BackgroundRandomized controlled trials (RCTs) often have more than one primary outcome and frequently have secondary and harm outcomes. Comparison of outcomes between study arms is the primary focus of RCTs, but there are times when the relation between outcomes is important, such as determining whether an intermediate outcome and a clinical outcome have a strong association. We sought to determine how often reports of RCTs depict the relations among outcomes at the individual patient level and, for those studies that use composite outcomes, how often the relations between component elements are depicted.MethodsWe selected 20 general, specialty and subspecialty medical journals with high impact factors that publish original clinical research. We identified every RCT in the 2011 and 2012 issues and randomly selected 10 articles per journal. For each article we recorded the number of outcomes, the number of composite outcomes and how often the relations between outcomes or elements of composite outcomes were portrayed.ResultsAll but 16 of the 200 RCTs had more than one outcome. Thus, outcomes could have been related in 92% of studies, but such relations were only reported in 2 (1%). A total of 33 (17%) investigations measured a composite outcome, 32 of which showed data for each component. None, however, showed cross-tabulation of the components.ConclusionsReaders are rarely shown the relation between outcomes. Mandatory posting of datasets or requirements for detailed appendices would allow readers to see these cross-tabulations, helping future investigators know which outcomes are redundant, which provide unique information and which are most responsive to changes in the independent variables. While not every relationship between outcomes requires depiction, at present such information is seldom portrayed.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0584-6) contains supplementary material, which is available to authorized users.
Delusions of foul body odors (often referred to as olfactory reference syndrome [ORS]) currently fall under the category of delusional disorder, somatic type (DDST), in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). We present the case of a 51-year-old man with no previous psychiatric history who presented with perceived foul odors that he delusionally attributed to trimethylaminuria (TMAU). TMAU is a rare metabolic disorder associated with foul body odors. The patient also experienced severe concurrent mood symptoms because of social isolation resulting from his delusion about his body odors. After considerable discussion of differential diagnoses, a diagnosis of DDST was ultimately made, given the patient's unrelenting nonbizarre delusions and lack of insight pertaining to his body odors. However, this case proved to be very useful in exploring the diagnostic challenges in this type of disorder and recent discussions of ORS and its proposed inclusion in the DSM-5.
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