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Junhai Z, Fei L, Jixiang Z, Huabing X, Cheng T, Weiguo D. Negative predictive value of fecal immunochemical testing in significant bowel disease screening: a systematic review and meta-analysis. Int J Surg 2025; 111:1182-1190. [PMID: 38920326 PMCID: PMC11745644 DOI: 10.1097/js9.0000000000001844] [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: 04/23/2024] [Accepted: 06/12/2024] [Indexed: 06/27/2024]
Abstract
OBJECTIVES General practitioners (GPs) must assess significant bowel disease (SBD) in patients with lower bowel symptoms during primary care. Studies have evaluated the efficacy of fecal immunochemical testing (FIT) for SBD screening. However, the effectiveness of FIT remains controversial. This study aimed to investigate the value of FIT in SBD screening. METHODS PubMed, the Cochrane Database, and EMBASE were systematically searched. Studies that estimated FIT values in screening for SBD among patients with lower bowel symptoms were included. Sensitivity, specificity, negative likelihood ratio (NLR), positive likelihood ratio (PLR), diagnostic odds ratio (DOR), and negative predictive value (NPV) were calculated. Additionally, the pooled area under the summary receiver operating characteristic (SROC) curve was analyzed. RESULTS A total of 8615 patients with lower bowel symptoms who underwent FIT and colonoscopy to screen for SBD were enrolled and assessed in this meta-analysis; of these, 1226 patients were ultimately diagnosed with SBD. The pooled sensitivity, specificity, PLR, NLR, DOR, and NPV of FIT in SBD screening were 0.65 (95% CI: 0.50-0.78), 0.85 (95% CI: 0.72-0.92), 4.2 (95% CI: 2.60-6.90), 0.41 (95% CI: 0.29-0.58), 10 (95% CI: 6-17), and 0.90 (95% CI: 0.87-0.94), respectively. Besides, the pooled SROC was 0.82 (95% CI: 0.78-0.85). CONCLUSIONS This study indicates that the FIT provides a favorable NPV for SBD screening and could be a valuable technique for GPs to rule out SBD in primary care. At the same time, GPs need to remain vigilant and refer patients to gastroenterologists when necessary.
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Affiliation(s)
- Zhen Junhai
- Department of General Practice, Renmin Hospital of Wuhan University
| | - Liao Fei
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, People’s Republic of China
| | - Zhang Jixiang
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, People’s Republic of China
| | - Xie Huabing
- Department of General Practice, Renmin Hospital of Wuhan University
| | - Tan Cheng
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, People’s Republic of China
| | - Dong Weiguo
- Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, People’s Republic of China
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Afzal A, Aranan YS, Roberts T, Covington J, Vidal L, Ahmed S, Gill T, Francis N. Diagnostic accuracy of the faecal immunochemical test and volatile organic compound analysis in detecting colorectal polyps: meta-analysis. BJS Open 2024; 9:zrae154. [PMID: 39972538 PMCID: PMC11839406 DOI: 10.1093/bjsopen/zrae154] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2024] [Revised: 11/03/2024] [Accepted: 11/10/2024] [Indexed: 02/21/2025] Open
Abstract
BACKGROUND For the early detection of colorectal cancer, it is important to identify the premalignant lesions to prevent cancer development. Non-invasive testing methods such as the faecal immunochemical test are well established for the screening and triage of patients with suspected colorectal cancer but are not routinely used for polyps. Additionally, the role of volatile organic compounds has been tested for cancer detection. The aim of this review was to determine the diagnostic accuracy of the faecal immunochemical test and volatile organic compounds in detecting colorectal polyps. METHODS Original articles with diagnostic test accuracy measures for both the faecal immunochemical test and volatile organic compounds for advanced adenomas were included. Four databases including Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, and Web of Science were searched. The quality assessment tool for diagnostic accuracy study was used to assess the risk of bias and applicability. Meta-analysis was performed using RStudio® and the combined faecal immunochemical test-volatile organic compounds sensitivity and specificity were computed. RESULTS Twenty-two faecal immunochemical tests and 12 volatile organic compound-related articles were included in the systematic review whilst 18 faecal immunochemical tests and eight volatile organic compound-related studies qualified for the meta-analysis. The estimated pooled sensitivity and specificity of the faecal immunochemical test to diagnose advanced adenoma(s) were 36% (95% c.i. 30 to 41) and 89% (95% c.i. 86 to 91) respectively, with an area under the curve of 0.65, whilst volatile organic compounds pooled sensitivity and specificity was 83% (95% c.i. 70 to 91) and 76% (95% c.i. 60 to 87) respectively, with an area under the curve of 0.84. The combined faecal immunochemical test-volatile organic compounds increased the sensitivity to 89% with a specificity of 67%. CONCLUSION Faecal immunochemical testing has a higher specificity but poor sensitivity for detecting advanced adenomas, while volatile organic compound analysis is more sensitive. The combination of both tests enhances the detection rate of advanced adenomas.
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Affiliation(s)
- Asma Afzal
- Department of Colorectal Surgery, North Tees & Hartlepool NHS Foundation Trust, Stockton-on-Tees, UK
- School of Health & Life Sciences, Teesside University, Middlesbrough, UK
| | | | - Tom Roberts
- Undergraduate Department, University of Bristol, Bristol, UK
| | - James Covington
- Department of School of Engineering, Warwick University, Warwick, UK
| | - Lorena Vidal
- Department of Analytical Chemistry, Nutrition and Food Science, University Institute of Materials and ISABIAL, University of Alicante, Alicante, Spain
| | - Sonia Ahmed
- School of Health & Life Sciences, Teesside University, Middlesbrough, UK
| | - Talvinder Gill
- Department of Colorectal Surgery, North Tees & Hartlepool NHS Foundation Trust, Stockton-on-Tees, UK
| | - Nader Francis
- Department of Surgery, Yeovil Hospital, Southwest Yeovil, UK
- Department of Education and Research, Griffin Institute, London, UK
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Atwal GK, Digby J, Nobes J, Strachan J, Mowat C. The impact of primary-care led, faecal immunochemical test-based, triage of new-onset colorectal symptoms on time to diagnosis of colorectal cancer-An observational study. Colorectal Dis 2024; 26:1544-1550. [PMID: 38949100 DOI: 10.1111/codi.17083] [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: 01/12/2024] [Revised: 03/27/2024] [Accepted: 04/02/2024] [Indexed: 07/02/2024]
Abstract
AIM Since December 2015, a faecal immunochemical test (FIT) has been provided to primary care in NHS Tayside as an adjunct to clinical acumen in the assessment of new-onset bowel symptoms. The aim of this work was to assess the impact of this approach on time to diagnosis of colorectal cancer (CRC). METHOD NHS Tayside Cancer audit data from January 2013 to December 2019 were reviewed to identify all CRC patients diagnosed via the primary-care referral pathway for a period before and after the introduction of FIT. Their electronic patient records were accessed and date of referral and any contemporaneous FIT and full blood count (FBC) result were recorded. Time from referral to diagnosis of CRC was calculated for each patient and compared between subgroups. RESULTS The study cohort consisted of 959 patients: 378 and 581 from the time periods before and after the introduction of FIT, respectively. The median time to diagnosis before FIT was 30 days [interquartile range (IQR) 16-57 days] versus 25 days (IQR 14-47 days) following the introduction of FIT (p = 0.006). Following the introduction of FIT, patients who completed a FIT had a median of time to diagnosis of 23 days (IQR 14-43 days) compared with 30 days (IQR 16-62 days) for patients not completing a FIT (p = 0.019). FBC results were available for 97.5% of FIT patients to aid safety-netting of patients with a low or undetectable faecal haemoglobin concentration. CONCLUSION The introduction of FIT-based triage of new bowel symptoms in primary care as an adjunct to clinical acumen is associated with a reduced time to CRC diagnosis.
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Affiliation(s)
| | - Jayne Digby
- School of Medicine, University of Dundee, Dundee, UK
| | - Jennifer Nobes
- School of Medicine, University of Dundee, Dundee, UK
- Department of Blood Sciences, Ninewells Hospital, Dundee, UK
| | - Judith Strachan
- Department of Blood Sciences, Ninewells Hospital, Dundee, UK
| | - Craig Mowat
- School of Medicine, University of Dundee, Dundee, UK
- Department of Gastroenterology, Ninewells Hospital, Dundee, UK
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Limsrivilai J, Yodmalai C, Chaemsupaphan T, Sattayalertyanyong O, Subdee N, Permpim P, Phaophu P, Kaosombatwattana U, Pausawasdi N, Riansuwan W, Charatcharoenwitthaya P, Pongprasobchai S. Evaluating the Efficacy of Fecal Immunochemical Test, Fecal Calprotectin, and Serum C-Reactive Protein in Diagnosing Patients With Chronic Lower Gastrointestinal Symptoms. Clin Transl Gastroenterol 2024; 15:e00747. [PMID: 38994833 PMCID: PMC11346899 DOI: 10.14309/ctg.0000000000000747] [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: 02/14/2024] [Accepted: 06/27/2024] [Indexed: 07/13/2024] Open
Abstract
INTRODUCTION Accurate early detection of ileocolonic lesions in patients with chronic lower gastrointestinal symptoms (LGISs) is often difficult due to the rarity of early-stage alarm signs. This study assesses the effectiveness of noninvasive blood and stool biomarkers in diagnosing ileocolonic lesions in patients with chronic LGISs undergoing colonoscopy. METHODS We conducted a prospective study between April 2020 and July 2022 involving patients with LGISs lasting a month or more. Before colonoscopy, we gathered clinical data, blood samples for C-reactive protein (CRP) and stool samples for fecal immunochemical test (FIT) and fecal calprotectin (FC) analysis. RESULTS Of 922 participants analyzed (average age 62 years, 37% male), 130 (14.1%) had significant colonoscopy findings, including cancer, advanced adenoma, and inflammatory conditions. Test effectiveness showed an area under the curve of 0.630 for alarm features, 0.643 for CRP, 0.781 for FIT, and 0.667 for FC. Combining stool tests with alarm features improved diagnostic precision. Those without alarm features had a high negative predictive value of 0.97 with low threshold FIT and FC, missing minimal significant lesions, and no cancer. For patients with alarm features, dual high-cutoff test positivity showed a positive predictive value of 0.67. Adding CRP to fecal tests did not enhance accuracy. DISCUSSION FIT and FC are valuable in evaluating LGISs. Negative results at low cutoffs can delay colonoscopy in limited resource settings while positive results at dual high cutoffs substantiate the need for the procedure.
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Affiliation(s)
- Julajak Limsrivilai
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Chatrawee Yodmalai
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Thanaboon Chaemsupaphan
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Onuma Sattayalertyanyong
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Nichcha Subdee
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Parinya Permpim
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Phutthaphorn Phaophu
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Uayporn Kaosombatwattana
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Nonthalee Pausawasdi
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Woramin Riansuwan
- Colorectal Surgery Unit, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | | | - Supot Pongprasobchai
- Division of Gastroenterology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
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Cole E, Narayanan D, Tiam RN, Shepherd J, Hajjawi MOR. Faecal Immunochemical Test (FIT) Sensitivity; A Five Year Audit. Br J Biomed Sci 2024; 81:12862. [PMID: 38868754 PMCID: PMC11167630 DOI: 10.3389/bjbs.2024.12862] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2024] [Accepted: 05/09/2024] [Indexed: 06/14/2024]
Abstract
Introduction: Colorectal cancer has a high prevalence and mortality rate in the United Kingdom. Cancerous colorectal lesions often bleed into the gastrointestinal lumen. The faecal immunochemical test (FIT) detects haemoglobin (Hb) in the faeces of patients and is used as a first line test in the diagnosis of colorectal cancer. Materials and Methods: A retrospective audit of all FIT performed and all colorectal cancers diagnosed in the Hull and East Riding of Yorkshire counties of the United Kingdom (population approximately 609,300) between 2018 and 2022 was conducted. FIT were performed using a HM-JACKarc analyser from Kyowa medical. The predominant symptom suggestive of colorectal cancer which prompted the FIT was recorded. Colorectal cancer was diagnosed using the gold standard of histological biopsy following colonoscopy. Results: Between 2018 and 2022, 56,202 FIT were performed on symptomatic patients. Follow on testing identified 1,511 with colorectal cancer. Of these people, only 450 people with a confirmed colorectal cancer had a FIT within the 12 months preceding their diagnosis. Of these 450 FIT results, 36 had a concentration of <10 μg/g and may be considered to be a false negative. The sensitivity of FIT in the patients identified was 92.00%. The most common reason stated by the clinician for a FIT being performed in patients with colorectal cancer was a change in bowel habits, followed by iron deficient anaemia. The number of patients diagnosed with colorectal cancer decreased in 2020, but increased significantly in 2021. Discussion: This study shows that 8.00% of people diagnosed with colorectal cancer in the Hull and East Riding of Yorkshire regions had a negative FIT. This study also shows that the SARS-CoV-2 pandemic affected the number of people diagnosed with colorectal cancer, and therefore skews the prevalence and pre-test probability of a positive test. There are many reasons why a FIT could produce a false negative result, the most likely being biological factors affecting the stability of haemoglobin within the gastrointestinal tract, or pre-analytical factors influencing faecal sampling preventing the detection of haemoglobin. Some colorectal lesions do not protrude into the gastrointestinal lumen and are less likely to bleed. Conclusion: This is the first study showing data from outside of a structured clinical trial and provides the largest study to date showing the sensitivity of FIT in a routine clinical setting. This study also provides evidence for the impact COVID-19 had on the rate of colorectal cancer diagnosis.
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Affiliation(s)
- Eddie Cole
- Blood Sciences Department, York and Scarborough Teaching Hospitals NHS Foundation Trust, York, United Kingdom
| | - Deepa Narayanan
- Clinical Biochemistry Department, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom
| | - Ree Nee Tiam
- Cellular Pathology Department, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom
| | - John Shepherd
- Blood Sciences Department, York and Scarborough Teaching Hospitals NHS Foundation Trust, York, United Kingdom
| | - Mark O. R. Hajjawi
- Blood Sciences Department, York and Scarborough Teaching Hospitals NHS Foundation Trust, York, United Kingdom
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Digby J, Fraser CG, Clark G, Mowat C, Strachan JA, Steele RJC. Do risk scores improve use of faecal immunochemical testing for haemoglobin in symptomatic patients in primary care? Colorectal Dis 2024; 26:675-683. [PMID: 38424669 DOI: 10.1111/codi.16925] [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: 08/01/2023] [Revised: 09/26/2023] [Accepted: 10/28/2023] [Indexed: 03/02/2024]
Abstract
AIM Faecal immunochemical testing (FIT) is used in the detection of colorectal cancer (CRC). FIT is invariably used at a single faecal haemoglobin (f-Hb) concentration threshold. The aim of this observational study was to explore risk scoring models (RSMs) with f-Hb and other risk factors for CRC in symptomatic patients attending primary care, potentially speeding diagnosis and saving endoscopy resources. METHOD Records of patients completing FIT were linked with The Scottish Cancer Registry and with other databases with symptoms, full blood count and demographic variables, and randomized into derivation and validation cohorts. Stepwise multivariable logistic regression created RSMs assessed in the validation cohort. RESULTS Of 18 805 unique patients, 9374 and 9431 were in the derivation and validation cohorts, respectively: f-Hb, male sex, increasing age, iron deficiency anaemia and raised systemic immune inflammation index created the final RSM. A risk score threshold of ≥2.363, generating the same number of colonoscopies as a f-Hb threshold of ≥10 μg Hb/g gave improved sensitivity for CRC in both cohorts. A RSM which excluded f-Hb was used to investigate the effect of raising the f-Hb threshold from ≥10 to ≥20 μg Hb/g in those with a low risk score. This approach would have generated 234 fewer colonoscopies but missed four CRCs. CONCLUSION The RSM conferred no significant benefit to patients with very low f-Hb and CRC. Alternative strategies combining FIT with other variables may be more appropriate for safety-netting of symptomatic patients. Further work to develop and investigate the value of RSM for significant bowel disease other than CRC may also be beneficial.
