总体协议可以适应有效性-实施混合研究吗?
Justin J Chapman1,2,3,4, Taren Massey-Swindle5,6,7, Urska Arnautovska8,9,10
1Griffith University, Centre for Mental Health, School of Pharmacy and Medical Science, 170 Kessels Road, Nathan, Brisbane, QLD, 4111, Australia. justinjchapman@gmail.com.
BMC medical research methodology
|November 19, 2025
概括
主协议可以适应有效性-实施混合研究,加速将研究转化为现实世界的实践. 需要进一步测试以确认它们在常规护理环境中的可行性.
科学领域:
- 翻译科学 翻译科学
- 实施科学 实施科学
- 临床试验设计 临床试验设计
背景情况:
- 主协议简化了使用共享基础设施的多项研究临床试验.
- 翻译性研究通过评估干预的有效性和现实世界的有效性,弥合了科学发现和公共卫生影响.
- 对有效性实施混合研究的总体协议的应用仍然未得到充分研究.
研究的目的:
- 制定建议,以适应有效性实施研究的总体协议方法.
- 探索主协议如何支持混合有效性实施子研究.
- 为在总协议设计中整合实施科学提供一个框架.
主要方法:
- 在2024年1月至12月与翻译研究网络进行商.
- 在翻译研究中对服务提供商的要求分析.
- 对实施框架的审查,以告知协议的调整.
主要成果:
- 建议涵盖了共同的试验基础设施,假设,数据收集,控制组,适应性元素和资格标准.
- 利用跨部门合作伙伴关系和共同生产的研究加速了翻译管道.
- 总体协议中的适应性元素提高了有效性实施研究的效率.
结论:
- 适应混合研究的主协议可以改善在常规护理中的基于证据的干预措施的实施.
- 对于有效性实施研究的总体协议的可行性需要进一步研究.
- 测试拟议的方法对于在主协议中推进实施科学至关重要.
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