Enhancing the Classification of Congenital Heart Defects for Outcome Association Studies in Birth Defects Registries

IF 1.6 4区 医学 Q4 DEVELOPMENTAL BIOLOGY
Sara B. Stephens, Renata H. Benjamin, Keila N. Lopez, Brett R. Anderson, Angela E. Lin, Charles J. Shumate, Wendy N. Nembhard, Shaine A. Morris, A. J. Agopian
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Abstract

Introduction

Traditional strategies for grouping congenital heart defects (CHDs) using birth defect registry data do not adequately address differences in expected clinical consequences between different combinations of CHDs. We report a lesion-specific classification system for birth defect registry–based outcome studies.

Methods

For Core Cardiac Lesion Outcome Classifications (C-CLOC) groups, common CHDs expected to have reasonable clinical homogeneity were defined. Criteria based on combinations of Centers for Disease and Control-modified British Pediatric Association (BPA) codes were defined for each C-CLOC group. To demonstrate proof of concept and retention of reasonable case counts within C-CLOC groups, Texas Birth Defect Registry data (1999–2017 deliveries) were used to compare case counts and neonatal mortality between traditional vs. C-CLOC classification approaches.

Results

C-CLOC defined 59 CHD groups among 62,262 infants with CHDs. Classifying cases into the single, mutually exclusive C-CLOC group reflecting the highest complexity CHD present reduced case counts among lower complexity lesions (e.g., 86.5% of cases with a common atrium BPA code were reclassified to a higher complexity group for a co-occurring CHD). As expected, C-CLOC groups had retained larger sample sizes (i.e., representing presumably better-powered analytic groups) compared to cases with only one CHD code and no occurring CHDs.

Discussion

This new CHD classification system for investigators using birth defect registry data, C-CLOC, is expected to balance clinical outcome homogeneity in analytic groups while maintaining sufficiently large case counts within categories, thus improving power for CHD-specific outcome association comparisons. Future outcome studies utilizing C-CLOC-based classifications are planned.

加强先天性心脏缺陷分类,促进出生缺陷登记结果关联研究。
导言:利用出生缺陷登记数据对先天性心脏缺陷(CHD)进行分组的传统策略并不能充分解决不同CHD组合之间预期临床后果的差异。我们报告了一种基于出生缺陷登记结果研究的病变特异性分类系统:对于核心心脏病变结果分类(C-CLOC)组,定义了预期具有合理临床同质性的常见 CHD。为每个 C-CLOC 组定义了基于疾病与控制中心(Centers for Disease and Control)修改后的英国儿科协会(British Pediatric Association,BPA)代码组合的标准。为了证明概念和在 C-CLOC 组内保留合理的病例数,我们使用德克萨斯州出生缺陷登记数据(1999-2017 年分娩情况)比较了传统分类方法与 C-CLOC 分类方法的病例数和新生儿死亡率:结果:C-CLOC 在 62,262 名患有先天性心脏病的婴儿中定义了 59 个先天性心脏病组。将病例归入单一的、相互排斥的 C-CLOC 组别,反映了复杂程度最高的 CHD,这减少了复杂程度较低的病变的病例数(例如,86.5% 的具有普通心房 BPA 代码的病例被重新归入复杂程度较高的组别,因为并发了 CHD)。不出所料,与仅有一个CHD代码且未发生CHD的病例相比,C-CLOC组保留了更大的样本量(即代表了可能更好的分析组):讨论:对于使用出生缺陷登记数据的研究人员来说,C-CLOC 这一新的 CHD 分类系统有望平衡分析组中临床结果的同质性,同时在分类中保持足够大的病例数,从而提高 CHD 特异性结果关联比较的功率。我们计划在未来利用基于C-CLOC的分类进行结果研究。
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来源期刊
Birth Defects Research
Birth Defects Research Medicine-Embryology
CiteScore
3.60
自引率
9.50%
发文量
153
期刊介绍: The journal Birth Defects Research publishes original research and reviews in areas related to the etiology of adverse developmental and reproductive outcome. In particular the journal is devoted to the publication of original scientific research that contributes to the understanding of the biology of embryonic development and the prenatal causative factors and mechanisms leading to adverse pregnancy outcomes, namely structural and functional birth defects, pregnancy loss, postnatal functional defects in the human population, and to the identification of prenatal factors and biological mechanisms that reduce these risks. Adverse reproductive and developmental outcomes may have genetic, environmental, nutritional or epigenetic causes. Accordingly, the journal Birth Defects Research takes an integrated, multidisciplinary approach in its organization and publication strategy. The journal Birth Defects Research contains separate sections for clinical and molecular teratology, developmental and reproductive toxicology, and reviews in developmental biology to acknowledge and accommodate the integrative nature of research in this field. Each section has a dedicated editor who is a leader in his/her field and who has full editorial authority in his/her area.
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