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Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study
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 disc...
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| Published in: | Health technology assessment (Winchester, England) England), 2019-01, Vol.23 (1), p.1-84 |
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| creator | Atkin, Wendy Cross, Amanda J Kralj-Hans, Ines MacRae, Eilidh Piggott, Carolyn Pearson, Sheena Wooldrage, Kate Brown, Jeremy Lucas, Fiona Prendergast, Aaron Marchevsky, Natalie Patel, Bhavita Pack, Kevin Howe, Rosemary Skrobanski, Hanna Kerrison, Robert Swart, Nicholas Snowball, Julia Duffy, Stephen W Morris, Stephen von Wagner, Christian Halloran, Stephen |
| description | 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.
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).
Diagnostic accuracy study with health psychology assessment and economic evaluation.
Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England.
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.
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.
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.
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 annua |
| doi_str_mv | 10.3310/hta23010 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_cb3398fda28b4cb3915ca8d980f85aee</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_cb3398fda28b4cb3915ca8d980f85aee</doaj_id><sourcerecordid>2165051717</sourcerecordid><originalsourceid>FETCH-LOGICAL-c368t-81ad2ca0948214138e64d67f4131a9dca5e76f543a4051ad6cd3906bf57ceaef3</originalsourceid><addsrcrecordid>eNpVkc1u1TAQhS0EorcFiSdAWbIgYMeO47BAQhUtlSqxgbU1GU96UyVxsJ0rZcWr40t_oKuZ8Rx945nD2BvBP0gp-Md9gkpywZ-xXcWVLlVbqedsJ6TWZV015oSdxnjLuRK6Fi_ZieRaGFk3O_b7AghhLIZpWmePe5qGY5koplgcKMQ1FuhHP_uIftmK3odi8TGVix-3hTD5aSviGg40jCPMSJ8KmAtAXAPg9v6Y0ZKgG8YhbbnlCsIMy1OKmFa3vWIvehgjvb6PZ-znxdcf59_K6--XV-dfrkuU2qTSCHAVAm-VqYQS0pBWTjd9TgW0DqGmRve1kqB4nbUanWy57vq6QQLq5Rm7uuM6D7d2CcMEYbMeBvv3wYcbCyENOJLFTsrW9A4q06lctKJGMK41vDc1EGXW5zvWsnYTOaQ5BRifQJ925mFvb_zBaqmySSoD3t0Dgv-15lPbaYhIxwOSX6Otsk15jUY0_6QYfIyB-scxgtuj9_bB-yx9-_-3HoUPZss_68-umQ</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2165051717</pqid></control><display><type>article</type><title>Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study</title><source>Alma/SFX Local Collection</source><creator>Atkin, Wendy ; Cross, Amanda J ; Kralj-Hans, Ines ; MacRae, Eilidh ; Piggott, Carolyn ; Pearson, Sheena ; Wooldrage, Kate ; Brown, Jeremy ; Lucas, Fiona ; Prendergast, Aaron ; Marchevsky, Natalie ; Patel, Bhavita ; Pack, Kevin ; Howe, Rosemary ; Skrobanski, Hanna ; Kerrison, Robert ; Swart, Nicholas ; Snowball, Julia ; Duffy, Stephen W ; Morris, Stephen ; von Wagner, Christian ; Halloran, Stephen</creator><creatorcontrib>Atkin, Wendy ; Cross, Amanda J ; Kralj-Hans, Ines ; MacRae, Eilidh ; Piggott, Carolyn ; Pearson, Sheena ; Wooldrage, Kate ; Brown, Jeremy ; Lucas, Fiona ; Prendergast, Aaron ; Marchevsky, Natalie ; Patel, Bhavita ; Pack, Kevin ; Howe, Rosemary ; Skrobanski, Hanna ; Kerrison, Robert ; Swart, Nicholas ; Snowball, Julia ; Duffy, Stephen W ; Morris, Stephen ; von Wagner, Christian ; Halloran, Stephen</creatorcontrib><description>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.
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).
Diagnostic accuracy study with health psychology assessment and economic evaluation.
Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England.
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.
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.
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.
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.
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.
Evaluate the impact of ACN missed by FITs on quality-adjusted life-years.
Current Controlled Trials ISRCTN18040196.
