Cargando…

Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review

Objective To determine how often health surveys and quality of life evaluations reach different conclusions from those of primary efficacy outcomes and whether discordant results make a difference in the interpretation of trial findings. Design Systematic review. Data sources PubMed, contact with au...

Descripción completa

Detalles Bibliográficos
Autores principales: Contopoulos-Ioannidis, Despina G, Karvouni, Anastasia, Kouri, Ioanna, Ioannidis, John P A
Formato: Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628302/
https://www.ncbi.nlm.nih.gov/pubmed/19139138
http://dx.doi.org/10.1136/bmj.a3006
_version_ 1782163683933159424
author Contopoulos-Ioannidis, Despina G
Karvouni, Anastasia
Kouri, Ioanna
Ioannidis, John P A
author_facet Contopoulos-Ioannidis, Despina G
Karvouni, Anastasia
Kouri, Ioanna
Ioannidis, John P A
author_sort Contopoulos-Ioannidis, Despina G
collection PubMed
description Objective To determine how often health surveys and quality of life evaluations reach different conclusions from those of primary efficacy outcomes and whether discordant results make a difference in the interpretation of trial findings. Design Systematic review. Data sources PubMed, contact with authors for missing information, and author survey for unpublished SF-36 data. Study selection Randomised trials with SF-36 outcomes (the most extensively validated and used health survey instrument for appraising quality of life) that were published in 2005 in 22 journals with a high impact factor. Data extraction Analyses on the two composite and eight subdomain SF-36 scores that corresponded to the time and mode of analysis of the primary efficacy outcome. Results Of 1057 screened trials, 52 were identified as randomised trials with SF-36 results (66 separate comparisons). Only eight trials reported all 10 SF-36 scores in the published articles. For 21 of the 66 comparisons, SF-36 results were discordant for statistical significance compared with the results for primary efficacy outcomes. Of 17 statistically significant SF-36 scores where primary outcomes were not also statistically significant in the same direction, the magnitude of effect was small in six, moderate in six, large in three, and not reported in two. Authors modified the interpretation of study findings based on SF-36 results in only two of the 21 discordant cases. Among 100 additional randomly selected trials not reporting any SF-36 information, at least five had collected SF-36 data but only one had analysed it. Conclusions SF-36 measurements sometimes produce different results from those of the primary efficacy outcomes but rarely modify the overall interpretation of randomised trials. Quality of life and health related survey information should be utilised more systematically in randomised trials.
format Text
id pubmed-2628302
institution National Center for Biotechnology Information
language English
publishDate 2009
publisher BMJ Publishing Group Ltd.
record_format MEDLINE/PubMed
spelling pubmed-26283022009-01-16 Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review Contopoulos-Ioannidis, Despina G Karvouni, Anastasia Kouri, Ioanna Ioannidis, John P A BMJ Research Objective To determine how often health surveys and quality of life evaluations reach different conclusions from those of primary efficacy outcomes and whether discordant results make a difference in the interpretation of trial findings. Design Systematic review. Data sources PubMed, contact with authors for missing information, and author survey for unpublished SF-36 data. Study selection Randomised trials with SF-36 outcomes (the most extensively validated and used health survey instrument for appraising quality of life) that were published in 2005 in 22 journals with a high impact factor. Data extraction Analyses on the two composite and eight subdomain SF-36 scores that corresponded to the time and mode of analysis of the primary efficacy outcome. Results Of 1057 screened trials, 52 were identified as randomised trials with SF-36 results (66 separate comparisons). Only eight trials reported all 10 SF-36 scores in the published articles. For 21 of the 66 comparisons, SF-36 results were discordant for statistical significance compared with the results for primary efficacy outcomes. Of 17 statistically significant SF-36 scores where primary outcomes were not also statistically significant in the same direction, the magnitude of effect was small in six, moderate in six, large in three, and not reported in two. Authors modified the interpretation of study findings based on SF-36 results in only two of the 21 discordant cases. Among 100 additional randomly selected trials not reporting any SF-36 information, at least five had collected SF-36 data but only one had analysed it. Conclusions SF-36 measurements sometimes produce different results from those of the primary efficacy outcomes but rarely modify the overall interpretation of randomised trials. Quality of life and health related survey information should be utilised more systematically in randomised trials. BMJ Publishing Group Ltd. 2009-01-12 /pmc/articles/PMC2628302/ /pubmed/19139138 http://dx.doi.org/10.1136/bmj.a3006 Text en © Contopoulos et al 2009 http://creativecommons.org/licenses/by-nc/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Contopoulos-Ioannidis, Despina G
Karvouni, Anastasia
Kouri, Ioanna
Ioannidis, John P A
Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
title Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
title_full Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
title_fullStr Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
title_full_unstemmed Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
title_short Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review
title_sort reporting and interpretation of sf-36 outcomes in randomised trials: systematic review
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628302/
https://www.ncbi.nlm.nih.gov/pubmed/19139138
http://dx.doi.org/10.1136/bmj.a3006
work_keys_str_mv AT contopoulosioannidisdespinag reportingandinterpretationofsf36outcomesinrandomisedtrialssystematicreview
AT karvounianastasia reportingandinterpretationofsf36outcomesinrandomisedtrialssystematicreview
AT kouriioanna reportingandinterpretationofsf36outcomesinrandomisedtrialssystematicreview
AT ioannidisjohnpa reportingandinterpretationofsf36outcomesinrandomisedtrialssystematicreview