Patient-reported outcomes: A new era in clinical research

Prasanna R Deshpande, Surulivel Rajan, B Lakshmi Sudeepthi, C P Abdul Nazir, Prasanna R Deshpande, Surulivel Rajan, B Lakshmi Sudeepthi, C P Abdul Nazir

Abstract

Now-a-days there is significant discussion about patient-reported outcomes (PRO) in medical world. The following article covers almost all the areas of PRO including-their importance, important concepts for understanding of PRO, significance, ideal properties, types, development and evaluation of PRO instruments. It is useful for physicians, pharmacists and patients for the assessment and improvement of the therapy.

Keywords: PRO; Patient reported outcomes; clinical research; quality of life.

Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Conceptual framework in PRO instrument
Figure 2
Figure 2
End-point model
Figure 3
Figure 3
Factors affecting health related quality of life
Figure 4
Figure 4
Development of PRO instrument

References

    1. What is Patient-centred Health Care? A Review of Definitions and Principles. 2nd ed. London: IAPO; 2007. International Alliance of Patients’ Organizations; pp. 1–34.
    1. 1st Ed. Washington, DC: National Academies Press; 2001. Institute of Medicine, Crossing the Quality Chasm-A New Health System for the 21st Century.
    1. U.S Department of Health and Human Services Food and Drug Administration Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. [Last Accessed on2011 Apr 20];U.S. FDA, Clinical/Medical. 2009 available from: [. ]
    1. Chin R, Lee BY. Economics and patient reported outcomes, Principles and practice of clinical trial medicine. London, Amsterdam, Burlington, San Diego: Elsevier Inc; 2008. pp. 145–66.
    1. Singh DP. Quality of life in cancer patients receiving palliative care. Indian J Palliat Care. 2010;16:36–43.
    1. Kozma CM, Reeder CE, Schulz RM. Economic, clinical, and humanistic outcomes: a planning model for pharmacoeconomic research. ClinTher. 1993;15:1121–32. discussion 1120.
    1. Shields A, Gwaltney C, Paty J, Shiffman S. Distinguishing Among Symptom vs.Health Related Quality of Life PRO Concepts: Developing a Conceptual Framework August 22, 2006. [Last Accessed on 2011 May 20]. Available from; .
    1. Pashos CL, Klein EG, Wanke LA, editors. ISPOR Lexicon™. Princeton: International Society for Pharmacoeconomics and Outcomes Research. 1998 NJ.
    1. Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, et al. Incorporating the Patient's Perspective into Drug Development and Communication: An Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003;6:522–31.
    1. Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2:1–74.
    1. Chen H, Taichman DB, Doyle RL. Health-related quality of life and patient-reported outcomes in pulmonary arterial hypertension. Proc Am ThoracSoc. 2008;5:623–30.
    1. Chao J, Nau DP, Aikens JE. Patient-reported perceptions of side effects of antihyperglycemic medication and adherence to medication regimens in persons with diabetes mellitus. clinTher. 2007;29:177–80.
    1. Miller R, Walsh D. Psychosocial aspects of palliative care in advanced cancer. J Pain Symptom Manage. 1991;6:24–9.
    1. Yarbro CH, Wujcik D, Gobel BH. Cancer Nursing: Principles and Practice. Sudbury, Ontario, London: John and Bartlett; 2011. Quality of life as an outcome in cancer care; pp. 201–18.
    1. Assessing and reporting outcomes important to patients in clinical trials and Cochrane reviews XV Cochrane collaboration 25 Oct. 2007 by Donald L. Patrick. [Last Accessed on 2011 June 1]. Available from: .
    1. Willke RJ. Measuring the value of treatment to patients: Patient-reported outcomes in drug development. Am Health Drug Benefits. 2008;1:34–40.
    1. Patient reported outcomes quality of life outcomes instruments database. Mapi research institute. [Last Accessed on 2011 Apr 1]. Available from: .
    1. Standards for Educational and Psychological Testing. Washington, DC: American Educational Research Association; 1999. American Educational Research Association, American Psychological Association, National Council on Measurement in Education.
    1. Messick S. Validity. In: Linn RL, editor. Educational Measurement. 3rd Ed. New York: American Council on Education and Macmillan; 1989.
    1. Assessing Respondent Understanding of Newly-Developed Patient-Reported Outcome (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices on Establishing and Reporting Evidence of Content Validity Task Force Report – Part II. [Last Accessed on 2001 Mar 25]. Available from: .
    1. Andrich D. Rasch models for measurement. Beverly Hills: Sage Publications; 1988.
    1. Hambleton R, Swaminathan H, Rogers HJ. Fundamentals of item response theory. Newbury Park, CA: Sage Press; 1991.
    1. Bryce Reeve., Ph.D Applications of Item Response Theory (IRT) Modeling for Building and Evaluating Questionnaires Measuring Patient-Reported Outcomes. Available from:
    1. [Last accessed on 2011 Jul 15]. .
    1. Reeve BB, Fayers P. Applying item response theory modeling for evaluating questionnaire item and scale properties. [Last Accessed on 2011 May 25]. Available from: .
    1. Rasch Analysis RUMM2020 is the Trademark of RUMMLaboratory Pty Ltd. [Last accessed on 2011 Jul 15]. Available from: .
    1. Research methods knowledge base. [Last accessed on 2011 Mar 27]. Available from: .
    1. Downing SM. Validity: On the meaningful interpretation of assessment data. Med Educ. 2003;37:830–7.
    1. Feldt LS, Brennan RL. Reliability. In: Linn RL, editor. Educational Measurement. 3rd Ed. New York: American Council on Education and Macmillan; 1989.
    1. Cook DA, Beckman TJ. Current Concepts in Validity and Reliability for Psychometric Instruments: Theory and Application. Am J Med. 2006;119:166.e7–166.e16.
    1. Farlex Huntington Valley, PA: Farlex; The Free Dictionary. Dictionary/Thesaurus >test-retest reliability [Web definition] [Accessed 20 Aug 2011]. Available on: .
    1. Internal consistency reliability. [Last Accessed on 2011 Mar 30]. Available from: .
    1. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297–334.
    1. Devellis RF. Scale Development Theory and Applications. London: Sage Publications; 1991. pp. 24–33.
    1. Key terms, abbreviations, and definitions. [Last Accessed on 2011 Mar 30]. Available from: .
    1. Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, et al. ISPOR ePRO Task Force.Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient reported outcome (PRO) measure: ISPOR ePRO Good Research Practices Task Force Report. Value Health. 2009;12:419–29.
    1. Prescribing Information Climara Pro® (Estradiol/Levonorgestrel Transdermal System) [Last Accessed on 2011 Jul 15]. Available from: .
    1. Kearney N, McCann L, Norrie J, Taylor L, Gray P, McGee-Lennon M, et al. Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. Support Care Cancer. 2009;17:437–44.

Source: PubMed

3
구독하다