Background:Registry studies and clinical trials are increasingly incorporating patient reported outcomes (PROs) to measure the full burden of disease and better measure the efficacy and value of medicines; however, the burden of paper-based surveys, time constraints, and privacy concerns impede the widespread use of PROs in routine clinical care.Objectives:To develop a simple and secure technological solution to incorporate validated PROs into routine clinical care for patients with rheumatic diseases, and to assess the patient response to functional assessment of chronic illness therapy fatigue (FACIT-F), patient health questionnaire-2 (PHQ-2), and healthcare resource utilization (HCRU) questionnaires delivered using this ePRO method.Methods:A novel ePRO questionnaire delivery system was developed by Software4Specialists in partnership with OPAL Rheumatology. Validated PRO questionnaires were sent from the patient’s electronic medical record (Audit4, Software4Specialists) and delivered to the patient’s email address at time intervals specified by the rheumatologist (defaults to quarterly) or completed in the clinic waiting room prior to the consultation using a tablet or the patient’s smart phone (in-practice). Completed questionnaires were encrypted and returned directly to the patient’s Audit4 electronic medical record held on the clinician’s server for review at the next clinical consultation. The link to the PRO questionnaire expired within 28 days if the questionnaire was not completed, and the questionnaires were automatically cancelled if 2 consecutive links expired. This technology was made available to up to 111 rheumatologists located in 42 clinics in 6 states/territories in Australia, and the use of this technology to furnish the clinical consultation was voluntary for clinicians and patients. Deidentified clinical data was extracted from the servers of participating rheumatologists and aggregated across all sites.1 Data collected between April 2016-Dec 2020 was analysed descriptively.Results:Between April 2016-Dec 2020, 99,505 FACIT-F, PHQ-2 and HCRU questionnaires have been delivered to 5,784 patients from 39 of 42 contributing clinics (93%). 85% of questionnaires were delivered via email and 15% in-practice. Overall, 85% of patients completed at least one questionnaire, and of all questionnaires sent, 73% were completed. These rates have remained consistent over time. The completion rates were higher when questionnaires were delivered to patients in-practice compared to email (96% vs 69%). Females were more likely to engage with the questionnaires than males (87% vs 81%), and older patients were slightly more likely to complete all questionnaires delivered. 69% of questionnaires sent via email were completed on the day they were delivered and 94% were completed within 7 days. The median (IQR) number of questionnaires completed per patient was 3 (1,7) and the median (IQR) time since the first questionnaire was completed was 13 months (5,26).Conclusion:The novel Audit4 ePRO delivery system is an effective tool for incorporating PROs into routine clinical care to capture data directly from the patient on the impact of their condition on their quality of life. The data generated provides a unique opportunity to understand the full burden of disease for patients in the real-world setting and the impact of interventions.References:[1]Littlejohn GO, Tymms KE, Smith T, Griffiths HT. Using big data from real-world Australian rheumatology encounters to enhance clinical care and research. Clin Exp Rheum 2020:38(5): 874 -880.Acknowledgements:The authors acknowledge the members of OPAL Rheumatology Ltd and their patients for providing clinical data for this study, and Software4Specialists Pty Ltd for providing the Audit4 platform.Disclosure of Interests:Kathleen Tymms: None declared, Tegan Smith: None declared, Claire Deakin: None declared, Tim Freeman: None declared, David Hoffman: None declared, Dana Segelov: None declared, Hedley Griffiths Consultant of: AbbVie, Gilead, Novartis and Lilly., Sabina Ciciriello: None declared, Peter Youssef: None declared, David Mathers: None declared, Catherine OSullivan: None declared, Geoff Littlejohn Consultant of: Over the last 5 years Geoffrey Littlejohn has received educational grants and consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Novartis, Pfizer, Janssen, Sandoz, Sanofi and Seqirus
Disease monitoring of biologic treatment in IBD: early impact and future implications of COVID-19 pandemic
