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Open Access Study protocol

Test performance of faecal occult blood testing for the detection of bowel cancer in people with chronic kidney disease (DETECT) protocol

Germaine Wong123*, Kirsten Howard1, Jeremy R Chapman2, Allison Tong1, Michael J Bourke4, Andrew Hayen1, Petra Macaskill1, Richard L Hope5, Narelle Williams1, Anh Kieu1, Richard Allen6, Steven Chadban6, Carol Pollock7, Angela Webster123, Simon D Roger8 and Jonathan C Craig123

Author Affiliations

1 Sydney School of Public Health University of Sydney, Australia

2 Centre for Transplant and Renal Research, Westmead Hospital, Australia

3 Centre for kidney research, Kids Research Institute at the Children's Hospital at Westmead, Australia

4 Department of Gastroenterology, Westmead Hospital, Australia

5 Department of Gastroenterology, Blacktown Hospital, Australia

6 Central Clinical School, Royal Prince Alfred Hospital, University of Sydney, Australia

7 Kollings Institute, University of Sydney, Australia

8 Department of Renal Medicine, Gosford Hospital, Australia

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BMC Public Health 2011, 11:516  doi:10.1186/1471-2458-11-516

Published: 29 June 2011

Abstract

Background

Cancer is a major cause of mortality and morbidity in patients with chronic kidney disease (CKD). In patients without kidney disease, screening is a major strategy for reducing the risk of cancer and improving the health outcomes for those who developed cancers by detecting treatable cancers at an early stage. Among those with CKD, the effectiveness, the efficacy and patients' preferences for cancer screening are unknown.

Methods/Design

This work describes the protocol for the DETECT study examining the effectiveness, efficiency and patient's perspectives of colorectal cancer screening using immunochemical faecal occult blood testing (iFOBT) for people with CKD. The aims of the DETECT study are 1) to determine the test performance characteristics of iFOBT screening in individuals with CKD, 2) to estimate the incremental costs and health benefits of iFOBT screening in CKD compared to no screening and 3) to elicit patients' perspective for colorectal cancer screening in the CKD population. Three different study designs will be used to explore the uncertainties surrounding colorectal cancer screening in CKD. A diagnostic test accuracy study of iFOBT screening will be conducted across all stages of CKD in patients ages 35-70. Using individually collected direct healthcare costs and outcomes from the diagnostic test accuracy study, cost-utility and cost-effective analyses will be performed to estimate the costs and health benefits of iFOBT screening in CKD. Qualitative in-depth interviews will be undertaken in a subset of participants from the diagnostic test accuracy study to investigate the perspectives, experiences, attitudes and beliefs about colorectal cancer screening among individuals with CKD.

Discussion

The DETECT study will target the three major unknowns about early cancer detection in CKD. Findings from our study will provide accurate and definitive estimates of screening efficacy and efficiency for colorectal cancer, and will allow better service planning and budgeting for early cancer detection in this at-risk population.

The DETECT study is also registered with the Australia New Zealand Clinical Trials Registry ACTRN12611000538943