Linking e-health records, patient-reported symptoms and environmental exposure data to characterise and model COPD exacerbations: protocol for the COPE study.

Abstract

INTRODUCTION: Relationships between exacerbations of chronic obstructive pulmonary disease (COPD) and environmental factors such as temperature, humidity and air pollution are not well characterised, due in part to oversimplification in the assignment of exposure estimates to individuals and populations. New developments in miniature environmental sensors mean that patients can now carry a personal air quality monitor for long periods of time as they go about their daily lives. This creates the potential for capturing a direct link between individual activities, environmental exposures and the health of patients with COPD. Direct associations then have the potential to be scaled up to population levels and tested using advanced human exposure models linked to electronic health records. METHODS AND ANALYSIS: This study has 5 stages: (1) development and deployment of personal air monitors; (2) recruitment and monitoring of a cohort of 160 patients with COPD for up to 6 months with recruitment of participants through the Clinical Practice Research Datalink (CPRD); (3) statistical associations between personal exposure with COPD-related health outcomes; (4) validation of a time-activity exposure model and (5) development of a COPD prediction model for London. ETHICS AND DISSEMINATION: The Research Ethics Committee for Camden and Islington has provided ethical approval for the conduct of the study. Approval has also been granted by National Health Service (NHS) Research and Development and the Independent Scientific Advisory Committee. The results of the study will be disseminated through appropriate conference presentations and peer-reviewed journals.This work is funded by the Medical Research Council (MR/L019744/1). MRC-PHE funding has been obtained for a pilot study to collect blood and sputum samples on a subset of 20 participants. Enrolment will take place at The Royal Brompton and Harefield (RBH) and Guy's and St Thomas' (GSTT) NHS Foundation Trusts. Support will be provided by the Respiratory Clinical Research Facility at RBH and the Lane Fox Unit at GSTT. The project is a portfolio adopted by the National Institute for Health Research (NIHR) UK Clinical Research Network (CRN). Additional support was provided by the NIHR Biomedical Research Centre based at GSTT and King's College London.This is the final version of the article. It first appeared from the BMJ Publishing Group via http://dx.doi.org/10.1136/bmjopen-2016-01133