ABSTRACT
BACKGROUND: Due 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. METHODS: Design: 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. DISCUSSION: The 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 REGISTRATION: ISRCTN52402811 . Date: 15/01/2015. Prospectively registered.
Subject(s)
Disease Progression , Pulmonary Disease, Chronic Obstructive/mortality , Pulmonary Disease, Chronic Obstructive/physiopathology , Severity of Illness Index , Europe , Humans , Logistic Models , Multivariate Analysis , Primary Health Care , Prognosis , Proportional Hazards Models , Prospective Studies , Respiratory Function Tests , Risk Assessment/methods , Risk Factors , Surveys and QuestionnairesABSTRACT
INTRODUCTION: Multimorbidity is a health issue with growing importance. During the last few decades the populations of most countries in the world have been ageing rapidly. Bulgaria is affected by the issue because of the high prevalence of ageing population in the country with multiple chronic conditions. The AIM of the present study was to validate the translated definition of multimorbidity from English into the Bulgarian language. MATERIALS AND METHODS: The present study is part of an international project involving 8 national groups. We performed a forward and backward translation of the original English definition of multimorbidity using a Delphi consensus procedure. RESULTS: The physicians involved accepted the definition with a high percentage of agreement in the first round. The backward translation was accepted by the scientific committee using the Nominal group technique. DISCUSSION: Some of the GPs provided comments on the linguistic expressions which arose in order to improve understanding in Bulgarian. The remarks were not relevant to the content. The conclusion of the discussion, using a meta-ethnographic approach, was that the differences were acceptable and no further changes were required. CONCLUSIONS: A native version of the published English multimorbidity definition has been finalized. This definition is a prerequisite for better management of multimorbidity by clinicians, researchers and policy makers.
