Background European Respiratory Society and American Thoracic Society (ERS/ATS) guidelines for pulmonary function test (PFT) interpretation recommend the use of a normal forced vital capacity (FVC) to exclude restriction. However, this recommendation is based upon a single study from 1999, which was limited to White patients, and used race-specific reference equations that are no longer recommended by ERS/ATS. We sought to reassess the support for this recommendation by calculating the negative predictive value (NPV) of a normal FVC in a diverse, multicenter cohort using race-neutral reference equations. Methods We interpreted PFTs performed between 2000 and 2023 in two academic medical systems and in a national electronic health record (EHR) database. We calculated the NPV of a normal FVC to exclude restriction overall and among pre-specified racial and ethnic groups. Results We included PFTs from 85 990 patients. The prevalence of restriction was 35.1%. The overall NPV of a normal FVC to exclude restriction was 80.5% (95% CI 80.1% to 80.8%), compared to an NPV of 97.6% cited in support of ERS/ATS guidelines. The NPV ranged from 65.2% (95% CI 64.4% to 66.0%) among non-Hispanic Black patients to 85.9% (95% CI 85.6% to 86.3%) among non-Hispanic White patients. This difference was largely attributable to lower FVC z-scores among non-Hispanic Black patients. Conclusions The NPV of a normal FVC is lower than has been previously reported and varies by race and ethnicity. The approach to PFT interpretation recommended by ERS/ATS guidelines results in the under-recognition of restriction, particularly among non-Hispanic Black patients.
Competing Interest StatementThe authors have declared no competing interest.
Funding StatementATM reports funding from NHLBI F32 HL167456. GEW reports funding from NHLBI R03 HL171424.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The study was approved by the Johns Hopkins University and University of Pennsylvania Institutional Review Boards.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors.
留言 (0)