Evaluation of quality of life in a clinical trial with nonrandom dropout: the effect of epoetin alfa in anemic cancer patients.
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| Title: | Evaluation of quality of life in a clinical trial with nonrandom dropout: the effect of epoetin alfa in anemic cancer patients. |
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| Authors: | Fairclough, D.L., Gagnon, D.D., Zagari, M.J., Marschner, N., Dicato, M., Epoetin Alfa Study Group (CORPORATE AUTHOR) |
| Source: | Quality of Life Research. Dec2003, Vol. 12 Issue 8, p1013-1027. 15p. |
| Subjects: | Quality of life, Clinical trials, Placebos, Cancer treatment, Anemia, Drug therapy |
| Abstract: | Quality of life (QOL) endpoints from a randomized, placebo-controlled trial of anemic cancer patients treated with nonplatinum-containing chemotherapy who received epoetin alfa or placebo were subjected to a sensitivity analysis. Three QOL instruments were used: the Functional Assessment of Cancer Therapy-Anemia (FACT-An), the Cancer Linear Analog Scale (CLAS), and the Medical Outcomes Study Short Form-36 (SF-36). The seven primary endpoints chosen a priori for analysis were: the Functional Assessment of Cancer Therapy-General (FACT-G) Total, FACT-An fatigue subscale, CLAS energy, CLAS daily activities, CLAS overall QOL, and the SF-36 physical and mental component summary scales. Lower QOL scores were reported for patients who discontinued early, suggesting a nonrandom dropout process. Significant correlations (ranging from 0.37 to 0.77) between individual rates of change and the time to early termination of therapy or death supported this conclusion. Estimates of within-treatment-arm QOL change over time are more conservative with the missing not at random (MNAR) assumption as compared with the more optimistic estimates with the assumption that missing QOL data are missing at random (MAR). However, the between-treatment-arm comparisons were consistent across analyses, demonstrating statistically significant differences in favor of the epoetin alfa arm for four of the seven outcome measures. [ABSTRACT FROM AUTHOR] |
| Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 11092825 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Evaluation of quality of life in a clinical trial with nonrandom dropout: the effect of epoetin alfa in anemic cancer patients. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Fairclough%2C+D%2EL%2E%22">Fairclough, D.L.</searchLink><br /><searchLink fieldCode="AR" term="%22Gagnon%2C+D%2ED%2E%22">Gagnon, D.D.</searchLink><br /><searchLink fieldCode="AR" term="%22Zagari%2C+M%2EJ%2E%22">Zagari, M.J.</searchLink><br /><searchLink fieldCode="AR" term="%22Marschner%2C+N%2E%22">Marschner, N.</searchLink><br /><searchLink fieldCode="AR" term="%22Dicato%2C+M%2E%22">Dicato, M.</searchLink><br /><searchLink fieldCode="AR" term="%22Epoetin+Alfa+Study+Group%22">Epoetin Alfa Study Group</searchLink> (CORPORATE AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Quality+of+Life+Research%22">Quality of Life Research</searchLink>. Dec2003, Vol. 12 Issue 8, p1013-1027. 15p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Quality+of+life%22">Quality of life</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Placebos%22">Placebos</searchLink><br /><searchLink fieldCode="DE" term="%22Cancer+treatment%22">Cancer treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Anemia%22">Anemia</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+therapy%22">Drug therapy</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Quality of life (QOL) endpoints from a randomized, placebo-controlled trial of anemic cancer patients treated with nonplatinum-containing chemotherapy who received epoetin alfa or placebo were subjected to a sensitivity analysis. Three QOL instruments were used: the Functional Assessment of Cancer Therapy-Anemia (FACT-An), the Cancer Linear Analog Scale (CLAS), and the Medical Outcomes Study Short Form-36 (SF-36). The seven primary endpoints chosen a priori for analysis were: the Functional Assessment of Cancer Therapy-General (FACT-G) Total, FACT-An fatigue subscale, CLAS energy, CLAS daily activities, CLAS overall QOL, and the SF-36 physical and mental component summary scales. Lower QOL scores were reported for patients who discontinued early, suggesting a nonrandom dropout process. Significant correlations (ranging from 0.37 to 0.77) between individual rates of change and the time to early termination of therapy or death supported this conclusion. Estimates of within-treatment-arm QOL change over time are more conservative with the missing not at random (MNAR) assumption as compared with the more optimistic estimates with the assumption that missing QOL data are missing at random (MAR). However, the between-treatment-arm comparisons were consistent across analyses, demonstrating statistically significant differences in favor of the epoetin alfa arm for four of the seven outcome measures. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=11092825 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1023/A:1026116426494 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 15 StartPage: 1013 Subjects: – SubjectFull: Quality of life Type: general – SubjectFull: Clinical trials Type: general – SubjectFull: Placebos Type: general – SubjectFull: Cancer treatment Type: general – SubjectFull: Anemia Type: general – SubjectFull: Drug therapy Type: general Titles: – TitleFull: Evaluation of quality of life in a clinical trial with nonrandom dropout: the effect of epoetin alfa in anemic cancer patients. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Fairclough, D.L. – PersonEntity: Name: NameFull: Gagnon, D.D. – PersonEntity: Name: NameFull: Zagari, M.J. – PersonEntity: Name: NameFull: Marschner, N. – PersonEntity: Name: NameFull: Dicato, M. – PersonEntity: Name: NameFull: Epoetin Alfa Study Group IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 12 Text: Dec2003 Type: published Y: 2003 Identifiers: – Type: issn-print Value: 09629343 Numbering: – Type: volume Value: 12 – Type: issue Value: 8 Titles: – TitleFull: Quality of Life Research Type: main |
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