Prospective validation of 'Allergy-Control-SCORE(TM)': a novel symptom-medication score for clinical trials.
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 (P < 0.0001), quality of life (P < 0.0001), and allergy-related medical consultations (P < 0.0001). Scores were highly related to pollen counts. Allergy-Control-SCORE© showed a good retest reliability (r = 0.81; P < 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.
Department of Clinical Research, Allergopharma J. Ganzer KG, Reinbek, Germany. dietrich.haefner@allergopharma.de
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Matricardi
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D000293:Adolescent; D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D002986:Clinical Trials as Topic / Q000379:methods*; D003233:Conjunctivitis, Allergic; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D011058:Pollen; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D055815:Young Adult