A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer

Abstract

Objectives: To investigate the effect on participation in colorectal cancer screening of testing for blood products in faeces using technologies that remove dietary restrictions (i.e. immunochemical tests) and simplify faecal sampling (i.e. tests that use brush sampling).

Setting: Urban residents (n=1818) of Adelaide, Australia, aged between 50 and 69 years, randomly selected from the electoral roll.

Design: Three randomised cohorts of 606 invitees were offered a screening test by mail in 2001. The Hemoccult SENSA and FlexSure OBT cohorts were instructed to sample three stools using a spatula while the InSureTM cohort sampled two stools using a brush. The Hemoccult SENSA cohort was asked to restrict certain (high-peroxidase) foods and drugs.

Main outcome measures: Participation (i.e. return of completed sample kits within 12 weeks) and generalised linear modelling (GLM) of relationships between participation, test technologies and demographic variables.

Results: Participation was 23.4%, 30.5% and 39.6% for the Hemoccult, FlexSure and InSure cohorts, respectively (chi(2)=37.1, p<0.00001). GLM demonstrated that participation was increased by 28% by removal of restrictions (p=0.01) and by 30% by simplification of sampling (p=0.001); both together increased participation by 66% (p<0.001). The differences in participation between tests occurred in the first three weeks. Socio-economic status, gender or age did not significantly influence technology-based improvements in participation.

Conclusions: The brush-sampling faecal immunochemical test for haemoglobin (InSure) achieves the best participation rates by simplifying sampling and removing the need for restrictions of diet and drugs. Because participation in screening is vital to detection, this new technology should contribute to better detection of neoplasia at the population level.