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 : Official Journal of the Multinational Association of Supportive Care in Cancer
Liang ZengAndrew Bottomley

Abstract

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). 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. 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, respe...Continue Reading

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Citations

Apr 16, 2013·Clinical Oncology : a Journal of the Royal College of Radiologists·M PoonE Chow
Apr 5, 2013·Asia-Pacific Journal of Clinical Oncology·Gillian BedardEdward Chow
Feb 11, 2015·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Erin WongEdward Chow
May 4, 2016·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Srinivas RamanMichael Brundage
Jul 9, 2016·BMC Medical Research Methodology·Åsa NordinAnna Dencker
Dec 1, 2017·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Srinivas RamanMichael Brundage
Feb 11, 2018·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Janneke van RoijNatasja Raijmakers
May 4, 2020·Radiotherapy and Oncology : Journal of the European Society for Therapeutic Radiology and Oncology·E OldenburgerK Haustermans

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