Porszasz, J, Blonshine, S, Cao, R et al. (3 more authors) (2016) Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulmonary Medicine, 16 (1). 13. ISSN 1471-2466
Abstract
Background: 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. Methods: BioQC testing was 6-min treadmill walking at 20W and 70W (below the lactate threshold) with healthy non-smoking laboratory staff (15 centers; ~16months). Measurements were made twice within the initial 4weeks and quarterly thereafter. Quality control was based on: 1) within-center precision (coefficient of variation [CV] for oxygen uptake [VO2], carbon dioxide output [VCO2], and minute ventilation [VE] within ±10%); and 2) a criterion that VO2 at 20W and 70W, and VO2/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 VO2 at 70W and VO2/WR, was compared with the other methods. Results: Of 129 tests (5 to 8 per center), 98 (76%) were accepted by within-center precision alone. Within-center CV was <9%, but between-center CV remained high (9.6 to 12.5%). Only 43 (33%) tests had all VO2 measurements within the ±10% predicted criterion. However, a composite z-score of 0.67 identified 67 (52%) non-normal outlying tests, exclusion of which coincided with the minimum CV for CPET variables. Conclusions: Study-wide BioQC using a composite z-score can increase study-wide precision and accuracy, and optimize the design and conduct of multicenter clinical trials involving CPET. Trial registration: ClinicalTrials.gov identifier: NCT01072396 ; February 19, 2010.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 Porszasz et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Calibration, Treadmill test, Pulmonary gas exchange, Z-score, Precision and accuracy |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Biological Sciences (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 02 Feb 2016 15:55 |
Last Modified: | 21 Nov 2018 13:42 |
Published Version: | http://dx.doi.org/10.1186/s12890-016-0174-8 |
Status: | Published |
Publisher: | BioMed Central |
Identification Number: | 10.1186/s12890-016-0174-8 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:94471 |