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	TITLE PAGE
Paper Title
The role of Skin Prick Test in Assessment of Rhinitis: Our Institution�s Experience
Authors
Yu Feng Soh (Corresponding author)MBBS
David Chao-Wu Chin MBBS, MRCS(Edin), MRCS(Irel), MMed(ORL)
Hsu Pon PohMD, MBChB, FRCS(Edin), FRCS(Glasg), FAMS
Peter Kuo Sun LuMBBS, FRCS(Edin), FAMS
Heng Wai Yuen MBBS, GDFM, MRCS(Edin), DOHNS(Eng), MMed(ORL), FAMS

Affiliation/Mailing Address
Department of Otolaryngology-Head & Neck SurgeryChangi General Hospital 2 Simei Street 3 Singapore 529889Republic of Singapore

Email Address (Corresponding Author) HYPERLINK "mailto:yufengsoh@gmail.com" yufengsoh@gmail.com

Telephone Number (Corresponding Author)
+6594594890














ABSTRACT
Introduction
The SPT is routinely applied to identify allergens in clinical practice.  However, the reliability and clinical relevance of SPT results in the management of rhinitis remains controversial
 
Objectives
To evaluate the utility of the skin prick test (SPT) in prediction of clinical symptoms severity in patients with rhinitis .

Methods
Cross sectional study of patients with a clinical diagnosis of rhinitis with SPT from January to December 2010.  Symptoms severity global score (SSGS) was tabulated based on results from a standardised questionnaire.  Patient demographics, pre morbid conditions (presence of co-existing asthma and atopic dermatitis), SPT result and symptoms severity score were evaluated. 

Results
151 patients were evaluated.  SPT result was positive in 86 patients (57.0%).  The most prevalent allergen type was Dermatophagoides Pteronyssinus (68 patients; 79.1%).  The 4 most common symptoms experienced were nasal obstruction (91.3%), sneezing (81.5%), rhinorrhoea (80.1%) and nasal itching (77.5%).  Asthmatic patients were 3.18 times more likely (p = 0.031) to have a positive SPT result.  Elderly patients were less likely to have positive SPT results (p < 0.001), and had significantly less severe symptoms (p = 0.001).  There was no significant correlation (p > 0.05) between SPT result and SSGS.  


Conclusions
The positivity of SPT among patients with clinical diagnoses of rhinitis was not high, nor predictive of symptoms severity.  The value of routine SPT in the prognostication and initial management of rhinitis appears to be limited.  

Keywords
Skin prick test; Rhinitis; Symptoms severity; Management













INTRODUCTION

Rhinitis symptoms result from an inflammatory process within the nasal mucosal linings.  Cardinal symptoms include rhinorrhoea, nasal obstruction, nasal itching and sneezing [1].  Allergic rhinitis is the most common form of non-infectious rhinitis and is associated with an IgE-mediated immune response against allergens [2,3].  Other non-allergic conditions can also result in similar symptoms: infections, occupational exposure, hormonal imbalance and the use of certain drugs.  Following clinical diagnosis of rhinitis, allergen identification tests [4-8] may be further ordered to confirm the identity of provoking allergens and differentiate patients with an allergy etiology.

The SPT is routinely applied to rhinitis patients to identify allergens in clinical practice [9,10], in view of its straightforward, relatively innocuous and highly efficacious nature [1].  However, the reliability and clinical relevance of SPT results in the initial management of rhinitis remains controversial.  The outcome of SPT can be significantly affected by several factors.  These include the patient�s age [11-13] and seasonal variations [14].  Furthermore, SPT is prone to false-positive and false-negative results. The  former arises  from issues such as inadequate methodology and dermographism [4], while the latter may be attributed to factors such as poor preparations of allergen extract [15,16] or drugs and diseases which can alter the allergic response [1].   
 
SPT result do not always have a clear correlation with symptoms severity in rhinitis [17-19].  There may be multiple reasons for this.  For example, the skin may be a poor reflection of systemic changes in rhinitic disease [20].  Alternatively, psychological factors of hypochondriasis and somatic awareness play a significant role in modification of patients� perception of symptom intensity [21].  Various subjective grading and assessment modalities, such as control questionnaires and visual analogue tests, can be used to quantify symptoms severity [22-24]. 

In this retrospective study, we sought to evaluate the relevance of SPT in the management of patients presenting with rhinitis to our institution.  The objectives of the study were to a) describe the role of positive SPT findings in patients with clinically diagnosed rhinitis and b) to evaluate the correlation of SPT result with symptoms severity.  

