External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort)

BMC Pulmonary Medicine

Study Protocol

Rosa Magallon-Botaya¹  Berta Anta-Agudo²  Claudia Iftode³  Ana Duarte-Pérez⁴  Radost S. Assenova⁵  Durdica Kasuba Lazic⁶  Biljana Gerasimovska Kitanovska⁷  Francisco Gude-Sampedro⁸  Pere Torán Monserrat⁹  Heidrun Lingner^1,10  Jaime Gonzálvez-Rey^1,11  Ana Clavería^1,12  Miguel Román Rodríguez^1,13  Pedro A. Callejas-Cabanillas^1,14  Maite Espantoso-Romero^1,14 

[1] Arrabal Health Centre, Zaragoza, Spain;Preventative Activities and Health Promotion Network (REDIAPP), Instituto Aragonés de Ciencias de la Salud (IACS), Zaragoza, Spain;Barrio La Salud Health Centre, Santa Cruz de Tenerife, Spain;Cabinet Medical De Medicina Familiei, Timisoara, Romania;Cangas Health Centre, Xerencia de Xestión Integrada, Vigo, Spain;Department General Practice, Medical University of Plovdiv, Plovdiv, Bulgaria;Department of Family Medicine, School of Medicine, University of Zagreb, Zagreb, Croatia;Department of Family Medicine, University of Sts. Cyril and Methodius, Skopje, Macedonia;Epidemiology Department, Clinical University Hospital of Santiago de Compostela, Santiago de Compostela, Spain;Preventative Activities and Health Promotion Network (REDIAPP), Santiago de Compostela, Spain;Family Medicine, Jordi Gol Institute for Primary Care Research, Santa Coloma de Gramenet, Spain;Hannover Medical School, Centre for Public Health and Healthcare, Hannover, Germany;Matamá Health Centre, Xerencia de Xestión Integrada, Vigo, Spain;Primary Care, Instituto Investigación Sanitaria Galicia Sur, Xerencia de Xestión Integrada, Vigo, Spain;Preventative Activities and Health Promotion Network (REDIAPP), Vigo, Spain;Son Pisà Health Centre, IB-Salut Balears, Palma de Mallorca, Spain;Teis Health Centre, Xerencia de Xestión Integrada, Vigo, Spain;

关键词: Chronic obstructive pulmonary disease;    Validation studies as topic;    Primary health care;    Prognosis;   

DOI  :  10.1186/s12890-016-0305-2

 received in 2016-04-29, accepted in 2016-11-02,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundDue to the heterogeneous and systemic nature of the chronic obstructive pulmonary disease (COPD), the new guidelines are oriented toward individualized attention. Multidimensional scales could facilitate its proper clinical and prognostic assessment, but not all of them were validated in an international primary care cohort, different from the original ones used for model development. Therefore, our main aim is to assess the prognostic capacity of the ADO, BODEx and DOSE indices in primary care for predicting mortality in COPD patients and to validate the models obtained in subgroups of patients, classified by revised Global Initiative for Chronic Obstructive Lung Disease (2011) and updated Spanish Guideline (2014). Besides, we want to confirm that the prognostic capacity of all indices increases if the number of exacerbations is substituted by the interval between them and to assess the impact on health of the patient’s lifestyle, social network and adherence to treatment.MethodsDesign: External validation of scales, open and prospective cohort study in primary care.Setting: 36 health centres in 6 European high, medium and low income countries.Subjects: 477 patients diagnosed with COPD, captured in clinical visit by their General Practitioner/Nurse.Predictors: Detailed patient history, exacerbations, lung function test and questionnaires at baseline.Outcomes: Exacerbations, all-cause mortality and specific mortality, within 5 years of recruitment.Analysis: Multivariate logistic regression and Cox regression will be used. Possible non-linear effect of the indices will be studied by using Structured Additive Regression models with penalised splines. Subsequently, we will assess different aspects of the regression models: discrimination, calibration and diagnostic precision. Clinical variables modulated in primary care and the interval between exacerbations will be considered and incorporated into the analysis.DiscussionThe Research Agenda for General Practice/Family Medicine highlights that the evidence on predictive values of prognostic indices in primary care is scarce. A prospective cohort like that of PROEPOC/COPD provides good opportunities for research into COPD and make communication easier between family practitioners, nursing staff, pneumologists and other professionals, supporting a multi-disciplinary approach to the treatment of these patients.Trial registrationISRCTN52402811. Date: 15/01/2015. Prospectively registered.

【 授权许可】

CC BY   
© The Author(s). 2016