School of Medicine, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, New South Wales, Australia.
Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.
PLoS One. 2019 Aug 12;14(8):e0221047. doi: 10.1371/journal.pone.0221047. eCollection 2019.
High quality dietary intake data is required to support evidence of diet-disease relationships exposed in clinical research. Source data verification may be a useful quality assurance method in this setting. The present pilot study aimed to apply source data verification to evaluate the quality of the data coding process for dietary intake in a clinical trial and to explore potential barriers to data quality in this setting.
Using a sample of 20 cases from a clinical trial, source data verification was conducted between three sets of data derived documents: transcripts of audio-recorded diet history interviews, matched paper-based diet history forms and outputs from nutrition analysis software. The number of cases and rates of discrepancies between documents were calculated. A total of five in-depth interviews with dietitians collecting and coding dietary data were thematically analysed.
Some 2024 discrepancies were identified. The highest discrepancy rate was 57.49%, and occurred between diet history interviews and nutrition analysis software outputs. Sources of the discrepancies included both quantities and frequencies of food intake. The highest discrepancy rate was for the food group "vegetable products and dishes". In-depth interviews implicated recall bias of trial participants as a cause of discrepancies, but dietitians also acknowledged a possible subconscious influence of having to code reported foods into nutrition analysis software programs.
The accuracy of dietary intake data appeared to depend on the level of detailed food data required. More support for participants on reporting consumption, and incorporating supportive tools to guide estimates of food quantities may facilitate a more consistent coding process and improve data quality. This pilot study offers a novel method and an overview of dietary intake data coding measurement errors. These findings may warrant further investigation in a larger sample.
高质量的饮食摄入数据是支持临床研究中暴露的饮食与疾病关系的证据所必需的。源数据验证可能是这种情况下一种有用的质量保证方法。本初步研究旨在应用源数据验证来评估临床试验中饮食摄入数据编码过程的质量,并探讨该环境下数据质量的潜在障碍。
使用临床试验中的 20 例样本,对三种衍生文档之间的源数据进行验证:音频记录的饮食史访谈的转录本、匹配的纸质饮食史表格和营养分析软件的输出。计算了文档之间差异的案例数和发生率。对 5 名收集和编码饮食数据的营养师进行了 5 次深入访谈,并对访谈内容进行了主题分析。
共发现 2024 个差异。差异发生率最高的为 57.49%,发生在饮食史访谈和营养分析软件输出之间。差异的来源包括食物摄入量的数量和频率。差异发生率最高的食物组为“蔬菜制品和菜肴”。深入访谈表明,试验参与者的回忆偏差是差异的原因之一,但营养师也承认,在将报告的食物编码到营养分析软件程序中时,可能会受到潜意识的影响。
饮食摄入数据的准确性似乎取决于所需详细食物数据的水平。为报告摄入量的参与者提供更多支持,并纳入支持工具来指导食物数量的估计,可能会促进更一致的编码过程并提高数据质量。本初步研究提供了一种新的方法和饮食摄入数据编码测量误差的概述。这些发现可能需要在更大的样本中进一步研究。