OTHER FUNCTIONS TAS::75 0849::TAS AGRICULTURAL HEALTH STUDY PHASE IV--MOD 3:
OTHER FUNCTIONS TAS::75 0849::TAS AGRICULTURAL HEALTH STUDY PHASE IV--MOD 3:
批准号:
8563044
负责人:
MARSHA DUNN
金额:
$13.5万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-09-23 至 2013-07-30
关键词:
AddressAgeAgricultureAwardB-LymphocytesBiologicalBiological MarkersBloodBusinessesCarcinogenesis MechanismCessation of lifeChronic Lymphocytic LeukemiaCohort StudiesCollectionColorectalComputer SystemsContractorContractsCountyDataData FilesDatabasesEnrollmentEtiologyEvaluationFundingGeneral PopulationHealthHome environmentIncidenceInstitutesInterviewIowaLicensingLinkLungLymphocytosisMalignant NeoplasmsMolecular EpidemiologyMonoclonal gammopathy of uncertain significanceMultiple MyelomaNational Health and Nutrition Examination SurveyNewsletterNorth CarolinaOccupational ExposureOvarianParticipantPesticidesPhasePrevalencePrevalence StudyProstateProstate, Lung, Colorectal, and Ovarian Cancer Screening TrialProtocols documentationQuestionnairesRecordsRecruitment ActivityResearchResearch PersonnelResourcesRetrievalSamplingSecureSelf-AdministeredSpecific qualifier valueSpecimenSpousesStudy SubjectTechnologyTelephone InterviewsUniversitiesUpdateUrineWorkcohortfarmerfield studyfollow-upindexinginterestleukemialifestyle factorsmeetingsmembermortalityneoplasm registryoperationphase 1 studyphase 2 studyphase 3 studyphase 4 studypopulation basedresearch studytechnology developmentweb site
中文摘要
农业健康研究(AHS)队列包括来自爱荷华州和北卡罗来纳州的大约52,000名私人农药施用者(主要是农民)和32,000名私人施药者的配偶,以及来自爱荷华州的大约5,000名商业农药施用者。杀虫剂施用者是在1993-1997年(AHS第一阶段)获得或续签使用限制使用杀虫剂许可证时招募的;配偶主要是通过美国农业部带回家的问卷招募的。
农药施用者(81%)。除了关于终生使用杀虫剂的广泛信息外,人口统计和其他生活方式因素在登记时使用自我管理的问卷从所有参与者那里收集(在AHS第一阶段)。自注册以来,已经进行了两次后续电话面试。第一次后续访谈是在1999年至2003年(AHS第二阶段期间)进行的,第二次后续访谈是在2005-2009年(AHS第三阶段期间)进行的。自1993年研究实地工作开始以来,癌症发病率通过与各州癌症登记处的年度联系来确定,死亡率通过与国家死亡指数的联系来确定。
AHS于1993年开始了研究第一阶段的实地工作,签订了三份合同。其中一份合同是建立一个协调中心(SRA技术),该中心主要负责研究的总体协调,编制调查问卷,并提供一个安全的计算机系统,以存储来自爱荷华州和北卡罗来纳州实地站的大量调查问卷和其他研究数据。另外两份合同是在爱荷华州(爱荷华州大学)建立一个野战站和在北方建立第二个野战站。
卡罗莱纳(巴特尔纪念学院)。外勤站主要负责管理向符合条件的研究对象分发和检索自填式问卷。通过全面和公开的竞争,协调中心的合同授予了SRA技术公司的第二阶段研究和Westat Inc.的第三阶段研究;当SRA技术公司停业时,Westat公司在第二阶段承担了协调中心合同。授予了野战站合同
再次,通过全面和公开的竞争,爱荷华州的爱荷华大学和北卡罗来纳州的巴特尔纪念研究所进行第二和第三阶段的研究。
在第四阶段合同中,承包商将负责研究的全面协调和日常管理,维护和更新包含所有研究和行政记录的安全数据库,与进行这项研究所需的适当州和联邦办公室联系,通过网站和年度通讯向队列适当传达研究结果,并从选定的研究对象收集特定的生物标本。在AHS第四阶段,一名承包商将执行所有与研究相关的活动,因为作为本合同的一部分,不会进行全群体访谈。协调中心将继续负责日常研究运作,管理和维护研究数据文件,并协调国家咨询小组会议。此外,协调中心现在将负责维护和保护队列成员的个人身份信息;与州癌症登记处、州和联邦死亡率文件、美国国税局地址数据库进行年度链接;以及促进附加研究。根据这份合同,新的责任将是进行Biomarker研究(BEA:附录中所附的方案),其中将涉及从队列的一部分收集血液和尿液样本。
英文摘要
The Agricultural Health Study (AHS) cohort consists of approximately 52,000 private pesticide applicators (primarily farmers) and 32,000 spouses of private applicators from Iowa and North Carolina, as well as approximately 5,000 commercial pesticide applicators from Iowa. The pesticide applicators were recruited between 1993-1997 (during Phase I of the AHS) when they obtained or renewed their license to apply restricted use pesticides; spouses were recruited largely by questionnaires brought home by the
pesticide applicator (81%). In addition to the extensive information on lifetime use of pesticides, demographic and other lifestyle factors were collected from all participants at enrollment using selfadministered questionnaires (during Phase I of the AHS). Two follow-up telephone interviews have been conducted since enrollment. The first follow-up interview was conducted from 1999 to 2003 (during Phase II of AHS), and the second follow-up interview was conducted from 2005-2009 (during Phase III of the AHS). Cancer incidence has been ascertained by annual linkage to the cancer registries in each state and mortality through linkage to the National Death Index since the inception of the study field work in 1993.
The AHS began field work for Phase I of the study with three contracts in 1993. One contract was for a coordinating center (SRA Technology) which was primarily responsible for overall coordination of the study, developing questionnaires, and providing a secure computer system to store the vast amount of questionnaire and other research data coming from the field stations in Iowa and North Carolina. The other two contracts were for a field station in Iowa (University of Iowa) and a second field station in North
Carolina (Battelle Memorial Institute). Field Stations were primarily responsible for managing the distribution and retrieval of self-administered questionnaires to eligible study subjects. The coordinating center contract was awarded, via a full and open competition, to SRA Technologies for Phase II of the study and to Westat Inc. for Phase III of the study; Westat assumed the coordinating center contract during Phase II when SRA Technologies went out of business. The field station contracts were awarded
again, via a full and open competition, to the University of Iowa in Iowa and Battelle Memorial Institute in North Carolina for Phases II and III of the study.
In the Phase IV contract, the contractor will be responsible for overall coordination and day-to-day management of the study, maintaining and updating a secure data base containing all study research and administrative records, provide liaison with appropriate state and federal offices necessary to conduct this research, appropriately communicate research findings to the cohort through a website and annual newsletter, and to collect specified biospecimens from selected study subjects. In Phase IV of the AHS, one contractor will perform all study related activities as there will be no cohort-wide interview conducted as part of this contract. The coordinating center will continue to be responsible for day-to-day study operations, managing and maintaining study data files, and coordinating National Advisory Panel meetings. In addition, the coordinating center will now assume responsibility for maintaining and securing the personal identifying information for cohort members; conducting annual linkages to the state cancer registries, state and federal mortality files, IRS address data bases; and facilitating add-on studies. New responsibilities under this contract will be the conduct of the Biomarker Study (BEEA: protocol attached in appendix) which will involve the collection of blood and urine samples from a subset of the cohort.
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