Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study
-
Published:2019-01
Issue:1
Volume:23
Page:1-84
-
ISSN:1366-5278
-
Container-title:Health Technology Assessment
-
language:en
-
Short-container-title:Health Technol Assess
Author:
Atkin Wendy1ORCID, Cross Amanda J1ORCID, Kralj-Hans Ines1ORCID, MacRae Eilidh1ORCID, Piggott Carolyn2ORCID, Pearson Sheena2ORCID, Wooldrage Kate1ORCID, Brown Jeremy1ORCID, Lucas Fiona1ORCID, Prendergast Aaron1ORCID, Marchevsky Natalie1ORCID, Patel Bhavita1ORCID, Pack Kevin1ORCID, Howe Rosemary1ORCID, Skrobanski Hanna3ORCID, Kerrison Robert3ORCID, Swart Nicholas4ORCID, Snowball Julia2ORCID, Duffy Stephen W5ORCID, Morris Stephen4ORCID, von Wagner Christian3ORCID, Halloran Stephen2ORCID
Affiliation:
1. Cancer Screening and Prevention Research Group, Department of Surgery and Cancer, Imperial College London, London, UK 2. Bowel Cancer Screening Programme Southern Hub, Guildford, UK 3. Research Department of Behavioural Science and Health, University College London, London, UK 4. Department of Applied Health Research, University College London, London, UK 5. Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University, London, UK
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.
Trial registration
Current Controlled Trials ISRCTN18040196.
Funding
National Institute for Health Research (NIHR) Health Technology Assessment programme, NIHR Imperial Biomedical Research Centre and the Bobby Moore Fund for Cancer Research UK. MAST Group Ltd provided FIT kits.
Funder
Health Technology Assessment programme NIHR Imperial Biomedical Research Centre Bobby Moore Fund for Cancer Research UK MAST Group Ltd
Publisher
National Institute for Health Research
Cited by
83 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|