Kochar Bharati, Aldridge Molly, Cook Suzanne Follan, Bright Renee, Mallette Meaghan, Moniz Heather, Shah Samir A, LeLeiko Neal S, Shapiro Jason, Sands Bruce E, Chen Wenli, Jaeger Elizabeth, Galanko Joseph, Long Millie D, Martin Christopher F, Sandler Robert S, Kappelman Michael D
University of North Carolina, Center for Gastrointestinal Biology and Disease, Chapel Hill, NC, United States.
J Med Internet Res. 2016 Jun 3;18(6):e124. doi: 10.2196/jmir.5655.
BACKGROUND: Traditional cohort studies are important contributors to our understanding of inflammatory bowel diseases, but they are labor intensive and often do not focus on patient-reported outcomes. Internet-based studies provide new opportunities to study patient-reported outcomes and can be efficiently implemented and scaled. If a traditional cohort study was linked to an Internet-based study, both studies could benefit from added synergy. Existing cohort studies provide an opportunity to develop and test processes for cohort linkage. The Crohn's and Colitis Foundation of America's (CCFA) Partners study is an Internet-based cohort of more than 14,000 participants. The Ocean State Crohn's and Colitis Area Registry (OSCCAR) is an inception cohort. The Sinai-Helmsley Alliance for Research Excellence (SHARE) is a multicentered cohort of inflammatory bowel disease patients. Both the later cohorts include medical record abstraction, patient surveys, and biospecimen collection. OBJECTIVE: Given the complementary nature of these existing cohorts, we sought to corecruit and link data. METHODS: Eligible OSCCAR and SHARE participants were invited to join the CCFA Partners study and provide consent for data sharing between the 2 cohorts. After informed consent, participants were directed to the CCFA Partners website to complete enrollment and a baseline Web-based survey. Participants were linked across the 2 cohorts by the matching of an email address. We compared demographic and clinical characteristics between OSCCAR and SHARE participants who did and did not enroll in CCFA Partners and the data linkage. RESULTS: Of 408 participants in the OSCCAR cohort, 320 were eligible for participation in the CCFA Partners cohort. Of these participants, 243 consented to participation; however, only 44 enrolled in CCFA Partners and completed the linkage. OSCCAR participants who enrolled in CCFA Partners were better educated (17% with doctoral degrees) than those who did not (3% with doctoral degrees, P=.01). In the SHARE cohort, 436 participants enrolled and linked to the Partners cohort. More women (60% vs 50%) linked and those who linked were predominantly white (96%; P<.01). Crohn's disease patients who linked had lower mean scores on the Harvey-Bradshaw Index (3.6 vs 4.4, P<.01). Ulcerative colitis patients who linked had less extensive disease than those who did not link (45% vs 60%, P<.01). CONCLUSIONS: Linkage of CCFA Partners with cohorts such as OSCCAR and SHARE may be a cost-effective way to expand the infrastructure for clinical outcomes and translational research. Although linkage is feasible from a technical, legal, and regulatory perspective, participant willingness appears to be a limiting factor. Overcoming this barrier will be needed to generate meaningful sample sizes to conduct studies of biomarkers, natural history, and clinical effectiveness using linked data.
背景:传统队列研究对我们理解炎症性肠病有重要贡献,但这类研究劳动强度大,且往往未关注患者报告的结局。基于互联网的研究为研究患者报告的结局提供了新机会,并且能够高效实施和扩大规模。如果将传统队列研究与基于互联网的研究相联系,两项研究都能从增强的协同效应中获益。现有的队列研究为开发和测试队列关联流程提供了机会。美国克罗恩病和结肠炎基金会(CCFA)的“合作伙伴”研究是一个基于互联网的队列,有超过14,000名参与者。罗德岛克罗恩病和结肠炎地区登记处(OSCCAR)是一个起始队列。西奈山-赫尔姆斯利卓越研究联盟(SHARE)是一个炎症性肠病患者的多中心队列。后两个队列均包括病历摘要、患者调查和生物样本采集。 目的:鉴于这些现有队列的互补性质,我们试图进行联合招募并关联数据。 方法:邀请符合条件的OSCCAR和SHARE参与者加入CCFA“合作伙伴”研究,并同意在两个队列之间共享数据。在获得知情同意后,参与者被引导至CCFA“合作伙伴”网站完成注册和基于网络的基线调查。通过匹配电子邮件地址在两个队列之间对参与者进行关联。我们比较了参与和未参与CCFA“合作伙伴”研究及数据关联的OSCCAR和SHARE参与者之间的人口统计学和临床特征。 结果:在OSCCAR队列的408名参与者中,320名有资格参与CCFA“合作伙伴”队列。在这些参与者中,243名同意参与;然而,只有44名注册加入CCFA“合作伙伴”研究并完成了关联。注册加入CCFA“合作伙伴”研究的OSCCAR参与者受教育程度更高(17%拥有博士学位),而未参与者中这一比例为3%(P = 0.01)。在SHARE队列中,436名参与者注册并与“合作伙伴”队列建立了关联。关联的女性更多(60%对50%),且关联者主要为白人(96%;P < 0.01)。建立关联的克罗恩病患者哈维-布拉德肖指数平均得分较低(3.6对4.4,P < 0.01)。建立关联的溃疡性结肠炎患者疾病范围比未建立关联者小(45%对60%,P < 0.01)。 结论:将CCFA“合作伙伴”研究与OSCCAR和SHARE等队列相联系,可能是一种经济有效的方式来扩展临床结局和转化研究的基础设施。尽管从技术、法律和监管角度来看关联是可行的,但参与者的意愿似乎是一个限制因素。需要克服这一障碍,以获得有意义的样本量,从而利用关联数据开展生物标志物、自然史和临床疗效的研究。
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