Identification of COPD paitents in clinical pratice: An enriched methodology-based study- protocol status

Background Chronic obstructive pulmonary disease is a progressive and debilitating disease associated with substantial morbidity and mortality. Patients with COPD often suffer episodes of disease instability reflected by worsening of symptoms and exacerbations leading to a sustained worsening of patient`s condition beyond day-to-day variability and frequently require adjustment of treatment. It has been shown that exacerbation history is a main driver of future exacerbation risk in COPD patients; thus, identification and adequate management of these patients in everyday practice is pivotal in order to improve functional status and quality of life.

Aim To conduct a multi-centre, prospective, observational cohort study in Germany to identify COPD patients with an increased risk of exacerbation in routine practice and assess changes in COPD control, treatment patterns, health outcomes and environmental influences over a 24-month follow-up through an enriched study design using 3 integrated data sources: EMR, electronic case report form (eCRF) and the smartphone SaniQ App.

Methods In a first step, COPD patients with exacerbation history and therefore increased risk for further exacerbations were digitally identified from electronic medical records (EMR) using a software containing defined trigger criteria based on WHO ICD-10 diagnosis codes and prescribed medication matching the criteria for COPD diagnosis and at least one moderate to severe exacerbation in the previous 12 months. In a second step, all eligible participants included in the study were assessed over a 24-month follow-up period using a modified version of the SaniQ App Triple_B — an easy-to-use patient smartphone app in a special configuration for lung diseases — to collect patient information on COPD control, medication intake and physical activity. Information from environmental databases, e.g. peaks in fine particle load, ozone levels, air pollution, pollen count and sun exposure are integrated in the SaniQ App. Additional relevant patient information is provided by physicians via eCRF. The objectives of the study are the assessment of COPD patients with a high exacerbation risk, their clinical characteristics, medication use, physical activity, quality of life and environmental factors impacting on disease status over 24 months.

Publication History

Article published online:
09 March 2023