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Affiliation(s)
- Jayne Digby
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | - Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | | | - Craig Mowat
- Department of Gastroenterology, Ninewells Hospital, Dundee, UK
| | - Judith A Strachan
- Blood Sciences and Scottish Bowel Screening Laboratory, Ninewells Hospital and Medical School, Dundee, UK
| | - Robert J C Steele
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, 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. 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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8
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Brands HJ, Van Dijk B, Brohet RM, van Westreenen HL, de Groot JWB, Moons LMG, de Vos tot Nederveen Cappel WH. Possible Value of Faecal Immunochemical Test (FIT) When Added in Symptomatic Patients Referred for Colonoscopy: A Systematic Review. Cancers (Basel) 2023; 15:cancers15072011. [PMID: 37046672 PMCID: PMC10093340 DOI: 10.3390/cancers15072011] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2023] [Revised: 03/15/2023] [Accepted: 03/22/2023] [Indexed: 03/30/2023] Open
Abstract
If Colorectal cancer (CRC) is detected and treated early, the survival rate is high. This is one of the reasons that population-based screening programs for the early detection of CRC using the faecal immunochemical test (FIT) started worldwide. These programs compete with regular colonoscopy programs and increase the waiting time for symptomatic patients. However, the literature has shown that the correlation between intestinal complaints and the gain of colonoscopy is poor. The aim of this study is to assess the diagnostic utility of symptoms for the yield (CRC) of colonoscopy and to compare this with the diagnostic utility of FIT when offered to symptomatic patients. Methods: We performed a systematic review search for CRC as an outcome of colonoscopy in referred symptomatic patients and separately for CRC as an outcome in symptomatic patients with a positive FIT. We searched systematically for clinical trials or observational studies in databases, followed by hand-searching of reference lists. We used random Meta-Disc to evaluate the diagnostic performance, using the exploration of heterogeneity with a variety of test statistics and by computing the pooled estimates. Results: We included 35 studies, with almost 5 million symptomatic patients. In addition, we included nine prospective studies with a positive FIT in symptomatic patients, with more than 5000 patients. Significant heterogeneity was found for every symptom and the outcome of colonoscopy in the effect size of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio. In a random effect model, the pooled sensitivity of colonoscopy in symptomatic patients was very low (25%). However, the pooled sensitivity in symptomatic patients with a positive FIT was 83% and the pooled specificity 77%. A total of 75 symptomatic patients (1.4%) had a false-negative FIT. Conclusion: Adding FIT in symptomatic patients seems useful for predicting CRC as an outcome of colonoscopy. FIT seems a potential tool for an improved triage of colonoscopy in symptomatic patients.
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Affiliation(s)
- Henrike Jacoba Brands
- Gastroenterology and Hepatology, Isala Hospital, 8025 AB Zwolle, The Netherlands
- Correspondence:
| | - Brigit Van Dijk
- Gastroenterology and Hepatology, Isala Hospital, 8025 AB Zwolle, The Netherlands
| | - Richard M. Brohet
- Department of Epidemiology and Statistics, Isala Hospital, 8025 AB Zwolle, The Netherlands
| | | | | | - Leon M. G. Moons
- Gastroenterology and Hepatology, Universitair Medisch Centrum Utrecht, 3584 CX Utrecht, The Netherlands
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Delson D, Ward M, Haddock R, Nobes J, Digby J, Strachan JA, Mowat C. Impact of faecal haemoglobin based triage of bowel symptoms presenting to primary care on colorectal cancer diagnosis. Colorectal Dis 2022; 25:787-793. [PMID: 36495081 DOI: 10.1111/codi.16451] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/28/2022] [Revised: 10/20/2022] [Accepted: 11/02/2022] [Indexed: 12/30/2022]
Abstract
AIM Faecal immunochemical testing (FIT) for faecal haemoglobin was introduced into primary care in National Health Service Tayside in 2015 as an adjunct to clinical assessment of new bowel symptoms. We aimed to assess the impact of FIT-based triage in primary care on colorectal cancer (CRC) diagnosis. METHOD Cancer audit data between January 2016 and December 2019 were reviewed to identify all patients diagnosed locally with CRC. The mode of presentation and stage at diagnosis were noted and patient records were interrogated to identify whether FIT and full blood count (FBC) had been performed prior to referral. Results were compared between the FIT and non-FIT groups. RESULTS In all, 1245 patients were diagnosed with CRC of whom 581 (46.7%) presented through primary care. FIT was performed prior to referral in 440/581 (75.7%), with the proportion increasing from 62.3% in 2016 to 85.8% in 2019. At faecal haemoglobin ≥10 μg Hb/g faeces, sensitivity for CRC was 94.1%. Over the study period the annual proportion of non-emergency presentations increased significantly; presentations from primary care increased from 43.1% to 53.5% (P = 0.0096). After excluding non-FIT patients who had an overt CRC at referral, there was no difference in stage at diagnosis between FIT and non-FIT cancers. Safety-netting with FBC was widely used in our cohort with 97.3% of FIT patients having also had FBC. CONCLUSION FIT-based triage of new bowel symptoms in primary care is associated with increased non-emergency presentation of CRC but this did not influence stage at diagnosis.
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Affiliation(s)
- Dwi Delson
- School of Medicine, University of Dundee, Dundee, UK
| | - Mark Ward
- School of Medicine, University of Dundee, Dundee, UK
| | | | - Jennifer Nobes
- School of Medicine, University of Dundee, Dundee, UK.,Department of Blood Sciences, Ninewells Hospital, Dundee, UK
| | - Jayne Digby
- School of Medicine, University of Dundee, Dundee, UK
| | - Judith A Strachan
- School of Medicine, University of Dundee, Dundee, UK.,Department of Blood Sciences, Ninewells Hospital, Dundee, UK
| | - Craig Mowat
- School of Medicine, University of Dundee, Dundee, UK.,Department of Gastroenterology, Ninewells Hospital, Dundee, UK
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10
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Monahan KJ, Davies MM, Abulafi M, Banerjea A, Nicholson BD, Arasaradnam R, Barker N, Benton S, Booth R, Burling D, Carten RV, D'Souza N, East JE, Kleijnen J, Machesney M, Pettman M, Pipe J, Saker L, Sharp L, Stephenson J, Steele RJ. Faecal immunochemical testing (FIT) in patients with signs or symptoms of suspected colorectal cancer (CRC): a joint guideline from the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG). Gut 2022; 71:gutjnl-2022-327985. [PMID: 35820780 PMCID: PMC9484376 DOI: 10.1136/gutjnl-2022-327985] [Citation(s) in RCA: 74] [Impact Index Per Article: 24.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2022] [Accepted: 07/01/2022] [Indexed: 12/12/2022]
Abstract
Faecal immunochemical testing (FIT) has a high sensitivity for the detection of colorectal cancer (CRC). In a symptomatic population FIT may identify those patients who require colorectal investigation with the highest priority. FIT offers considerable advantages over the use of symptoms alone, as an objective measure of risk with a vastly superior positive predictive value for CRC, while conversely identifying a truly low risk cohort of patients. The aim of this guideline was to provide a clear strategy for the use of FIT in the diagnostic pathway of people with signs or symptoms of a suspected diagnosis of CRC. The guideline was jointly developed by the Association of Coloproctology of Great Britain and Ireland/British Society of Gastroenterology, specifically by a 21-member multidisciplinary guideline development group (GDG). A systematic review of 13 535 publications was undertaken to develop 23 evidence and expert opinion-based recommendations for the triage of people with symptoms of a suspected CRC diagnosis in primary care. In order to achieve consensus among a broad group of key stakeholders, we completed an extended Delphi of the GDG, and also 61 other individuals across the UK and Ireland, including by members of the public, charities and primary and secondary care. Seventeen research recommendations were also prioritised to inform clinical management.
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Affiliation(s)
- Kevin J Monahan
- The Wolfson Endoscopy Unit, Gastroenterology Department, St Mark's Hospital and Academic Institute, Harrow, London, UK
- Faculty of Medicine, Department of Surgery & Cancer, Imperial College, London, UK
| | - Michael M Davies
- Department of Colorectal Surgery, University Hospital of Wales, Cardiff, UK
| | - Muti Abulafi
- Colorectal Surgery, Croydon Health Services NHS Trust, Croydon, Greater London, UK
| | - Ayan Banerjea
- Nottingham Colorectal Service, Nottingham University Hospitals NHS Trust, Nottingham, UK
| | - Brian D Nicholson
- Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Ramesh Arasaradnam
- University of Warwick, Clinical Sciences Research Institute, Coventry, UK
- Gastroenterology Department, University Hospital Coventry, Coventry, UK
| | | | - Sally Benton
- Hub Director, NHS Bowel Cancer Screening South of England Hub, Royal Surrey County Hospital NHS Foundation Trust, Guildford, Surrey, UK
| | - Richard Booth
- Colorectal Surgery, Croydon University Hospital, Croydon, UK
| | - David Burling
- Radiology, St Mark's Hospital and Academic Institute, Harrow, London, UK
| | | | | | - James Edward East
- Translational Gastroenterology Unit, Univerity of Oxford Nuffield Department of Medicine, Oxford, UK
- Gastroenterology, Mayo Clinic Healthcare, London, UK
| | - Jos Kleijnen
- Kleijnen Systematic Reviews Ltd, York, North Yorkshire, UK
| | - Michael Machesney
- Colorectal Surgery, Whipps Cross Hospital, Barts Health NHS Trust, London, UK
| | - Maria Pettman
- Colorectal Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK
| | | | - Lance Saker
- General Practice, Oak Lodge Medical Centre, London, UK
| | - Linda Sharp
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | | | - Robert Jc Steele
- Surgery and Oncology Department, University of Dundee, Dundee, UK
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11
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Johnstone MS, Miller G, Pang G, Burton P, Kourounis G, Winter J, Crighton E, Mansouri D, Witherspoon P, Smith K, McSorley ST. Alternative diagnoses and demographics associated with a raised quantitative faecal immunochemical test in symptomatic patients. Ann Clin Biochem 2022; 59:277-287. [PMID: 35044264 PMCID: PMC9280700 DOI: 10.1177/00045632221076771] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Background The faecal immunochemical test (FIT) has proven utility for colorectal cancer
detection in symptomatic patients. However, most patients with a raised
faecal haemoglobin (f-Hb) do not have colorectal cancer. We investigated
alternative diagnoses and demographics associated with a raised f-Hb in
symptomatic patients. Methods A retrospective, observational study was performed of patients with FIT
submitted between August 2018 to January 2019 in NHS Greater Glasgow and
Clyde followed by colonoscopy. Colonoscopy/pathology reports were searched
for alternative diagnoses. Covariables were compared using the χ2 test. Multivariate binary logistic regression identified independent
predictors of a raised f-Hb. Results 1272 patients were included. In addition to colorectal cancer (odds ratio
(OR), 9.27 (95% confidence interval (CI): 3.61–23.83; p
< 0.001)), older age (OR, 1.52 (95% CI: 1.00–2.32; p =
0.05)), deprivation (OR, 1.54 (95% CI: 1.21–1.94; p <
0.001)), oral anticoagulants (OR, 1.78 (95% CI: 1.01–3.15;
p = 0.046)), rectal bleeding (OR, 1.47 (95% CI:
1.15–1.88; p = 0.002)), advanced adenoma (OR, 7.52 (95% CI:
3.90–14.49; p < 0.001)), non-advanced polyps (OR, 1.78
(95% CI: 1.33–2.38; p < 0.001)) and inflammatory bowel
disease (IBD) (OR, 4.19 (95% CI: 2.17–8.07; p < 0.001))
independently predicted raised f-Hb. Deprivation (Scottish Index of Multiple
Deprivation (SIMD) 1-2: OR, 2.13 (95% CI: 1.38–3.29; p =
0.001)) independently predicted a raised f-Hb in patients with no pathology
found at colonoscopy. Conclusions An elevated f-Hb is independently associated with older age, deprivation,
anticoagulants, rectal bleeding, advanced adenoma, non-advanced polyps and
IBD in symptomatic patients. Deprivation is associated with a raised f-Hb in
the absence of pathology. This must be considered when utilising FIT in
symptomatic patients.
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Affiliation(s)
- Mark S Johnstone
- Academic Unit of Surgery, School of Medicine, 3526University of Glasgow, Glasgow, UK
| | - Gillian Miller
- Academic Unit of Surgery, School of Medicine, 3526University of Glasgow, Glasgow, UK
| | - Grace Pang
- Academic Unit of Surgery, School of Medicine, 3526University of Glasgow, Glasgow, UK
| | - Paul Burton
- eHealth, Corporate Services, Business Intelligence, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Georgios Kourounis
- Academic Unit of Surgery, School of Medicine, 3526University of Glasgow, Glasgow, UK
| | - Jack Winter
- Department of Gastroenterology, 59736Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Emilia Crighton
- Public Health, Health Service, Public Health Screening, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - David Mansouri
- Department of Coloproctology, 59736Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Paul Witherspoon
- Department of Colorectal Surgery, 427872Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Karen Smith
- Department of Clinical Biochemistry, 59736Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Stephen T McSorley
- Academic Unit of Surgery, School of Medicine, 3526University of Glasgow, Glasgow, UK
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12
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Fraser CG, Benton SC. Faecal haemoglobin examinations have come of age, but further maturation seems desirable. Ann Clin Biochem 2022; 59:97-100. [PMID: 35060392 DOI: 10.1177/00045632211063459] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Affiliation(s)
- Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, Population Health and Genomics, School of Medicine, 85326University of Dundee, Scotland, UK
| | - Sally C Benton
- Department of Clinical Biochemistry and NHS Bowel Cancer Screening South of England Hub, Royal Surrey County Hospital, Berkshire and Surrey Pathology Services, Guildford, Surrey, UK
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13
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Schwettmann L, Lied A, Eriksen R. Evaluation of the Sentinel-FOB gold faecal immunochemical test for the presence of haemoglobin using the automated Roche Cobas 8000 system. Pract Lab Med 2022; 29:e00263. [PMID: 35198716 PMCID: PMC8792414 DOI: 10.1016/j.plabm.2022.e00263] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2021] [Revised: 07/14/2021] [Accepted: 01/12/2022] [Indexed: 02/07/2023] Open
Abstract
Objectives Design Results Conclusion
The SENTIFIT-FOB Gold assay for the quantitation of haemoglobin in faeces was evaluated on the widely used automated Roche Cobas 8000 system. Good analytical and clinical performance were confirmed. The diagnostic accuracy was assessed and the optimal cutoff for use in symptomatic patients was determined.
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14
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Saw KS, Liu C, Xu W, Varghese C, Parry S, Bissett I. Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis. Br J Surg 2021; 109:182-190. [PMID: 34907419 PMCID: PMC10364725 DOI: 10.1093/bjs/znab411] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2021] [Accepted: 10/31/2021] [Indexed: 12/19/2022]
Abstract
BACKGROUND This review evaluated the utility of single quantitative faecal immunochemical test (FIT) as a triaging tool for patients with symptoms of possible colorectal cancer, the effect of symptoms on FIT accuracy, and the impact of triaging incorporating FIT on service provision. METHODS Five databases were searched. Meta-analyses of the extracted FIT sensitivities and specificities for detection of colorectal cancer at reported f-Hb thresholds were performed. Secondary outcomes included sensitivity and specificity of FIT for advanced colorectal neoplasia and serious bowel disease. Subgroup analysis by FIT brand and symptoms was undertaken. RESULTS Fifteen prospective cohort studies, including 28 832 symptomatic patients were included. At the most commonly reported f-Hb positivity threshold of ≥ 10 µg Hb/g faeces (n=13), the summary sensitivity was 88.7% (95% c.i. 85.2 to 91.4) and the specificity was 80.5% (95% c.i. 75.3 to 84.8) for colorectal cancer. At lower limits of detection of ≥ 2 µg Hb/g faeces, the summary sensitivity was 96.8% (95% c.i. 91.0 to 98.9) and the specificity was 65.6% (95% c.i. 59.0 to 71.6). At the upper f-Hb positivity thresholds of ≥ 100 µg Hb/g faeces and ≥ 150 µg Hb/g faeces, summary sensitivities were 68.1% (95% c.i. 59.2 to 75.9) and 66.3% (95% c.i. 52.2 to 78.0), with specificities of 93.4% (95% c.i. 91.3 to 95.1) and 95.1% (95% c.i. 93.6 to 96.3) respectively. FIT sensitivity was comparable between different assay brands. FIT sensitivity may be higher in patients reporting rectal bleeding. CONCLUSION Single quantitative FIT at lower f-Hb positivity thresholds can adequately exclude colorectal cancer in symptomatic patients and provides a data-based approach to prioritization of colonoscopy resources.
