Utilization of health care services by patients with chronic obstructive pulmonary disease.

In order to identify healthcare resource use patterns associated with chronic obstructive pulmonary disease (COPD), resource utilization (RU) data collection was integrated into a randomized, double-blind placebo-controlled study of Viozan (sibenadet HCl). This study enrolled patients with symptomatic, smoking-related COPD, randomized to receive sibenadet or placebo for a 52-week treatment period. A questionnaire establishing typical pre-trial, COPD-related RU was completed by each patient. Subsequent data were collected by means of an Interactive Voice Response System (IVRS) at 30-day intervals (14 time points) during the study and in the follow-up period. The IVRS system facilitated data collection and minimized inconvenience to the patient. Compliance with the requirement to record details of the healthcare services during the year-long study was high. No overall trend for lower RU was associated with sibenadet therapy, which correlates with the lack of sustained clinical effect seen in studies conducted concurrently. These data do, however, provide valuable information on RU associated with COPD and insights into adjustments associated with changes in disease course. Physicians were seen to be the most common source of care for patients with COPD and more of the patients with severe COPD (stage III) than mild (stage I) were seen to utilize the most expensive resources (e.g. inpatient hospital care). For those patients who experienced an exacerbation during the trial (irrespective of treatment group), resource use was increased during the periods when an exacerbation was reported when compared with the periods before or after an exacerbation. The proportion of cases attending the physician doubled and with a trip to the Emergency Room (ER) increased approximately ninefold during the reporting period in which the exacerbation occurred compared with the previous month. This study has shown that use of an IVRS, even in elderly patients, is an effective means of gathering RU data over long periods. The study findings suggest that the advent of effective therapeutic interventions, particularly any with the ability to minimize exacerbations and limit disease progression, could impact on the health care services used and potentially reduce associated costs.

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.