Cohort Profile: Design and methods of the PREDIMED study
Cohort Profile: Design and methods of the PREDIMED study
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DOI：
10.1093/ije/dyq250
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发表时间：
2012-04-01
影响因子：
7.7
通讯作者：
Estruch, Ramon
中科院分区：
文献类型：
--
作者：
Angel Martinez-Gonzalez, Miguel;Corella, Dolores;Estruch, Ramon
2002年，西班牙政府(卡洛斯三世萨卢德研究所)发出了赠款呼吁。这一呼吁是专门为启动西班牙生物医学研究人员之间的网络研究而设计的。在2002年期间，我们倡议的领导者Ramón Estruch从不同的角度联系了从事营养工作的不同西班牙研究人员(我们其他人)。我们一起申请了一项拨款，开始了一项大型随机试验，以测试地中海饮食(MeDiet)对心血管疾病(CVD)的初级预防的有效性，并继续作为高危参与者的观察性队列进行长期跟踪。2003年1月6日，我们的项目获得资助。2003年1月至6月，我们制定了议定书：后勤、操作手册、文书、表格和数据输入/管理系统。然后雇用、培训和认证所需人员(11个外地中心中每个中心至少有一名营养师和一名护士)。每个FC联系了大约20个初级保健实践(PCP)来招募参与者。参与者的招募工作于2003年10月开始。PREDIMED(西班牙语：Prevención con Dieta地中海)是由多洛雷斯·科雷拉提出的。这一名称同时适用于队列研究和网络小组。尽管这是一项干预性研究，但PREDIMED研究提供了一个独特的机会，可以在地中海环境下对一大批高心血管风险受试者进行长期随访(在试验完成后)。
A call for grants was issued in 2002 by the Spanish Government (Instituto de Salud Carlos III). This call was specifically designed to initiate networking research among Spanish biomedical investigators. During 2002, Ramón Estruch—the leader of our initiative—contacted different Spanish investigators (the rest of us) working in nutrition from different perspectives. We applied together for a grant to start a large randomized trial to test the effectiveness of a Mediterranean diet (MeDiet) on the ‘primary’prevention of cardiovascular disease (CVD) and to continue the study as an observational cohort of high-risk participants to be followed-up in the long term. On 6 January 2003 our project was funded. From January to June 2003, we developed the protocol: logistics, manual of operations, instruments, forms and data entry/management systems. The needed personnel (a minimum of a dietician and a nurse for each of the 11 field centres, FCs) were then hired, trained and certified. Each FC contacted approximately 20 primary care practices (PCPs) to recruit participants. The recruitment of participants started in October 2003. The name PREDIMED (in Spanish: PREvención con DIeta MEDiterránea) was proposed by Dolores Corella. This name is applied to both the cohort study and the networking group. Despite being an interventional study, the PREDIMED study provides a unique opportunity for conducting the long-term follow-up (after the completion of the trial) of a large observational cohort of high cardiovascular risk subjects in a Mediterranean setting.