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Affiliation(s)
- Kai Sheng Saw
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Chen Liu
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - William Xu
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Chris Varghese
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Susan Parry
- Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
| | - Ian Bissett
- Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
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15
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Black CJ. Review article: Diagnosis and investigation of irritable bowel syndrome. Aliment Pharmacol Ther 2021; 54 Suppl 1:S33-S43. [PMID: 34927756 DOI: 10.1111/apt.16597] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2021] [Revised: 08/22/2021] [Accepted: 08/24/2021] [Indexed: 12/17/2022]
Abstract
Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction. It is defined by the Rome criteria as the presence of abdominal pain, related to defaecation, associated with a change in stool form and/or frequency. The approach to diagnosis and investigation of suspected IBS varies between clinicians and, due in part to the uncertainty that can surround the diagnosis, many still consider it to be a diagnosis of exclusion. However, exhaustive investigation is both unnecessary and costly, and may also be counterproductive. Instead, physicians should aim to make a positive diagnosis, based on their clinical assessment of symptoms, and limit their use of investigations. The yield of routine blood tests in suspected IBS is low overall, but normal inflammatory markers may be reassuring. All patients should have serological testing for coeliac disease, irrespective of their predominant stool form. Routine testing of stool microbiology or faecal elastase is unnecessary; however, all patients with diarrhoea aged <45 should have a faecal calprotectin or a similar marker measured which, if positive, should lead to colonoscopy to exclude possible inflammatory bowel disease. Colonoscopy should also be undertaken in any patient reporting alarm symptoms suggestive of colorectal cancer, and in those whose presentation raises suspicion for microscopic colitis. Testing for bile acid diarrhoea should be considered for patients with IBS with diarrhoea where available. Hydrogen breath tests for lactose malabsorption or small intestinal bacterial overgrowth have no role in the routine assessment of suspected IBS. Adopting a standardised approach to the diagnosis and investigation of IBS will help to promote high-quality and high-value care for patients overall.
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Affiliation(s)
- Christopher J Black
- Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, UK.,Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK
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16
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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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17
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Miller J, Maeda Y, Au S, Gunn F, Porteous L, Pattenden R, MacLean P, Noble CL, Glancy S, Dunlop MG, Din FVN. Short-term outcomes of a COVID-adapted triage pathway for colorectal cancer detection. Colorectal Dis 2021; 23:1639-1648. [PMID: 33682302 PMCID: PMC8250907 DOI: 10.1111/codi.15618] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/16/2020] [Revised: 02/16/2021] [Accepted: 03/01/2021] [Indexed: 12/29/2022]
Abstract
AIM The dramatic curtailment of endoscopy and CT colonography capacity during the coronavirus pandemic has adversely impacted timely diagnosis of colorectal cancer (CRC). We describe a rapidly implemented COVID-adapted diagnostic pathway to mitigate risk and maximize cancer diagnosis in patients referred with symptoms of suspected CRC. METHOD The 'COVID-adapted pathway' integrated multiple quantitative faecal immunochemical tests (qFIT) to enrich for significant colorectal disease with judicious use of CT with oral contrast to detect gross pathology. Patients reporting 'high-risk' symptoms were triaged to qFIT+CT and the remainder underwent an initial qFIT to inform subsequent investigation. Demographic and clinical data were prospectively collected. Outcomes comprised cancer detection frequency. RESULTS Overall, 422 patients (median age 64 years, 220 women) were triaged using this pathway. Most (84.6%) were referred as 'urgent suspicious of cancer'. Of the 422 patients, 202 (47.9%) were triaged to CT and qFIT, 211 (50.0%) to qFIT only, eight (1.9%) to outpatient clinic and one to colonoscopy. Fifteen (3.6%) declined investigation and seven (1.7%) were deemed unfit. We detected 13 cancers (3.1%), similar to the mean cancer detection rate from all referrals in 2017-2019 (3.3%). Compared with the period 1 April-31 May in 2017-2019, we observed a 43% reduction in all primary care referrals (1071 referrals expected reducing to 609). CONCLUSION This COVID-adapted pathway mitigated the adverse effects on diagnostic capacity and detected cancer at the expected rate within those referred. However, the overall reduction in the number of referrals was substantial. The described risk-mitigating measures could be a useful adjunct whilst standard diagnostic services remain constrained due to the ongoing pandemic.
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Affiliation(s)
- Janice Miller
- Department of Colorectal SurgeryWestern General HospitalEdinburghUK
- Clinical SurgeryRoyal Infirmary of EdinburghUniversity of EdinburghEdinburghUK
| | - Yasuko Maeda
- Department of Colorectal SurgeryWestern General HospitalEdinburghUK
- Clinical SurgeryRoyal Infirmary of EdinburghUniversity of EdinburghEdinburghUK
| | - Stephanie Au
- Department of Colorectal SurgeryWestern General HospitalEdinburghUK
| | - Frances Gunn
- Department of Colorectal SurgeryWestern General HospitalEdinburghUK
| | - Lorna Porteous
- Lead GP for Cancer and Palliative CareNHS LothianEdinburghUK
| | | | - Peter MacLean
- Department of RadiologyWestern General HospitalEdinburghUK
| | - Colin L. Noble
- Department of GastroenterologyWestern General HospitalEdinburghUK
| | - Stephen Glancy
- Department of RadiologyWestern General HospitalEdinburghUK
| | - Malcolm G. Dunlop
- Department of Colorectal SurgeryWestern General HospitalEdinburghUK
- Clinical SurgeryRoyal Infirmary of EdinburghUniversity of EdinburghEdinburghUK
- Edinburgh CRUK Cancer Research CentreEdinburghUK
- Institute if Genetics and Molecular MedicineEdinburghUK
| | - Farhat V. N. Din
- Department of Colorectal SurgeryWestern General HospitalEdinburghUK
- Clinical SurgeryRoyal Infirmary of EdinburghUniversity of EdinburghEdinburghUK
- Edinburgh CRUK Cancer Research CentreEdinburghUK
- Institute if Genetics and Molecular MedicineEdinburghUK
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18
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Hicks G, D'Souza N, Georgiou Delisle T, Chen M, Benton SC, Abulafi M. Using the faecal immunochemical test in patients with rectal bleeding: evidence from the NICE FIT study. Colorectal Dis 2021; 23:1630-1638. [PMID: 33605522 DOI: 10.1111/codi.15593] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2020] [Revised: 02/10/2021] [Accepted: 02/11/2021] [Indexed: 12/13/2022]
Abstract
AIM The aim of this work was to investigate whether the faecal immunochemical test (FIT) could safely rule out colorectal cancer (CRC) in patients with rectal bleeding (RB). METHOD This was a multicentre, double-blinded diagnostic accuracy study in 50 National Health Service hospitals. Patients referred from primary care with suspected CRC on an urgent 2-week-wait pathway were asked to perform a FIT prior to colonoscopy. The primary outcome measure was the sensitivity of the FIT for CRC in patients with RB versus nonrectal bleeding symptoms (NRB). The secondary outcome measures included the diagnostic accuracy of the FIT for CRC and other serious bowel disease. RESULTS Of 9822 patients included in the study, 3143 (32.0%) were referred with RB. CRC was present in 4.7% of patients with RB versus 2.7% of patients with NRB (p < 0.05). Faecal haemoglobin (f-Hb) was detectable (>2 µg/g) in 44.1% of patients with RB and 33.9% with NRB (p < 0.05). In RB patients, CRC was present in 10.4% when f-Hb was >2 µg/g compared with 0.1% when f-Hb was not detected. Flexible sigmoidoscopy in this group would further reduce the risk of CRC to 0.03%. The sensitivity of the FIT for CRC in RB versus NRB groups was 98.6% (95% CI 95.2%-99.8%) vs 95.6% (91.5%-98.1%) for f-Hb >2 µg/g and 96.6% (92.2%-98.9%) vs 86.3 (80.4%-90.9%) for f-Hb >10 µg/g. CONCLUSION Faecal haemoglobin is not always detectable in patients with RB; 56% of patients had undetectable f-Hb (<2 µg/g) and CRC was present in 0.1%. The high sensitivity of the FIT can be used to rule out CRC in patients with RB and triage them more appropriately for investigation.
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Affiliation(s)
| | - Nigel D'Souza
- Croydon University Hospital, Croydon, UK.,University Hospital Southampton NHS Foundation Trust, Southampton, UK.,Imperial College London, London, UK
| | | | - Michelle Chen
- RM Partners, The West London Cancer Alliance, London, UK
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19
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Kearsey CC, Graham C, Lobb HS, Chacko J, Weatherburn R, Rooney PS. Cost effectiveness of using Faecal Immunochemical Testing (FIT) as an initial diagnostic investigation for patients with lower gastrointestinal symptoms suggestive of malignancy. BMC FAMILY PRACTICE 2021; 22:90. [PMID: 33980161 PMCID: PMC8117514 DOI: 10.1186/s12875-021-01435-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/10/2021] [Accepted: 04/05/2021] [Indexed: 12/05/2022]
Abstract
Background There has been an increase in the numbers of patients presenting to primary care with suspected colorectal malignancy and subsequently an increase in demand for endoscopy. This study aims to forecast the cost of faecal immunochemical testing (FIT) compared to conventional diagnostic tests as a primary investigation for patients with symptoms suggestive of colorectal malignancy. Methods Retrospectively, 1950 patients with symptoms suggestive of colorectal malignancy who were referred through primary care and underwent investigations through standard endoscopic evaluation were included. These patients were used to forecast the cost of faecal immunochemical testing creating theoretical data for sensitivity and specificity. Outcome measures included: the number of investigations under current protocol; cost of current investigations; number of predicted false negatives and false positives and positive/negative predictive values using current sensitivity data for FIT; the cost forecast of using FIT as the primary investigation for colorectal malignancy. Results Median age was 65 (IQR 47–82) with 43.7% male and 56.3% female. A total of 1950 investigations were carried out with a diagnostic yield of 26 cancers (18 colon, 8 rectal), 138 polyps and 29 high risk adenomas (HGD ± > 10 mm). In total, £713,948 was spent on the investigations. The commonest investigation was colonoscopy totalling £533,169. The total cost per cancer diagnosis was £27,459. Sensitivity (92.1% CI 86.9–95.3) and specificity (85.8% CI 78.3–90.1) for FIT in colorectal cancer was taken from NICE and was costed via the manufacturer(s). The projected total cost of FIT for the same population using a ≥ 4 μg haemoglobin cut off was £415,680 (£15,554 per cancer). The total cost of high-risk polyps using ≥ 4 μg cut off was £404,427 (sensitivity 71.2% CI 60.5–87.2, specificity 79.8%CI 76.1–83.7) or £13,945 per polyp. Conclusions FIT is a cheaper and effective alternative test with the potential to replace current expensive methods. The forecast is based on the limited data available for sensitivity/specificity in the current literature. FIT has now been commenced for symptomatic patients in the UK and therefore sensitivity may change in the future. Supplementary Information The online version contains supplementary material available at 10.1186/s12875-021-01435-7.
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Affiliation(s)
| | - C Graham
- Department of Coloproctology, Halton Teaching Hospitals NHS Foundation Trust, Warrington, UK
| | - H S Lobb
- Bristol Royal Infirmary, Bristol, UK.
| | - J Chacko
- University of Liverpool, Liverpool, UK
| | - R Weatherburn
- Department of Colorectal Surgery, Royal Liverpool University Hospital, Liverpool, UK
| | - P S Rooney
- Department of Colorectal Surgery, Royal Liverpool University Hospital, Liverpool, UK
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20
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Rodríguez-Alonso L, Rodríguez-Moranta F, Maisterra S, Botargues JM, Berrozpe A, Ruíz-Cerulla A, Suris G, Camps B, Gornals JB, Guardiola J. The EPAGE guidelines are not an effective strategy for managing colonoscopies during the COVID-19 pandemic. GASTROENTEROLOGIA Y HEPATOLOGIA 2021; 45:9-17. [PMID: 33545240 PMCID: PMC8054645 DOI: 10.1016/j.gastrohep.2020.11.020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/03/2020] [Revised: 11/15/2020] [Accepted: 11/28/2020] [Indexed: 11/10/2022]
Abstract
Introducción La pandemia producida por el virus SARS-CoV-2 ha generado un grave impacto en el funcionamiento de las unidades de endoscopia digestiva. La Asociación Española de Gastroenterología y la Sociedad Española de Endoscopia Digestiva (AEG-SEED) han propuesto la utilización de la guía European Panel on the Appropriateness of Gastrointestinal Endoscopy II (EPAGE) para la gestión de las colonoscopias pospuestas. Objetivo Evaluar la guía EPAGE como herramienta de gestión en comparación con el test de sangre oculta en heces inmunológico (TSOHi) y con una calculadora de riesgo (CR), que incluye la edad, el sexo y el TSOHi, para la detección de cáncer colorrectal (CCR) y lesión significativa colónica (LSC). Métodos Estudio unicéntrico prospectivo. Se incluyeron 743 pacientes derivados para una colonoscopia diagnóstica. Se clasificó cada solicitud según EPAGE en apropiada, indeterminada e inapropiada. Se les entregó un TSOHi y se calculó el valor de la CR. Resultados El TSOHi (p<0,001), pero no EPAGE (p = 0,742), fue una variable independiente de riesgo de CCR. El área bajo la curva receiver operating characteristic (ROC) de EPAGE, TSOHi y CR fue: 0,61(IC 95% 0,49 a 0,75), 0,95 (0,93 a 0,97) y 0,90 (0,87 a 0,93) para CCR; y 0,55 (0,49 a 0,61), 0,75 (0,69 a 0,813) y 0,78 (0,73 a 0,83) para LSC, respectivamente. El número necesario de colonoscopias para detectar un CCR y una LSC fue de 38 y siete para EPAGE, de siete y dos para TSOHi, y de 19 y cuatro para CR ≥ cinco puntos, respectivamente. Conclusión La EPAGE, a diferencia del TSOHi, no es adecuada para seleccionar a los pacientes candidatos a colonoscopia diagnóstica para la detección de CCR. El TSOHi, en combinación con la edad y el sexo, es la estrategia correcta para gestionar la demanda de endoscopia en un escenario de acceso restrictivo.
