Skip to main content
SpringerLink
Log in

Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Purpose

Validated tools for evaluating quality of life (QOL) in patients with bone metastases include the EORTC QLQ-BM22 and QLQ-C15-PAL modules. A statistically significant difference in metric scores may not be clinically significant. To aid in their interpretation, we performed analyses to determine the minimal clinically important differences (MCID) for these QOL instruments.

Methods

Both anchor-based and distribution-based methods were used to determine the MCID among patients with bone metastases enrolled in a randomized phase III trial. For the anchor-based approach, overall QOL as measured by the QLQ-C15-PAL module was used as the anchor and only the subscales with moderate or better correlation were used for subsequent MCID analysis. In the anchor-based approach, patients were classified as improved, stable or deteriorated by the change in the overall QOL score from baseline to follow-up after 42 days. The MCID and confidence interval was then calculated for all subscales. In the distribution-based approach, the MCID was expressed as a proportion of the standard deviation and standard error measurement from the subscale score distribution.

Results

A total of 204 patients completed the questionnaires at baseline and follow-up. Only the dyspnea and insomnia subscales did not have at least moderate correlation with the overall QOL anchor. Using the anchor-based approach, 10/11 subscales had an MCID score significantly different than 0 for improvement and 3/11 subscales had a significant MCID score for deterioration. The magnitude of MCID scores was higher for improvement in comparison with deterioration. For improvement, the anchor-based approach showed good agreement with the distribution-based approach when using 0.5 SD as the MCID. However, there was greater lack of agreement between these approaches for deterioration.

Conclusion

We present the MCID scores for the EORTC QLQ-BM22 and QLQ-C15-PAL QOL instruments. The results of this study can guide clinicians in the interpretation of these instruments.

Clinical Trials Registry

NCT01248585.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Lutz, S., Berk, L., Chang, E., Chow, E., Hahn, C., Hoskin, P., et al. (2011). Palliative radiotherapy for bone metastases: An ASTRO evidence-based guideline. International Journal of Radiation Oncology Biology Physics, 79(4), 965–976.

    Article  Google Scholar 

  2. Chow, E., Hird, A., Velikova, G., Johnson, C., Dewolf, L., Bezjak, A., et al. (2009). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with bone metastases: the EORTC QLQ-BM22. European Journal of Cancer, 45(7), 1146–1152.

    Article  PubMed  Google Scholar 

  3. Groenvold, M., Petersen, M. A., Aaronson, N. K., Arraras, J. I., Blazeby, J. M., Bottomley, A., et al. (2006). The development of the EORTC QLQ-C15-PAL: A shortened questionnaire for cancer patients in palliative care. European Journal of Cancer, 42(1), 55–64.

    Article  PubMed  Google Scholar 

  4. Zeng, L., Chow, E., Bedard, G., Zhang, L., Fairchild, A., Vassiliou, V., et al. (2012). Quality of life after palliative radiation therapy for patients with painful bone metastases: Results of an international study validating the EORTC QLQ-BM22. International Journal of Radiation Oncology Biology Physics, 84(3), e337–e342.

    Article  Google Scholar 

  5. Chow, E., Nguyen, J., Zhang, L., Tseng, L. M., Hou, M. F., Fairchild, A., et al. (2012). International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases. Cancer, 118(5), 1457–1465.

    Article  PubMed  Google Scholar 

  6. Caissie, A., Zeng, L., Nguyen, J., Zhang, L., Jon, F., Dennis, K., et al. (2012). Assessment of health-related quality of life with the European organization for research and treatment of cancer QLQ-C15-PAL after palliative radiotherapy of bone metastases. Clinical Oncology, 24(2), 125–133.

    Article  CAS  PubMed  Google Scholar 

  7. Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of Clinical Epidemiology, 56(5), 395–407.

    Article  PubMed  Google Scholar 

  8. Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61(2), 102–109.

    Article  PubMed  Google Scholar 

  9. Chow, E., Meyer, R. M., Ding, K., Nabid, A., Chabot, P., Wong, P., et al. (2015). Dexamethasone in the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases: A double-blind, randomised placebo-controlled, phase 3 trial. The lancet Oncology, 16(15), 1463–1472.

    Article  CAS  PubMed  Google Scholar 

  10. Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., 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. Journal of the National Cancer Institute, 85(5), 365–376.

    Article  CAS  PubMed  Google Scholar 

  11. Maringwa, J., Quinten, C., King, M., Ringash, J., Osoba, D., Coens, C., et al. (2011). Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Annals of Oncology, 22, 2107–2112.

    Article  CAS  PubMed  Google Scholar 

  12. Maringwa, J. T., Quinten, C., King, M., Ringash, J., Osoba, D., Coens, C., et al. (2011). Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials. Supportive Care in Cancer, 19(11), 1753–1760.

    Article  PubMed  Google Scholar 

  13. Osoba, D., Rodrigues, G., Myles, J., Zee, B., & Pater, J. (1998). Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology, 16(1), 139–144.

