Virtual research organization (VRO) ObvioHealth has created digital tools intended to increase the objectivity of assessments in clinical trials involving pediatric patients.
The instruments are intended to address the subjectivity and variability of existing tools. Today, the Bristol Stool Scale is used to assess stool samples but it relies completely on the rating and accuracy of the provider, patient, or caregiver.
“This variability and issues with caregiver recall can skew the results. This scale also does not take into account the color, which can be a significant clue to some diagnoses,” said a spokesperson for ObvioHealth.
Similarly, parents and caregivers can struggle to collect accurate data on how long their children cry, with ObvioHealth saying that people typically overestimate the duration of the episodes. ObvioHealth, a virtual research organization, has developed instruments to address the variability of data on stools and crying episodes.
The gastrointestinal instrument guides the caregiver through the process of capturing high-quality, privacy-compliant photos of stool for automatic uploading to an expert rater portal. ObvioHealth has designed the portal to make it easy for the experts to rate stools and flag up potential adverse events and adopted technology to alert a rater to variability in their scores to help standardize grading.
“By capturing high-quality images that can be rated by experts and flagging rater inconsistencies, we can reduce the subjectivity inherent in stool rating,” said the spokesperson for ObvioHealth.
The pediatric cry capture instrument sits within the ObvioHealth application to allow caregivers to record episodes using their own devices. Alternatively, sponsors can provide a dedicated device for continuous ambient recording and integrate it with ObvioHealth’s app.
“Data collected includes duration, type, and/or sounds of crying. Here too, the rater portal can be used to facilitate all rating and annotation by experts. Research has shown that parents/caregivers can overestimate the duration of their kids' cries by as much as four times. This makes it difficult to collect accurate data,” said the spokesperson.
The two instruments are part of a push by ObvioHealth to improve data collection and analysis. Other instruments are in development for use in an upcoming clinical trial. ObvioHealth sees opportunities to use the instruments in trials and in clinical practice.