Assessing post-BD improvement in FEV1 and FVC as a percent of the predicted

The 2005 ATS/ERS standards for assessing post-bronchodilator changes in FVC and FEV1 have been criticized numerous times. A recent article in the May issue of Chest (Quanjer et al) has taken it to task on two specific points:

  • the change in FVC and FEV1 has to be at least 200 ml
  • the change is assessed based on the percent change (≥12%) from the baseline value

The article points out that the 200 ml minimum change requires a proportionally larger change for a positive bronchodilator response in the short and the elderly. Additionally, by basing the post-BD change on the baseline value it lowers the threshold (in terms of an absolute change) for a positive bronchodilator response as airway obstruction become more severe. As a way of mitigating these problems the article recommends looking at the post-bronchodilator change as a percent of predicted rather than as a percent of baseline.

The article is notable (and its authors are to be commended) because it studied 31,528 pre- and post-spirometry records from both clinical and epidemiological sources from around the world. For the post-bronchodilator FEV1 and FVC:

  • the actual change in L
  • the percent change from baseline
  • the change in percentage of predicted
  • the Z-score

were determined.

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Normal or obstruction?

I had finished reviewing a pre- and post-BD spirometry report yesterday and was about to toss it on my out pile when I noticed something a bit odd about the post-BD results. I pulled it back and spent some time trying to decide if the interpretation needed to be changed but after a lot of internal debate I finally let it go as it was. I’ve continued to think about it however, and although I’m not sure that was the right decision I still haven’t come up with a clear answer.

Here’s what I saw:

Observed: %Predicted: Post-BD: %Predicted: %Change:
FVC: 3.70 97% 3.91 103% +6%
FEV1: 2.82 94% 2.79 93% -1%
FEV1/FVC: 76 95% 71 89% -6%
PEF: 6.62 94% 7.19 102% +9%
Exp. Time: 10.92 11.15

The reported pre-BD and post-BD results were from good quality tests and met the criteria for repeatability. My problem is that the baseline results were normal but if I had seen the post-BD results by themselves I would have considered them to show mild airway obstruction.

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Which time is it?

The ATS/ERS standard for spirometry recommends reporting the highest FEV1 and the highest FVC even when they come from different tests. Our lab software allows us to do this, but only with some annoying limitations. One of the bigger limitations has to do with how expiratory time is reported. In particular, expiratory time is lumped in with a number of other values like Peak Flow (PEF) and FEF25-75. As importantly, the flow-volume loop and volume-time curve can only come from a single effort.

Our lab software defaults to choosing a single effort with the highest combined FVC+FEV1. The technician performing the tests will override this when other spirometry efforts have a larger FVC or a better FEV1 (which is chosen not just if it is higher but also on the basis of peak flow, back-extrapolation and other quality indicators). The usual order for this is to first choose a spirometry effort with the “best” FEV1, then if there is a different effort with a larger FVC that FVC is selected for reporting. When things are done this way what happens is that the expiratory time, flow-volume loop and volume-time curve that come from the effort selected for its FEV1 are reported. This means is that the expiratory time and volume-time curve often don’t match the reported FVC.

I always take a look at the raw test data whenever a spirometry report comes across my desk with an expiratory time less than 6 seconds or the technician noted that the spirometry effort is a composite. What I often find is that even though the reported expiratory time may be low, the FVC actually comes from an effort with an adequate expiratory time. Although I can select the right expiratory time the problem is that doing so also selects the PEF and the PEF from the effort with the highest FVC is often significantly less than the effort from the best FEV1. The same problem applies to selecting the volume-time curve since the associated flow-volume loop often doesn’t match the effort with the best FEV1 and best PEF. For these reasons I only select the correct expiratory time and volume-time curve when it doesn’t really affect the flow-volume loop and PEF.

However, I’ve always assumed that the expiratory time from the effort with the highest FVC was probably the most correct expiratory time. Yesterday however, this spirometry effort came across my desk:

Blue Red
FVC: 2.53 2.54
FEV1: 2.19 2.13
FEV1/FVC: 86 84
PEF: 6.94 5.07
Exp. Time: 3.05 5.09

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Is there airway obstruction when the FEV1 is normal?

I’ve been reviewing the literature on PFT interpretation lately and in doing so I ran across one of the issues that’s bothered me for a while. Specifically, my lab has been tasked with following the 2005 ATS/ERS guidelines for interpretation and using this algorithm these results:

Observed: %Predicted: LLN: Predicted:
FVC: 2.83 120% 1.76 2.36
FEV1: 1.77 100% 1.26 1.76
FEV1/FVC: 63 84% 65 75

would be read as mild airway obstruction.

Although it’s seems odd to have to call a normal FEV1 as obstruction I’ve been mostly okay with this since my lab has a number of patients with asthma whose best FVC and FEV1 obtained at some point in the past were 120% of predicted or greater but whose FEV1 frequently declines to 90% or 100% of predicted. In these cases since prior studies showed a normal FEV1/FVC ratio then an interpretation of a mild OVD is probably correct even though the FEV1 itself is well above the LLN, and this is actually the situation for this example.
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The FVC/DLCO ratio. Will the real percent predicted please stand up?

