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Signant Health, the leader in evidence generation for modern clinical trials, announced the ability to deliver computerized adaptive tests (CATs) in clinical trials utilizing the Patient-Reported Outcome Measure Information System (PROMIS), designed to reduce patient completion burden while maintaining measurement precision of patient-reported outcomes.
The new digital health measures, developed by the National Institutes of Health, take advantage of an emerging model of assessment administration and scoring to enable researchers to minimize the number of questions asked and time required for assessment completion. These measures and associated software are disseminated by Northwestern University via the HealthMeasures team.
Patient-reported outcome measures (PROMs) commonly used in today’s trials typically use questionnaires containing a fixed number of questions. In contrast, PROMIS CATs use a dynamic approach that aims to measure concepts, such as fatigue or physical functioning, with fewer questions while maintaining precision. It does this by using a statistical model to determine which questions to ask, based on the patient’s previous responses. This has proven to generate precise measures with fewer questionnaire items.
Signant’s implementation of PROMIS CATs facilitates measurement of numerous concepts of interest including anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and social function.
“PROMIS measures were developed using state-of-the-science methods, leveraging the item response theory statistical model, to efficiently measure specific health domains,” noted Michelle Langer, PhD, executive director at the Northwestern University Center on Outcomes Research and Education (NUCORE). “By presenting only the most informative questions [items], we can reduce the burden of completion for patients while preserving precise PRO scores.”
Fully hosted by Signant Health, PROMIS CATs can be rapidly implemented and incorporated seamlessly into the company’s eCOA solution alongside conventional PROMs.
“We’re excited to build on our pioneering heritage of eCOA innovations with the release of this unique PROMIS CAT implementation, an important leap forward in patient-centric clinical development,” said Sanjiv Waghmare, Signant’s chief product officer. “Through significant research and development investments, we’ve ensured these novel PRO measures are license-holder-approved, fully validated, and available in multiple languages, and that sponsors can implement it at scale in global trials alongside other traditional measures.”
State-of-the-science electronic PROMIS CATs can be delivered seamlessly through the same eCOA application patients use to complete conventional PROMs, and includes scientific consultation and support by Signant’s clinical and digital health science experts.
Signant Health is the evidence generation company. The company is focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models.
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