Collecting patient data is a necessary and critical step in clinical research. When done well, it can be fundamental in determining the safety and efficacy of an intervention.
But finding ways to keep patients engaged and informed throughout the course of a trial continues to plague researchers, especially when the study requires patients to manually report outcomes or track diaries between site visits.
Electronic patient-reported outcome (ePRO) solutions are helping bridge the gap between patient-centric workflows that engage patients while generating higher quality, more reliable data that successful studies need.
Although ePRO approaches are not new, it took COVID-19’s disruption to clinical research to garner wider acceptance of remote data capture and monitoring solutions across the industry.
A greater willingness—paired with growing regulatory acceptance of decentralized technologies—helped sponsors and CROs implement ePRO on a larger scale and realize the impact it can have on patient retention, compliance, adherence, and engagement.
As the industry looks ahead at the future of post-pandemic trials, it’s important to consider the role ePRO plays in patient engagement and how to harness it moving forward.
1. ePRO Meets the Demands of a More Digital Generation
More than a quarter of clinical trials use patient-reported outcomes, but less than half are estimated to use electronic systems to capture PRO responses.1
Sponsors and CROS commonly cite the high cost of digital solutions, complex workflows, and resistance from sites as leading reasons why they still implement paper-based PRO approaches. But patients continue to reaffirm their preference for digital solutions.
A 2016 study by Deloitte Centre for Health Solutions found that 31% of responding patients would be more likely to participate in clinical research if it offered a mobile app.2
That same study found that there were over 260,000 health apps worldwide and 70% of patient groups reported using at least one app to manage their condition.
These numbers are important when you consider that nearly 90% of healthcare consumers are estimated to have low health literacy.3
Individuals in this group struggle to adhere to treatments, provide informed consent, or enter accurate and complete data into PRO diaries.
Digital solutions that leverage commonly used technology, such as mobile devices or tablets, are allowing patients to engage more comfortably with devices they use for personal and health reasons every day.
Engaging with patients on mobile or web-based devices helps drive better patient outcomes, compliance, and adherence.
This can be further reinforced when ePROs implement “bring your own device” (BYOD) models where patients can record and access health information from their personal mobile device or wearables.
While paper-based collection may appear easier for patients to use and record at their convenience, ePRO can implement skip logic, data validation, and automatic alerts for missing data to ensure the right information is being collected.
Access to personalized reminders about site visits or dosing schedules, notifications with clear instructions, and content enriched with media all strengthen patient engagement and comprehension while making patients more autonomous in their health journey.
2. Real-Time Insights Power a Proactive Response
Clinical trials are growing more complex, creating a greater need to improve visibility and oversight of data collection. With paper-based PRO approaches, data is prone to delays, littered with human errors, and requires thorough data validation to ensure its accuracy.
ePRO approaches transform trials to be more patient-centric and proactive by allowing real-time data collection, sharing, and analysis across remote and in-clinic teams. With automatic data validation workflows, you can view patient-reported outcomes immediately and respond to adverse events (AE) more quickly while trusting that your data is accurate.
Clinicians benefit from real-time insights into patient-reported and clinical data, as well as live visibility into patient adherence.
Patients benefit from increased safety knowing that their protected health information (PHI) is secure, supported by audit trails, and shared directly with their healthcare team for immediate response. This symbiotic relationship strengthens patient engagement and trust between patients and their clinical teams.
3. Increase Data Integrity for PHI
When clinical teams rely on paper processes, they are leaving sensitive PHI vulnerable to transcription errors, form misplacements, or data inaccuracies. Pre-validated ePRO solutions help improve data quality while strengthening patient engagement in the following ways:
- Always Accurate Data—Unlike paper-based processes, ePRO workflows leverage skip logic and missing data alerts to guide patients through study protocol while minimizing inaccuracies. Enhance adherence with media-enriched forms and trigger alerts that support time-sensitive data collection.
- Reduce Transcription Errors—Paper forms require site personnel to manually transcribe data into their EDC, leaving a greater chance for inconsistencies. ePRO solutions create a more seamless experience for patients and clinicians by syncing data in real-time and reducing manual data validation.