    CAS  PubMed  Google Scholar 

  14. King, M. T. (1996). The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Quality of Life Research, 5(6), 555–567.

    Article  CAS  PubMed  Google Scholar 

  15. Bedard, G., Zeng, L., Zhang, L., Lauzon, N., Holden, L., Tsao, M., et al. (2016). Minimal important differences in the EORTC QLQ‐C15‐PAL to determine meaningful change in palliative advanced cancer patients. Asia‐Pacific Journal of Clinical Oncology, 12(1), e38–e46.

    PubMed  Google Scholar 

  16. Zeng, L., Chow, E., Zhang, L., Tseng, L. M., Hou, M. F., Fairchild, A., et al. (2012). An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases. Supportive Care in Cancer, 20(12), 3307–3313.

    Article  PubMed  Google Scholar 

  17. Ringash, J., O’Sullivan, B., Bezjak, A., & Redelmeier, D. A. (2007). Interpreting clinically significant changes in patient-reported outcomes. Cancer, 110(1), 196–202.

    Article  PubMed  Google Scholar 

  18. Cella, D., Hahn, E. A., & Dineen, K. (2002). Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening. Quality of Life Research, 11(3), 207–221.

    Article  PubMed  Google Scholar 

  19. Yost, K. J., Cella, D., Chawla, A., Holmgren, E., Eton, D. T., Ayanian, J. Z., & West, D. W. (2005). Minimally important differences were estimated for the functional assessment of cancer therapy-colorectal (FACT-C) instrument using a combination of distribution-and anchor-based approaches. Journal of Clinical Epidemiology, 58(12), 1241–1251.

    Article  CAS  PubMed  Google Scholar 

  20. Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592.

    PubMed  Google Scholar 

Download references

Acknowledgments

This study was supported by the NCIC CTG’s programmatic grants from the Canadian Cancer Society Research Institute. We thank the participation of all the patients and the research teams.

Funding

This study was funded by the NCIC CTG’s programmatic grants from the Canadian Cancer Society Research Institute.

Authors contribution

The following authors enrolled the patients into the study: Edward Chow MBBS PhD, Abdenour Nabid MD, Pierre Chabot MD, Genevieve Coulombe MD, Shahida Ahmed MD, Joda Kuk MD, A Rashid Dar MD, Aamer Mahmud MD, Alysa Fairchild MD, Jackson SY Wu MD MSc, Kristopher Dennis MD, Rebecca KS Wong MBChB MSc, Michael Brundage MD MSc. The following authors helped in the data management and statistical analysis: Srinivas Raman MD MASc, Keyue Ding PhD, Edward Chow MBBS PhD, Ralph M Meyer MD, Carolyn F Wilson MSc, Carlo DeAngelis PharmD, Liting Zhu MSc. All authors helped in the design of this secondary analysis, the interpretation of the statistical analysis and writing of this manuscript.

Author information

Authors and Affiliations

  1. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada

    Srinivas Raman, Edward Chow & Carlo DeAngelis

  2. Canadian Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, ON, Canada

    Keyue Ding, Carolyn F. Wilson & Liting Zhu

  3. Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, ON, Canada

    Ralph M. Meyer

  4. Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada

    Abdenour Nabid

  5. Hopital Maisonneuve-Rosemont, Montreal, QC, Canada

    Pierre Chabot

  6. CHUM-Hopital Notre-Dame, Montreal, QC, Canada

    Genevieve Coulombe

  7. CancerCare Manitoba, Winnipeg, MB, Canada

    Shahida Ahmed

  8. Grand River Regional Cancer Centre, Grand River Hospital, Kitchener, ON, Canada

    Joda Kuk

  9. London Regional Cancer Program, London, ON, Canada

    A. Rashid Dar

  10. Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada

    Aamer Mahmud

  11. Cross Cancer Institute, Edmonton, AB, Canada

    Alysa Fairchild

  12. Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada

    Jackson S. Y. Wu

  13. Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada

    Kristopher Dennis

  14. Radiation Medicine Program, Ontario Cancer Institute, Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada

    Rebecca K. S. Wong

  15. Queen’s University, Kingston, ON, Canada

    Michael Brundage

  16. Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada

    Edward Chow

Authors
  1. Srinivas Raman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Keyue Ding
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Edward Chow
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ralph M. Meyer
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Abdenour Nabid
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Pierre Chabot
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Genevieve Coulombe
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Shahida Ahmed
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Joda Kuk
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. A. Rashid Dar
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Aamer Mahmud
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Alysa Fairchild
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Carolyn F. Wilson
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Jackson S. Y. Wu
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Kristopher Dennis
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Carlo DeAngelis
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Rebecca K. S. Wong
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Liting Zhu
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. Michael Brundage
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Edward Chow.

Ethics declarations

Conflict of interest

There are no conflicts of interest to declare for all authors.

Ethical approval

Ethical approval for research involving human participants: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Acceptable principles of ethical and professional conduct were followed, and research ethics board approval was obtained at all participating institutions.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Raman, S., Ding, K., Chow, E. et al. Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy. Qual Life Res 25, 2535–2541 (2016). https://doi.org/10.1007/s11136-016-1308-4

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-016-1308-4

Keywords

Search

Navigation