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Patient-Reported Outcome Measures in Clinical Research

To identify the key insights or developments described in this article
1 Credit CME

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
2.
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.PubMedGoogle ScholarCrossref
3.
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.PubMedGoogle ScholarCrossref
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Fayers  PM , Machin  D .  Quality of Life: The Assessment, Analysis, and Reporting of Patient-Reported Outcomes. 3rd ed. John Wiley & Sons Inc; 2016.
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Copay  AG , Glassman  SD , Subach  BR ,  et al.  Minimum clinically important difference in lumbar spine surgery patients.   Spine J. 2008;8(6):968-974.PubMedGoogle ScholarCrossref
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McGlothlin  AE , Lewis  RJ .  Minimal clinically important difference.   JAMA. 2014;312(13):1342-1343.PubMedGoogle ScholarCrossref
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Calvert  M , King  M , Mercieca-Bebber  R ,  et al.  SPIRIT-PRO extension explanation and elaboration.   BMJ Open. 2021;11(6):e045105.PubMedGoogle Scholar
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Calvert  M , Blazeby  J , Altman  DG ,  et al.  Reporting of patient-reported outcomes in randomized trials.   JAMA. 2013;309(8):814-822.PubMedGoogle ScholarCrossref
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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.PubMedGoogle ScholarCrossref
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Cao  J , Zhang  S .  Multiple comparison procedures.   JAMA. 2014;312(5):543-544.PubMedGoogle ScholarCrossref
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