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ePRO Resources > Recent PRO Publications
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.
- Read “Increasing Study Sensitivity Early in Trials”; Applied Clinical Trials, April 2010; Shiffman, S.
Summary: This peer-reviewed article demonstrates why eDiaries are important in Phase II clinical trials, delivering a greater ability to detect treatment effects and reducing the size and costs of drug development programs. Multiple case studies are presented, outlining how researchers who have adopted ePRO methods early in clinical development have gained greater insight into the full therapeutic potential of their candidate drugs.
- Read "The PROs of ePRO"; The Monitor, Feb., 2010; Waife, R.
Summary: In this article, industry consultant Ron Waife of Waife & Associates reviews the "pros" of ePRO in three ways: pros, pro's, and prose. The article highlights of capturing PRO data electronically, how professional ePRO providers deliver value, and the need for more information about when and how ePRO should be added to the clinical development program.
- Read “PDA or IVR_based Patient-Reported Outcomes Systems: Criteria to be considered when selecting an electronic PRO technology,” Pierce, J., Tiplady, B., 2009
Summary: This white paper describes an electronic patient-reported outcomes (ePRO) modality decision tool that provides a systematic, standardized framework for assessing the utility and feasibility of the two main electronic patient-reported outcomes modalities: handheld device and interactive voice response (IVR) systems. The components of this tool are based on published and unpublished research as well as the substantial experience of two ePRO market leaders and have been further validated by market research with clinical trial sponsors.
- "Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report"; Coons, S., Gwaltney, C., Hays, R., Lundy, J., Sloan, J., Revicki, D., Lenderking, W., Cella, D., Basch, E., on behalf of the ISPOR ePRO Task Force, Value in Health, November, 2008
Summary: The article presents recommendations from ISPOR’s ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or equivalence, of ePROs to the paper-based PRO measures from which they were adapted. It provides a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices in accordance with the current U.S FDA’s Draft Guidance on PROs in Clinical Research.
- “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.
- “ePRO and EDC: Perfect Together”; McClelland, J., and Newbigging, A., Applied Clinical Trials, 2008
Summary: This article review the evolving role of electronic Patient Reported Outcomes (ePRO) and Electronic Data Capture (EDC) integration in clinical development, including the requirements for success, benefits, and future of ePRO/EDC integration.
- “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.