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Faecal immunochemical tests versus colonoscopy for post-poly pectomy surveillance: An accuracy, acceptability and economic study

Atkin, W., Cross, A.J., Kralj-Hans, I., Macrae, E., Piggott, C., Pearson, S., Wooldrage, K., Brown, J., Lucas, F., Prendergast, A. , Marchevsky, N., Patel, B., Pack, K., Howe, R., Skrobanski, H., Kerrison, R., Swart, N., Snowball, J., Duffy, S.W., Morris, S., von Wagner, C. and Halloran, S. (2019) Faecal immunochemical tests versus colonoscopy for post-poly pectomy surveillance: An accuracy, acceptability and economic study HEALTH TECHNOLOGY ASSESSMENT, 23 (1). I-84.

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Abstract

Background In the UK, patients with one or two adenomas, of which at least one is ≥ 10 mm in size, or three or four small adenomas, are deemed to be at intermediate risk of colorectal cancer (CRC) and referred for surveillance colonoscopy 3 years post polypectomy. However, colonoscopy is costly, can cause discomfort and carries a small risk of complications. Objectives To determine whether or not annual faecal immunochemical tests (FITs) are effective, acceptable and cost saving compared with colonoscopy surveillance for detecting CRC and advanced adenomas (AAs). Design Diagnostic accuracy study with health psychology assessment and economic evaluation. Setting Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England. Participants Men and women, aged 60–72 years, deemed to be at intermediate risk of CRC following adenoma removal after a positive guaiac faecal occult blood test were invited to participate. Invitees who consented and returned an analysable FIT were included. Intervention We offered participants quantitative FITs at 1, 2 and 3 years post polypectomy. Participants testing positive with any FIT were referred for colonoscopy and not offered further FITs. Participants testing negative were offered colonoscopy at 3 years post polypectomy. Acceptibility of FIT was assessed using discussion groups, questionnaires and interviews. Main outcome measures The primary outcome was 3-year sensitivity of an annual FIT versus colonoscopy at 3 years for detecting advanced colorectal neoplasia (ACN) (CRC and/or AA). Secondary outcomes included participants’ surveillance preferences, and the incremental costs and cost-effectiveness of FIT versus colonoscopy surveillance. Results Of 8008 invitees, 5946 (74.3%) consented and returned a round 1 FIT. FIT uptake in rounds 2 and 3 was 97.2% and 96.9%, respectively. With a threshold of 40 µg of haemoglobin (Hb)/g faeces (hereafter referred to as µg/g), positivity was 5.8% in round 1, declining to 4.1% in round 3. Over three rounds, 69.2% (18/26) of participants with CRC, 34.3% (152/443) with AAs and 35.6% (165/463) with ACN tested positive at 40 µg/g. Sensitivity for CRC and AAs increased, whereas specificity decreased, with lower thresholds and multiple rounds. At 40 µg/g, sensitivity and specificity of the first FIT for CRC were 30.8% and 93.9%, respectively. The programme sensitivity and specificity of three rounds at 10 µg/g were 84.6% and 70.8%, respectively. Participants’ preferred surveillance strategy was 3-yearly colonoscopy plus annual FITs (57.9%), followed by annual FITs with colonoscopy in positive cases (31.5%). FIT with colonoscopy in positive cases was cheaper than 3-yearly colonoscopy (£2,633,382), varying from £485,236 (40 µg/g) to £956,602 (10 µg/g). Over 3 years, FIT surveillance could miss 291 AAs and eight CRCs using a threshold of 40 µg/g, or 189 AAs and four CRCs using a threshold of 10 µg/g. Conclusions Annual low-threshold FIT with colonoscopy in positive cases achieved high sensitivity for CRC and would be cost saving compared with 3-yearly colonoscopy. However, at higher thresholds, this strategy could miss 15–30% of CRCs and 40–70% of AAs. Most participants preferred annual FITs plus 3-yearly colonoscopy. Further research is needed to define a clear role for FITs in surveillance. Future work Evaluate the impact of ACN missed by FITs on quality-adjusted life-years.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Health Sciences
Authors :
NameEmailORCID
Atkin, W.
Cross, A.J.
Kralj-Hans, I.
Macrae, E.
Piggott, C.
Pearson, S.
Wooldrage, K.
Brown, J.
Lucas, F.
Prendergast, A.
Marchevsky, N.
Patel, B.
Pack, K.
Howe, R.
Skrobanski, H.h.skrobanski@surrey.ac.uk
Kerrison, R.
Swart, N.
Snowball, J.
Duffy, S.W.
Morris, S.
von Wagner, C.
Halloran, S.S.Halloran@surrey.ac.uk
Date : January 2019
DOI : 10.3310/hta23010
Copyright Disclaimer : © Queen’s Printer and Controller of HMSO 2019. This work was produced by Atkin et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 2019 Queen’s Printer and Controller of HMSO
Uncontrolled Keywords : hemoglobin, adenoma, adult, advanced cancer, aged, Article, colonoscopy, colorectal cancer, controlled study, cost control, cost effectiveness analysis, diagnostic accuracy, diagnostic test accuracy study, economic evaluation, female, human, intermethod comparison, major clinical study, male, middle aged, occult blood test, outcome assessment, polypectomy, postoperative care, psychologic assessment, quality adjusted life year, sensitivity analysis, sensitivity and specificity, clinical trial
Depositing User : Diane Maxfield
Date Deposited : 26 Jun 2019 13:20
Last Modified : 26 Jun 2019 13:20
URI: http://epubs.surrey.ac.uk/id/eprint/852092

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