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* From the Division of Pulmonary/Critical Care Medicine, Department of Medicine, Cedars-Sinai Medical Center, UCLA School of Medicine, Los Angeles, CA.
Correspondence to: David Balfe, MD, MBBCh, Division of Pulmonary and Critical Care, Cedars-Sinai Medical Center, Room 6732, 8700 Beverly Blvd, Los Angeles, CA 90048; e-mail: balfed{at}csmc.edu
| Abstract |
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Design: Retrospective analysis.
Setting: Tertiary medical center.
Patients: A retrospective analysis of 21,499 patient pulmonary function tests (PFTs) was performed. The predicted values of Crapo and coworkers were used.
Measurements and results: The distribution of the severity of the obstruction was compared using the ATS and ITS methods for PFTs with normal, increased, or decreased total lung capacity (TLC). Analysis was performed using the
2 method. Of the 21,499 PFTs that were analyzed, TLC was measured in 28% (5,962 PFTs). In this cohort, 44% (2,619 PFTs) gave evidence of obstruction. Of these, 147 PFTs demonstrated additional restriction. While the ATS criteria graded 133 of these PFTs (90%) as being severe, the ITS criteria graded only 4 PFTs (3%) as severe (the severity distribution between the methods was significantly different [p < 0.01]).
Conclusions: In view of the possible overestimation of the severity of obstruction in PFTs with concurrent restriction using the percentage of predicted FEV1 values, consideration should be given to grading the severity of obstruction on the basis of the FEV1/FVC ratio in this specific subset of PFTs.
Key Words: American Thoracic Society obstructive airways disease pulmonary function test restrictive lung disease severity spirometry
| Introduction |
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Ideally, the prediction equations used to obtain the reference values should include a means to define the lower limit of normal. What is considered normal is generally taken as those values in the reference population lying above the fifth percentile for a one-tailed test such as FEV1 or FVC.1 The difference between the predicted value derived from the prediction equation and the value representing the fifth percentile is the 95% CI.2 The difference between the measured value of a spirometric variable and the predicted value can be expressed as a multiple of the 95% CI, with this multiple used as an index of severity.2 An alternative is to define normal as being > 80% of the predicted value. However, this will result in shorter, older subjects being more readily classified as abnormal.1
To address this issue (ie, the grading obstruction in the presence of concurrent restriction), we embarked on a retrospective analysis of PFTs by comparing the grading of obstruction using those criteria recommended by the ATS and the ITS.
| Materials and Methods |
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A retrospective analysis was performed on a computerized database of all PFTs meeting the ATS criteria that had been performed between April 1, 1978, and June 8, 1999, on patients
18 years of age. Demographic data were obtained in addition to prebronchodilator FEV1, FVC, FEV1/FVC ratio, and TLC parameters. Predicted values for these PFT parameters were based on the data of Crapo and coworkers.4
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These data sets provided the lower limits of normal based on the 95th percentile, thus allowing the calculation of the 95% CIs.
Obstruction was determined to be present if the FEV1/FVC ratio was significantly reduced (ie, greater than one CI below the predicted value). Restriction was deemed to be present when the TLC was greater than 1 CI below the predicted value. Hyperinflation was present where the TLC was > 1 CI above the predicted value. In the PFT results that exhibited evidence of obstruction, the ATS and ITS grading systems were used to divide the PFTs into the following two categories of severity: severe grades of obstruction; and all other severity grades (ie, normal, mild, moderate) [Table 1 ].
The distribution of the severity of obstruction using the ATS and ITS methods was then compared between PFTs with TLC values judged to be below, above, or within the normal range.
Data and Statistical Analysis
Pulmonary function data that previously had been collected were analyzed using a database (ACCESS; Microsoft Corporation; Redmond, WA). The results of the database queries were exported to a spreadsheet (EXCEL; Microsoft Corporation) and subsequently to a software package (SIGMASTAT; Jandel Scientific Software; San Rafael, CA) for further analysis.
The distribution of the pattern of severity grading (using the two categories derived from both the ATS and ITS grading systems) was compared. An analysis of the severity distribution was made with the
2 test. The distributions of the following three patterns of severity grading were compared: (1) the ATS grading being more severe than the ITS; (2) ATS and ITS grading having equal severity; and (3) the ITS grading being more severe than the ATS grading. The severity grading differences were compared between PFT results with a normal TLC, restriction, and hyperinflation. A p value of < 0.05 was considered to be significant.
| Results |
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TLC was measured in 5,962 of the above PFTs (both by means of helium dilution and plethysmography). Of these studies, the results of 2,619 PFTs (43.9%) gave evidence of obstruction, of which 512 (19.5%) were graded as revealing severe obstruction using the ITS grading system, with the remainder graded as revealing either mild or moderate obstruction. In contrast, using the ATS grading criteria on the same data that had exhibited obstruction, a far higher percentage (51.2%; 1,341 PFTs) were graded as being severe (ie, moderately severe, severe, or very severe), while 48.8% were in the alternative category (normal, mild, or moderate). Of the all the studies graded as severe by ATS grading criteria, 28% were moderately severe, 43% were severe, and 29% were very severe.
