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ePRO Resource Center > Overview of Patient Reported Outcomes (PRO)
Overview of Patient Reported Outcomes (PRO)
Patient Reported Outcomes (PRO) data represent an increasingly important component of new drug, biologics, and medical device development. As such, a wealth of information has been published on the merits of PRO data and the appropriate methods for capturing PRO data to support a trial’s primary efficacy endpoints.
To access any of the related articles listed below, select the corresponding link.
- “Two Decades of Change for PROs: How patient-reported data collection has been transformed since 1987"; Shiffman, S., Applied Clinical Trials, 2008
Summary: In this commentary, Dr. Shiffman reflects on how Patient Reported Outcomes (PROs) have changed since he started using electronic diaries in clinical research twenty years ago, including examples of how PROs have grown more important to drug development, more scientifically robust, and more technologically sophisticated. - “The Past, Present, and Future of Capturing Subject’s Experience in Clinical Trials”; Paty, J., Engfer, D., Good Clinical Practice Journal, 2003
Summary: A growing trend in clinical research is to directly ask subjects to report on their experience with the drug. The primary shortcomings of this approach are that most data is captured only at the clinical research site, meaning we only obtain a brief snapshot of the drug’s effect on the subject. This brief article discusses how technology will enable clinical research to move beyond the brief snapshot view of drug impact. - “Methodological Issues Affecting the Value of Patient Reported Outcomes Data”; Hufford, M., Shiffman, S., Expert Rev. Pharmacoeconomics Outcomes Res., 2002
Summary: This review examines the impact of a variety of methodological issues on the value of PRO data. In particular, when patients are asked to self-monitor their experiences over time, a variety of methodological issues must be addressed if the data are to be considered a reliable and valid reflection of their daily lives. - “Subject Experience Diaries in Clinical Research Parts I & II”; Shiffman, S., Hufford, M., Paty, J., Applied Clinical Trials, 2001
Summary: The first of this two-part article explores the meaning and importance to clinical research of subject experience data. It also reviews the methods used to collect the data, focusing in particular on paper and electronic subject experience diaries. The second part discusses the scientific principles underlying ecological momentary assessment and how these principles can enhance protocol design and measurement sensitivity.