Srinivas Raman1, Keyue Ding2, Edward Chow3, Ralph M Meyer4, Yvette M van der Linden5, Daniel Roos6, William F Hartsell7, Peter Hoskin8, Jackson S Y Wu9, Abdenour Nabid10, Rick Haas11, Ruud Wiggenraad12, Scott Babington13, William F Demas14, Carolyn F Wilson2, Rebecca K S Wong15, Liting Zhu2, Michael Brundage16. 1. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. 2. Canadian Cancer Trials Group, Cancer Research Institute, Queen's University, Kingston, ON, Canada. 3. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. edward.chow@sunnybrook.ca. 4. Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, ON, Canada. 5. Leiden University Medical Centre, Leiden and Radiotherapy Institute Friesland, Leeuwarden, The Netherlands. 6. Royal Adelaide Hospital, University of Adelaide, Adelaide, Australia. 7. Northwestern Medicine Central DuPage Hospital, Warrenville, IL, USA. 8. Mount Vernon Hospital Cancer Centre, Middlesex, UK. 9. Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. 10. Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. 11. Netherlands Cancer Institute / Antoni van Leeuwenhoek, Amsterdam, The Netherlands. 12. HMC, The Hague, Netherlands. 13. Christchurch Hospital, Christchurch, New Zealand. 14. Akron City Hospital, Northeast Ohio Medical University, Akron, OH, USA. 15. Princess Margaret Cancer Centre, Radiation Medicine Program, Ontario Cancer Institute University of Toronto, Toronto, ON, Canada. 16. Queen's University, Kingston, ON, Canada.
Abstract
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.
RCT Entities:
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.
Entities:
Keywords:
Bone metastases; Brief pain inventory; EORTC QLQ-C30; Minimal clinically important differences; Radiation
Authors: Edward Chow; Keyue Ding; Wendy R Parulekar; Rebecca K S Wong; Yvette M van der Linden; Daniel Roos; William F Hartsell; Peter Hoskin; Jackson S Y Wu; Abdenour Nabid; Jan Willem Leer; Ernest Vonk; Scott Babington; William F Demas; Carolyn F Wilson; Michael Brundage; Liting Zhu; Ralph M Meyer Journal: Radiother Oncol Date: 2015-10-26 Impact factor: 6.280
Authors: Erin Wong; Liying Zhang; Marc Kerba; Palmira Foro Arnalot; Brita Danielson; May Tsao; Gillian Bedard; Nemica Thavarajah; Paul Cheon; Cyril Danjoux; Natalie Pulenzas; Edward Chow Journal: Support Care Cancer Date: 2015-02-10 Impact factor: 3.603
Authors: Srinivas Raman; Keyue Ding; Edward Chow; Ralph M Meyer; Abdenour Nabid; Pierre Chabot; Genevieve Coulombe; Shahida Ahmed; Joda Kuk; A Rashid Dar; Aamer Mahmud; Alysa Fairchild; Carolyn F Wilson; Jackson S Y Wu; Kristopher Dennis; Carlo DeAngelis; Rebecca K S Wong; Liting Zhu; Michael Brundage Journal: Qual Life Res Date: 2016-05-02 Impact factor: 4.147
Authors: Karrie Wong; Liang Zeng; Liying Zhang; Gillian Bedard; Erin Wong; May Tsao; Elizabeth Barnes; Cyril Danjoux; Arjun Sahgal; Lori Holden; Natalie Lauzon; Edward Chow Journal: Support Care Cancer Date: 2013-02-15 Impact factor: 3.603
Authors: G Mitera; L Zhang; A Sahgal; E Barnes; M Tsao; C Danjoux; L Holden; E Chow Journal: Clin Oncol (R Coll Radiol) Date: 2011-10-02 Impact factor: 4.126
Authors: John T Maringwa; Chantal Quinten; Madeleine King; Jolie Ringash; David Osoba; Corneel Coens; Francesca Martinelli; Jurgen Vercauteren; Charles S Cleeland; Henning Flechtner; Carolyn Gotay; Eva Greimel; Martin J Taphoorn; Bryce B Reeve; Joseph Schmucker-Von Koch; Joachim Weis; Egbert F Smit; Jan P van Meerbeeck; Andrew Bottomley Journal: Support Care Cancer Date: 2010-10-01 Impact factor: 3.603
Authors: M H J van den Beuken-van Everdingen; J M de Rijke; A G Kessels; H C Schouten; M van Kleef; J Patijn Journal: Ann Oncol Date: 2007-03-12 Impact factor: 32.976
Authors: Signe Ladegaard Harder; Mogens Groenvold; Jørn Herrstedt; Anna Thit Johnsen Journal: Support Care Cancer Date: 2018-06-26 Impact factor: 3.603
Authors: Ahmad Ousmen; Célia Touraine; Nina Deliu; Francesco Cottone; Franck Bonnetain; Fabio Efficace; Anne Brédart; Caroline Mollevi; Amélie Anota Journal: Health Qual Life Outcomes Date: 2018-12-11 Impact factor: 3.186
Authors: Mikko Tuomas Rantasalo; Riku Palanne; Katarina Juutilainen; Pekka Kairaluoma; Rita Linko; Elina Reponen; Teemu Helkamaa; Anne Vakkuri; Klaus T Olkkola; Rami Madanat; Noora Kati Annukka Skants Journal: BMJ Open Date: 2018-12-22 Impact factor: 2.692
Authors: Alexander Molassiotis; Lorna K P Suen; Hui Lin Cheng; T S K Mok; Sara C Y Lee; C H Wang; Paul Lee; Howan Leung; V Chan; T K H Lau; Winnie Yeo Journal: Integr Cancer Ther Date: 2019 Jan-Dec Impact factor: 3.279
Authors: Mark Clemons; Michelle Liu; Carol Stober; Gregory Pond; Mashari Jemaan Alzahrani; Michael Ong; Scott Ernst; Christopher Booth; Mihaela Mates; Anil Abraham Joy; Olexiy Aseyev; Phillip Blanchette; Lisa Vandermeer; Megan Tu; Kednapa Thavorn; Dean Fergusson Journal: J Bone Oncol Date: 2021-09-02 Impact factor: 4.072
Authors: Mark Clemons; Michael Ong; Carol Stober; Scott Ernst; Christopher Booth; Christina Canil; Mihaela Mates; Andrew Robinson; Phillip Blanchette; Anil Abraham Joy; John Hilton; Olexiy Aseyev; Gregory Pond; Ahwon Jeong; Brian Hutton; Sasha Mazzarello; Lisa Vandermeer; Igal Kushnir; Dean Fergusson Journal: Eur J Cancer Date: 2020-10-03 Impact factor: 9.162