The online version of this article (doi:10.1186/2045-7022-2-17) contains supplementary material, which is available to authorized users.
Competing interests
Dietrich Häfner, Hanns Meyer, Jens Kettner, and Annemie Narkus are employees of Allergopharma J. Ganzer KG, which develops and sells allergen immunotherapy products.
Kristian Reich, Ina Zschocke, and Annett Lotzin acted as a paid consultant to develop and validate a questionnaire and have received funding for research carried out in this work.
Author’s contributions
DH participated in the design of the study and drafted the manuscript; KR participated in the design of the study and acted as investigator; IZ participated in the design and the analyses of the study; AL performed the statistical analyses; HM participated in the design of the study and checked the statistical analyses; JK participated in the design of the study and contributed to the elaboration of scoring; AN conceived the scoring system and participated in the design of the study. All authors read and approved the final manuscript.
Patients (age 19 to 65 years) were recruited from the outpatient clinic department of “Dermatologikum Hamburg”, Germany, between 21 June and 17 August 2008. Inclusion criteria were: 1) atopic sensitization (SPT positivity to at least one of the following allergens: grass, rye, mugwort pollen, house dust mites) (Allergopharma J. Ganzer KG, Reinbek, Germany); 2) current clinical manifestations of allergic rhino-conjunctivitis and/or asthma due to exposure to one of the four allergens listed above; 3) expected natural exposure to the relevant allergens during the study period. Controls were non-atopic volunteers with a negative history for IgE-mediated allergies. The following exclusion criteria were applied to patients and controls: 1) current use of systemic or nasal corticosteroids, inhaled corticosteroids (>400μg budesonide or >500μg beclomethasone dipropionate per day); 2) long-term prophylactic use of anti-allergic medication with constant dose; 3) current treatment with specific immunotherapy; 4) food allergy; 5) clinically-relevant rhinitis/rhino-conjunctival or respiratory symptoms related to other unidentified causes; 6) vasomotor, drug-induced or other kinds of non-allergic rhinitis/rhino-conjunctivitis; 7) febrile infections or inflammation of the respiratory tract; 8) irreversible secondary alterations of the upper and lower airways (e.g. emphysema, bronchiectasis etc.). The study protocol was discussed with the local Ethics Committee before it was commenced. The committee advised that formal approval was not required, because the study was observational and no changes in treatment were involved. However, written informed consent was received from all patients involved before they were included into the study.
To objectively monitor severity of allergic rhinitis and allergic conjunctivitis
Population
Adult and adolescent patients with allergic rhinitis/conjunctivitis
Administration
Patient diaries
Original language
English
Existing translations
German, Polish and others
Number of items
7 symptoms and 745 drugs
Tool dimensions
see methods
Scaling of items
Score points
Scoring of items
0-42 (global)
List of items
see methods
Minimal important difference
To be determined
Shortened versions
none
Performed trials
Validation and use in different clinical trials
Copyright
Allergopharma Joachim Ganzer KG
Contact information
Häfner D. Medical Department Allergopharma J. Ganzer KG, Hermann-Körner-Str. 52 21465 Reinbek e-mail: dietrich.haefner@allergopharma.de
Medication score
Patients also have to document the allergy medication needed. All allergy medications for treating related symptoms are scored for each patient and each available day. Categories of medication taken into consideration include nasal and ocular anti-histamines and glucocorticoids, nasal decongestants, nasal cromoglycate acid and salts, systemic antihistamines, glucocorticoids and their combinations, leukotriene receptor antagonists. Drugs not foreseen by international Guidelines for treating allergic rhino-conjunctivitis are not included (e.g. anti-IgE). The total number of “score points” (SP) for symptoms on one day is 21 (i.e. each of the 7 symptoms scored with a maximum of 3). The maximum SP that can be achieved by intake of medication is also set to 21 SP, subdivided into the two sub-scores for nose (max. 12 SP) and eyes (max. 9 SP). Each drug is scored considering pharmacological action (according to the corresponding ATC code), expected impact on symptoms, route of administration, the dose taken and duration of effect. Each medication score is balanced for the respective weight on symptoms and within the maximum score of each organ system. Thus scoring of medication cannot yield a higher value than symptoms at the respective organ. An example for the scoring of medications is given in Table 2. In this example a patient had a combined intake of glucocorticoid-containing nasal spray, antihistaminic eye drops and nasal spray as well as systemic antihistamine. The most potent drugs are scored first; in this case the local glucocorticoids are scored. In case the maximum score of the corresponding subscore is not reached, the score for topical or systemic antihistamines is added until the maximum score points are reached (nose: 12 SP eyes: 9 SP). In case both systemic antihistamines and local antihistamines are given, the systemic antihistamine e.g. loratadine is scored first. The sum of SP of topical, systemic antihistamines and combination-drugs containing antihistamine cannot exceed 7 SP for the subscore nose and 5 SP for the subscore eyes, respectively.
