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.