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Recent PRO Publications
Are you looking for the most current information on Patient Reported Outcomes data capture? Click any link below to access some of the most recently published literature available.
- “Equivalence of Electronic and Paper-and-Pencil Administration of Patient-Reported Outcome Measures: A Meta-Analytic Review”; Shields, A., Gwaltney, C., Shiffman, S., Value in Health, April 2008 (Blackwell Synergy Download Fee Applies)
Summary: Patient-reported outcomes (PROs; self-report assessments) are increasingly important in evaluating medical care and treatment efficacy. Electronic administration of PROs via computer is becoming widespread. This article reviews the literature addressing whether computer-administered tests are equivalent to their paper-and-pencil forms. - "Two Decades of Change for PROs: How patient-reported data collection has been transformed since 1987"; Krueger, A., Stone, A.; The Lancet, 2008
Summary: The researchers conducted a community-based telephone survey using the Princeton Affect and Time Survey (PATS) to assess the proportion of people experiencing pain, and the severity of pain, at randomly selected times in a representative sample of individuals in the USA. This article describes their findings which replicate previous ones, contradict some previous findings, and extend our knowledge about daily pain and activities. - “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. - “Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective”; Sloan, J., Halyard, M., Frost, M., Dueck, A., Teschendorf, B., Rothman, M, the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group, Value in Health, 2007 (Online Article - Blackwell Synergy Download Fee Applies)
Summary: Patient-reported outcomes (PROs) have become increasingly prevalent in clinical research and practice. On February 2, 2006, the Food and Drug Administration (FDA) released a draft guidance document with respect to incorporating PROs into clinical research endeavors which include FDA involvement. Researchers at the Mayo Clinic worked with FDA personnel and experts from academia, industry, clinical research, and clinical practice to facilitate discussion, dissemination, and operationalization of the FDA guidance document. This article introduces a manuscript series that resulted from this collective effort.