Multiplex Initiative

多重倡议

• 批准号: 7594350
• 负责人: Colleen McBride
• 金额: $ 103.63万
• 依托单位: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7594350
• 关键词: Adoption; Affective; Baltimore; Behavioral; Belief; Bioinformatics; Biological; Biology; Blood; Caring; Categories; Characteristics; Clinic; Clinic Visits; Clinical; Clinical Data; Code; Cognitive; Condition; Counseling; Custom; Data; Data Collection; Data Set; Databases; Disease; Empirical Research; Enrollment; Ensure; Event; Feedback; Genetic Predisposition to Disease; Genetic Risk; Genetic Variation; Genetic screening method; Genomics; Genotype; Health; Health Benefit; Health Personnel; Health Resources; Health behavior; Health system; Incentives; Individual; Informed Consent; Inherited; Insurance Coverage; Internet; Intervention; Interview; Interviewer; Knowledge; Learning; Letters; Link; Location; Mails; Medical Records; Modeling; Nature; Numbers; Outcome; Pamphlets; Participant; Persons; Preventive; Procedures; Process; Process Assessment; Protocols documentation; Public Health; Public Policy; Reaction Time; Research; Research Infrastructure; Research Personnel; Risk; Sampling; Site; Social Impacts; Socioeconomic Status; Specific qualifier value; Study Subject; Surveys; System; Telephone; Test Result; Testing; Time; Training; Visit; Zip Code; base; care seeking; day; design; disorder risk; emotional factor; experience; follow-up; health care service utilization; interest; member; pressure; programs; prototype; psychologic; response; social; systems research; technology development; tool

There are six data collection points in the cascade of procedures: (1) a baseline telephone assessment, (2) a post-baseline assessment that can be completed online or by telephone, (3) a clinic visit assessment, (4) a telephone call following mailing of results, (5) a six month follow-up telephone assessment, and (6) abstraction of automated medical records to assess health care utilization and health care seeking outcomes. Enrollees are being identified from those who receive care at ten clinics within the Henry Ford Health System (HFHS). Identified potential participants are mailed a letter from HFHS describing the study and requesting their participation in the baseline assessment. Interviews are conducted by a trained survey interviewer at the Center for Health Studies (CHS) in Seattle. Following the baseline assessment, participants who are eligible are sent information about multiplex genetic testing and encouraged to visit the Web site and participate in an on-line decision process assessment for a $50 incentive. As part of their experience, individuals are asked to consider having the Multiplex Genetic Susceptibility Test. Test results of genetic variations that confer an increased risk for disease are communicated by NHGRI directly to participants through the mail. Results are not given to health-care providers or included in medical records. A HFHS research educator attempts to contact participants by telephone as soon after they have received their test results as possible, preferably within ten days of receipt of mailed results (depending on the availability of the participant). The research educator offers assistance in interpreting the test results as well as the option to consider other preventive health resources available to HFHS members. The Bioinformatics and Scientific Programming Core (led by Dr. Andy Baxevanis) has taken primary responsibility for all computational- and IT-related aspects of the Multiplex Initiative. This has included developing data specifications and data transfer protocols involving NHGRI, HFHS, CHS, and the Center for Inherited Disease Research (CIDR) in Baltimore. These data transfer protocols track each step that a study participant experiences as part of this study. These data transfers are critical, since they serve as event triggers during the study and ensure that a study subject (and their biological samples) move smoothly through the data collection pipeline. The data themselves are incredibly disparate in nature and include the results of baseline interviews, information on study subject enrollment, the tracking of blood draws, the location of samples at any given time, responses to on-line and in-person surveys conducted by CHS, relevant clinical data from HFHS, genotyping data from CIDR, the status of mailing result booklets, and the status of follow-up visits. We have spent a significant amount of time modifying LabMatrix, NHGRIs clinical database system, to accommodate these data as they arrive at specified intervals, as well as to be able to automatically generate result booklets for mailing to study participants. Since LabMatrix will be the storehouse for all Multiplex Initiative data, we have given significant consideration to ensuring that LabMatrix can also be used as an analysis tool downstream, enabling investigators who wish to perform secondary analyses on these data to easily amass and interrogate custom data sets. As part of the data collection pipeline, they have also spent a significant amount of time developing the Multiplex Initiative Web site (http://multiplex.nih.gov). This Web site is the studys primary tool for collecting survey information and has been designed so that each participants visit to the site can be precisely tracked, down to the amount of time spent on each page and the order of links that were selected; these data are important for answering some of the studys behaviorally related questions.

在一系列程序中有六个数据收集点：（1）基线电话评估，（2）可以在线或通过电话完成的基线后评估，（3）诊所访问评估，（4）邮寄结果后的电话，（5）六个月随访电话评估，以及（6）提取自动化医疗记录以评估卫生保健利用和卫生保健寻求结果。 登记者正在从亨利福特卫生系统（HFHS）的十个诊所接受护理的人中确定。 HFHS将向确定的潜在参与者邮寄一封信，描述研究并要求他们参与基线评估。 访谈由西雅图健康研究中心（CHS）的一名训练有素的调查访谈员进行。 在基线评估之后，向符合条件的参与者发送关于多重基因检测的信息，并鼓励他们访问网站，参加在线决策过程评估，奖励50美元。 作为他们经验的一部分，个人被要求考虑进行多重遗传易感性测试。 NHGRI通过邮件直接向参与者传达增加疾病风险的遗传变异的测试结果。 结果不提供给保健提供者，也不列入医疗记录。 HFHS研究教育工作者试图在参与者收到测试结果后尽快通过电话联系参与者，最好在收到邮寄结果的十天内（取决于参与者的可用性）。 研究教育工作者提供帮助，解释测试结果，以及选择考虑其他预防健康资源提供给HFHS成员。 生物信息学和科学编程核心（由安迪·马奇瓦尼斯博士领导）主要负责多重计划的所有计算和IT相关方面。这包括制定涉及NHGRI、HFHS、CHS和巴尔的摩遗传疾病研究中心（CIDR）的数据规范和数据传输协议。这些数据传输协议跟踪研究参与者在本研究中经历的每个步骤。这些数据传输至关重要，因为它们在研究期间充当事件触发器，并确保研究受试者（及其生物样本）顺利通过数据收集管道。这些数据本身在性质上是完全不同的，包括基线访谈的结果、研究受试者入组的信息、抽血的跟踪、任何给定时间的样本位置、对CHS进行的在线和面对面调查的响应、HFHS的相关临床数据、CIDR的基因分型数据、邮寄结果手册的状态以及随访的状态。我们花了大量的时间修改LabMatrix，NHGRI临床数据库系统，以适应这些数据，因为它们在指定的时间间隔到达，以及能够自动生成结果小册子邮寄给研究参与者。由于LabMatrix将成为所有多重计划数据的仓库，因此我们重点考虑确保LabMatrix也可用作下游分析工具，使希望对这些数据进行二次分析的研究人员能够轻松收集和查询自定义数据集。 作为数据收集管道的一部分，他们还花了大量时间开发多重倡议网站（http：multiplex.nih.gov）。该网站是研究收集调查信息的主要工具，其设计目的是使每个访问该网站的参与者都能被精确跟踪，跟踪到每个页面上花费的时间和所选链接的顺序;这些数据对于回答一些与研究行为相关的问题非常重要。