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.</description><identifier>ISSN: 1366-5278</identifier><identifier>EISSN: 2046-4924</identifier><identifier>DOI: 10.3310/hta23010</identifier><identifier>PMID: 30618357</identifier><language>eng</language><publisher>England: NIHR Journals Library</publisher><subject>Aged ; Colonoscopy - economics ; Colonoscopy - methods ; Colorectal Neoplasms - diagnosis ; Cost-Benefit Analysis ; Early Detection of Cancer - economics ; Early Detection of Cancer - methods ; Early Detection of Cancer - psychology ; Early Detection of Cancer - standards ; Female ; Health Knowledge, Attitudes, Practice ; Hemoglobins - analysis ; Humans ; Immunochemistry - economics ; Immunochemistry - methods ; Male ; Middle Aged ; Occult Blood ; Patient Preference ; Sensitivity and Specificity ; United Kingdom</subject><ispartof>Health technology assessment (Winchester, England), 2019-01, Vol.23 (1), p.1-84</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c368t-81ad2ca0948214138e64d67f4131a9dca5e76f543a4051ad6cd3906bf57ceaef3</citedby><cites>FETCH-LOGICAL-c368t-81ad2ca0948214138e64d67f4131a9dca5e76f543a4051ad6cd3906bf57ceaef3</cites><orcidid>0000-0002-6214-8831 ; 0000-0002-7971-0691 ; 0000-0002-9668-6689 ; 0000-0001-8209-3113 ; 0000-0002-8900-749X ; 0000-0001-9171-7514 ; 0000-0002-9765-6182 ; 0000-0001-7583-5764 ; 0000-0003-4901-7922 ; 0000-0002-8454-9046 ; 0000-0003-3289-2018 ; 0000-0003-1055-0033 ; 0000-0001-7401-6281 ; 0000-0001-9073-9658 ; 0000-0002-0893-2377 ; 0000-0002-9941-7759 ; 0000-0001-9283-0666 ; 0000-0002-6961-0101 ; 0000-0002-6343-6202 ; 0000-0002-5828-3563 ; 0000-0003-0868-8914 ; 0000-0001-8343-766X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,786,790,891,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30618357$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Atkin, Wendy</creatorcontrib><creatorcontrib>Cross, Amanda J</creatorcontrib><creatorcontrib>Kralj-Hans, Ines</creatorcontrib><creatorcontrib>MacRae, Eilidh</creatorcontrib><creatorcontrib>Piggott, Carolyn</creatorcontrib><creatorcontrib>Pearson, Sheena</creatorcontrib><creatorcontrib>Wooldrage, Kate</creatorcontrib><creatorcontrib>Brown, Jeremy</creatorcontrib><creatorcontrib>Lucas, Fiona</creatorcontrib><creatorcontrib>Prendergast, Aaron</creatorcontrib><creatorcontrib>Marchevsky, Natalie</creatorcontrib><creatorcontrib>Patel, Bhavita</creatorcontrib><creatorcontrib>Pack, Kevin</creatorcontrib><creatorcontrib>Howe, Rosemary</creatorcontrib><creatorcontrib>Skrobanski, Hanna</creatorcontrib><creatorcontrib>Kerrison, Robert</creatorcontrib><creatorcontrib>Swart, Nicholas</creatorcontrib><creatorcontrib>Snowball, Julia</creatorcontrib><creatorcontrib>Duffy, Stephen W</creatorcontrib><creatorcontrib>Morris, Stephen</creatorcontrib><creatorcontrib>von Wagner, Christian</creatorcontrib><creatorcontrib>Halloran, Stephen</creatorcontrib><title>Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study</title><title>Health technology assessment (Winchester, England)</title><addtitle>Health Technol Assess</addtitle><description>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.
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).
Diagnostic accuracy study with health psychology assessment and economic evaluation.
Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England.
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.
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.
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.
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.
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.
Evaluate the impact of ACN missed by FITs on quality-adjusted life-years.
Current Controlled Trials ISRCTN18040196.