- Meet Global Regulatory Standards—Studies that rely on error-prone paper diaries for important patient-reported outcomes may be allowing unnecessary risks into their trials. Pre-validated ePRO solutions meet all regulatory guidelines while supporting a variety of common validated survey instruments.
4. Improve Patient Comprehension and Compliance
One of the biggest challenges facing clinical research is keeping patients enrolled and compliant throughout the duration of a study.
As many as 30% of patients are estimated to drop out of trials, but research confirms that patients are more compliant when using electronic devices to record outcomes over paper diaries.4
In fact, compliance levels exceed 90% using electronic reported outcomes, compared to 11% with paper-based methods.
This stems from the fact that protocol compliance tends to increase and drop-out levels tend to fall when patients are more engaged with a trial. ePRO engages patients while strengthening compliance, in the following ways:
- Direct Patient-to-Clinician Communication—Clinicians can share pertinent information directly with patients through their ePRO and include dosing instructions, site visit reminders, and automatic trigger alerts that increase patient adherence.
- Flexible Scheduling—Patients live busy lives. ePRO makes it easy for patients to access, complete, and submit the information required by study protocol at their convenience. Improve adherence with flexible scheduling based on patients’ timezones and study closeout windows.
- Compliance Workflows—Configure workflows specific to your unique studies with edit checks and validated controls that prevent patients from pre-entering data. Gain live visibility over patient compliance and comprehension with timestamps and audit trails.
5. Unified ePRO Positions Patients as Partners
Patients and their families are inherently impacted by study protocol and technology as they go through a trial. In one device study, a patient may interact with wearables, reminder apps, eConsent, and an e-Diary.
These technologies may run on disparate systems that require specialist vendors and a learning curve for patients to understand unique access points and compliance requirements.
Unifying ePRO with your larger eClinical suite not only reduces the burden of managing a clinical trial, it’s also been found to reduce patient dropout rates by as much as 50%.5
Streamlining all clinical and patient-reported data creates a unified user experience, reducing complex burden that leads patients to quit studies or deviate from protocol.
How ePRO benefits each stakeholder with patient-centric workflows:
- Trial Operators—Simplify set-up and reduce the need for multiple vendors, user accepted testing (UAT), and training coordination among sites and patients. View all trial data in one aggregated dashboard for data-driven decisions that benefit the patient experience.
- Sites—Foster efficiency for site staff with unified single sign-on (SSO), audit trails, and live data sharing across teams. Efficiencies for sites result in streamlined recruitment, less manual data entry, and more time to focus on patient engagement.
- Patients—Remove the need for patients to manage multiple systems by streamlining visit reminders, form libraries, dosing instructions, clinical updates, and consent into one singular patient experience.
Boost Your Patient Engagement with Medrio ePRO
Not all ePROs are created equal. As patient-reported outcomes become a more critical component of engagement, it’s imperative to have a trusted, unified ePRO solution behind you.
Medrio ePRO handles all of the complexities of patient-reported data—from flexibility to support in-clinic and remote data collection, to supporting a variety of validated survey instruments. Our BYOD model allows patients to respond to surveys anywhere and automated notifications ensure compliance with your protocol while boosting patient engagement.
The unification of ePRO and EDC allows you to view all of your clinical and patient-reported data in one place and accelerates study build times. Gain faster insights into patient-reported data, more control over timelines, and increased patient engagement.
- Holzbaur, E., Ross, J. (2016). ‘With the Multitude of Benefits that ePRO Provides, Why are Clinical Trials Still Using Paper?’
- Taylor, K., Steedman, M., Sanghera, A. (2017). ‘Pharma and the connected patient’. Deloitte Centre for Health Solutions.
- (2008) ‘America’s Health Literacy: Why We Need Accessible Health Information’. U.S. Department of Health and Human Services.
- How to Use ePRO in Clinical Trials
- How a Patient-Centric ePRO Solution is Proving to Boost Study Compliance and Completion