PMID- 22562607
OWN - NLM
STAT- MEDLINE
DCOM- 20130513
LR  - 20211021
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Linking)
VI  - 20
IP  - 12
DP  - 2012 Dec
TI  - An international prospective study establishing minimal clinically important 
      differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone 
      metastases.
PG  - 3307-13
LID - 10.1007/s00520-012-1484-x [doi]
AB  - PURPOSE: 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). METHODS: 
      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. RESULTS: 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, respectively, demonstrated clinical relevance. Decreases of 12.4 (0.3 to 
      24.6), 22.4 (11.8 to 32.9) and 13.5 (1.9 to 25.1) were required to represent 
      clinically relevant deterioration in emotional functioning, global health status 
      and financial issues, respectively. Minimal differences for improvement were 
      closest to 0.5 standard deviations (SD) while for deterioration, closer to 0.3 SD 
      on the QLQ-BM22. CONCLUSION: Identification of requirements for clinical 
      significance can assist in determining the relevance of QOL changes after 
      treatment and in sample size determination in future trials. Our study is limited 
      by the small sample size. Future studies should continue to determine MCID and 
      confirm our findings using a variety of appropriate anchors and in a larger 
      sample.
FAU - Zeng, Liang
AU  - Zeng L
AD  - Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health 
      Sciences Centre, University of Toronto, 2075 Bayview Avenue, Toronto, Ontario, 
      Canada M4N 3M5.
FAU - Chow, Edward
AU  - Chow E
FAU - Zhang, Liying
AU  - Zhang L
FAU - Tseng, Ling-Ming
AU  - Tseng LM
FAU - Hou, Ming-Feng
AU  - Hou MF
FAU - Fairchild, Alysa
AU  - Fairchild A
FAU - Vassiliou, Vassilios
AU  - Vassiliou V
FAU - Jesus-Garcia, Reynaldo
AU  - Jesus-Garcia R
FAU - Alm El-Din, Mohamed A
AU  - Alm El-Din MA
FAU - Kumar, Aswin
AU  - Kumar A
FAU - Forges, Fabien
AU  - Forges F
FAU - Chie, Wei-Chu
AU  - Chie WC
FAU - Bedard, Gillian
AU  - Bedard G
FAU - Bottomley, Andrew
AU  - Bottomley A
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20120506
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Bone Neoplasms/complications/*psychology/secondary
MH  - Fatigue/etiology
MH  - Female
MH  - Humans
MH  - Karnofsky Performance Status
MH  - Male
MH  - Middle Aged
MH  - Outcome Assessment, Health Care/methods
MH  - Pain/etiology
MH  - Prospective Studies
MH  - Psychometrics/instrumentation
MH  - *Quality of Life
MH  - Surveys and Questionnaires
EDAT- 2012/05/09 06:00
MHDA- 2013/05/15 06:00
CRDT- 2012/05/08 06:00
PHST- 2012/03/08 00:00 [received]
PHST- 2012/04/22 00:00 [accepted]
PHST- 2012/05/08 06:00 [entrez]
PHST- 2012/05/09 06:00 [pubmed]
PHST- 2013/05/15 06:00 [medline]
AID - 10.1007/s00520-012-1484-x [doi]
PST - ppublish
SO  - Support Care Cancer. 2012 Dec;20(12):3307-13. doi: 10.1007/s00520-012-1484-x. 
      Epub 2012 May 6.