PMID- 27138964 OWN - NLM STAT- MEDLINE DCOM- 20171017 LR - 20181202 IS - 1573-2649 (Electronic) IS - 0962-9343 (Linking) VI - 25 IP - 10 DP - 2016 Oct TI - Minimal clinically important differences in the EORTC QLQ-BM22 and EORTC QLQ-C15-PAL modules in patients with bone metastases undergoing palliative radiotherapy. PG - 2535-2541 LID - 10.1007/s11136-016-1308-4 [doi] AB - PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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: NCT01248585. FAU - Raman, Srinivas AU - Raman S AD - Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. FAU - Ding, Keyue AU - Ding K AD - Canadian Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada. FAU - Chow, Edward AU - Chow E AD - Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. Edward.Chow@sunnybrook.ca. AD - Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada. Edward.Chow@sunnybrook.ca. FAU - Meyer, Ralph M AU - Meyer RM AD - Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, ON, Canada. FAU - Nabid, Abdenour AU - Nabid A AD - Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. FAU - Chabot, Pierre AU - Chabot P AD - Hopital Maisonneuve-Rosemont, Montreal, QC, Canada. FAU - Coulombe, Genevieve AU - Coulombe G AD - CHUM-Hopital Notre-Dame, Montreal, QC, Canada. FAU - Ahmed, Shahida AU - Ahmed S AD - CancerCare Manitoba, Winnipeg, MB, Canada. FAU - Kuk, Joda AU - Kuk J AD - Grand River Regional Cancer Centre, Grand River Hospital, Kitchener, ON, Canada. FAU - Dar, A Rashid AU - Dar AR AD - London Regional Cancer Program, London, ON, Canada. FAU - Mahmud, Aamer AU - Mahmud A AD - Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada. FAU - Fairchild, Alysa AU - Fairchild A AD - Cross Cancer Institute, Edmonton, AB, Canada. FAU - Wilson, Carolyn F AU - Wilson CF AD - Canadian Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada. FAU - Wu, Jackson S Y AU - Wu JSY AD - Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. FAU - Dennis, Kristopher AU - Dennis K AD - Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada. FAU - DeAngelis, Carlo AU - DeAngelis C AD - Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. FAU - Wong, Rebecca K S AU - Wong RKS AD - Radiation Medicine Program, Ontario Cancer Institute, Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada. FAU - Zhu, Liting AU - Zhu L AD - Canadian Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada. FAU - Brundage, Michael AU - Brundage M AD - Queen's University, Kingston, ON, Canada. LA - eng SI - ClinicalTrials.gov/NCT01248585 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20160502 PL - Netherlands TA - Qual Life Res JT - Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation JID - 9210257 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Bone Neoplasms/*radiotherapy/secondary MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Minimal Clinically Important Difference MH - Neoplasm Metastasis MH - Palliative Care MH - Prospective Studies MH - *Sickness Impact Profile MH - Surveys and Questionnaires OTO - NOTNLM OT - Bone metastases OT - EORTC QLQ-BM22 module OT - EORTC QLQ-C15-PAL module OT - Minimal clinically important differences OT - Radiation EDAT- 2016/05/04 06:00 MHDA- 2017/10/19 06:00 CRDT- 2016/05/04 06:00 PHST- 2016/04/26 00:00 [accepted] PHST- 2016/05/04 06:00 [entrez] PHST- 2016/05/04 06:00 [pubmed] PHST- 2017/10/19 06:00 [medline] AID - 10.1007/s11136-016-1308-4 [pii] AID - 10.1007/s11136-016-1308-4 [doi] PST - ppublish SO - Qual Life Res. 2016 Oct;25(10):2535-2541. doi: 10.1007/s11136-016-1308-4. Epub 2016 May 2.