Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials

BMC Pulmonary Medicine
Janos PorszaszHarry B Rossiter

Abstract

Precision and accuracy assurance in cardiopulmonary exercise testing (CPET) facilitates multicenter clinical trials by maximizing statistical power and minimizing participant risk. Current guidelines recommend quality control that is largely based on precision at individual testing centers (minimizing test-retest variability). The aim of this study was to establish a multicenter biological quality control (BioQC) method that considers both precision and accuracy in CPET. BioQC testing was 6-min treadmill walking at 20 W and 70 W (below the lactate threshold) with healthy non-smoking laboratory staff (15 centers; ~16 months). Measurements were made twice within the initial 4 weeks and quarterly thereafter. Quality control was based on: 1) within-center precision (coefficient of variation [CV] for oxygen uptake [V̇O2], carbon dioxide output [V̇CO2], and minute ventilation [V̇E] within ±10%); and 2) a criterion that V̇O2 at 20 W and 70 W, and ∆V̇O2/∆WR were each within ±10 % predicted. "Failed" BioQC tests (i.e., those outside the predetermined criterion) prompted troubleshooting and repeated measurements. An additional retrospective analysis, using a composite z-score combining both BioQC precision and accuracy of V̇O2 at 70 W an...Continue Reading

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Citations

Dec 1, 2017·Medicine and Science in Sports and Exercise·Thomas W DecatoMatthew J Hegewald
May 8, 2018·European Journal of Applied Physiology·Susan A Ward
Jul 22, 2021·JAMA Cardiology·Fàtima CrispiEduard Gratacós

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Clinical Trials Mentioned

NCT01072396

Software Mentioned

BioQC
SigmaPlot
CPET
CPET BioQC

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