The PROTECCT-M study: a cohort study investigating associations between novel specific biomarkers, patient-related, healthcare system markers and the trajectory of COPD patients treated in primary care.

backgroundChronic Obstructive Pulmonary Disease (COPD) is the most common severe chronic disease in primary care. It is typically diagnosed at a late stage, and it is also difficult to predict its trajectory and hence to tailor treatment and rehabilitation. The overall aim is to study determinants of exacerbations of COPD treated in primary care and to study, if the prognosis is related to patient-related, healthcare system markers or levels of the potential biomarkers such as microfibrillar-associated protein 4 (MFAP4) and surfactant protein D (SP-D). Furthermore, we aim to establish a cohort of COPD patients treated in Danish primary care comprising register data, data captured from the GPs' electronic patient record system (EPR) and a biobank in order to make analyses on factors associated with different tractories of COPD treated in primary care. METHODS/

designA cohort study of incident and prevalent COPD patients treated and followed by their GPs using data capture, which is a computer system collecting data from the GPs' own EPR and transferring them to the Danish General Practice Research Database. The participating COPD patients were investigated at a baseline consultation by their own GP, and the results were registered using a pop-up menu by the GP. During the consultation blood samples were taken and the patients were given a questionnaire. The patients will then be followed prospectively at yearly consultations and in between these consultations by means of the data capture system. The collected data will also be combined with register data from other sources. The data collection started in December 2012, and so far 30 practices with 77 GPs have included about 350 patients. The study aims to include 2000 patients till the end of 2016, and after that to continue to collect data on these patients using the data capture system. DISCUSSION: The GP currently lacks tools to predict trajectory of their COPD patients. The measurement of lung function only reflects loss of lung capacity and not disease activity. Use of biomarkers for detection of early COPD could be a possible way of predicting trajectory to aid both the GP and his/her patients. This study aims to provide evidence of determinants of a COPD trajectory, including novel specific biomarkers and other patient- and healthcare system-related markers.

trial registrationClinicalTrials.gov Protocol Registration System, Identifier: NCT01698151.