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Mansvelders MSE, Kleif J, Andersen MR, Karstensen JG, Therkildsen C. Use of Fecal Immunochemical Testing for Risk Stratification of Patients With Symptoms of Colorectal Cancer Referred for Diagnostic Colonoscopy. Gastroenterology 2025; 168:795-797.e2. [PMID: 39672519 DOI: 10.1053/j.gastro.2024.11.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/21/2024] [Revised: 10/13/2024] [Accepted: 11/15/2024] [Indexed: 12/15/2024]
Affiliation(s)
| | - Jakob Kleif
- Gastro Unit, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Surgery, Copenhagen University Hospital-North Zealand, Hilleroed, Denmark
| | - Malene Rohr Andersen
- Department of Clinical Biochemistry, Copenhagen University Hospital-Herlev and Gentofte, Herlev, Denmark
| | - John Gásdal Karstensen
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Danish Polyposis Register, Gastro Unit, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark
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Martinez-Gutierrez J, Soto MG, Rioseco A, Bienzobas C, Fowler M, Ulloa G, Soto M, Emery JD, Puschel K. Are we ready? assessing effectiveness and implementation of cancer control strategies in primary care: a comprehensive review of systematic reviews. Fam Pract 2025; 42:cmae078. [PMID: 39918006 PMCID: PMC11803426 DOI: 10.1093/fampra/cmae078] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/11/2025] Open
Abstract
BACKGROUND Cancer is a major global cause of death, and primary care is crucial for cancer prevention and early detection. However, there is conflicting information on the effectiveness, implementation, and sustainability of cancer control interventions in primary care. OBJECTIVE This study aimed to summarize the evidence for cancer control in primary care, focussing on identifying relevant factors for implementation and sustainability. STUDY SETTING AND DESIGN We conducted a narrative, mixed-methods review of systematic reviews, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Four databases were screened, and two independent reviewers selected studies reporting on cancer prevention, screening, or early detection in primary or community settings. We analysed findings using the extended Reach-Effectiveness-Adopt-Implementation-Maintenance (RE-AIM) Framework. PRINCIPAL FINDINGS From the 37 reviews that met the inclusion criteria, 6 focussed on primary prevention, 23 on screening, and 12 on early detection. Most reviews (78%) addressed intervention effectiveness, such as HPV vaccination, tobacco cessation, and cervical, breast, and colorectal screening. One-third of the reviews mentioned adoption and implementation factors, including barriers and facilitators to the implementation of cancer screening programs. Only one review addressed maintenance and sustainability factors, exploring continuous resources and funding strategies. CONCLUSION While numerous interventions are effective for cancer prevention and detection in primary care, literature on implementation and sustainability strategies is lacking. Focusing on continuous resources and funding for cancer strategies in primary care may aid sustainability. Future research should prioritize reporting on implementation and sustainability factors to enhance cancer prevention and control in primary care settings.
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Affiliation(s)
- Javiera Martinez-Gutierrez
- Department of Family and Community Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Vicuña Mackenna 4860, Macul, Santiago, Región Metropolitana, 7820436, Chile
- Centre for Cancer Research and Department of General Practice, University of Melbourne, 780 Elizabeth St, Melbourne Victoria 3010, Australia
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
| | - María Gabriela Soto
- Department of Family and Community Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Vicuña Mackenna 4860, Macul, Santiago, Región Metropolitana, 7820436, Chile
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
| | - Andrea Rioseco
- Department of Family and Community Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Vicuña Mackenna 4860, Macul, Santiago, Región Metropolitana, 7820436, Chile
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
| | - Catalina Bienzobas
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
- School of Public Health, Pontificia Universidad Católica de Chile, Avda. Libertador Bernando O’Higgins 340, Santiago, 3580000Chile
| | - Madeline Fowler
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
- School of Public Health, Pontificia Universidad Católica de Chile, Avda. Libertador Bernando O’Higgins 340, Santiago, 3580000Chile
| | - Gonzalo Ulloa
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
- Department of Hematology and Oncology, School of Medicine, Pontificia Universidad Católica de Chile, Avda. Libertador Bernando O’Higgins 340, Santiago, 3580000Chile
| | - Mauricio Soto
- Department of Family and Community Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Vicuña Mackenna 4860, Macul, Santiago, Región Metropolitana, 7820436, Chile
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
| | - Jon David Emery
- Centre for Cancer Research and Department of General Practice, University of Melbourne, 780 Elizabeth St, Melbourne Victoria 3010, Australia
- The Primary Care Unit, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 0SR, United Kingdom
| | - Klaus Puschel
- Department of Family and Community Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Vicuña Mackenna 4860, Macul, Santiago, Región Metropolitana, 7820436, Chile
- Center for Cancer Prevention and Control (CECAN), ANID FONDAP ID 152220002, Avda. Libertador Bernando O'Higgins 340, Santiago, 3580000 Chile
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Martinez-Gutierrez J, De Mendonca L, Ly P, Lee A, Hunter B, Manski-Nankervis JA, Chima S, Daly D, Fishman G, Lim FS, Wang B, Nelson C, Nicholson B, Emery J. A scoping review of unexpected weight loss and cancer: risk, guidelines, and recommendations for follow-up in primary care. BJGP Open 2024; 8:BJGPO.2024.0025. [PMID: 39054298 PMCID: PMC11687243 DOI: 10.3399/bjgpo.2024.0025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2024] [Revised: 05/15/2024] [Accepted: 06/27/2024] [Indexed: 07/27/2024] Open
Abstract
BACKGROUND Cancer diagnoses often begin with consultations with GPs, but the non-specific nature of symptoms can lead to delayed diagnosis. Unexpected weight loss (UWL) is a common non-specific symptom linked to undiagnosed cancer, yet guidelines for its diagnostic assessment in general practice lack consistency. AIM To synthesise evidence on the association between UWL and cancer diagnosis, and to review clinical guidelines and recommendations for assessing patients with UWL. DESIGN & SETTING Systematic search and analysis of studies conducted in primary care. METHOD Four databases were searched for peer-reviewed literature from 2012 to 2023. Two reviewers conducted all the steps. A narrative review was conducted detailing the evidence for UWL as a risk factor for undiagnosed cancer, existing clinical guidance, and recommended diagnostic approach. RESULTS We included 25 studies involving 916 092 patients; 92% provided strong evidence of an association between UWL and undiagnosed cancer. The National Institute for Health Care and Excellence (NICE) Cancer Guideline in the UK was frequently cited. General suggestions encompassed regular weight monitoring, family history, risk factor evaluation, additional signs and symptoms, and a comprehensive physical examination. Commonly recommended pathology tests included C-reactive protein (CRP), complete blood count, alkaline phosphatase, and thyroid-stimulating hormone. Immunochemical faecal occult blood test, abdominal ultrasound, and chest X-ray were also prevalent. One large cohort study provided age, sex, and differential diagnosis-specific recommendations. CONCLUSION This evidence review informs recommendations for investigating patients with UWL and will contribute to a computer decision support tool implementation in primary care, enhance UWL assessment, and potentially facilitate earlier cancer diagnosis.
