Swipe om te navigeren naar een ander artikel
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.
Log in om toegang te krijgen
Met onderstaand(e) abonnement(en) heeft u direct toegang:
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. CrossRef
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. CrossRef
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. CrossRefPubMed
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. CrossRefPubMed
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. CrossRefPubMed
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. CrossRefPubMed
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. PubMed
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
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. CrossRefPubMed
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. CrossRefPubMed
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
- Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy
Ralph M. Meyer
A. Rashid Dar
Carolyn F. Wilson
Jackson S. Y. Wu
Rebecca K. S. Wong
- Springer International Publishing