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.</description><subject>Aged</subject><subject>Colonoscopy - economics</subject><subject>Colonoscopy - methods</subject><subject>Colorectal Neoplasms - diagnosis</subject><subject>Cost-Benefit Analysis</subject><subject>Early Detection of Cancer - economics</subject><subject>Early Detection of Cancer - methods</subject><subject>Early Detection of Cancer - psychology</subject><subject>Early Detection of Cancer - standards</subject><subject>Female</subject><subject>Health Knowledge, Attitudes, Practice</subject><subject>Hemoglobins - analysis</subject><subject>Humans</subject><subject>Immunochemistry - economics</subject><subject>Immunochemistry - methods</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Occult Blood</subject><subject>Patient Preference</subject><subject>Sensitivity and Specificity</subject><subject>United Kingdom</subject><issn>1366-5278</issn><issn>2046-4924</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpVkc1u1TAQhS0EorcFiSdAWbIgYMeO47BAQhUtlSqxgbU1GU96UyVxsJ0rZcWr40t_oKuZ8Rx945nD2BvBP0gp-Md9gkpywZ-xXcWVLlVbqedsJ6TWZV015oSdxnjLuRK6Fi_ZieRaGFk3O_b7AghhLIZpWmePe5qGY5koplgcKMQ1FuhHP_uIftmK3odi8TGVix-3hTD5aSviGg40jCPMSJ8KmAtAXAPg9v6Y0ZKgG8YhbbnlCsIMy1OKmFa3vWIvehgjvb6PZ-znxdcf59_K6--XV-dfrkuU2qTSCHAVAm-VqYQS0pBWTjd9TgW0DqGmRve1kqB4nbUanWy57vq6QQLq5Rm7uuM6D7d2CcMEYbMeBvv3wYcbCyENOJLFTsrW9A4q06lctKJGMK41vDc1EGXW5zvWsnYTOaQ5BRifQJ925mFvb_zBaqmySSoD3t0Dgv-15lPbaYhIxwOSX6Otsk15jUY0_6QYfIyB-scxgtuj9_bB-yx9-_-3HoUPZss_68-umQ</recordid><startdate>201901</startdate><enddate>201901</enddate><creator>Atkin, Wendy</creator><creator>Cross, Amanda J</creator><creator>Kralj-Hans, Ines</creator><creator>MacRae, Eilidh</creator><creator>Piggott, Carolyn</creator><creator>Pearson, Sheena</creator><creator>Wooldrage, Kate</creator><creator>Brown, Jeremy</creator><creator>Lucas, Fiona</creator><creator>Prendergast, Aaron</creator><creator>Marchevsky, Natalie</creator><creator>Patel, Bhavita</creator><creator>Pack, Kevin</creator><creator>Howe, Rosemary</creator><creator>Skrobanski, Hanna</creator><creator>Kerrison, Robert</creator><creator>Swart, Nicholas</creator><creator>Snowball, Julia</creator><creator>Duffy, Stephen W</creator><creator>Morris, Stephen</creator><creator>von Wagner, Christian</creator><creator>Halloran, Stephen</creator><general>NIHR Journals Library</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-6214-8831</orcidid><orcidid>https://orcid.org/0000-0002-7971-0691</orcidid><orcidid>https://orcid.org/0000-0002-9668-6689</orcidid><orcidid>https://orcid.org/0000-0001-8209-3113</orcidid><orcidid>https://orcid.org/0000-0002-8900-749X</orcidid><orcidid>https://orcid.org/0000-0001-9171-7514</orcidid><orcidid>https://orcid.org/0000-0002-9765-6182</orcidid><orcidid>https://orcid.org/0000-0001-7583-5764</orcidid><orcidid>https://orcid.org/0000-0003-4901-7922</orcidid><orcidid>https://orcid.org/0000-0002-8454-9046</orcidid><orcidid>https://orcid.org/0000-0003-3289-2018</orcidid><orcidid>https://orcid.org/0000-0003-1055-0033</orcidid><orcidid>https://orcid.org/0000-0001-7401-6281</orcidid><orcidid>https://orcid.org/0000-0001-9073-9658</orcidid><orcidid>https://orcid.org/0000-0002-0893-2377</orcidid><orcidid>https://orcid.org/0000-0002-9941-7759</orcidid><orcidid>https://orcid.org/0000-0001-9283-0666</orcidid><orcidid>https://orcid.org/0000-0002-6961-0101</orcidid><orcidid>https://orcid.org/0000-0002-6343-6202</orcidid><orcidid>https://orcid.org/0000-0002-5828-3563</orcidid><orcidid>https://orcid.org/0000-0003-0868-8914</orcidid><orcidid>https://orcid.org/0000-0001-8343-766X</orcidid></search><sort><creationdate>201901</creationdate><title>Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study</title><author>Atkin, Wendy ; Cross, Amanda J ; Kralj-Hans, Ines ; MacRae, Eilidh ; Piggott, Carolyn ; Pearson, Sheena ; Wooldrage, Kate ; Brown, Jeremy ; Lucas, Fiona ; Prendergast, Aaron ; Marchevsky, Natalie ; Patel, Bhavita ; Pack, Kevin ; Howe, Rosemary ; Skrobanski, Hanna ; Kerrison, Robert ; Swart, Nicholas ; Snowball, Julia ; Duffy, Stephen W ; Morris, Stephen ; von Wagner, Christian ; Halloran, Stephen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c368t-81ad2ca0948214138e64d67f4131a9dca5e76f543a4051ad6cd3906bf57ceaef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Colonoscopy - economics</topic><topic>Colonoscopy - methods</topic><topic>Colorectal Neoplasms - diagnosis</topic><topic>Cost-Benefit Analysis</topic><topic>Early Detection of Cancer - economics</topic><topic>Early Detection of Cancer - methods</topic><topic>Early Detection of Cancer - psychology</topic><topic>Early Detection of Cancer - standards</topic><topic>Female</topic><topic>Health Knowledge, Attitudes, Practice</topic><topic>Hemoglobins - analysis</topic><topic>Humans</topic><topic>Immunochemistry - economics</topic><topic>Immunochemistry - methods</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Occult Blood</topic><topic>Patient Preference</topic><topic>Sensitivity and Specificity</topic><topic>United Kingdom</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Atkin, Wendy</creatorcontrib><creatorcontrib>Cross, Amanda J</creatorcontrib><creatorcontrib>Kralj-Hans, Ines</creatorcontrib><creatorcontrib>MacRae, Eilidh</creatorcontrib><creatorcontrib>Piggott, Carolyn</creatorcontrib><creatorcontrib>Pearson, Sheena</creatorcontrib><creatorcontrib>Wooldrage, Kate</creatorcontrib><creatorcontrib>Brown, Jeremy</creatorcontrib><creatorcontrib>Lucas, Fiona</creatorcontrib><creatorcontrib>Prendergast, Aaron</creatorcontrib><creatorcontrib>Marchevsky, Natalie</creatorcontrib><creatorcontrib>Patel, Bhavita</creatorcontrib><creatorcontrib>Pack, Kevin</creatorcontrib><creatorcontrib>Howe, Rosemary</creatorcontrib><creatorcontrib>Skrobanski, Hanna</creatorcontrib><creatorcontrib>Kerrison, Robert</creatorcontrib><creatorcontrib>Swart, Nicholas</creatorcontrib><creatorcontrib>Snowball, Julia</creatorcontrib><creatorcontrib>Duffy, Stephen W</creatorcontrib><creatorcontrib>Morris, Stephen</creatorcontrib><creatorcontrib>von Wagner, Christian</creatorcontrib><creatorcontrib>Halloran, Stephen</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Open Access: DOAJ - Directory of Open Access Journals</collection><jtitle>Health technology assessment (Winchester, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Atkin, Wendy</au><au>Cross, Amanda J</au><au>Kralj-Hans, Ines</au><au>MacRae, Eilidh</au><au>Piggott, Carolyn</au><au>Pearson, Sheena</au><au>Wooldrage, Kate</au><au>Brown, Jeremy</au><au>Lucas, Fiona</au><au>Prendergast, Aaron</au><au>Marchevsky, Natalie</au><au>Patel, Bhavita</au><au>Pack, Kevin</au><au>Howe, Rosemary</au><au>Skrobanski, Hanna</au><au>Kerrison, Robert</au><au>Swart, Nicholas</au><au>Snowball, Julia</au><au>Duffy, Stephen W</au><au>Morris, Stephen</au><au>von Wagner, Christian</au><au>Halloran, Stephen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study</atitle><jtitle>Health technology assessment (Winchester, England)</jtitle><addtitle>Health Technol Assess</addtitle><date>2019-01</date><risdate>2019</risdate><volume>23</volume><issue>1</issue><spage>1</spage><epage>84</epage><pages>1-84</pages><issn>1366-5278</issn><eissn>2046-4924</eissn><notes>SourceType-Other Sources-1</notes><notes>ObjectType-Article-2</notes><notes>content type line 63</notes><notes>ObjectType-Feature-1</notes><abstract>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.
