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Research, Methods, Statistics

Patient-Reported Outcome Measures in Clinical Research

To identify the key insights or developments described in this article

1 Credit CME

JAMA

Published Online: July 15, 2022

JAMA Guide to Statistics and Methods

Article Information and Disclosures

Kevin P. Weinfurt, PhD¹;

Bryce B. Reeve, PhD¹

Author Affiliations

¹Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina

Read article on JAMA Network

Special Communication

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

Melanie Calvert, PhD; Derek Kyte, PhD; Rebecca Mercieca-Bebber, PhD; Anita Slade, PhD; An-Wen Chan, MD, DPhil; Madeleine T. King, PhD; and the SPIRIT-PRO Group; Amanda Hunn, MA; Andrew Bottomley, PhD; Antoine Regnault, PhD; An-Wen Chan, MD; Carolyn Ells, PhD; Daniel O’Connor, PhD; Dennis Revicki, PhD; Donald Patrick, PhD; Doug Altman, DSc; Ethan Basch, MD; Galina Velikova, PhD; Gary Price; Heather Draper, PhD; Jane Blazeby, MD; Jane Scott, PhD; Joanna Coast, PhD; Josephine Norquist, PhD; Julia Brown, MSc; Kirstie Haywood, PhD; Laura Lee Johnson, PhD; Lisa Campbell, MD; Lori Frank, PhD; Maria von Hildebrand; Michael Brundage, MD; Michael Palmer, MSc; Paul Kluetz, MD; Richard Stephens, MA; Robert M. Golub, MD; Sandra Mitchell, PhD; Trish Groves, MRCPsych
Original Investigation

Effect of Ventral vs Dorsal Spinal Surgery on Physical Functioning in Cervical Spondylotic Myelopathy

Zoher Ghogawala, MD; Norma Terrin, PhD; Melissa R. Dunbar, MPH; Janis L. Breeze, MPH; Karen M. Freund, MD, MPH; Adam S. Kanter, MD; Praveen V. Mummaneni, MD, MBA; Erica F. Bisson, MD, MPH; Fred G. Barker II, MD; J. Sanford Schwartz, MD; James S. Harrop, MD; Subu N. Magge, MD; Robert F. Heary, MD; Michael G. Fehlings, MD, PhD; Todd J. Albert, MD; Paul M. Arnold, MD; K. Daniel Riew, MD; Michael P. Steinmetz, MD; Marjorie C. Wang, MD, MPH; Robert G. Whitmore, MD; John G. Heller, MD; Edward C. Benzel, MD
Special Communication

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research

Samantha Cruz Rivera, PhD; Olalekan Lee Aiyegbusi, PhD; Jonathan Ives, PhD; Heather Draper, PhD; Rebecca Mercieca-Bebber, PhD; Carolyn Ells, PhD; Amanda Hunn, MA; Jane A. Scott, PhD; Conrad V. Fernandez, MD; Andrew P. Dickens, PhD; Nicola Anderson, MSc; Vishal Bhatnagar, MD; Andrew Bottomley, PhD; Lisa Campbell, MD; Clive Collett, MA; Philip Collis; Kathrine Craig, PhD; Hugh Davies, MD; Robert Golub, MD; Lesley Gosden; Ari Gnanasakthy, MSc; Elin Haf Davies, PhD; Maria von Hildebrand; Janet M. Lord, PhD; Nirosha Mahendraratnam, PhD; Tempei Miyaji, MSc; Thomas Morel, PhD; Joao Monteiro, PhD; Ann-Dorthe Olsen Zwisler, PhD; John Devin Peipert, PhD; Jessica Roydhouse, PhD; Angela M. Stover, PhD; Roger Wilson, CBE; Christina Yap, PhD; Melanie J. Calvert, PhD
Original Investigation

Electronic Symptom Monitoring With Patient-Reported Surveys and Outcomes Among Patients With Metastatic Cancer

Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH; Sydney Henson, BS; Jennifer Jansen, MPH; Brenda Ginos, MS; Angela M. Stover, PhD; Philip Carr, MPH; Patricia A. Spears, BS; Mattias Jonsson, BA; Allison M. Deal, MS; Antonia V. Bennett, PhD; Gita Thanarajasingam, MD; Lauren J. Rogak, MA; Bryce B. Reeve, PhD; Claire Snyder, PhD; Deborah Bruner, PhD; David Cella, PhD; Lisa A. Kottschade, MSN; Jane Perlmutter, PhD; Cindy Geoghegan, MA; Cleo A. Samuel-Ryals, PhD; Barbara Given, PhD; Gina L. Mazza, PhD; Robert Miller, MD; Jon F. Strasser, MD; Dylan M. Zylla, MD; Anna Weiss, MD; Victoria S. Blinder, MD; Amylou C. Dueck, PhD

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Health conditions may cause patients to feel ill and have impaired functioning in their daily lives. Thus, it is important to assess how patients are feeling and functioning when evaluating the effects of interventions to prevent or treat health conditions. Aspects of health that patients can report on directly, such as the severity of pain or limitations in physical functioning, are patient-reported outcomes.

The recommended quantitative approach to measure these aspects of health status is to ask patients directly using a standardized questionnaire. Patient-reported outcome measures are reports 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.”¹ An example of a patient-reported outcome measure, the Short Form 36 (SF-36), was used in a randomized clinical trial conducted by Ghogawala et al² to compare 2 surgical approaches (ventral or dorsal) for the treatment of cervical spondylotic myelopathy, which is a condition that can cause significant impairments in physical functioning.

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Article Information

Corresponding Author: Kevin P. Weinfurt, PhD, Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701 (kevin.weinfurt@duke.edu).

Published Online: July 15, 2022. doi:10.1001/jama.2022.11238

Conflict of Interest Disclosures: Dr Weinfurt reported receiving personal fees from Regeneron Pharmaceuticals and being a co-developer of the National Institutes of Health–funded Patient-Reported Outcomes Measurement Information System (PROMIS) and the Comprehensive Assessment of Self-Reported Urinary Symptoms. Dr Reeve reported receiving personal fees from Johns Hopkins University; receiving nonfinancial support from the European Organisation for Research and Treatment of Cancer; and being a co-developer of PROMIS, the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, the Observer-Reported Communication Ability, the Piper Fatigue Scale-12, the Patient-Centered Communication in Cancer Care, the Comprehensive Heart Disease Knowledge Questionnaire, the 2005 Healthy Eating Index, and the Everyday Discrimination Scale.

References

US Food and Drug Administration. Patient-reported outcome measures. Accessed December 29, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims

Ghogawala Z , Terrin N , Dunbar MR , et al. Effect of ventral vs dorsal spinal surgery on patient-reported physical functioning in patients with cervical spondylotic myelopathy. JAMA. 2021;325(10):942-951.PubMed Google Scholar Crossref

Weinfurt KP , Lin L , Bruner DW , et al. Development and initial validation of the PROMIS® sexual function and satisfaction measures version 2.0. J Sex Med. 2015;12(9):1961-1974.PubMed Google Scholar Crossref

Fayers PM , Machin D . Quality of Life: The Assessment, Analysis, and Reporting of Patient-Reported Outcomes. 3rd ed. John Wiley & Sons Inc; 2016.

Copay AG , Glassman SD , Subach BR , et al. Minimum clinically important difference in lumbar spine surgery patients. Spine J. 2008;8(6):968-974.PubMed Google Scholar Crossref

McGlothlin AE , Lewis RJ . Minimal clinically important difference. JAMA. 2014;312(13):1342-1343.PubMed Google Scholar Crossref

Calvert M , King M , Mercieca-Bebber R , et al. SPIRIT-PRO extension explanation and elaboration. BMJ Open. 2021;11(6):e045105.PubMed Google Scholar

Calvert M , Blazeby J , Altman DG , et al. Reporting of patient-reported outcomes in randomized trials. JAMA. 2013;309(8):814-822.PubMed Google Scholar Crossref

Cruz Rivera S , Aiyegbusi OL , Ives J , et al. Ethical considerations for the inclusion of patient-reported outcomes in clinical research. JAMA. 2022;327(19):1910-1919.PubMed Google Scholar Crossref

Cao J , Zhang S . Multiple comparison procedures. JAMA. 2014;312(5):543-544.PubMed Google Scholar Crossref

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.