In this cohort of studies exhibiting obstruction, TLC was normal in 72.2% of PFTs (1,890 PFTs), increased in 22.2% (582 PFTs), and reduced in 5.6% (147 PFTs). All the PFTs demonstrating restriction with concomitant obstruction utilized plethysmography to assess lung volumes. In the hyperinflated group, 254 PFTs (43.6%) were graded as having severe obstruction using the ITS grading system, with 328 being graded as having either mild or moderate obstruction. In contrast, using the ATS grading criteria on the same group of obstructed pulmonary functions with hyperinflation, 363 PFTs (62.4%) were graded as being severe (ie, moderately severe, severe, or very severe), while 219 were in the alternative category (ie, normal, mild, or moderate). In the group with normal TLC values, 254 PFTs (13.4%) were graded as having severe obstruction using the ITS grading system, and 1,636 PFTs were graded as having either mild or moderate obstruction. In contrast, using the ATS grading criteria on the same group, 845 PFTs (44.7%) were graded as being severe (ie, moderately severe, severe or very severe), while 1,045 were in the alternative category (ie, normal, mild, or moderate) [Table 2 ].
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Analyzing the distribution in the discordant grading between the ATS and ITS grading systems revealed distinct differences. There was a significantly higher frequency of the ATS grading being more severe than the ITS grading for obstruction in the presence of restriction than in either the normal or hyperinflated group. The number of PFTs in which the ATS system graded PFTs more severely than the ITS system was 595 in the normal TLC group and 129 in the restricted group, which result was significantly different from those of the grading distribution of PFTs in which the ITS system grading was found to be more severe than that of the ATS system (normal TLC, 4 PFTs; restricted TLC, 0 PFTs; p < 0.01). The number of PFTs in which the ATS system graded PFTs more severely than the ITS system was 113 in the hyperinflated group and 129 in the restricted group, which was significantly different than the distribution of PFTs in which the ITS system was more severe than the ATS system (hyperinflated TLC, 4 PFTs; restricted TLC, 0 PFTs; p < 0.01). This relationship in the distribution of the two categories of severity in the normal, hyperinflated, and restrictive groups is graphically depicted in Figure 1 .
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1.5 CIs; moderate obstruction, > 1.5 and
2 CIs; and severe obstruction, > 2 CIs. Using this system in the group with PFT results indicating obstruction with restriction (ie, combined defects) would have resulted in 56 studies (38.1%) being graded as having severe obstruction, with the remainder (ie, 91 studies) being graded as having either mild or moderate obstruction. In contrast, as reported earlier, using the ATS grading criteria on the same group of obstructed pulmonary functions would have yielded a far greater percentage being graded as severe (90%) [Table 2
]. This approach would also lead to a more balanced severity difference distribution in the group of PFTs with results indicating obstruction and concurrent restriction (Fig 1)
. | Discussion |
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PFTs may be used to assess the causes of dyspnea and to address major issues in clinical case management including describing dysfunction and assessing its severity.1 Severity assessment ideally is derived from studies that relate PFT values to independent indexes of performance, such as inability to work and function in daily life, morbidity, and prognosis.1
The ITS (in 1974)2 and subsequently the ATS1 undertook the responsibility of standardizing pulmonary function laboratory procedures and establishing reference values. Reference values can vary widely, so it is important to select reference values that are representative of the population being studied.2 3 The adult reference equations that are used most commonly by pulmonary function laboratories in the United States are those of Crapo et al,4 Morris et al,6 Knudson et al,7 and Enright.8
The criteria that were used for selecting reference equations include population samples with wide ranges of height and weight, never smokers, and absence of heart or lung disease or the presence of chronic respiratory symptoms.1
Both FEV1 and FEV1/FVC ratio have been found to be independent predictors of both all-cause and respiratory mortality.9 10 11 Our study found that using either FEV1 as a percentage of predicted values or the FEV1/FVC ratio resulted in a similar relative frequency distribution of severity in obstructed PFT results with either concurrent hyperinflation or normal TLC (Fig 1) . However, in PFTs exhibiting an obstructive pattern together with concurrent restriction, the use of FEV1 as a percentage of predicted values to grade obstruction resulted in a far greater grading of severity than using the FEV1/FVC ratio (using CI multiples as described in the ITS recommendations). Use of the intermediate CI ranges for FEV1/FVC ratio that we propose would yield a severity grading for obstruction in between the ATS and ITS criteria for that cohort of patients exhibiting combined obstructive and restrictive ventilatory patterns. Another reason to propose this modification in the CI range modification is to account for the fact that restriction often produces a supernormal FEV1/FVC ratio as a consequence of higher elastic recoil. Grading the severity of obstruction has important implications for disability rating, which has effects on the patients perceptions of their disease. A different severity rating could have implications for therapeutic intervention.
In summary, the severity of obstruction in patients with additional restriction is overestimated if it is based on the percent predicted FEV1 alone. It is therefore suggested that an alternative grading system be used only in this cohort of studies (which would be based on multiples of the FEV1/FVC ratio CIs). This would avoid the problem of overestimating the degree of obstruction in the presence of a concurrent restrictive ventilatory pattern and would serve to standardize the interpretation of such test results across different laboratories.
| Footnotes |
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Received for publication December 18, 2001. Accepted for publication April 23, 2002.
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