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Affiliation(s)
- Lorena Rodríguez-Alonso
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España.
| | | | - Sandra Maisterra
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Josep M Botargues
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Ana Berrozpe
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Alexandra Ruíz-Cerulla
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Gerard Suris
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Blau Camps
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Joan B Gornals
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
| | - Jordi Guardiola
- Servicio de Aparato Digestivo, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, España
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Mowat C, Digby J, Strachan JA, McCann RK, Carey FA, Fraser CG, Steele RJ. Faecal haemoglobin concentration thresholds for reassurance and urgent investigation for colorectal cancer based on a faecal immunochemical test in symptomatic patients in primary care. Ann Clin Biochem 2021; 58:211-219. [PMID: 33334134 PMCID: PMC8114428 DOI: 10.1177/0004563220985547] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Background Faecal haemoglobin concentration (f-Hb), estimated using a faecal immunochemical test, can be safely implemented in primary care to assess risk of colorectal cancer (CRC). Clinical outcomes of patients presenting with symptoms of lower gastrointestinal disease were examined using an extensive range of f-Hb thresholds to decide on reassurance or referral for further investigation. Methods All patients who attended primary care and submitted a single faecal specimen faecal immunochemical test in the first year of the routine service had f-Hb estimated using HM-JACKarc: f-Hb thresholds from <2 to ≥ 400 µg Hb/g faeces (µg/g) were examined. Results Low f-Hb thresholds of <2, <7, <10 and <20 µg/g gave respective CRC risks of 0.1, 0.3, 0.3 and 0.4%, numbers needed to scope for one CRC of 871, 335, 300 and 249, and ‘false negative’ rates of 2.9, 11.4, 13.3 and 17.1%. With thresholds of <2, <7, <10 and <20 µg/g, 48.6, 74.6, 78.1 and 83.2% respectively of symptomatic patients could be managed without further investigation. With reassurance thresholds of <2 µg/g, <7 µg/g and <10 µg/g, the thresholds for referral for urgent investigation would be >400 µg/g, ≥200 µg/g and ≥100 µg/g. However, patients with a f-Hb concentration of <10 or <20 µg/g with iron deficiency anaemia, or with severe or persistent symptoms, should not be denied further investigation. Conclusions In primary care, f-Hb, in conjunction with clinical assessment, can safely and objectively determine individual risk of CRC and decide on simple reassurance or urgent, or routine referral.
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Affiliation(s)
- Craig Mowat
- Department of Gastroenterology, University of Dundee, School of Medicine Ninewells Hospital and Medical School, Dundee, Scotland, UK
| | - Jayne Digby
- Centre for Research into Cancer Prevention and Screening, University of Dundee, School of Medicine, Ninewells Hospital and Medical School, Dundee, Scotland, UK
| | - Judith A Strachan
- Department of Blood Sciences, Ninewells Hospital and Medical School, NHS Tayside, Dundee, Scotland, UK
| | - Rebecca K McCann
- Department of Blood Sciences, Ninewells Hospital and Medical School, NHS Tayside, Dundee, Scotland, UK
| | - Francis A Carey
- Department of Pathology, Ninewells Hospital and Medical School, NHS Tayside, Dundee, Scotland, UK
| | - Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, School of Medicine, Ninewells Hospital and Medical School, Dundee, Scotland, UK
| | - Robert Jc Steele
- Centre for Research into Cancer Prevention and Screening, University of Dundee, School of Medicine, Ninewells Hospital and Medical School, Dundee, Scotland, UK
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22
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Högberg C, Gunnarsson U, Jansson S, Thulesius H, Cronberg O, Lilja M. Diagnosing colorectal cancer in primary care: cohort study in Sweden of qualitative faecal immunochemical tests, haemoglobin levels, and platelet counts. Br J Gen Pract 2020; 70:e843-e851. [PMID: 33139332 PMCID: PMC7643823 DOI: 10.3399/bjgp20x713465] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2020] [Accepted: 05/13/2020] [Indexed: 01/12/2023] Open
Abstract
BACKGROUND Colorectal cancer (CRC) diagnostics are challenging in primary care and reliable diagnostic aids are desired. Qualitative faecal immunochemical tests (FITs) have been used for suspected CRC in Sweden since the mid-2000s, but evidence regarding their effectiveness is scarce. Anaemia and thrombocytosis are both associated with CRC. AIM To evaluate the usefulness of qualitative FITs requested for symptomatic patients in primary care, alone and combined with findings of anaemia and thrombocytosis, in the diagnosis of CRC. DESIGN AND SETTING A population-based cohort study using electronic health records and data from the Swedish Cancer Register, covering five Swedish regions. METHOD Patients aged ≥18 years in the five regions who had provided FITs requested by primary care practitioners from 1 January 2015 to 31 December 2015 were identified. FIT and blood-count data were registered and all CRC diagnoses made within 2 years were retrieved. Diagnostic measurements were calculated. RESULTS In total, 15 789 patients provided FITs (four different brands); of these patients, 304 were later diagnosed with CRC. Haemoglobin levels were available for 13 863 patients, and platelet counts for 10 973 patients. Calculated for the different FIT brands only, the sensitivities for CRC were 81.6%-100%; specificities 65.7%-79.5%; positive predictive values 4.7%-8.1%; and negative predictive values 99.5%-100%. Calculated for the finding of either a positive FIT or anaemia, the sensitivities increased to 88.9-100%. Adding thrombocytosis did not further increase the diagnostic performance. CONCLUSION Qualitative FITs requested in primary care seem to be useful as rule-in tests for referral when CRC is suspected. A negative FIT and no anaemia indicate a low risk of CRC.
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Affiliation(s)
| | - Ulf Gunnarsson
- Department of Surgical and Perioperative Sciences, Umeå University, Umeå
| | - Stefan Jansson
- University Health Care Research Centre, Örebro University, Örebro
| | - Hans Thulesius
- Department of Clinical Sciences, Lund University, Malmö; professor of primary care, Department of Medicine and Optometry, Linnaeus University, Kalmar
| | - Olof Cronberg
- Department of Clinical Sciences, Lund University, Malmö
| | - Mikael Lilja
- Department of Public Health and Clinical Medicine
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Khan AA, Klimovskij M, Harshen R. Accuracy of faecal immunochemical testing in patients with symptomatic colorectal cancer. BJS Open 2020; 4:1180-1188. [PMID: 32949085 PMCID: PMC7709370 DOI: 10.1002/bjs5.50346] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2019] [Accepted: 07/23/2020] [Indexed: 01/22/2023] Open
Abstract
BACKGROUND The aim of this study was to determine the diagnostic accuracy of the faecal immunochemical test (FIT) for detecting colorectal cancer in symptomatic patients. METHODS This was a prospective study of patients with bowel symptoms. Stool samples were collected during rectal examination. The HM-JACKarc assay (Kyowa Medex, Tokyo, Japan) was used to quantify faecal haemoglobin (Hb); positive results were those with at least 10 μg Hb/g faeces. Two-by-two tables and receiver operating characteristic (ROC) curve analysis were used to determine diagnostic accuracy; χ2 and Mann-Whitney U tests were used to compare other parameters. RESULTS A total of 928 patients were included (M : F ratio 1 : 1·5; median age 72 (i.q.r. 64-80) years). The overall prevalence of colorectal cancer was 5·1 per cent. The FIT had sensitivity of 85·1 per cent, specificity of 83·5 per cent, positive predictive value of 22·6 per cent and negative predictive value of 99·0 per cent. ROC analysis of FIT for diagnosing colorectal cancer gave an area under the curve value of 0·89 (95 per cent c.i. 0·84 to 0·94). Significant bowel pathology was detected more frequently in FIT-positive patients (35·1 per cent versus 7·1 per cent in FIT-negative patients; P < 0·001). There were sex differences in FIT positivity (23·7 per cent in men versus 17·4 per cent in women; P = 0·019); the sensitivity of FIT for colorectal cancer in women was also low. False-negative FIT results were found mainly in women referred with iron-deficiency anaemia, who were found to have caecal cancer. CONCLUSION FIT effectively excluded colorectal cancer in symptomatic patients. Integration of FIT into the diagnostic pathway for colorectal cancer would direct resources appropriately to patients with a greater likelihood of having the disease.
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Affiliation(s)
- A. A. Khan
- Departments of SurgeryConquest Hospital, St Leonards‐on‐Sea, and Eastbourne District General HospitalEastbourneUK
| | - M. Klimovskij
- Departments of SurgeryConquest Hospital, St Leonards‐on‐Sea, and Eastbourne District General HospitalEastbourneUK
| | - R. Harshen
- Departments of SurgeryConquest Hospital, St Leonards‐on‐Sea, and Eastbourne District General HospitalEastbourneUK
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Gutierrez-Stampa MA, Aguilar V, Sarasqueta C, Cubiella J, Portillo I, Bujanda L. Impact of the faecal immunochemical test on colorectal cancer survival. BMC Cancer 2020; 20:616. [PMID: 32611328 PMCID: PMC7328266 DOI: 10.1186/s12885-020-07074-y] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2020] [Accepted: 06/15/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND There is already evidence that the faecal immunochemical test (FIT) is a useful tool for the diagnosis of colorectal cancer (CRC) that helps to identify symptomatic patients requiring early colonoscopy. Although the recommendation to use FIT is widely accepted, there are no data concerning whether this strategy improves patient survival.The objective was to assess whether the survival is higher if CRC patients have been first diagnosed by FIT (as compared with the rest of patients with CRC). METHODS We identified all cases of CRC diagnosed between 2009 and 2016 in Donostialdea (Spain), excluding all the CRC detected in population screening. We focused on symptomatic patients. One thousand five hundred twenty-seven cases of CRC were divided into two groups based on the route to diagnosis: group 1: individuals who tested positive in a FIT during the year before diagnosis, and group 2: others.Survival was assessed by Kaplan-Meier estimation, and with the log-rank test. A Cox regression model was used to adjust for differences between groups due to other variables associated with survival. RESULTS One thousand nine hundred sixty-seven cases of invasive CRC were identified, of which 22.4% were detected in population screening. Of the 1527 cases diagnosed in symptomatic patients, 317 patients had undergone a FIT in the year before the diagnosis of CRC. In 279 cases(18.3%), the result had been positive and this was the first step towards their CRC diagnosis (group 1). Group 2 was composed of the 1248 cases of CRC (81.7%). Considering these cases, 1210 patients with CRC did not undergo any FIT while 38 patients presented a negative result in the year before the diagnosis. The rate of early-stage disease (stage I or II) was higher in group 1 (51.3% vs 45.5% in group 2) (p = 0.04). Furthermore, the 3-year survival was longer in group 1 (72% vs 59% in group 2) (HR 1.50; 95% CI 1.22-1.84).The variables independently associated with worse survival were: group 2, age > 70 years and stage at the moment of diagnosis. CONCLUSIONS The use of FIT as a diagnostic strategy in symptomatic patients may improve survival in CRC. Nonetheless,FIT is still not widely used in our region.
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Affiliation(s)
| | - Vanessa Aguilar
- Osakidetza, OSI Donostialdea, Altza Primary Care; Biodonostia Health Research Institute, San Sebastián, Spain
| | - Cristina Sarasqueta
- Biodonostia Health Research Institute, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), San Sebastián, Spain
- Osakidetza, Hospital Universitario Donostia, San Sebastian, Spain
| | - Joaquín Cubiella
- Gastroenterology Department, Complejo Hospitalario Universitario de Ourense, Ourense, Spain
| | - Isabel Portillo
- Colorectal Cancer Screening Programme, Osakidetza, Basque Health Service, Bilbao, Spain
| | - Luis Bujanda
- BIOEF: the Basque Foundation for Health Innovation and Research, Department of Gastroenterology, Biodonostia Institute, Avda Paseo Beguiristain s/n 20014, San Sebastián, Spain.
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25
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Högberg C, Karling P, Rutegård J, Lilja M. Patient-reported and doctor-reported symptoms when faecal immunochemical tests are requested in primary care in the diagnosis of colorectal cancer and inflammatory bowel disease: a prospective study. BMC FAMILY PRACTICE 2020; 21:129. [PMID: 32611307 PMCID: PMC7331274 DOI: 10.1186/s12875-020-01194-x] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/16/2020] [Accepted: 06/15/2020] [Indexed: 01/19/2023]
Abstract
BACKGROUND Rectal bleeding and a change in bowel habits are considered to be alarm symptoms for colorectal cancer and they are also common symptoms for inflammatory bowel disease. However, most patients with these symptoms do not have any of these diseases. Faecal immunochemical tests (FITs) for haemoglobin are used as triage tests in Sweden and other countries but little is known about the symptoms patients have when FITs are requested. OBJECTIVE Firstly, to determine patients' symptoms when FITs are used as triage tests in primary care and whether doctors record the symptoms that patients report, and secondly to evaluate the association between symptoms, FIT results and possible prediction of colorectal cancer or inflammatory bowel disease. METHODS AND MATERIALS This prospective study included 364 consecutive patients for whom primary care doctors requested a FIT. Questionnaires including gastrointestinal symptoms were completed by patients and doctors. RESULTS Concordance between symptoms reported from patients and doctors was low. Rectal bleeding was recorded by 43.5% of patients versus 25.6% of doctors, FITs were negative in 58.3 and 52.7% of these cases respectively. The positive predictive value (PPV) of rectal bleeding recorded by patients for colorectal cancer or inflammatory bowel disease was 9.9% (95% confidence interval [CI] 5.2-14.7); for rectal bleeding combined with a FIT the PPV was 22.6% (95% CI 12.2-33.0) and the negative predictive value (NPV) was 98.9% (95% CI 96.7-100). For patient-recorded change in bowel habits the PPV was 6.1% (95% CI 2.4-9.8); for change in bowel habits combined with a FIT the PPV was 18.2% (95% CI 9.1-30.9) and the NPV 100% (95% CI 90.3-100). CONCLUSIONS Doctors should be aware that, during consultations, they do not record all symptoms experienced by patients. FITs requested in primary care, when found positive, may potentially be of help in prioritising referrals, also when patients present with rectal bleeding or change in bowel habits.
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Affiliation(s)
- Cecilia Högberg
- Department of Public Health and Clinical Medicine, Unit of Research, Education and Development – Östersund, Östersund Hospital, Umeå University, Umeå, Sweden
| | - Pontus Karling
- Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University, Umeå, Sweden
| | - Jörgen Rutegård
- Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden
| | - Mikael Lilja
- Department of Public Health and Clinical Medicine, Unit of Research, Education and Development – Östersund, Östersund Hospital, Umeå University, Umeå, Sweden
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26
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Chang WY, Chiu HM. Bringing fecal immunochemical test into play in symptomatic population: Exploring the feasibility of fecal immunochemical test-symptom combined approach. J Gastroenterol Hepatol 2020; 35:911-912. [PMID: 32537752 DOI: 10.1111/jgh.15100] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Affiliation(s)
- Wei-Yuan Chang
- Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan
| | - Han-Mo Chiu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
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27
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Lué A, Hijos G, Sostres C, Perales A, Navarro M, Barra MV, Mascialino B, Andalucia C, Puente JJ, Lanas Á, Gomollon F. The combination of quantitative faecal occult blood test and faecal calprotectin is a cost-effective strategy to avoid colonoscopies in symptomatic patients without relevant pathology. Therap Adv Gastroenterol 2020; 13:1756284820920786. [PMID: 32523623 PMCID: PMC7235671 DOI: 10.1177/1756284820920786] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2019] [Accepted: 03/20/2020] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND Faecal occult blood test (FOBT) has demonstrated effectiveness in colorectal cancer (CRC) screening. Faecal calprotectin (FC) has proven efficient for evaluating activity in inflammatory bowel disease (IBD), but its value in CRC detection is less established. Most symptomatic patients have benign pathologies, but still undergo colonoscopy in many settings. AIMS To evaluate the diagnostic accuracy and cost-effectiveness of the combination of FOBT plus FC in symptomatic patients. METHODS Patients who completed colonic investigations and returned stool samples, on which FOBT and FC were performed, were recruited prospectively. CRC, advanced adenoma, IBD and angiodysplasia were considered as relevant pathologies. RESULTS A total of 404 patients were included, of whom 87 (21.5%) had relevant pathologies. Sensitivity and specificity were 50.6% and 69.6% for FOBT, 78.2% and 54.4% for FC. Negative predictive value (NPV) was 90.1% for FC and 86.9% for FOBT. NPV for the combination of FOBT and FC was 94.1%, with a sensitivity and specificity of 88.5% and 50.3%. The area under ROC (receiver operator curve) (AUC) was 0.741 for FOBT, 0.736 for FC and 0.816 for the combination. The total cost for visits and procedures was €233,016 (€577/patient). Using a combination of FOBT and FC as pre-endoscopic tool allows colonoscopies to be reduced by 39.4%, reducing total costs by 20.5%. CONCLUSION The combination of FOBT and FC has a better diagnostic accuracy compared with each test alone. Performing both tests before colonoscopy is a less costly and more effective strategy, reducing unnecessary procedures and complications.
