How to Include Patient-Reported Outcome Measures in Clinical Trials

Curr Osteoporos Rep. 2020 Oct;18(5):480-485. doi: 10.1007/s11914-020-00611-5.


Purpose of review: Patient-reported outcome measures are increasingly important measures of patient experience, which can increase research robustness, maximise economic value and improve patient outcomes. This review outlines the benefits, challenges and practicalities of incorporating patient-reported outcome measures in clinical trials.

Recent findings: Patient-reported outcome measures are often the best way of measuring patient symptoms and quality of life. Patient-reported outcome measures can help reduce observer bias, engage patients in the research process, and inform health service resource planning. A range of tools exist to help facilitate clinicians and researchers in selecting and utilising patient reported outcome measures. Key issues to consider when selecting an appropriate tool include the development, format and psychometric properties of the patient-reported outcome measures. The use of patient-reported outcome measures allow us to better understand the patient experience and their values. A range of tools exist to help facilitate the use of patient-reported outcome measures. This article outlines how we can incorporate patient-reported outcome measures in clinical trials.

Keywords: Clinical trial endpoint; Clinical trials; Health care; Outcome assessment; Patient-centered care; Patient-reported outcome measures.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic*
  • Humans
  • Patient Reported Outcome Measures*
  • Quality of Life