PRO Data Collection in Clinical Trials Using Mixed Modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force

US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. [Accessed June 1, 2014]. US Food and Drug Administration. Clinical Outcome Assessment Qualification Program. October 11, 2013 update. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm. [Accessed June 1, 2014]. Walton MK, Powers JH, Hobart J, et al. Clinical outcomes assessments (COAs): a conceptual foundation. ISPOR ClinRO Task Force report. Value Health. In press. US Food and Drug Administration. Measurement in clinical trials: review and qualification of clinical outcome assessments. In: Public Workshop; Silver Spring, MD; October 19, 2011. Available from: http://www.fda.gov/Drugs/NewsEvents/ucm276110.htm. [Accessed June 1, 2014]. Hyland, 1993, Diary keeping in asthma: comparison of written and electronic methods, BMJ, 306, 487, 10.1136/bmj.306.6876.487 Tourangeau, 1996, Asking sensitive questions: the impact of data collection mode, question format, and question context, Public Opin Q, 60, 275, 10.1086/297751 Taenzer, 1997, Computerized quality-of-life screening in an oncology clinic, Cancer Pract, 5, 168 Bloom, 1998, Technology, experimentation, and the quality of survey data, Science, 280, 847, 10.1126/science.280.5365.847 Velikova, 1999, Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires, J Clin Oncol, 17, 998, 10.1200/JCO.1999.17.3.998 Stone, 2002, Patient non-compliance with paper diaries, BMJ, 324, 1193, 10.1136/bmj.324.7347.1193 Bushnell, 2006, Validation of electronic data capture of the Irritable Bowel Syndrome—Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol, Value Health, 9, 98, 10.1111/j.1524-4733.2006.00087.x Tiplady, 2010, Electronic patient diaries and questionnaires – ePRO now delivering on promise?, Patient, 3, 179, 10.2165/11537600-000000000-00000 Yeomans, 2014, The future of ePRO platforms, Appl Clin Trials Ganser, 2010, Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial Streiner, 2008 Gnanasakthy, 2013, Integration of patient-reported outcomes in multiregional confirmatory clinical trials, Contemp Clin Trials, 35, 62, 10.1016/j.cct.2013.02.006 Gwaltney, 2008, Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: a meta-analytic review, Value Health, 11, 322, 10.1111/j.1524-4733.2007.00231.x Rosenthal, 1979, The “file drawer problem” and tolerance for null results, Psychol Bull, 86, 638, 10.1037/0033-2909.86.3.638 Song, 2009, Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies, BMC Med Res Methodol, 9, 79, 10.1186/1471-2288-9-79 Ramachandran, 2008, Testing the measurement equivalence of paper and touch-screen versions of the EQ-5D visual analog scale (EQ VAS), Qual Life Res, 17, 1117, 10.1007/s11136-008-9384-8 Athale, 2004, A web-compatible instrument for measuring self-reported disease activity in arthritis, J Rheumatol, 31, 223 McCabe, 2006, Comparing web and mail responses in a mixed mode survey in college alcohol use research, Addict Behav, 31, 1619, 10.1016/j.addbeh.2005.12.009 Bennett, 2013, Is between-mode equivalence comparable to test-retest reliability for patient-reported outcome (PRO) measures: a test case of Web versus IVRS versus paper for the MSKCC Bowel Function Instrument and LASA QOL, Value Health, 16, A33, 10.1016/j.jval.2013.03.192 Bennett, 2013, Mode equivalence and acceptability of Web‐, Interactive Voice Response System‐, and Paper‐based administration of US National Cancer Institute’s Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE), Qual Life Res, 22, 42 Lundy, 2011, Measurement equivalence of interactive voice response and paper versions of the EQ-5D in a cancer patient sample, Value Health, 14, 867, 10.1016/j.jval.2011.03.001 Lundy, 2014, Testing the measurement equivalence of paper and interactive voice response system versions of the EORTC QLQ-C30, Qual Life Res, 23, 229, 10.1007/s11136-013-0454-1 Bent, 2005, Computer administered bath ankylosing spondylitis and Quebec Scale outcome questionnaires for low back pain: agreement with traditional paper format, J Rheumatol, 32, 669 Bellamy, 1997, Validation study of a computerized version of the Western Ontario and McMaster Universities VA3.0 Osteoarthritis Index, J Rheumatol, 24, 2413 Coons, 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, Value Health, 12, 10.1111/j.1524-4733.2008.00470.x Raymond, 2010, Forward – the patient’s viewpoint: impact of ePRO technologies on clinical research Tiplady, 2010, Diary design considerations: interface issues and patient acceptability Taylor NP. Pfizer: ‘Bring your own device’ is coming to clinical trials. December 2, 2013. Available from: www.fiercebiotechit.com/story/pfizer-sees-smartphones-taking-center-stage-clinical-trials/2013-12-02. [Accessed June 1, 2014]. Zbrozek, 2013, Validation of electronic systems to collect patient-reported outcome (PRO) data—recommendations for clinical trial teams: report of the ISPOR ePRO Systems Validation Good Research Practices Task Force, Value Health, 16, 480, 10.1016/j.jval.2013.04.002 Willis, 2005 McEntegart, 2010, Equivalence testing: validation and supporting evidence when using modified PRO instruments Gallo, 2008, Treatment-by-center interaction Wild, 2009, Value Health, 12, 430, 10.1111/j.1524-4733.2008.00471.x