Table 2
Example for the calculation of the medication score (combination of topical and systemic drugs)
** It would be 2 SP for use of Levocabastine NS alone, but in combination with the scores for Mometasone and Loratadine the maximum of 12 SP for nose is reached.
*** It would be 7 SP for use of Loratadine alone, but in combination with the Mometasone score the maximum of 12 SP for nose is reached.
Pollen counts (grasses, rye and mugwort) were derived from the European pollen information database (European Aeroallergen Network, Vienna, Austria) between 21 June and 17 August 2008 for the pollen traps in Lübeck and Reinbek. Pollen exposition was assessed using the 4-point scale (“None”, “Weak”, “Moderate”, “Strong”) according to the definition of the German Meteorological Service) for each week of assessment (Table 3).
Table 3
Assessment of pollen counts according to the definition of the German Meteorological Service
Pollen
No exposure
Weak exposure
Moderate exposure
Strong exposure
[grains/m3]
[grains/m3]
[grains/m3]
Hazel
0
1-10
11-100
> 100
Alder
0
1-10
11-100
> 100
Birch
0
1-10
11-50
> 50
Grasses
0
1-5
6-30
> 30
Rye
0
1-2
3-6
> 6
Mugwort
0
1-2
3-6
> 6
Ragweed
0
1-5
6-10
> 10
Statistics
Descriptive analysis
Background and demographic characteristics of subjects are summarized for both groups. Continuous variables are displayed by sample size, mean, median, standard deviation and range. Discrete variables are shown with frequencies and percentages. Missing SMS values were replaced by linear interpolation if at most 25% of the values were missing. Regarding all other parameters, the last-observation-carried-forward (LOCF) method was applied. Data management and statistical analysis were performed using the statistical analysis program SPSS Version 15.0 (SPSS Inc., Chicago, USA).
Retest Reliability is the extent to which scores for patients who have not changed are the same for repeated measurement over time. The retest reliability was determined for the patient group only, by correlating the SMS values of the first week with the values of the second week. Comparisons were conducted using Spearman’s rank correlations.
Results
Socio-demographic and clinical data
A total of 122 adults (82 allergic patients and 40 healthy controls) were screened for inclusion into the study. Of the 82 patients, 81 fulfilled the in/exclusion criteria and were included in the study and 80 completed the entire study. All 40 control subjects completed the study. The socio-demographic data of both groups are shown in Table 4 and the data on medical history of allergic diseases are given in Table 5 for the patient group.
Table 4
Socio-demographic data of the patient and control group
Patient group
Control group
(n = 81)
(n = 40)
M ± SD
Min
Max
Median
M ± SD
Min
Max
Median
Age (years)
30.4 ± 9.7
19.0
65.0
28.0
35.5 ± 9.1
19.0
58.0
34.0
Height (cm)
172.3 ± 8.6
154.0
195.0
172.0
173.1 ± 9.6
156.0
191.0
173.5
Weight (kg)
68.0 ± 14.7
48.0
147.5
65.0
74.8 ± 18.9
45.0
130.0
71.0
Sex
n
%
n
%
Male
20
25.0
18
45.0
Female
61
75.0
22
55.0
Race
n
%
n
%
Caucasian
77
95.1
37
92.5
Hispanic
1
1.2
0
0.0
African
0
0.0
1
2.5
Asian
2
2.5
2
5.0
n: Sample size of subgroup M: Arithmetic mean. SD: Standard deviation. Min: Minimum. Max: Maximum.
