstructive pulmonary disease (COPD): the Breathlessness, Cough and Sputum Scale (BCSS). Designed as a daily diary, the BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms, each on a 5-point scale; higher scores indicate more severe symptoms. Item scores are summed to yield a total score. Secondary analysis of data were from two multinational trials (n = 629; 765). The BCSS item and total scores exhibited evidence of internal consistency (alpha = 0.70 daily; 0.95 to 0.99 over time) and reproducibility (ICC = 0.77 to 0.88). Correlations (r) with pulmonary function (FEV1 % predicted, PEF) were -0.01 (n.s.) to -0.36 (P < 0.001). Correlations with the St George's Respiratory Questionnaire total and SF-36 Physical Functioning subscale were 0.44 to 0.59 (P < 0.0001). Breathlessness and total scores differentiated patients by disease severity (P < 0.01) and rescue medication use (P < 0.01). Cough, sputum, and total scores increased with sputum volume (r = 0.27, 0.30, 0.31; P < 0.001). Patients for whom treatment was moderately or highly effective reported significant improvements in BCSS scores (P < 0.0001). Results suggest that the BCSS is a reliable, valid, and responsive patient-reported outcome measure of symptom severity in patients with COPD.

Smoking cessation in hospitalized patients.

The components of readiness to change for smoking cessation that are found in the general population are also applicable to hospitalized smokers. Smoking cessation interventions must be specifically tailored to subgroups among hospitalized patients, with emphasis on smoking-related diagnosis when applicable. Interventions should include key components related to smoking cessation, such as knowledge, self-efficacy, exposure to smoking, and social support. Interventions that include relapse prevention and are conducted in the context of other risk reduction strategies should be developed.

Psychometric properties of the VSQLQ in black patients with mild hypertension. Vital Signs Quality of Life Questionnaire.

The Vital Signs Quality of Life Questionnaire (VSQLQ) is a condition- and culture-specific measure designed to assess health-related quality of life (HRQL) in black patients with hypertension. This study examined the instrument's reliability and validity when administered via personal interview to patients with mild systemic hypertension. Data were gathered from 304 black patients during the screening visit of a multicenter trial evaluating the efficacy of candesartan cilexetil (ATACAND). In addition to internal consistency and reproducibility, validity was assessed by correlating the VSQLQ with the Short Form-36 (SF-36). Sensitivity to sociodemographic effects and responsiveness to change was also examined. Cronbach's alpha levels were high (0.90, 0.92, 0.92 for frequency, intensity and combined scores, respectively) and the instrument was stable in patients reporting no health change over 8 weeks (ICC = 0.79, 0.79, and 0.80). Correlations between the VSQLQ and the SF-36 were moderate to high (0.32 to - 0.69) and statistically significant (p < 0.001). VSQLQ scores varied by gender, education, and income (p < 0.05). Patients who reported improvement in their general health status also reported significant improvements on the VSQLQ (n = 90; p < 0.05). Results support the reliability and validity of VSQLQ administered via personal interview to black patients with mild systemic hypertension.

Cost effectiveness of acute imipramine therapy versus two imipramine maintenance treatment regimens for panic disorder.

