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Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design.

Juul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P - BMC Cancer (2016)

Bottom Line: Currently, Danish general practitioners have limited access to this test.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.

View Article: PubMed Central - PubMed

Affiliation: Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. j.juul@ph.au.dk.

ABSTRACT

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: A Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.

No MeSH data available.


Related in: MedlinePlus

Flowchart of inclusion date for the participating municipalities
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Fig2: Flowchart of inclusion date for the participating municipalities

Mentions: During the first seven months of the study period, each municipality and their appertaining GPs will be randomly and stepwise included in the study to receive intervention (Fig. 1). The intervention (see details later) consists of sending iFOBT kits and a clinical guideline to the GPs and to offer an optional continuous medical education (CME) session about CRC diagnosis. The invitation to the CME is sent to the chairman of the GP unit who will arrange the date and time of the meeting. The month in which the CME is arranged determines the date of inclusion for each municipality. Thus, the date at which a municipality is included is defined as the first working day of the month in which the CME is planned to be conducted. As the CME component is optional, the GP units can choose not to participate in the CME. These municipalities are included on the first working day in the month after confirmation of non-participation (Fig. 2). The specific date of the CME is flexibly arranged as the CME can be scheduled to take place on any of the first 7 months, depending on the preferences of the GPs in the municipality (in consideration of other arrangements targeting GPs in the municipality, availability of venue, etc.).Fig. 1


Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design.

Juul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P - BMC Cancer (2016)

Flowchart of inclusion date for the participating municipalities
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4940713&req=5

Fig2: Flowchart of inclusion date for the participating municipalities
Mentions: During the first seven months of the study period, each municipality and their appertaining GPs will be randomly and stepwise included in the study to receive intervention (Fig. 1). The intervention (see details later) consists of sending iFOBT kits and a clinical guideline to the GPs and to offer an optional continuous medical education (CME) session about CRC diagnosis. The invitation to the CME is sent to the chairman of the GP unit who will arrange the date and time of the meeting. The month in which the CME is arranged determines the date of inclusion for each municipality. Thus, the date at which a municipality is included is defined as the first working day of the month in which the CME is planned to be conducted. As the CME component is optional, the GP units can choose not to participate in the CME. These municipalities are included on the first working day in the month after confirmation of non-participation (Fig. 2). The specific date of the CME is flexibly arranged as the CME can be scheduled to take place on any of the first 7 months, depending on the preferences of the GPs in the municipality (in consideration of other arrangements targeting GPs in the municipality, availability of venue, etc.).Fig. 1

Bottom Line: Currently, Danish general practitioners have limited access to this test.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.

View Article: PubMed Central - PubMed

Affiliation: Research Unit for General Practice, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark. j.juul@ph.au.dk.

ABSTRACT

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: A Trial of the Implementation of iFOBT in General Practice NCT02308384 . Date of registration: 26 November 2014.

No MeSH data available.


Related in: MedlinePlus