Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지
DOI QR코드

DOI QR Code

Current status of routine use of Patient-Reported Outcome in the tertiary hospital clinical setting in Republic of Korea

대한민국 상급 종합병원 임상현장에서 환자자기평가결과(Patient-Reported Outcome)의 일상적인 사용 현황

  • Bang, Garam (School of pharmacy, Sungkyunkwan University) ;
  • Kang, Danbee (Center for Clinical Epidemiology, Samsung Medical Center) ;
  • Cho, Juhee (Center for Clinical Epidemiology, Samsung Medical Center)
  • 방가람 (성균관대학교 약학대학) ;
  • 강단비 (삼성서울병원 임상역학연구센터) ;
  • 조주희 (삼성서울병원 임상역학연구센터)
  • Received : 2022.02.07
  • Accepted : 2022.05.20
  • Published : 2022.06.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objective: There is a growing movement to introduce Patient-Reported Outcome (PRO) to clinical settings. This study aimed to investigate the routine use of PRO in tertiary hospital clinical settings. Methods: From January 2016 to December 2018, the usage status of Patient-Reported Outcome Measures (PROMs) submitted to the electronic medical record of a tertiary hospital clinical setting was investigated. Descriptive analysis was conducted to investigate the usage status of PROMs by 42 departments. Also, the most frequently used PROMs by departments, the purpose of measurement, the use rate of verified PROMs were investigated. Results: The PROMs accounted for 66% (98) of the 148 Instruments. Of the 98 PROMs, 64% (63) were using a validation Korean version of PROMs. Only about 1% of total outpatient visits applied PROMs, and among them, it was frequently used in urology (13%), orthopedics (8%), and otolaryngology (5%). The use rate of the validated PROMs was found to be 64%. Conclusions: The use of PROMs in domestic clinical settings was found to be very limited and frequently used only in specific departments. It is essential to use a PROMs that has been validated according to guidelines, as the use of validated PROMs will provide beneficial information to health professionals and also for the patient health improvement by objectively measuring the patient's health status.

