4 Patient-Centric ePRO Solutions that Enhance Data Collection
Capturing and assessing patient-reported outcomes is key to driving patient centricity in healthcare research and delivery. However, the life sciences industry has frequently struggled to gather adequate, high-quality participant data in clinical trials, resulting in costly delays for study teams.
The emergence of decentralized clinical trials directly addresses these challenges through electronic patient-reported outcomes (ePRO). Effective ePRO solutions allow sponsors to gather quality data from participants in real time, so they can accurately assess how treatments impact patients.
Within a decentralized or hybrid clinical trial, study teams can adopt practices from the tech industry—improving the user experience and user interface to produce findings that accurately reflect participants’ lived experiences.
Effective electronic patient-reported outcomes (ePRO) are the missing link to delivering better data, supporting patient engagement, mitigating risk, and streamlining clinical trials.
Traditional study design often prioritizes a study team’s “ideal” scenarios for data capture. But, best-in-class ePRO solutions put patients at the forefront through a human-centered design approach.
Human-centered design acknowledges that although participants want the study to succeed, most of them lead busy lives. Sponsors can set participants up for success by meeting them where they are, making study tasks as intuitive and convenient as possible.
Simplifying data collection through ePRO is in the best interest of sponsors and patients alike. Let’s examine four ways that ePRO reduces the participant burden and delivers better data.
In a traditional urology study with nonelectronic patient-reported outcomes, researchers might ask patients to keep a bladder diary. The study team asks participants to manually log each bathroom trip as it occurs, but this “ideal” may not be feasible for busy participants.
Instead, participants may find themselves logging an entire day’s worth of restroom visits in a single sitting. This scenario can lead to recall bias: the tendency to remember events differently than they occurred.
To solve this challenge, ePRO solutions allow participants to document behaviors and symptoms in real time through seamless electronic data capture. For example:
Many clinical trial protocols require participants to complete daily e-patient diaries. Innovative ePRO instruments not only allow participants to take surveys on their own mobile devices—they also enable study teams to deliver automated reminders, which improve adherence and compliance.
For instance, patients receive a push notification on their phones in the morning with a reminder to finish a questionnaire. This alert could include a realistic estimate that the study task will take 5 to 10 minutes to complete, so participants can build the task into their daily schedule. These small, yet intentional, interactions add up to create a truly patient-centric experience.
One of the most common myths about ePRO is that it simply digitizes the same study tasks that would be included in a traditional, site-based trial. But, for effective ePRO, teams optimize questionnaires within a digital context that supports patients in the comfort of their homes.
For instance, a questionnaire may make scales more interactive, visual, and user-friendly. It may also immediately highlight when the patient forgets to enter a required response. Here again, a well-designed user interface plays an assistive role, helping participants understand their responsibilities without getting confused or overwhelmed.
Optimizing ePRO also takes digital specifications into account. Discrepancies in the appearance of questionnaires on an iPhone and an Android, for example, could affect participants’ answers, compromising data quality. Experienced ePRO vendors maintain data integrity with responsive design scales that look the same across multiple devices, no matter the screen size.
Virtual research organizations (VROs) can help sponsors standardize research questions and formatting before participants encounter them on their screen. With a range of clinically validated ePRO solutions on the market, choosing the right ePRO scale for the study’s specific needs is vital to data collection and interpretation.
The most useful ePRO solutions offer tools beyond electronic diaries and questionnaires. Participants often need to convey crucial pieces of unstructured data to the study team.
Image, video, and audio capture are among the most groundbreaking ePRO solutions, reducing data subjectivity and minimizing the participant burden. Simple, built-in uploading tools within the study app can streamline the trial process for patients and study teams alike.
For instance, if a patient develops a rash while taking the medication being studied, researchers will need unbiased data to accurately assess this potential side effect. The problem: In a traditional study, people may wait before reporting, their perceptions vary, their recall may be imprecise and their estimates inaccurate. With photo and audio capture, the patient could simply snap and submit photos of the rash, instead of trying to precisely describe its size or color.
“Smart capture” capabilities support participants through technology. These tools help people submit high-quality data by correcting poor lighting, autofocusing the camera lens, and flagging distracting objects in the background. Similarly, participants can use audio capture to automatically detect snoring or nighttime coughing while they’re asleep and unaware of their symptoms.
These aspects of ePRO allow study teams to collect data that might otherwise go unreported (or be inaccurately reported). Alongside gathering unstructured ePRO data, teams can synthesize and analyze this data with electronic clinical outcome assessment (eCOA) solutions. Integrated eCOA tools help sponsors translate unstructured inputs into meaningful outcomes.
The benefits of patient-centric ePRO solutions extend well beyond a clinical trial. High-quality participant data can help guide medical decisions that save or improve lives, according to Gillian McGovern, MPH, Director of Product at ObvioHealth.
Accurate data points help clinicians make informed recommendations for treatment options by giving them a clearer picture of all relative pros and cons identified in a treatment’s clinical trial. For instance, two drugs may have identical effects on extending the survivability of a disease. However, these two options could have dramatically different impacts on quality-of-life measures. If one of these medications causes constipation, for example, ePRO allows patients to report this side effect to the clinical trial management team in real time. In this way, ePRO supports the entire spectrum of healthcare research and delivery.
As patients continue to rely more and more on their mobile devices to access and manage their healthcare, study teams must keep pace with innovative, participant-centric solutions.
Within a decentralized or hybrid study, well-designed ePRO tools are proven to engage participants and produce high-quality data. Integrating a supportive user experience and user interface into the DCT environment improves the patient experience and ultimately delivers better data for sponsors.
ObvioHealth is a virtual research organization (VRO) that has enabled end-to-end and hybrid clinical trials in 16 therapeutic areas across 28 countries.
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