Improving the measurement of longitudinal change in renal function: Automated detection of changes in laboratory creatinine assay
Poh N., McGovern A., De Lusignan S.
Copyright © 2015 The Author(s). Introduction Renal function is reported using the estimates of glomerular filtration rate (EGFR). However, EGFR values are recorded without reference to the particular serum creatinine (SCr) assays used to derive them, and newer assays were introduced at different time points across the laboratories in the United Kingdom. These changes may cause systematic bias in EGFR reported in routinely collected data, even though laboratory-reported EGFR values have a correction factor applied. Design An algorithm to detect changes in SCr that in turn affect EGFR calculation method was developed. It compares the mapping of SCr values on to EGFR values across a time series of paired EGFR and SCr measurements. Setting Routinely collected primary care data from 20,000 people with the richest renal function data from the quality improvement in chronic kidney disease trial. Results The algorithm identified a change in EGFR calculation method in 114 (90%) of the 127 included practices. This change was identified in 4736 (23.7%) patient time series analysed. This change in calibration method was found to cause a significant step change in the reported EGFR values, producing a systematic bias. The EGFR values could not be recalibrated by applying the Modification of Diet in Renal Disease equation to the laboratory reported SCr values. Conclusions This algorithm can identify laboratory changes in EGFR calculation methods and changes in SCr assay. Failure to account for these changes may misconstrue renal function changes over time. Researchers using routine EGFR data should account for these effects.