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Affiliation(s)
- Javiera Martinez-Gutierrez
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
- Centre for Cancer Research, University of Melbourne, Melbourne, Australia
- Department of Family Medicine, School of Medicine. Pontificia Universidad Católica de Chile, Santiago, Chile
- Data Connect, Victorian Comprehensive Cancer Centre, Melbourne, Australia
| | - Lucas De Mendonca
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
| | - Philip Ly
- The Daffodil Centre, The University of Sydney, a joint venture with Cancer Council NSW, Sydney, Australia
| | - Alex Lee
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
- Centre for Cancer Research, University of Melbourne, Melbourne, Australia
- Data Connect, Victorian Comprehensive Cancer Centre, Melbourne, Australia
| | - Barbara Hunter
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
| | - Jo-Anne Manski-Nankervis
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
- Primary Care and Family Medicine Department., Lee Kong Chian School of Medicine. Nanyang Technological University., Singapore, Singapore
| | - Sophie Chima
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
| | - Deborah Daly
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
- Primary Care Collaborative Cancer Clinical Trials Group (PC4), Melbourne, Australia
| | - George Fishman
- Primary Care Collaborative Cancer Clinical Trials Group (PC4), Melbourne, Australia
| | - Fong Seng Lim
- Singapore Primary Care Cancer Network (SPriNT), Singapore, Singapore
- Department of Family Medicine, National University Health System, Singapore, Singapore
| | - Benny Wang
- Singapore Primary Care Cancer Network (SPriNT), Singapore, Singapore
| | - Craig Nelson
- Western Health Chronic Disease Alliance, Western Health Melbourne, Victoria, Australia
- Department of Medicine - Western Health, The University of Melbourne, Melbourne, Australia
| | - Brian Nicholson
- Nuffield Department of Primary Care Health Sciences. University of Oxford, Oxford, UK
| | - Jon Emery
- Department of General Practice and Primary Care, The University of Melbourne, Melbourne, Australia
- Centre for Cancer Research, University of Melbourne, Melbourne, Australia
- Data Connect, Victorian Comprehensive Cancer Centre, Melbourne, Australia
- The Primary Care Unit, University of Cambridge, Cambridge, UK
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Pham J, Laven-Law G, Symonds EL, Wassie MM, Cock C, Winter JM. Faecal immunochemical tests can improve colonoscopy triage in patients with iron deficiency: A systematic review and meta-analysis. Crit Rev Oncol Hematol 2024; 201:104439. [PMID: 38977142 DOI: 10.1016/j.critrevonc.2024.104439] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2024] [Revised: 06/30/2024] [Accepted: 07/03/2024] [Indexed: 07/10/2024] Open
Abstract
BACKGROUND Use of the faecal immunochemical test (FIT) to triage patients with iron deficiency (ID) for colonoscopy due to suspected colorectal cancer (CRC) may improve distribution of colonoscopic resources. We reviewed the diagnostic performance of FIT for detecting advanced colorectal neoplasia, including CRC and advanced pre-cancerous neoplasia (APCN), in patients with ID, with or without anaemia. METHODS We performed a systematic review of three databases for studies comprising of patients with ID, with or without anaemia, completing a quantitative FIT within six months prior to colonoscopy, where test performance was compared against the reference standard colonoscopy. Random effects meta-analyses determined the diagnostic performance of FIT for advanced colorectal neoplasia. RESULTS Nine studies were included on a total of n=1761 patients with ID, reporting FIT positivity thresholds between 4-150 µg haemoglobin/g faeces. Only one study included a non-anaemic ID (NAID) cohort. FIT detected CRC and APCN in ID patients with 90.7 % and 49.3 % sensitivity, and 81.0 % and 82.4 % specificity, respectively. FIT was 88.0 % sensitive and 83.4 % specific for CRC in patients with ID anaemia at a FIT positivity threshold of 10 µg haemoglobin/g faeces. CONCLUSIONS FIT shows high sensitivity for advanced colorectal neoplasia and may be used to triage those with ID anaemia where colonoscopic resources are limited, enabling those at higher risk of CRC to be prioritised for colonoscopy. There is a need for further research investigating the diagnostic performance of FIT in NAID patients.
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Affiliation(s)
- Jennifer Pham
- Department of Medicine, College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia
| | - Geraldine Laven-Law
- Flinders University, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Adelaide, SA 5042, Australia.
| | - Erin L Symonds
- Flinders University, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Adelaide, SA 5042, Australia; Department of Gastroenterology and Hepatology, Flinders Medical Centre, Southern Adelaide Local Health Network, Adelaide, SA, Australia
| | - Molla M Wassie
- Flinders University, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Adelaide, SA 5042, Australia
| | - Charles Cock
- Flinders University, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Adelaide, SA 5042, Australia; Department of Gastroenterology and Hepatology, Flinders Medical Centre, Southern Adelaide Local Health Network, Adelaide, SA, Australia
| | - Jean M Winter
- Flinders University, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Adelaide, SA 5042, Australia
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Wen CP, Tsai MK, Lee JH, Chiou HY, Wen C, Chu TWD, Chen CH. Uncovering a dose-response relationship between positive fecal immunochemical test (FIT) and all-cause, cardiovascular and cancer-related mortality. Eur J Intern Med 2024; 120:69-79. [PMID: 37777425 DOI: 10.1016/j.ejim.2023.09.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/28/2023] [Revised: 09/17/2023] [Accepted: 09/22/2023] [Indexed: 10/02/2023]
Abstract
BACKGROUND Fecal immunochemical test (FIT) is for colorectal cancer (CRC) screening. Its association with non-CRC mortality has been overlooked. Given the quantitative FIT values, its dose-response relationships with different causes of deaths and years of life shortened were assessed. METHODS This retrospective study included 546,214 adults aged ≥ 20 who attended a health surveillance program from 1994 to 2017 and were followed up until the end of 2020. FIT ≥ 20 μg Hb/g was defined as positive. The Cox model was used to assess adjusted hazard ratios (aHR). RESULTS Positive FIT was associated with increased all-cause mortality (aHR: 1.34, 95 % CI: 1.25-1.44) and all-cancer mortality (aHR: 1.71, 95 % CI: 1.55-1.89), with a reduction of life expectancy by 4 years. The association remained even with CRC excluded. With each 10 μg Hb/g increase in FIT above 20 μg Hb/g, life expectancy was reduced by one year, and mortality increased by 4 %. About 18.6 % of deaths with positive FIT were attributed to cardiovascular disease (CVD), followed by CRC (13.5 %) and upper gastrointestinal (GI) cancers (4.5 %). The all-cause mortality rate after excluding CRC for positive FIT was 3.56/1,000 person-year, comparable to the all-cause mortality rate of 3.69/1,000 person-year for hypertension. CONCLUSION Positive FIT was associated with increased mortality in a dose-response manner and shortened life expectancy by 4 years, an overlooked risk comparable to hypertension, even with CRC excluded. After a negative colonoscopy, subjects with positive FIT should undergo a workup on CVD risk factors and look for other upper GI cancers.
