Patient-Centered Outcomes
Overview
Co-chairs:
Patient-centered outcomes (PCOs) comprise measurable health outcomes that are important, impactful, and/or meaningful to patients. PCOs include data collected directly from patients – patient reported outcomes (PROs) – and data collected through other sources, such as electronic health records (EHRs), registries, and claims data. Capturing PCOs well in embedded pragmatic clinical trials raises challenges that go beyond measure selection, including integrating data collection with EHRs, building partnerships with health systems, and developing analytic methods to derive and validate PCOs from existing data. The Core works across all of these areas.
PRO data are defined by the FDA as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” These data are increasingly used to inform and guide patient-centered care, clinical decision-making, and health policy decisions and are an important component of many of the Collaboratory’s NIH Collaboratory Trials.
Areas of Focus
The Patient-Centered Outcomes Core works closely with the Collaboratory to create guidelines and define best practices with respect to
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Selecting, compiling, and curating the most appropriate PCO measures, including PRO measures and outcomes derived from other data sources.
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Stimulating the development of new instruments when new solutions are needed.
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Creating efficient, high-quality data collection and integration systems compatible with EHRs and registries, and building partnerships with health systems to support this integration.
- Developing and applying analytic methods for deriving PCOs from existing data (eg, EHRs, registries, claims) and assessing their validity.
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Conducting statistical analyses of PCO endpoints.
Interview
During the NIH Pragmatic Trials Collaboratory 2024 Steering Committee meeting, Drs. Emily O'Brien and Christy Zigler discussed challenges and lessons learned in collecting patient-centered outcome data in pragmatic clinical trials.
As part of this work, the Core conducts interviews with clinicians and other investigators using PROs, including NIH Collaboratory Trial principle investigators, to determine how PROs are currently used in the field, brainstorm solutions to challenges, and monitor progress with PRO implementation and data collection.
The Core has written a PCOs Living Textbook chapter, a white paper Strategies for Overcoming Barriers to Patient-Reported Outcomes Measures, and a chapter on including PROs in registries as a part of the AHRQ handbook on registries. It also helped lead the development of an Effectiveness Guidance Document (EGD) for incorporating PROs into comparative effectiveness research in adult oncology and held a workshop to help clinicians implement the NIH Patient Reported Outcomes Measurement Information System (PROMIS).
News and Interviews
- News_Harnessing Qualitative Methods in Pragmatic Trials - An Interview With Emily O’Brien and David Chambers
June 11, 2026: Harnessing Qualitative Methods in Pragmatic Trials: An Interview With Emily O’Brien and David Chambers
- News_A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
- Podcast 56_Avoiding the Fumble in PCTs
Podcast 56: "Avoiding the Fumble" in Pragmatic Clinical Trials
- News_How to Choose Patient-Reported Outcome Measures in Pragmatic Clinical Trials
June 23, 2025: How to Choose Patient-Reported Outcome Measures in Pragmatic Clinical Trials?
- News_A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
- News_Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations
November 26, 2024: Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations
- News_EHR Core and Patient-Centered Outcomes Core Reflect on Challenges in Pragmatic Trials
August 13, 2024: EHR Core and Patient-Centered Outcomes Core Reflect on Challenges in Pragmatic Trials
- News_Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
- News_A Year of New Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
- News_Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data
July 3, 2023: Report Shares Strategies for Addressing Bias and Lack of Generalizability of EHR Data
Products and Publications
- Cheville et al Appl Clin Inform 2024
Collection of patient-reported outcome measures in rural and underserved populations
- Zigler et al Contemp Clin Trials 2023
Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Patient-Centered Outcomes Core Toolkit
Patient-Centered Outcomes Core Toolkit
- Boyd et al J Am Med Inform Assoc 2023
Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory
- Ali et al Contemp Clin Trials 2022
Responding to signals of mental and behavioral health risk in pragmatic clinical trials: ethical obligations in a healthcare ecosystem
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Living Textbook Chapter_Patient-Reported Outcomes
Living Textbook Chapter: Patient-Reported Outcomes
- Bennett et al Healthcare 2020
ADAPTABLE Supplement Publication: Applying patient-reported outcome methodology to capture patient-reported health data: report from an NIH Collaboratory roundtable
- Weinfurt JAMA 2019
Clarifying the meaning of clinically meaningful benefit in clinical research: noticeable change vs valuable change
- ADAPTABLE Supplement Patient-Reported Health Data Standards-2018-07-19
Final report ADAPTABLE Supplement Patient Reported Health Data Elements
Presentations
- PCO_Core Onboarding Slides _18OCT2024_Final
Onboarding Meeting October 2024 - Patient-Centered Outcomes Intro
- PCO Slides OCT2025
Onboarding Meeting Oct. 29, 2025 - Patient-Centered Outcomes Intro
- PCO Slides 28OCT2025
Onboarding Meeting Oct. 28, 2025 - Patient-Centered Outcomes Intro
- PCO Core Slides NOV2024
Onboarding Meeting Nov 2024 - Patient-Centered Outcomes Intro
- PCO Core Slides JAN2025
Onboarding Meeting Jan. 2025 - Patient-Centered Outcomes Intro
- GR-Video-08-22-25
Avoiding the Fumble: Building on a Decade of Lessons from Pragmatic Clinical Trials
- GR-Video-01-10-14
Incorporating Research Driven Changes into Health Care Systems' IT Operations: A Multi Perspective Panel Discussion (GR Video 2014)
- GR-Slides-08-22-25
Avoiding the Fumble: Building on a Decade of Lessons from Pragmatic Clinical Trials
- GR-Slides-01-10-14
Incorporating Research Driven Changes into Health Care Systems' IT Operations: A Multi Perspective Panel Discussion (GR Slides 2014)
- 17-10-13 GR-Video
Users' Guide for Integrating Patient-Reported Outcomes in Electronic Health Records (GR Video 2017)