title: Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design.
abstract: Colorectal cancer is a common malignancy and a leading cause of cancer-related death. Half of patients with colorectal cancer initially present with non-specific or vague symptoms. In the need for a safe low-cost test, the immunochemical faecal occult blood test (iFOBT) may be part of the evaluation of such patients in primary care. Currently, Danish general practitioners have limited access to this test. The aim of this article is to describe a study that will assess the uptake and clinical use of iFOBT in general practice. Furthermore, it will investigate the diagnostic value and the clinical implications of using iFOBT in general practice on patients presenting with non-alarm symptoms of colorectal cancer.
  
  
  
  The study uses a cluster-randomised stepped-wedge design and is conducted in the Central Denmark Region among 836 GPs in 381 general practices. The municipalities of the Region and their appertaining general practitioners will be included sequentially in the study during the first 7 months of the 1-year study period. The following intervention has been developed for the study: a mandatory intervention providing all general practitioners with a starting package of 10 iFOBTs, a clinical instruction on iFOBT use in general practice and online information material from the date of inclusion, and an optional intervention consisting of a continuous medical education on colorectal cancer diagnostics and use of iFOBT.
  
  
  
  This study is among the first and largest trials to investigate the diagnostic use and the clinical value of iFOBT on patients presenting with non-alarm symptoms of colorectal cancer. The findings will be of national and international importance for the future planning of colorectal cancer diagnostics, particularly for 'low-risk-but-not-no-risk' patients with non-alarm symptoms of colorectal cancer.
  
  
  
  A Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.
authors.affiliation: Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. j.juul@ph.au.dk.|Research Centre for Cancer Diagnosis in Primary Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. j.juul@ph.au.dk.
authors.forename: Jakob Søgaard
authors.initials: JS
authors.lastname: Juul
authors.affiliation: Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
authors.forename: Flemming
authors.initials: F
authors.lastname: Bro
authors.affiliation: Department of Clinical Biochemistry, Regional Hospital of Randers, Skovlyvej 1, 8930, Randers NE, Denmark.
authors.forename: Nete
authors.initials: N
authors.lastname: Hornung
authors.affiliation: Department of Public Health Programs, Regional Hospital of Randers, Skovlyvej 1, 8930, Randers NE, Denmark.
authors.forename: Berit Sanne
authors.initials: BS
authors.lastname: Andersen
authors.affiliation: Department of Surgery, Aarhus University Hospital, Tage Hansens Gade 2, 8000, Aarhus C, Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Laurberg
authors.affiliation: Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
authors.forename: Frede
authors.initials: F
authors.lastname: Olesen
authors.affiliation: Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.|Research Centre for Cancer Diagnosis in Primary Care, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Vedsted
mesh_terms: D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000473:pathology; D003718:Denmark; D055088:Early Detection of Cancer / Q000191:economics / Q000379:methods*; D005194:Family Practice / Q000592:standards*; D058006:General Practice / Q000379:methods*; D006801:Humans; D007120:Immunochemistry; D008403:Mass Screening / Q000191:economics / Q000379:methods*; D009780:Occult Blood; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000379:methods; D011897:Random Allocation
keywords: Colorectal cancer; Denmark; Early diagnosis; FIT; Faecal occult blood test; General practice; Symptoms; iFOBT