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Affiliation(s)
- Chi Pang Wen
- Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan; China Medical University, Taichung, Taiwan
| | | | - June Han Lee
- Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan
| | - Hung Yi Chiou
- Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan
| | - Christopher Wen
- Long Beach VAMC Hospital, University of Irvine, Irvine, CA, USA
| | | | - Chien Hua Chen
- College of Medicine, National Chung Hsing University, Taichung, Taiwan; Digestive Disease Center, Changhua Show-Chwan Memorial Hospital, Changhua, Taiwan; Department of Food Science and Technology, Hungkuang University, Taichung, Taiwan.
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Pham J, Laven-Law G, Winter JM, Wassie MM, Cock C, Symonds EL. The Diagnostic Accuracy of a Fecal Immunochemical Test in Detecting Colorectal Cancer and Advanced Precancerous Colorectal Neoplasia in Patients with Iron Deficiency: A Protocol for Systematic Review and Meta-Analysis. Gastroenterol Res Pract 2023; 2023:5982580. [PMID: 38107205 PMCID: PMC10723928 DOI: 10.1155/2023/5982580] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2023] [Revised: 11/10/2023] [Accepted: 11/25/2023] [Indexed: 12/19/2023] Open
Abstract
Background. Iron deficiency (ID) is a common micronutrient deficiency and the leading cause of anemia worldwide. ID can be caused by chronic occult blood loss from colorectal neoplasia including colorectal cancer (CRC) and advanced precancerous colorectal lesions. Current guidelines recommend colonoscopy in both men and postmenopausal women presenting with ID anemia (IDA). However, there is controversy on the investigation of patients presenting with a lower risk of CRC including younger women with ID and those with nonanemic ID (NAID). There is a need for a triaging tool to identify which ID patients may benefit from colonoscopy. The fecal immunochemical test (FIT) is sensitive for CRC screening in an asymptomatic population, but its role in ID patients is unclear. The aim of this study is to conduct a systematic review to determine the diagnostic accuracy of FIT for detecting CRC and advanced precancerous neoplasia in individuals presenting with ID with or without anemia. Methods and Analysis. This protocol conforms with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. A comprehensive search of the MEDLINE, Embase, and Web of Science databases will be undertaken for studies published after 2010 which involve patients with ID, who completed a FIT in the 6 months prior to colonoscopy, with FIT sensitivity and specificity calculated against the reference standard colonoscopy. The search will be limited to studies conducted after 2010 to reduce variability in colonoscopy quality. Risk of bias assessment will be conducted using the Quality Assessment of Diagnostic Accuracy Studies version 2. FIT sensitivity and specificity will be the primary measure of diagnostic accuracy, and data will be analysed using a random effects meta-analysis. Discussion. This review and meta-analysis will be the first to systematically explore the value of the FIT as a triaging tool for patients with ID. This trial is registered with CRD42022367162.
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Affiliation(s)
- Jennifer Pham
- Department of Medicine, College of Medicine and Public Health, Flinders University, Bedford Park, SA 5042, Australia
| | - Geraldine Laven-Law
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA 5042, Australia
| | - Jean M. Winter
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA 5042, Australia
| | - Molla M. Wassie
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA 5042, Australia
| | - Charles Cock
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA 5042, Australia
- Department of Gastroenterology, Flinders Medical Centre, Bedford Park, SA 5042, Australia
| | - Erin L. Symonds
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA 5042, Australia
- Department of Gastroenterology, Flinders Medical Centre, Bedford Park, SA 5042, Australia
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Rees CJ, Hamilton W. BSG guidelines on faecal immunochemical testing: are they 'FIT' for purpose? Gut 2023; 72:1805-1806. [PMID: 36113978 DOI: 10.1136/gutjnl-2022-328201] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2022] [Accepted: 09/04/2022] [Indexed: 12/08/2022]
Affiliation(s)
- Colin J Rees
- Gastroenterology, Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK
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Lanas Á, Balaguer F, Sánchez‐Luengo M, Hijos‐Mallada G, Hernández‐Mesa G, Piñero M, Castillo J, Ocaña T, Cubiella J, Crespo A, Iglesias Á, Medeiros I, Cacho G, Jover‐Martínez R, Alustiza M, Diaz‐Tasende J, Poves C, Macedo G, Quintero E, The Advantage study group. Fecal occult blood and calprotectin testing to prioritize primary care patients for colonoscopy referral: The advantage study. United European Gastroenterol J 2023; 11:692-699. [PMID: 37614054 PMCID: PMC10493338 DOI: 10.1002/ueg2.12446] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/24/2023] [Accepted: 06/26/2023] [Indexed: 08/25/2023] Open
Abstract
BACKGROUND Colonoscopy is the gold standard for colorectal cancer (CRC) diagnosis and screening, but endoscopy services are usually overburdened. This study aims to investigate the usefulness of fecal hemoglobin (fHb) and calprotectin (FC) for the identification of patients with high probability of CRC who need urgent referral. METHODS In a multicenter prospective study, we enrolled symptomatic patients referred from primary care for colonoscopy. Prior to bowel preparation, fHb and FC quantitative tests were performed. The diagnostic performance was estimated for each biomarker/combination. We built a multivariable predictive model based on logistic regression, translated to a nomogram and a risk calculator to assist clinicians in the decision-making process. RESULTS The study included 1224 patients, of whom 69 (5.6%) had CRC. At the fHb cut-offs of >0 and 10 μg/g, the negative predictive values for CRC were 98.8% (95% confidence interval 97.8%-99.3%) and 98.6% (95%CI 97.7%-99.1%), and the sensitivities were 85.5% (95%CI 75.0%-92.8%) and 79.7% (95%CI 68.3%-88.4%), respectively. When we added the cut-off of 150 μg/g of FC to both fHb thresholds, the sensitivity of fecal tests improved. In the multivariate logistic regression model, the concentration of fHb was an independent predictor for CRC; age and gender were also independently associated with CRC. CONCLUSIONS fHb and FC are useful as part of a triage tool to identify those symptomatic patients with high probability of CRC. This can be easily applied by physicians to prioritize high-risk patients for urgent colonoscopy.
