Juul Jakob Søgaard, Bro Flemming, Hornung Nete, Andersen Berit Sanne, Laurberg Søren, Olesen Frede, Vedsted Peter
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.
BMC Cancer. 2016 Jul 11;16:445. doi: 10.1186/s12885-016-2477-9.
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.
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.
结直肠癌是一种常见的恶性肿瘤，也是癌症相关死亡的主要原因。一半的结直肠癌患者最初表现为非特异性或模糊的症状。鉴于需要一种安全且低成本的检测方法，免疫化学粪便潜血试验（iFOBT）可能是基层医疗中对此类患者进行评估的一部分。目前，丹麦全科医生获取该检测的途径有限。本文旨在描述一项研究，该研究将评估iFOBT在基层医疗中的采用情况及临床应用。此外，还将调查在基层医疗中对出现结直肠癌非警报症状的患者使用iFOBT的诊断价值及临床意义。
方法/设计：该研究采用整群随机阶梯式楔形设计，在丹麦中部地区的381家基层医疗诊所的836名全科医生中开展。该地区的各市镇及其所属的全科医生将在为期1年的研究期的前7个月内依次纳入研究。为该研究制定了以下干预措施：一项强制性干预措施，为所有全科医生提供一套包含10次iFOBT检测的起始套装、关于iFOBT在基层医疗中使用的临床指导以及自纳入之日起的在线信息资料；一项可选干预措施，包括关于结直肠癌诊断和iFOBT使用的继续医学教育。
本研究是最早且规模最大的试验之一，旨在调查iFOBT对出现结直肠癌非警报症状的患者的诊断用途和临床价值。这些研究结果对于结直肠癌诊断的未来规划具有国内和国际重要意义，特别是对于有结直肠癌非警报症状的“低风险但并非无风险”患者。
基层医疗中iFOBT实施试验NCT02308384。注册日期：2014年11月26日。
