Outcome reporting bias

In many studies, a range of outcome measures is recorded but not all are reported (Pocock 1987, Tannock 1996). The choice of outcomes that are reported can be influenced by the results, potentially making published results misleading.  For example, two separate analyses (Mandel 1987, Cantekin 1991) of a double-blind placebo-controlled trial assessing the efficacy of amoxicillin in children with non-suppurative otitis media reached opposite conclusions mainly because different ‘weight’ was given to the various outcome measures that were assessed in the study. This disagreement was conducted in the public arena, since it was accompanied by accusations of impropriety against the team producing the findings favourable to amoxicillin. The leader of this team had received substantial fiscal support, both in research grants and as personal honoraria, from the manufacturers of amoxicillin (Rennie 1991).  It is a good example of how reliance upon the data chosen to be presented by the investigators can lead to distortion (Anonymous 1991). Such ‘outcome reporting bias’ may be particularly important for adverse effects. Hemminki examined reports of clinical trials submitted by drug companies to licensing authorities in Finland and Sweden and found that unpublished trials gave information on adverse effects more often than published trials (Hemminki 1980). Since then several other studies have shown that the reporting of adverse events and safety outcomes in clinical trials is often inadequate and selective (Ioannidis 2001, Melander 2003, Heres 2006). A group from Canada, Denmark and the UK recently pioneered empirical research into the selective reporting of study outcomes (Chan 2004a, Chan 2004b, Chan 2005). These studies are described in Chapter 8 (Section 8.14), along with a more detailed discussion of outcome reporting bias.