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Affiliation(s)
- Alberto Lué
- Hospital Clínico Universitario Lozano Blesa, Servicio de Aparato Digestivo, Zaragoza, Spain,Instituto de Investigación Sanitaria Aragón, Zaragoza, Spain
| | | | - Carlos Sostres
- Hospital Clínico Universitario Lozano Blesa, Servicio de Aparato Digestivo, Zaragoza, Spain,Instituto de Investigación Sanitaria Aragón, Zaragoza, Spain,CIBERehd, Madrid, Spain
| | | | - Mercedes Navarro
- Hospital Clínico Universitario Lozano Blesa, Servicio de Aparato Digestivo, Zaragoza, Spain,Instituto de Investigación Sanitaria Aragón, Zaragoza, Spain
| | - Maria Victoria Barra
- Hospital Clínico Universitario Lozano Blesa, Servicio de Bioquímica, Zaragoza, Spain
| | | | | | - Juan José Puente
- Hospital Clínico Universitario Lozano Blesa, Servicio de Bioquímica, Zaragoza, Spain
| | - Ángel Lanas
- Hospital Clínico Universitario Lozano Blesa, Servicio de Aparato Digestivo, Zaragoza, Spain,Instituto de Investigación Sanitaria Aragón, Zaragoza, Spain,CIBERehd, Madrid, Spain Universidad de Zaragoza, Zaragoza, Spain
| | - Fernando Gomollon
- Hospital Clínico Universitario Lozano Blesa, Servicio de Aparato Digestivo, Zaragoza, Spain,Instituto de Investigación Sanitaria Aragón, Zaragoza, Spain,CIBERehd, Madrid, Spain Universidad de Zaragoza, Zaragoza, Spain
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Tsapournas G, Hellström PM, Cao Y, Olsson LI. Diagnostic accuracy of a quantitative faecal immunochemical test vs. symptoms suspected for colorectal cancer in patients referred for colonoscopy. Scand J Gastroenterol 2020; 55:184-192. [PMID: 31906738 DOI: 10.1080/00365521.2019.1708965] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
Objective: Determine diagnostic accuracy of a quantitative faecal immunochemical haemoglobin test (QuikRead go® FIT, Orion Diagnostica Oy) in symptomatic patients referred for colonoscopy, at various cut-offs and for one or two tests.Methods: Patients referred to four endoscopy units in mid-Sweden between 2013 and 2017 provided information on lower abdominal symptoms and faecal samples from two separate days prior to colonoscopy.Results: In all, 5.4% (13/242) patients had colorectal cancer (CRC). For one FIT at cut-off 10 µg Hb/g faeces, sensitivity for CRC was 92% (95% CI 78-100%) and specificity 77% (95% CI 72-83%); equal to 74%; 95% CI 68-80 (178/242) colonoscopies potentially avoidable and one CRC missed. Based on the maximal outcome of two FITs, sensitivity was 100%, specificity 71% (66-77%) and 68%; 95% CI 62-74 (160/237) colonoscopies potentially avoidable. Among 17% (42/242) patients with one FIT of >200 µg Hb/g faeces, 85% (11/13) had CRC. Positive predictive values of FIT varied 16.9-26.2% depending on cut-off and one or two FITs, whereas NPVs were 99% and above in all scenarios.In 60 patients reporting rectal bleeding, one FIT at cut-off 10 µg Hb/g discriminated well between CRC and other conditions (p = .001). In regression models, FIT was more important than age, sex and all symptoms.Conclusion: One or two FITs in symptomatic patients referred for colonoscopy imply powerful risk stratification abilities for CRC, even among patients reporting rectal bleeding. Larger studies in various settings will clarify how to make the best use of this opportunity. Trial registration: Clinicaltrails.gov NCT02491593.
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Affiliation(s)
| | - Per M Hellström
- Department of Medical Sciences, Uppsala University, Uppsala, Sweden
| | - Yang Cao
- Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Sweden
| | - Louise I Olsson
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.,Camtö, Örebro University Hospital, Örebro, Sweden
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Cornish JS, Wirthgen E, Däbritz J. Biomarkers Predictive of Response to Thiopurine Therapy in Inflammatory Bowel Disease. Front Med (Lausanne) 2020; 7:8. [PMID: 32064265 PMCID: PMC7000528 DOI: 10.3389/fmed.2020.00008] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2019] [Accepted: 01/10/2020] [Indexed: 12/15/2022] Open
Abstract
The complex nature of inflammatory bowel disease (IBD) often results in treatment failure for many patients. With some patients cycling through multiple therapies before achieving a sustained period of remission, the ability to predict a patient's response to therapeutics could decrease the time from active disease to clinical remission and mucosal healing. The prospect of such individualized treatment of IBD would be aided by accurate biomarkers, both fecal and serological, which have to date shown value as indicators of IBD activity. Here we review the utility of generic biomarkers for inflammation or mucosal healing, such as calprotectin, C-reactive protein (CRP), and fecal hemoglobin (fHb) as predictors of response to treatment of IBD. We further provide a deeper insight into the utility of monitoring the thiopurine treatment by thiopurine metabolites or alternative hematologic parameters. In light of multiple recent publications of biomarkers and biological therapy, our focus in this review is predicting response to thiopurine treatment only, that is, Azathioprine and 6-Mercaptopurine.
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Affiliation(s)
- Jack S Cornish
- University Hospital Geelong, Barwon Health, Geelong, VIC, Australia
| | - Elisa Wirthgen
- Department of Pediatrics, Rostock University Medical Center, Rostock, Germany
| | - Jan Däbritz
- Department of Pediatrics, Rostock University Medical Center, Rostock, Germany.,Center for Immunobiology, The Barts and the London School of Medicine and Dentistry, Blizard Institute, Barts Cancer Institute, Queen Mary University, London, United Kingdom
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30
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Fraser CG, Benton SC. Detection capability of quantitative faecal immunochemical tests for haemoglobin (FIT) and reporting of low faecal haemoglobin concentrations. Clin Chem Lab Med 2019; 57:611-616. [PMID: 29995629 DOI: 10.1515/cclm-2018-0464] [Citation(s) in RCA: 35] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/01/2018] [Accepted: 06/05/2018] [Indexed: 01/25/2023]
Abstract
Faecal immunochemical tests for haemoglobin (FIT) are widely used in asymptomatic population screening for colorectal (bowel) cancer. FIT are also used to assist with the assessment of patients presenting with lower abdominal symptoms. Quantitative FIT allow the generation of numerical estimates of faecal haemoglobin (f-Hb) concentrations. There is now great interest in "low" f-Hb concentrations in these clinical settings: in consequence, knowledge of the detection capability is very important for f-Hb concentration examinations. There are a number of current problems associated with the reporting of low f-Hb concentrations and wide misunderstanding of the metrological aspects of examinations of f-Hb at low concentrations. These would be solved if the detectability characteristics of f-Hb concentration examinations, namely, the limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ), were generated, validated and used in reporting systems exactly as recommended in the EP17-A2 guideline of the Clinical Laboratory Standards Institute. LoB and LoD are statistical concepts, but the LoQ depends on definition of analytical performance specifications (APS). In this Opinion Paper proposals for interim APS are made, based on the current state of the art achieved with examinations of faecal samples. It is proposed that LoQ is determined at an examination imprecision of CV≤10% using faecal samples naturally positive for Hb rather than faeces spiked with haemolysate. Detailed proposals for reporting f-Hb data at low concentrations are also made.
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Affiliation(s)
- Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, Scotland, UK
| | - Sally C Benton
- NHS Bowel Cancer Screening Programme, Southern Hub, Royal Surrey County Hospital NHS Foundation Trust, Guildford, Surrey, UK
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Chuter C, Keding A, Holmes H, Turnock D, Turvill J. Getting the best out of faecal immunochemical tests and faecal calprotectin. Frontline Gastroenterol 2019; 11:414-416. [PMID: 32884634 PMCID: PMC7447280 DOI: 10.1136/flgastro-2019-101381] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/27/2019] [Revised: 12/09/2019] [Accepted: 12/13/2019] [Indexed: 02/04/2023] Open
Affiliation(s)
- Charlotte Chuter
- Gastroenterology, York Teaching Hospital NHS Foundation Trust, York, North Yorkshire, UK
| | - Ada Keding
- Health Sciences, University of York, York, North Yorkshire, UK
| | - Hayden Holmes
- York Health Economics Consortium, York, North Yorkshire, UK
| | - Daniel Turnock
- Biochemistry, York Teaching Hospital NHS Foundation Trust, York, North Yorkshire, UK
| | - James Turvill
- Gastroenterology, York Teaching Hospital NHS Foundation Trust, York, North Yorkshire, UK
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32
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Karling P, Lundgren D, Eklöf V, Palmqvist R, Hultdin J. Improved monitoring of inflammatory activity in patients with ulcerative colitis by combination of faecal tests for haemoglobin and calprotectin. Scandinavian Journal of Clinical and Laboratory Investigation 2019; 79:341-346. [PMID: 31164011 DOI: 10.1080/00365513.2019.1622148] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
Faecal calprotectin (FC) tests and faecal immunological tests (FIT) for haemoglobin have been used to monitor disease activity in patients with ulcerative colitis (UC) but used alone they have some limitation concerning the predictive ability. We aimed to test if an FC test used in combination with FIT could improve the predictive ability. Consecutive out-patients with UC (n = 93) who were admitted for colonoscopy completed a single faecal sample before the start of bowel preparation. A quantitative CALPRO® calprotectin ELISA test and a qualitative FIT (cut-off < 40 ng/mL) were analyzed. An estimated Mayo score and a score of histological inflammation was performed blinded to the result of the faecal tests. The sensitivity, specificity, negative predictive value and positive predictive value for endoscopic inflammation (Mayo score > 1) was for FIT 85%, 83%, 96%, 57% and for FC > 186 µg/g 73%, 87%, 87%, 54%. Corresponding results for FIT*FC > 186 µg/g (at least one test positive) were 92%, 69%, 97%, 43%. For detecting moderate/severe histological inflammation the results were for FIT 69%, 79%, 92%, 43%, for FC > 75 µg/g 95%, 62%, 98%, 41%, and for FIT*FC > 75 µg/g 100%, 60%, 100%, 36%. None of the markers alone or in combination were useful to predict deep remission (Mayo score = 0 and no histological inflammation). We conclude that using the combination of an FC test and FIT shows minor improvement in predictive ability for inflammatory activity and remission in patients with UC.
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Affiliation(s)
- Pontus Karling
- a Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University , Umeå , Sweden
| | - David Lundgren
- a Department of Public Health and Clinical Medicine, Division of Medicine, Umeå University , Umeå , Sweden
| | - Vincy Eklöf
- b Department of Medical Biosciences, Division of Pathology, Umeå University , Umeå , Sweden
| | - Richard Palmqvist
- b Department of Medical Biosciences, Division of Pathology, Umeå University , Umeå , Sweden
| | - Johan Hultdin
- c Department of Medical Biosciences, Division of Clinical Chemistry, Umeå University , Umeå , Sweden
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Pin Vieito N, Zarraquiños S, Cubiella J. High-risk symptoms and quantitative faecal immunochemical test accuracy: Systematic review and meta-analysis. World J Gastroenterol 2019; 25:2383-2401. [PMID: 31148909 PMCID: PMC6529892 DOI: 10.3748/wjg.v25.i19.2383] [Citation(s) in RCA: 38] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2019] [Revised: 03/20/2019] [Accepted: 03/29/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The quantitative faecal immunochemical test for haemoglobin (FIT) has been revealed to be highly accurate for colorectal cancer (CRC) detection not only in a screening setting, but also in the assessment of patients presenting lower bowel symptoms. Therefore, the National Institute for Health and Care Excellence has recommended the adoption of FIT in primary care to guide referral for suspected CRC in low-risk symptomatic patients using a 10 µg Hb/g faeces threshold. Nevertheless, it is unknown whether FIT´s accuracy remains stable throughout the broad spectrum of possible symptoms. AIM To perform a systematic review and meta-analysis to assess FIT accuracy for CRC detection in different clinical settings. METHODS A systematic literature search was performed using MEDLINE and EMBASE databases from inception to May 2018 to conduct a meta-analysis of prospective studies including symptomatic patients that evaluated the diagnostic accuracy of quantitative FIT for CRC detection. Studies were classified on the basis of brand, threshold of faecal haemoglobin concentration for a positive test result, percentage of reported symptoms (solely symptomatic, mixed cohorts) and CRC prevalence (< 2.5%, ≥ 2.5%) to limit heterogeneity and perform subgroup analysis to assess the influence of clinical spectrum on FIT´s accuracy to detect CRC. RESULTS Fifteen cohorts including 13073 patients (CRC prevalence 0.4% to 16.8%) were identified. Pooled estimates of sensitivity for studies using OC-Sensor at 10 µg Hb/g faeces threshold (n = 10400) was 89.6% [95% confidence interval (CI): 82.7% to 94.0%). However, pooled estimates of sensitivity for studies formed solely by symptomatic patients (n = 4035) and mixed cohorts (n = 6365) were 94.1% (95%CI: 90.0% to 96.6%) and 85.5% (95%CI: 76.5% to 91.4%) respectively (P < 0.01), while there were no statistically significant differences between pooled sensitivity of studies with CRC prevalence < 2.5% (84.9%, 95%CI: 73.4% to 92.0%) and ≥ 2.5% (91.7%, 95%CI: 83.3% to 96.1%) (P = 0.25). At the same threshold, OC-Sensor® sensitivity to rule out any significant colonic lesion was 78.6% (95%CI: 75.6% to 81.4%). We found substantial heterogeneity especially when assessing specificity. CONCLUSION The results of this meta-analysis confirm that, regardless of CRC prevalence, quantitative FIT is highly sensitive for CRC detection. However, FIT ability to rule out CRC is higher in studies solely including symptomatic patients.
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Affiliation(s)
- Noel Pin Vieito
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense 32005, Spain
- Instituto de Investigación Sanitaria Galicia Sur, Ourense 32005, Spain
- Department of Biochemistry, Genetics and Immunology, Faculty of Biology University of Vigo, Vigo 36310, Pontevedra, Spain
| | - Sara Zarraquiños
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense 32005, Spain
- Instituto de Investigación Sanitaria Galicia Sur, Ourense 32005, Spain
| | - Joaquín Cubiella
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense 32005, Spain
- Instituto de Investigación Sanitaria Galicia Sur, Ourense 32005, Spain
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Mowat C, Digby J, Strachan JA, McCann R, Hall C, Heather D, Carey F, Fraser CG, Steele RJC. Impact of introducing a faecal immunochemical test (FIT) for haemoglobin into primary care on the outcome of patients with new bowel symptoms: a prospective cohort study. BMJ Open Gastroenterol 2019; 6:e000293. [PMID: 31275586 PMCID: PMC6577357 DOI: 10.1136/bmjgast-2019-000293] [Citation(s) in RCA: 65] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/25/2019] [Revised: 03/28/2019] [Accepted: 04/01/2019] [Indexed: 12/14/2022] Open
Abstract
Objective To determine whether a faecal immunochemical test (FIT) for faecal haemoglobin concentration (f-Hb) can be safely implemented in primary care as a rule-out test for significant bowel disease (SBD) (colorectal cancer (CRC), higher risk adenoma (HRA) and inflammatory bowel disease (IBD)) when used as an adjunct to the clinical assessment of new bowel symptoms. Design Single-centre prospective cohort study of all patients who attended primary care and submitted a FIT in the first calendar year of the service beginning December 2015. f-Hb was estimated using HM-JACKarc (Kyowa Medex) with a clinical cut-off of ≥10 µg Hb/g faeces. Incident cases of CRC were verified via anonymised record linkage to the Scottish Cancer Registry. Results 5422 patients submitted 5660 FIT specimens, of which 5372 were analysed (positivity: 21.9%). 2848 patients were referred immediately to secondary care and three with f-Hb <10 µg/g presented acutely within days with obstructing CRC. 1447 completed colonoscopy in whom overall prevalence of SBD was 20.5% (95 CRC (6.6%), 133 HRA (9.2%) and 68 IBD (4.7%)); 6.6% in patients with f-Hb <10 µg/g vs 32.3% in patients with f-Hb ≥10 µg/g. One CRC was detected at CT colonoscopy. 2521 patients were not immediately referred (95.3% had f-Hb <10 µg/g) of which four (0.2%) later developed CRC. Record linkage identified no additional CRC cases within a follow-up period of 23–35 months. Conclusion In primary care, measurement of f-Hb, in conjunction with clinical assessment, can safely and objectively determine a patient’s risk of SBD.
