Development and validation of software for Internet and PC SCID administration
Development and validation of software for Internet and PC SCID administration
批准号:
8708967
负责人:
BENJAMIN B BRODEY
金额:
$34.42万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-05-26 至 2016-06-30
关键词:
Algorithmic SoftwareAlgorithmsAmericanCategoriesChinese PeopleClinicalClinical TrialsCodeComprehensionComputer softwareCountryDataDatabasesDevelopmentDiagnosisDiagnosticDiagnostic and Statistical Manual of Mental DisordersDocumentationEducational StatusEnsureEthnic OriginFutureGenesGoalsGoldHispanic AmericansHumanIndividualInternetInterventionLanguageLife Cycle StagesMapsMedicineMental HealthMental disordersMexicoNationalitiesPaperPatientsPhasePopulationProceduresProcessPuerto RicoRegulationRelative (related person)ResearchResearch InstituteResearch PersonnelSoftware ValidationStrategic PlanningSymptomsTerminologyTestingTextTranslatingTranslationsUnited StatesUnited States National Institutes of HealthUpdateValidationWitWorkWorld Health Organizationbaseclinical practicedesignflexibilityimprovedphase 2 studyproduct developmentprogramsresearch studyresponsesoftware systemstooluser friendly software
中文摘要
描述(由申请人提供):SCID是美国所有基于研究的精神健康诊断和全球中枢神经系统临床试验的“黄金标准”。但是,它的管理一直既昂贵又繁琐。在这个项目的第一和第二阶段,我们成功地开发了NetSCID,这是一个用于管理SCID的高度灵活的软件包。在第二阶段竞争性更新项目中,我们建议增强NetSCID诊断软件包,使其符合DSM-5。此外,我们打算创建4个标准化的NetSCID官方翻译成中文、俄语、拉丁美洲西班牙语和法语。这些语言加起来占世界人口的30%到50%,如果把母语和所说的第二语言包括在内的话。我们的第二阶段研究表明,相对于纸质SCID,75%的临床医生更喜欢NetSCID,而且它已经被证明可以减少分支和数据输入错误。此外,该程序还包含一个数据库,其中包含患者对每个项目的反应。这个相同的数据库也将在所有语言之间共享。由于存在一个可搜索的单一数据库,NetSCID将使研究人员能够识别“症状群”,而不仅仅是与研究结果相关的DSM诊断。APA主席建议,需求侧管理的有效性必须基于对研究研究中出现的“症状群”的研究,而不是像传统上存在于需求侧管理中的固定症状类别。美国国立卫生研究院还在RDoC战略计划倡议中确定,DSM诊断不能很好地映射到人类基因。由于除了诊断外,NetSCID还可以用来识别“症状群”的独特能力,NetSCID可能会促进未来DSM版本的开发,还可能有助于识别与特定症状群可能比DSM诊断更密切相关的基因。NetSCID还将使研究人员能够识别中枢神经系统试验中的症状群,这些症状群对干预的反应可能比传统诊断类别所建议的更好。这也可以促进“个性化医疗”的发展。因为DSM-5的NetSCID将立即允许这些新类型的研究,而且因为额外的四个“官方翻译”将促进全球临床试验和跨文化研究,30%到50%的
作为世界人口的一部分,我们相信这一项目能够对全球产生持久的影响。
英文摘要
DESCRIPTION (provided by applicant): The SCID is the 'gold standard' for all research-based mental health diagnoses in the United States and for CNS clinical trials worldwide. But, it has been expensive and cumbersome to administer. In Phase I & II of this project we successfully developed the NetSCID, a highly flexible software package for administering the SCID. In this Phase II competing renewal project, we propose to enhance the NetSCID diagnostic software package to make it compliant with DSM-5. In addition, we intend to create 4 standardized 'official translations' of the NetSCID into Chinese, Russian, Latin American Spanish, and French. Together these languages represent between 30 and 50% of the world's population, when one includes native and secondary languages spoken. Our Phase II study indicated that the NetSCID is preferred my 75% of clinician relative to the paper SCID and it has been shown to reduce branching and data entry errors. In addition the program contains a database with the patient's response to every item. This same database will also be shared between all languages. Because of the existence of a single searchable database, the NetSCID will give researchers the ability to identify 'clusters of symptoms' rather than just the DSM diagnoses associated with a study result. The president of the APA has suggested that the validity of the DSM must be based on research on 'clusters of symptoms' as they appear in research studies rather than on fixed categories of symptoms as they have traditionally existed in DSM. The NIH has also established in the RDoC strategic plan initiative that DSM diagnoses do not map well to human genes. Because of its unique ability to be used to identify 'clusters of symptoms' in addition to diagnoses, the NetSCID may facilitate the development of future versions of the DSM and it may also facilitate the identification of genes that may be more closely associated with specific symptom clusters than DSM diagnoses. The NetSCID will also enable researchers to identify clusters of symptoms in CNS trials that may respond better to an intervention than would be suggested by comparison with traditional diagnostic categories. This could also facilitate the development of 'personalized medicine'. Because the NetSCID for DSM-5 would immediately allow for these new types of research and because the four additional 'official translations' will promote global clinical trials and cross-cultural research with 30 to 50% of the
world's population, we believe that this project could have a lasting global impact.
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