Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy
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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.
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.
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.
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
KeywordsBone metastases Radiation Minimal clinically important differences EORTC QLQ-BM22 module EORTC QLQ-C15-PAL module
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.
This study was funded by the NCIC CTG’s programmatic grants from the Canadian Cancer Society Research Institute.
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.
Compliance with ethical standards
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 was obtained from all individual participants included in the study.
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