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Affiliation(s)
- Craig Mowat
- Department of Gastroenterology, Ninewells Hospital and Medical School, Dundee, UK
| | - Jayne Digby
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | - Judith A Strachan
- Department of Blood Sciences, Ninewells Hospital and Medical School, Dundee, UK
| | - Rebecca McCann
- Department of Blood Sciences, Ninewells Hospital and Medical School, Dundee, UK
| | | | - Duncan Heather
- Health Informatics Centre, University of Dundee, Dundee, UK
| | - Francis Carey
- Department of Pathology, Ninewells Hospital and Medical School, Dundee, UK
| | - Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | - Robert J C Steele
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
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Von Wagner C, Stoffel ST, Freeman M, Laszlo HE, Nicholson BD, Sheringham J, Szinay D, Hirst Y. General practitioners' awareness of the recommendations for faecal immunochemical tests (FITs) for suspected lower gastrointestinal cancers: a national survey. BMJ Open 2019; 9:e025737. [PMID: 30975679 PMCID: PMC6500239 DOI: 10.1136/bmjopen-2018-025737] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
OBJECTIVES In July 2017, UK National Institute for Health and Care Excellence (NICE) published a diagnostic guidance (DG30) recommending the use of faecal immunochemical tests (FITs) for symptomatic patients who do not meet the urgent referral pathway for suspected colorectal cancer (CRC). We assessed general practitioners' (GP) awareness of DG30 in primary care 6 months after its publication. DESIGN AND SETTING Cross-sectional online survey of GPs hosted by an English panel of Primary health care professionals. PARTICIPANTS In December 2017, 1024 GPs registered on an online panel (M3) based in England took part in an online survey. OUTCOMES AND VARIABLES We investigated a number of factors including previous experience of using FIT and guaiac faecal occult blood tests (FOBTs), the number of urgent referrals for CRC that GPs have made in the last year and their sociodemographic and professional characteristics that could be associated with their self-reported awareness of the FIT diagnostic guidance. RESULTS Of the 1024 GPs who completed the survey, 432 (42.2%) were aware of the current recommendation but only 102 (10%) had used it to guide their referrals. Awareness was lowest in North West England compared with London (30.5% vs 44.9%; adjusted OR: 0.55, 95% CI 0.33 to 0.92). Awareness of the FIT guidance was positively associated with test usage after the NICE update (adjusted OR: 13.00, 95% CI 6.87 to 24.61) and having specialist training (adjusted OR: 1.48, 95% CI 1.05 to 2.08). The number of urgent referrals, the previous use of FOBt, GPs' age and gender, work experience and practice size (both in terms of the number of GPs or patients at the practice) were not associated with awareness. CONCLUSIONS Less than half of GPs in this survey recognised the current guidance on the use of FIT. Self-reported awareness was not systematically related to demographic of professional characteristics.
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Affiliation(s)
| | | | - Madeline Freeman
- Research Department of Behavioural Science and Health, UCL, London, UK
| | | | - Brian D Nicholson
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Jessica Sheringham
- Department of Applied Health Research, University College London, London, UK
| | - Dorothy Szinay
- Research Department of Behavioural Science and Health, UCL, London, UK
| | - Yasemin Hirst
- Research Department of Behavioural Science and Health, UCL, London, UK
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Turvill J, Mellen S, Jeffery L, Bevan S, Keding A, Turnock D. Diagnostic accuracy of one or two faecal haemoglobin and calprotectin measurements in patients with suspected colorectal cancer. Scand J Gastroenterol 2018; 53:1526-1534. [PMID: 30621475 DOI: 10.1080/00365521.2018.1539761] [Citation(s) in RCA: 31] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND The role of faecal biomarkers in patients at 'high risk' of colorectal cancer (CRC) is not yet defined. Pre-analytical factors, such as heterogeneity of biomarker distribution within faeces, may influence their optimisation in clinical practice. We undertook to determine whether repeat or combined biomarker testing improves diagnostic accuracy for CRC or clinically significant disease. METHODS Patients referred with suspected CRC provided two separate faecal samples each for faecal immunochemical testing (FIT) and faecal calprotectin (FC) prior to investigation. Diagnostic accuracy of FIT and FC were evaluated based on final diagnoses. RESULTS Five hundred fifteen patients completed a full colorectal evaluation. The optimal cut-off for CRC using a single FIT was ≥12 µgHb/g faeces (84.6% sensitivity, 88.5% specificity). For two FIT, the cut-off was ≥43 µgHb/g faeces if either and ≥2 µgHb/g faeces if both were positive. There was no advantage in their diagnostic accuracy compared with a single FIT. FC had a lower diagnostic accuracy for CRC than FIT, which was not improved by repeat FC. No benefit was identified with FIT-FC combined. For CRC, significant adenomatous polyps and organic enteric disease combined, FIT and FC performed similarly to each other but were poorer predictors (AUC 0.677 and 0.660). There was no uplift in diagnostic accuracy when the tests were repeated or combined. CONCLUSION This study supports using a single FIT at a cut-off close to that recommended by NICE DG30 to improve diagnostic accuracy for 'two-week wait' patients referred with suspected CRC.
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Affiliation(s)
- James Turvill
- a Department of Gastroenterology , York Teaching Hospital NHS Foundation Trust , York , UK
| | - Samantha Mellen
- b Department of Clinical Biochemistry , York Teaching Hospital NHS Foundation Trust , York , UK
| | - Laura Jeffery
- b Department of Clinical Biochemistry , York Teaching Hospital NHS Foundation Trust , York , UK
| | - Sarah Bevan
- b Department of Clinical Biochemistry , York Teaching Hospital NHS Foundation Trust , York , UK
| | - Ada Keding
- c Department of Health Sciences, Faculty of Sciences , University of York , York , UK
| | - Daniel Turnock
- b Department of Clinical Biochemistry , York Teaching Hospital NHS Foundation Trust , York , UK
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Fraser CG. Faecal immunochemical tests for haemoglobin (FIT) in the assessment of patients with lower abdominal symptoms: current controversies. GASTROENTEROLOGIA Y HEPATOLOGIA 2018; 42:263-270. [PMID: 30459060 DOI: 10.1016/j.gastrohep.2018.09.007] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/14/2018] [Revised: 09/05/2018] [Accepted: 09/21/2018] [Indexed: 12/21/2022]
Abstract
Faecal immunochemical tests for haemoglobin (FIT), as an adjunct to clinical information, assist in the triage of patients presenting in primary care with lower abdominal symptoms. Controversy remains regarding whether and which qualitative and quantitative FIT can be used, which groups of patients would benefit most from FIT, whether FIT should be done in primary and/or secondary care, and how FIT should be incorporated into diagnostic pathways. Controversy also exists as to the optimum cut-off used for referral for colonoscopy. A single sample of faeces may be sufficient. Reporting of results requires consideration. FIT provide a good rule in test for colorectal cancer and a good rule out test for significant bowel disease, but robust safety-netting is required for patients with negative results and ongoing symptoms. Risk scoring models have been developed, but their value is unclear as yet. Further evaluation of these topics is required to inform good practice.
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Affiliation(s)
- Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland, UK.
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38
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Auge JM, Rodriguez C, Espanyol O, Rivero L, Sandalinas S, Grau J, Jimenez W, Castells A. An evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer. Clin Chem Lab Med 2018; 56:625-633. [PMID: 29150989 DOI: 10.1515/cclm-2017-0605] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2017] [Accepted: 10/09/2017] [Indexed: 12/13/2022]
Abstract
BACKGROUND An evaluation of SENTiFIT® 270 (Sentinel Diagnostics, Italy; Sysmex, Spain) analyser for the quantitation of faecal haemoglobin (f-Hb) was performed. METHODS The analytical imprecision, linearity, carry over and f-Hb stability were determined. Evaluation of the diagnostic accuracy was performed on 487 patients. RESULTS Within-run and between-run imprecision ranged 1.7%-5.1% and 3.8%-6.2%, respectively. Linearity studies revealed a mean recovery of 101.1% (standard deviation, 6.7%) for all dilutions. No carry over was detected below 7650 μg Hb/g faeces. Decay of f-Hb in refrigerated samples ranged 0.2%-0.5% per day. f-Hb in patients with advanced colorectal neoplasia (ACRN) (colorectal cancer [CRC] plus advanced adenoma [AA]) were significantly higher than from those with a normal colonoscopy. Sensitivity for ACRN at f-Hb cutoffs from 10 to 60 μg Hb/g faeces ranged from 28.9% (95% confidence interval [CI], 21.7%-37.2%) to 46.5% (95% CI, 38.1%-55%), the specificity ranged from 85% (95% CI, 82.3%-87.3%) to 93.2% (95% CI, 91.2%-94.8%), positive predictive values for detecting CRC and AA ranged from 11.6% (95% CI, 7.6%-17.2%) to 20.6% (95% CI, 13.3%-30.3%) and from 34.7% (95% CI, 28.1%-42%) to 42.3% (95% CI, 32.4%-52.7%), respectively, and the negative predictive value for ACRN ranged from 90.2% (95% CI, 87.9%-92.2%) to 88.4% (95% CI, 86%-90.4%). Using two samples per patient sensitivity increased with a slight decrease in specificity. CONCLUSIONS The analytical and clinical performances of SENTiFIT assay demonstrate a specific and accurate test for detecting ACRN in symptomatic patients and those undergoing surveillance.
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Affiliation(s)
- Josep M Auge
- Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic, C/Villarroel 170, 08036 Barcelona, Spain
| | - Cristina Rodriguez
- Gastroenterology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain; and IDIBAPS, CIBERehd, Barcelona, Spain
| | - Oihana Espanyol
- Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic, Barcelona, Spain
| | - Liseth Rivero
- Gastroenterology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain; and IDIBAPS, CIBERehd, Barcelona, Spain
| | - Silvia Sandalinas
- Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic, Barcelona, Spain
| | - Jaume Grau
- Unit of Evaluation, Support and Prevention, Hospital Clinic, Barcelona, Spain
| | - Wladimiro Jimenez
- Biochemistry and Molecular Genetics Department, Biomedical Diagnostic Center, Hospital Clinic, Barcelona, Spain
| | - Antoni Castells
- Gastroenterology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain; and IDIBAPS, CIBERehd, Barcelona, Spain
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Herrero JM, Vega P, Salve M, Bujanda L, Cubiella J. Symptom or faecal immunochemical test based referral criteria for colorectal cancer detection in symptomatic patients: a diagnostic tests study. BMC Gastroenterol 2018; 18:155. [PMID: 30359225 PMCID: PMC6203209 DOI: 10.1186/s12876-018-0887-7] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/18/2018] [Accepted: 10/16/2018] [Indexed: 01/02/2023] Open
Abstract
BACKGROUND Symptom based referral criteria for colorectal cancer (CRC) detection are the cornerstone of the strategy to improve prognosis in CRC. In 2017, the National Institute for Health and Care Excellence (NICE) updated their referral criteria (2017 NG12). Recently, several studies have evaluated the faecal haemoglobin (f-Hb) concentration in this setting. The aim of this study is to evaluate the diagnostic accuracy of the 2017 NG12 referral criteria and to compare them with the CG27 referral criteria, the f-Hb concentration and two f-Hb based prediction model: COLONPREDICT and FAST Score. METHODS This is a post-hoc diagnostic test study performed within the COLONPREDICT study database (1572 patients, CRC prevalence 13.6%). We assessed symptoms, the 2017 NG12 and CG27 referral criteria and determined the f-Hb before performing a colonoscopy. We compared the discriminatory ability using the area under the curve (AUC) and the sensitivity and specificity at pre-stablished thresholds with the McNemar's test. RESULTS The 2017 NG12 referral criteria discriminatory ability (AUC 0.53; 95% confidence interval- CI 0.49-0.57) was inferior to the CG27 version (AUC 0.59; 95% CI 0.55-0.63; p = 0.01), the f-Hb concentration (AUC 0.86; 95% CI 0.84-0-89; p < 0.001), the COLONPREDICT Score (AUC 0.92; 95% CI 0.91-0.94; p < 0.001) or the FAST Score (AUC 0.87; 95% CI 0.85-0.89; p < 0.001). The number of patients meeting each criteria were as follows: 2017 NG12 and CG27 = 94.1% and 52.2%; f-Hb ≥20 and ≥ 10 μg/g faeces = 38.6 and 44.3%; COLONPREDICT Score ≥ 5.6 and ≥ 3.2 = 29.4 and 63.2% and FAST Score ≥ 4.50 and ≥ 2.12 = 37.1 and 87.0%. The 2017 NG12 criteria were more sensitive (100%) than the CG27 criteria (68.2%), the f-Hb (≥20 μg/g) (91.2%), the f-Hb (≥10 μg/g) (93.5%), the COLONPREDICT Score (≥5.6) (90.1%) and the FAST Score (≥4.50) (89.8%) (p ≤ 0.001) and equivalent to the COLONPREDICT Score (≥3.5) (99.5%) or the FAST Score (≥2.12) (100.0%) (p = 1). However, their specificity (6.8%) was significantly lower than any of the evaluated criteria (50.3%, 69.6%, 63.4%, 78.7%, 45.8%, 71.3%, 13.9%; p < 0.001). CONCLUSION Referral criteria based on f-Hb measurement, either as a single test or within prediction models, are more accurate than symptom-based referral criteria for CRC detection in symptomatic patients.
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Affiliation(s)
- Jesús-Miguel Herrero
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
- Instituto de Investigación Biomédica Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd),, Ourense, Spain
| | - Pablo Vega
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
- Instituto de Investigación Biomédica Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd),, Ourense, Spain
| | - María Salve
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
- Instituto de Investigación Biomédica Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd),, Ourense, Spain
| | - Luis Bujanda
- Donostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU, CIBERehd, San Sebastian, Spain
| | - Joaquín Cubiella
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
- Instituto de Investigación Biomédica Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd),, Ourense, Spain
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Juul JS, Andersen B, Laurberg S, Carlsen AH, Olesen F, Vedsted P. Differences in diagnostic activity in general practice and findings for individuals invited to the danish screening programme for colorectal cancer: a population-based cohort study. Scand J Prim Health Care 2018; 36:281-290. [PMID: 29929415 PMCID: PMC6381544 DOI: 10.1080/02813432.2018.1487378] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/27/2023] Open
Abstract
OBJECTIVE To investigate the diagnostic activity in general practice and the cumulative incidence of colorectal cancer (CRC) in individuals invited to the Danish national screening programme for CRC. DESIGN A historical population-based cohort study. SETTING The Danish CRC screening programme and general practice. SUBJECTS The 376,198 individuals invited to the Danish CRC screening programme from 1 March to 31 December 2014. MAIN OUTCOME MEASURES The diagnostic activity (consultations and haemoglobin measures) in general practice in the year preceding the screening invitation and the cumulated incidence of CRC in the year following the screening invitation. RESULTS Screening participants had significantly higher diagnostic activity than non-participants. Individuals with a positive faecal immunochemical test (FIT) had higher diagnostic activity compared to individuals with a negative FIT, and a small increase in the months leading up to the invitation. Individuals with a screen-detected CRC had lower diagnostic activity than individuals with no CRC. In total, 308 (25.3%) of CRCs diagnosed in the invited population were diagnosed outside the screening programme. Non-participants with CRC more often had low socio-economic status, high comorbidity and stage IV CRC than participants with CRC. CONCLUSIONS There was a tendency that participants and those with a positive FIT had a higher diagnostic activity the year before the screening. This was not seen for those with CRC detected through screening. CRC must still be diagnosed in general practice in the invited population and non-participants are of special interest as they have higher risk of late stage CRC. Key Points Current awareness:Individuals with colorectal cancer (CRC) in screening may be symptomatic and CRC may still occur outside screening in the invited population. Most important points:The majority of individuals with CRC in screening cannot be expected to be diagnosed on symptomatic presentation in general practice GPs have to be aware that CRC still occurs outside screening in the invited population Non-participants with CRC are often deprived and have late stage CRC.
