Heterogeneous validity of daily data on symptoms of seasonal allergic rhinitis recorded by patients using the e‐diary AllergyMonitor®

Abstract

Background Patient‐generated symptom and medication scores are essential for diagnostic and therapeutic decisions in seasonal allergic rhinitis (SAR). Previous studies have shown solid consistencies between different scores at population level in real‐life data and trials. For clinicians, the evaluation of individual data quality over time is essential to decide whether to rely on these data in clinical decision‐making. Objective To analyze the consistency of different symptom (SS) and symptom medication scores (SMSs) at individual level in two study cohorts with different characteristics and explore individual patient trajectories over time. Methods Within the pilot phase of the @IT.2020 project on diagnostic synergy of mobile health and molecular IgE assessment in patients with SAR, we analyzed data of 101 children and 93 adults with SAR and instructed them to record their symptoms and medication intake daily via the mobile app AllergyMonitor®. We then assessed the correlation between different SMS and a visual analogue scale (VAS) on the impact of allergy symptoms on daily life at population and individual level. Results At population level, the Rhinoconjunctivitis total symptom score (RTSS) correlated better with VAS than the combined symptom and medication score (CSMS). At individual level, consistency among RTSS and VAS was highly heterogeneous and unrelated to disease severity or adherence to recording. Similar heterogeneity was observed for CSMS and VAS. Conclusions The correlation of clinical information provided by different disease severity scores based on data collected via electronic diaries (e‐diaries), is sufficient at population level, but broadly heterogeneous for individual patients. Consistency of the recorded data must be examined for each patient before remotely collected information is used for clinical decision making.

Patient‐reported outcome measures in birch pollen allergic patients treated with sublingual immunotherapy reflect real life

“…The strong correlation between VAS-RS with TSS 4 and TNSS indicates the concurrent validity of VAS. The correlations between RQLQ and daily PROMs were similar when considering the last study day or the median weekly values.…”

Beyond ARIA: Will e‐diaries replace retrospective questionnaires in measuring the severity of allergic rhinitis in clinical research and daily practice?

“…27 Major scientific organizations and research networks agree that the smartphone technology opens new avenues for disease monitoring 15,28,29 but they also alert on the need of finding consensus on their proper use, based on scientific validation of the elements composing this new diagnostic procedure. 15,30 To this end, the quantity, and the quality 31,32 of the data entered by each individual patient must be proven before the acquired information is used for clinical decisions. Once the data are validated, the clinician may wish to analyse the individual patient's trends of disease control scores, ideally via user-friendly visualizations.…”

“…via specific VAS). 30,31 The use of these scores has been widely investigated and approved by consensus in international guidelines for clinical research. 30,35,36 From the broad spectrum of possible parameters, taken alone or combined and weighted through indices and scores, the proper choice of the most adequate ones may be difficult.…”

“…combined symptom‐medication score, CSMS), 36,37 or assess the impact of symptoms on the quality of life or other domains (e.g. via specific VAS) 30,31 . The use of these scores has been widely investigated and approved by consensus in international guidelines for clinical research 30,35,36 …”

Real‐world data using mHealth apps in rhinitis, rhinosinusitis and their multimorbidities

“…The quality of the AllergyMonitor ® data was checked by estimating the percentage of changes in trends of the trajectories produced by the patients' data. 49 …”