随机试验对参与者的经济影响:从职业治疗师干预研究 (OTIS) 的案例研究
Athanasios Gkekas1, Sarah Ronaldson2, Adwoa Parker1
1Department of Health Sciences, York Trials Unit, University of York, York, UK.
Journal of evaluation in clinical practice
|October 22, 2024
概括
在随机试验中,参与者对随访的损失会产生显著的机会成本,即使退出率低. 估计这些成本对于优化试验预算和改进参与者保留策略至关重要.
科学领域:
- 临床试验方法论 临床试验方法论
- 卫生经济学 卫生经济学
- 研究管理研究管理管理
背景情况:
- 随机对照试验的统计学有效性和财务效率可能受到损害.
- 职业治疗师干预研究 (OTIS) 经历了因参与者退出而导致的机会成本,尽管整体退出率低 (<10%).
研究的目的:
- 量化参与者在OTIS试验中失去跟进后的经济影响.
- 为研究小组提供一个框架,以估计随机试验中与参与者退出相关的机会成本.
主要方法:
- 按消耗时间,治疗组分配和对问卷的响应模式来分类的参与者失去了跟踪.
- 收集的协议驱动成本 (管理,打印,运输) 和干预成本.
- 计算单位和总的机会成本,通过将相关成本乘以随访中丢失的参与者数量来计算.
主要成果:
- 在OTIS试验中,每位参与者因随访而失去的平均成本为98.41英.
- 从试验团队的经济角度来看,参与者对随访的损失的总机会成本为10,234.90英.
- 大约1.42%的资金被错误分配,原因是参与者缩.
结论:
- 即使消耗率低,随机试验中参与者对随访的损失也会产生相当大的机会成本.
- 决策者应优先考虑提高试验参与者保留率的战略,以优化资源分配和预算效率.
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