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LOST to follow-up Information in Trials (LOST-IT) : a protocol on the potential impact

Akl, Elie A. and Briel, Matthias and You, John J. and Lamontagne, Francois and Gangji, Azim and Cukierman-Yaffe, Tali and Alshurafa, Mohamad and Sun, Xin and Nerenberg, Kara A. and Johnston, Bradley C. and Vera, Claudio and Mills, Edward J. and Bassler, Dirk and Salazar, Arturo and Bhatnagar, Neera and Busse, Jason W. and Khalid, Zara and Walter, Sd and Cook, Deborah J. and Schünemann, Holger J. and Altman, Douglas G. and Guyatt, Gordon H.. (2009) LOST to follow-up Information in Trials (LOST-IT) : a protocol on the potential impact. Trials, Vol. 10. p. 40.

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Official URL: http://edoc.unibas.ch/dok/A6006928

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Abstract

BACKGROUND: Incomplete ascertainment of outcomes in randomized controlled trials (RCTs) is likely to bias final study results if reasons for unavailability of patient data are associated with the outcome of interest. The primary objective of this study is to assess the potential impact of loss to follow-up on the estimates of treatment effect. The secondary objectives are to describe, for published RCTs, (1) the reporting of loss to follow-up information, (2) the analytic methods used for handling loss to follow-up information, and (3) the extent of reported loss to follow-up. METHODS: We will conduct a systematic review of reports of RCTs recently published in five top general medical journals. Eligible RCTs will demonstrate statistically significant effect estimates with respect to primary outcomes that are patient-important and expressed as binary data. Teams of 2 reviewers will independently determine eligibility and extract relevant information from each eligible trial using standardized, pre-piloted forms. To assess the potential impact of loss to follow-up on the estimates of treatment effect we will, for varying assumptions about the outcomes of participants lost to follow-up (LTFU), calculate (1) the percentage of RCTs that lose statistical significance and (2) the mean change in effect estimate across RCTs. The different assumptions we will test are the following: (1) none of the LTFU participants had the event; (2) all LTFU participants had the event; (3) all LTFU participants in the treatment group had the event; none of those in the control group had it (worst case scenario); (4) the event incidence among LTFU participants (relative to observed participants) increased, with a higher relative increase in the intervention group; and (5) the event incidence among LTFU participants (relative to observed participants) increased in the intervention group and decreased in the control group. DISCUSSION: We aim to make our objectives and methods transpare. The results of this study may have important implications for both clinical trialists and users of the medical literature.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
UniBasel Contributors:Briel, Matthias
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:BioMed Central
ISSN:1468-6708
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:01 Feb 2013 08:46
Deposited On:01 Feb 2013 08:40

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