How practice and science are balanced and blended in the NIDA Clinical Trials Network: the bidirectional process in the development of the STAGE-12 protocol as an example.

How practice and science are balanced and blended in the NIDA Clinical Trials Network: the bidirectional process in the development of the STAGE-12 protocol as an example.
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DOI:
10.3109/00952990.2011.596970
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发表时间:
2011-09
期刊:
The American journal of drug and alcohol abuse
影响因子:
--
通讯作者:
Floyd AS
Floyd AS
中科院分区:
其他
文献类型:
--
作者:
Donovan DM;Daley DC;Brigham GS;Hodgkins CC;Perl HI;Floyd AS

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学术研究人员和从业者之间的双向合作伙伴关系一直是实现国家药物滥用研究所(NIDA)临床试验网络(CTN)改善社区药物治疗结果的目标的基本工具。这些伙伴关系融合了从业者的临床观点和研究人员的方法学专业知识,共同努力通过在社区治疗环境中进行的随机临床试验来解决临床上有意义的问题。双向性是CTN的一项指导原则,但其在议定书制定和执行的实际层面上的可操作性尚未阐明。这篇描述性文章介绍了一个协议的开发,作为研究人员和实践者之间这种双向、协作、迭代伙伴关系的示例和模型。本文阐述了在开发Stage-12时遇到的几个具体问题,Stage-12是一种促进12步相互支持小组参与的行为干预,以及为解决每个问题而采取的决策的基本原理。通过考虑设计因素以及临床实践需求和现实的一系列决定,成功地制定了12阶段方案,从而保持了方法严密性和普适性之间的平衡。审查说明了在制定议定书时将研究和实践相结合的过程,体现了双向的基本原则,这是NIDA CTN成功的一个关键因素。CTN中衍生的双向伙伴关系采用了功效-效果研究的混合模式,能够设计和实施在方法上严格且在临床上有意义的方案,从而增加采用的可能性和最终改善公共卫生的可能性。
Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings. Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners. This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each. The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability. The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN. Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.
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