Letter to the Editor Annals of Clinical Biochemistry 2014, Vol. 51(2) 301–302 acb.sagepub.com
A standard for Faecal Immunochemical TesTs for Haemoglobin Evaluation Reporting (FITTER) There is much current and ever-growing interest in using faecal tests to screen for colorectal cancer, a major health concern in many countries.1 Faecal immunochemical tests for haemoglobin (FIT)2 are widely recommended for asymptomatic population screening3 and have considerable potential for use in other clinical situations.4 There are many publications of different types concerning FIT. These have appeared in a variety of journals and other media. Most document the major clinical findings and outcomes in detail, but adequate descriptions of the pre-analytical aspects (specimen collection, handling and storage prior to analysis) and the analytical performance characteristics attained are very often deficient or simply missing. Such a situation is also found in publications on many other biomarkers. However, in order to evaluate published data, compare and contrast the results of published studies and translate published results into practice, these pre-analytical and analytical aspects need to be adequately described and documented. The Expert Working Group (EWG) on FIT for Screening, which was formed by the Colorectal Cancer Screening Committee of the World Endoscopy Organization, has a broad remit to improve all aspects of FIT and has produced a number of informative discussion documents and publications (www.worldendo. org/weo-crcsc-expert-working-group-fit-for-screening. html). We recognized the importance of improving published papers on FIT and have now produced a standard for adequate reporting of FIT studies. This involves, as is the case for other such standards, a checklist. The checklist details items to be documented in any publication describing the use of FIT. This requires data on specimen collection and handling (10 items), analysis (5 items), quality management (4 items) and result handling (4 items). The standard and checklist are available at: www.worldendo.org/
assets/downloads/pdf/activities/weo_expert_working_ group_fit_discussion_doc_no5_pu.pdf We recommend that investigators and authors adhere to the FITTER standards and use the checklist provided. We advocate that reviewers of submitted manuscripts on FIT request adherence to the standards and look for inclusion of a completed checklist. We also hope that the editors of medical journals and editorial staff will appreciate the value of good documentation of studies on FIT and request authors make the checklist available to all readers. Professionals working in laboratory medicine are well placed to help clinical investigators provide pertinent analytical information required in the FITTER standard and checklist.5 Declaration of conflicting interests None declared.
Funding This received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Ethical approval Not applicable.
Guarantor CGF.
Contributorship All authors contributed to the intellectual content and have met the following requirements: (a) significant contributions to the concept, (b) drafting or revising the article for intellectual content and (c) final approval of the published article.
References 1. Ayling RM. New faecal tests in gastroenterology. Ann Clin Biochem 2012; 49: 44–54. 2. Allison JE, Fraser CG, Halloran SP, et al. Comparing fecal immunochemical tests: improved standardization is needed. Gastroenterology 2012; 142: 422–424.
302 3. Halloran SP, Launoy G and Zappa M International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition—faecal occult blood testing. Endoscopy 2012; 44(Suppl 3): SE65–SE87. 4. Fraser CG. A future for faecal haemoglobin measurements in the medical laboratory. Ann Clin Biochem 2012; 49: 518–526. 5. Fraser CG, Allison JE, Young GP, et al. Newer fecal tests: opportunities for professionals in laboratory medicine. Clin Chem 2012; 58: 963–965.
