The scientists at PRO Consulting have published more than 100 peer-reviewed articles on PRO methods, and presented more than 500 papers at national and international conferences. Click here for a complete listing of our peer-reviewed publications on PRO data collection.

A sample of some of our recent papers on methodological issues affecting PRO data capture are listed below. Click on the title of any article in order to view a summary. To receive a copy of the article, please complete the form on the subsequent pages:

• “The Evidence for Endpoints:  PROs and Beyond”; Paty, J., Life Science Leader; January 2012
  
• “ePRO:  Electronic Solutions for Patient-Reported Data”, Edited by Bill Byrom and Brian Tiplady, Gower Publishing, 2010.
• “Electronic Patient Reported Outcomes (ePRO): Focus on Site-Based Assessments“, Tiplady, B., Ocotber 2010
• “Measurement is Strategic“, Paty, J., October 2010
• “ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes“, Craig, G., September 2010
• “Increasing Study Sensitivity Early in Trials”; Applied Clinical Trials, April 2010; Shiffman, S.
• “PDA or IVR-based Patient-Reported Outcomes Systems:  Criteria to be considered when selecting an electronic PRO technology,” Pierce, J., Tiplady, B., 2009
• “Alcohol and Cognitive Function: Assessment in Everyday Life and Laboratory Settings Using Mobile Phones”; Tiplady, B., Oshinowo, B., Thompson, J., Drummond, G.B.; Alcoholism: Clinical and Experimental Research;   December, 2009
• “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
• ePRO and EDC:  Perfect Together; McClelland, J., and Newbigging, A., Applied Clinical Trials, 2008
• ePROs: Practical Issues in Pen and Touchscreen Systems; Tiplady, G., Applied Clinical Trials, 2007
• Profile of PRO Consulting; CenterWatch, September, 2008
• Assessment of pain: a community-based diary survey in the USA; Krueger, A., Stone, A.; The Lancet, May 2008
• Two Decades of Change for PROs: How patient-reported data collection has been transformed since 1987; Shiffman, S., Applied Clinical Trials, January 2008
• Equivalence of Electronic and Paper-and-Pencil Administration of Patient-Reported Outcome Measures: A Meta-Analytic Review, Value in Health , April 2008
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• Grasping the FDA’s PRO Guidance, Applied Clinical Trials , August 2006
• White Paper: Documentation of PRO Instruments to Meet Contemporary FDA Standards , August, 2006
• White Paper: Conceptualizing Modifications & Identifying Validation Procedures for PRO Instruments, August, 2006
• White Paper: Distinguishing among Symptom vs. Health Related Quality of Life PRO Concepts: Developing a Conceptual Framework, August, 2006
• White Paper: Equivalence of Computerized and Paper and Pencil PRO Measures, June 2006
• Delivering on the eDiary Promise, Applied Clinical Trials , September, 2005
• Pain Assessment in Patients with Fibromyalgia Syndrome: A Consideration of Methods for Clinical Trials, The Clinical Journal of Pain , 2004
• Electronic diaries and questionnaires: Designing user interfaces that are easy for all patients to use, Quality of Life Research , 2004
• Proving the eDiary Dividend, Applied Clinical Trials , June 2004
• Assessment Methods for Patient-Reported Outcomes, Disease Management and Health Outcomes , November 2003