Comparative Analysis of Smartphone Application and Web-based Electronic Clinical Outcome Assessment (eCOA) Modalities
Author(s)
Indira Jain-Figueroa, MSc1, Shannon Kummer, MS1, Anna Kündig, RN, Bsc2, Christian Knaus, MSc3, Annabelle Chan, PhD4, Matthew Reaney, BSc, MSc, PhD5, Dara O'Neill, PhD6, Aleksandra Sjöström-Bujacz, PhD7, Gerasimos Dumi, BSc, MSc8;
1Evinova, Gaithersburg, MD, USA, 2Evinova, Gothenburg, Sweden, 3Evinova, Durham, NC, USA, 4IQVIA, Parsippany, NJ, USA, 5IQVIA, Reading, United Kingdom, 6IQVIA, Barcelona, Spain, 7IQVIA, Solna, Sweden, 8IQVIA, Athens, Greece
1Evinova, Gaithersburg, MD, USA, 2Evinova, Gothenburg, Sweden, 3Evinova, Durham, NC, USA, 4IQVIA, Parsippany, NJ, USA, 5IQVIA, Reading, United Kingdom, 6IQVIA, Barcelona, Spain, 7IQVIA, Solna, Sweden, 8IQVIA, Athens, Greece
Presentation Documents
OBJECTIVES: To maximize inclusivity and compliance, it is useful to allow eCOA data collection via multiple modalities in clinical trials. We assessed the equivalence of these modalities using an eCOA data capture system.
METHODS: Stage 1 involved qualitative interviews with 10 adults in the US who completed COAs using a smartphone application and 3 web-based modalities: computer, tablet, and smartphone. Participants were interviewed on the usability of modalities and response scales: Verbal Rating Scale (VRS), Numeric Rating Scale (NRS), Visual Analogue Scale-Vertical (VAS-V), and VAS-Horizontal (VAS-H). Stage 2 was a quantitative equivalence study with 59 adults who completed the 4 scales and usability questions. They were randomized on 2 modalities each (to use the smartphone application and one of the 3 web modalities) with a 4-12-hour washout. Inter-modality equivalence for each COA was assessed by intraclass correlation coefficients (ICC).
RESULTS: Stage 1: Participants generally found the design to be simple and clear, and reported that the items were easy or very easy to complete. The VRS and NRS performed similarly across all modalities, with greater variability in responses on the VAS. Stage 2: All modalities had ICCs above the acceptable threshold for all items across smartphone application versus combined web-based formats. The VAS-V, NRS, and VRS performed well (ICC≥0.87), while for the VAS-H, agreement was slightly lower (ICC=0.77).
CONCLUSIONS: Findings demonstrated the high usability and equivalency of the VRS and NRS items across web-based modalities compared with the smartphone application; areas of improvement were identified for VAS items. Web-based formats can supplement smartphone applications in an eCOA digital solution suite.
METHODS: Stage 1 involved qualitative interviews with 10 adults in the US who completed COAs using a smartphone application and 3 web-based modalities: computer, tablet, and smartphone. Participants were interviewed on the usability of modalities and response scales: Verbal Rating Scale (VRS), Numeric Rating Scale (NRS), Visual Analogue Scale-Vertical (VAS-V), and VAS-Horizontal (VAS-H). Stage 2 was a quantitative equivalence study with 59 adults who completed the 4 scales and usability questions. They were randomized on 2 modalities each (to use the smartphone application and one of the 3 web modalities) with a 4-12-hour washout. Inter-modality equivalence for each COA was assessed by intraclass correlation coefficients (ICC).
RESULTS: Stage 1: Participants generally found the design to be simple and clear, and reported that the items were easy or very easy to complete. The VRS and NRS performed similarly across all modalities, with greater variability in responses on the VAS. Stage 2: All modalities had ICCs above the acceptable threshold for all items across smartphone application versus combined web-based formats. The VAS-V, NRS, and VRS performed well (ICC≥0.87), while for the VAS-H, agreement was slightly lower (ICC=0.77).
CONCLUSIONS: Findings demonstrated the high usability and equivalency of the VRS and NRS items across web-based modalities compared with the smartphone application; areas of improvement were identified for VAS items. Web-based formats can supplement smartphone applications in an eCOA digital solution suite.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR18
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation
Disease
STA: Multiple/Other Specialized Treatments