Annals of Clinical Biochemistry 51(2) Callum G Fraser1, James E Allison2, Graeme P Young3, Stephen P Halloran4 and Helen Seaman4 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Scotland 2 Division of Gastroenterology, University of California San Francisco, California 3 Flinders Centre for Cancer Prevention and Control, Bedford Park (Adelaide), South Australia 4 Bowel Cancer Screening Hub – South of England, Royal Surrey County Hospital NHS Trust and University of Surrey, Guildford, UK Corresponding author: Callum G Fraser, Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, Scotland. Email: [email protected] ! The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav acb.sagepub.com doi: 10.1177/0004563213514392 available online at http://acb.sagepub.com
Copyright of Annals of Clinical Biochemistry is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
A standard for Faecal Immunochemical TesTs for Haemoglobin Evaluation Reporting (FITTER) There is much current and ever-growing interest in using faecal tests to screen for colorectal cancer, a major health concern in many countries.1 Faecal immunochemical tests for haemoglobin (FIT)2 are widely recommended for asymptomatic population screening3 and have considerable potential for use in other clinical situations.4 There are many publications of different types concerning FIT. These have appeared in a variety of journals and other media. Most document the major clinical findings and outcomes in detail, but adequate descriptions of the pre-analytical aspects (specimen collection, handling and storage prior to analysis) and the analytical performance characteristics attained are very often deficient or simply missing. Such a situation is also found in publications on many other biomarkers. However, in order to evaluate published data, compare and contrast the results of published studies and translate published results into practice, these pre-analytical and analytical aspects need to be adequately described and documented. The Expert Working Group (EWG) on FIT for Screening, which was formed by the Colorectal Cancer Screening Committee of the World Endoscopy Organization, has a broad remit to improve all aspects of FIT and has produced a number of informative discussion documents and publications (www.worldendo. org/weo-crcsc-expert-working-group-fit-for-screening. html). We recognized the importance of improving published papers on FIT and have now produced a standard for adequate reporting of FIT studies. This involves, as is the case for other such standards, a checklist. The checklist details items to be documented in any publication describing the use of FIT. This requires data on specimen collection and handling (10 items), analysis (5 items), quality management (4 items) and result handling (4 items). The standard and checklist are available at: www.worldendo.org/
assets/downloads/pdf/activities/weo_expert_working_ group_fit_discussion_doc_no5_pu.pdf We recommend that investigators and authors adhere to the FITTER standards and use the checklist provided. We advocate that reviewers of submitted manuscripts on FIT request adherence to the standards and look for inclusion of a completed checklist. We also hope that the editors of medical journals and editorial staff will appreciate the value of good documentation of studies on FIT and request authors make the checklist available to all readers. Professionals working in laboratory medicine are well placed to help clinical investigators provide pertinent analytical information required in the FITTER standard and checklist.5 Declaration of conflicting interests None declared.
Funding This received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Ethical approval Not applicable.
Guarantor CGF.
Contributorship All authors contributed to the intellectual content and have met the following requirements: (a) significant contributions to the concept, (b) drafting or revising the article for intellectual content and (c) final approval of the published article.
References 1. Ayling RM. New faecal tests in gastroenterology. Ann Clin Biochem 2012; 49: 44–54. 2. Allison JE, Fraser CG, Halloran SP, et al. Comparing fecal immunochemical tests: improved standardization is needed. Gastroenterology 2012; 142: 422–424.
302 3. Halloran SP, Launoy G and Zappa M International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition—faecal occult blood testing. Endoscopy 2012; 44(Suppl 3): SE65–SE87. 4. Fraser CG. A future for faecal haemoglobin measurements in the medical laboratory. Ann Clin Biochem 2012; 49: 518–526. 5. Fraser CG, Allison JE, Young GP, et al. Newer fecal tests: opportunities for professionals in laboratory medicine. Clin Chem 2012; 58: 963–965.
Annals of Clinical Biochemistry 51(2) Callum G Fraser1, James E Allison2, Graeme P Young3, Stephen P Halloran4 and Helen Seaman4 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Scotland 2 Division of Gastroenterology, University of California San Francisco, California 3 Flinders Centre for Cancer Prevention and Control, Bedford Park (Adelaide), South Australia 4 Bowel Cancer Screening Hub – South of England, Royal Surrey County Hospital NHS Trust and University of Surrey, Guildford, UK Corresponding author: Callum G Fraser, Centre for Research into Cancer Prevention and Screening, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, Scotland. Email: [email protected] ! The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav acb.sagepub.com doi: 10.1177/0004563213514392 available online at http://acb.sagepub.com
Copyright of Annals of Clinical Biochemistry is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
