Supportive Care in Cancer

, Volume 24, Issue 6, pp 2503–2512 | Cite as

PRO-ONKO—selection of patient-reported outcome assessments for the clinical use in cancer patients—a mixed-method multicenter cross-sectional exploratory study

  • Heike Schmidt
  • Daniela Merkel
  • Michael Koehler
  • Hans-Henning Flechtner
  • Jörg Sigle
  • Bernd Klinge
  • Karin Jordan
  • Dirk Vordermark
  • Margarete Landenberger
  • Patrick Jahn
Original Article

Abstract

Purpose

Cancer patients frequently suffer from multiple symptoms often impairing functional status and health-related quality of life (HRQOL). A comprehensive assessment including patient-reported outcomes (PROs) is recommended to enable individualized supportive care. However, PRO assessments are still not part of routine clinical practice. Therefore, this project aimed to compile an item pool from validated assessment instruments to facilitate the use of PROs for clinical decision-making in oncology clinics.

Methods

This qualitative dominant mixed-method cross-sectional exploratory study was carried out in four centers and comprised two stages. Stage I: Six interdisciplinary focus groups were conducted to choose questionnaires meeting particular clinical requirements. Stage II: Adult patients with heterogeneous cancer diagnoses, receiving in- or out-patient treatment were asked to participate and complete the chosen questionnaires (participation 71/74). Resulting PROs were compared with clinical records. Health care professionals (HCPs) and patients rated the usefulness for routine clinical practice.

Results

The European Organisation of Research and Treatment of Cancer (EORTC) QLQ-C30 and Distress Thermometer were chosen for screening and M.D. Anderson Symptom Inventory (MDASI) and EORTC single items for monitoring. Comparison of n = 88 PRO assessments with clinical records showed consistent documentation of side effects like fever and emesis. Symptoms like fatigue, sadness, or sleep disturbance were not documented regularly in the medical records but captured by PRO assessments. Patients and HCPs judged the chosen questionnaires and electronic data collection as useful.

Conclusions

Future studies should examine how PROs can complement or substitute routine documentation in order to achieve standardized assessment and documentation during the treatment process in different settings and examine possible benefits for patients.

Keywords

Patient-reported outcomes Cancer Quality of life Screening Monitoring Supportive therapy 

