Jensen Peter S, Youngstrom Eric A, Steiner Hans, Findling Robert L, Meyer Roger E, Malone Richard P, Carlson Gabrielle A, Coccaro Emil F, Aman Michael G, Blair James, Dougherty Donald, Ferris Craig, Flynn Laurie, Green Evelyn, Hoagwood Kimberly, Hutchinson Janice, Laughren Tom, Leve Leslie D, Novins Douglas K, Vitiello Benedetto
Dr. Vitiello's and Dr. Laughren's contributions to this article were made in their private capacity. No official support or endorsement by the National Institute of Mental Health or the U.S. Food and Drug Administration is intended nor should be inferred.
Dr. Vitiello's and Dr. Laughren's contributions to this article were made in their private capacity. No official support or endorsement by the National Institute of Mental Health or the U.S. Food and Drug Administration is intended nor should be inferred.
J Am Acad Child Adolesc Psychiatry. 2007 Mar;46(3):309-322. doi: 10.1097/chi.0b013e31802f1454.
To determine whether impulsive aggression (IA) is a meaningful clinical construct and to ascertain whether it is sufficiently similar across diagnostic categories, such that parallel studies across disorders might constitute appropriate evidence for pursuing indications. If so, how should IA be assessed, pharmacological studies designed, and ethical issues addressed?
Experts from key stakeholder communities, including academic clinicians, researchers, practicing clinicians, U.S. Food and Drug Administration, National Institute of Mental Health, industry sponsors, and patient and family advocates, met for a 2-day consensus conference on November 4 and 5, 2004. After evaluating summary presentations on current research evidence, participants were assigned to three workgroups, examined core issues, and generated consensus guidelines in their areas. Workgroup recommendations were discussed by the whole group to reach consensus, and then further iterated and condensed into this report postconference by the authors.
Conference participants agreed that IA is a substantial public health and clinical concern, constitutes a key therapeutic target across multiple disorders, and can be measured with sufficient precision that pharmacological studies are warranted. Additional areas of consensus concerned types of measures, optimal study designs, and ethical imperatives.
Derived from scientific evidence and clinical experience, these consensus-driven recommendations can guide the design of future studies.
确定冲动性攻击行为(IA)是否为一个有意义的临床概念,并确定其在不同诊断类别中是否足够相似,以便跨疾病的平行研究可为寻求适应症提供适当证据。如果是这样,IA应如何评估、设计药理学研究以及解决伦理问题?
来自关键利益相关者群体的专家,包括学术临床医生、研究人员、执业临床医生、美国食品药品监督管理局、美国国立精神卫生研究所、行业赞助商以及患者和家属倡导者,于2004年11月4日和5日参加了为期两天的共识会议。在评估了关于当前研究证据的总结报告后,参与者被分成三个工作组,研究核心问题,并在各自领域制定共识指南。工作组的建议由全体成员进行讨论以达成共识,然后作者在会后进一步迭代并浓缩成本报告。
会议参与者一致认为,IA是一个重大的公共卫生和临床问题,是多种疾病的关键治疗靶点,并且可以进行足够精确的测量,因此有必要开展药理学研究。其他达成共识的领域包括测量类型、最佳研究设计和伦理要求。
这些基于共识的建议源自科学证据和临床经验,可指导未来研究的设计。