Development, validation, and evaluation of allergic rhinitis symptoms and impact assessment (ARSIA) questionnaire

INTRODUCTION: Allergic rhinitis (AR) is an inflammatory disease of the nasal mucosa. It is among the most common diseases globally and usually persists throughout life. Allergic Rhinitis and Its Impact on Asthma (ARIA) is a wellestablished guideline applicable to AR and was updated regularly since 2001, aiming to improve the care for AR patients. We proposed a new questionnaire that addresses the severity of allergic rhinitis symptoms, specifically nasal symptoms, and its impact on quality of life in terms of specific vital activities such as sleeping, working, school performance, leisure, or sport, based on the ARIA guideline. The objective was to develop, validate and evaluate Allergic Rhinitis Symptoms and Impact Assessment (ARSIA) questionnaire among allergic rhinitis patients in Hospital Sultan Abdul Halim, Sungai Petani (HSAH), and Hospital Universiti Sains Malaysia (HUSM).

MATERIALS AND METHODS: This is a prospective observational study to develop, validate and evaluate the ARSIA questionnaire based on ARIA guidelines. The sample will be obtained from the list of patients under follow-up in the ORL clinic HSAH and HUSM with ages of 18 to 60 years, patients clinically diagnosed with allergic rhinitis, and with positive skin prick test.

RESULTS: A total of 150 patients with a positive skin prick test participated in this study. In the 'nasal symptom' and 'impact on daily activities' domains, calculated Cronbach's alpha shows a value of 0.878 and 0.811 respectively. The inter-item correlation was calculated to analyse internal consistency reliability. Items B3 and B4 were dropped from the questionnaire as both showed a low correlation with other items. New Cronbach's alpha for the daily activities domain was 0.830, which showed better internal consistency reliability. All of the items were analysed for sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Clinician diagnosis from the proforma was used as a comparison to the participant's responses. In the analysis, a cut-off points of 12 was used to classify the patient's nasal symptoms into intermittent or persistent, with a sensitivity of 75%, specificity of 86%, PPV of 95%, and NPV of 51%. Whereas, a cut-off point of 15 was used to classify the rhinitis impact on daily activities into mild or moderate/severe, with a sensitivity of 58%, specificity of 100%, PPV of 100%, and NPV of 42%. The only item in the 'control' domain has been dropped out following a consensus of experts and judgement as it has not been used in the clinician diagnosis and thus, is unable to test for sensitivity, specificity, PPV, and NPV.

CONCLUSION: This newly developed, validated, and evaluated questionnaire is a good tool for the evaluation of allergic rhinitis symptoms and their impact on daily activities. It is important to understand that AR symptoms could have a significant impact on daily activities. Although further study and testing are needed, it provides an initial means for evaluating the patient condition and control level, as well as patients' perception of their rhinitis control.