Patient-reported outcomes and home-based self-swabs for influenza-like illness events - lessons learned from the 2023/2024 DANFLU-2 Homeswab PRO substudy
Abstract Background Self-swabs and digital patient-reported outcomes (PROs) offer innovative tools for decentralized monitoring of infectious diseases. The DANFLU-2 HomeSwab PRO substudy evaluated the feasibility of using these methods for tracking influenza-like illness (ILI) within a large-scale,...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2025-08-01
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| Series: | Journal of Patient-Reported Outcomes |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41687-025-00936-8 |
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| Summary: | Abstract Background Self-swabs and digital patient-reported outcomes (PROs) offer innovative tools for decentralized monitoring of infectious diseases. The DANFLU-2 HomeSwab PRO substudy evaluated the feasibility of using these methods for tracking influenza-like illness (ILI) within a large-scale, pragmatic, randomized trial. Methods During the 2023/2024 influenza season, adults aged ≥ 65 years were recruited from the DANFLU-2 trial, which evaluates the relative effectiveness of high-dose influenza vaccine compared to standard-dose. Participants were instructed to self-swab at home upon ILI symptom onset and complete the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) for 14 days. Swabs were registered via QR code in a webapp and mailed for centralized PCR testing. Compliance was defined as completing all 14 days of RiiQ™ reporting. Results Among 1,976 enrolled participants, 208 (10.5%) completed at least one RiiQ™, and 171 (82.2%) met the ILI case definition. Most participants found self-swabbing easy (66.1%) and more practical than visiting a clinic (78.6%). Compliance with daily RiiQ™ symptom tracking was 85.7%. Among those with ILI, 89.4% performed a self-swab within 1 day [IQR: 0; 3] of symptom onset; 65.8% of swabs were correctly registered in the webapp, and 96.5% were RNaseP-positive. Thirty-six participants (1.8%) withdrew, mainly due to weekly reminders; allowing reduced reminder frequency improved retention. Conclusion The study confirmed the feasibility of using home-based self-swabs for remote disease diagnosis and digital PRO tracking for symptoms during ILI events in a large-scale, pragmatic randomized trial. While the approach proved viable, the findings also highlighted areas for improvement in participant engagement and data collection efficiency. Clinicaltrials.gov ID NCT05517174. |
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| ISSN: | 2509-8020 |