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Patient-Reported Outcome Data

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Clinical Research Informatics

Part of the book series: Health Informatics ((HI))

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Abstract

This chapter provides a brief introduction to patient-reported outcome measures (PROs), with an emphasis on measure characteristics and the implications for informatics of the use of PROs in clinical research. Because of increased appreciation on behalf of health-care funders and regulatory agencies for actual patient experience, PROs have become recognized as legitimate and attractive endpoints for clinical studies and for comparative effectiveness research. “Patient-reported outcomes” is an internationally recognized umbrella term that includes both single dimension and multidimension measures of symptoms, with the defining characteristic that all information is provided directly by the patient. PROs can be administered in a variety of formats and settings, ranging from face-to-face interaction in clinics to web interfaces to mobile devices (e.g., smart phones). PRO instruments measure one or more aspects of patients’ health status and are especially important when more objective measures of disease outcome are not available. PROs can be used to measure a broad array of health status indicators within the context of widely varying study designs exploring a multitude of diseases. As a result, they need to be well characterized so that they can be identified and used appropriately. The standardization, indexing, access, and implementation of PROs are issues that are particularly relevant to clinical research informatics. In this chapter, we discuss design characteristics of PROs, measurement issues relating to the use of PROs, modes of administration, item and scale development, scale repositories, and item banking.

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References

  1. FDA. Guidance for industry: patient-reported outcome measures; use in medical product development to support labeling claims. Silver Spring: U. S. D. o. H. a. H. Services; 2009.

    Google Scholar 

  2. McKenna P, Doward L. Integrating patient reported outcomes. Value Health. 2004;7:S9–12.

    Article  Google Scholar 

  3. Garratt A. Patient reported outcome measures in trials. BMJ. 2009;338:a2597.

    Article  Google Scholar 

  4. Wiklund I. Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life. Fundam Clin Pharmacol. 2004;18:351–63.

    Article  CAS  Google Scholar 

  5. Fayers PM, Machin D. Quality of life: the assessment, analysis and interpretation of patient-reported outcomes. Chichester: Wiley; 2013.

    Google Scholar 

  6. Atkinson MJ, Lennox RD. Extending basic principles of measurement models to the design and validation of patient reported outcomes. Health Qual Life Outcomes. 2006;4(1):65.

    Article  Google Scholar 

  7. Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD, Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health. 2007a;10:S94–S105.

    Article  Google Scholar 

  8. Shields A, Gwaltney C, Tiplady B, et al. Grasping the FDA’s PRO guidance: what the agency requires to support the selection of patient reported outcome instruments. Appl Clin Trials. 2006;15:69–83.

    Google Scholar 

  9. Valderas J, Alonso J. Patient reported outcome measures: a model-based classification system for research and clinical practice. Qual Life Res. 2008;17:1125–35.

    Article  Google Scholar 

  10. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, CONSORT PRO Group. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814–22.

    Article  CAS  Google Scholar 

  11. Skinner J, Teresi J, et al. Measurement in older ethnically diverse populations: overview of the volume. J Ment Health Aging. 2001;7:5–8.

    Google Scholar 

  12. Anastasi A. Psychological testing. 6th ed. New York: Macmillan Publishing Company; 1998.

    Google Scholar 

  13. Morgan R, Teal C, et al. Measurement in VA health services research: veterans as a special population. Health Serv Res. 2005;40:1573–83.

    Article  Google Scholar 

  14. Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD, the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health. 2007b;10(S2):S94–S105.

    Article  Google Scholar 

  15. DeVellis RF. Scale development: theory and applications. 3rd ed. Thousand Oaks: Sage; 2012.

    Google Scholar 

  16. Vogt W. Dictionary of statistics and methodology: a nontechnical guide for the social sciences. 2nd ed. Thousand Oaks: Sage Publications; 1999.

    Google Scholar 

  17. Aday L, Cornelius L. Designing and conducting health surveys: a comprehensive guide. 3rd ed. San Francisco: Jossey-Bass; 2006.

    Google Scholar 

  18. McDowell I. Measuring health: a guide to rating scales and questionnaires. 3rd ed. New York: Oxford University Press; 2006.

    Book  Google Scholar 

  19. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–9.

    Article  Google Scholar 

  20. Bowling A. Mode of questionnaire administration can have serious effects on data quality. J Public Health. 2005;27:281–91.

