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Using the congestion quantifier seven-item test to assess change in patient symptoms and their impact.
Authors:Donald E Stull  Margaret K Vernon  G Walter Canonica  Simone Crespi  David Sandor
Affiliation:Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland 20814, USA. Donald.Stull@unitedbiosource.com
Abstract:Generally, nasal congestion is reported to be the most troublesome symptom of allergic rhinitis and has been shown to have negative effects on sleep, productivity, work, and school performance. A new patient-reported outcome (PRO) tool called the Congestion Quantifier Seven-Item Test (CQ7) was developed and shown to be a reliable and valid screening tool for nasal congestion. The purpose of this study was to assess the CQ7 as a tool for clinical use that can monitor changes in nasal congestion or determine if patients are showing meaningful improvement in symptoms. This study examined the responsiveness of the CQ7 to changes in nasal congestion and changes in relevant PRO to explore whether the CQ7 can serve as a monitoring tool and a valid screening tool for nasal congestion using latent growth curve models. Results showed that the CQ7 is sensitive to changes in patients' symptoms and their impact. Change in the CQ7 from baseline to day 15 was highly related to the change in symptom scores from baseline to day 15 (beta = -0.99); and regression coefficients for the relationships between the CQ7 and changes in the other PRO subscales also were very high (betas ranged from -0.79 to -0.95), lending evidence to support the use of the CQ7 as a monitoring tool. The large sizes of the coefficients suggest that the efficient, seven-item monitoring tool captures change in congestion very well. Analyses of responsiveness to change suggest that a three- to four-point improvement is meaningful to patients.
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