But routine use of scientifically validated surveys to gather
patient-reported outcomes is rare outside of clinical studies.
Patient-reported outcomes (PROs) and
patient-reported outcome measures (PROMs).
inSight Advantage is a cloud-based,
patient-reported outcome (PRO) software designed to meet the needs and integrate seamlessly with the workflow of point-of-care physicians.
The company has built two proprietary software applications Sirona exChange, a healthcare content platform (HCP) that aggregates, profiles and qualifies patients seeking medical treatments and Sirona inSight, a
patient-reported outcome (PRO) software that collects, analyses & visualizes the long-term impact of treatments.
Primary endpoints include change in distance walked during the six-minute walk test and change in total fatigue as measured by a
patient-reported outcome measure, the Barth Syndrome Symptom Assessment.
The study met its primary endpoint with the product indicating a marked decrease in menstrual blood loss from Week six to Week 12 as evaluated by a
patient-reported outcome (p < 0.0003 at relugolix 40-mg dose vs.
In both clinical trials, bremelanotide met the pre-specified co-primary efficacy endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated
patient-reported outcome instruments.
M2 EQUITYBITES-February 21, 2017-ICON partners with US FDA to validate
patient-reported outcome endpoints for antibacterial drug trials
Additional objectives include the evaluation of safety and tolerability of IFX-1, as well as an assessment of additional efficacy and
patient-reported outcome parameters.
Both trials assessed the absolute change from baseline in sweat production following treatment with Qbrexza and the proportion of patients who achieved at least a four-point improvement from baseline in their sweating severity, as measured by the Axillary Sweating Daily Diary, Dermira's proprietary
patient-reported outcome instrument.
According to Walgreens, this outcome analysis is the first to validate
patient-reported outcomes measures (PROMs) gathered by any home infusion provider administering IG therapy, a treatment projected to be ordered 10% more often each year that is increasingly provided in the home setting.