Patient-reported outcomes and home-based self-swabs for influenza-like illness events - lessons learned from the 2023/2024 DANFLU-2 Homeswab PRO substudy.
Filip Soeskov Davidovski, Kristoffer Grundtvig Skaarup, Niklas Dyrby Johansen, Daniel Modin, Nabila Shaikh, Jose Bartelt-Hofer, Matthew M Loiacono, Rebecca C Harris, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen, Randi Jessen, Nina Steenhard, Brian L Claggett, Scott D Solomon, Lars Køber, Pradeesh Sivapalan, Jens Ulrik Staehr Jensen, Cyril Jean-Marie Martel, Tor Biering-Sørensen
{"title":"Patient-reported outcomes and home-based self-swabs for influenza-like illness events - lessons learned from the 2023/2024 DANFLU-2 Homeswab PRO substudy.","authors":"Filip Soeskov Davidovski, Kristoffer Grundtvig Skaarup, Niklas Dyrby Johansen, Daniel Modin, Nabila Shaikh, Jose Bartelt-Hofer, Matthew M Loiacono, Rebecca C Harris, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen, Randi Jessen, Nina Steenhard, Brian L Claggett, Scott D Solomon, Lars Køber, Pradeesh Sivapalan, Jens Ulrik Staehr Jensen, Cyril Jean-Marie Martel, Tor Biering-Sørensen","doi":"10.1186/s41687-025-00936-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov id: </strong>NCT05517174.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"108"},"PeriodicalIF":2.9000,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373587/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Patient-Reported Outcomes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41687-025-00936-8","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
