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2016 ; 6
(8
): e009972
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Assessment of the extent of unpublished studies in prognostic factor research: a
systematic review of p53 immunohistochemistry in bladder cancer as an example
#MMPMID27531721
Sekula P
; Pressler JB
; Sauerbrei W
; Goebell PJ
; Schmitz-Dräger BJ
BMJ Open
2016[Aug]; 6
(8
): e009972
PMID27531721
show ga
OBJECTIVES: When study groups fail to publish their results, a subsequent
systematic review may come to incorrect conclusions when combining information
only from published studies. p53 expression measured by immunohistochemistry is a
potential prognostic factor in bladder cancer. Although numerous studies have
been conducted, its role is still under debate. The assumption that unpublished
studies too harbour evidence on this research topic leads to the question about
the attributable effect when adding this information and comparing it with
published data. Thus, the aim was to identify published and unpublished studies
and to explore their differences potentially affecting the conclusion on its
function as a prognostic biomarker. DESIGN: Systematic review of published and
unpublished studies assessing p53 in bladder cancer in Germany between 1993 and
2007. RESULTS: The systematic search revealed 16 studies of which 11 (69%) have
been published and 5 (31%) have not. Key reason for not publishing the results
was a loss of interest of the investigators. There were no obviously larger
differences between published and unpublished studies. However, a meaningful
meta-analysis was not possible mainly due to the poor (ie, incomplete) reporting
of study results. CONCLUSIONS: Within this well-defined population of studies, we
could provide empirical evidence for the failure of study groups to publish their
results that was mainly caused by loss of interest. This fact may be
coresponsible for the role of p53 as a prognostic factor still being unclear. We
consider p53 and the restriction to studies in Germany as a specific example, but
the critical issues are probably similar for other prognostic factors and other
countries.