Addressing the challenges of a cross-national investigation: lessons from the Pittsburgh-Pisa study of treatment-relevant phenotypes of unipolar depression
Addressing the challenges of a cross-national investigation: lessons from the Pittsburgh-Pisa study of treatment-relevant phenotypes of unipolar depression
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DOI：
10.1177/1740774508091965
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发表时间：
2008-01-01
期刊：
影响因子：
2.7
通讯作者：
Forgione, Rocco Nicola
中科院分区：
文献类型：
--
作者：
Frank, Ellen;Cassano, Giovanni B.;Forgione, Rocco Nicola
背景：迄今为止，还没有一项跨国家的随机对照试验探讨抑郁症药物和心理治疗干预相对成功的机制。一项包括心理治疗作为治疗方法之一的多中心临床试验提出了许多与跨中心一致性和沟通相关的挑战。目的本报告描述了在研究“抑郁症：匹兹堡大学和比萨大学正在进行的"治疗相关表型研究”，意大利.方法实施该研究要求研究者解决与两个机构审查委员会（IRB）的不同要求、心理治疗培训、独立评估者培训、患者招募，数据输入，质量控制和患者进展的每周报告的生成，以及建立一个类似的临床和研究框架，在两个国家与实质上不同的卫生保健systems.Results双语调查员和工作人员谁花时间在对方的网站，研究者利用频繁的电话会议和在IRB有时相互矛盾的要求范围内的灵活性，能够满足两个机构的人类受试者保护要求，克服语言障碍，进行一致的治疗师和评估员培训，并开发研究管理的通用工具。因此，两个地点都实现了征聘目标，保留率很高。在第一年内纠正了一个不一致的实施方案的实例。限制本研究是在两个西方文化的研究人员进行了长期的合作。我们的研究结果可能无法推广到其他国家或research settings.Conclusions跨国协议的实施和通过和维护的共同程序是可能的，当调查人员意识到这可能带来的挑战，并积极主动地试图解决这些问题。
Background To date, no cross-national RCT has addressed the mechanisms underlying the relative success of pharmacological and psychotherapeutic interventions for depression. A multi-site clinical trial that includes psychotherapy as one of the treatments presents numerous challenges related to cross-site consistency and communication.Purpose This report describes how those challenges were met in the study "Depression: The Search for Treatment Relevant Phenotypes", being carried out at the University of Pittsburgh and the University of Pisa, Italy.Methods Implementing the study required the investigators to address methodological and practical challenges related to the different requirements of the two Institutional Review Boards (IRBs), psychotherapy training, independent evaluator training, patient recruitment, development of common tools for data entry, quality control and generation of weekly reports of patient progress as well as establishing a similar clinical and research framework in two countries with substantially different health care systems.Results By having bilingual investigators and staff members who spent time at one another's sites, making use of frequent conference-call staff meetings and being flexible within the bounds of the sometimes contradictory requirements of the IRBs, the investigators were able to meet the human subjects protection requirements of both institutions, surmount language barriers to consistent therapist and evaluator training and develop common tools for study management. As a result, recruitment goals were met at both sites and retention rates were high. One instance of inconsistent implementation of the protocol was corrected within the first year.Limitations This study was conducted in two Western cultures by researchers with long-standing collaboration. Our findings may not be generalizable to other countries or research settings.Conclusions The implementation of a cross-national protocol and the adoption and maintenance of common procedures is possible when investigators are aware of the challenges this may present and are proactive in trying to address them.