Comparative effectiveness of ECG screening in children with Attention Deficit Hyp

注意力缺陷儿童心电图筛查的效果比较

• 批准号: 7833223
• 负责人: Laurel K. Leslie
• 金额: $ 49.59万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7833223
• 关键词: Academy; Accounting; Address; Adolescent; Adolescent Psychiatry; Adverse effects; Affect; American; American Heart Association; American Medical Association; Applications Grants; Area; Attention; Attention deficit hyperactivity disorder; Benefits and Risks; Blood Circulation; Cardiac; Cardiac Death; Cardiology; Cardiovascular system; Child; Childhood; Clinical; Clinical Research; Conflict (Psychology); Data; Data Collection; Data Compromising; Data Set; Decision Analysis; Decision Making; Development; Diagnosis; Disease; Education; Eligibility Determination; Ethics; Evaluation; Family; Foundations; Future; Goals; Guidelines; Health; Health Planning; Health Professional; Hearing; Heart Diseases; Human Resources; Incidence; Insurance; Journals; Link; Low Prevalence; Mandatory Reporting; Measurement; Medical; Mental Health; Methodology; Modeling; National Heart, Lung, and Blood Institute; Outcome; Parents; Pediatrics; Pharmaceutical Preparations; Physicians; Policies; Population; Practice Guidelines; Primary Care Physician; Procedures; Professional Organizations; Protocols documentation; Public Policy; Published Comment; Publishing; Randomized Clinical Trials; Recommendation; Recording of previous events; Reporting; Research; Research Personnel; Resolution; Risk; Risk Estimate; Risk Factors; Role; Schools; Screening procedure; Series; System; Testing; Theoretical model; Translational Research; Uncertainty; United States National Institutes of Health; Work; Youth; base; clinical practice; comparative effectiveness; cost; effectiveness research; effectiveness trial; evidence base; functional status; mathematical model; novel; preference; public health relevance; sudden cardiac death

DESCRIPTION (provided by investigator): This application addresses broad Challenge Area 04, Clinical Research, and Specific Challenge Topic 04- HL-114, Using existing datasets to plan effectiveness trials in pediatric cardiology. This challenge topic specifically identifies a critical need for the development of novel, computational theoretical models or the adaptation of existing procedures to promote guidelines development and comparative effectiveness research in pediatrics. As an example of the type of work appropriate to this challenge topic, the NHLBI cites the use of decision analysis to assess the role of electrocardiograph screening (ECG) in identifying previously undiagnosed cardiac disorders that cause Sudden Cardiac Death (SCD) among youth with Attention Deficit Hyperactivity Disorder (ADHD) prior to beginning stimulant medications. This application specifically targets this challenge topic and proposes to employ evidence-based synthesis, decision analysis, and preference elicitation to examine the risks and benefits (both clinical and fiscal) of alternative screening and management protocols for youth with ADHD with no known cardiac risks for SCD. Our overarching goal is to use existing data to its best advantage to clarify the comparative effectiveness of three different screening and management approaches: (1) comprehensive screening (i.e., all children receive a history, physical and ECG), (2) targeted screening (i.e., all children receive a history and physical, and ECG screening is reserved for those children with risk factors identified on the history and/or physical), and (3) no screening. Because of the rarity of SCD in the pediatric population and the lack of a national, mandatory system for reporting adverse effects of medications, the evidentiary foundation for current policy statements or guidelines advanced by professional organizations regarding the comparative effectiveness of ECG screening protocols is severely compromised by data gaps that cannot be resolved quickly by traditional analytic approaches. Decision analysis produces mathematical models that account for data limitations and can incorporate fiscal cost estimates as well as estimates of parental and physician preferences. In addition, decision analysis permits quantification of the impact of uncertainty accompanying the available data that may affect estimates of the tradeoffs between different screening and management strategies and delineate areas of particular uncertainty, where targeted data collection and analysis in future research would most affect clinical decision-making. Formative research on physician and parental preferences regarding treatment will also be conducted and incorporated into the decision analysis models. The research team assembled for this application has previously published together on the application of decision analysis to the current controversy regarding the use of ECG screening in children with ADHD and is poised to address this critical research question immediately. Ultimately, study results will identify future areas of research that should be prioritized to address this challenge area further and provide professional organizations with urgently needed information on which to base pediatric practice guidelines. PUBLIC HEALTH RELEVANCE: Over the last three years, FDA committees and professional organizations have debated the value of electrocardiograph (ECG) screening to identify undiagnosed disorders linked to sudden cardiac death (SCD) in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) prior to beginning stimulant medications. Resolution of this controversy has enormous implications for primary care physicians, cardiologists, mental health professionals, school personnel, health plans, insurance companies, families, and the children and adolescents with ADHD. In this application, we propose to apply three up-to-date methodologies - evidence-based synthesis, decision analysis, and preference elicitation - to address this pressing clinical and public policy issue.

