Adjustment for Propensity Score in Nonrandomized Clinical Studies: Comparison of Sivelestat Versus Conventional Therapy for Acute Lung Injury in Acute Respiratory Distress Syndrome

Therapeutic Innovation & Regulatory Science
Satoru FukimbaraTakuhiro Yamaguchi

Abstract

To confirm the effectiveness of sivelestat, a clinical trial was conducted comparing sivelestat with conventional treatment in an open, nonrandomized, multicenter study of patients with systemic inflammatory response syndrome (SIRS)-associated acute lung injury. The primary endpoint was ventilator-free days (VFD). This study adopted a "cluster entry" method to control for patient selection bias arising from the unblinded and nonrandomized clinical trial. Thus, all patients in the same hospital during the same entry period entered the same treatment arm, and entry periods did not overlap. In the primary analysis of VFD, adjusted mean VFD values were compared between groups using the inverse probability of treatment weighted (IPTW) method, based on propensity score, for control of confounding factors. There were 374 patients in the sivelestat group and 168 in the conventional therapy group. The primary analysis confirmed that sivelestat was effective (between-group difference of adjusted mean was 3.5 [2-sided 95% confidence interval, 1.3-5.8]; P = .0022). In general, a study where all patients in the same cluster enter the same treatment arm has within-cluster correlations, which need to be considered in the study analysis. Howev...Continue Reading

References

Jun 14, 1991·Biochemical and Biophysical Research Communications·K KawabataT Miyamoto
Mar 1, 1994·American Journal of Respiratory and Critical Care Medicine·G R BernardR Spragg
May 4, 2000·The New England Journal of Medicine·UNKNOWN Acute Respiratory Distress Syndrome NetworkArthur Wheeler
Aug 24, 2000·Epidemiology·J M RobinsB Brumback
Jun 2, 2007·Internal Medicine·Tadatomo KodamaSeiichi Kitagawa

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Citations

Feb 28, 2018·Clinical Pharmacology and Therapeutics·Musaddique HussainXimei Wu

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Methods Mentioned

BETA
X-ray

Software Mentioned

IPTW

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