We’ve Got Your Back! A proof of concept innovative methodology for participant recruitment, real time data collection and data enrichment through the combination of Digital Patient Generated Data and linked health records

Problem

Traditional methods used to deliver clinical trials and observational research can be burdensome and costly due to the time and data collection effort required by clinicians, CTU’s, study teams and patients. Clinical trials create scientifically precise data but the strict/specialised environment can restrict the generalizability of findings. Observational research data can also be limited given a range of biases and barriers to data quality. Hence, novel study and data collection methods are required, to reflect as close as possible, real patient experience. Patient reported outcomes (PRO) data can also be enhanced with an accurate reflection of participants’ true health status from their electronic medical record (EMR) to create research outputs that are as relevant to clinicians and patients as possible.

Approach

In collaboration between IQVIA, the NIHR, CRN West Midlands, uMotif, EMIS Health and The University of Leeds, the “We’ve Got Your Back” study (WGYB) was developed which uses a novel recruitment and data capture methodology. This comprised: automated participant identification through the EMR and mobile app (uMotif) prescribed by a GP. After agreeing to receive an invite to the WGYB study, a text/email was automatically sent to the patient during consultation. At this referral point, the EMIS App Library creates a Unique Study ID, which is used to anonymously track patients study progress and linking the study data with their EMR. Patients could then download the uMotif WGYB app. Consent, enrolment and data collection (QoL, work productivity, physical/mental impacts of back pain) was handled by the WGYB app. PRO data was then combined with each patients’ retrospective EMR using a single patient ID to create an enriched dataset. IQVIA developed a live study dashboard where site, user and patient progress could be monitored by the study team and CRN to view data completion, patient recruitment and feedback progress to practices on their performance.

Findings

24 practices in the West Midlands took part in the study. 322 patients were invited and 42% downloaded the app, consented to participate and provided regular PRO data comparing favourably with other observational study methods. Data analysis is currently being completed. Further presentation and demonstration of GP app prescription, data management processes, app use demographics and GP critical feedback of the WGYB methodology will be presented.

Consequences

This novel method allows seamless combination of real-time patient PRO data through the WGYB app with components from the patients’ health record. It represents a significant step forward in the way in which we could utilise technology and digital methods to produce high quality enriched real-world data. The efficient utility and remote study set-up, also means that study set-up time can be rapidly achieved. Further, its use in clinical trials could be valuable, particularly for self-administered or on-line interventions.