Skip to main content

Advertisement

SpringerLink
Log in

Minimal clinically important differences in the EORTC QLQ-C30 and brief pain inventory in patients undergoing re-irradiation for painful bone metastases

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

Abstract

Purpose

The EORTC QLQ-C30 and the Brief Pain Inventory (BPI) are validated tools for measuring quality of life (QOL) and the impact of pain in patients with advanced cancer. Interpretation of these instrument scores can be challenging and it is difficult to know what numerical changes translate to clinically significant impact in patients’ lives. To address this issue, our study sought to establish the minimal clinically important differences (MCID) for these two instruments in a prospective cohort of patients with advanced cancer and painful bone metastases.

Methods

Both anchor-based and distribution-based methods were used to estimate the MCID scores from patients enrolled in a randomized phase III trial evaluating two different re-irradiation treatment schedules. For the anchor-based method, the global QOL item from the QLQ-C30 was chosen as the anchor. Spearman correlation coefficients were calculated for all items and only those items with moderate or better correlation (|r| ≥ 0.30) with the anchor were used for subsequent analysis. A 10-point difference in the global QOL score was used to classify improvement and deterioration, and the MCID scores were calculated for each of these categories. These results were compared with scores obtained by the distribution-method, which estimates the MCID purely from the statistical characteristics of the sample population.

Results

A total of 375 patients were included in this study with documented pain responses and completed QOL questionnaires at 2 months. 9/14 items in the QLQ-C30 and 6/10 items in the BPI were found to have moderate or better correlation with the anchor. For deterioration, statistically significant MCID scores were found in all items of the QLQ-C30 and BPI. For improvement, statistically significant MCID scores were found in 7/9 items of the QLQ-C30 and 2/6 items of the BPI. The MCID scores for deterioration were uniformly higher than the MCIDs for improvement. Using the distribution-based method, there was good agreement between the 0.5 standard deviation (SD) values and anchor-based scores for deterioration. For improvement, there was less agreement and the anchor-based scores were lower than the 0.5 SD values obtained from the distribution-based method.

Conclusion

We present MCID scores for the QLQ-C30 and BPI instruments obtained from a large cohort of patients with advanced cancer undergoing re-irradiation for painful bone metastases. The results from this study were compared to other similar studies which showed larger MCID scores for improvement compared to deterioration. We hypothesize that disease trajectory and patient expectations are important factors in understanding the contrasting results. The results of this study can guide clinicians and researchers in the interpretation of these instruments.

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

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

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. Coleman, R. E. (2006). Clinical features of metastatic bone disease and risk of skeletal morbidity. Clinical Cancer Research, 12(20), 6243s–9s.

    Article  Google Scholar 

  2. Chow, E., Zeng, L., Salvo, N., Dennis, K., Tsao, M., & Lutz, S. (2012). Update on the systematic review of palliative radiotherapy trials for bone metastases. Clinical Oncology, 24(2), 112–124.

    Article  CAS  PubMed  Google Scholar 

  3. Wong, E., Hoskin, P., Bedard, G., Poon, M., Zeng, L., Lam, H., Vulpe, H., Tsao, M., Pulenzas, N., & Chow, E. (2014). Re-irradiation for painful bone metastases—a systematic review. Radiotherapy and Oncology, 110(1), 61–70.

    Article  PubMed  Google Scholar 

  4. Chow, E., van der Linden, Y. M., Roos, D., Hartsell, W. F., Hoskin, P., Wu, J. S., Brundage, M. D., Nabid, A., Tissing-Tan, C. J., Oei, B., & Babington, S. (2014). Single versus multiple fractions of repeat radiation for painful bone metastases: A randomized, controlled, non-inferiority trial. The Lancet Oncology, 15(2), 164–171.

    Article  PubMed  Google Scholar 

  5. Van den Beuken-van Everdingen, M. H., De Rijke, J. M., Kessels, A. G., Schouten, H. C., Van Kleef, M., & Patijn, J. (2007). Prevalence of pain in patients with cancer: A systematic review of the past 40 years. Annals of Oncology, 18(9), 1437–1449.

