Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials.
Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials.
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DOI：
10.1093/advances/nmaa109
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发表时间：
2021-02-01
期刊：
影响因子：
--
通讯作者：
Matthan NR
中科院分区：
文献类型：
--
作者：
Lichtenstein AH;Petersen K;Barger K;Hansen KE;Anderson CAM;Baer DJ;Lampe JW;Rasmussen H;Matthan NR
在人类营养领域，随机对照试验(RCT)被认为是确定暴露于营养物质、食物或饮食模式与预先指定的结果指标(如身体成分、生物标记物或事件发生率)之间因果关系的金标准。循证饮食指导通常来源于对这些随机对照试验的系统评价和荟萃分析。在人体营养学随机对照试验的设计和实施过程中所做的每一项决定都会影响研究结果的实用性和推广性。在资源有限的情况下，目标是最大限度地扩大调查结果的概括性，同时产生最高质量的数据，并保持最高水平的道德和科学诚信。本文件的目的是讨论进行人类营养随机对照试验的关键方面，包括研究设计的考虑因素(平行、交叉、因素、群组)、机构伦理批准(机构审查委员会)、招募和筛选、干预实施、遵守和保留评估以及统计分析考虑因素。其他主题包括区分有效性和有效性，界定研究问题(S)，监测生物标记物和结果衡量标准，以及收集和归档数据。涉及规划和实施人类营养随机对照试验的具体方面，包括干预类型、纳入/排除标准、参与者负担、随机化和盲法、试验启动和监测以及分析计划。
In the field of human nutrition, randomized controlled trials (RCTs) are considered the gold standard for establishing causal relations between exposure to nutrients, foods, or dietary patterns and prespecified outcome measures, such as body composition, biomarkers, or event rates. Evidence-based dietary guidance is frequently derived from systematic reviews and meta-analyses of these RCTs. Each decision made during the design and conduct of human nutrition RCTs will affect the utility and generalizability of the study results. Within the context of limited resources, the goal is to maximize the generalizability of the findings while producing the highest quality data and maintaining the highest levels of ethics and scientific integrity. The aim of this document is to discuss critical aspects of conducting human nutrition RCTs, including considerations for study design (parallel, crossover, factorial, cluster), institutional ethics approval (institutional review boards), recruitment and screening, intervention implementation, adherence and retention assessment, and statistical analyses considerations. Additional topics include distinguishing between efficacy and effectiveness, defining the research question(s), monitoring biomarker and outcome measures, and collecting and archiving data. Addressed are specific aspects of planning and conducting human nutrition RCTs, including types of interventions, inclusion/exclusion criteria, participant burden, randomization and blinding, trial initiation and monitoring, and the analysis plan.
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影响因子：
120.7
作者：
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作者：
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作者：
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通讯作者：
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DOI：
10.3390/ijerph8010015
发表时间：
2011-01-01
影响因子：
--
作者：
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通讯作者：
Efird, Jimmy