Prospective validation of the “rhino conjunctivitis allergy-control-SCORE©” (RC-ACS©)

Clinical and Translational Allergy

Annemie Narkus¹  Jens Kettner¹  Hanns Meyer¹  Annett Lotzin²  Ina Zschocke²  Kristian Reich²  Dietrich Häfner¹ 

[1] Medical Department, Allergopharma J. Ganzer KG, Hermann-Körner-Str. 52, Reinbek, 21465, Germany;Dermatologikum Hamburg, Hamburg, Germany

关键词: Symptom severity;    Rhino conjunctivitis;    Allergic disease;    Medication score;    Symptom score;   

Others  :  794539
DOI  :  10.1186/2045-7022-2-17

 received in 2012-06-13, accepted in 2012-09-02,  发布年份 2012

【 摘 要 】

Background

Recently we reported the validation of the “Allergy-Control-SCORE^© (ACS)” which assesses symptom severity as well as medication use on three dimensions lung, nose and eyes. The aim of this study was to test the validity of the score for eyes and nose.

Methods

One-hundred-twenty-one consenting subjects (age 19-65y), including 81 patients with allergic rhino-conjunctivitis (RC) and 40 healthy controls, participated in the study. Patients rated daily nasal and eye symptoms using a 4-point scale (none, mild, moderate, and severe) and their use of anti-symptomatic medication. Validation criteria were pollen counts in the course of the study period. Discrimination capacity was analyzed by comparing the rhino-conjunctivitis Allergy-Control-SCORE^© (RC-ACS^©) values of allergic patients and healthy controls. Convergent reliability was assessed by correlating RC-ACS^© values with the global severity of allergy, the quality of life, and the allergy-related medical consultations. Retest reliability was assessed by the correlation of the repeated measured RC-ACS^© scores during each of two consecutive weeks.

Results

Convergent reliability analysis indicated a significant correlation between RC-Allergy-Control-SCORE^© and global severity of allergy (r = 0.691; p < 0.0001), quality of life (r = 0.757; p < 0.0001) and allergy-related medical consultations (r = 0.329; p = 0.0019). RC-Allergy-Control-SCORE^© showed a good retest reliability (r = 0.813; p < 0.001) and discriminated extremely well between allergic patients and healthy controls (Median: 3.7 range: 0; 14.1 vs. Median: 0 range: 0; 2.9; p < 0.001), with a sensitivity of 93.8% and a specificity of 92.5% at a score value of 0.786.

Conclusions

The RC-ACS^© can be considered as valid and reliable to assess the severity of rhino-conjunctivitis severity in clinical trials and observational studies.

【 授权许可】

   
2012 Häfner et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]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.
• [2]Canonica GW, Baena-Cagnani CE, Bousquet J, Bousquet PJ, Lockey RF, Malling HJ, Passalacqua G, Potter P, Valovirta E: Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce. Allergy 2007, 62:317-324.
• [3]European Medicines Agency CHMP/EWP/18504/2006): Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases. European Medicines Agency (EMEA): Committee for Medicinal Products of Human Use (CHMP); 2008.
• [4]Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A: Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy 2005, 60:801-807.
• [5]Pfaar O, Klimek L: Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol 2008, 100:256-263.
• [6]Klimek L, Mewes T, Wolf H, Hansen I, Schnitker J, Mann WJ: The effects of short-term immunotherapy using molecular standardized grass and rye allergens compared with symptomatic drug treatment on rhinoconjunctivitis symptoms, skin sensitivity, and specific nasal reactivity. Otolaryngol Head Neck Surg 2005, 133:538-543.
• [7]Bousquet PJ, Combescure C, Neukirch F, Klossek JM, Méchin H, Daures JP, Bousquet J: Visual analog scales can assess the severity of rhinitis graded according to ARIA guidelines. Allergy 2007, 62:367-372.
• [8]Juniper EF, Guyatt GH: Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy 1991, 21:77-83.
• [9]Baiardini I, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, et al.: The Global Allergy and Asthma European Network: Recommendations for assessing patient-reported outcomes and health-related quality of life in clinical trials on allergy: a GA2LEN taskforce position paper. Allergy 2010, 65:290-295.
• [10]Cohen J: Statistical power analysis for the behavioral sciences. Hillsdale, New York: Erlbaum; 1988.
• [11]Melioli G, Marcomini L, Agazzi A, Bazurro G, Tosca M, Rossi GA, Minale P, Rossi R, Reggiardo G, Canonica GW, Passalacqua G: The IgE repertoire in children and adolescents resolved at component level: A cross-sectional study. Pediatr Allergy Immunol 2012, 23:433-440.
• [12]Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, et al.: Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 Update (in collaboration with the World Health Organization, GA2LEN and AllerGen). Allergy 2008, 63(Suppl. 86):8-160.
• [13]Clark J, Shall R: Assessment of combined symptom and medication scores for rhinconjunctivitis immunotherapy clinical trials. Allergy 2007, 62:1023-1028.
• [14]Pfaar O, Kleine-Tebbe J, Hörmann K, Klimek L: Allergen-specific immunotherapy: Which outcome measures are useful in monitoring clinical trials? Immunol Allergy Clin N Am 2011, 31:289-309.