Cited by 4,305Chronic Obstructive Pulmonary Disease (COPD) ResearchClinical Laboratory Practices and Quality ControlClinical practice guidelines implementation

Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement

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Graham, Brian L., Steenbruggen, Irene, Miller, Martin R., Barjaktarevic, Igor Z., Cooper, Brendan G., Hall, Graham L., Hallstrand, Teal S., Kaminsky, David A. +7 more·2019·American Journal of Respiratory and Critical Care Medicine

Abstract

Abstract Background Spirometry is the most common pulmonary function test. It is widely used in the assessment of lung function to provide objective information used in the diagnosis of lung diseases and monitoring lung health. In 2005, the American Thoracic Society and the European Respiratory Society jointly adopted technical standards for conducting spirometry. Improvements in instrumentation and computational capabilities, together with new research studies and enhanced quality assurance approaches, have led to the need to update the 2005 technical standards for spirometry to take full advantage of current technical capabilities. Methods This spirometry technical standards document was developed by an international joint task force, appointed by the American Thoracic Society and the European Respiratory Society, with expertise in conducting and analyzing pulmonary function tests, laboratory quality assurance, and developing international standards. A comprehensive review of published evidence was performed. A patient survey was developed to capture patients’ experiences. Results Revisions to the 2005 technical standards for spirometry were made, including the addition of factors that were not previously considered. Evidence to support the revisions was cited when applicable. The experience and expertise of task force members were used to develop recommended best practices. Conclusions Standards and consensus recommendations are presented for manufacturers, clinicians, operators, and researchers with the aims of increasing the accuracy, precision, and quality of spirometric measurements and improving the patient experience. A comprehensive guide to aid in the implementation of these standards was developed as an online supplement.

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Crossref · 10.1164/rccm.201908-1590st

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  • For spirometry assessments, only grade A and B FVC measurements, as determined by central read/adjudication, were considered valid for analysis.

    “For spirometry assessments, only grade A and B FVC measurements, as determined by central read/adjudication, were considered valid for analysis.12”

    From Deupirfenidone Compared with Pirfenidone and Placebo in Idiopathic Pulmonary Fibrosis (ELEVATE-IPF): a Phase 2b Randomized Placebo-Controlled Trial (2026) · cites this paper as [12]

    The ‘Grading the Quality of the Test Session’ section (Table 10; page not available) defines grades A and B for FVC, but it also recognizes acceptable measurements at grades C–E. The ‘Reported Values’ section says usable values may be reported when no acceptable values exist. The source does not specify central read/adjudication or a rule restricting analysis to grades A and B. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • Fifty subjects (70.4%) had FVC and FEV1 measured at baseline/randomization with centrally sourced SpiroSphere devices (Clario) provided by the sponsor with study-specific training and proficiency tests to the operating staff to meet 2019 ATS/ERS guideline criteria with central overread.

    “Fifty subjects (70.4%) had FVC and FEV1 measured at baseline/randomization with centrally sourced SpiroSphere devices (Clario) provided by the sponsor with study-specific training and proficiency tests to the operating staff to meet the 2019 ATS/ERS guideline criteria63 with central overread.”
  • Twenty-one subjects (29.6%) had FVC and FEV1 measured at baseline with local site spirometry equipment meeting 2019 ATS/ERS guideline criteria, provided baseline and end-of-treatment spirometry were performed with the same equipment.

    “Twenty-one subjects (29.6%) had FVC and FEV1 measured at baseline (randomization with spirometry equipment sourced from the local site meeting the 2019 American Thoracic Society and European Respiratory Society guideline criteria)63, provided that the subject’s baseline and end-of-treatment spirometry were performed with the same equipment.”

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Research works printed but not linked: 2

  1. [79]Czajkowska-Malinowska M Tomalak W Radliński J Quality of spirometry in the elderly Pneumonol Alergol Pol 2013 81 511 517 24142780
  2. [126]Hansen LM Pedersen OF Lyager S Naerra N Differences in vital capacity due to the methods employed Ugeskr Laeger 1983 145 2752 2756 6636337

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Authors
Graham, B. L., Steenbruggen, I., Miller, M. R., Barjaktarevic, I. Z., Cooper, B. G., Hall, G. L., Hallstrand, T. S., Kaminsky, D. A., McCarthy, K., McCormack, M. C., Oropez, C. E., Rosenfeld, M., Stanojevic, S., Swanney, M. P., & Thompson, B. R.
Affiliations
University of Saskatchewan (CA)
Corresponding author
Graham, Brian L.
Venue
American Journal of Respiratory and Critical Care Medicine
Published
2019-10
Volume
200
Issue
8
Pages
e70-e88
ISSN
  • 1073-449X (ISSN-L)
  • 1535-4970
OpenAlex
W2981067716
Cited by
4,305
References
148
Citations by year
2026: 798 · 2025: 807 · 2024: 756 · 2023: 659 · 2022: 625 · 2021: 460 · 2020: 192 · 2019: 4
FWCI
235.47
Type
journal article
Language
en
Open access
Locations
  • American Journal of Respiratory and Critical Care Medicine (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
  • Swinburne figshare (Swinburne University of Technology) (submittedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
spirometry, technical standards, pulmonary function tests, lung function assessment, quality assurance, patient experience, best practices
MeSH terms
Europe, Humans, Lung Diseases, Respiratory Function Tests, Societies, Medical, Spirometry, United States, Practice Guidelines as Topic, Advisory Committees

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