Evaluation of patients' expectations and benefits in the treatment of allergic rhinitis with a new tool: the patient benefit index - the benefica study

Abstract

Background: Symptoms of allergic rhinitis (AR) have a detrimental effect on quality of life. The AR-Patient Benefit Index (AR-PBI), a specific self-assessment tool has been developed to assess treatment-related benefit in two separate sections: the Patient Needs Questionnaire (PNQ) which explores the patient's expectations before treatment and the Patient Benefit Questionnaire (PBQ) which evaluates treatment benefit. For the PNQ, three dimensions summarize patients' expectations: symptoms, social life and emotional state, thus covering a larger field than symptomatic relief. The aim of the study was to validate the French language version of the AR-PBI and to assess the treatment-related expectations and benefits provided in patients with allergic rhinitis treated with H1-antihistamines in a real-life study.

Methods: BENEFICA was a prospective, observational study involving patients with allergic rhinitis who were starting treatment with H1-antihistamines. The Patient Needs Questionnaire (PNQ) was administered before treatment (D0) and the Patient Benefit Questionnaire (PBQ) was collected after a 14-day course of H1-antihistamines (D15). Discomfort (visual analog scale), and quality of life (miniRQLQ) were measured on D0 and D15.

Results: Three thousands and eighty-nine patients were enrolled in the study: mean age 39 ± 14 years, women 52%, 81% of patients with moderate to severe persistent rhinitis (Allergic Rhinitis and its Impact on Asthma, ARIA); 19% had (a) concomitant condition(s), 18% were asthmatic, and 12% had atopic dermatitis. Discomfort and quality of life improved between D0 and D15. AR-PBI was 2.7 ± 0.8, superior to 1 (threshold for clinically relevant benefit) for 97% of patients and greater in patients willing to continue the treatment. PBI was moderately correlated to change in miniRQLQ (r = -0.45, p < 0.0001) and change in discomfort (r = -0.38, p < 0.0001), suggesting a richer conceptual content than symptoms relief.

Conclusions: The French version of the Allergic Rhinitis-Patient Benefit Index (AR-PBI) has been validated. It complements the discomfort and quality of life tools and assesses the needs and benefits in patients suffering from allergic rhinitis. This new tool may help physicians to better understand patients' expectations and to discuss treatment issues with their patients.

Keywords: AR-PBI; Allergic rhinitis; Antihistamine; Patient benefit index; Patients’ needs; Real-life study; Satisfaction; Treatment-related benefit.

Figure 1

Intensity of symptoms at entry in the study (n = 3089). The percentage of patients is reported on the vertical axis. Symptoms are reported on the horizontal axis, from left to right: rhinorrhea, a blocked nose, sneezing, nasal pruritus, red eye, eye stinging, watery eye, pharyngeal discomfort. Symptom intensity (absent, mild, moderate, severe) is represented by columns: white columns correspond to absent; hatched columns correspond to mild; dotted columns correspond to moderate; and black columns correspond to severe.

Figure 2

AR-PBI distribution in patients with AR after a 14-day treatment period with antihistamines (n = 3089). The percentage of patients is reported on the vertical axis while the patient benefit index (PBI) score is reported on the horizontal axis. This score ranges from 0 to 4 and is divided into 8 intervals.