Clinical impact of the lower limit of normal of FEV 1 /FVC on detecting chronic obstructive pulmonary disease: A follow-up study based on cross-sectional data.

BACKGROUND: Criteria of obstruction that establish a diagnosis of COPD have been debated in recent years. We carried out a follow-up study to assess the impact of the new LLN reference equation for Chinese on detecting COPD compared with the traditional 0.7fixed criteria.

METHODS: We examined the prevalence and characteristics of airflow limitation for a non-child population using post-bronchodilator airflow with both age-dependent predicted lower limit of the normal value and fixed-ratio spirometric criterion. Questionnaires and spirometry were completed for all eligible subjects during the baseline examination. Participants with inconsistent diagnosis according to the two criteria, normal participants (controls) and COPD patients in stages I or II, were invited to take a cardiopulmonary exercise testing (CPET) examination and follow up for 2-4 years.

RESULTS: A total of 5448 (mean age 50.51 ± 13.2 yr) study subjects with acceptable spirometry and complete questionnaire data were included in our final analyses. COPD detection based on LLN was consistent with the GOLD 0.7 fixed-ratio in general, as 51 subjects (0.9%) were underdiagnosed, and 61 subjects (1.1%) were overdiagnosed when using LLN as the reference diagnostic criterion. The underdiagnosed subjects were younger, had more symptoms, more exposure to biofuels and worse FEV1 than the normal group; they also demonstrated a damaged cardiopulmonary reserve capacity and significant FEV1 decline. Except for being older, the overdiagnosed subjects differed little from the normal group.

CONCLUSIONS: Individual-dependent LLN appears to better reveal impacts on detecting airflow limitation. Participants underdiagnosed by GOLD criterion should be paid more attention.

CLINICAL TRIAL REGISTRATION: ChiCTR-ECS-13004110.