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Translation of Patient-Reported Outcomes in Oncology Clinical Trials to Everyday Practice

  • Translational Research and Biomarkers
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Purpose

Clinical trials in oncology evaluating the effects of patient-reported outcomes (PRO) collection have found that monitoring of symptoms with PROs is associated with improved clinical care through reduced acute care utilization and decreased patient symptom burden. This educational review will evaluate strategies for systematic PRO integration into everyday oncology clinical practice.

Methods

We outline key considerations for using PROs in clinical practice, highlighting evidence from published studies. We also discuss the benefits and challenges of PRO implementation in oncology.

Results

Implementing PRO collection in clinical practice can improve care delivery and facilitate patient-centered clinical research. Considerations for using PROs in clinical practice include choice of instrument, method of delivery, and frequency of query. Challenges with implementing systematic PRO collection include the costs and resources needed for implementation, impact on clinical workflow, and controlling/monitoring physician burnout.

Conclusions

While challenges exist in terms of financial resources and staff participation/burnout, patient-reported outcomes in clinical practice provide a number of benefits, including symptom monitoring, clinical research, and potential real-time personalized clinical-decision support.

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References

  1. U.S. Food and Drug Administration. Guidance for Industry. Patient-reported outcome measures: use in medical product development to support labeling claims. Federal Register 2009;74(35):65132–13.

  2. Velikova G, Velikova G, BoothL, Smith AB, Brown PM, Lynch P, Brown JM, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004;22(4):714–24.

    Article  Google Scholar 

  3. Velikova G, Keding A, Harley C, Cocks K, Booth L, Smith AB, et al. Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. Eur J Cancer. 2010;46(13):2381–88.

    Article  Google Scholar 

  4. Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34(6):557–65.

    Article  CAS  Google Scholar 

  5. Basch E, Abernethy AP. Supporting clinical practice decisions with real-time patient-reported outcomes. J Clin Oncol. 2011;29(8):954–6.

    Article  Google Scholar 

  6. Boyes A, Newell S, Girgis A, McElduff P, Sanson‐Fisher R. Does routine assessment and real-time feedback improve cancer patients’ psychosocial well-being? Eur J Cancer Care. 2006;15(2):163–71.

    Article  CAS  Google Scholar 

  7. Snyder CF, Herman JM, White SM, Luber BS, Blackford AL, Carducci MA, et al. When using patient-reported outcomes in clinical practice, the measure matters: a randomized controlled trial. J Oncol Pract. 2014;10(5):e299–306.

    Article  Google Scholar 

  8. Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, et al. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer. 2012;106(5):826–38.

    Article  CAS  Google Scholar 

  9. Sprangers MAG, Cull A, Bjordal K, Grønvold M, Aaronson NK. The European Organization for RESEARCH AND TREATMENT OF CAncer approach to quality of life assessment: guidelines for developing questionnaire modules. Qual Life Res. 1993;2(4):287–295. http://dx.doi.org/10.1007/bf00434800.

    Article  CAS  PubMed  Google Scholar 

  10. Rolstad, S., Adler, J. & Rydén, A., Response burden and questionnaire length: is shorter better? A review and meta-analysis. Value Health J Int Soc Pharm Outcomes Res. 2011;14(8):1101–08.

    Article  Google Scholar 

  11. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000;56(6):899–05.

    Article  Google Scholar 

  12. Aaronson N, Elliott T, Greenhalgh J, et al. (eds). User’s guide to implementing patient-reported outcomes assessment in clinical practice version 2. Milwaukee: International Society for Quality of Life Research; 2015.

    Google Scholar 

  13. Gibbons MC, Wilson RF, Samal L, Lehman CU, Dickersin K, Lehmann HP. Impact of consumer health informatics applications. Evidence Rep/Technol Assessment. 2009;188:1–546.

    Google Scholar 

  14. Archer N, Fevrier-Thomas U, Lokker C, McKibbon KA, Straus SE. Personal health records: a scoping review. J Am Med Inf Assoc JAMIA. 2011;18(4):515–22.

    Article  CAS  Google Scholar 

  15. Galliher JM, Stewart TV, Pathak PK, Werner JJ, Dickinson LM, Hickner JM. Data collection outcomes comparing paper forms with PDA forms in an office-based patient survey. Ann Fam Med. 2008;6(2):154–60. http://dx.doi.org/10.1370/afm.762.

