Using patient-reported outcomes and PROMIS in research and clinical applications: experiences from the PCORI pilot projects

PurposeThe field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes and, in particular the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications.MethodsLead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects’ experiences.ResultsLessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care.ConclusionThe PCORI pilot projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders.

[1]  Michael Hoerger,et al.  Educating the Psychology Workforce in the Age of the Affordable Care Act: A Graduate Course Modeled after the Priorities of the Patient-Centered Outcomes Research Institute (PCORI). , 2015, Training and education in professional psychology.

[2]  Claire F. Snyder,et al.  Communicating patient-reported outcome scores using graphic formats: results from a mixed-methods evaluation , 2015, Quality of Life Research.

[3]  Jodi B Segal,et al.  Patient-reported Outcomes (PROs): Putting the Patient Perspective in Patient-centered Outcomes Research , 2013, Medical care.

[4]  Arthur Zbrozek,et al.  Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force. , 2013, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[5]  A. Orbai,et al.  Reliability and Validity of Selected PROMIS Measures in People with Rheumatoid Arthritis , 2015, PloS one.

[6]  Raj Sabharwal,et al.  Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned , 2015, Journal of General Internal Medicine.

[7]  L. McLeod,et al.  ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research , 2013, Quality of Life Research.

[8]  David Cella,et al.  Bringing PROMIS to practice: Brief and precise symptom screening in ambulatory cancer care , 2015, Cancer.

[9]  C. Bingham,et al.  Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 4: patient-reported outcomes can inform clinical decision making in chronic care. , 2017, Journal of clinical epidemiology.

[10]  Paul A. Pilkonis,et al.  Evaluating PROMIS® instruments and methods for patient-centered outcomes research: Patient and provider voices in a substance use treatment setting , 2015, Quality of Life Research.

[11]  A. Boonen,et al.  Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus , 2012, Annals of the rheumatic diseases.

[12]  Anne C. Beal,et al.  The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. , 2012, Journal of the American Medical Association (JAMA).

[13]  M. C. Lima.  Cross-cultural adaptation to Portuguese of a measure of satisfaction with participation of the Patient-Reported Outcomes Measurement Information System (PROMIS ® ) , 2015 .

[14]  P. Tugwell,et al.  Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process , 2015, The Journal of Rheumatology.

[15]  A. Wu,et al.  Adding the patient perspective to comparative effectiveness research. , 2010, Health affairs.

[16]  C. Forrest,et al.  The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative , 2013, Health and Quality of Life Outcomes.

[17]  J. Fries,et al.  The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. , 2014, Journal of clinical epidemiology.

[18]  Joanne Greenhalgh,et al.  Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations , 2012, Quality of Life Research.