Volume 26, Issue 3 - Observational Studies

Patient-reported outcomes: How useful are they?

Author: Silvia Paz Ruiz

Abstract

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References

1. Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Pers Clin Res 2011;2:137–44. [cited 2017 July 5]. Available from: Available from: https://www.ncbi. nlm.nih.gov/pmc/articles/PMC3227331/#!po=6.25000
2. Willke RJ. Measuring the value of treatment to patients: Patient-reported outcomes in drug development. Am Health Drug Benefits 2008;1:34–40. Available from: http://
3. Food and Drug Administration. Guidance for industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; 2009 [cited 2017 June 10]. Available from Available from: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf
4. European Medicines Agency. Reflection paper on the use of patient reported outcome (PRO) measures in oncology studies, 2014 [cited 2017 June 10]. Available from Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf
5. McKenna SP. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Medicine. 2011;9:86. Available from Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170214/pdf/1741-7015-9- 86.pdf
6. University of Oxford. Instrument Types. Patient Reported Outcomes Measurement Group;2017. [cited 2017 July 5]. Available from Available from: http://phi.uhce.ox.ac.uk/inst_types.php
7. Coons Sj, Gwaltney CJ, Hays RD et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patientreported outcome (pro) measures: ISPOR ePRO Good Research Practices Task Force Report. Value Health 2009;12:419–29. Available from Available from: https://www.ispor.org/workpaper/patient_reported_outcomes/Coons.pdf
8. Dueck AC, Sloan JA. Meeting on the FDA draft guidance on patient-reported outcomes. Value Health 2007;10:S64–5. Available from: http://
9. 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 2007;10:S94–S105. Available from: http://
10. Blinman P, King M, Norman R, Viney R, Stockler MR. Preferences for cancer treatments: an overview of methods and applications in oncology. Ann Oncol 2012;23 (5):1104–10. Available from: http://
11. Cheung KL, Wijnen BFM, Hollin IL et al. Using best–worst scaling to investigate preferences in health care. Pharmacoecon 2016;34:1195-1209. Available from: http://
12. Kaplan RM, Frosch DL. Decision Making in medicine and health care. Ann Rev Clin Psychol 2005;1:525-56. Available from Available from: http://rmkaplan.bol.ucla.edu/Robert_M._Kaplan/2005_Publications_files/395-%20AnnRevClinPsycy.pdf
13. Arnold D, Girling A, Stevens A, Lilford R. Comparison of direct and indirect methods of estimating health state utilities for resource allocation: review and empirical analysis. BMJ. 2009;339(b2):688. Available on Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2714630/
14. ePROVIDE. Online support for clinical outcomes assessment; 2017.[cited 2017 July 5] Available from Available from: http://www.proqolid.org
15. OLGA. The On-line Guide to Quality of Life Assessment; 2012 [cited 2017 July 5] Available from Available from: http://www.olga-qol.com/
16. Health Measures. PROMIS; 2017 [cited 2017 July 5] Available from Available from: http://www.nihpromis.org/
17. Morillas C, Feliciano R, Catalina PF, Ponte C, Botella M, Rodrigues J et al. Patients’ and physicians’ preferences for type 2 diabetes mellitus treatments in Spain and Portugal: a discrete choice experiment. Patient Prefer Adherence 2015;9:1443-58 Available from: http://
18. Dilla T, Lizan L, Paz S, Garrido P, Avendaño C, Cruz-Hernandez JJ et al. Do new cancer drugs offer good value for money? The perspectives of oncologists, health care policy makers, patients, and the general population. Patient Preference and Adherence 2016; 10. Available from Available from: https://www.dovepress.com/do-newcancer-drugs-offer-good-value-for-moneythe-perspectives-of-onc-peer-reviewedarticle-PPA
19. Flores LT, Bennett AV, Law EB, Hajj C, Griffith MP, Goodman KA. Patientreported outcomes vs. clinician symptom reporting during chemoradiation for rectal cancer. Gastroint Cancer Res 2012;5: 119-24 Available from: http://
20. Szende A, Leidy NK, Revicki D. Health- Related Quality of Life and other patientreported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorisations of medicinal products 1995 to 2003. Value Health 2005;8: 534-48. Available from: http://
21. Gnanasakthy A, Mordin M, Clark M, DeMuro C, Sheri F, Copley-Merriman C. A review of patient-reported outcomes labels in the United States: 2006 to 2010. Value Health 2012;15:437-42. Available from: http://
22. Gnanasakthy A, Mordin M, Evans E, Doward L, DeMuro C. A review of patientreported outcomes labeling in the United States (2011-2015). Value Health 2016;20:420-9. Available from: http://
23. Ashley L, Jones H, Thomas J et al. Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system. J Med Internet Res 2013;15:e230. Available from: http://
24. Franklin PD, Harrold L, Ayers DC. Incorporating patient-reported outcomes in total joint arthroplasty registries: challenges and opportunities. Clin Orthop Relat Res 2013;471:3482-8. Available from: http://
25. Doward LC, McKenna SP. Defining patient-reported outcomes. Value Health 2004;7: S4-8. Available from: http://
26. Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User’s Guide [Internet]. 3rd edition.Rockville (MD): Agency for Healthcare Research and Quality (US); 2014. Available from Available from: https://www.ncbi.nlm.nih.gov/books/NBK208628/