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Proposal 1053

Title of the Proposed Research

Validation of the spirometric LMS equations in the Spanish population

Lead Researcher

Dr. Patricia Sobradillo

Affiliation

Universitary Hospital of Araba
Vitoria, Spain

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

24 November 2014

Lay Summary

Spirometry is an essential test in the diagnosis and grading of respiratory diseases. Its interpretation requires calculation of predicted values for each subject from normal values obtained from healthy subjects. Nevertheless, these considered “normal” values show wide ranges of normality, great interindividual variation and depend on the anthropometric characteristics of the subjects. The reference equations recommended by the Spanish Society of Pneumology (SEPAR) were obtained in 1986. Recently a European Respiratory Society (ERS) Task Force (Global Lung Function Initiative (GLI)addressed the above problems by producing predicted values for spirometric indices for a variety of ethnic groups, valid across the 3–95 years age range. These are based on the LMS methodology (?, µ, s), that allows a simultaneous evaluation of the mean (mu), the variation coefficient (sigma) and the bias (lambda) of the distribution. The aim of this study is to determine the diagnostic and interpretative consequences of adopting the Global Lungs Initiative (GLI) 2012 spirometric prediction equations. To that end a retrospective study of the EPI-SCAN database will be carried out. AIMS: 1)Validations of the predicted values from de LMS equations in a sample of healthy subjects of the Spanish population included in the Epidemiologic Study of COPD in Spain (EPI-SCAN study). 2)Comparison of these with the predicted values obtained from other equations (Spanish and European) in COPD patients.

If these equations were valid in the Spanish population their use would reflect spirometric indices and provide an age-specific spirometric values in a wide range of subjects, enabling improved diagnostic accuracy.

Study Data Provided

Study 107335: COPD prevalence estimation in Spanish population

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation