Lag-censoring analysis: lights and shades

Giovanni Tripepi; Georg Heinze; Kitty J Jager; Vianda S Stel; Friedo W Dekker; Carmine Zoccali

doi:10.1093/ndt/gfv068

Lag-censoring analysis: lights and shades

Nephrol Dial Transplant. 2015 May;30(5):700-5. doi: 10.1093/ndt/gfv068. Epub 2015 Apr 16.

Authors

Giovanni Tripepi¹, Georg Heinze², Kitty J Jager³, Vianda S Stel³, Friedo W Dekker⁴, Carmine Zoccali¹

Affiliations

¹ CNR-IFC/IBIM, Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Reggio Calabria, Italy.
² Section for Clinical Biometrics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
³ ERA-EDTA Registry, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
⁴ ERA-EDTA Registry, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, The Netherlands.

PMID: 25883199
DOI: 10.1093/ndt/gfv068

Abstract

'Intention-to-treat' (ITT) analysis is the recommended approach for the data analysis of randomized clinical trials (RCT). ITT analysis considers patients in the active or in the control arm as originally allocated by randomization, independently of their actual adherence to the assigned treatment. Lag-censoring analysis is a statistical method which takes into account the compliance of patients to the study protocol because the investigator censors a patient when or shortly after he/she stops the treatment being tested. Herein we describe the methodology underlying lag-censoring analysis in general terms and by considering the application of this technique in the analysis of a large RCT in haemodialysis patients, the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. Use and misuse of this technique are discussed.

Keywords: intention-to-treat analysis; lag-censoring analysis.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Data Interpretation, Statistical*
Humans
Kidney Failure, Chronic / therapy*
Nephrology / standards
Patient Compliance
Randomized Controlled Trials as Topic*
Renal Dialysis / methods*
Research Design*
Time Factors
Treatment Outcome