title: Test performance of faecal occult blood testing for the detection of bowel cancer in people with chronic kidney disease (DETECT) protocol.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Sydney School of Public Health University of Sydney, Australia. germainw@chw.edu.au
authors.forename: Germaine
authors.initials: G
authors.lastname: Wong
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
authors.forename: Jeremy R
authors.initials: JR
authors.lastname: Chapman
authors.forename: Allison
authors.initials: A
authors.lastname: Tong
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Bourke
authors.forename: Andrew
authors.initials: A
authors.lastname: Hayen
authors.forename: Petra
authors.initials: P
authors.lastname: Macaskill
authors.forename: Richard L
authors.initials: RL
authors.lastname: Hope
authors.forename: Narelle
authors.initials: N
authors.lastname: Williams
authors.forename: Anh
authors.initials: A
authors.lastname: Kieu
authors.forename: Richard
authors.initials: R
authors.lastname: Allen
authors.forename: Steven
authors.initials: S
authors.lastname: Chadban
authors.forename: Carol
authors.initials: C
authors.lastname: Pollock
authors.forename: Angela
authors.initials: A
authors.lastname: Webster
authors.forename: Simon D
authors.initials: SD
authors.lastname: Roger
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols / Q000592:standards*; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D015897:Comorbidity; D019937:Diagnostic Techniques and Procedures / Q000592:standards*; D005243:Feces; D006801:Humans; D007407:Interviews as Topic; D007676:Kidney Failure, Chronic; D008875:Middle Aged; D009780:Occult Blood; D017063:Outcome Assessment, Health Care; D057240:Patient Preference