Effective strategies for implementing a multicenter international clinical trial
Effective strategies for implementing a multicenter international clinical trial
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DOI：
10.1111/j.1547-5069.2008.00213.x
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发表时间：
2008-01-01
影响因子：
3.4
通讯作者：
Dracup, Kathleen
中科院分区：
文献类型：
--
作者：
Aitken, Leanne M.;Pelter, Michele M.;Dracup, Kathleen
目的：研究领域的国际合作对于改善全球健康至关重要。设计：设计一项两组随机多中心国际临床试验，以确定护士提供的简短教育和咨询干预是否可以减少先前诊断为心血管疾病的患者出现急性冠脉综合征(ACS)症状时的院前延迟。方法：灵活但定义明确的项目结构在三个国家的五个地点显示干预措施的一致性，包括经验丰富的项目协调员、多维沟通方法、优化干预保真度的策略、特定地点的招募和保留技术、集中数据管理、以及伦理和预算要求的考虑。结果：五个地点的工作人员从三个国家招募了3522名参与者，并在12个月和24个月获得了80%的随访。结论：多维方法保持研究地点之间的一致性，同时允许灵活性来满足当地的期望和需求，有助于试验的成功。临床相关性：为了支持实践证据基础的适当发展，护理干预措施应该在多个环境中进行测试。本文描述了一系列在进行多中心国际试验中被证明有效的策略。
Purpose: International collaboration in research is essential in order to improve worldwide health. The purpose of this paper is to describe strategies used to administer an international multicenter trial to assess the effectiveness of a nursing educational intervention.Design: The study design was a two-group randomized multicenter international clinical trial conducted to determine whether a brief education and counselling intervention delivered by a nurse could reduce prehospital delay in the event of symptoms suggestive of acute coronary syndrome (ACS) in patients previously diagnosed with cardiovascular disease.Method: A flexible but well-defined project structure showed intervention consistency in five sites among three countries and included experienced project coordinators, multidimensional communication methods, strategies to optimize intervention fidelity, site-specific recruitment and retention techniques, centralized data management, and consideration of ethical and budgetary requirements.Findings: Staff at five sites enrolled 3,522 participants from three countries and achieved 80% follow-up obtained at both 12 and 24 months.Conclusion: Multidimensional approaches to maintain consistency across study sites, while allowing flexibility to meet local expectations and needs, contributed to the success of this trial.Clinical Relevance:In order to support appropriate development of an evidence base for practice, nursing interventions should be tested in multiple settings. A range of strategies is described in this paper that proved effective in conducting a multicenter international trial.