Table 5
Medical history data of the patient group
Type I Allergy to
n
%
Grass pollen
67
83
Dust mites
57
73
Rye
53
65
Mugwort
26
33
Duration of Allergy (years)
M ± SD
Min
Max
Median
Any allergy disorder
12.8 ± 8.7
1.0
50.0
10.0
Grass pollen
13.7 ± 9.2
1.0
50.0
11.0
Rye
15.1 ± 9.7
3.0
50.0
12.0
Mugwort
15.0 ± 8.6
3.0
37.0
14.0
Dust mites
11.8 ± 7.2
1.0
28.0
10.0
Allergic Illnesses
n
%
Allergic rhinitis
80
98.8
Allergic conjunctivitis
69
85.2
Allergic asthma
31
38.3
Atopic dermatitis
9
11.1
n: Number of subjects. M: Arithmetic mean. SD: Standard deviation. Min: Minimum. Max: Maximum.
Severity of symptoms in allergic patients vs. healthy controls
The severity of symptoms in allergic patients vs. healthy controls is shown in Table 6. Clearly, patients had higher values than healthy controls. Controls had values close to the lowest possible values. Since healthy controls were non-allergic based on their medical history, symptom rating of the control patients is due to other factors than allergic symptoms.
Table 6
Severity of allergy in allergic patients vs. healthy controls
Discrimination capacity of the SMS. Frequency distribution of the SMS among 81 allergic patients (A) and 40 healthy control subjects (B). Panel (C) shows a ROC curve of the discrimination power of patients vs. controls; the area under the curve is 0.9755; the best discrimination point is 0.786, corresponding to a sensitivity of 93.8% and a specificity of 92.5%.
The pollen counts of Poaceae in the two aerobiology stations were monitored during an eight-week period (Figure 2). Patients recorded their symptoms in a diary during this period.
Figure 2
Pollen exposure during the study period. Pollen counts in two sites representative for this region during the whole study period.
A visual analog scale as used by Bousquet and colleagues [7] seems to be an easy to use instrument to assess efficacy of e.g. specific immunotherapy. However, nowadays a visual analog scale as used by Bousquet and colleagues [7] will no longer be accepted by health authorities to achieve approval for new medications especially if used for specific immunotherapy because the EMA guideline [3] states that “…the primary endpoint has to reflect both, symptom severity as well as the intake of rescue medication”. The present article does not claim to have a comprehensive discussion of all available instruments. For this purpose the authors would like to refer to a recently published review on such instruments by Pfaar and colleagues [14].
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Competing interests
Dietrich Häfner, Hanns Meyer, Jens Kettner, and Annemie Narkus are employees of Allergopharma J. Ganzer KG, which develops and sells allergen immunotherapy products.
Kristian Reich, Ina Zschocke, and Annett Lotzin acted as a paid consultant to develop and validate a questionnaire and have received funding for research carried out in this work.
Author’s contributions
DH participated in the design of the study and drafted the manuscript; KR participated in the design of the study and acted as investigator; IZ participated in the design and the analyses of the study; AL performed the statistical analyses; HM participated in the design of the study and checked the statistical analyses; JK participated in the design of the study and contributed to the elaboration of scoring; AN conceived the scoring system and participated in the design of the study. All authors read and approved the final manuscript.
In einer Leseranfrage in der Zeitschrift Journal of the American Academy of Dermatology möchte ein anonymer Dermatologe bzw. eine anonyme Dermatologin wissen, ob er oder sie einen Patienten behandeln muss, der eine rassistische Tätowierung trägt.
Extreme Arbeitsverdichtung und kaum Supervision: Dr. Andrea Martini, Sprecherin des Bündnisses Junge Ärztinnen und Ärzte (BJÄ) über den Frust des ärztlichen Nachwuchses und die Vorteile des Rucksack-Modells.
In einer Metaanalyse von 18 Studien war die Rate von Nachblutungen nach einer Abszesstonsillektomie mit weniger als 7% recht niedrig. Nur rund 2% der Behandelten mussten nachoperiert werden. Die Therapie scheint damit recht sicher zu sein.
Die erotischen Dimensionen von Peritonsillarabszessen scheinen eng begrenzt zu sein. Das heißt aber nicht, solche Abszesse und Erotik hätten nichts miteinander gemein, wie ein Fallbericht verdeutlicht.
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