在炎症性肠病的饮食试验中研究设计复杂性和参与者完成:系统性审查和元研究研究
Laura Gregersen1, Caroline Moos2, Zainab Hikmat3
1Molecular diagnostics and Clinical Research Unit, University of Southern Denmark, Odense, Denmark; The Faculty of Health Sciences, Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark; Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
患者在炎症性肠病 (IBD) 饮食试验中的坚持至关重要. 这次审查发现,总体而言,完成率很高,但便采样和较短的研究持续时间等因素与IBD研究的遵守率较低有关.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 营养科学 营养科学
背景情况:
- 饮食干预对于管理炎症性肠病 (IBD) 至关重要.
- 患者在IBD饮食干预试验中的坚持提出了重大挑战.
- 了解影响试验完成的因素对于提高研究有效性至关重要.
研究的目的:
- 系统地审查和评估IBD患者饮食干预试验中的完成率.
- 评估试验设计特征与参与者完成率之间的关联.
主要方法:
- 在MEDLINE,Embase和CINAHL数据库中进行系统搜索.
- 包括62个随机对照试验 (122个研究手臂,3523名参与者),不包括肠道/肠道营养.
- 超回归分析以确定与完成率相关的因素,包括偏差风险评估.
主要成果:
- 整体综合完成率为0.84 (95% CI:0.800.87).
- 较低的完成率与便抽样 (0.75),研究持续时间为48周 (0.79),以及缺失数据管理中偏差风险较低 (0.74) 相关.
- 完成率显示与试验设计相关的变化不到15%;没有发现与试验持续时间的线性相关性.
结论:
- 患有IBD的患者在受控饮食干预试验中表现出高的完成率.
- 综合性干预内容,如便抽样,与较低的完成率最强烈相关.
- 进一步的研究应该考虑试验设计要素,以优化IBD饮食研究的遵守.
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