Universität zu Köln

Vervoelgyi, Elke, Kromp, Mandy, Skipka, Guido, Bender, Ralf and Kaiser, Thomas (2011). Reporting of loss to follow-up information in randomised controlled trials with time-to-event outcomes: a literature survey. BMC Med. Res. Methodol., 11. LONDON: BMC. ISSN 1471-2288

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Abstract

Background: To assess the reporting of loss to follow-up (LTFU) information in articles on randomised controlled trials (RCTs) with time-to-event outcomes, and to assess whether discrepancies affect the validity of study results. Methods: Literature survey of all issues of the BMJ, Lancet, JAMA, and New England Journal of Medicine published between 2003 and 2005. Eligible articles were reports of RCTs including at least one Kaplan-Meier plot. Articles were classified as assessable if sufficient information was available to assess LTFU. In these articles, LTFU information was derived from Kaplan-Meier plots, extracted from the text, and compared. Articles were then classified as consistent or not consistent. Sensitivity analyses were performed to assess the validity of study results. Results: 319 eligible articles were identified. 187 (59%) were classified as assessable, as they included sufficient information for evaluation; 140 of 319 (44%) presented consistent LTFU information between the Kaplan-Meier plot and text. 47 of 319 (15%) were classified as not consistent. These 47 articles were included in sensitivity analyses. When various imputation methods were used, the results of a chi(2)-test applied to the corresponding 2 x 2 table changed and hence were not robust in about half of the studies. Conclusions: Less than half of the articles on RCTs using Kaplan-Meier plots provide assessable and consistent LTFU information, thus questioning the validity of the results and conclusions of many studies presenting survival analyses. Authors should improve the presentation of both Kaplan-Meier plots and LTFU information, and reviewers of study publications and journal editors should critically appraise the validity of the information provided.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Vervoelgyi, Elke UNSPECIFIED UNSPECIFIED UNSPECIFIED Kromp, Mandy UNSPECIFIED UNSPECIFIED UNSPECIFIED Skipka, Guido UNSPECIFIED UNSPECIFIED UNSPECIFIED Bender, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaiser, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-488916
DOI:	10.1186/1471-2288-11-130
Journal or Publication Title:	BMC Med. Res. Methodol.
Volume:	11
Date:	2011
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-2288
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STATISTICS NOTES; CLINICAL-TRIALS; SURVIVAL Multiple languages Health Care Sciences & Services Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48891