Recently a reader asked me a question about the FVC/DLCO ratio. To be honest I’d never heard of this ratio before which got me intrigued so I spent some time researching it. What I found leaves me concerned that a lack of understanding about reference equations may invalidate several dozen interrelated studies published over the last two decades.

Strictly speaking the FVC/DLCO ratio is the %predicted FVC/%predicted DLCO ratio (which is usually abbreviated FVC%/DLCO%) and it appears to be used exclusively by specialists involved in the treatment of systemic sclerosis and related disorders. Specifically, the ratio is used to determine whether or not a patient has pulmonary hypertension. The basic idea is that (quoting from a letter to the editor):

“As we know, in ILD both FVC and DLCO fall and their fall is proportionate, whereas in pulmonary arterial hypertension DLCO falls significantly and disproportionately to FVC.”

A variety of algorithms using the FVC%/DLCO% have been devised. Inclusion factors are usually an FVC < 70% of predicted and a DLCO (corrected for hemoglobin) < 60% of predicted. A number of different threshold values for FVC%/DLCO% have been published ranging from 1.4 to 2.2 with the differences appearing to be dependent on study population characteristics and the type of statistical analysis performed. It is thought that individuals meeting the inclusion factors with an FVC%/DLCO% ratio above the threshold most probably have pulmonary hypertension.

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COPD and the FEV1/FVC ratio. GOLD or LLN?

Everyone uses the FEV1/FVC ratio as the primary factor in determining the presence or absence of airway obstruction but there are differences of opinion about what value of FEV1/FVC should be used for this purpose. Currently there are two main schools of thought; those that advocate the use the GOLD fixed 70% ratio and those that instead advocate the use the lower limit of normal (LLN) for the FEV1/FVC ratio.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has stated that a post-bronchodilator FEV1/FVC ratio less than 70% should be used to indicate the presence of airway obstruction and this is applied to individuals of all ages, genders, heights and ethnicities. The official GOLD protocol was first released in the early 2000’s and was initially (although not currently) seconded by both the ATS and ERS. The choice of 70% is partly happenstance since it was one of two fixed FEV1/FVC ratio thresholds in common use at the time (the other was 75%) and partly arbitrary (after all why not 69% or 71% or ??).

The limitations of using a fixed 70% ratio were recognized relatively early. In particular it has long been noted that the FEV1/FVC ratio declines normally with increasing age and is also inversely proportional to height. For these reasons the 70% threshold tends to over-diagnose COPD in the tall and elderly and under-diagnose airway obstruction in the short and young. Opponents of the GOLD protocol say that the age-adjusted (and sometimes height-adjusted) LLN for the FEV1/FVC ratio overcomes these obstacles.

Proponents of the GOLD protocol acknowledge the limitation of the 70% ratio when it is applied to individuals of different ages but state that the use of a simple ratio that is easy to remember means that more individuals are assessed for COPD than would be otherwise. They point to other physiological threshold values (such as for blood pressure or blood sugar levels) that are also understood to have limitations, yet remain in widespread use. They also state that it makes it easier to compare results and prevalence statistics from different studies. In addition at least two studies have shown that there is a higher mortality of all individuals with an FEV1/FVC ratio below 70% regardless of whether or not they were below the FEV1/FVC LLN. Another study noted that in a large study population individuals with an FEV1/FVC ratio below 70% but above the LLN had a greater degree of emphysema and more gas trapping (as measured by CT scan), and more follow-up exacerbations than those below the LLN but above the 70% threshold.

Since many of the LLN versus GOLD arguments are based on statistics it would be useful to look at the predicted FEV1/FVC ratios in order to get a sense of how much under- and over-estimation occurs with the 70% ratio. For this reason I graphed the predicted FEV1/FVC ratio from 54 different reference equations for both genders and a variety of ethnicities. Since a number of PFT textbooks have stated that the FEV1/FVC ratio is relatively well preserved across different populations what I initially expected to see was a clustering of the predicted values. What I saw instead was an exceptionally broad spread of values.

Male_175cm_Predicted

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Airway obstruction and the FVC

Spirometry is the most commonly performed (and mis-performed) pulmonary function test around the world. The apparent simplicity of spirometry is misleading since there are numerous subtleties that have a significant effect on the results.

