Skip to main content
Top
Published in: Clinical and Translational Allergy 1/2012

Open Access 01-12-2012 | Research

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

Authors: Dietrich Häfner, Kristian Reich, Ina Zschocke, Annett Lotzin, Hanns Meyer, Jens Kettner, Annemie Narkus

Published in: Clinical and Translational Allergy | Issue 1/2012

Login to get access

Abstract

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.
Appendix
Available only for authorised users
Literature
1.
go back to reference 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. 10.1111/j.1398-9995.2010.02531.x.CrossRefPubMed 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. 10.1111/j.1398-9995.2010.02531.x.CrossRefPubMed
2.
go back to reference 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. 10.1111/j.1398-9995.2006.01312.x.CrossRefPubMed 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. 10.1111/j.1398-9995.2006.01312.x.CrossRefPubMed
3.
go back to reference European Medicines Agency CHMP/EWP/18504/2006): Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases. 2008, European Medicines Agency (EMEA): Committee for Medicinal Products of Human Use (CHMP) European Medicines Agency CHMP/EWP/18504/2006): Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases. 2008, European Medicines Agency (EMEA): Committee for Medicinal Products of Human Use (CHMP)
4.
go back to reference 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. 10.1111/j.1398-9995.2005.00790.x.CrossRefPubMed 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. 10.1111/j.1398-9995.2005.00790.x.CrossRefPubMed
5.
go back to reference 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. 10.1016/S1081-1206(10)60451-6.CrossRefPubMed 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. 10.1016/S1081-1206(10)60451-6.CrossRefPubMed
6.
go back to reference 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. 10.1016/j.otohns.2005.07.020.CrossRefPubMed 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. 10.1016/j.otohns.2005.07.020.CrossRefPubMed
7.
go back to reference 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. 10.1111/j.1398-9995.2006.01276.x.CrossRefPubMed 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. 10.1111/j.1398-9995.2006.01276.x.CrossRefPubMed
8.
go back to reference 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. 10.1111/j.1365-2222.1991.tb00807.x.CrossRefPubMed 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. 10.1111/j.1365-2222.1991.tb00807.x.CrossRefPubMed
9.
go back to reference Baiardini I, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A: 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. 10.1111/j.1398-9995.2009.02263.x.CrossRefPubMed Baiardini I, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A: 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. 10.1111/j.1398-9995.2009.02263.x.CrossRefPubMed
10.
go back to reference Cohen J: Statistical power analysis for the behavioral sciences. 1988, Hillsdale, New York: Erlbaum Cohen J: Statistical power analysis for the behavioral sciences. 1988, Hillsdale, New York: Erlbaum
11.
go back to reference 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. 10.1111/j.1399-3038.2011.01228.x.CrossRefPubMed 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. 10.1111/j.1399-3038.2011.01228.x.CrossRefPubMed
12.
go back to reference Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C: 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.CrossRefPubMed Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C: 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.CrossRefPubMed
13.
go back to reference Clark J, Shall R: Assessment of combined symptom and medication scores for rhinconjunctivitis immunotherapy clinical trials. Allergy. 2007, 62: 1023-1028. 10.1111/j.1398-9995.2007.01469.x.CrossRefPubMed Clark J, Shall R: Assessment of combined symptom and medication scores for rhinconjunctivitis immunotherapy clinical trials. Allergy. 2007, 62: 1023-1028. 10.1111/j.1398-9995.2007.01469.x.CrossRefPubMed
14.
go back to reference 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. 10.1016/j.iac.2011.02.004.CrossRef 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. 10.1016/j.iac.2011.02.004.CrossRef
Metadata
Title
Prospective validation of the “rhino conjunctivitis allergy-control-SCORE©” (RC-ACS©)
Authors
Dietrich Häfner
Kristian Reich
Ina Zschocke
Annett Lotzin
Hanns Meyer
Jens Kettner
Annemie Narkus
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Clinical and Translational Allergy / Issue 1/2012
Electronic ISSN: 2045-7022
DOI
https://doi.org/10.1186/2045-7022-2-17

Other articles of this Issue 1/2012

Clinical and Translational Allergy 1/2012 Go to the issue