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: 7933928
• 负责人: Laurel K. Leslie
• 金额: $ 49.55万
• 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/7933928
• 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; 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 decision-making; 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）：该应用程序涉及广泛的挑战领域 04、临床研究和特定挑战主题 04-HL-114，使用现有数据集规划儿科心脏病学的有效性试验。这一挑战主题明确指出了开发新颖的计算理论模型或改编现有程序以促进儿科指南制定和比较有效性研究的迫切需要。作为适合这一挑战主题的工作类型的一个例子，NHLBI 引用了使用决策分析来评估心电图筛查 (ECG) 在识别患有注意力缺陷多动障碍 (ADHD) 青少年在开始服用兴奋剂药物之前未诊断的导致心脏性猝死 (SCD) 的心脏疾病方面的作用。该应用程序专门针对这一挑战主题，并建议采用基于证据的综合、决策分析和偏好诱导来检查针对患有 ADHD 且没有已知的 SCD 心脏风险的青少年的替代筛查和管理方案的风险和益处（临床和财务）。我们的总体目标是充分利用现有数据来阐明三种不同筛查和管理方法的相对有效性：(1) 全面筛查（即所有儿童均接受病史、体格检查和心电图检查），(2) 有针对性的筛查（即所有儿童均接受病史检查和体格检查，心电图筛查仅用于那些在病史和/或体格检查中发现危险因素的儿童），(3) 不进行筛查。由于 SCD 在儿科人群中很少见，并且缺乏报告药物不良反应的国家强制性系统，专业组织就心电图筛查方案的相对有效性提出的当前政策声明或指南的证据基础受到数据差距的严重损害，而传统分析方法无法快速解决这些问题。决策分析产生的数学模型可以解释数据的局限性，并且可以纳入财政成本估计以及父母和医生偏好的估计。此外，决策分析允许量化伴随可用数据的不确定性的影响，这些不确定性可能会影响不同筛查和管理策略之间权衡的估计，并描绘出特定不确定性的区域，其中未来研究中的有针对性的数据收集和分析将最影响临床决策。还将对医生和家长对治疗的偏好进行形成性研究，并将其纳入决策分析模型中。为此应用程序组建的研究团队之前曾共同发表过关于决策分析在当前关于多动症儿童使用心电图筛查的争议中的应用的文章，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，并为专业组织提供迫切需要的信息，作为儿科实践指南的基础。 公共健康相关性：在过去三年中，FDA 委员会和专业组织一直在争论心电图 (ECG) 筛查的价值，以在患有注意力缺陷多动障碍 (ADHD) 的儿童和青少年开始使用兴奋剂药物之前识别与心源性猝死 (SCD) 相关的未确诊疾病。这一争议的解决对于初级保健医生、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、家庭以及患有多动症的儿童和青少年具有巨大的影响。在此应用中，我们建议应用三种最新的方法——基于证据的综合、决策分析和偏好引发——来解决这一紧迫的临床和公共政策问题。