Psychometric validation of a patient-reported sensory perception and preference instrument: the Sensory Perceptions Questionnaire.

This study evaluated the psychometric properties of content validity, construct validity, and test-retest reliability of a 23-item Sensory Perceptions Questionnaire (SPQ) used to survey sensory perceptions of intranasal corticosteroid sprays. Two patient cohorts (men and women aged > or =18 years who had at least a 1-year history of allergic rhinitis and had been using a corticosteroid nasal spray) were enrolled. The content validity and construct validity of the SPQ questions were evaluated using a cognitive debriefing method after cohort 1 (n=15) completed the SPQ. Test-retest reliability (assessed with intraclass correlation coefficients [ICCs] of the SPQ questions) was evaluated in cohort 2 (n=50), after they answered a Web-based version of the SPQ on two occasions, each separated by 7 days. In cohort 1, 7 of 15 patients believed all relevant sensory perceptions were addressed in the questionnaire. Although 8 patients mentioned at least 1 sensory perception that was not addressed, only 4 sensory perceptions were mentioned by more than 1 patient, and none was mentioned reliably by more than 2 patients. Those 4 sensory perceptions not addressed in the SPQ were all intentionally excluded, because they were potential symptoms of rhinitis or adverse events associated with intranasal corticosteroid spray use. Patients regarded the questions as straightforward, nonburdensome, and nonthreatening, signs suggesting the questions were not likely to challenge the construct validity of the SPQ. The responses to 2 questions (one in which patients were asked to indicate whether they were pleased or displeased overall with a particular spray; the other to indicate their overall product preference) were somewhat influenced by the effectiveness of the sprays. Results of test-retest reliability (cohort 2) showed both high (>0.8) and low (<0.7) ICCs. A high degree of correspondence between the 2 administrations produced a low between-patient variance, which likely resulted in lower ICCs. The SPQ adequately represents the sensory attributes reported by patients regarding intranasal corticosteroid spray use and, overall, is a valid measure of patient preference based on sensory perception.

The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation.

BACKGROUND: A patient report of respiratory symptoms in COPD is essential to successfully monitoring disease, adjusting treatment, and evaluating outcomes. OBJECTIVE: To develop empirically based guidelines for interpreting mean changes in symptom scores using the Breathlessness, Cough, and Sputum Scale (BCSS). METHODS: Analyses were performed on data from three multinational trials (n = 2,971). Mean changes in BCSS score with treatment were examined by physician and patient ratings of treatment efficacy, juxtaposed with percentage change in symptoms, statistical effect size (ES), DeltaFEV(1), and change in St. George Respiratory Questionnaire (SGRQ) score. BCSS scores during an exacerbation were examined relative to changes in peak expiratory flow and rescue medication use. RESULTS: Mean baseline BCSS total score was 5.2 +/- 2 (+/- SD); 90% of scores were between 2 and 9. Highly efficacious treatment (n = 257; physician rating) was associated with a DeltaBCSS total score of - 1.3 +/- 1.8, representing a 24% improvement (ES = 0.7), and corresponding to a 10% improvement in FEV(1) and DeltaSGRQ score total of - 10.3 +/- 13.8. Similar changes in BCSS score were observed during recovery from an exacerbation (n = 713; - 1.3 +/- 1.8). Mean change with moderately efficacious treatment (n = 965) was - 0.7 +/- 1.8, a 13% improvement (ES = 0.3) corresponding to DeltaSGRQ total score of - 6.8 +/- 12.6. Mildly efficacious treatment (n = 891) was associated with a change of - 0.35, a 7% improvement (ES = 0.18), with a DeltaFEV(1) <1% and DeltaSGRQ total score of - 2.6 +/- 11.7. CONCLUSIONS: Patient-reported daily symptom data are sensitive to change and useful for both observational studies and controlled clinical trials of patients with COPD. A mean DeltaBCSS total score > 1.0 represents substantial symptomatic improvement, changes of approximately 0.6 can be interpreted as moderate, and changes of 0.3 can be considered small.

Two multicenter, randomized, single-blind, single-dose, crossover studies of specific sensory attributes of budesonide aqueous nasal spray and fluticasone propionate nasal spray.

BACKGROUND: Intranasal corticosteroids are effective for the treatment of allergic rhinitis. Sensory attributes associated with these sprays may affect patient preference and adherence to treatment regimens. OBJECTIVES: These 2 studies compared patients' perceptions of and preferences for specific sensory attributes of budesonide aqueous nasal spray (BANS) and fluticasone propionate nasal spray (FPNS). METHODS: In 2 multicenter, randomized, single-blind (patient), single-dose, 2-period, 1-day crossover studies, adults with mild to moderate allergic rhinitis received single doses of BANS (one 32-pg spray per nostril in both studies, 64-microg total dose) and FPNS (two 50-microg sprays per nostril in study 1, 200-pg total dose; one 50-microg spray per nostril in study 2, 100-microg total dose). Study 1 compared the once-daily recommended starting doses of BANS and FPNS, and study 2 compared BANS with half the once-daily recommended dose of FPNS to balance the number of actuations for delivery of study drug. Patients completed the 23-item Sensory Perceptions Questionnaire and indicated their product preference (if any). RESULTS: A total of 110 women and 71 men in study 1 and 136 women and 54 men in study 2 were randomized to treatment. None had previously used BANS or FPNS. In both studies, fewer patients perceived scent or taste (both P < 0.001 in both studies), forceful spray (P < 0.001 in both studies), and a wet feel in both the nose and throat (study 1, P < 0.004; study 2, P < 0.002) with BANS than with FPNS. In addition, more patients in both studies liked the spray force (study 1, P < 0.01; study 2, P < 0.001) and moisture content in the throat (study 1, P < 0.001; study 2, P < 0.006) of BANS and indicated a greater overall satisfaction with the sensory features of BANS than those of FPNS (study 1, P < 0.001; study 2, P < 0.015). In analyses that included all responding patients, 54.4% of patients in study 1 preferred BANS and 37.8% preferred FPNS (P < 0.022). In study 2, 47.4% preferred BANS and 41.1% preferred FPNS (not significant). Of the 92.2% of patients in study 1 and 88.4% in study 2 who specified a product preference, 59.0% preferred BANS and 41.0% preferred FPNS in study 1 (P = 0.021), and 53.6% preferred BANS and 46.4% preferred FPNS in study 2 (not significant). CONCLUSIONS: On the basis of perceptions of specific sensory attributes reported after 1 administration in these 2 studies, BANS was rated as more pleasing and preferred over the recommended QD starting dose of FPNS, and was also rated as more pleasing than half the QD recommended starting dose of FPNS.