Patient-Centered Outcomes
Overview
Co-chairs:
Patient-reported outcome (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 PRO measures (and stimulating the development of new instruments when new solutions are needed).
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Creating efficient, high-quality PRO data collection systems compatible with electronic health records and registries.
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Conducting statistical analyses of PRO endpoints.
Presentation
Kevin Weinfurt, PhD, of Duke University, and Kathryn Flynn, PhD, of the Medical College of Wisconsin, discuss patient-reported health measures as endpoints 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 PROs 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_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
- News_PCO Core Values Collaboration and Real-World Knowledge
July 7, 2022: Patient-Centered Outcomes Core Values Cross-Core Collaboration and Real-World Knowledge
- News_EHR Core Manuscript
October 5, 2021: New Article Identifies Challenges and Prerequisites for Using Electronic Health Record Systems for Pragmatic Research
- News_PCO Core update
September 23, 2021: PCO Core Aims for Greater Consistency in Integrating Patient-Reported Outcomes in Research and Clinical Care
- News_PRO GR
September 22, 2021: PCT Grand Rounds Explores Enabling Patient-Reported Outcome Measures in Clinical Trials
- News_Cultural and Linguistic Adaptation
March 17, 2021: Cultural and Linguistic Adaptations: Results of a Survey of PRISM Trials
- Assessing Data Quality
Assessing Data Quality (Living Textbook Video Module)
- Defining Outcomes With Electronic Health Record Data
Defining Outcomes With Electronic Health Record Data (Living Textbook Video Module)
Products and Publications
- 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
- Locklear et al eGems 2017
Case studies from the clinic: initiating and implementing patient-reported outcome measures
- Impact_of_Patient-Reported_Outcomes_on_Clinical_Practice_Jan_19_2016_Version_1
Impact of Patient-Reported Outcomes on Clinical Practice
- PROMIS workshop summary_6 10 15_FORMATTED
Challenges and Opportunities for the Use of NIH-supported PRO Tools in Comparative Effectiveness Research
- Strategies-for-Overcoming-Barriers-to-PROs
Strategies for Overcoming Barriers to Patient Reported Outcomes V1.0
- Howie et al Health Aff 2014
Assessing the value of patient-generated data to comparative effectiveness research
- PRO Resource Chapter
Patient-Reported Outcomes Resource Chapter
Presentations
- 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-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)
- 17-10-13 GR-Slides
Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records (GR Slides 2017)
- 16-04-22 GR-Video
Challenges and Opportunities for Using Common PRO Measures in Comparative Effectiveness Research (GR Video 2016)
- 16-04-22 GR-Slides
Challenges and Opportunities for Using Common PRO Measures in Comparative Effectiveness Research (GR Slides 2016)
- 15-04-10 GR-Video
How Do We Make Patient-Reported Health Measures Available as Endpoints in Pragmatic Clinical Trials? (GR Video 2015)
- 15-04-10 GR Slides
How Do We Make Patient-Reported Health Measures Available as Endpoints in Pragmatic Clinical Trials? (GR Slides 2015)
- 14-08-14 Weinfurt_PRO Core Update
PRO Core Update at Aug 2014 SC Meeting
- 14-02-25 PRO_Weinfurt
PRO Core Update at Feb 2014 SC Meeting
- 13-08-23 GR-Video
What Have We Learned About Integrating PROs with EMRs for Learning Systems? (GR Video 2013)
- 13-08-23 GR Slides
What Have We Learned About Integrating PROs with EMRs for Learning Systems? (GR Slides 2013)
- 13-05-17 GR-Video
Patient-Reported Outcomes Core Update (GR Video 2013)
- 13-05-17 GR Slides
Patient-Reported Outcomes Core Update (GR Slides 2013)