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An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases

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Abstract

Purpose

Quality of life (QOL) is frequently an endpoint in clinical trials involving patients with advanced cancer. Statistical significance of minimal differences can be achieved with sufficient sample size, yet the actual clinical relevance is unknown. The purpose of this study was to establish the minimal clinically important difference (MCID) for the European Organisation for Research and Treatment of Cancer (EORTC) bone metastases module (EORTC QLQ-BM22).

Methods

Patients with bone metastases across seven countries were prospectively enrolled in a trial validating the EORTC QLQ-BM22 and completed the QLQ-BM22 and core measure (QLQ-C30) at baseline and 1-month follow-up. MCIDs were calculated for each QOL scale for both improvement and deterioration using both an anchor- (performance status) and distribution-based approach.

Results

A total of 93 patients completed both baseline and follow-up QOL and had recorded performance status at both intervals. Statistically significant meaningful differences were seen in seven scales. There were improvements of 30.5 (95 % confidence interval, 9.0 to 52.0), 20.1 (7.1 to 33.2), 30.5 (13.8 to 47.3) and 19.6 (5.0 to 34.3) in the pain, painful site, painful characteristic and functional interference scales, respectively, demonstrated clinical relevance. Decreases of 12.4 (0.3 to 24.6), 22.4 (11.8 to 32.9) and 13.5 (1.9 to 25.1) were required to represent clinically relevant deterioration in emotional functioning, global health status and financial issues, respectively. Minimal differences for improvement were closest to 0.5 standard deviations (SD) while for deterioration, closer to 0.3 SD on the QLQ-BM22.

Conclusion

Identification of requirements for clinical significance can assist in determining the relevance of QOL changes after treatment and in sample size determination in future trials. Our study is limited by the small sample size. Future studies should continue to determine MCID and confirm our findings using a variety of appropriate anchors and in a larger sample.

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Acknowledgments

We would like to thank Mr. Colin Johnson for his helpful input. This study was funded in part by Novartis Oncology, Bratty Family Fund, Michael and Karyn Goldstein Cancer Research Fund, Joseph and Silvana Melara Cancer Research Fund and Ofelia Cancer Research Fund. We have full control of all primary data and agree to allow the journal to review the data if necessary.

Conflict of interest

Dr. Andrew Bottomley is an author of the EORTC QLG measurement system. These tools are provided free to academics, but the EORTC charges a user fee for the use of the EORTC QLQ-C30 in industry-sponsored research in order to cover the cost of future psychometric validation, testing and translation of QOL tools.

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Authors and Affiliations

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

    Liang Zeng, Edward Chow, Liying Zhang & Gillian Bedard

  2. Department of Surgery, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan

    Ling-Ming Tseng

  3. Department of Gastroenterologic Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

    Ming-Feng Hou

  4. Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada

    Alysa Fairchild

  5. Department of Radiation Oncology, Bank of Cyprus Oncology Centre, Nicosia, Cyprus

    Vassilios Vassiliou

  6. Department of Orthopedic Oncology, Federal University of Sao Paulo, Sao Paulo, Brazil

    Reynaldo Jesus-Garcia

  7. Department of Clinical Oncology, Tanta Faculty of Medicine, Tanta University Hospital, Tanta, Egypt

    Mohamed A. Alm El-Din

  8. Division of Gynaecology and Genitourinary Oncology, Department of Radiation Oncology, Regional Cancer Center, Trivandrum, Kerala, India

    Aswin Kumar

  9. Inserm CIE3, Saint Etienne University Hospital, Saint-Etienne, France

    Fabien Forges

  10. Unit of Clinical Research, Innovation, and Pharmacology, Saint Etienne University Hospital, Saint-Etienne, France

    Fabien Forges

  11. Department of Public Health and Institute of Epidemiology and Preventative Medicine, National Taiwan University, Taipei, Taiwan

    Wei-Chu Chie

  12. European Organisation for Research and Treatment of Cancer, EORTC Headquarters, Brussels, Belgium

    Andrew Bottomley

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  1. Liang Zeng
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  2. Edward Chow
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  3. Liying Zhang
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  6. Alysa Fairchild
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  7. Vassilios Vassiliou
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  8. Reynaldo Jesus-Garcia
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  9. Mohamed A. Alm El-Din
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  10. Aswin Kumar
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  11. Fabien Forges
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  12. Wei-Chu Chie
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  13. Gillian Bedard
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  14. Andrew Bottomley
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Corresponding author

Correspondence to Edward Chow.

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Zeng, L., Chow, E., Zhang, L. et al. An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases. Support Care Cancer 20, 3307–3313 (2012). https://doi.org/10.1007/s00520-012-1484-x

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  • DOI: https://doi.org/10.1007/s00520-012-1484-x

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