试验团队在试验的设计阶段如何计划保留? 一个范围审查审查
Ellen Murphy1,2, Katie Gillies3, Frances Shiely4,5,6
1Health Research Board - Trials Methodology Research Network (HRB-TMRN), Galway, Ireland. ellen.murphy@ucc.ie.
参与者保留对于可靠的试验结果至关重要. 然而,很少有试验协议主动详细说明了参与者保留和全面跟进的计划,突出了研究设计中的差距.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究设计研究研究设计
- 参与者的坚持 参与者的坚持
背景情况:
- 参与者保留对于确保临床试验结果的有效性和可靠性至关重要.
- 在SPIRIT (标准协议项目:干预试验建议) 的指导方针中,要求将参与者保留计划纳入试验协议.
- 试验协议中报告这些保留计划的程度尚不清楚.
研究的目的:
- 进行范围审查,以确定试验团队是否以及如何在试验设计阶段报告参与者保留计划.
- 评估SPIRIT指南第18b项关于试验协议中的参与者保留策略的报告.
主要方法:
- 使用PubMed,Scopus,EMBASE,CINAHL和Web of Science (2014-2019) 的数据进行了全面的范围审查.
- 随机对照试验 (RCT) 协议和试点/可行性试验协议被确定和分析.
- 对于协议特征和遵守SPIRIT项目18b的描述性统计数据被生成,并补充了保留策略的叙事综合.
主要成果:
- 在包括的824个协议中,只有9.5% (RCT) 和11.4% (试点/可行性) 完全报告了SPIRIT项目18b.
- 无论SPIRIT是否遵守,36.8%的RCT协议和40.2%的试点/可行性协议都包括积极的保留计划.
- 结合策略,特别是"提醒和数据收集位置/方法"或"提醒和货币激励",是最常见的,其中"提醒"和"有条件的货币激励"是受欢迎的个人策略.
结论:
- 在临床试验协议中报告参与者保留策略存在重大缺陷.
- 建议在试验设计阶段主动规划保留策略,而不是反应性实施.
- 加强预期保留计划和明确的协议沟通可以改善战略选择,成本,实施和整体试验透明度.
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