Prospective validation of ‘Allergy-Control-SCORETM’: a novel symptom–medication score for clinical trials

Authors


  • Edited by: Hans-Uwe Simon

D. Häfner, Department Clinical Research, Allergopharma J. Ganzer KG, Hermann-Körner-Str. 52, 21465 Reinbek, Germany.
Tel.: +49 40 72765316
Fax: +49 40 72765600
E-mail: dietrich.haefner@allergopharma.de

Abstract

To cite this article: Häfner D, Reich K, Matricardi PM, Meyer H, Kettner J, Narkus A. Prospective validation of ‘Allergy-Control-SCORETM’: a novel symptom–medication score for clinical trials. Allergy 2011; 66: 629–636

Abstract

Background:  Combined symptom and medication scores (SMS) are recommended as primary endpoints in clinical trials. Several SMS have been created, but none has been formally validated.

Objective:  To evaluate the validity of the ‘Allergy-Control-SCORE© (ACS)’, a novel instrument to assess patient’s allergy severity by recording symptoms and rescue medication.

Methods:  One hundred and twenty-one consenting subjects (age 18–65 year), including 81 patients with allergic rhino-conjunctivitis and/or asthma and 40 healthy controls, participated in the study. They recorded daily nasal, eye, and lung symptoms using a 4-point scale (none, mild, moderate, and severe) and use of anti-symptomatic medication. Pollen counts were monitored during the study period. Symptom and medication scores values were compared to global allergy severity, quality of life, and allergy-related medical consultations. Feasibility was tested through a questionnaire on comprehensibility, easiness of use, and completeness. Retest reliability was assessed by testing consistency, in relation to pollen exposure, and for values recorded during each of 2 consecutive weeks.

Results:  Convergent reliability analysis indicated a highly significant correlation between ACS© and global allergy severity (< 0.0001), quality of life (< 0.0001), and allergy-related medical consultations (< 0.0001). Scores were highly related to pollen counts. Allergy-Control-SCORE© showed a good retest reliability (r = 0.81; < 0.0001) and discriminated extremely well between patients with allergy and healthy controls (6.1 ± 4.8 vs 0.2 ± 0.5; t = 10.82; P < 0.0001) with a sensitivity of 97% and a specificity of 87%. Study participants evaluated the feasibility of the SMS as excellent.

Conclusions:  Allergy-Control-SCORE© is a valid and reliable instrument to assess allergy severity in clinical trials and observational studies of respiratory allergic diseases.

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