METHODS

Patients
The sample population was drawn from a common pool of new patient encounters at a specialist outpatient clinic between January to December 2010.  Inclusion criteria were: a) Positive clinical diagnosis of rhinitis based on cardinal symptoms (rhinorrhoea, nasal obstruction, nasal itching and sneezing), b) Occurrence of symptoms during 2 or more consecutive days for more than 1 hour on most days [1], c) Having undergone a subsequent SPT evaluation following clinical diagnosis of rhinitis.  Patients with a history of dermographism, previous immunotherapy and those taking medication which could affect SPT result, such as long term corticosteroids, were excluded from the study.  Clinical data on patient demographics (age, sex, and race) and pre-existing medical conditions (e.g. asthma, atopic dermatitis) was collected from medical records.

Skin Prick Test
Alyostal� Prick (Stallergenes S.A., Antony, France) standardised allergen extract solutions were used for the SPT.  Allergens used in this study were chosen based on findings from previous studies on local population [25-27].  These included 14 aeroallergens, such as house dust mites, mould, dog hair, cat fur and 4 food allergens, such as shrimp, egg, soya and crab.  SPT was performed with the standardised technique.  It is performed on the flexor aspect of the forearm, after initial preparation of skin with alcohol and let dry.  Positions of each tested allergen were marked and spaced 3cm apart.  Following, the arm skin is applied with a standardised prick test needle - Stallerpoint� (Stallergenes S.A., Antony, France) vertically through a single drop of concentrated allergen extract.  A negative control of Phenolated glycerol-saline and a positive control of Histamine Hydrochloride (10mg/mL) were made under the same conditions.  The results were read on an average at 20 minutes.  A single observer evaluated the results to avoid inter-observer discrepancies.  Evaluation of the sensitivity was made by comparison of the (wheal + erythema) reaction due to the tested allergen with that due to the controls.  Sensitisation was considered positive when the wheal diameter was superior to the negative control wheal diameter by at least 3mm and at least equal to half of the positive control wheal diameter. 




Symptoms Evaluation
Following the clinical diagnosis of rhinitis, each subject was further evaluated with a standardized questionnaire.  Non cardinal symptoms associated with impairment of social life, work and school were also elicited and assessed [1].  For each symptom, an option that best matched the level of complaint (absent, minimal, mild, moderate, severe or very severe) was selected.  These options were allocated scores of 0, 1, 2, 3, 4 and 5 respectively.  A final SSGS for each patient was then computed by adding together these scorings.    

Data Analysis
Statistical analysis was performed using commercially available software (SPSS Statistics 20.0, SPSS Inc, Chicago, IL, USA).  Associations between patient demographic factors, premorbid medical conditions and SPT result were investigated with a logistic regression model.  SPT result (positive vs negative) was defined as the dependent variable, with all other factors being independent variables.  Following, stepwise linear regression models were built to detect and evaluate factors which could affect symptom severity global score.  Levels of significance for entry or removal of covariates from regression models were set at 0.05 and 0.10 respectively.  P < 0.05 was considered to be statistically significant unless otherwise stated.  










RESULTS
Patients
A total of 151 patients were recruited.  Median age was 28 (12-82) years and majority race was ethnic Chinese (77.5%).  The proportion of male patients was more than twice that of female patients (70.9% vs 29.1%).  A total of 33 (21.9%) and 10 (6.6%) patients had concurrent premorbid diagnoses of asthma and atopic dermatitis respectively (Table I).  

Skin Prick Test
57.0% of the sample population had positive SPT response to at least one allergen (Table I) while 76.7% of patients were sensitized to more than one type of allergen.  The majority of patients with poly-sensitisation had 3 allergens identified (Figure I).  Most prevalent allergen type was Dermatophagoides Pteronyssinus (68 patients; 79.1%); followed by Blomia Tropicalis (61 patients; 70.9%) and Dermatophagoides Farinae (60 patients; 69.8%) (Figure II).  

Symptoms Evaluation
Majority of symptoms reported by patients were nasal obstruction (138 patients); followed by sneezing (123 patients), rhinorrhoea (121 patients) and nasal itching (117 patients) (Figure III). 

