构建一个强大的调查员发起的平台:I-CARE体验
Julien Kirchgesner1, Laurent Beaugerie1, Cédric Baumann2,3
1Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Team FORECAST, Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, Department of Gastroenterology, F-75012, Paris, France.
患者参与研究的数量越来越多. 该I-CARE研究发现,虽然大多数炎症性肠病患者完成了电子患者报告的结果,但年轻男性和学生更有可能提前退出. 调查人员数据验证至关重要.
科学领域:
- 临床研究 临床研究
- 患者报告的结果
- 炎症性肠道疾病研究研究
背景情况:
- 研究人员发起的利用患者收集数据的研究越来越多.
- 对于这些研究中患者和研究者经验的理解有限.
- I-CARE队列的目标是解决炎症性肠病 (IBD) 研究中的这一差距.
研究的目的:
- 描述患者和研究人员参与I-CARE队列研究.
- 为了确定患者因不参与而提前退出治疗的预测因素.
- 评估电子患者报告结果 (ePRO) 的准确性和研究人员修改.
主要方法:
- 一项前性队列研究,涉及15个国家的12846名IBD患者.
- 每月收集临床信息和ePRO,长达6年.
- 后勤回归分析以确定提前退出的预测因素;评估数据编码和调查员纠正.
主要成果:
- 79.3%的患者完成了一次以上的ePRO; 72.8%在第一年完成了所有ePRO.
- 年龄较小 (<20岁),男性性别,失业/学生身份,没有先前的腹部手术预测了早期戒断.
- 研究人员纠正了52.5%的癌症/发育不良报告,并对19%的生物治疗患者修改了治疗序列.
结论:
- 患者参与研究很重要,但早期戒断等挑战仍然存在.
- 研究人员对患者报告数据的验证对于数据准确性至关重要.
- 研究结果为未来的各种疾病患者参与的研究计划提供了洞察力.
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