Burden of disease in patients with COPD and high blood eosinophil counts

Study type
Protocol
Date of Approval
Study reference ID
16_299
Lay Summary

In respiratory diseases, white blood cells called eosinophils are present in high amounts when there is inflammation of the airways. In asthma, high eosinophil counts indicate more severe disease, and could be used to predict future symptom levels or asthma attacks. Less is known about the use of eosinophil measurement in patients with chronic obstructive pulmonary disease (COPD), but recent findings suggest a very similar role in the burden of disease in a substantial proportion of patients. COPD is associated with high hospital use: in particular, patients may suffer from 'exacerbations', when symptoms, such as chest tightness and shortness of breath, rapidly become worse. Exacerbations often require admission to hospital, contributing to the high annual healthcare costs of COPD. Furthermore, one in five patients is estimated to be readmitted to hospital within 30 days, despite extensive drug treatment to prevent exacerbations. Knowing which patients are at most risk is highly useful if COPD management is to be improved. As with asthma, this risk could be indicated with a high eosinophil count. This study will examine a large sample of UK patients with COPD, with high and normal eosinophil counts, in terms of their exacerbation rates and healthcare costs.

Technical Summary

Objectives: 1. To study whether patients admitted to hospital for COPD exacerbation are more likely to be re-admitted if their pre-admission blood eosinophil counts (BEC) is high 2. To compare COPD-related health care resource use (HRU) and costs of patients who are at risk of exacerbations while on triple therapy, with that of average COPD patients 3. To study whether high BEC are associated with greater costs and explore other accessible factors that may drive costs Methods: Patients will be characterised in a baseline year prior to index date (ID). Objective 1: The risk of COPD-related re-admission to hospital within 4 and 52 weeks after ID will be compared for patients with and without high eosinophil counts. ID is date of most recent first discharge from hospital for COPD exacerbation, occurring within one year after a blood eosinophil count measurement at a time of no recent exacerbation. Objectives 2/3: HRU and costs- total, and broken down by type of utilisation - will be estimated, stratified by smoking status, in a follow-up year after ID. ID is date of most recent eosinophil count recorded at the time of no recent exacerbation. A model will be developed to predict future costs.

Health Outcomes to be Measured

COPD exacerbations; Hospital admissions as the index date (first admission) in HES linked data; Occurrence of a hospital admission (spell) for COPD exacerbation in HES linked data: 1 of the following ICD-10-CM codes in any diagnostic position: - J44.0: Chronic obstructive pulmonary disease with acute lower respiratory infection; - J44.1: Chronic obstructive pulmonary disease with (acute) exacerbation Hospital re-admission as outcome event; COPD exacerbations in any diagnostic position b. ICD-10 codes J40-J44; Any COPD-related code as primary diagnosis Mortality; All-cause mortality; Health care Resource Use (HRU): The following outcomes of HRU are described in the baseline year and outcome year in patients with HES data available. 1. Physician office visits 2. Outpatient visits 3. Accident & Emergency (A&E) attendances / out of hours services 4. Hospital admissions 5. Number of COPD-related drug prescriptions

Collaborators

David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Chin Kook Rhee - Collaborator - Seoul St. Mary's Hospital The Catholic University of Korea
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Gopalan Gokul - Collaborator - Astra Zeneca Inc - USA
Ian Pavord - Collaborator - University of Oxford
Marc Miravitlles - Collaborator - Hospital Universitari Vall d'Hebron
Rupert Jones - Collaborator - Plymouth University
Sadia Halim - Collaborator - Astra Zeneca Inc - USA
Sarang Rastogi - Collaborator - Astra Zeneca Inc - USA

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Practice Level Index of Multiple Deprivation