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Accepted for/Published in: JMIR mHealth and uHealth

Date Submitted: Jun 23, 2021
Date Accepted: Dec 7, 2021

The final, peer-reviewed published version of this preprint can be found here:

Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study

Dramburg S, Perna S, Di Fraia M, Tripodi S, Arasi S, Castelli S, Villalta D, Buzzulini F, Sfika I, Villella V, Potapova E, Brighetti MA, Travaglini A, Verardo PL, Pelosi S, Matricardi PM

Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study

JMIR Mhealth Uhealth 2022;10(6):e31491

DOI: 10.2196/31491

PMID: 35657659

PMCID: 9206201

Exploring validation parameters of patient-generated data for digitally recorded allergic rhinitis symptom and medication scores: the @IT.2020 project.

  • Stephanie Dramburg; 
  • Serena Perna; 
  • Marco Di Fraia; 
  • Salvatore Tripodi; 
  • Stefania Arasi; 
  • Sveva Castelli; 
  • Danilo Villalta; 
  • Francesca Buzzulini; 
  • Ifigenia Sfika; 
  • Valeria Villella; 
  • Ekaterina Potapova; 
  • Maria Antonia Brighetti; 
  • Alessandro Travaglini; 
  • Pier Luigi Verardo; 
  • Simone Pelosi; 
  • Paolo Maria Matricardi

ABSTRACT

Background:

Mobile health technologies enable allergists to monitor disease trends by collecting daily patient-reported outcomes of allergic rhinitis (AR). To this end, allergic patients are usually required to enter their symptoms and medication repetitively over long time periods, which may present a risk to data completeness and quality in the case of inefficient effort reporting. Completeness of patient’s recording is easily measured. In contrast, the intrinsic quality and reliability of the data entered by the patients are more elusive.

Objective:

To explore the association of adherence to compilation with a pre-defined set of parameters of the patient-generated symptom and medication scores. To identify parameters that may serve as proxy measure of quality and reliability of the information recorded by the patient.

Methods:

The @IT2020 project is investigating the diagnostic synergy of mobile health and molecular allergology in patients with seasonal allergic rhinitis. In its pilot phase, 101 children with seasonal allergic rhinitis were recruited in Rome and instructed to record their symptoms, medication intake, and general conditions daily through a mobile app (AllergyMonitor®) during the relevant pollen season. We measured adherence to compilation as the percentage of days with data recording in the observation period. As putative proxies of data quality we examined the patient’s trajectories of three disease indexes (RTSS, CSMS, VAS) with the following four parameters: 1) the intra-variation index; 2) percentage of zero values; 3) the coefficient of variation; 4) the percentage of changes signs (+/-). Last, we examined the relationship between adherence to compilation and each of the four proxy measures.

Results:

Adherence to compilation ranged from 19.6% to 100%, with 64% and 36% of the patients’ values above (highly adherent patients) or below (low adherent patients) the threshold of 80%, respectively. The percentage of zero values, the coefficient of variation and the intra-variation index did not significantly change with the adherence of compilation. By contrast, the proportion of changes in signs was significantly higher among highly adherent patients, independently from the analysed score (RTSS, CSMS, VAS).

Conclusions:

The percentage of changes in sign of RTSS, CSMS, and VAS is a valuable candidate to validate the quality and reliability of the data recorded by patients with AR during the pollen season. The performance of this parameter must be further investigated in real-life conditions before it can be recommended for routine use in apps and e-diaries devoted to the management of patients with allergic rhinitis.


 Citation

Please cite as:

Dramburg S, Perna S, Di Fraia M, Tripodi S, Arasi S, Castelli S, Villalta D, Buzzulini F, Sfika I, Villella V, Potapova E, Brighetti MA, Travaglini A, Verardo PL, Pelosi S, Matricardi PM

Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study

JMIR Mhealth Uhealth 2022;10(6):e31491

DOI: 10.2196/31491

PMID: 35657659

PMCID: 9206201

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