References

  1. 1.
    Kroenke K et al (2013) Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer 21(3):765–773CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Walker MS et al (2014) Early treatment discontinuation and switching in first-line metastatic breast cancer: the role of patient-reported symptom burden. Breast Cancer Res Treat 144(3):673–681CrossRefPubMedGoogle Scholar
  3. 3.
    Trotti A et al (2003) CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 13(3):176–181CrossRefPubMedGoogle Scholar
  4. 4.
    Xiao C, Polomano R, Bruner DW (2013) Comparison between patient-reported and clinician-observed symptoms in oncology. Cancer Nurs 36(6):E1–e16CrossRefPubMedGoogle Scholar
  5. 5.
    Basch E (2010) The missing voice of patients in drug-safety reporting. N Engl J Med 362(10):865–869CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Snyder CF et al (2012) Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Qual Life Res 21(8):1305–1314CrossRefPubMedGoogle Scholar
  7. 7.
    Cleeland CS et al (2000) Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer 89(7):1634–1646CrossRefPubMedGoogle Scholar
  8. 8.
    Reeve BB et al (2014) Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst 106(7)Google Scholar
  9. 9.
    Reeve BB et al (2013) ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 22(8):1889–1905CrossRefPubMedGoogle Scholar
  10. 10.
    Howell D et al (2013) Core domains for a person-focused outcome measurement system in cancer (PROMS-Cancer Core) for routine care: a scoping review and Canadian Delphi Consensus. Value Health 16(1):76–87CrossRefPubMedGoogle Scholar
  11. 11.
    Kotronoulas G et al (2014) What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol 32(14):1480–1501CrossRefPubMedGoogle Scholar
  12. 12.
    Snyder CF et al (2014) When using patient-reported outcomes in clinical practice, the measure matters: a randomized controlled trial. J Oncol Pract 10(5):e299–e306CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Chen J, Ou L, Hollis SJ (2013) A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res 13:211CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Greenhalgh J (2009) The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res 18(1):115–123CrossRefPubMedGoogle Scholar
  15. 15.
    Snyder CF et al (2011) Can patient-reported outcome measures identify cancer patients’ most bothersome issues? J Clin Oncol 29(9):1216–1220CrossRefPubMedGoogle Scholar
  16. 16.
    Huebner J et al (2014) Integrating cancer patients’ perspectives into treatment decisions and treatment evaluation using patient-reported outcomes - a concept paper. Eur J Cancer Care (Engl) 23(2):173–179CrossRefGoogle Scholar
  17. 17.
    Velikova G et al (2010) 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 46(13):2381–2388CrossRefPubMedGoogle Scholar
  18. 18.
    Chung AE, Basch EM (2015) Incorporating the patient’s voice into electronic health records through patient-reported outcomes as the “Review of Systems”. J Am Med Inform AssocGoogle Scholar
  19. 19.
    Sigle J, Porzsolt F (1996) Practical aspects of quality-of-life measurement: design and feasibility study of the quality-of-life recorder and the standardized measurement of quality of life in an outpatient clinic. Cancer Treat Rev 22 Suppl A:75–89CrossRefPubMedGoogle Scholar
  20. 20.
    Gamper EM et al (2014) The EORTC emotional functioning computerized adaptive test: phases I-III of a cross-cultural item bank development. Psychooncology 23(4):397–403CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    NCCN (2013) Distress management. Available from: http://www.oralcancerfoundation.org/treatment/pdf/distress.pdf
  22. 22.
    EHA (2012) Guidelines. Patient reported outcomes in hematology. Genua: forum service editoreGoogle Scholar
  23. 23.
  24. 24.
    Santana MJ et al (2015) Training clinicians in how to use patient-reported outcome measures in routine clinical practice. Qual Life ResGoogle Scholar
  25. 25.
    Antunes B, Harding R, Higginson IJ (2014) Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers. Palliat Med 28(2):158–175CrossRefPubMedGoogle Scholar
  26. 26.
    Boyce MB, Browne JP, Greenhalgh J (2014) The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research. BMJ Qual Saf 23(6):508–518CrossRefPubMedGoogle Scholar
  27. 27.
    Howell D et al (2015) Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann OncolGoogle Scholar
  28. 28.
    Osoba D (2007) Translating the science of patient-reported outcomes assessment into clinical practice. J Natl Cancer Inst Monogr 37:5–11CrossRefPubMedGoogle Scholar
  29. 29.
    Warrington L, Absolom K, Velikova G (2015) Integrated care pathways for cancer survivors - a role for patient-reported outcome measures and health informatics. Acta Oncol 54(5):600–608CrossRefPubMedGoogle Scholar
  30. 30.
    Basch E, Abernethy AP (2011) Supporting clinical practice decisions with real-time patient-reported outcomes. J Clin Oncol 29(8):954–956CrossRefPubMedGoogle Scholar
  31. 31.
    Cleeland CS, Sloan JA (2010) Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards. J Pain Symptom Manage 39(6):1077–1085CrossRefPubMedGoogle Scholar
  32. 32.
    Howell D et al (2012) Psychosocial health care needs assessment of adult cancer patients: a consensus-based guideline. Support Care CancerGoogle Scholar
  33. 33.
    von Elm E et al (2014) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg 12(12):1495–1499CrossRefGoogle Scholar
  34. 34.
    Johnson RB, Onwuegbuzie AJ, Turner LA (2007) Toward a definition of mixed methods research. J Mixed Methods Res 1(2):112–133CrossRefGoogle Scholar
  35. 35.
    Mayring P (2000) Qualitative content analysis [28 paragraphs]. Forum Qualitative Sozialforschung / Forum: Qualitative Social Research 1(2) Art. 20Google Scholar
  36. 36.
    Bonomi AE et al (1996) Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res 5(3):309–320CrossRefPubMedGoogle Scholar
  37. 37.
    Aaronson NK et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376CrossRefPubMedGoogle Scholar
  38. 38.
    Schaeffeler N et al (2015) Assessing the need for psychooncological support: screening instruments in combination with patients’ subjective evaluation may define psychooncological pathways. PsychooncologyGoogle Scholar
  39. 39.
    Donovan KA et al (2014) Validation of the distress thermometer worldwide: state of the science. Psychooncology 23(3):241–250CrossRefPubMedGoogle Scholar
  40. 40.
    Schmidt H et al (2015) Symptom burden of cancer patients: validation of the German M. D. Anderson Symptom Inventory: a cross-sectional multicenter study. J Pain Symptom Manage 49(1):117–125CrossRefPubMedGoogle Scholar
  41. 41.
    Landenberger M et al (2015) Trans-sectoral care for patients with colorectal cancer: design of a prospective randomized controlled multi-center trial (FKZ 01GY1143). Z Evid Fortbild Qual Gesundhwes 109(2):171–180CrossRefPubMedGoogle Scholar
  42. 42.
    Brundage MD et al (2015) Communicating patient-reported outcome scores using graphic formats: results from a mixed-methods evaluation. Qual Life ResGoogle Scholar
  43. 43.
    Jagsi R et al (2013) Qualitative analysis of practicing oncologists’ attitudes and experiences regarding collection of patient-reported outcomes. J Oncol Pract 9(6):e290–e297CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Heike Schmidt
    • 1
  • Daniela Merkel
    • 1
  • Michael Koehler
    • 2
  • Hans-Henning Flechtner
    • 3
  • Jörg Sigle
    • 4
    • 5
  • Bernd Klinge
    • 6
  • Karin Jordan
    • 7
  • Dirk Vordermark
    • 8
  • Margarete Landenberger
    • 1
  • Patrick Jahn
    • 1
    • 9
  1. 1.Medical Faculty, Institute of Health and Nursing SciencesMartin Luther University Halle-WittenbergHalle (Saale)Germany
  2. 2.Department of Hematology and OncologyUniversity Hospital, Otto-von-Guericke-University MagdeburgMagdeburgGermany
  3. 3.Department of Child and Adolescent PsychiatryOtto-von-Guericke-University MagdeburgMagdeburgGermany
  4. 4.Scientific IT ConsultingBettingenSwitzerland
  5. 5.Reha ChrischonaBettingenSwitzerland
  6. 6.Surgical DepartmentHelios KlinikSangerhausenGermany
  7. 7.Department of Internal Medicine IV, Hematology and OncologyUniversity Hospital Halle, Martin Luther University Halle-WittenbergHalle (Saale)Germany
  8. 8.Department of Radiation OncologyUniversity Hospital Halle, Martin Luther University Halle-WittenbergHalle (Saale)Germany
  9. 9.Nursing Research UnitUniversity Hospital Halle, Martin Luther University Halle-WittenbergHalle (Saale)Germany

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