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International validation of two EORTC questionnaires for assessment of health-related quality of life for patients with high-grade non-Hodgkin lymphoma (QLQ-NHL-HG29) and low-grade non-Hodgkin lymphoma (QLQ-NHL-LG20)
Authors:Simone Oerlemans PhD  Fabio Efficace PhD  Charalampia Kyriakou PhD  MD  Ana Carolina Freitas PhD  MD  Omar Shamieh PhD  MD  Carien L Creutzberg PhD  MD  Jens Lehmann PhD  Duska Petranovic PhD  MD  Eva Nagele PhD  Anne Bredart PhD  Dong Dong PhD  Christian W Scholz PhD  MD  Giovanni Caocci PhD  MD  Stefano Molica PhD  MD  Laimonas Griskevicius PhD  MD  Aliki Xochelli PhD  MD  Jacobien M Kieffer PhD  Joost A Agelink van Rentergem PhD  Waleed Alrjoub BSN  Anja Mueller PhD  Maria Gomes Da Silva PhD  MD  Filipa Alves da Costa PhD  PharmD  Sandra Malak PhD  MD  Kim Cocks PhD  Lonneke V van de Poll-Franse PhD  the EORTC Quality of Life Group
Institution:1. Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands;2. Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases Data Centre, Rome, Italy;3. University College London Hospital, London, UK;4. Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, Portugal;5. Department of Palliative Medicine, King Hussein Cancer Center, Amman, Jordan;6. Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands;7. Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria;8. Clinical Hospital Center Rijeka, University of Rijeka, Rijeka, Croatia;9. Division of Haematology, Department of Internal Medicine, Medical University of Graz, Graz, Austria;10. Institut Curie, Psycho-Oncology Unit, Paris, France

Psychopathology and Health Process Laboratory (UR 4057), Paris University, Paris, France

PSL University, Paris, France;11. JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong SAR, China;12. Hematology and Oncology, Vivantes Klinikum Am Urban, Berlin, Germany;13. Hematology, Businco Hospital, University of Cagliari, Cagliari, Italy;14. Azienda Ospedalier Ciaccio, Catanzaro, Italy;15. Hematology, Oncology and Transfusion Medicine, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania

Faculty of Medicine, Vilnius University, Vilnius, Lithuania;16. Institute of Applied Biosciences, Center for Research and Technology Hellas, Thessaloniki, Greece;17. Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands;18. Department of Epidemiology and National Cancer Registry, Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, Portugal;19. Hôpital René Huguenin-Institut Curie-Hématologie, Saint-Cloud, France;20. York Trials Unit, University of York, York, UK

Adelphi Values, Bollington, Cheshire, UK;21. Department of Research and Development, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands

Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands

Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands
Abstract:

Background

Health-related quality of life (HRQOL) is a critical aspect to consider when making treatment decisions for patients with non-Hodgkin-lymphoma (NHL). This international study by the European Organisation for Research and Treatment of Cancer (EORTC) tested the psychometric properties of two newly developed measures for patients with high-grade (HG)- and low-grade (LG)-NHL: the EORTC QLQ-NHL-HG29 and the EORTC QLQ-NHL-LG20 to supplement the core questionnaire (EORTC QLQ-C30).

Methods

Overall, 768 patients with HG-NHL (N = 423) and LG-NHL (N = 345) from 12 countries completed the QLQ-C30, QLQ-NHL-HG29/QLQ-NHL-LG20 and a debriefing questionnaire at baseline, and a subset at follow-up for either retest (N = 125/124) or responsiveness to change (RCA; N = 98/49).

Results

Confirmatory factor analysis showed an acceptable to good fit of the 29 items of the QLQ-NHL-HG29 on its five scales (symptom burden SB], neuropathy, physical condition/fatigue PF], emotional impact EI], and worries about health/functioning WH]), and of the 20 items of the QLQ-NHL-LG20 on its four scales (SB, PF, EI, and WH). Completion took on average 10 minutes. Test–retest reliability, convergent validity, known-group comparisons, and RCA find satisfactory results of both measures. A total of 31%–78% of patients with HG-NHL and 22%–73% of patients with LG-NHL reported symptoms and/or worries (e.g., tingling in hands/feet, lack of energy, and worries about recurrence). Patients reporting symptoms/worries had substantially lower HRQOL compared to those without.

Discussion

The use of the EORTC QLQ-NHL-HG29 and QLQ-NHL-LG20 questionnaires in clinical research and practice will provide clinically relevant data to better inform treatment decision-making.

Plain language summary

  • The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed two questionnaires.
  • These questionnaires measure health-related quality of life.
  • The questionnaires are for patients with high-grade or low-grade non-Hodgkin lymphoma.
  • They are called the EORTC QLQ-NHL-HG29 and QLQ-NHL-LG20.
  • The questionnaires are now internationally validated.
  • This study demonstrates that the questionnaires are reliably and valid, which are important aspects of a questionnaire.
  • The questionnaires can now be used in clinical trials and practice.
  • With the information gathered from the questionnaires, patients and clinicians can better evaluate treatments and discuss the best choice for a patient.
Keywords:EORTC  non-Hodgkin lymphoma  PRO  psychometric properties  quality of life  questionnaire  symptoms
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