    Article  PubMed  Google Scholar 

  6. Teunissen, S. C., Wesker, W., Kruitwagen, C., de Haes, H. C., Voest, E. E., & de Graeff, A. (2007). Symptom prevalence in patients with incurable cancer: A systematic review. Journal of Pain and Symptom Management, 34(1), 94–104.

    Article  PubMed  Google Scholar 

  7. Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., de Haes, J. C., & Kaasa, S. (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 

  8. Fayers, P., & Bottomley, A. E. (2002). EORTC Quality of Life Group. Quality of life research within the EORTC—the EORTC QLQ-C30. European Journal of Cancer 38, 125–133.

    Article  Google Scholar 

  9. Cleeland, C. S., & Ryan, K. M. The Brief Pain Inventory. https://www.mdanderson.org/education-andresearch/departments-programs-and-labs/departments-and-divisions/symptom-research/symptomassessment-tools/BPI_UserGuide. Accessed on 1 March 2016.

  10. Furler, L. (2013). Validity and reliability of the pain questionnaire” Brief Pain Inventory”. A literature research. Pflege Zeitschrift, 66(9), 546–550.

    PubMed  Google Scholar 

  11. Chow, E., Wu, J. S., Hoskin, P., Coia, L. R., Bentzen, S. M., & Blitzer, P. H. (2002). International Bone Metastases Consensus Working Party. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiotherapy and Oncology 64(3):275–280.

    Article  PubMed  Google Scholar 

  12. Maringwa, J., Quinten, C., King, M., Ringash, J., Osoba, D., Coens, C., Martinelli, F., Reeve, B. B., Gotay, C., Greimel, E., & Flechtner, H. (2011). Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Annals of Oncology, 15, 726.

    Google Scholar 

  13. Maringwa, J. T., Quinten, C., King, M., Ringash, J., Osoba, D., Coens, C., Martinelli, F., Vercauteren, J., Cleeland, C. S., Flechtner, H., & Gotay, C. (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 

  14. 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 

  15. 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.

    Article  CAS  PubMed  Google Scholar 

  16. Redelmeier, D. A., & Lorig, K. (1993). Assessing the clinical importance of symptomatic improvements: an illustration in rheumatology. Archives of Internal Medicine, 153(11), 1337–1342.

    Article  CAS  PubMed  Google Scholar 

  17. 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 

  18. 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 

  19. Wong, E., Zhang, L., Kerba, M., Arnalot, P. F., Danielson, B., Tsao, M., Bedard, G., Thavarajah, N., Cheon, P., Danjoux, C., & Pulenzas, N. (2015). Minimal clinically important differences in the EORTC QLQ-BN20 in patients with brain metastases. Supportive Care in Cancer, 23(9), 2731–2737.

    Article  PubMed  Google Scholar 

  20. Raman, S., Ding, K., Chow, E., Meyer, R. M., Nabid, A., Chabot, P., Coulombe, G., Ahmed, S., Kuk, J., Dar, A. R., & Mahmud, A. (2016). Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy. Quality of Life Research, 25(10), 2535–2541.

    Article  PubMed  Google Scholar 

  21. Wong, K., Zeng, L., Zhang, L., Bedard, G., Wong, E., Tsao, M., Barnes, E., Danjoux, C., Sahgal, A., Holden, L., & Lauzon, N. (2013). Minimal clinically important differences in the brief pain inventory in patients with bone metastases. Supportive Care in Cancer, 21(7), 1893–1899.

    Article  PubMed  Google Scholar 

  22. Zeng, L., Chow, E., Zhang, L., Tseng, L. M., Hou, M. F., Fairchild, A., Vassiliou, V., Jesus-Garcia, R., El-Din, M. A., Kumar, A., & Forges, F. (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 

  23. Bedard, G., Zeng, L., Zhang, L., Lauzon, N., Holden, L., Tsao, M., Danjoux, C., Barnes, E., Sahgal, A., Poon, M., & Chow, E. (2013). Minimal clinically important differences in the Edmonton Symptom Assessment System in patients with advanced cancer. Journal of Pain and Symptom Management, 46(2), 192–200.

