Document Detail


Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers.
MedLine Citation:
PMID:  21110123     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
PURPOSE: To assess the patterns of, and trends over time in, health-related quality of life (HRQL) reporting in randomized controlled trials (RCTs).
METHODS: The English-language literature of RCTs published in 2002-2008 was identified using Medline, Embase, and Healthstar databases, in addition to the Cochrane Clinical Trials Registry. Eligible trials were phase III studies that included an HRQL outcome. Data were abstracted on eight outcomes derived from previously recommended quality standards for reporting HRQL, and on four outcomes describing how HRQL data are presented in RCT reports. Two readers examined each article; discrepancies were resolved through discussion and third review if required.
RESULTS: A sample of 794 RCTs was identified. HRQL was a primary outcome in 25.4% (200/794). One hundred and ten RCTs (14%) used "supplementary" reports (separate from the first publication) to report HRQL findings. The proportion of RCTs that met the eight quality indicators ranged from 15% (HRQL used in the calculation of sample size) to 81% (reporting instrument validity). RCTs with HRQL as a primary outcome or with a supplementary report had higher concordance on the quality measures. Reporting improved on many indicators over time. Substantive variation in how HRQL data are presented in RCTs was evident.
CONCLUSIONS: Current practice of reporting HRQL outcomes in RCTs remains highly variable, both with regard to quality of reporting and the patterns of data analysis and presentation. This variation presents challenges for clinicians to apply these data in clinical practice. Consistent reporting practices, which are interpretable by clinicians, are required, as are processes to achieve this consistency in future reports.
Authors:
Michael Brundage; Brenda Bass; Judith Davidson; John Queenan; Andrea Bezjak; Jolie Ringash; Anna Wilkinson; Deb Feldman-Stewart
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Publication Detail:
Type:  Journal Article     Date:  2010-11-26
Journal Detail:
Title:  Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation     Volume:  20     ISSN:  1573-2649     ISO Abbreviation:  Qual Life Res     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-26     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9210257     Medline TA:  Qual Life Res     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  653-64     Citation Subset:  IM    
Affiliation:
Department of Oncology, Queen's University, Kingston, ON, Canada, michael.brundage@krcc.on.ca.
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