Keywords

References

  1. Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of patient-reported outcomes in routine medical care. Am Soc Clin Oncol Educ Book 2018;38:122-34.
  2. Lohr KN, Zebrack BJ. Using patient reported outcomes in clinical practice challenges and opportunities. Qual Life Res 2009;18(1):99-107. https://doi.org/10.1007/s11136-008-9413-7
  3. Jensen RE, Snyder CF, Abernethy AP, et al. Review of electronic patient-reported outcomes systems used in cancer clinical care. J Oncol Pract 2014;10(4):215-22. https://doi.org/10.1200/JOP.2014.001405
  4. Weldring T, Smith SM. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMSs). Health Serv Insights 2013;6:61-8.
  5. Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education 2017;17(4):137-44. https://doi.org/10.1093/bjaed/mkw060
  6. Feldman-Stewart D, Brundage MD. A conceptual framework for patient provider communication a tool in the PRO research tool box. Qual Life Res 2009;18(1):109-14. https://doi.org/10.1007/s11136-008-9417-3
  7. Howell D, Molloy S, Wilkinson K, et al. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol 2015;26(9):1846-58. https://doi.org/10.1093/annonc/mdv181
  8. Cruz Rivera S, McMullan C, Jones L, Kyte D, Slade A, Calvert M. The impact of patient-reported outcome data from clinical trials: perspectives from international stakeholders. J Patient Rep Outcomes 2020;4(1):51. https://doi.org/10.1186/s41687-020-00219-4
  9. Mercieca-Bebber R, King MT, Calvert MJ, Stockler MR, Friedlander M. The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Relat Outcome Meas 2018;9:353-67. https://doi.org/10.2147/prom.s156279
  10. Rivera SC, Kyte DG, Aiyegbusi OL, Slade AL, McMullan C, Calvert MJ. The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis. Health Qual Life Outcomes 2019;17(1):156. https://doi.org/10.1186/s12955-019-1220-z
  11. Ingela Wiklund. Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life. Fundam Clin Pharmacol 2004;18(3):351-63. https://doi.org/10.1111/j.1472-8206.2004.00234.x
  12. Richard J Willke, Laurie B Burke, Pennifer Erickson. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels 2004;25(6):535-52. https://doi.org/10.1016/j.cct.2004.09.003
  13. Marzorati C, Pravettoni G. Value as the key concept in the health care system: how it has influenced medical practice and clinical decision-making processes. J Multidiscip Healthc 2017;10:101-6. https://doi.org/10.2147/JMDH.S122383
  14. Hutchings HA, Alrubaiy L. Patient-reported outcome measures in routine clinical care: The PROMSise of a better future? Dig Dis Sci 2017;62(8):1841-3. https://doi.org/10.1007/s10620-017-4658-z
  15. Souza AC, Alexandre NMC, Guirardello EB. Psychometric properties in instruments evaluation of reliability and validity. Epidemiol Serv Saude 2017;26(3):649-59. https://doi.org/10.5123/S1679-49742017000300022
  16. Patrick DL, Burke LB, Powers JH, et al. Patient-reported outcomes to support medical product labeling claims FDA perspective. Value Health 2007;10(Suppl 2):S125-37. https://doi.org/10.1111/j.1524-4733.2007.00275.x
  17. Bottomley A, Jones D, Claassens L. Patient-reported outcomes assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer 2009;45(3):347-53. https://doi.org/10.1016/j.ejca.2008.09.032
  18. Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007-2013). Contemp Clin Trials 2015;43:1-9. https://doi.org/10.1016/j.cct.2015.04.004
  19. Bevans M, Ross A, Cella D. Patient-Reported Outcomes Measurement Information System (PROMIS): efficient, standardized tools to measure self-reported health and quality of life. Nurs Outlook 2014;62(5):339-45. https://doi.org/10.1016/j.outlook.2014.05.009
  20. Zhang R, Burgess ER, Reddy MC, et al. Provider perspectives on the integration of patientreported outcomes in an electronic health record. JAMIA 2019;2(1):73-80.
  21. Santana MJ, Haverman L, Absolom K, et al. Training clinicians in how to use patient-reported outcome measures in routine clinical practice. Qual Life Res 2015;24(7):1707-18. https://doi.org/10.1007/s11136-014-0903-5
  22. Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Patient-reported outcomes in cancer clinical trials: Measuring symptomatic adverse events with the national cancer institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Am Soc Clin Oncol Educ Book 2016;35:67-73. https://doi.org/10.14694/EdBook_AM.2015.35.67
  23. Choi J-S, Park Y-S, Kim J-A, Park C-S. International trends on patient-reported outcome measures for improving care quality and its implication for South Korea: Focus on OECD PaRIS. Qual Improv Helath Care 2019;25(1):11-28. https://doi.org/10.14371/QIH.2019.25.1.11
  24. Coyne KS, Wyrwich KW. ISPOR task force for clinical outcomes assessment: Clinical outcome assessments: Conceptual foundation-report of the ISPOR clinical outcomes assessment-Emerging good practices for outcomes research task force. Value Health 2015;18(6):739-40. https://doi.org/10.1016/j.jval.2015.09.2863
  25. 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 PROTask force report. Value Health 2009;12(8):1075-83. https://doi.org/10.1111/j.1524-4733.2009.00603.x
  26. Rothrock NE, Kaiser KA, Cella D. Developing a valid patient-reported outcome measure. Clin Pharmacol Ther 2011;90(5):737-42. https://doi.org/10.1038/clpt.2011.195
  27. van der Wees PJ, Verkerk EW, Verbiest ME, et al. Development of a framework with tools to support the selection and implementation of patient-reported outcome measures. J Patient Rep Outcomes 2019;3(1):75. https://doi.org/10.1186/s41687-019-0171-9
  28. Donovan JL, Hamdy FC, Lane JA, et al. Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016;375(15):1425-37. https://doi.org/10.1056/NEJMoa1606221
  29. Falavigna A, Dozza DC, Teles AR, et al. Current status of worldwide use of Patient-Reported Outcome Measures (PROMs) in Spine care. World Neurosurg 2017;108:328-35. https://doi.org/10.1016/j.wneu.2017.09.002
  30. Mosher ZA, Ewing MA, Collins CS, et al. Usage trends of patient-reported outcome measures in shoulder literature. J Am Acad Orthop Surg 2020;28(17):e774-81. https://doi.org/10.5435/JAAOS-D-19-00455
  31. Wylde V, Blom AW, Whitehouse SL, et al. Patient-reported outcomes after total hip and knee arthroplasty: comparison of midterm results. J Arthroplasty 2009;24(2):210-6. https://doi.org/10.1016/j.arth.2007.12.001
  32. Franklin PD, Lewallen D, Bozic K, Hallstrom B, Jiranek W, Ayers DC. Implementation of patient-reported outcome measures in U.S. total joint replacement registries: Rationale, status, and plans. J Bone Joint Surg Am 2014;96(Suppl 1):104-9. https://doi.org/10.2106/JBJS.N.00328
  33. Ayers DC, Zheng H, Franklin PD. Integrating patient-reported outcomes Into orthopaedic clinical practice. Clin Orthop Relat Res 2013;471(11):3419-25. https://doi.org/10.1007/s11999-013-3143-z
  34. Canfield M, Savoy L, Cote MP, Halawi MJ. Patient-reported outcome measures in total joint arthroplasty: defining the optimal collection window. Arthroplast Today 2019;6(1):62-7. https://doi.org/10.1016/j.artd.2019.10.003
  35. Terner M, Louie K, Chow C, Webster G. Advancing PROMSs for health system use in Canada and beyond. J Patient Rep Outcomes 2021;5(Suppl 2):94. https://doi.org/10.1186/s41687-021-00370-6
  36. Francis DO, McPheeters ML, Noud M, Penson DF, Feurer ID. Checklist to operationalize measurement characteristics of patient-reported outcome measures. Syst Rev 2016;5(1):129. https://doi.org/10.1186/s13643-016-0307-4
  37. McKown S, Acquadro C, Anfray C, et al. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observerreported outcome, and performance outcome measures. J Patient Rep Outcomes 2020;4(1):89. https://doi.org/10.1186/s41687-020-00248-z
  38. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set"-a practical guideline. Trials 2016;17(1):449. https://doi.org/10.1186/s13063-016-1555-2
  39. Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Quality Life Res 2018;27(5):1147-57. https://doi.org/10.1007/s11136-018-1798-3
  40. Horn ME, Reinke EK, Mather RC, O'Donnell JD, George SZ. Electronic health record-integrated approach for collection of patient-reported outcome measures: a retrospective evaluation. BMC Health Serv Res 2021;21(1):626. https://doi.org/10.1186/s12913-021-06626-7
  41. Coons SJ, Gwaltney CJ, Hays RD, 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(4):419-29. https://doi.org/10.1111/j.1524-4733.2008.00470.x