Serial echocardiographic assessment of left ventricular mass: how blinded should readers be?

Philippe Gosse1, Giovanni de Simone, Olivier Dubourg

  • 1Service de Cardiologie -- Hypertension Artérielle, Groupe Hospitalier Saint André, Bordeaux, France. philippe.gosse@chu-bordeaux.fr

Journal of Hypertension
|August 18, 2004
PubMed

Insights

Analyzing echocardiograms together in a blinded review significantly reduces measurement variability. This

Area of Science:

  • Cardiology
  • Clinical Trials
  • Medical Imaging

Background:

  • Left ventricular (LV) hypertrophy is a key indicator in hypertensive patients.
  • Accurate measurement of LV mass (LVM) is crucial for assessing treatment efficacy.
  • Central blinded review of echocardiograms aims to reduce measurement variability.

Purpose of the Study:

  • To evaluate the effect of group-analysis of echocardiograms on measurement variability.
  • To compare the impact of individual serial versus simultaneous group-analysis on LVM change.
  • To determine the optimal methodology for central blinded review in clinical trials.

Main Methods:

  • 630 echocardiograms from 210 hypertensive patients were analyzed.
  • Three echocardiograms per patient (baseline, W0, W52) were read twice using two methods.
  • Method 1: Individual serial echocardiogram review. Method 2: Simultaneous group-analysis of all echocardiograms per patient (blinded sequence).

Main Results:

  • Simultaneous group-analysis reduced LVM change variability by 22% compared to individual review.
  • Despite good agreement in LVM values, LVM change under treatment was reduced by 41% with group-analysis.
  • This indicates that pooling echocardiograms enhances the detection of treatment effects.

Conclusions:

  • The 'full-blind' methodology, involving simultaneous group-analysis, maximizes study power.
  • This approach can lead to a reduced sample size in clinical trials.
  • This optimized review process improves the efficiency of assessing antihypertensive treatments.
Abstract