Usability of IBDoc, a Novel Fecal Calprotectin Home-Based Rapid Test in Clinical Practice

M. Røer, M. Småstuen, A. Røseth
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引用次数: 3

Abstract

Abstract The aim of this study was to examine sustained usability and adherence to a fecal calprotectin (FC) home-based rapid test in an inflammatory bowel disease (IBD) monitoring program in clinical practice. Methods In total, 59 consecutive IBD outpatients were recruited. The participants were asked to measure FC with a home-based rapid test, IBDoc, every second month for a period of 14 months. At start and termination of this time period, they were invited to answer a questionnaire concerning the IBDoc device. The participants were also asked to deliver one stool sample for FC to be analyzed with enzyme-linked immunosorbent assay and analyze the same sample with the home-based FC test at start and termination. Results In total, one-third (34%) of the participants were adherent to the IBDoc program. No patient characteristics were significantly associated with being adherent. The home-based test correlated well with enzyme-linked immunosorbent assay method (Spearman rank correlation coefficient was 0.92, P < 0.001 and 0.74, P < 0.001, at study start and termination, respectively). After having used the IBDoc for over a year, all except for 1 of the 36 participants answering the follow-up questionnaire completely agreed with the statement “I would like to use IBDoc in the future.” Conclusions We found a low adherence to home-based FC measurements every second month for a period of 14 months. Nevertheless, all but 1 of the 36 participants who answered the follow-up questionnaire were interested in continuing using the IBDoc test.
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新型粪钙保护蛋白家庭快速检测方法IBDoc的临床应用
本研究的目的是在临床实践中检查在炎症性肠病(IBD)监测项目中粪便钙保护蛋白(FC)家庭快速检测的持续可用性和依从性。方法共招募59例连续IBD门诊患者。参与者被要求在14个月的时间里,每两个月用基于家庭的快速测试IBDoc来测量FC。在这段时间的开始和结束时,他们被邀请回答一份关于IBDoc装置的问卷。参与者还被要求提供一份粪便样本进行FC分析,用酶联免疫吸附法分析,并在开始和结束时用家庭FC测试分析同一样本。结果:总共有三分之一(34%)的参与者坚持IBDoc计划。没有患者特征与依从性显著相关。家庭检测与酶联免疫吸附法相关性良好(在研究开始和结束时,Spearman秩相关系数分别为0.92,P < 0.001和0.74,P < 0.001)。在使用IBDoc一年多后,36名回答随访问卷的参与者中,除了1人之外,其余的人都完全同意“我想在未来使用IBDoc”的说法。结论:我们发现,在14个月的时间里,每两个月进行一次家庭FC测量的依从性很低。然而,在36名回答了后续问卷的参与者中,除了1人之外,其他人都对继续使用IBDoc测试感兴趣。
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