Prevention of Stroke after STOP, A Retrospective Chart Review

停止后预防中风，回顾性图表回顾

• 批准号: 7922143
• 负责人: ROBERT J ADAMS
• 金额: $ 65.06万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7922143
• 关键词: Adult; Area; Attitude; Behavior; Brain Infarction; Child; Childhood; Clinical; Clinical Trials; Data; Databases; Diagnosis; Education; Enrollment; Event; Failure; Frequencies; Goals; Guidelines; Human Resources; Incidence; Infarction; Investigation; Investments; Medical Records; Modeling; Outcome; Participant; Patients; Persons; Phase; Prevention strategy; Probability; Protocols documentation; Provider; Publishing; Quality of Care; Recommendation; Research; Research Personnel; Risk; Screening Result; Screening procedure; Sickle Cell Anemia; Stroke; Stroke prevention; Symptoms; System; Testing; Time; Transfusion; Transient Ischemic Attack; Treatment Failure; Validation; base; care systems; cerebrovascular; clinical practice; cohort; evidence base; experience; high risk; improved; insight; interest; prevent; programs; prophylactic; public health relevance; real world application; trial comparing; young adult

DESCRIPTION (provided by applicant): The STOP and STOP II studies provided the first comprehensive stroke prevention strategy in Sickle Cell Disease supported by Class I evidence. While the strategy of TCD screening and prophylactic transfusion was very efficacious in the Stroke Prevention in Sickle Cell Anemia (STOP trial), and reversion to high risk or stroke was observed if this therapy is removed even after 30 or more months of transfusion (STOP II) it is unclear how effective this approach is in real world practice after the trials were completed. This project leverages the enormous financial and human resources expended to obtain STOP and STOP II data, and their resulting data bases (available to the investigators) with information on over 3400 children, by making an in-depth analysis of the medical records of study participants in the post trial period regarding stroke prevention behaviors (re-screening with TCD and transfusion) and stroke as well as other important outcomes. Two outcomes are of paramount interest: 1) stroke - in this respect were the strokes that took place after the trial the result of screening failures (no TCD or inadequate timing or compliance with screening programs) or treatment failures (transfusion not recommended or accepted or breakthrough stroke despite compliance with adequate transfusion) and how can this information be best used to improve stroke prevention practices; 2) conversion to high risk TCD. The data bases contain preliminary (pre abnormal) TCD data on over 3000 children, and probabilities for conversion have been published from STOP based on rescreening during the trail. Assuming varying degrees of rescreening in clinical practice post trial, and new abnormals identified post trial; does the post trial model predicting the incidence of abnormal TCD confirm STOP or vary substantially from what was observed in STOP? In either case post trial experience will be combined with STOP data to formulate stronger evidence based clinical guidelines for re screening with TCD (if the first TCD does not indicate need for treatment) to insure adequate surveillance for stroke risk. STOP and STOP II were carried out in specialized pediatric SCD centers, the impact of transition to adult provider systems on stroke prevention will be studied, attitudes assessed and these data used to inform recommendations for further research and education. Overall the project provides substantial new information that will insure the major investment made in STOP and STOP II is used to best advantage in real world applications to prevent stroke in children with SCD. PUBLIC HEALTH RELEVANCE: The goal of this investigation is to obtain and analyze information that can improve the quality of care for children and young adults with sickle cell disease especially in the area of preventing stroke. The analysis of information will directly influence guidelines for TCD screening. These qualitative data will also provide insight into the value of competing therapies as well as the impact of treatment options and stroke events, and ultimately provide information to help prevent devastating stroke in young persons with Sickle Cell Disease.

描述（由申请人提供）：Stop and Stop II研究提供了I类证据支持的镰状细胞疾病中的第一个全面预防策略。虽然TCD筛查和预防性输血的策略在镰状细胞贫血的中风预防（停止试验）中非常有效，并且即使在经过30个月或更长时间的输血（停止II）之后，该疗法被去除（停止II），但在试验后的世界实践中，即使在30或更长时间进行了恢复，即使在30或更长时间进行了这种疗法（停止II之后）。该项目利用了大量的财务和人力资源来获取Stop and Stop II数据，并通过深入分析有关中风预防行为的研究参与者的医疗记录（通过TCD和TCD和Transfusion和Transfusiful Recreation the the The The The The The The The The The The The The The The The The The The The The The The The The The The Play参与者的医疗记录）的信息，并提供有关3400多名儿童的信息的数据库（可供调查人员使用）。两个结果具有最高的兴趣：1）中风 - 在这方面是试验后发生的中风，筛查失败的结果（没有TCD或不足的时间或不足或遵守筛查程序）或治疗失败（不建议输血，不建议接受或尽管对适当转移的顺应性顺应性，并且该信息能够最佳地使用练习，以改善动画的练习。 2）转换为高风险TCD。数据库包含有关3000多名儿童的初步（异常）TCD数据，并且根据步道期间的筛查，已从Stop发表了转换概率。假设在临床实践试验后的临床实践中有不同程度的纠正，而新的异常则确定了后试验；预测异常TCD的发生率的试验模型是否确认停止或与停止中观察到的情况有很大差异？在任何一种情况下，试验后的经验都将与停止数据结合使用，以制定使用TCD重新筛查的更强大的基于证据的临床指南（如果第一个TCD未表明需要进行治疗），以确保对中风风险进行适当的监视。在专业的儿科SCD中心进行了Stop and Stop II，将研究向成人提供者系统过渡对预防中风的影响，评估态度以及这些数据用于为进一步的研究和教育提供建议。总体而言，该项目提供了大量的新信息，可以确保在Stop中进行的主要投资，而Stop II则用于在现实世界中最大程度的优势，以防止SCD儿童中风。公共卫生相关性：这项调查的目的是获取和分析可以提高患有镰状细胞疾病的儿童和年轻人的护理质量的信息，尤其是在预防中风领域。信息分析将直接影响TCD筛选的指南。这些定性数据还将洞悉竞争疗法的价值以及治疗选择和中风事件的影响，并最终提供信息，以防止镰状细胞疾病的年轻人的毁灭性中风。