Associations
SPT result
Asthmatic patients were approximately three times more likely to have a positive SPT result (p = 0.031) compared to non-asthmatic patients.  In addition, an increase in age was associated with a lower likelihood of positive SPT result (odds ratio: 0.922 per year of increase in age, 95% CI 0.892 � 0.953, p<0.001).  Race, gender and pre-existing atopic dermatitis were not correlated with SPT result (Table I).

Symptoms Severity Score
Increase in age was associated with a decrease in SSGS (unstandardized coefficient -0.131, 95% CI -0.205 to -0.058, p = 0.001).  The presence of a concurrent drug allergy was also associated with a higher severity score (unstandardized coefficient 3.10, 95% CI 0.417 to 5.79, p = 0.024).  SPT result (positive vs negative), gender, race and co-existing atopic diseases were not correlated with SSGS (Table II).















DISCUSSION  
As part of health care rationalisation, investigations are justified when they impact on prognostication or decision making in disease management.  The management of rhinitis encompasses patient education, pharmacotherapy and allergen specific immunotherapy when warranted [1].  Precise identification of trigger allergens through SPT would then allow for patient education on targeted allergen avoidance [1], and be important prior to initiation of allergen specific immunotherapy [28].  Symptoms severity and duration play a significant role in determining the treatment of rhinitis [1].  However, there is a paucity of studies examining the relationship between SPT result and symptoms severity in rhinitis amongst our nation.

This study revealed that only slightly more than half of the patients who were diagnosed clinically with rhinitis had a positive SPT result. In addition, a positive SPT reading does not predict a higher symptoms severity global score in rhinitis.  The pathophysiological mechanisms underpinning such correlations or the lack thereof are complex.  SPT results have been shown to be a poor indicator of rhinitic symptoms [20].  Dermographism and irritant effects or indeterminate attenuations from a close-by allergic reaction can be substantial enough to result in false positive SPT results [4].  Objective assessments of the nasal airways may be warranted to validate the role of SPT in the management of rhinitis.

Elderly patients were found to experience less severe symptoms of rhinitis.  In addition, we also found that this group of patients were less likely to have a positive SPT result compared to younger subjects.  This finding is consistent with results from previous studies which have investigated the association between skin histamine reactivity and age [11-13,29].  Jung et al identified a lower incidence of SPT positive results in participants older than 50 years of age, compared to those younger than 30 years of age[4].  Increasing age may cause a blunting of the hypersensitivity reactions mounted by the immune system against allergens, resulting in the abovementioned trends.  The use of SPT amongst elderly patients should be more selective, and other alternative diagnoses should be considered e.g. vasomotor or infectious rhinitis [1].

This study also found that asthmatic patients were approximately three times more likely to have a positive SPT result compared to non-asthmatic patients.  However, asthmatic patients were not found to have higher rhinitis symptom severity scores compared to non-asthmatics.  Previous epidemiology studies have shown that there is often a co-existence of asthma and rhinitis in the same patients [30-33].  Togias proposed the concept that rhinitis and asthma are both manifestations of one syndrome � the chronic allergic respiratory syndrome, with manifestations in two separate parts of the respiratory tract [34].   Patho-physiologically, common inflammatory pathways are shared between asthma and rhinitis: circulating levels of IgE are elevated in both conditions [35,36] and multi-functional mediators � cysteinyl leukotrienes are released from inflammatory cells, leading to the clinical manifestations of nasal symptoms [37].  Logically, a higher frequency of positive SPT results and a higher rhinitis symptom severity score would thus be expected in asthmatic patients.  The paucity of the latter trend in this study may possibly be due to the fact that patients were recruited from a specialist clinic in a tertiary healthcare setting.  Patients who had earlier been diagnosed with asthma prior to this study were already under management at a primary care level, with control of lower airways symptoms.

There are several limitations in the design of this retrospective study, chief of which is the small number of patients surveyed and possibility of an underpowered analysis.  The site of study was not necessarily reflective of the general population.  This study also failed to quantify SPT result in terms of elicited wheal size following exposure to the tested allergen.  Thirdly, quantitative measures of rhinitis symptoms, such as peak nasal inspiratory flow, could have been included in the study to allow for objective comparisons of symptom severity, in addition to the subjective questionnaire administered.      

In conclusion, results from this study show the absence of a correlation between positive SPT result and symptom severity in rhinitis.  Symptoms severity was negatively and positively correlated with increasing age and presence of a drug allergy respectively. Further studies are warranted to confirm these trends and to determine the role of SPT in the diagnosis and management of patients presenting with rhinitis. 







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