Faecal occult blood testing for population health screening May 2004

Selection criteria
The ideal study design for a study of the accuracy of diagnostic tests is that in which each
test being compared is performed in all individuals. In addition, for the generalisability
and external validity of studies being assessed to apply to the Australian population,
studies must be performed in a screening population, rather than a hospital-based highrisk
population. For this reason the inclusion and exclusion criteria were as follows.
Inclusion criteria
• All human head-to-head studies comparing at least two FOBTs that have been, or
are currently, commercially available.
• Population health screening studies.
• Use of an appropriate reference standard (eg, colonoscopy and/or double contrast
barium enema (DCBE) where colonoscopy is incomplete or contra-indicated).
Exclusion criteria
• Trials with fewer than 100 patients.
• Non-systematic reviews and opinion pieces.
• Non-comparative studies.
The flow chart in Figure 1 summarises the exclusion of studies from the safety and
effectiveness review of FOBTs. A total of 1214 references were identified by the search,
of which 30 met the criteria to be considered as evidence in the effectiveness review. A
complete list of the citations identified in the literature search, identified as FOBT studies
and later excluded at higher levels is included in Appendix E, together with reasons for
exclusion from the review.
Publications that duplicated all or some of the patient data were included in the first
instance. They were then reviewed, and excluded if necessary. Publications that failed to
report outcomes adequately (eg, sensitivity, specificity, true positive rates, false positive
rates, positive predictive value) were also excluded after review.
10 Faecal occult blood testing