Marshfield Clinic Personalized Medicine Research Project (PMRP): design, methods and recruitment for a large population-based biobank.
Marshfield Clinic Personalized Medicine Research Project (PMRP): design, methods and recruitment for a large population-based biobank.
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DOI：
10.1517/17410541.2.1.49
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发表时间：
2005-03-01
影响因子：
2.3
通讯作者：
Caldwell, Michael D
中科院分区：
文献类型：
--
作者：
McCarty, Catherine A;Wilke, Russell A;Caldwell, Michael D
目的：本文的目的是总结马什菲尔德诊所个性化医学研究项目（PMRP）一期的规划，并描述前两年的招募工作。
方法：PMRP一期的目的是建立一个包含DNA、血浆和血清样本的大型人群生物样本库，以促进基因组学研究。通过三个外部委员会促进规划和咨询：伦理与安全咨询委员会、科学咨询委员会以及社区咨询小组。从2002年9月开始，邀请居住在美国威斯康星州马什菲尔德周边19个邮政编码区域之一、年龄在18岁及以上的居民参与。在提供书面知情同意后，参与者完成简短的问卷调查，问卷内容包括人口统计学问题、一些环境暴露情况、疾病家族史、药物不良反应以及居住在研究区域的家庭成员情况。参与者提供50毫升血液，从中提取DNA，并储存血浆和血清样本。知情同意文件允许获取电子病历，并包含有关不披露个人研究结果的条款。还包括一个勾选框，以便参与者可以选择允许或拒绝后续为未来研究进行再次联系。
结果：在招募的前23个月内，共有17463名受试者入组（占研究项目助理能够联系到的居民的44.3%）。参与者年龄在18岁到98.5岁之间（平均年龄 = 48.9岁，中位数 = 48岁）；57.2%（n = 9986）为女性。研究队列中自我报告的种族与美国威斯康星州伍德县2000年的人口普查情况相似，大多数（98%）报告自己为白人高加索人。大多数受试者（n = 13391，76.7%）表示自己有德国血统。只有142名参与者（<1%）在同意书上选择退出未来研究的联系。大多数队列成员报告他们目前的居住区域是郊区、城市或村庄（n = 10630，60.87%）；其余的报告居住在农村住宅或业余农场（n = 5365，30.72%），或工作农场或牧场（n = 1451，8.31%）。超过一半的队列成员（n = 9409，53.88%）在其人生的某个阶段曾在工作农场生活过。
结论：PMRP数据库将允许在三个领域进行研究：遗传流行病学、药物遗传学和群体遗传学。人群的规模和稳定性以及相对的种族同质性将有助于促进具有有效研究结果的纵向研究，这些结果不会因人群分层而产生偏差。
OBJECTIVES: The objective of this paper is to summarize the planning for Phase I of the Marshfield Clinic Personalized Medicine Research Project (PMRP) and to describe the recruitment efforts in the first 2 years.METHODS: The purpose of Phase I of the PMRP was to develop a large population-based biobank with DNA, plasma and serum samples to facilitate genomics research. Planning and consultation was facilitated with three external boards: the Ethics and Security Advisory Board; the Scientific Advisory Board; and the Community Advisory Group. Commencing in September 2002, residents aged 18 and above who resided in 1 of 19 zip codes surrounding Marshfield, WI, USA, were invited to participate. After providing written informed consent, participants completed brief questionnaires that included questions about demographics, some environmental exposures, family history of disease, and adverse drug reactions, as well as family members living in the study area. Participants provided 50ml of blood from which DNA was extracted and plasma and serum samples were stored. The informed consent document allowed access to electronic medical records and included language about non-disclosure of personal research results. A tick-off box was also included so that participants could either allow or decline subsequent recontact for future research studies.RESULTS: A total of 17,463 subjects were enrolled during the first 23months of recruitment (44.3% of the residents who the Research Project Assistants were able to contact). The participants ranged in age from 18 to 98.5years (mean = 48.9, median = 48); 57.2% (n = 9986) were female. Self-reported race in the study cohort was similar to the year 2000 census for Wood County, WI, USA, with the majority (98%) reporting themselves to be White Caucasian. The majority of subjects (n= 13,391, 76.7%) indicated that they had German ancestry. Only 142participants (< 1%) opted out on the consent form for contact for future studies. The majority of the cohort reported that their current area of residence was a suburb, city or village (n = 10630, 60.87%); the remainder reported residence in a rural home or hobby farm (n=5365, 30.72%), or a working farm or ranch (n = 1451, 8.31%). More than half the cohort (n = 9409, 53.88%) had lived on a working farm at some point in their life.CONCLUSION: The PMRP database will allow research in three areas: genetic epidemiology, pharmacogenetics, and population genetics. The size and the stability of the population as well as the relative ethnic homogeneity will help facilitate longitudinal studies with valid research results that are not biased by population stratification.