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Affiliation(s)
- Ángel Lanas
- University Clinic Hospital Lozano Blesa. University of Zaragoza. IIS Aragón. CIBERHEDZaragozaSpain
| | - Francesc Balaguer
- Department of GastroenterologyHospital Clínic de BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)University of BarcelonaBarcelonaSpain
| | - Marta Sánchez‐Luengo
- Department of GastroenterologyHospital Clínico Universitario Lozano BlesaZaragozaSpain
| | - Gonzalo Hijos‐Mallada
- Department of GastroenterologyHospital Clínico Universitario Lozano BlesaZaragozaSpain
| | - Goretti Hernández‐Mesa
- Department of GastroenterologyHospital Universitario de CanariasInstituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN)Universidad de La LagunaTenerifeSpain
| | - Melisa Piñero
- Department of GastroenterologyHospital Universitario de CanariasInstituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN)Universidad de La LagunaTenerifeSpain
| | - Joaquin Castillo
- Department of GastroenterologyHospital Clínic de BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)University of BarcelonaBarcelonaSpain
| | - Teresa Ocaña
- Department of GastroenterologyHospital Clínico Universitario Lozano BlesaZaragozaSpain
| | - Joaquín Cubiella
- Department of GastroenterologyComplexo Hospitalario Universitario de OurenseOurenseSpain
| | - Anais Crespo
- Department of GastroenterologyComplexo Hospitalario Universitario de OurenseOurenseSpain
| | - Águeda Iglesias
- Department of GastroenterologyComplexo Hospitalario Universitario de OurenseOurenseSpain
| | - Isabel Medeiros
- Department of GastroenterologyHospital Espirito Santo de ÉvoraÉvoraPortugal
| | - Guillermo Cacho
- Department of GastroenterologyHospital Universitario Fundación AlcorcónMadridSpain
| | | | - Miren Alustiza
- Department of GastroenterologyHospital General Universitario de AlicanteMadridSpain
| | - José Diaz‐Tasende
- Department of GastroenterologyHospital Universitario 12 de OctubreMadridSpain
| | - Carmen Poves
- Department of GastroenterologyHospital Clínico Universitario San CarlosMadridSpain
| | - Guilherme Macedo
- Department of GastroenterologyCentro Hospitalar São JoãoPortoPortugal
| | - Enrique Quintero
- Department of GastroenterologyHospital Universitario de CanariasInstituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN)Universidad de La LagunaTenerifeSpain
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Jones NR, Round T, Nicholson BD. Guidance on faecal immunochemical testing (FIT) to help diagnose colorectal cancer among symptomatic patients in primary care. Br J Gen Pract 2023; 73:283-285. [PMID: 37230774 DOI: 10.3399/bjgp23x733173] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2023] [Revised: 02/28/2023] [Accepted: 04/04/2023] [Indexed: 05/27/2023] Open
Affiliation(s)
| | - Thomas Round
- School of Life Course and Population Sciences, and Cancer Prevention Trials Unit, King's College London
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10
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Maclean W, Whyte MB, Farkas N, Benton SC, Rockall T, Jourdan I. Patient-reported outcome measures show FIT as an acceptable investigation to rule out colorectal cancer in the two-week wait cohort. Ann R Coll Surg Engl 2023; 105:336-341. [PMID: 35639078 PMCID: PMC10066637 DOI: 10.1308/rcsann.2022.0025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/08/2022] [Indexed: 11/22/2022] Open
Abstract
INTRODUCTION Use of faecal immunochemical testing (FIT) for symptomatic patients is increasing. FIT is recommended as a triage tool from primary care to the two-week wait (TWW) suspected cancer pathway, but there is still little known about patient attitudes. AIM The aim of this study was to explore patient opinions of FIT and how it might be applied in the TWW pathway. METHODS A telephone survey was conducted for patients from the TWW pathway who had undergone both conventional colonic investigation and FIT. Five questions explored expectations, attitudes towards results and experience of the investigations using a Likert scale 1-5. Differences in opinion were compared using median and mode scores and visualised using bar charts. RESULTS One hundred and nine TWW patients agreed to answer the five questions. All had taken a stool sample for FIT, 50 underwent colonoscopy, 51 had a CT colonography and 8 underwent flexible sigmoidoscopy. Most patients (85%) scored 5 (completely satisfied) with these conventional colonic investigation methods they underwent for ruling out colorectal cancer (median 5). However, 30% of patients scored 5 (completely satisfied) if using a negative FIT to not require additional colonic investigation. The median score to perform FIT was 5 (very easy) compared with a median of 4 (easy) to undergo the other colonic investigations. CONCLUSIONS Symptomatic patients can perform FIT with little difficulty, and often would have been happy to avoid conventional colonic investigations with a negative result. However, shared decision-making should be employed to identify those who would be dissatisfied with relying on FIT for further investigation decisions.
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Affiliation(s)
- W Maclean
- Royal Surrey NHS Foundation Trust, UK
| | | | - N Farkas
- Royal Surrey NHS Foundation Trust, UK
| | - SC Benton
- Royal Surrey NHS Foundation Trust, UK
| | - T Rockall
- Royal Surrey NHS Foundation Trust, UK
| | - I Jourdan
- Royal Surrey NHS Foundation Trust, UK
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11
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Högberg C, Cronberg O, Thulesius H, Lilja M, Jansson S, Gunnarsson U. Use of faecal immunochemical tests common in patients with suspected colorectal cancer but unrelated to travel distance to secondary care: a population-based study from Swedish primary care. Scand J Prim Health Care 2022; 40:459-465. [PMID: 36380479 PMCID: PMC9848230 DOI: 10.1080/02813432.2022.2144934] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/18/2022] Open
Abstract
BACKGROUND Evidence is increasing for the use of faecal immunochemical tests (FITs) for occult blood as diagnostic tools when colorectal cancer can be suspected. FITs have been used for this purpose in Swedish primary care since around 2005 despite absence of supporting guidelines. To our knowledge, the extent of this use has not been studied. OBJECTIVE To investigate the use of FITs as diagnostic tools, and if the use was related to patient age, sex and travel time from primary care to diagnostic facilities in secondary care. DESIGN Population-based retrospective study using data from electronic health records. SETTING AND SUBJECTS Patients ≥18 years that provided FITs in primary care in five Swedish health care regions during 2015. Driving times from their primary care centres to secondary care were calculated. MAIN OUTCOME MEASURES The proportion of patients that provided FITs was calculated for each region, different age intervals and grouped driving times. RESULTS 18,913 patients provided FITs. The proportion of listed patients in the five regions that provided FITs increased with age: 0.86-1.2% for ages <65 years, 3.6-4.1% for ages 65-79 years and 3.8-6.1% for ages ≥80 years. Differences between the regions were small. There was no overall correlation between the proportion of patients that provided FITs and driving time to secondary care. CONCLUSION FITs were used extensively in Swedish primary care with a higher use in older age groups. There was no tendency towards a higher use of FITs at primary care centres with longer driving times to secondary care.Key PointsEvidence is increasing for the use of faecal immunochemical tests (FITs) as diagnostic tools when colorectal cancer can be suspected. We investigated the use of FITs in Sweden.FITs were used extensively in primary care especially in older age groups.There were small differences in the use of FITs between five studied health care regions.There was no tendency towards a higher use of FITs at primary care centres with longer driving times to diagnostic facilities in secondary care.
