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Validation of the spirometric LMS equations in the Spanish population
Proposal
1053
Title of Proposed Research
Validation of the spirometric LMS equations in the Spanish population
Lead Researcher
Dr. Patricia Sobradillo
Affiliation
Universitary Hospital of ArabaVitoria, Spain
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
11 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
[{ "PostingID": 1656, "Title": "GSK-107335", "Description": "COPD prevalence estimation in Spanish population." }]
Statistical Analysis Plan
Mean predicted values and Z-scores will be derived using prediction equations from the European Community for Steel and Coal (ECSC)/ERS, National Health and Nutrition Examination Survey (NHANES) III, Mediterranean population and GLI 2012. Z-scores according to the ECSC/ERS will be calculated by (measured - predicted)/standard deviation of the predicted value. The NHANES III predicted values will provide the mean and the LLN. As the LLN is defined as the fifth percentile, i.e. 1.6445 times the standard deviation below the predicted value, the standard deviation of the predicted values will be calculated as (predicted - LLN)/1.6445. The GLI 2012 calculations utilise mean predicted value, variation and skewness of the data to provide Z-scores and LLN specifically calculated for each individual.
Publication Citation
Validacion de las ecuaciones espirometricas LMS en la poblacion espanola: Estudio VALEMOS. P.Sobradillo, E.Marquez, M.Barrecheguren, F.J.Callejas, J.L.Garcia Rivero, B.Abascal, L.Puente, M.Calle Sessión: 71Área: EPOC
https://www.separcontenidos.es/posters/index.php?frameInferior=publicaciones_detalles&ID_Normativa=12&Admin=1&Idioma=Esp&ID_MenuPublicaciones=6455
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