OBJECTIVE: To examine the medical costs and effectiveness of acute treatment with imipramine versus acute treatment plus 2 different maintenance therapies for panic disorder. METHODS: A clinical decision model was constructed to estimate 18-month costs and outcomes associated with these treatment scenarios based on the medical literature and clinician judgment. The clinical parameters and outcomes for the model were derived from a series of systematic clinical trials with imipramine utilising uniform dosage procedures and validated response criteria. Costs were calculated based on standardised treatment regimens. The outcome measures were 18-month medical costs, quality-adjusted life years (QALYs) and costs per QALY gained. A sensitivity analysis was performed to explore the impact of treatment withdrawals on outcomes. STUDY PERSPECTIVE: US mental healthcare system. RESULTS: Over 18 months, the total costs (1997 values) and QALYs associated with half-dose maintenance therapy (imipramine 1.1 mg/kg/day) [$US3377; QALYs = 0.991] and full-dose maintenance therapy (imipramine 2.25 mg/kg/ day) [$US3361; QALYs = 0.991] were almost identical; both were cost saving compared with acute imipramine therapy (2.25 mg/kg/day) with no maintenance treatment ($US3691; QALYs = 0.979). Whether patients withdrawing from treatment were considered to have continued to respond to treatment or to have relapsed, the half-dose and full-dose maintenance treatments were still cost saving compared with acute treatment alone. CONCLUSIONS: The results indicate that imipramine maintenance treatment is cost effective compared with acute imipramine treatment for patients with panic disorder. The basic findings and conclusions are not affected after modifying model assumptions for clinical response in patients withdrawing from treatment.

Patient preferences and utilities for 'off-time' outcomes in the treatment of Parkinson's disease.

The purpose of this study was to derive patient preferences and utilities for outcomes associated with treatment of motor fluctuations, or 'off-time', for patients with Parkinson's disease (PD). Visual analog scale (VAS) and standard gamble (SG) approaches were used with 60 patients to determine patient preferences and utilities for 10 health state descriptions. Health state descriptions were categorized according to two factors: disease severity, and proportion of the day with 'off-time'. There were two representative levels of disease severity, based on Hoehn and Yahr stages 1.5 and 2.5: unilateral disease with no postural instability, and bilateral disease with some postural instability. These severity levels were combined with five levels of 'off-time' per day ranging from none to > 75% of the day. Patients' mean preference or utility for their own current health ranged from 0.65 +/- 0.20 (VAS) to 0.74 +/- 0.22 (SG). Patients assigned the lowest mean values to the health state description for Hoehn and Yahr stage 2.5 with 'off-time' for > 75% of the day (VAS: 0.17 +/- 0.17; SG: 0.49 +/- 0.27). The highest mean values were assigned to Hoehn and Yahr stage 1.5 with no 'off-time' (VAS: 0.83 +/- 0.17; SG: 0.85 +/- 0.18). The results of this study indicated patients with PD would likely seek treatment that would minimize the amount of 'off-time' experienced per day, and that patients were relatively risk averse.

The impact of asthma on health-related quality of life.

Although a substantial body of epidemiological and economic literature on asthma exists, relatively little is known about the impact of asthma on health-related quality of life (HRQL). The purpose of this review was to synthesize results from recent studies, profile the factors influencing HRQL in asthmatics, discuss the impact of treatment on HRQL outcomes, and offer recommendations for further research. The results of this review support the premise that asthma can adversely affect the physical, psychological, and social domains of HRQL. Published data suggest that females, those from lower socioeconomic groups, and ethnic minorities experience poorer quality of life as a result of their asthma symptoms. Results of published clinical trials indicate treatment regimens can have a significant impact on HRQL outcomes. Pharmacological interventions appear to effect change primarily in the physical domain and behavioral interventions lead to improvements in both physical and psychosocial domains. Future research should focus on precise a priori delineation of research hypotheses, including the selection of primary and secondary endpoints, the clarification and consistent application of criteria for defining asthma severity, thoughtful selection of HRQL instruments appropriate for the research hypotheses and target population, and careful delineation of clinically meaningful change scores of asthma-specific outcome measures.

The complexity of treatment adherence in adults with asthma: challenges and opportunities.

The therapeutic program for persons with asthma includes recommendations for altering the environment and a drug regimen designed to alleviate symptoms, minimize exacerbations, and improve quality of life. Unfortunately, patients can have difficulty adhering to these recommendations, which contributes to treatment failure and increased costs. This paper provides a comprehensive review of the challenge of adherence in adults with asthma, including the costs and benefits, optimal adherence levels, assessment methods commonly used in research and practice, factors believed to predict poor adherence, and tested and untested strategies for improving adherence. Opportunities for further research are discussed throughout the paper.