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Affiliation(s)
- Cecilia Högberg
- Department of Public Health and Clinical Medicine, Unit of Research, Education and Development Östersund, Umeå University, Umeå, Sweden
- CONTACT Cecilia Högberg Department of Public Health and Clinical Medicine, Unit of Research, Education and Development Östersund, Östersund Hospital, ÖstersundSE-83127, Sweden
| | - Olof Cronberg
- Department of Clinical Sciences, Lund University, Lund, Malmö
- Department of R & D, Region Kronoberg, Växjö, Sweden
| | - Hans Thulesius
- Department of Clinical Sciences, Lund University, Lund, Malmö
- Department of R & D, Region Kronoberg, Växjö, Sweden
- Department of Medicine and Optometry, Linnaeus University, Kalmar, Sweden
| | - Mikael Lilja
- Department of Public Health and Clinical Medicine, Unit of Research, Education and Development Östersund, Umeå University, Umeå, Sweden
| | - Stefan Jansson
- School of Medical Sciences, University Health Care Research Centre, Örebro University, Örebro, Sweden
- Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden
| | - Ulf Gunnarsson
- Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden
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12
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Symonds EL, Winter JM. FIT for colonoscopy: Benefits of the faecal immunochemical test for triaging symptomatic patients. THE LANCET REGIONAL HEALTH. EUROPE 2022; 23:100528. [PMID: 36263006 PMCID: PMC9574769 DOI: 10.1016/j.lanepe.2022.100528] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 06/16/2023]
Affiliation(s)
- Erin L. Symonds
- Gastroenterology Department, Flinders Medical Centre, Bedford Park, South Australia, Australia
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, South Australia, Australia
| | - Jean M. Winter
- Cancer Research, Flinders Health and Medical Research Institute, Flinders University, Bedford Park, South Australia, Australia
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13
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Ball AJ, Aziz I, Parker S, Sargur RB, Aldis J, Kurien M. Fecal Immunochemical Testing in Patients With Low-Risk Symptoms of Colorectal Cancer: A Diagnostic Accuracy Study. J Natl Compr Canc Netw 2022; 20:989-996.e1. [PMID: 36075395 DOI: 10.6004/jnccn.2022.7037] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2022] [Accepted: 05/23/2022] [Indexed: 11/17/2022]
Abstract
BACKGROUND The fecal immunochemical test (FIT) is recommended for triaging primary care patients in England with low-risk symptoms of colorectal cancer (CRC). The evidence underpinning recommendations by the National Institute for Health and Care Excellence had limitations, with a paucity of primary care evidence. This study examines the diagnostic accuracy of FIT in a defined low-risk symptom primary care population. PATIENTS AND METHODS Consecutive symptomatic adult patients referred for a FIT between October and December 2019 were included. Patients were derived from 225 primary care practices in England. Serious colorectal diseases (CRC, high-risk polyps, and inflammatory bowel disease [IBD]) were identified through patient follow-up over 18 months, using both primary and secondary healthcare records. Performance characteristics of FIT are reported according to differing thresholds, including the currently recommended threshold of ≥10 μg hemoglobin per gram of feces (μg/g). RESULTS A total of 3,506 patients were included in the final analysis. Of these, 708 had a positive FIT result (≥10 μg/g). The prevalence of CRC was 1.3%. FIT positivity declined from 20.2% to 5.8% and 4.5% at cutoffs of 10, 80, and 120 μg/g, respectively. The sensitivity of FIT at ≥10 μg/g to detect CRC was 91.1% (95% CI, 77.9%-97.1%); its specificity was 80.7% (95% CI, 79.3%-82.0%); the positive predictive value (PPV) was 5.8% (95% CI, 4.2%-7.8%); and the negative predictive value (NPV) was 99.9% (95% CI, 99.6%-99.95%). The area under the receiver operating characteristic curve was 0.93 (0.91-0.96). PPV and specificity increased, whereas sensitivity and NPV decreased when serious colorectal diseases (CRC, high-risk polyps, and IBD) were combined. Age, sex, socioeconomic deprivation, and anemia did not significantly influence FIT sensitivity on subgroup analysis. CONCLUSIONS Utilization of FIT at a threshold ≥10 μg/g can safely triage patients with low-risk symptoms in primary care, with negative results effectively ruling out CRC.
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Affiliation(s)
- Alex J Ball
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield
| | - Imran Aziz
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield.,Academic Unit of Gastroenterology, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield Medical School, Sheffield, South Yorkshire; and
| | - Sophie Parker
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield
| | - Ravishankar B Sargur
- Department of Allergy and Immunology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
| | - Jonathan Aldis
- Department of Allergy and Immunology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom
| | - Matthew Kurien
- Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield.,Academic Unit of Gastroenterology, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield Medical School, Sheffield, South Yorkshire; and
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14
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Pin-Vieito N, Tejido-Sandoval C, de Vicente-Bielza N, Sánchez-Gómez C, Cubiella J. Faecal immunochemical tests safely enhance rational use of resources during the assessment of suspected symptomatic colorectal cancer in primary care: systematic review and meta-analysis. Gut 2022; 71:950-960. [PMID: 34108236 DOI: 10.1136/gutjnl-2021-324856] [Citation(s) in RCA: 23] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2021] [Accepted: 06/02/2021] [Indexed: 12/14/2022]
Abstract
OBJECTIVE Implementation of faecal immunochemical tests (FIT) as a triage test in primary healthcare may improve the efficiency of referrals without missing cases of colorectal cancer (CRC). We aim to summarise the performance characteristics of FITs for CRC in symptomatic patients presenting to primary healthcare. DESIGN We performed a systematic literature review of Medline and EMBASE databases from May 2018 to November 2020. Previous related systematic searches were also adapted to this aim and completed with reference screening. We identified studies performed on adult patients consulting for abdominal symptoms in primary care which reported data such that the FIT diagnostic performance parameters for CRC could be obtained. Bivariate models were used to synthesise available evidence. Meta-regression analysis was performed to evaluate the causes of heterogeneity. RESULTS Twenty-three studies (69 536 participants) were included (CRC prevalence 0.3%-6.2%). Six studies (n=34 691) assessed FIT as rule in test (threshold of ≥150 µg Hb/g faeces) showing a sensitivity of 64.1% (95% CI 57.8% to 69.9%) and a specificity of 95.0% (95% CI 91.2% to 97.2%). A threshold of 10 µg/g (15 studies; n=48 872) resulted in a sensitivity of 87.2% (95% CI 81.0% to 91.6%) and a specificity of 84.4% (95% CI 79.4% to 88.3%) for CRC. At a 20 µg Hb/g faeces threshold (five studies; n=24 187) less than one additional CRC would be missed per 1000 patients investigated compared with 10 µg Hb/g faeces threshold (CRC prevalence 2%). CONCLUSION FIT is the test of choice to evaluate patients with new-onset lower gastrointestinal symptoms in primary healthcare.