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).
Diagnostic accuracy study with health psychology assessment and economic evaluation.
Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England.
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.
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.
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.
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.
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.
Evaluate the impact of ACN missed by FITs on quality-adjusted life-years.
Current Controlled Trials ISRCTN18040196.
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.</abstract><cop>England</cop><pub>NIHR Journals Library</pub><pmid>30618357</pmid><doi>10.3310/hta23010</doi><tpages>84</tpages><orcidid>https://orcid.org/0000-0002-6214-8831</orcidid><orcidid>https://orcid.org/0000-0002-7971-0691</orcidid><orcidid>https://orcid.org/0000-0002-9668-6689</orcidid><orcidid>https://orcid.org/0000-0001-8209-3113</orcidid><orcidid>https://orcid.org/0000-0002-8900-749X</orcidid><orcidid>https://orcid.org/0000-0001-9171-7514</orcidid><orcidid>https://orcid.org/0000-0002-9765-6182</orcidid><orcidid>https://orcid.org/0000-0001-7583-5764</orcidid><orcidid>https://orcid.org/0000-0003-4901-7922</orcidid><orcidid>https://orcid.org/0000-0002-8454-9046</orcidid><orcidid>https://orcid.org/0000-0003-3289-2018</orcidid><orcidid>https://orcid.org/0000-0003-1055-0033</orcidid><orcidid>https://orcid.org/0000-0001-7401-6281</orcidid><orcidid>https://orcid.org/0000-0001-9073-9658</orcidid><orcidid>https://orcid.org/0000-0002-0893-2377</orcidid><orcidid>https://orcid.org/0000-0002-9941-7759</orcidid><orcidid>https://orcid.org/0000-0001-9283-0666</orcidid><orcidid>https://orcid.org/0000-0002-6961-0101</orcidid><orcidid>https://orcid.org/0000-0002-6343-6202</orcidid><orcidid>https://orcid.org/0000-0002-5828-3563</orcidid><orcidid>https://orcid.org/0000-0003-0868-8914</orcidid><orcidid>https://orcid.org/0000-0001-8343-766X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1366-5278 |
| ispartof | Health technology assessment (Winchester, England), 2019-01, Vol.23 (1), p.1-84 |
| issn | 1366-5278 2046-4924 |
| language | eng |
| recordid | cdi_doaj_primary_oai_doaj_org_article_cb3398fda28b4cb3915ca8d980f85aee |
| source | Alma/SFX Local Collection |
| subjects | Aged Colonoscopy - economics Colonoscopy - methods Colorectal Neoplasms - diagnosis Cost-Benefit Analysis Early Detection of Cancer - economics Early Detection of Cancer - methods Early Detection of Cancer - psychology Early Detection of Cancer - standards Female Health Knowledge, Attitudes, Practice Hemoglobins - analysis Humans Immunochemistry - economics Immunochemistry - methods Male Middle Aged Occult Blood Patient Preference Sensitivity and Specificity United Kingdom |
| title | Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-09-21T03%3A16%3A51IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Faecal%20immunochemical%20tests%20versus%20colonoscopy%20for%20post-polypectomy%20surveillance:%20an%20accuracy,%20acceptability%20and%20economic%20study&rft.jtitle=Health%20technology%20assessment%20(Winchester,%20England)&rft.au=Atkin,%20Wendy&rft.date=2019-01&rft.volume=23&rft.issue=1&rft.spage=1&rft.epage=84&rft.pages=1-84&rft.issn=1366-5278&rft.eissn=2046-4924&rft_id=info:doi/10.3310/hta23010&rft_dat=%3Cproquest_doaj_%3E2165051717%3C/proquest_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c368t-81ad2ca0948214138e64d67f4131a9dca5e76f543a4051ad6cd3906bf57ceaef3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2165051717&rft_id=info:pmid/30618357&rfr_iscdi=true |