Outcomes Measurement and Remote Monitoring
A frequent complaint of site-based data collection is that it is not reflective of reality. Participants are not in their natural setting, they often fill in their data at the last minute before visiting a site and their behavior and even vitals can be skewed by the ‘white coat effect’.
ObvioHealth’s driving principle when designing and/or choosing data capture methodologies is to make it easier for participants to report and share data in real time, from the comfort of their homes or when on the go. We offer a range of technologies that enable easier and more accurate data collection.
Too often, ePRO’s (electronic patient reported outcomes) are direct translations from paper questionnaires and are not optimized for digital use. ObvioHealth has designed more intuitive ways of capturing information with smoother navigation. User-friendly questionnaires and diaries make it easy for participants to enter their data at the moment an event occurs. At the push of a button, they can capture the duration, frequency and/or intensity of a symptom. Concomitant medication dose and frequency can also be captured and reconciled via our clinical study and data management teams, who review participant records for accuracy and react quickly if they see any issues.
Keeping up with the workflow of a trial can be particularly challenging for busy patients and caregivers. Participants often inject bias into their reporting of data, particularly when they are tired, in a rush or may not fully understand the event they are experiencing.
The ObvioHealth app is programmed to capture visual (eg:skin rash), audio (eg:coughing or crying ) or video (movement) inputs that can help to eliminate bias while providing richer and more nuanced understanding of symptoms, resulting in better, more accurate and more complete data sets
Until recently, it was assumed that patients needed to travel to a hospital or clinic for certain types of measurement. However, inroads in the development of accurate devices for in-home use have shifted this paradigm.
ObvioHealth’s virtual environment integrates a growing ecosystem of apps and devices that enable patients to measure heart rates, blood pressure, respiration rates, weight, temperature, oxygen and glucose levels and even take ECGs from home. Test kits, devices and instructions are shipped to the patient and virtual training sessions ensure they are being used correctly. This opens up a world of opportunity for more convenient capture of accurate real time data.
There are also a growing number of digital devices that can be downloaded from patient’s phones. These include fitbits, activity and sleep trackers, and of course smart watches. With participant permission, passive information on vital signs and/or activity levels can be captured and automatically transmitted to the trial platform. Our technical team has considerable experience in device and biosensor integrations and can quickly assess your trial needs to make informed recommendations on the device(s) that will most safely and accurately deliver your study’s outcomes.
The ObvioHealth unified platform has full in-house EDC capabilities. Site staff can access the platform via a single sign-in to complete medical forms/history, electronic case report forms, and electronic clinician reported outcomes (eClinRO). Our EDC system has branching, sub-scoring, total scoring and edit checks, easing the burden on site raters and staff when completing forms and questionnaires. Our cloud-based EDC system manages and cleans data in real time and resolves queries and includes a complete clinical trial management system (CTMS) and electronic trial master file (eTMF).
Participants access “my tasks” to review and complete each assigned task. But of course they sometimes, forget. We use notifications and reminders to ensure that the participant continues to complete the study as per requirements and that he or she remains engaged throughout. Notifications are most often scheduled generic messages, but they can also be fully customizable to specific participant situations. Our experience shows that these reminders have a strong positive impact on participant compliance and retention.
A combination of human and computer-generated interactions ensures that participants remain engaged throughout the trial. Our virtual clinical study team is able to help participants by answering questions about workflow, how to complete tasks or provide any other assistance. Regular virtual check-ins with participants ensure they feel engaged with the study. Clinical team members are available at the click of a button to respond to questions or concerns. They may also reach out directly to participants when they see compliance dropping off or simply to make them feel looked after.
ObvioHealth is developing innovative diagnostic tools that leverage AI and machine learning to accurately score and make inferences about outcomes without the need for patient reporting
In studies where are there is concern about a participant’s ability to use validated scales to evaluate their own experiences, central expert clinical raters can be a tremendous asset. Unstructured data in the form of images, audio or video captured directly by participants on their smart phones or other devices can be scored by central experts for greater accuracy.
Training site raters can significantly improve the reliability and consistency of ClinRO/eClinRO data. ObvioHealth’s in-house and expert KOL training team creates custom and configurable modules that cover topics like reducing rater variability, optimizing navigation of study workflow and improving clinical interview quality. Our digital qualification process and best practice training sessions are adaptive, interactive and gamified with check-ins and tests throughout. And because we engage directly with raters, we are able to guarantee that those completing eClinRo’s are both qualified and fully certified. This single source training and scoring solution improves both efficiency and quality.