Reporting of outcomes in overactive bladder trials: Comparison of protocols and publications

evidence-based medicine Overactieve blaas Systematic Review

dr. M.H. Blanker
Dr. H. van der Worp

Nature of the research:
Literature study combined with analyzing a large database.

Fields of study:
epidemiology GP medicine urology

Background / introduction
Symptoms of overactive bladder syndrome (OAB) are the most burdensome and bothersome of all urinary symptoms affecting both genders. Treatment of OAB mainly consists of drug therapy. These drugs influence the smooth muscles of the bladder. Although trials have shown the efficacy of these drugs, the effect of these drugs is limited. We suspect that there are some issues with the reporting of these trials.
Research question / problem definition
In this project we will make a comparison between the outcomes that have been written down in protocols and the outcomes that have been reported in subsequently published articles. We will also study whether there is a relation between statistical significance of outcomes and whether they are published. In this way we will assess selective reporting.
We have identified studies of interest. For these studies a comparison has to be made between the protocols and the published papers. Next to that, data from a large trial database will be analyzed and the association between significance of findings and inclusion in an article will be assessed.
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