    Article  PubMed  Google Scholar 

  24. Groenvold, M., Petersen, M. A., Aaronson, N. K., Arraras, J. I., Blazeby, J. M., Bottomley, A., Fayers, P. M., de Graeff, A., Hammerlid, E., Kaasa, S., & Sprangers, M. A. (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 

  25. Chow, E., Ding, K., Parulekar, W. R., Wong, R. K., Van Der Linden, Y. M., Roos, D., Hartsell, W. F., Hoskin, P., Wu, J. S., Nabid, A., & Leer, J. W. (2016). Predictive model for survival in patients having repeat radiation treatment for painful bone metastases. Radiotherapy and Oncology, 118(3), 5475–51.

    Article  Google Scholar 

  26. Schwartz, C. E., & Sprangers, M. A. (1999). Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. Social Science & Medicine, 48(11), 1531–1548.

    Article  CAS  Google Scholar 

  27. Mitera, G., Zhang, L., Sahgal, A., Barnes, E., Tsao, M., Danjoux, C., Holden, L., & Chow, E. (2012). A survey of expectations and understanding of palliative radiotherapy from patients with advanced cancer. Clinical Oncology, 24(2), 134–138.

    Article  CAS  PubMed  Google Scholar 

  28. Chow, E., Meyer, R. M., Chen, B. E., van der Linden, Y. M., Roos, D., Hartsell, W. F., Hoskin, P., Wu, J. S., Nabid, A., Tissing-Tan, C. J., & Oei, B. (2014). Impact of reirradiation of painful osseous metastases on quality of life and function: a secondary analysis of the NCIC CTG SC. 20 randomized trial. Journal of Clinical Oncology, 32(34), 3867–3873.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

We thank all investigators, clinical research assistants, and patients for participation in this study coordinated by the NCIC Clinical Trials Group. This study was supported by the NCIC CTG’s programmatic grants from the Canadian Cancer Society Research Institute; the RTOG grant U10 CA21661 and CCOP grant U10 CA37422 from the National Cancer Institute in the US. Funding for Australia & New Zealand was from Cancer Council Australia (Grant for International Infrastructure Support) and Royal Adelaide Hospital (Special Purposes Fund Research Grant). The Dutch Cancer Society funded the national data management for Dutch patients (Dutch Cancer Society; CKTO 2004-06). Funding for the French investigators was from Assistance Publique-Hopitaux de Paris.

Funding

This study was funded by the NCIC CTG’s programmatic grants from the Canadian Cancer Society Research Institute and other sources as detailed above.

Author information

Authors and Affiliations

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

    Srinivas Raman & Edward Chow

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

    Keyue Ding, Carolyn F. Wilson & Liting Zhu

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

    Ralph M. Meyer

  4. Leiden University Medical Centre, Leiden and Radiotherapy Institute Friesland, Leeuwarden, The Netherlands

    Yvette M. van der Linden

  5. Royal Adelaide Hospital, University of Adelaide, Adelaide, Australia

    Daniel Roos

  6. Northwestern Medicine Central DuPage Hospital, Warrenville, IL, USA

    William F. Hartsell

  7. Mount Vernon Hospital Cancer Centre, Middlesex, UK

    Peter Hoskin

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

    Jackson S. Y. Wu

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

    Abdenour Nabid

  10. Netherlands Cancer Institute / Antoni van Leeuwenhoek, Amsterdam, The Netherlands

    Rick Haas

  11. HMC, The Hague, Netherlands

    Ruud Wiggenraad

  12. Christchurch Hospital, Christchurch, New Zealand

    Scott Babington

  13. Akron City Hospital, Northeast Ohio Medical University, Akron, OH, USA

    William F. Demas

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

    Rebecca K. S. Wong

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

    Michael Brundage

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. Yvette M. van der Linden
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Daniel Roos
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. William F. Hartsell
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Peter Hoskin
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Jackson S. Y. Wu
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Abdenour Nabid
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Rick Haas
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Ruud Wiggenraad
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Scott Babington
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. William F. Demas
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Carolyn F. Wilson
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Rebecca K. S. Wong
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Liting Zhu
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. 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 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-C30 and brief pain inventory in patients undergoing re-irradiation for painful bone metastases. Qual Life Res 27, 1089–1098 (2018). https://doi.org/10.1007/s11136-017-1745-8

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-017-1745-8

Keywords

Search

Navigation