2019 ATS/ERS Spirometry Standards

The 2019 ATS/ERS Spirometry Standards were recently released. The standards are open-access and can be downloaded without charge from the October 15th issue of the American Journal of Respiratory and Critical Care Medicine. Supplements are available from the same web page.

The 2019 Spirometry Standards have been extensively re-organized with numerous updates. Notably, a number of sections that were previously discussed in the 2005 General Considerations for Lung Function Testing have been updated and included in the 2019 Spirometry Standards. Also notably, a number of stand-alone spirometry tests, including the Flow-Volume Loop, PEF and MVV are not included in the 2019 Standards.

An overview of changes and updates from the 2005 Spirometry Standards are detailed within the 2019 Spirometry Standards (page e71, column 1, paragraph 2) and in the Data Supplement (pages E2-E3). In more detail these include:

◆ The list of indications for spirometry (page e73, table 1) was updated primarily with changes in language.

  • “To measure the effect of disease on pulmonary function” was updated to “To measure the physiological effect of disease or disorder”
  • “To describe the course of diseases that affect lung function” was updated to “To monitor disease progression”
  • “To monitor people exposed to injurious agents” was updated to “To monitor people for adverse effects of exposure to injurious agents”

◆ Items added to indications:

  • “Research and clinical trials”
  • “Preemployment and lung health monitoring for at-risk occupations”

◆ Contraindications were previously mentioned in the 2005 General Considerations rather than the 2005 Spirometry Standards and these have been extensively updated and expanded. Although the list of contraindications (page e74, table 2) is fairly inclusive (and should be reviewed by all concerned) there were items mentioned in the body of text that were not in the table:

  • “Spirometry should be discontinued if the patient experiences pain during the maneuver.”
  • “…because spirometry requires the active participation of the patient, inability to understand directions or unwillingness to follow the directions of the operator will usually lead to submaximal test results.”

◆ Notably, abdominal aortic aneurysm (AAA) was not included as a contraindication in the 2019 standards. (page e72, column 3, paragraph 1)

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A modest proposal for a clinical spirometry grading system

A while back I reviewed the spirometry grading system that was included in the 2017 ATS reporting standards. My feeling was, and continues to be, that its usefulness is very limited because it’s mostly a reproducibility grading system that relies on a few easy-to-measure parameters. This doesn’t mean that a grading system can’t be helpful, just that it needs to be focused differently.

In a clinical PFT lab many patients have difficulty performing adequate and reproducible spirometry, but that doesn’t mean the results aren’t clinically useful. Moreover, suboptimal quality results may be the very best the patient is ever able to produce. So what’s more important in a grading system than reproducibility is the ability to assess the clinical utility of a reported spirometry effort.

The two most important results that come from spirometry are the FEV1 and the FVC, and I strongly believe that they need to be assessed separately. For each of these values there are two aspects that need to be determined. First, is there a reliable probability that the reported value is correct? Second, are any errors causing the reported value to be underestimated or overestimated? The two are inter-related since a value with excellent reliability is not going to have any significant errors, but if there are errors then a reviewer needs to know which direction the result is being biased.

The current ATS/ERS standards contain specific thresholds for certain spirometry values such as expiratory time and back-extrapolation. Although these are certainly indications of test quality they are almost always used in a binary [pass | fail] manner. In order to assess clinical usefulness however, you instead need to grade these on a scale. For example an expiratory time of 5.9 seconds for spirometry from a 60 year-old individual would mean that there is a small probability that the FVC is underestimated, but with an expiratory time of 1.9 seconds the FVC would have a very high probability of being underestimated and this needs to be recognized in order to assess clinical utility.

Note: Although the A-B-C-D-F grading system is rather prosaic it is still universally understandable, so I will use it for grading reliability. An A grade or an F grade are probably easy to assign but differentiating between B-C-D may be more subjective, particularly since reliability depends on multiple parameters and judging their relative contribution is always going to be subjective at some point. For bias, I will be using directional characters (↑↓) to show the direction of the bias (i.e. positive or negative), so ↑ will indicate probable overestimation, ↓ will indicate probable underestimation, and ~ indicates a neutral bias.

FEV1 / Back extrapolation:

Back-extrapolation is a way to assess the quality of the start of a spirometry effort and the accuracy of the timing of the FEV1. The ATS/ERS statement says that the back-extrapolated volume must be less that 5% of the FVC or less than 0.150 L, whichever is greater.

My experience is that an elevated back-extrapolation tends to cause FEV1 to be overestimated far more often than underestimated. So a suggested grading system for back-extrapolation would be (and I’ll be the first to admit these are off the top of my head and open for discussion):

FEV1:    
Back-Extrapolation: Reliability: Bias:
Within standards: A ~
> 1 x standard, < 1.5 x standard: B
> 1.5 x standard, < 2 x standard C ↑↑
> 2 x standard, < 2.5 x standard: D ↑↑↑
> 2.5 x standard F ↑↑↑↑

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Hidden FIVC

I was about to put a PFT report I’d been reviewing in my outbox when I noticed something odd about the flow-volume loop.

Hidden FIVC_redacted 1

What I saw was that the final inspiration of the FVC maneuver had ended to the left of the initial inspiration. This means a couple of thing, first and foremost that the FIVC was larger than the FVC and that the FVC was likely underestimated because the patient hadn’t really taken a full inspiration prior to exhaling. I had already looked at the raw data for the patient’s spirometry results for other reasons but I pulled them up again to see if I had missed something.

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