Visualizing adverse events in clinical trials using correspondence analysis with R-package visae

被引:2
|
作者
Diniz, Marcio A. [1 ]
Gresham, Gillian [1 ]
Kim, Sungjin [1 ]
Luu, Michael [1 ]
Henry, N. Lynn [2 ]
Tighiouart, Mourad [1 ]
Yothers, Greg [3 ,4 ]
Ganz, Patricia A. [5 ,6 ]
Rogatko, Andre [1 ]
机构
[1] Cedars Sinai Med Ctr, Samuel Oschin Comprehens Canc Ctr, Los Angeles, CA 90048 USA
[2] Univ Michigan, Rogel Canc Ctr, Ann Arbor, MI 48109 USA
[3] Univ Pittsburgh, Grad Sch Publ Hlth, Pittsburgh, PA USA
[4] NRG Oncol, Pittsburgh, PA USA
[5] Univ Calif Los Angeles, Jonsson Comprehens Canc Ctr, Los Angeles, CA 90024 USA
[6] Univ Calif Los Angeles, Fielding Sch Publ Hlth, Los Angeles, CA USA
关键词
Data visualization; Correspondence analysis; Adverse event; CTCAE; Clinical trials; PATIENT-REPORTED-OUTCOMES; CARCINOMA IN-SITU; SURGICAL-ADJUVANT-BREAST; RADIOTHERAPY NSABP B-35; DOUBLE-BLIND; POSTMENOPAUSAL WOMEN; CONFIDENCE-REGIONS; CANCER; ANASTROZOLE; PREVENTION;
D O I
10.1186/s12874-021-01368-w
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background Graphical displays and data visualization are essential components of statistical analysis that can lead to improved understanding of clinical trial adverse event (AE) data. Correspondence analysis (CA) has been introduced decades ago as a multivariate technique that can communicate AE contingency tables using two-dimensional plots, while quantifying the loss of information as other dimension reduction techniques such as principal components and factor analysis. Methods We propose the application of stacked CA using contribution biplots as a tool to explore differences in AE data among treatments in clinical trials. We defined five levels of refinement for the analysis based on data derived from the Common Terminology Criteria for Adverse Events (CTCAE) grades, domains, terms and their combinations. In addition, we developed a Shiny app built in an R-package, visae, publicly available on Comprehensive R Archive Network (CRAN), to interactively investigate CA configurations based on the contribution to the explained variance and relative frequency of AEs. Data from two randomized controlled trials (RCT) were used to illustrate the proposed methods: NSABP R-04, a neoadjuvant rectal 2 x 2 factorial trial comparing radiation therapy with either capecitabine (Cape) or 5-fluorouracil (5-FU) alone with or without oxaliplatin (Oxa), and NSABP B-35, a double-blind RCT comparing tamoxifen to anastrozole in postmenopausal women with hormone-positive ductal carcinoma in situ. Results In the R04 trial (n = 1308), CA biplots displayed the discrepancies between single agent treatments and their combinations with Oxa at all levels of AE classes, such that these discrepancies were responsible for the largest portion of the explained variability among treatments. In addition, an interaction effect when adding Oxa to Cape/5-FU was identified when the distance between Cape+Oxa and 5-FU + Oxa was observed to be larger than the distance between 5-FU and Cape, with Cape+Oxa and 5-FU + Oxa in different quadrants of the CA biplots. In the B35 trial (n = 3009), CA biplots showed different patterns for non-adherent Anastrozole and Tamoxifen compared with their adherent counterparts. Conclusion CA with contribution biplot is an effective tool that can be used to summarize AE data in a two-dimensional display while minimizing the loss of information and interpretation.
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页数:11
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