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Affiliation(s)
- Noel Pin-Vieito
- Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.,Instituto de Investigacíon Sanitaria Galicia Sur, Ourense, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense, Spain.,Biochemistry, Genetics and Immunology, Faculty of Biology, University of Vigo, Vigo, Spain
| | | | | | | | - Joaquín Cubiella
- Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain .,Instituto de Investigacíon Sanitaria Galicia Sur, Ourense, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense, Spain
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15
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Withrow DR, Shine B, Oke J, Tamm A, James T, Morris E, Davies J, Harris S, East JE, Nicholson BD. Combining faecal immunochemical testing with blood test results for colorectal cancer risk stratification: a consecutive cohort of 16,604 patients presenting to primary care. BMC Med 2022; 20:116. [PMID: 35287679 PMCID: PMC8920746 DOI: 10.1186/s12916-022-02272-w] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/09/2021] [Accepted: 01/24/2022] [Indexed: 02/24/2023] Open
Abstract
BACKGROUND Faecal immunochemical tests (FITs) are used to triage primary care patients with symptoms that could be caused by colorectal cancer for referral to colonoscopy. The aim of this study was to determine whether combining FIT with routine blood test results could improve the performance of FIT in the primary care setting. METHODS Results of all consecutive FITs requested by primary care providers between March 2017 and December 2020 were retrieved from the Oxford University Hospitals NHS Foundation Trust. Demographic factors (age, sex), reason for referral, and results of blood tests within 90 days were also retrieved. Patients were followed up for incident colorectal cancer in linked hospital records. The sensitivity, specificity, positive and negative predictive values of FIT alone, FIT paired with blood test results, and several multivariable FIT models, were compared. RESULTS One hundred thirty-nine colorectal cancers were diagnosed (0.8%). Sensitivity and specificity of FIT alone at a threshold of 10 μg Hb/g were 92.1 and 91.5% respectively. Compared to FIT alone, blood test results did not improve the performance of FIT. Pairing blood test results with FIT increased specificity but decreased sensitivity. Multivariable models including blood tests performed similarly to FIT alone. CONCLUSIONS FIT is a highly sensitive tool for identifying higher risk individuals presenting to primary care with lower risk symptoms. Combining blood test results with FIT does not appear to lead to better discrimination for colorectal cancer than using FIT alone.
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Affiliation(s)
- Diana R Withrow
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, OX2 6GG, UK
| | - Brian Shine
- Department of Clinical Biochemistry, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation, Oxford, UK
| | - Jason Oke
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, OX2 6GG, UK
| | - Andres Tamm
- Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK
| | - Tim James
- Department of Computer Science, Big Data Institute, University of Oxford, Oxford, UK
| | - Eva Morris
- Nuffield Department of Population Health, Big Data Institute, University of Oxford, Oxford, UK
| | - Jim Davies
- Department of Computer Science, Big Data Institute, University of Oxford, Oxford, UK
| | - Steve Harris
- Oxford BRC Informatics Theme, Big Data Institute, University of Oxford, Oxford, UK
| | - James E East
- Translational Gastroenterology Unit, and Oxford NIHR Biomedical Research Centre, John Radcliffe Hospital, University of Oxford, Oxford, UK
| | - Brian D Nicholson
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, OX2 6GG, UK.
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16
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Pin-Vieito N, Puga M, Fernández-de-Castro D, Cubiella J. Faecal immunochemical test outside colorectal cancer screening? World J Gastroenterol 2021; 27:6415-6429. [PMID: 34720531 PMCID: PMC8517780 DOI: 10.3748/wjg.v27.i38.6415] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/07/2021] [Revised: 06/27/2021] [Accepted: 08/16/2021] [Indexed: 02/06/2023] Open
Abstract
Faecal immunochemical tests (FITs) are the most widely colorectal cancer (CRC) diagnostic biomarker available. Many population screening programmes are based on this biomarker, with the goal of reducing CRC mortality. Moreover, in recent years, a large amount of evidence has been produced on the use of FIT to detect CRC in patients with abdominal symptoms in primary healthcare as well as in surveillance after adenoma resection. The aim of this review is to highlight the available evidence on these two topics. We will summarize the evidence on diagnostic yield in symptomatic patients with CRC and significant colonic lesion and the different options to use this (thresholds, brands, number of determinations, prediction models and combinations). We will include recommendations on FIT strategies in primary healthcare proposed by regulatory bodies and scientific societies and their potential effects on healthcare resources and CRC prognosis. Finally, we will show information regarding FIT-based surveillance as an alternative to endoscopic surveillance after high-risk polyp resection. To conclude, due to the coronavirus disease 2019 pandemic, FIT-based strategies have become extremely relevant since they enable a reduction of colonoscopy demand and access to the healthcare system by selecting individuals with the highest risk of CRC.
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Affiliation(s)
- Noel Pin-Vieito
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense 32005, Spain
| | - Manuel Puga
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense 32005, Spain
| | - Daniel Fernández-de-Castro
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense 32005, Spain
| | - Joaquín Cubiella
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Ourense 32005, Spain
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17
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Turvill JL, Turnock D, Cottingham D, Haritakis M, Jeffery L, Girdwood A, Hearfield T, Mitchell A, Keding A. The Fast Track FIT study: diagnostic accuracy of faecal immunochemical test for haemoglobin in patients with suspected colorectal cancer. Br J Gen Pract 2021; 71:e643-e651. [PMID: 33798091 PMCID: PMC8279659 DOI: 10.3399/bjgp.2020.1098] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2020] [Accepted: 03/24/2021] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND The faecal immunochemical test (FIT) is now available to support clinicians in the assessment of patients at low risk of colorectal cancer (CRC) and within the bowel cancer screening programme. AIM To determine the diagnostic accuracy of FIT for CRC and clinically significant disease in patients referred as they were judged by their GP to fulfil National Institute for Health and Care Excellence guideline 12 (NG12) criteria for suspected CRC. DESIGN AND SETTING Patients referred from primary care with suspected CRC, meeting NG12 criteria, to 12 secondary care providers in Yorkshire and Humber were asked to complete a FIT before investigation. METHOD The diagnostic accuracy of FIT based on final diagnosis was evaluated using receiver operating characteristics analysis. This permitted a statistically optimal cut-off value for FIT to be determined based on the maximisation of sensitivity and specificity. Clinicians and patients were blinded to the FIT results. RESULTS In total, 5040 patients were fully evaluated and CRC was detected in 151 (3.0%). An optimal cut-off value of 19 µg Hb/g faeces for CRC was determined, giving a sensitivity of 85.4% (95% confidence interval [CI] = 78.8% to 90.6%) and specificity of 85.2% (95% CI = 84.1% to 86.2%). The negative predictive value at this cut-off value was 99.5% (95% CI = 99.2% to 99.7%) and the positive predictive value 15.1% (95% CI = 12.8% to 17.7%). Sensitivity and specificity of FIT for CRC and significant premalignant polyps at this cut-off value were 62.9% (95% CI = 57.5% to 68.0%) and 86.4% (95% CI = 85.4% to 87.4%), respectively; and when including all organic enteric disease were 35.7% (95% CI = 32.9% to 38.5%) and 88.6% (95% CI = 87.5% to 89.6%), respectively. CONCLUSION FIT used in patients fulfilling NG12 criteria should allow for a more personalised CRC risk assessment. FIT should permit effective, patient-centred decision-making to inform the need for, type, and timing of further investigation.
