http://precedings.nature.com/users/772de2428cf0229e1dd6b0225a0d0c1a/ Documents posted by Martin Daumer Nature Publishing Group en Nature Precedings http://precedings.nature.com/images/header_logo.gif http://precedings.nature.com http://dx.doi.org/10.1038/npre.2007.980.2 Recording of fetal heart rate via CTG monitoring has been routinely performed as an important part of antenatal and subpartum care for several decades. The current guidelines of the FIGO (ref1) recommend a normal range of the fetal heart rate from 110 to 150 bpm. However, there is no agreement in the medical community whether this is the correct range (ref2). We aim to address this question by computerized analysis (ref 3) of a high quality database (HQDb, ref 4) of about one billion electronically registered fetal heart rate measurements from about 10,000 pregnancies in three medical centres over seven years. In the present paper, we lay out a detailed analysis plan for this evidence-based project in the vein of the validation policy of the Sylvia Lawry Centre for Multiple Sclerosis Research (ref 5) with a split of the database into an exploratory part and a part reserved for validation. We will perform the analysis and the validation after publication of this plan in order to reduce the probability of publishing false positive research findings (ref 6-7). http://dx.doi.org/10.1038/npre.2007.980.2 Mon, 12 Nov 2007 16:48:34 UTC The Normal Fetal Heart Rate Study: Analysis Plan doi:10.1038/npre.2007.980.2 2007-11-12 Martin Daumer Nature Precedings 2007-11-12T16:48:34Z Manuscript Bioinformatics http://creativecommons.org/licenses/by/2.5/ http://precedings.nature.com/documents/433/version/1 ObjectiveWe have assessed the utility of a pre-publication validation policy in reducing the probability of publishing false positive research findings. Study design and settingThe large database of the Sylvia Lawry Centre for Multiple Sclerosis Research was split in two parts: one for hypothesis generation and a validation part for confirmation of selected results. We present case studies from 5 finalized projects that have used the validation policy and results from a simulation study.ResultsIn one project, the “relapse and disability” project as described in section II (example 3), findings could not be confirmed in the validation part of the database. The simulation study showed that the percentage of false positive findings can exceed 20% depending on variable selection. ConclusionWe conclude that the validation policy has prevented the publication of at least one research finding that could not be validated in an independent data set (and probably would have been a “true” false-positive finding) over the past three years, and has led to improved data analysis, statistical programming, and selection of hypotheses. The advantages outweigh the lost statistical power inherent in the process. http://precedings.nature.com/documents/433/version/1 Thu, 12 Jul 2007 06:10:54 UTC Reducing the Probability of False Positive Research Findings by Pre-Publication Validation – Experience with a Large Multiple Sclerosis Database hdl:10101/npre.2007.433.1 2007-09-10 Martin M. Daumer Nature Precedings 2007-07-12T06:10:54Z Manuscript Neuroscience Bioinformatics http://creativecommons.org/licenses/by/2.5/