I suspect that when the FVC is thought about it is most often considered to be an index towards the total capacity of the lung. That’s certainly true in it’s own way, but the FVC is actually a critically important factor when determining airway obstruction. I’ve had a number of reports across my desk lately where the patient had a reasonably large change in FVC when compared to their last visit but little change in FEV1, and this has made a difference in how the results are interpreted. For example:

Visit 1: Observed: %Predicted: Predicted:
FVC: 4.27 87% 4.91
FEV1: 3.36 84% 3.99
FEV1/FVC: 79 96% 82
Visit 2: Observed: %Predicted: Predicted:
FVC: 4.67 95% 4.91
FEV1: 3.38 85% 3.99
FEV1/FVC: 72 88% 82

Although the change in FVC is not significant by my lab’s standards (+0.40 L, +9%) and the FEV1 has hardly changed at all, the FEV1/FVC ratio has gone from being within normal limits to being under the LLN and therefore showing mild airway obstruction. Continue reading

Short efforts, gas trapping and leaks

Outside the pulmonary lab there is this notion that spirometry is supposed to be so easy that anyone can do it. You just tell the patient to take a deep breath in and blow out fast and to keep blowing until they’re empty. What’s so hard about that?

Sheesh. GIGO. I keep finding ways in which the patient, their physiology and our equipment can conspire in ways to produce errors that even experienced technicians can miss. I’ve been paying a lot of attention to flow-volume loops lately and maybe it’s for this reason that I’ve seen a steady stream of spirometry tests that have something wrong with the FVC volume.

What I’ve been seeing are flow-volume loops where the end of exhalation is to the left of either the start of the FVC inhalation or of the tidal loop. Taken at face value this means that the patient did not exhale as much as they inhaled (and that the FVC is therefore underestimated) but there are several reasons why this happens and it takes a bit of detective work to figure out the cause and what to do about it.

The simplest reason is a short expiratory time. Flow-volume loops however, do not show time, only flow and volume. Sometimes when a patient stops exhaling abruptly it’s easy to see that the effort is short.

Abrupt_Termination_02_FVL

Other times it isn’t as clear:

Short_Exhalation_FVL

and you need to look at the volume-time curve as well.

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An FVC is not an SVC

I’ve discussed the issue of inserting a predicted FVC into the predicted lung volumes several times now. At the risk of beating this issue to death I’d like to put to rest the notion that an FVC and an SVC are the same thing.

A Forced Vital Capacity (FVC) maneuver is designed to measure the maximum expiratory flow rates, in particular the expired volume in 1 second (FEV1). It has long been recognized that the effort involved in the FVC maneuver can cause early airway closure, even in individuals with normal lungs, and that for this reason the vital capacity can be underestimated due to gas trapping. This effect is usually magnified with increasing age and in individuals with obstructive lung disease.

A Slow Vital Capacity (SVC) maneuver is designed to measure the lung volume subdivisions Inspiratory Capacity (IC) and Expiratory Reserve Volume (ERV), and to maximize the measured volume of the vital capacity. Due to the more relaxed nature of the SVC maneuver there is significantly less airway closure and for this reason the SVC volume is usually larger than the FVC, again even in individuals with normal lungs.

Comparing individual reference equations can be difficult but in general the reference equations for SVC and FVC agree with this. Taking the available SVC and FVC reference equations (unfortunately limited to Caucasian because there are almost no SVC equations for other ethnicities) it is apparent that the average predicted SVC is larger than the average predicted FVC, and that the magnitude of this difference increases with age:

SVC_vs_FVC_Male

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The ratio-nal approach to predicted TLC

I’ve been reading Miller et al’s Laboratory evaluation of Pulmonary Function which was published in 1987. That was an interesting time since PFT equipment manufacturers had mostly transitioned to computerized systems but there were still a lot of manual systems in the field. For this reason the book’s instructions are still oriented mostly around manual pulmonary function testing and there are numerous warnings about double-checking the results from automated systems.

The book includes extensive discussion on the calculations and formulas used for testing which makes it useful as a teaching resource. The authors were also very concerned about the correct way to run a PFT lab so there is a fair amount of discussion about staff requirements for education and training (including the medical director) and staff behavior and conduct. To this end each chapter includes extensive instructions on the proper way to perform tests and treat patients. Although the tone of this is somewhat dated and I’d like to say these kind of reminders shouldn’t be necessary, it doesn’t hurt to set a standard on the level of professionalism we should aspire to.

What caught my eye though, was a section in the chapter on Normal Values titled Interdependence of Normal Values which discussed of the value of deriving predicted TLC from predicted FVC. The authors were concerned that reference equations for different tests (and not just lung volumes) were being selected without concern for how well they fit together. I’ve previously written about the problems that results when inserting the reference equation for FVC into the reference equations for lung volumes. In one instance, the TLC was adjusted so that the final predicted TLC was equal to RV + VC, but this meant that TLC (and IC) were changed from the original reference equations. In another, the FVC was just substituted for SVC without adjustment which meant that RV + VC was not equal to TLC and IC + ERV was not equal to VC and this makes interpreting results problematic. What this means however, is that almost 30 years after this was published, this problem is still around.

As a solution, the authors point out that ratios, such as the FEV1/FVC ratio and the RV/TLC ratio tend to be relatively independent of height.

Since:

TLC = FVC + RV

This can be mathematically re-written as:

Which means that TLC can be derived from predicted FVC if the RV/TLC ratio is known.

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