DEVELOPMENT OF A NASAL COMFORT INDEX FOR NASAL SPRAYS IN ADULTS WITH SEASONAL ALLERGIC RHINITIS
Author(s)
Keresteci MA1, Ungar W1, Ryan N1, Mendelson L2, Tarlo S3, Nadal JC4, Rosano ME4, Evans C4, 1Innovus Research Inc, Burlington, Ontario, Canada; 2Connecticut Asthma and Allergy, West Hartford, CT, USA; 3University of Toronto, Toronto, Ontario, Canada; 4Astra Pharmaceuticals, Westborough, MA, USA
OBJECTIVE: The study purpose was to develop an instrument to assess patient comfort and satisfaction with prescribed nasal sprays in the treatment of seasonal allergic rhinitis. METHODS: Standard instrument development methodology was utilized. A list of pertinent items obtained from the literature was formulated. Each Nasal Comfort Index (NCI) draft was scrutinized by experts regarding item appropriateness, wording and anchor labels. Five-point Likert scales were utilized. The NCI was organized into pre-defined categories. Questions were included to establish perceived importance of each category in order to develop weights for determining a total score. Perception of content was assessed by 19 subjects. Qualitative and quantitative data were collected. Item combination/reduction was conducted after pre-test of the instrument. Correlations between domain and total scores were calculated to determine the best of four potential methods for calculating these scores. RESULTS: Literature review revealed no existing validated methods for assessing patient comfort, satisfaction and preferences in the target population. The final selection of items was based on qualitative and quantitative analysis. The resultant NCI contained 20 items which, through factor analysis, resulted in four domains explaining 82% of the variance. The most appropriate scoring method was deemed to be weighted means. CONCLUSIONS: Quantitative analysis confirmed many qualitative findings. A single total score, combining the domain scores, was considered the most clinically relevant method for differentiating the effects of nasal sprays. Validation analysis will occur on data gathered through NCI implementation in a clinical trial.
Conference/Value in Health Info
1999-05, ISPOR 1999, Arlington, VA, USA
Value in Health, Vol. 2, No. 3 (May/June 1999)
Code
PRD13
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Respiratory-Related Disorders