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Affiliation(s)
- James L Turvill
- Department of Gastroenterology, York and Scarborough Teaching Hospitals NHS Foundation Trust, York
| | - Daniel Turnock
- Department of Gastroenterology, York and Scarborough Teaching Hospitals NHS Foundation Trust, York
| | - Dan Cottingham
- Macmillan GP Cancer and End of Life lead, Vale of York Clinical Commissioning Group, West Offices Station Rise, York
| | - Monica Haritakis
- Department of Research and Development, York and Scarborough Teaching Hospitals NHS Foundation Trust, York
| | - Laura Jeffery
- Department of Research and Development, York and Scarborough Teaching Hospitals NHS Foundation Trust, York
| | - Annabelle Girdwood
- Department of Research and Development, York and Scarborough Teaching Hospitals NHS Foundation Trust, York
| | - Tom Hearfield
- Department of Research and Development, York and Scarborough Teaching Hospitals NHS Foundation Trust, York
| | - Alex Mitchell
- Department of Health Sciences, Faculty of Sciences, University of York, York
| | - Ada Keding
- Department of Health Sciences, Faculty of Sciences, University of York, York
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18
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D'Souza N, Georgiou Delisle T, Chen M, Benton S, Abulafi M, The NICE FIT Steering Group
WarrenOliverAhmadiSaidyousufParchmentCarleneShanmuganandanArunWestNicholasMitchellToniSahStephenJacksonNickMyersAlistairZiprinPaulBloomIanKayeStanRamwellAndyJenkinsJohn TMonahanKevin. Faecal immunochemical test is superior to symptoms in predicting pathology in patients with suspected colorectal cancer symptoms referred on a 2WW pathway: a diagnostic accuracy study. Gut 2021; 70:1130-1138. [PMID: 33087488 PMCID: PMC8108285 DOI: 10.1136/gutjnl-2020-321956] [Citation(s) in RCA: 103] [Impact Index Per Article: 25.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2020] [Revised: 08/06/2020] [Accepted: 08/09/2020] [Indexed: 12/14/2022]
Abstract
OBJECTIVE To assess whether a faecal immunochemical test (FIT) could be used to select patients with suspected colorectal cancer (CRC) symptoms for urgent investigation. DESIGN Multicentre, double-blinded diagnostic accuracy study in 50 National Health Service (NHS) hospitals across England between October 2017 and December 2019. Patients referred to secondary care with suspected CRC symptoms meeting NHS England criteria for urgent 2 weeks wait referral and triaged to investigation with colonoscopy were invited to perform a quantitative FIT. The sensitivity of FIT for CRC, and effect of relevant variables on its diagnostic accuracy was assessed. RESULTS 9822 patients were included in the final analysis. The prevalence of CRC at colonoscopy was 3.3%. The FIT positivity decreased from 37.2% to 19.0% and 7.6%, respectively, at cut-offs of 2, 10 and 150 µg haemoglobin/g faeces (µg/g). The positive predictive values of FIT for CRC at these cut-offs were 8.7% (95% CI, 7.8% to 9.7%), 16.1% (95% CI 14.4% to 17.8%) and 31.1% (95% CI 27.8% to 34.6%), respectively, and the negative predictive values were 99.8% (95% CI 99.7% to 99.9%), 99.6% (95% CI 99.5% to 99.7%) and 98.9% (95% CI 98.7% to 99.1%), respectively. The sensitivity of FIT for CRC decreased at the same cut-offs from 97.0% (95% CI 94.5% to 98.5%) to 90.9% (95% CI 87.2% to 93.8%) and 70.8% (95% CI 65.6% to 75.7%), respectively, while the specificity increased from 64.9% (95% CI 63.9% to 65.8%) to 83.5% (95% CI 82.8% to 84.3%) and 94.6% (95% CI 94.1% to 95.0%), respectively. The area under the receiver operating characteristic curve was 0.93 (95% CI 0.92 to 0.95). CONCLUSION FIT sensitivity is maximised to 97.0% at the lowest cut-off (2 µg/g); a negative FIT result at this cut-off can effectively rule out CRC and a positive FIT result is better than symptoms to select patients for urgent investigations. TRIAL REGISTRATION NUMBER ISRCTN49676259.
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Affiliation(s)
- Nigel D'Souza
- Colorectal Surgery, Croydon University Hospital, Croydon, UK,Colorectal Surgery, Basingstoke and North Hampshire Hospital, Basingstoke, UK,Surgery & Cancer, Imperial College London, London, UK
| | - Theo Georgiou Delisle
- Colorectal Surgery, Croydon University Hospital, Croydon, UK,Surgery & Cancer, Imperial College London, London, UK
| | | | - Sally Benton
- Clinical Biochemistry, Royal Surrey County Hospital, Guildford, UK
| | - Muti Abulafi
- Colorectal Surgery, Croydon University Hospital, Croydon, UK
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19
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Calanzani N, Chang A, Van Melle M, Pannebakker MM, Funston G, Walter FM. Recognising Colorectal Cancer in Primary Care. Adv Ther 2021; 38:2732-2746. [PMID: 33864597 PMCID: PMC8052540 DOI: 10.1007/s12325-021-01726-6] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2021] [Accepted: 03/24/2021] [Indexed: 12/15/2022]
Abstract
Colorectal cancer (CRC) is the third most common cancer worldwide. Primary care professionals can play an important role in both prevention and early detection of CRC. Most CRCs are attributed to modifiable lifestyle factors, which can be addressed within primary care, and promotion of population-based screening programmes can aid early cancer detection in asymptomatic patients. Primary care professionals have a vital role in clinically assessing patients presenting with symptoms that may indicate cancer, as most patients with CRC first present with symptoms. These assessments are often challenging—many of the symptoms of CRC are non-specific and commonly occur in patients presenting with non-malignant disease. The range of options for investigating symptomatic patients in primary care is rapidly growing. Simple tests, such as faecal immunochemical testing (FIT), are now being used to guide decisions around referral for more invasive tests, such as colonoscopy, while direct access to specialist investigations is also becoming more common. Clinical decision support tools (CDSTs) which calculate cancer risk based on symptomatology, patient characteristics and test results can provide an additional resource to guide decisions on further investigation. This article explores the challenges of CRC prevention and detection from the primary care perspective, discusses current evidence-based approaches for CRC detection used in primary care (with examples from UK guidelines), and highlights emerging research which may likely alter practice in the future.
