A change-point regression approach for estimating no observed adverse effect level from systematic review.

IF 2 4区 医学 Q3 NUTRITION & DIETETICS Journal of Clinical Biochemistry and Nutrition Pub Date : 2023-05-01 DOI:10.3164/jcbn.22-128
Yui Kuramochi, Kohsuke Hayamizu
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引用次数: 1

Abstract

Systematic reviews can be used not only to evaluate the efficacy and usefulness of a drug or food ingredient, but also as a safety assessment method. One of the aims of safety assessment is to estimate the no observed adverse effect level and the lowest observed adverse effect level. However, no methodology to statistically estimate the no observed adverse effect level from systematic review results has yet been reported. Estimation of the no observed adverse effect level involves a search for the dose above which adverse events occur is even exploration of the thresholds in dose response. To search for the dose above which adverse events occur, we examined an estimation method using the weighted change-point regression model, which includes the weights of each study used for systematic reviews in the model. This model could be applied to safety data of an omega-3 study in the form of a systematic review. We demonstrated that the dose response to omega-3 intake regarding adverse events had a threshold value and that the no observed adverse effect level could be estimated using the developed model.

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用于估计系统评价中未观察到的不良反应水平的变点回归方法。
系统评价不仅可以用来评价药物或食品成分的有效性和有用性,而且还可以作为一种安全评估方法。安全性评价的目的之一是估计未观察到的不良反应水平和最低观察到的不良反应水平。然而,尚无方法对系统评价结果中未观察到的不良反应水平进行统计估计。对未观察到的不良反应水平的估计包括寻找发生不良事件的剂量,甚至是探索剂量反应的阈值。为了寻找超过不良事件发生的剂量,我们检验了一种使用加权变点回归模型的估计方法,该模型包括用于模型中系统评价的每个研究的权重。该模型可以以系统评价的形式应用于omega-3研究的安全性数据。我们证明,摄入omega-3对不良事件的剂量反应有一个阈值,并且可以使用开发的模型估计未观察到的不良反应水平。
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来源期刊
CiteScore
4.30
自引率
8.30%
发文量
57
审稿时长
6-12 weeks
期刊介绍: Journal of Clinical Biochemistry and Nutrition (JCBN) is an international, interdisciplinary publication encompassing chemical, biochemical, physiological, pathological, toxicological and medical approaches to research on lipid peroxidation, free radicals, oxidative stress and nutrition. The Journal welcomes original contributions dealing with all aspects of clinical biochemistry and clinical nutrition including both in vitro and in vivo studies.
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