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Affiliation(s)
- Jakob Søgaard Juul
- Research Unit for General Practice & Section for General Medical Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, 8000, Denmark;
- Research Centre for Cancer Diagnosis in Primary Care, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, 8000, Denmark;
- CONTACT Jakob Søgaard JuulDepartment of Public Health, Aarhus University, Research Unit for General Practice, Bartholins Allé 2, 8000Aarhus C, Denmark
| | - Berit Andersen
- Department of Public Health Programmes, Randers Regional Hospital, Skovlyvej 1, Randers, NE, 8930, Denmark;
| | - Søren Laurberg
- Department of Surgery, Aarhus University Hospital, Tage Hansens Gade 2, Aarhus C, 8000, Denmark;
| | - Anders Helles Carlsen
- Research Unit for General Practice & Section for General Medical Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, 8000, Denmark;
| | - Frede Olesen
- Research Unit for General Practice & Section for General Medical Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, 8000, Denmark;
| | - Peter Vedsted
- Research Unit for General Practice & Section for General Medical Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, 8000, Denmark;
- Research Centre for Cancer Diagnosis in Primary Care, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, 8000, Denmark;
- Department of Clinical Medicine, University Clinic for Innovative Patient Pathways, Silkeborg Hospital, Aarhus University, Denmark
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The value of using the faecal immunochemical test in general practice on patients presenting with non-alarm symptoms of colorectal cancer. Br J Cancer 2018; 119:471-479. [PMID: 30065255 PMCID: PMC6133998 DOI: 10.1038/s41416-018-0178-7] [Citation(s) in RCA: 53] [Impact Index Per Article: 7.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2017] [Accepted: 06/18/2018] [Indexed: 12/15/2022] Open
Abstract
Background Around 50% of individuals with colorectal cancer (CRC) initially
present with non-alarm symptoms. Methods We investigated the value of using the faecal immunochemical test
(FIT) in the diagnostic process of CRC and other serious bowel disease in
individuals presenting with non-alarm symptoms in general practice. The study was
conducted in the Central Denmark Region from 1 September 2015 to 30 August 2016.
The FIT was used as a rule-in test on patients aged ≥30 years with non-alarm
symptoms of CRC. The cut-off value was set to 10 µg Hb/g faeces. Results A total of 3462 valid FITs were performed. Of these, 540 (15.6%)
were positive. Three months after FIT performance, 51 (PPV: 9.4% (95% CI:
7.0;11.9)) individuals with a positive FIT were diagnosed with CRC and 73 (PPV:
13.5% (95%CI: 10.6;16.4)) with other serious bowel disease. Of CRCs, 66.7% were
diagnosed in UICC stage I & II and 19.6% in stage IV. The false negative rate
for CRC was <0.1% for the initial 3 months after FIT performance. Conclusion The FIT may be used as a supplementary diagnostic test in the
diagnostic process of CRC and other serious bowel disease in individuals with
non-alarm symptoms of CRC in general practice.
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Fraser CG. Faecal immunochemical tests (FIT) in the assessment of patients presenting with lower bowel symptoms: Concepts and challenges. Surgeon 2018; 16:302-308. [PMID: 29548552 DOI: 10.1016/j.surge.2018.01.004] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2018] [Accepted: 01/30/2018] [Indexed: 12/25/2022]
Abstract
Colonoscopy is a relatively scarce resource in many countries, including Scotland, and a simple investigation which would aid general practitioners in particular in decision-making as to which patients presenting with lower bowel symptoms warranted referral would be of much help. Faecal immunochemical tests for haemoglobin (FIT) have many advantageous characteristics and are now proven to be of considerable value in the timely assessment of patients with symptoms of lower bowel disease. Quantitative FIT provide numerical estimates of faecal haemoglobin concentration (f-Hb) and, at low f-Hb cut-off, FIT have high sensitivity for colorectal cancer (CRC) and could be used as a rule-in test to stimulate rapid referral, especially when symptoms are suggestive of serious bowel disease. Perhaps more importantly, a low f-Hb gives considerable reassurance that significant bowel disease (CRC + higher-risk adenoma + inflammatory bowel disease) is absent and further investigation may not be warranted: however, no test is perfect, so some cases will remain undetected using FIT alone and robust safety netting is required, possibly including watching and waiting, referral to clinics in secondary care, or a repeat FIT. Moreover, the FIT results should not be taken in isolation, but clinical impressions and the results of other investigations, probably including the full blood count, should be considered. Challenges still exist, however, and harmonisation of aspects of the available FIT analytical systems is required. Moreover, a number of seemingly valid clinical concerns remain and these require resolution through further research and reporting of studies done in real clinical practice.
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Affiliation(s)
- Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, Scotland, UK.
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Westwood M, Corro Ramos I, Lang S, Luyendijk M, Zaim R, Stirk L, Al M, Armstrong N, Kleijnen J. Faecal immunochemical tests to triage patients with lower abdominal symptoms for suspected colorectal cancer referrals in primary care: a systematic review and cost-effectiveness analysis. Health Technol Assess 2018. [PMID: 28643629 DOI: 10.3310/hta21330] [Citation(s) in RCA: 51] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Colorectal cancer (CRC) is the third most common cancer in the UK. Presenting symptoms that can be associated with CRC usually have another explanation. Faecal immunochemical tests (FITs) detect blood that is not visible to the naked eye and may help to select patients who are likely to benefit from further investigation. OBJECTIVES To assess the effectiveness of FITs [OC-Sensor (Eiken Chemical Co./MAST Diagnostics, Tokyo, Japan), HM-JACKarc (Kyowa Medex/Alpha Laboratories Ltd, Tokyo, Japan), FOB Gold (Sentinel/Sysmex, Sentinel Diagnostics, Milan, Italy), RIDASCREEN Hb or RIDASCREEN Hb/Hp complex (R-Biopharm, Darmstadt, Germany)] for primary care triage of people with low-risk symptoms. METHODS Twenty-four resources were searched to March 2016. Review methods followed published guidelines. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model. The cost-effectiveness analysis considered long-term costs and quality-adjusted life-years (QALYs) that were associated with different faecal occult blood tests and direct colonoscopy referral. Modelling comprised a diagnostic decision model, a Markov model for long-term costs and QALYs that were associated with CRC treatment and progression, and a Markov model for QALYs that were associated with no CRC. RESULTS We included 10 studies. Using a single sample and 10 µg Hb/g faeces threshold, sensitivity estimates for OC-Sensor [92.1%, 95% confidence interval (CI) 86.9% to 95.3%] and HM-JACKarc (100%, 95% CI 71.5% to 100%) indicated that both may be useful to rule out CRC. Specificity estimates were 85.8% (95% CI 78.3% to 91.0%) and 76.6% (95% CI 72.6% to 80.3%). Triage using FITs could rule out CRC and avoid colonoscopy in approximately 75% of symptomatic patients. Data from our systematic review suggest that 22.5-93% of patients with a positive FIT and no CRC have other significant bowel pathologies. The results of the base-case analysis suggested minimal difference in QALYs between all of the strategies; no triage (referral straight to colonoscopy) is the most expensive. Faecal immunochemical testing was cost-effective (cheaper and more, or only slightly less, effective) compared with no triage. Faecal immunochemical testing was more effective and costly than guaiac faecal occult blood testing, but remained cost-effective at a threshold incremental cost-effectiveness ratio of £30,000. The results of scenario analyses did not differ substantively from the base-case. Results were better for faecal immunochemical testing when accuracy of the guaiac faecal occult blood test (gFOBT) was based on studies that were more representative of the correct population. LIMITATIONS Only one included study evaluated faecal immunochemical testing in primary care; however, all of the other studies evaluated faecal immunochemical testing at the point of referral. Further, validation data for the Faecal haemoglobin, Age and Sex Test (FAST) score, which includes faecal immunochemical testing, showed no significant difference in performance between primary and secondary care. There were insufficient data to adequately assess FOB Gold, RIDASCREEN Hb or RIDASCREEN Hb/Hp complex. No study compared FIT assays, or FIT assays versus gFOBT; all of the data included in this assessment refer to the clinical effectiveness of individual FIT methods and not their comparative effectiveness. CONCLUSIONS Faecal immunochemical testing is likely to be a clinically effective and cost-effective strategy for triaging people who are presenting, in primary care settings, with lower abdominal symptoms and who are at low risk for CRC. Further research is required to confirm the effectiveness of faecal immunochemical testing in primary care practice and to compare the performance of different FIT assays. STUDY REGISTRATION This study is registered as PROSPERO CRD42016037723. FUNDING The National Institute for Health Research Health Technology Assessment programme.
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Affiliation(s)
| | - Isaac Corro Ramos
- Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, the Netherlands
| | - Shona Lang
- Kleijnen Systematic Reviews Ltd, York, UK
| | - Marianne Luyendijk
- Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, the Netherlands
| | - Remziye Zaim
- Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, the Netherlands
| | - Lisa Stirk
- Kleijnen Systematic Reviews Ltd, York, UK
| | - Maiwenn Al
- Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, the Netherlands
| | | | - Jos Kleijnen
- School for Public Health and Primary Care (Care and Public Health Research Institute), Maastricht University, Maastricht, the Netherlands
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Picot J, Rose M, Cooper K, Pickett K, Lord J, Harris P, Whyte S, Böhning D, Shepherd J. Virtual chromoendoscopy for the real-time assessment of colorectal polyps in vivo: a systematic review and economic evaluation. Health Technol Assess 2017; 21:1-308. [PMID: 29271339 PMCID: PMC5757183 DOI: 10.3310/hta21790] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
BACKGROUND Current clinical practice is to remove a colorectal polyp detected during colonoscopy and determine whether it is an adenoma or hyperplastic by histopathology. Identifying adenomas is important because they may eventually become cancerous if untreated, whereas hyperplastic polyps do not usually develop into cancer, and a surveillance interval is set based on the number and size of adenomas found. Virtual chromoendoscopy (VCE) (an electronic endoscopic imaging technique) could be used by the endoscopist under strictly controlled conditions for real-time optical diagnosis of diminutive (≤ 5 mm) colorectal polyps to replace histopathological diagnosis. OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of the VCE technologies narrow-band imaging (NBI), flexible spectral imaging colour enhancement (FICE) and i-scan for the characterisation and management of diminutive (≤ 5 mm) colorectal polyps using high-definition (HD) systems without magnification. DESIGN Systematic review and economic analysis. PARTICIPANTS People undergoing colonoscopy for screening or surveillance or to investigate symptoms suggestive of colorectal cancer. INTERVENTIONS NBI, FICE and i-scan. MAIN OUTCOME MEASURES Diagnostic accuracy, recommended surveillance intervals, health-related quality of life (HRQoL), adverse effects, incidence of colorectal cancer, mortality and cost-effectiveness of VCE compared with histopathology. DATA SOURCES Electronic bibliographic databases including MEDLINE, EMBASE, The Cochrane Library and Database of Abstracts of Reviews of Effects were searched for published English-language studies from inception to June 2016. Bibliographies of related papers, systematic reviews and company information were screened and experts were contacted to identify additional evidence. REVIEW METHODS Systematic reviews of test accuracy and economic evaluations were undertaken in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Meta-analyses were conducted, where possible, to inform the independent economic model. A cost-utility decision-analytic model was developed to estimate the cost-effectiveness of VCE compared with histopathology. The model used a decision tree for patients undergoing endoscopy, combined with estimates of long-term outcomes (e.g. incidence of colorectal cancer and subsequent morbidity and mortality) derived from University of Sheffield School of Health and Related Research's bowel cancer screening model. The model took a NHS perspective, with costs and benefits discounted at 3.5% over a lifetime horizon. There were limitations in the data on the distribution of adenomas across risk categories and recurrence rates post polypectomy. RESULTS Thirty test accuracy studies were included: 24 for NBI, five for i-scan and three for FICE (two studies assessed two interventions). Polyp assessments made with high confidence were associated with higher sensitivity and endoscopists experienced in VCE achieved better results than those without experience. Two economic evaluations were included. NBI, i-scan and FICE are cost-saving strategies compared with histopathology and the number of quality-adjusted life-years gained was similar for histopathology and VCE. The correct surveillance interval would be given to 95% of patients with NBI, 94% of patients with FICE and 97% of patients with i-scan. LIMITATIONS Limited evidence was available for i-scan and FICE and there was heterogeneity among the NBI studies. There is a lack of data on longer-term health outcomes of patients undergoing VCE for assessment of diminutive colorectal polyps. CONCLUSIONS VCE technologies, using HD systems without magnification, could potentially be used for the real-time assessment of diminutive colorectal polyps, if endoscopists have adequate experience and training. FUTURE WORK Future research priorities include head-to-head randomised controlled trials of all three VCE technologies; more research on the diagnostic accuracy of FICE and i-scan (when used without magnification); further studies evaluating the impact of endoscopist experience and training on outcomes; studies measuring adverse effects, HRQoL and anxiety; and longitudinal data on colorectal cancer incidence, HRQoL and mortality. STUDY REGISTRATION This study is registered as PROSPERO CRD42016037767. FUNDING The National Institute for Health Research Health Technology Assessment programme.
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Affiliation(s)
- Joanna Picot
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
| | - Micah Rose
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
| | - Keith Cooper
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
| | - Karen Pickett
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
| | - Joanne Lord
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
| | - Petra Harris
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
| | - Sophie Whyte
- School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
| | - Dankmar Böhning
- Southampton Statistical Sciences Research Institute (S3RI), Mathematical Sciences, University of Southampton, Southampton, UK
| | - Jonathan Shepherd
- Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK
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Westwood M, Lang S, Armstrong N, van Turenhout S, Cubiella J, Stirk L, Ramos IC, Luyendijk M, Zaim R, Kleijnen J, Fraser CG. Faecal immunochemical tests (FIT) can help to rule out colorectal cancer in patients presenting in primary care with lower abdominal symptoms: a systematic review conducted to inform new NICE DG30 diagnostic guidance. BMC Med 2017; 15:189. [PMID: 29061126 PMCID: PMC5654140 DOI: 10.1186/s12916-017-0944-z] [Citation(s) in RCA: 76] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2017] [Accepted: 09/14/2017] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND This study has attempted to assess the effectiveness of quantitative faecal immunochemical tests (FIT) for triage of people presenting with lower abdominal symptoms, where a referral to secondary care for investigation of suspected colorectal cancer (CRC) is being considered, particularly when the 2-week criteria are not met. METHODS We conducted a systematic review following published guidelines for systematic reviews of diagnostic tests. Twenty-one resources were searched up until March 2016. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model. RESULTS Nine studies are included in this review. One additional study, included in our systematic review, was provided as 'academic in confidence' and cannot be described herein. When FIT was based on a single faecal sample and a cut-off of 10 μg Hb/g faeces, sensitivity estimates indicated that a negative result using either the OC-Sensor or HM-JACKarc may be adequate to rule out nearly all CRC; the summary estimate of sensitivity for the OC-Sensor was 92.1% (95% confidence interval, CI 86.9-95.3%), based on four studies (n = 4091 participants, 176 with CRC), and the only study of HM-JACKarc to assess the 10 μg Hb/g faeces cut-off (n = 507 participants, 11 with CRC) reported a sensitivity of 100% (95% CI 71.5-100%). The corresponding specificity estimates were 85.8% (95% CI 78.3-91.0%) and 76.6% (95% CI 72.6-80.3%), respectively. When the diagnostic criterion was changed to include lower grades of neoplasia, i.e. the target condition included higher risk adenoma (HRA) as well as CRC, the rule-out performance of both FIT assays was reduced. CONCLUSIONS There is evidence to suggest that triage using FIT at a cut-off around 10 μg Hb/g faeces has the potential to correctly rule out CRC and avoid colonoscopy in 75-80% of symptomatic patients. SYSTEMATIC REVIEW REGISTRATION PROSPERO 42016037723.
