Next-generation ePRO and centralized expert rating platform
Overcoming the subjectivity and variability that are characteristic of electronic patient-reported outcomes (ePRO) can be challenging. In any clinical trial model, these obstacles can negatively impact data accuracy and, ultimately, trial endpoints. We’ve responded to this industry-wide problem with a practical solution: Augmented ePRO for Clinical Trials. Our breakthrough offer combines AI-assisted ePRO instruments with a centralized clinical rating platform, all designed to deliver more accurate and standardized outcomes.Schedule a Demo
Until now, researchers have had a limited number of options for collecting clinical trial data: ePRO—more subjective but more real-time and easier for patients—and clinician assessments, which can be more burdensome for patients and are subject to variability across experts. BYOD apps have made ePRO more convenient and real-time, but the issue of bias remains. Additionally, remote administration and overread of clinical assessments have helped to minimize clinician variability but have also added a significant layer of complexity and cost.
ObvioHealth’s Augmented ePRO combines the ease and real-time characteristics of intuitive ePRO with the accuracy and consistency of standardized independent scoring. This multi-pronged tool aggregates and integrates best-in-class AI-assisted technology for capturing, submitting, and assessing patient-reported outcomes to deliver more accurate endpoints that increase study power.
Augmented ePRO has been developed to address pain points at every stage of the data capture and rating process—from symptom recording to outcome delivery. This single, unified platform is built for ease of use and streamlined productivity, benefitting patients, raters, and sponsors alike.
One of the most valuable ways to ensure clinical trial compliance and retention is to equip participants with simple and intuitive tools that shorten their “to do” lists. ObvioHealth’s patient-centric Augmented ePRO for clinical trials eliminate the guesswork with AI-assisted smart-capture technology, enabling participants to record source data—photos, audio, or videos—in real-time. Rating or scoring is left to the experts.
AI-assisted image capture capabilities, built into ObvioHealth’s intuitive app, make it easier for participants to record the required outcome. The tool’s features—such as automatic blur and angle detection, as well as lighting assistance—resemble those now found in banking and social media apps. Guided by these built-in tools, patients are able to snap and send high-quality images and videos with just a couple of taps on their mobile devices.
The ObvioHealth app’s audio recording features facilitate the recording of acoustic data—including coughs, infant cries, breathing, and more. Patients can effortlessly capture the required audio using their own devices and upload the data via the app. To further reduce patient burden, external devices can easily be linked directly to the app for continuous ambient recording. Our research team is actively developing semi-supervised, AI-assisted audio exploration, enabling the removal of false positives and negatives to produce outcomes that are easier for experts to rate.
Another key to successful electronic patient-reported outcome clinical trials is training. Patients must be equipped with the necessary information and have clarity on their roles and responsibilities during a trial. ObvioHealth onboards patients into their clinical trial through app screens and videos, providing clear direction on the tools they will be using for data capture and submission. ObvioHealth’s experienced COACH (Clinical Oversight And Coordination Hub) team stays connected with participants throughout the trial, offering reminders and on-demand tech support to resolve any questions or concerns. The COACH team also previews source data submissions and guides participants to improve image quality as needed.
The advantages of real-time ePRO can be undermined if data capture and submission are not part of a larger, seamless rating process. Cumbersome workflows, which are often associated with expert rating systems, can stagnate productivity, frustrate scorers, and impede progress towards accurate endpoints. ObvioHealth’s Augmented ePRO addresses these issues at the core, smoothing workflows into a single, unified platform, ensuring high-quality media that is ready to rate, and reducing the administrative burden on raters so that they can focus on what they do best.
Manual compilation of unstructured data from disparate sources can be time-consuming. The Augmented ePRO platform features a single-source, unified assignment queue so experts can view their tasks at a glance and dive in right away. With an integrated pipeline at their fingertips, they spend less time organizing data and more time assessing it.
Raters are blinded to both protocol details and subject history to avoid any bias. The platform also eliminates the distraction of blurry, poorly lit images, with quality oversight built-in so that experts get turnkey data that’s ready for scoring right away. To make accurate scoring easier, the COACH team reviews every submission against key criteria to catch and course-correct issues before they reach experts. And, most importantly, if a photo’s contents indicate a potential health issue, raters can flag the photo for immediate follow-up by a member of the COACH team.
Experts are not infallible; they can sometimes interpret the same data in different ways. Augmented ePRO addresses this variability issue by facilitating ratings of the same source document across raters. The platform helps teams to standardize scores by automatically flagging discrepancies across disparate ratings of the same data. Teams can configure the platform to auto-resend ratings that surpass specified thresholds for further expert review and explanation, thus resolving any discrepancies and improving rating objectivity and quality overall.
Advancing Endpoint Innovation: Building the Future of Expert Rating
All the benefits and features of ObvioHealth's Augmented ePRO for clinical trials are in the service of producing better data more accurate endpoints today. But, our platform also has features that can contribute to novel outcomes of tomorrow.
Augmented ePRO features AI-assisted technologies that support both patients and raters throughout the data collection and assessment processes. However, the platform is leveraging AI for future-facing purposes as well.
The clinical notes or annotation feature within Augmented ePRO allows experts to capture nuances in rating that can be used to train AI algorithms. These open text descriptions, which detail why a rating was determined, can serve over time to program automatic ratings that may augment expert raters’ work. Even now, these innovations are being tested and validated for their ability to deliver ratings that provide accuracy on par with expert raters. This system, optimized over time, will lead to better, ever more effective clinical rating processes in the future.
More reading on this topic - Virtual Clinical Trials, Decentralized Clinical Trials , ePRO and Expert Rating and AI Meets ePRO
This study compared the stool consistency ratings provided by caregivers using the Bristol Stool Scale (BSS) to ratings conducted by pediatric gastroenterologists. The findings demonstrate that caregiver ratings of pediatric stool consistency differ considerably from that of ratings provided by clinical experts.
In an effort to develop mechanisms for ingesting and cleaning unstructured image data quickly and effectively, image segmentation algorithms were developed on caregiver-provided pediatric stool photos. The results provide a foundation for training new algorithms for analyzing stool consistency or color in a context without bias.