    Article  PubMed  PubMed Central  Google Scholar 

  16. McCleary NJ, Wigler D, Berry D, et al. Feasibility of computer-based self-administered cancer-specific geriatric assessment in older patients with gastrointestinal malignancy. Oncologist. 2013;18(1):64–72.

    Article  Google Scholar 

  17. Heyworth L, Kleinman K, Oddleifson S, Bernstein L, Frampton J, Lehrer M, et al. Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial. Osteoporosis Int. 2014;25(5):1519–26.

    Article  CAS  Google Scholar 

  18. Scantron; 2019. https://www.scantron.com. Accessed 12 April 2019.

  19. Abernethy AP, Herndon JE, Wheeler JL, Patwardhan M, Shaw H, Lyerly HK, et al. Improving health care efficiency and quality using tablet personal computers to collect research-quality, patient-reported data. Health Serv Res. 2008;43(6):1975–91.

    Article  Google Scholar 

  20. Baumhauer JF, Dasilva C, Mitten D, et al. The cost of patient-reported outcomes in medicine. NEJM Catalyst. 2018. https://catalyst.nejm.org/cost-pro-collectionpatient-reported-outcomes/. Accessed 10 June 2019.

  21. Mobile Fact Sheet: Pew Research Center Internet and Technology; 2017. http://www.pewinternet.org/fact-sheet/mobile. Accessed 12 April 2019.

  22. Krebs P, Duncan DT. Health app use among US mobile phone owners: a national survey. JMIR mHealth uHealth. 2015;3(4):e101.

    Article  Google Scholar 

  23. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006;296(20):2441–50.

    Article  CAS  Google Scholar 

  24. Dartmouth Backpain. 2017. http://spinesurgerycalc.dartmouth.edu/calc/. Accessed 26 April 2019.

  25. Alberts L, Wolff HB, Kastelijn EA, et al. Patient-reported outcomes after the treatment of early stage non-small-cell lung cancer with stereotactic body radiotherapy compared with surgery. Clinical Lung Cancer. 2019. https://doi.org/10.1016/j.cllc.2019.04.001.

    Article  Google Scholar 

  26. Colt HG, Murgu SD, Korst RJ, et al. Follow-up and surveillance of the patient with lung cancer after curative-intent therapy: diagnosis and management of lung cancer: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5):e437S–54S.

    Article  Google Scholar 

  27. Sinsky C, Colligan L, Li L, et al. Allocation of physician time in ambulatory practice: a time and motion study in 4 specialties. Ann Internal Med. 2016;165(11):753–60.

    Article  Google Scholar 

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Authors and Affiliations

  1. Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

    Srinivas Joga Ivatury MD, MHA, FACS, FASCRS, Gabriel A. Brooks MD, MPH & Sandra L. Wong MD, MS, FACS

  2. Geisel School of Medicine, Lebanon, NH, USA

    Srinivas Joga Ivatury MD, MHA, FACS, FASCRS, Gabriel A. Brooks MD, MPH & Sandra L. Wong MD, MS, FACS

  3. West Virginia University Cancer Institute, Morgantown, WV, USA

    Hannah W. Hazard-Jenkins MD, FACS

  4. Dana-Farber Cancer Institute, Boston, MA, USA

    Nadine J. McCleary MD, MPH & Deborah Schrag MD, MPH

Authors
  1. Srinivas Joga Ivatury MD, MHA, FACS, FASCRS
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  2. Hannah W. Hazard-Jenkins MD, FACS
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  3. Gabriel A. Brooks MD, MPH
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  4. Nadine J. McCleary MD, MPH
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  5. Sandra L. Wong MD, MS, FACS
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  6. Deborah Schrag MD, MPH
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Contributions

All authors have substantial contributions to the conception or design of the work, the acquisition, analysis, or interpretation of data for the work, drafting the work or revising it critically for important intellectual content including final approval of the version to be published.

Corresponding author

Correspondence to Srinivas Joga Ivatury MD, MHA, FACS, FASCRS.

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All authors are investigators in the SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice study funded by the National Cancer Institute, UM1CA233080.

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Ivatury, S.J., Hazard-Jenkins, H.W., Brooks, G.A. et al. Translation of Patient-Reported Outcomes in Oncology Clinical Trials to Everyday Practice. Ann Surg Oncol 27, 65–72 (2020). https://doi.org/10.1245/s10434-019-07749-2

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  • DOI: https://doi.org/10.1245/s10434-019-07749-2

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