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Title:QT Correction Comparison

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Title QT Correction Comparison
Graph_Subgroup ECGVitals
ECG_Vitals_Clinical_Question 3. How do the different QT correction compare w.r.t relationship with RR?
Contributor/Email R.J. Anziano, Richard.J.Anziano@Pfizer.com
Background This figure plots the corrected QT by RR for all baseline p2 and p3 data with an overlay of the linear regression lines. The purpose of the QT correction is to make the resultant QTc independent of RR or heart rate. This independence would yield a linear regression line with zero slope. Bazzett correction is often considered to ‘over correct’ which means the cloud of QTc points are over rotated and therefore over estimated at high heart rates. Having the data along with the regression lines allows the user to point out specific data points and how different they are using two different corrections depending on how far the RR is from 1000msec.

Data is a one observation per subject dataset for a large p2/p3 program. Sample data is not provided for this plot. It is important that the data be one observation per subject for a SLR to maintain i.i.d. If not, the statistical model should take into account the within subject correlations.
Keywords QTc, Correction, Scatter plot, Bazzett, Fridericia
References http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf
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CLASSIFICATIONS

Graph_Type Scatterplot
Variable_Relationship Continuous versus Continuous
Data_Types Continuous
Special_Considerations It is important that this plot be produced only with baseline data as post baseline data may have effects of drug on the relationship of QTc and RR.
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Reference Image DRAFT_Comparison_QT_200.png
Topic revision: r3 - 02 May 2013 - 13:45:58 - MaryBanach
 

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