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Affiliation(s)
- Marie Westwood
- Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK.
| | - Shona Lang
- Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK
| | - Nigel Armstrong
- Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK
| | | | - Joaquín Cubiella
- Department of Gastroenterology, Complexo Hospitalario, Universitario de Ourense, Ourense, Spain
| | - Lisa Stirk
- Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK
| | - Isaac Corro Ramos
- Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Marianne Luyendijk
- Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Remziye Zaim
- Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Jos Kleijnen
- School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands
| | - Callum G Fraser
- University of Dundee, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK
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Quyn AJ, Steele RJ, Digby J, Strachan JA, Mowat C, McDonald PJ, Carey FA, Godber IM, Younes HB, Fraser CG. Application of NICE guideline NG12 to the initial assessment of patients with lower gastrointestinal symptoms: not FIT for purpose? Ann Clin Biochem 2017; 55:69-76. [PMID: 28661203 DOI: 10.1177/0004563217707981] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
Background The National Institute for Health and Care Excellence (NICE) published NG12 in 2015. The referral criteria for suspected colorectal cancer (CRC) caused controversy, because tests for occult blood in faeces were recommended. Faecal immunochemical tests for haemoglobin (FIT), which estimate faecal haemoglobin concentrations (f-Hb), might more than fulfil the intentions. Our aim was to compare the utility of f-Hb as the initial investigation with the NICE NG12 symptom-based guidelines. Methods Data from three studies were included. Patients had sex, age, symptoms, f-Hb and colonoscopy and histology data recorded. Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) of f-Hb and NG12 were calculated for all significant colorectal disease (SCD: CRC, higher risk adenoma and inflammatory bowel disease). Overall diagnostic accuracy was also estimated by the area under the receiver operating characteristic curve (AUC). Results A total of 1514 patients were included. At a cut-off of ≥10 µg Hb/g faeces, the sensitivity of f-Hb for CRC was 93.3% (95% confidence interval (CI): 80.7-98.3) with NPV of 99.7% (95%CI: 99.2-99.9). The sensitivity and NPV for SCD were 63.2% (95%CI: 56.6-69.4) and 96.0% (95%CI: 91.4-94.4), respectively. The NG12 sensitivity and NPV for SCD were 58.4% (95%CI: 51.8-64.8) and 87.6% (95%CI: 85.0-89.8), respectively. The AUC for CRC was 0.85 (95% CI: 0.87-0.90) for f-Hb versus 0.65 (95%CI: 0.58-0.73) for NG12 ( P < 0.005). For SCD, the AUC was 0.73 (95%CI: 0.69-0.77) for f-Hb versus 0.56 (95%CI: 0.52-0.60) for NG12 ( P < 0.0005). Conclusion f-Hb provides a good rule-out test for SCD and has significantly higher overall diagnostic accuracy than NG12.
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Affiliation(s)
- Aaron J Quyn
- 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | - Robert Jc Steele
- 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | - Jayne Digby
- 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
| | | | - Craig Mowat
- 3 Department of Gastroenterology, Ninewells Hospital and Medical School, Dundee, UK
| | - Paula J McDonald
- 2 Blood Sciences, Ninewells Hospital and Medical School, Dundee, UK
| | - Francis A Carey
- 4 Department of Pathology, Ninewells Hospital and Medical School, Dundee, UK
| | - Ian M Godber
- 5 Department of Biochemistry, Monklands Hospital, Lanarkshire, UK
| | - Hakim B Younes
- 6 Department of Surgery, Wishaw General Hospital, Lanarkshire, UK
| | - Callum G Fraser
- 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
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Cubiella J, Digby J, Rodríguez-Alonso L, Vega P, Salve M, Díaz-Ondina M, Strachan JA, Mowat C, McDonald PJ, Carey FA, Godber IM, Younes HB, Rodriguez-Moranta F, Quintero E, Álvarez-Sánchez V, Fernández-Bañares F, Boadas J, Campo R, Bujanda L, Garayoa A, Ferrandez Á, Piñol V, Rodríguez-Alcalde D, Guardiola J, Steele RJC, Fraser CG. The fecal hemoglobin concentration, age and sex test score: Development and external validation of a simple prediction tool for colorectal cancer detection in symptomatic patients. Int J Cancer 2017; 140:2201-2211. [PMID: 28187494 DOI: 10.1002/ijc.30639] [Citation(s) in RCA: 54] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2016] [Revised: 01/22/2017] [Accepted: 01/30/2017] [Indexed: 12/15/2022]
Abstract
Prediction models for colorectal cancer (CRC) detection in symptomatic patients, based on easily obtainable variables such as fecal haemoglobin concentration (f-Hb), age and sex, may simplify CRC diagnosis. We developed, and then externally validated, a multivariable prediction model, the FAST Score, with data from five diagnostic test accuracy studies that evaluated quantitative fecal immunochemical tests in symptomatic patients referred for colonoscopy. The diagnostic accuracy of the Score in derivation and validation cohorts was compared statistically with the area under the curve (AUC) and the Chi-square test. 1,572 and 3,976 patients were examined in these cohorts, respectively. For CRC, the odds ratio (OR) of the variables included in the Score were: age (years): 1.03 (95% confidence intervals (CI): 1.02-1.05), male sex: 1.6 (95% CI: 1.1-2.3) and f-Hb (0-<20 µg Hb/g feces): 2.0 (95% CI: 0.7-5.5), (20-<200 µg Hb/g): 16.8 (95% CI: 6.6-42.0), ≥200 µg Hb/g: 65.7 (95% CI: 26.3-164.1). The AUC for CRC detection was 0.88 (95% CI: 0.85-0.90) in the derivation and 0.91 (95% CI: 0.90-093; p = 0.005) in the validation cohort. At the two Score thresholds with 90% (4.50) and 99% (2.12) sensitivity for CRC, the Score had equivalent sensitivity, although the specificity was higher in the validation cohort (p < 0.001). Accordingly, the validation cohort was divided into three groups: high (21.4% of the cohort, positive predictive value-PPV: 21.7%), intermediate (59.8%, PPV: 0.9%) and low (18.8%, PPV: 0.0%) risk for CRC. The FAST Score is an easy to calculate prediction tool, highly accurate for CRC detection in symptomatic patients.
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Affiliation(s)
- Joaquín Cubiella
- Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
- Instituto de Investigación Biomedica (IBI) Ourense, Pontevedra y Vigo, Vigo, Spain
| | - Jayne Digby
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom
| | - Lorena Rodríguez-Alonso
- Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain
- Ciber de Epidemiología y Salud Pública (CIBERESP), Spain
| | - Pablo Vega
- Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
| | - María Salve
- Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
| | - Marta Díaz-Ondina
- Clinical Analysis Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain
| | - Judith A Strachan
- Blood Sciences, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom
| | - Craig Mowat
- Department of Gastroenterology, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom
| | - Paula J McDonald
- Kings Cross Hospital, Scottish Bowel Screening Centre, Dundee, Scotland, United Kingdom
| | - Francis A Carey
- Department of Pathology, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom
| | - Ian M Godber
- Department of Biochemistry, Monklands Hospital, Airdrie, Lanarkshire, Scotland, United Kingdom
| | - Hakim Ben Younes
- Department of Surgery, Wishaw General Hospital, Wishaw, Lanarkshire, Scotland, United Kingdom
| | - Francisco Rodriguez-Moranta
- Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain
- Ciber de Epidemiología y Salud Pública (CIBERESP), Spain
| | - Enrique Quintero
- Gastroenterology Department, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, Tenerife, Spain
| | | | - Fernando Fernández-Bañares
- Gastroenterology Department, Hospital Universitari Mútua de Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Terrassa, Spain
| | - Jaume Boadas
- Gastroenterology Department, Consorci Sanitari de Terrassa, Terrassa, Spain
| | - Rafel Campo
- Gastroenterology Department, Hospital de Sabadell, Corporació Sanitària i Universitària Parc Taulí, Sabadell, Spain
| | - Luis Bujanda
- Donostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU (CIBERehd), San Sebastian, Spain
| | - Ana Garayoa
- Gastroenterology Department, Hospital de Sagunto, Sagunto, Valencia, Spain
| | - Ángel Ferrandez
- Servicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, (CIBERehd), Zaragoza, Spain
| | - Virginia Piñol
- Gastroenterology Department, Hospital Dr. Josep Trueta, Girona, Spain
| | | | - Jordi Guardiola
- Department of Gastroenterology and Hepatology, University Hospital of Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain
- Ciber de Epidemiología y Salud Pública (CIBERESP), Spain
| | - Robert J C Steele
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom
| | - Callum G Fraser
- Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital & Medical School, Dundee, Scotland, United Kingdom
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Högberg C, Karling P, Rutegård J, Lilja M. Diagnosing colorectal cancer and inflammatory bowel disease in primary care: The usefulness of tests for faecal haemoglobin, faecal calprotectin, anaemia and iron deficiency. A prospective study. Scand J Gastroenterol 2017; 52:69-75. [PMID: 27623716 DOI: 10.1080/00365521.2016.1228120] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVE Abdominal complaints are common reasons to consult primary care but they are seldom caused by colorectal cancer (CRC), high-risk adenomas (HRAs), or inflammatory bowel disease (IBD). Reliable diagnostic aids would be helpful in deciding which patients to refer for bowel imaging. Our aim was to assess the value of a faecal immunochemical test (FIT) and a faecal calprotectin (FC) test in detecting CRC, HRAs and IBD in primary care, and the value of combining these tests with anaemia and iron-deficiency tests. MATERIALS AND METHODS This prospective study included 373 consecutive patients that received a FIT or a FC test ordered by a primary care physician. We collected samples for FITs, FC tests, full blood counts and iron-deficiency tests. Physicians were instructed to refer patients with a positive FIT or FC test (cut-off ≥100μg/g) for bowel imaging. The patients' presenting symptoms were recorded. Patients were followed for 2 years. RESULTS The best test for detecting CRC and IBD was the combination of the FIT and haemoglobin concentration. This test had a sensitivity, specificity, positive predictive value and negative predictive value of 100%, 61.7%, 11.7% and 100%, respectively. The FIT detected a significantly larger proportion of CRC, HRAs and IBD than the FC test (0.92 versus 0.46, 95% confidence interval 0.22-0.67). CONCLUSION A negative FIT combined with a normal haemoglobin concentration could rule out CRC and IBD with a high degree of safety. This could be useful in prioritising referrals for bowel imaging from primary care.
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Affiliation(s)
- Cecilia Högberg
- a Department of Public Health and Clinical Medicine, Unit of Research, Education, and Development, Östersund Hospital , Umeå University , Östersund , Sweden
| | - Pontus Karling
- b Department of Public Health and Clinical Medicine, Division of Medicine , Umeå University , Umeå , Sweden
| | - Jörgen Rutegård
- c Department of Surgical and Perioperative Sciences , Umeå University , Umeå , Sweden
| | - Mikael Lilja
- a Department of Public Health and Clinical Medicine, Unit of Research, Education, and Development, Östersund Hospital , Umeå University , Östersund , Sweden
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49
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Widlak MM, Thomas CL, Thomas MG, Tomkins C, Smith S, O'Connell N, Wurie S, Burns L, Harmston C, Evans C, Nwokolo CU, Singh B, Arasaradnam RP. Diagnostic accuracy of faecal biomarkers in detecting colorectal cancer and adenoma in symptomatic patients. Aliment Pharmacol Ther 2017; 45:354-363. [PMID: 27910113 DOI: 10.1111/apt.13865] [Citation(s) in RCA: 73] [Impact Index Per Article: 9.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2016] [Revised: 08/15/2016] [Accepted: 10/26/2016] [Indexed: 01/02/2023]
Abstract
BACKGROUND The diagnosis of colorectal cancer (CRC) can be difficult as symptoms are variable with poor specificity. Thus, there is a quest for simple, non-invasive testing that can help streamline those with significant colonic pathology. AIM To assess using faecal immunochemical test for haemoglobin (FIT) or faecal calprotectin (FCP) to detect CRC and adenoma in symptomatic patients referred from primary care. METHODS A total of 799 referred for urgent lower gastrointestinal investigations were prospectively recruited. Of these, 430 completed colonic investigations and returned stool samples, and were included in the final statistical analysis. Faecal immunochemical test for haemoglobin was performed on HM-JACKarc analyser (Kyowa Medex, Tokyo, Japan), and FCP by the EliA Calprotectin immunoassay (Thermo Fisher Scientific, Waltham, United States). RESULTS The negative predictive value (NPV) using FIT alone or both markers (FIT and FCP) in combination was similar at 99% for CRC, with a sensitivity and specificity of 84% and 93%, respectively. FIT measurements were significantly higher in left-sided colonic lesions compared with the right side; 713 vs. 94; P = 0.0203). For adenoma, the NPV using FIT alone, or both markers (FIT and FCP) in combination, was similar at 94% with a sensitivity and specificity of 69% and 56%, respectively. CONCLUSIONS Undetectable faecal immunochemical test for haemoglobin is sufficiently sensitive to exclude colorectal cancer, with higher values in left-sided lesions. FCP in combination does not appear to provide additional diagnostic information. Further studies to determine the health economic benefits of implementing faecal immunochemical test for haemoglobin in primary care are required.
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Affiliation(s)
- M M Widlak
- Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry, UK.,Medical School, University of Warwick, Coventry, UK
| | - C L Thomas
- Department of Biochemistry, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - M G Thomas
- Medical School, University of Oxford, Oxford, UK
| | - C Tomkins
- Department of Biochemistry, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - S Smith
- Midlands and North West Bowel Cancer Screening Hub, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - N O'Connell
- Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - S Wurie
- Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - L Burns
- Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - C Harmston
- Department of Colorectal Surgery, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - C Evans
- Department of Colorectal Surgery, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - C U Nwokolo
- Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry, UK
| | - B Singh
- Department of Colorectal Surgery, University Hospitals of Leicester, Leicester, UK
| | - R P Arasaradnam
- Department of Gastroenterology, University Hospitals Coventry and Warwickshire, Coventry, UK.,Medical School, University of Warwick, Coventry, UK.,Applied Biological and Experimental Sciences, University of Coventry, Coventry, UK
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50
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Fecal Immunochemical Test (FIT) for Colon Cancer Screening: Variable Performance with Ambient Temperature. J Am Board Fam Med 2016; 29:672-681. [PMID: 28076249 PMCID: PMC5624541 DOI: 10.3122/jabfm.2016.06.160060] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2016] [Revised: 05/19/2016] [Accepted: 05/23/2016] [Indexed: 12/14/2022] Open
Abstract
INTRODUCTION Fecal immunochemical tests (FITs) are widely used in colorectal cancer (CRC) screening, but hemoglobin degradation, due to exposure of the collected sample to high temperatures, could reduce test sensitivity. We examined the relation of ambient temperature exposure with FIT positivity rate and sensitivity. METHODS This was a retrospective cohort study of patients 50 to 75 years in Kaiser Permanente Northern California's CRC screening program, which began mailing FIT kits annually to screen-eligible members in 2007. Primary outcomes were FIT positivity rate and sensitivity to detect CRC. Predictors were month, season, and daily ambient temperatures of test result dates based on US National Oceanic and Atmospheric Administration data. RESULTS Patients (n = 472,542) completed 1,141,162 FITs. Weekly test positivity rate ranged from 2.6% to 8.0% (median, 4.4%) and varied significantly by month (June/July vs December/January rate ratio [RR] = 0.79, 95% confidence interval [CI], 0.76 to 0.83) and season. FIT sensitivity was lower in June/July (74.5%; 95% CI, 72.5 to 76.6) than January/December (78.9%; 95% CI, 77.0 to 80.7). CONCLUSIONS FITs completed during high ambient temperatures had lower positivity rates and lower sensitivity. Changing kit design, specimen transportation practices, or avoiding periods of high ambient temperatures may help optimize FIT performance, but may also increase testing complexity and reduce patient adherence, requiring careful study.
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