    Article  Google Scholar 

  21. Dillman DA. Internet, mail and mixed-mode surveys: the tailored design method. 4th ed. New York: Wiley; 2014.

    Google Scholar 

  22. Snyder CF, Blackford AL, Wolff AC, Carducci MA, Herman JM, Wu AW, the PatientViewpoint Scientific Advisory Board. Feasibility and value of PatientViewpoint: a web system for patient-reported outcomes assessment in clinical practice. Psycho-Oncology. 2013;22(4):895–901.

    Article  Google Scholar 

  23. Coons S, Gwaltney C, et al. 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. 2009;12:419–29.

    Article  Google Scholar 

  24. Electronic Patient Reported Outcomes. PAREXEL. https://www.parexel.com/solutions/infor-matics/clinical-outcome-assessments/epro. Accessed 2 Feb 2018.

  25. Electronic Patient Reported Outcomes (ePRO). ICON plc. http://www.iconplc.com/jp/tech-nology/application-areas/electronic-patient-report/. Accessed 2 Feb 2018.

  26. Patient Engagement|ePRO. IBM clinical development. https://www.ibmclinicaldevelop-ment.com/en/ibm-clinical-development-epro. Accessed 2 Feb 2018.

  27. Patient Reported Outcomes. VitalHealth Software. https://www.vitalhealthsoftware.com/prod-ucts/patient-health-questionnaires/patient-reported-outcomes. Accessed 2 Feb 2018.

  28. e-Patient Reported Outcomes.Acceliant. http://www.acceliant.com/products/e-patient-reported-outcomes. Accessed 2 Feb 2018.

  29. Rave eCOA/ePRO. Medidata. https://www.mdsol.com/en/products/rave/ecoa-epro. Accessed 2 Feb 2018.

  30. Cole E, Pisano ED, Clary GJ, Zeng D, Koomen M, Kuzmiak CM, Seo BK, Lee Y, Pavic D. A comparative study of mobile electronic data entry systems for clinical trials data collection. Int J Med Inform. 2006;75:722–9.

    Article  Google Scholar 

  31. Collins R, Kashdan T, et al. The feasibility of using cellular phones to collect ecological momentary assessment data: application to alcohol consumption. Exp Clin Psychopharmacol. 2003;11:73–8.

    Article  Google Scholar 

  32. Freedman M, Lester K, et al. Cell phones for ecological momentary assessment with cocaine-addicted homeless patients in treatment. J Subst Abus Treat. 2006;30:105–11.

    Article  Google Scholar 

  33. Reid S, Kauer S, et al. A mobile phone program to track young people’s experiences of mood, stress and coping. Soc Psychiatry Psychiatr Epidemiol. 2009;44(6):501–7.

    Article  Google Scholar 

  34. Muehlhausen W, Doll H, Quadri N, Fordham B, O’Donohoe P, Dogar N, Wild DJ. Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013. Health Qual Life Outcomes. 2015;13:167. https://doi.org/10.1186/s12955-015-0362-x.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO task force report. Value Health. 2009;12(8):1075–83.

    Article  Google Scholar 

  36. Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1—eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967–77.

    Article  Google Scholar 

  37. Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2—assessing respondent understanding. Value Health. 2011;14(8):978–88.

    Article  Google Scholar 

  38. Reeve BB, Hays RD, Bjorner JB, Cook KF, Crane PK, Teresi JA, et al. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007;45(5):S22–31.

    Article  Google Scholar 

  39. Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45(5 Suppl 1):S3.

    Article  Google Scholar 

  40. Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179–94.

    Article  Google Scholar 

  41. Harniss M, Amtmann D, et al. Considerations for developing interfaces for collecting patient-reported outcomes that allow the inclusion of individuals with disabilities. Med Care. 2007;45:S48–54.

    Article  Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Management, Policy and Community Health, University of Texas Health Science Center at Houston School of Public Health, Houston, TX, USA

    Robert O. Morgan PhD & Laura E. Witte MPH

  2. Health Economics and Outcomes Research, AbbVie Pharmaceuticals, North Chicago, IL, USA

    Kavita R. Sail PhD

Authors
  1. Robert O. Morgan PhD
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  2. Kavita R. Sail PhD
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  3. Laura E. Witte MPH
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Corresponding author

Correspondence to Robert O. Morgan PhD .

Editor information

Editors and Affiliations

  1. Duke University School of Nursing, Durham, NC, USA

    Rachel L. Richesson

  2. School of Information, University of South Florida, Tampa, FL, USA

    James E. Andrews

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Morgan, R.O., Sail, K.R., Witte, L.E. (2019). Patient-Reported Outcome Data. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-319-98779-8_12

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  • DOI: https://doi.org/10.1007/978-3-319-98779-8_12

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-98778-1

  • Online ISBN: 978-3-319-98779-8

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