Objective The English Bowel Cancer Screening Programme (BCSP) recommends 3 yearly colonoscopy surveillance for patients at intermediate risk of colorectal cancer (CRC) postpolypectomy (those with three to four small adenomas or one ≥10 mm). We investigated whether faecal immunochemical tests (FITs) could reduce surveillance burden on patients and endoscopy services.
Design Intermediate-risk patients (60–72 years) recommended 3 yearly surveillance were recruited within the BCSP (January 2012–December 2013). FITs were offered at 1, 2 and 3 years postpolypectomy. Invitees consenting and returning a year 1 FIT were included. Participants testing positive (haemoglobin ≥40 µg/g) at years one or two were offered colonoscopy early; all others were offered colonoscopy at 3 years. Diagnostic accuracy for CRC and advanced adenomas (AAs) was estimated considering multiple tests and thresholds. We calculated incremental costs per additional AA and CRC detected by colonoscopy versus FIT surveillance.
Results 74% (5938/8009) of invitees were included in our study having participated at year 1. Of these, 97% returned FITs at years 2 and 3. Three-year cumulative positivity was 13% at the 40 µg/g haemoglobin threshold and 29% at 10 µg/g. 29 participants were diagnosed with CRC and 446 with AAs. Three-year programme sensitivities for CRC and AAs were, respectively, 59% and 33% at 40 µg/g, and 72% and 57% at 10 µg/g. Incremental costs per additional AA and CRC detected by colonoscopy versus FIT (40 µg/g) surveillance were £7354 and £180 778, respectively.
Conclusions Replacing 3 yearly colonoscopy surveillance in intermediate-risk patients with annual FIT could reduce colonoscopies by 71%, significantly cut costs but could miss 30%–40% of CRCs and 40%–70% of AAs.
Trial registration number ISRCTN18040196; Results.
- colorectal cancer
- stool markers
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Contributors WSA, IK-H, CvW, SM, SWD, SPH, CP, IS and JS were responsible for obtaining funding and research approvals, and study design. EM, BP, KP and RH were responsible for trial management. WSA, AJC, AP, KW and SWD were responsible for data analysis and interpretation. SM and NS undertook the economic analysis. WSA, AJC, ECR and KW drafted the manuscript. All authors critically appraised the final manuscript. All authors gave final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. AJC and KW had final responsibility for the decision to submit for publication.
Funding This is a summary of independent research funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme and the Bobby Moore Fund for Cancer Research UK.
Disclaimer The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report, or in the decision to submit the manuscript for publication. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health or Cancer Research UK. Infrastructure support for this work was provided by the NIHR Imperial Biomedical Research Centre.
Competing interests WSA received non-financial support from Eiken Co. Ltd (MAST is UK distributor). SM is a member of the NIHR Health Services and Delivery Research (HS&DR) Funding Board. All other authors declare no competing interests.
Ethics approval Ethics approval was granted by London (City & East) Research Ethics Committee. All protocol amendments were approved (reference 11/LO/0326). The Ethics and Confidentiality Committee (ECC) of the Health Research Authority Confidentiality Advisory Group gave approval to access patient identifiers and contact details in June 2011, allowing identification and invitation of eligible participants (reference ECC 3-04(p)/2011).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the corresponding author.
Collaborators Trial steering committee: Dr Andrew Veitch (Chairperson), Ms Helen Watson and Ms Lynn Faulds-Wood (patient representatives), Professor Allan Hackshaw, Professor Sue Moss, Professor Marco Novelli, Professor Matt Rutter and Professor Christopher Todd. CSPRG study staff: Mrs Elizabeth Coles, Dr Paula Kirby, Ms Amy Brenner, Ms Jessica Martin, Mrs Urvi Shah, Ms Irene Simmonds, Dr Laura Turner, Mr Jeremy Brown and Dr Fiona Lucas. Collaborators: FIT kit provision: Mr Iain McElarney, MAST Group Ltd. FIT kits were generously provided by Eiken Chemical Co Ltd (through MAST Group Ltd). BCSP Southern Hub: Mrs Sheena Pearson, Mrs Sally Benton, Mrs Helen Bruce, Ms Carole Burtonwood, Dr Magdalen Carroll, Ms Cerin John, Ms Kate Randall, Mrs Katy Allen, Dr Helen Seaman and Mr Neil Stubbs. Clinical Informatics research unit at the University of Southampton: Professor James Batchelor and Mr Wez Morris. Health Behaviour Research Centre: Ms Bernardette Bonello, Ms Harriet Bowyer, Dr Gemma Vart and Professor Jane Wardle (deceased). Public Health England (PHE): Mr Tariq Malik, Ms Claire Nickerson and Dr Suzanne Wright. Clinical advice: Professor Brian Saunders, Professor Robert Steele and Dr Roland Valori.
Presented at Part of this work was presented at the British Society of Gastroenterology (BSG) Annual Meeting 2018 and has been published as a conference abstract (Robbins E, Wooldrage K, MacRae E, et al. OTU-029 Faecal immunochemical tests (FIT) for surveillance after screening and polypectomy: an accuracy and efficiency study. Gut 2018;67:A222).
Patient consent for publication Obtained.
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