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Affiliation(s)
- Natalia Calanzani
- Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, CB1 8RN, UK
| | - Aina Chang
- School of Clinical Medicine, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK
| | - Marije Van Melle
- Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, CB1 8RN, UK
| | - Merel M Pannebakker
- Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, CB1 8RN, UK
| | - Garth Funston
- Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, CB1 8RN, UK
| | - Fiona M Walter
- Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, CB1 8RN, UK.
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Melbourne, Australia.
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20
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Calanzani N, Druce PE, Snudden C, Milley KM, Boscott R, Behiyat D, Saji S, Martinez-Gutierrez J, Oberoi J, Funston G, Messenger M, Emery J, Walter FM. Identifying Novel Biomarkers Ready for Evaluation in Low-Prevalence Populations for the Early Detection of Upper Gastrointestinal Cancers: A Systematic Review. Adv Ther 2021; 38:793-834. [PMID: 33306189 PMCID: PMC7889689 DOI: 10.1007/s12325-020-01571-z] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/05/2020] [Accepted: 11/11/2020] [Indexed: 02/07/2023]
Abstract
INTRODUCTION Detecting upper gastrointestinal (GI) cancers in primary care is challenging, as cancer symptoms are common, often non-specific, and most patients presenting with these symptoms will not have cancer. Substantial investment has been made to develop biomarkers for cancer detection, but few have reached routine clinical practice. We aimed to identify novel biomarkers for upper GI cancers which have been sufficiently validated to be ready for evaluation in low-prevalence populations. METHODS We systematically searched MEDLINE, Embase, Emcare, and Web of Science for studies published in English from January 2000 to October 2019 (PROSPERO registration CRD42020165005). Reference lists of included studies were assessed. Studies had to report on second measures of diagnostic performance (beyond discovery phase) for biomarkers (single or in panels) used to detect pancreatic, oesophageal, gastric, and biliary tract cancers. We included all designs and excluded studies with less than 50 cases/controls. Data were extracted on types of biomarkers, populations and outcomes. Heterogeneity prevented pooling of outcomes. RESULTS We identified 149 eligible studies, involving 22,264 cancer cases and 49,474 controls. A total of 431 biomarkers were identified (183 microRNAs and other RNAs, 79 autoantibodies and other immunological markers, 119 other proteins, 36 metabolic markers, 6 circulating tumour DNA and 8 other). Over half (n = 231) were reported in pancreatic cancer studies. Only 35 biomarkers had been investigated in at least two studies, with reported outcomes for that individual marker for the same tumour type. Apolipoproteins (apoAII-AT and apoAII-ATQ), and pepsinogens (PGI and PGII) were the most promising biomarkers for pancreatic and gastric cancer, respectively. CONCLUSION Most novel biomarkers for the early detection of upper GI cancers are still at an early stage of matureness. Further evidence is needed on biomarker performance in low-prevalence populations, in addition to implementation and health economic studies, before extensive adoption into clinical practice can be recommended.
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Affiliation(s)
- Natalia Calanzani
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
| | - Paige E Druce
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia
| | - Claudia Snudden
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
| | - Kristi M Milley
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia
| | - Rachel Boscott
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
| | - Dawnya Behiyat
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
| | - Smiji Saji
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
| | - Javiera Martinez-Gutierrez
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia
- Department of Family Medicine, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile
| | - Jasmeen Oberoi
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia
| | - Garth Funston
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
| | - Mike Messenger
- Leeds Centre for Personalised Medicine and Health, University of Leeds, Leeds, UK
| | - Jon Emery
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia
| | - Fiona M Walter
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
- Centre for Cancer Research and Department of General Practice, University of Melbourne, Victoria, Australia
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21
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Koo MM, Unger-Saldaña K, Mwaka AD, Corbex M, Ginsburg O, Walter FM, Calanzani N, Moodley J, Rubin GP, Lyratzopoulos G. Conceptual Framework to Guide Early Diagnosis Programs for Symptomatic Cancer as Part of Global Cancer Control. JCO Glob Oncol 2021; 7:35-45. [PMID: 33405957 PMCID: PMC8081530 DOI: 10.1200/go.20.00310] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2020] [Revised: 10/06/2020] [Accepted: 11/06/2020] [Indexed: 12/15/2022] Open
Abstract
Diagnosing cancer earlier can enable timely treatment and optimize outcomes. Worldwide, national cancer control plans increasingly encompass early diagnosis programs for symptomatic patients, commonly comprising awareness campaigns to encourage prompt help-seeking for possible cancer symptoms and health system policies to support prompt diagnostic assessment and access to treatment. By their nature, early diagnosis programs involve complex public health interventions aiming to address unmet health needs by acting on patient, clinical, and system factors. However, there is uncertainty regarding how to optimize the design and evaluation of such interventions. We propose that decisions about early diagnosis programs should consider four interrelated components: first, the conduct of a needs assessment (based on cancer-site-specific statistics) to identify the cancers that may benefit most from early diagnosis in the target population; second, the consideration of symptom epidemiology to inform prioritization within an intervention; third, the identification of factors influencing prompt help-seeking at individual and system level to support the design and evaluation of interventions; and finally, the evaluation of factors influencing the health systems' capacity to promptly assess patients. This conceptual framework can be used by public health researchers and policy makers to identify the greatest evidence gaps and guide the design and evaluation of local early diagnosis programs as part of broader cancer control strategies.
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Affiliation(s)
- Minjoung Monica Koo
- Epidemiology of Cancer Healthcare and Outcomes (ECHO) Research Group, Department of Behavioural Science and Health, University College London, London, United Kingdom
| | - Karla Unger-Saldaña
- CONACYT (National Council of Science and Technology)–National Cancer Institute, Mexico City, Mexico
| | - Amos D. Mwaka
- Department of Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda
| | | | - Ophira Ginsburg
- Perlmutter Cancer Center and the Department of Population Health, NYU Grossman School of Medicine, NYU Langone Health, New York, NY
| | - Fiona M. Walter
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom
| | - Natalia Calanzani
- The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom
| | - Jennifer Moodley
- Women's Health Research Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
- Cancer Research Initiative, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
- SAMRC Gynaecology Cancer Research Centre, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
| | - Greg P. Rubin
- Institute of Health and Society, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom
| | - Georgios Lyratzopoulos
- Epidemiology of Cancer Healthcare and Outcomes (ECHO) Research Group, Department of Behavioural Science and Health, University College London, London, United Kingdom
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