Email updates

Keep up to date with the latest news and content from BMC Medical Research Methodology and BioMed Central.

Open Access Research article

Reporting of loss to follow-up information in randomised controlled trials with time-to-event outcomes: a literature survey

Elke Vervölgyi1*, Mandy Kromp1, Guido Skipka1, Ralf Bender12 and Thomas Kaiser1

Author Affiliations

1 Institute for Quality and Efficiency in Health Care (IQWiG), Dillenburger Str. 27, 51105 Cologne, Germany

2 Faculty of Medicine, University of Cologne, Joseph-Stelzmann-Str. 20, 50931 Cologne, Germany

For all author emails, please log on.

BMC Medical Research Methodology 2011, 11:130  doi:10.1186/1471-2288-11-130

Published: 21 September 2011

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 chi2-test applied to the corresponding 2 × 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.

Keywords:
randomised controlled trial; survival analysis; Kaplan-Meier plot; loss to follow-up