An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases

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dc.contributor.authorZeng, Liang
dc.contributor.authorChow, Edward
dc.contributor.authorZhang, Liying
dc.contributor.authorTseng, Ling-Ming
dc.contributor.authorHou, Ming-Feng
dc.contributor.authorFairchild, Alysa
dc.contributor.authorVassiliou, Vassilios
dc.contributor.authorJesus-Garcia, Reynaldo [UNIFESP]
dc.contributor.authorEl-Din, Mohamed A. Alm
dc.contributor.authorKumar, Aswin
dc.contributor.authorForges, Fabien
dc.contributor.authorChie, Wei-Chu
dc.contributor.authorBedard, Gillian
dc.contributor.authorBottomley, Andrew
dc.contributor.institutionUniv Toronto
dc.contributor.institutionNatl Yang Ming Univ
dc.contributor.institutionKaohsiung Med Univ Hosp
dc.contributor.institutionCross Canc Inst
dc.contributor.institutionBank Cyprus
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionTanta Univ Hosp
dc.contributor.institutionReg Canc Ctr
dc.contributor.institutionSt Etienne Univ Hosp
dc.contributor.institutionNatl Taiwan Univ
dc.contributor.institutionEORTC Headquarters
dc.date.accessioned2016-01-24T14:28:04Z
dc.date.available2016-01-24T14:28:04Z
dc.date.issued2012-12-01
dc.description.abstractQuality 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, 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.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.en
dc.description.affiliationUniv Toronto, Sunnybrook Hlth Sci Ctr, Dept Radiat Oncol, Odette Canc Ctr, Toronto, ON M4N 3M5, Canada
dc.description.affiliationNatl Yang Ming Univ, Taipei Vet Gen Hosp, Dept Surg, Taipei 112, Taiwan
dc.description.affiliationKaohsiung Med Univ Hosp, Dept Surg Gastroenterol, Kaohsiung, Taiwan
dc.description.affiliationCross Canc Inst, Dept Radiat Oncol, Edmonton, AB T6G 1Z2, Canada
dc.description.affiliationBank Cyprus, Ctr Oncol, Dept Radiat Oncol, Nicosia, Cyprus
dc.description.affiliationUniversidade Federal de São Paulo, Dept Orthoped Oncol, São Paulo, Brazil
dc.description.affiliationTanta Univ Hosp, Tanta Fac Med, Dept Clin Oncol, Tanta, Egypt
dc.description.affiliationReg Canc Ctr, Dept Radiat Oncol, Div Gynaecol & Genitourinary Oncol, Trivandrum 695011, Kerala, India
dc.description.affiliationSt Etienne Univ Hosp, INSERM, CIE3, St Etienne, France
dc.description.affiliationSt Etienne Univ Hosp, Unit Clin Res Innovat & Pharmacol, St Etienne, France
dc.description.affiliationNatl Taiwan Univ, Dept Publ Hlth, Taipei 10764, Taiwan
dc.description.affiliationNatl Taiwan Univ, Inst Epidemiol & Preventat Med, Taipei 10764, Taiwan
dc.description.affiliationEORTC Headquarters, European Org Res & Treatment Canc, Brussels, Belgium
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Dept Orthoped Oncol, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipNovartis Oncology
dc.description.sponsorshipBratty Family Fund
dc.description.sponsorshipMichael and Karyn Goldstein Cancer Research Fund
dc.description.sponsorshipJoseph and Silvana Melara Cancer Research Fund
dc.description.sponsorshipOfelia Cancer Research Fund
dc.description.sponsorshipEORTC QLQ-C30
dc.format.extent3307-3313
dc.identifierhttp://dx.doi.org/10.1007/s00520-012-1484-x
dc.identifier.citationSupportive Care in Cancer. New York: Springer, v. 20, n. 12, p. 3307-3313, 2012.
dc.identifier.doi10.1007/s00520-012-1484-x
dc.identifier.issn0941-4355
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/35543
dc.identifier.wosWOS:000310232500036
dc.language.isoeng
dc.publisherSpringer
dc.relation.ispartofSupportive Care in Cancer
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.springer.com/open+access/authors+rights?SGWID=0-176704-12-683201-0
dc.subjectMinimal clinically important differenceen
dc.subjectQuality of lifeen
dc.subjectBone metastasesen
dc.subjectEORTC QLQ-BM22en
dc.subjectEORTC QLQ-C30en
dc.titleAn international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastasesen
dc.typeinfo:eu-repo/semantics/article
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