描述（由研究者提供）：本申请解决了广泛的挑战领域04，临床研究和特定挑战主题04- HL-114，使用现有数据集计划儿科心脏病学的有效性试验。这一挑战主题特别确定了开发新的计算理论模型或适应现有程序以促进儿科指南开发和比较有效性研究的关键需求。作为适合这一挑战主题的工作类型的一个例子，NHLBI引用了决策分析的使用，以评估心电图筛查（ECG）在识别先前未诊断的心脏疾病中的作用，这些心脏疾病导致注意力缺陷多动障碍（ADHD）的年轻人在开始服用兴奋剂药物之前发生心脏性猝死（SCD）。该应用程序专门针对这一挑战主题，并建议采用循证综合、决策分析和偏好启发来检查患有ADHD且没有已知心脏风险的青少年的替代筛查和管理方案的风险和益处（临床和财政）SCD。我们的总体目标是最大限度地利用现有数据，阐明三种不同筛查和管理方法的比较有效性：（1）全面筛查（即，所有儿童都接受病史、体格检查和心电图检查），（2）有针对性的筛查（即，所有儿童都接受病史和体格检查，心电图筛查只用于那些在病史和/或体格检查中发现有危险因素的儿童），以及（3）不进行筛查。由于SCD在儿科人群中的罕见性以及缺乏国家强制性的药物不良反应报告系统，专业组织提出的关于ECG筛查方案比较有效性的现行政策声明或指南的证据基础受到传统分析方法无法快速解决的数据缺口的严重影响。决策分析产生的数学模型，考虑到数据的局限性，可以纳入财政成本估计以及父母和医生的偏好估计。此外，决策分析允许量化伴随现有数据的不确定性的影响，这些数据可能影响不同筛查和管理策略之间的权衡估计，并描绘特定不确定性的区域，其中未来研究中的目标数据收集和分析将最影响临床决策。还将对医生和父母关于治疗的偏好进行形成性研究，并将其纳入决策分析模型。为此应用而组建的研究团队此前曾共同发表过关于决策分析在ADHD儿童中使用ECG筛查的当前争议中的应用，并准备立即解决这一关键研究问题。最终，研究结果将确定未来应优先考虑的研究领域，以进一步解决这一挑战领域，并为专业组织提供急需的信息，以作为儿科实践指南的基础。 公共卫生关系：在过去的三年里，FDA委员会和专业组织一直在讨论心电图（ECG）筛查的价值，以确定与注意缺陷多动障碍（ADHD）儿童和青少年心脏性猝死（SCD）相关的未诊断疾病。这一争议的解决对初级保健医生、心脏病专家、心理健康专业人员、学校人员、健康计划、保险公司、家庭以及患有ADHD的儿童和青少年具有巨大的影响。在本申请中，我们建议应用三种最新的方法-循证综合，决策分析和偏好诱导-来解决这一紧迫的临床和公共政策问题。