PMID- 29188483 OWN - NLM STAT- MEDLINE DCOM- 20181003 LR - 20190318 IS - 1573-2649 (Electronic) IS - 0962-9343 (Linking) VI - 27 IP - 4 DP - 2018 Apr TI - Minimal clinically important differences in the EORTC QLQ-C30 and brief pain inventory in patients undergoing re-irradiation for painful bone metastases. PG - 1089-1098 LID - 10.1007/s11136-017-1745-8 [doi] AB - PURPOSE: The EORTC QLQ-C30 and the Brief Pain Inventory (BPI) are validated tools for measuring quality of life (QOL) and the impact of pain in patients with advanced cancer. Interpretation of these instrument scores can be challenging and it is difficult to know what numerical changes translate to clinically significant impact in patients' lives. To address this issue, our study sought to establish the minimal clinically important differences (MCID) for these two instruments in a prospective cohort of patients with advanced cancer and painful bone metastases. METHODS: Both anchor-based and distribution-based methods were used to estimate the MCID scores from patients enrolled in a randomized phase III trial evaluating two different re-irradiation treatment schedules. For the anchor-based method, the global QOL item from the QLQ-C30 was chosen as the anchor. Spearman correlation coefficients were calculated for all items and only those items with moderate or better correlation (|r| >/= 0.30) with the anchor were used for subsequent analysis. A 10-point difference in the global QOL score was used to classify improvement and deterioration, and the MCID scores were calculated for each of these categories. These results were compared with scores obtained by the distribution-method, which estimates the MCID purely from the statistical characteristics of the sample population. RESULTS: A total of 375 patients were included in this study with documented pain responses and completed QOL questionnaires at 2 months. 9/14 items in the QLQ-C30 and 6/10 items in the BPI were found to have moderate or better correlation with the anchor. For deterioration, statistically significant MCID scores were found in all items of the QLQ-C30 and BPI. For improvement, statistically significant MCID scores were found in 7/9 items of the QLQ-C30 and 2/6 items of the BPI. The MCID scores for deterioration were uniformly higher than the MCIDs for improvement. Using the distribution-based method, there was good agreement between the 0.5 standard deviation (SD) values and anchor-based scores for deterioration. For improvement, there was less agreement and the anchor-based scores were lower than the 0.5 SD values obtained from the distribution-based method. CONCLUSION: We present MCID scores for the QLQ-C30 and BPI instruments obtained from a large cohort of patients with advanced cancer undergoing re-irradiation for painful bone metastases. The results from this study were compared to other similar studies which showed larger MCID scores for improvement compared to deterioration. We hypothesize that disease trajectory and patient expectations are important factors in understanding the contrasting results. The results of this study can guide clinicians and researchers in the interpretation of these instruments. 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 Cancer 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. FAU - Meyer, Ralph M AU - Meyer RM AD - Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, ON, Canada. FAU - van der Linden, Yvette M AU - van der Linden YM AD - Leiden University Medical Centre, Leiden and Radiotherapy Institute Friesland, Leeuwarden, The Netherlands. FAU - Roos, Daniel AU - Roos D AD - Royal Adelaide Hospital, University of Adelaide, Adelaide, Australia. FAU - Hartsell, William F AU - Hartsell WF AD - Northwestern Medicine Central DuPage Hospital, Warrenville, IL, USA. FAU - Hoskin, Peter AU - Hoskin P AD - Mount Vernon Hospital Cancer Centre, Middlesex, UK. FAU - Wu, Jackson S Y AU - Wu JSY AD - Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. FAU - Nabid, Abdenour AU - Nabid A AD - Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. FAU - Haas, Rick AU - Haas R AD - Netherlands Cancer Institute / Antoni van Leeuwenhoek, Amsterdam, The Netherlands. FAU - Wiggenraad, Ruud AU - Wiggenraad R AD - HMC, The Hague, Netherlands. FAU - Babington, Scott AU - Babington S AD - Christchurch Hospital, Christchurch, New Zealand. FAU - Demas, William F AU - Demas WF AD - Akron City Hospital, Northeast Ohio Medical University, Akron, OH, USA. FAU - Wilson, Carolyn F AU - Wilson CF AD - Canadian Cancer Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada. FAU - Wong, Rebecca K S AU - Wong RKS AD - Princess Margaret Cancer Centre, Radiation Medicine Program, Ontario Cancer Institute University of Toronto, Toronto, ON, Canada. FAU - Zhu, Liting AU - Zhu L AD - Canadian Cancer 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 GR - NCIC CTG's programmatic grant/Canadian Cancer Society Research Institute/International GR - RTOG grant U10 CA21661/CA/NCI NIH HHS/United States GR - CCOP grant U10 CA37422/CA/NCI NIH HHS/United States GR - Grant for International Infrastructure Support/Cancer Council Australia/International GR - Special Purposes Fund Research Grant/Royal Adelaide Hospital/International GR - CKTO 2004-06/Dutch Cancer Society/International PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20171129 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 - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Bone Neoplasms/*complications/radiotherapy/secondary MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Minimal Clinically Important Difference MH - Pain/*diagnosis MH - Prospective Studies MH - Quality of Life/*psychology MH - Re-Irradiation/*adverse effects MH - Surveys and Questionnaires MH - Young Adult OTO - NOTNLM OT - *Bone metastases OT - *Brief pain inventory OT - *EORTC QLQ-C30 OT - *Minimal clinically important differences OT - *Radiation EDAT- 2017/12/01 06:00 MHDA- 2018/10/04 06:00 CRDT- 2017/12/01 06:00 PHST- 2017/11/26 00:00 [accepted] PHST- 2017/12/01 06:00 [pubmed] PHST- 2018/10/04 06:00 [medline] PHST- 2017/12/01 06:00 [entrez] AID - 10.1007/s11136-017-1745-8 [pii] AID - 10.1007/s11136-017-1745-8 [doi] PST - ppublish SO - Qual Life Res. 2018 Apr;27(4):1089-1098. doi: 10.1007/s11136-017-1745-8. Epub 2017 Nov 29.