Panel members described factors that will gradually facilitate the wider adoption of outcome measures, including:
- A move from process-oriented measures to outcome-oriented measures, providing an opportunity to phase out burdensome measures and replace them with brief and precise measures that are easy to administer and integrate in clinical workflows.
- Mobile patient portals, real-time data transfer to the EHR, improved data visualization techniques, and other technology-related advances that will change how assessments are administered and utilized at the point of care.
- Effective provider education and engagement that demonstrates how outcomes assessments can ultimately save time and improve the quality of care.
Members of this panel discussed the opportunities and challenges associated with large-scale collection and analysis of patient-reported outcomes (e.g., across healthcare systems, within population health studies). Panel members noted:
- The potential for real-time data collection that is being created by the fusion of ecological momentary assessment (EMA), item response theory (IRT), and patient-reported outcomes (PROs).
- The challenge of properly integrating and displaying PROs with other forms of outcomes data, especially sensor data.
- The importance of proper PRO data integration within the EHR and ongoing data quality management to ensure data can be used in a meaningful way to support clinical decision-making, predictive modeling, and other forms of analysis.
Michelle Campbell, a reviewer and scientific coordinator with the Food and Drug Administration (FDA), detailed efforts that the agency is leading to:
- Encourage the development and implementation of patient-focused clinical outcome assessments (COAs) in clinical trials to support drug approvals and labeling. At the center of this effort is the recognition that patients are the experts on living with a chronic disease, so benefit and risk information coming out of the drug development program must directly address their concerns.
- Incorporate COAs into patient-focused clinical trial endpoints and, ultimately, ensure that clinical benefit and risk is described in labeling in terms of the outcome of interest measured.
- Qualify several types of COAs for inclusion in trials, including patient-reported outcomes. Dr. Campbell highlighted several PROMIS measures currently undergoing the FDA qualification process and areas of HealthMeasures research that can inform the FDA’s efforts.
View the slides for HealthMeasures in the Regulatory Setting: The FDA Perspective>>
We thank the following organizations for their contributions as 2017 HealthMeasures User Conference sponsors: Bristol-Myers Squibb, Corporate Translations, Oberd, BrightOutcome, Pfizer, FACIT.org/FACITtrans.
