Assessment of the Burden and Association of Cardiopulmonary Outcomes and Risks with COPD: Focus on Cardiopulmonary Related Risks (ABACOS-Risk)

Study type
Protocol
Date of Approval
Study reference ID
24_004479
Lay Summary

Chronic Obstructive Pulmonary Disease (COPD) is a group of common lung conditions including chronic bronchitis and emphysema that are characterised by difficulty breathing. COPD often gets worse over time. In the United Kingdom it has been estimated that COPD affects three million people leading to 1.4 million general practice consultations and approximately 30,000 deaths per year. In addition to the disease itself, COPD patients appear to be at greater risk of cardiovascular events such as stroke and heart attacks than people of a similar age who do not have COPD. In this study we want use the Clinical Practice Research Datalink to select patients with a diagnosis of COPD and estimate how many of them have cardiovascular disease, other related conditions and important risk factors such as high cholesterol and blood pressure at the time they are diagnosed. We will analyse these factors for all patients with COPD and also those newly diagnosed with the condition. We will also compare the number of people with each condition with controls, that is people from the same general practice of the same age and, gender who are not diagnosed with COPD. Understanding the presence of risk factors such as these in patients with COPD is of public health benefit as it may allow for the targeting of early-stage patients with personalised, optimised treatment. This could result in improved patient outcomes and reduce the number of times these patients visit their general practice or our admitted to hospital.

Technical Summary

Chronic Obstructive Pulmonary Disease (COPD) causes shortness of breath, chest infections, and respiratory exacerbations. COPD patients are known to be at increased risk of cardiovascular (CV) and other respiratory events. This study aims to describe the presence of cardiopulmonary risk factors in COPD patients using the Clinical Practice Research Datalink (CPRD) Aurum database linked with Hospital Episode Statistics (HES) data and Office of National Statistics Index of Multiple Deprivation data. The primary objective of the study is to establish the prevalence and magnitude of individual morbidities representing cardiopulmonary risk factors. Secondary objectives will include: 1) assess the distribution, stability and variability of time varying risk factors during the study period; 2) assess the distribution, stability and variability of CV risk during the study period; 3) provide cardiopulmonary risk insights by COPD and non-COPD patients; 4) compare the prevalence or level of specific cardiopulmonary and CV risks in COPD vs. matched non-COPD patients and 5) describe general healthcare resource use (HCRU) and costs and compare these to controls. COPD cases will be selected between 01/01/2018 and 31/12/2019 with a COPD diagnosis recorded in either CPRD Aurum or HES. Patients will be categorised as incident and/or prevalent cases and risk factors will be ascertained in the previous 1, 2 and 3 years. To establish relative rates with non-COPD patients, age, gender and practice based controls will be matched at a ratio of 1:4. This study is primarily descriptive but comparison of risk scores will be tested by t-test or Mann-Whitney U test. HCRU activity and costs will be compared using a generalized linear models with Poisson/Gamma distributions Detecting high-risk patients creates the potential for earlier and more personalised treatment planning. This could reduce the occurrence of such events and create a lower healthcare resource use (HCRU) pathway for these patients.

Health Outcomes to be Measured

cerebral infarction; haemorrhagic stroke; unspecified stroke; transient ischaemic attack; angina pectoris; acute myocardial infarction; subsequent myocardial infarction; complications after myocardial infarction; other acute ischaemic heart disease ; chronic ischaemic heart disease; cardiomyopathy ;type II diabetes ;metabolic syndrome; hyperlipidemia; rheumatoid arthritis; atrial fibrillation; chronic kidney disease; heart failure; hypertension; disrupted sleep patterns/insomnia; percutaneous coronary intervention; coronary artery bypass grafting; angioplasty; endarterectomy; thrombectomy; low-density lipoprotein cholesterol; high-density lipoprotein cholesterol; Non-HDL-C, total cholesterol; triglycerides; haemoglobin A1C; and eosinophils), systolic blood pressure (SBP) and diastolic blood pressure (DBP), weight and body mass index

Collaborators

Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Deven Patel - Collaborator - Astra Zeneca Inc - USA
Jonathan Patrick - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Michael Pollack - Collaborator - Astra Zeneca Inc - USA
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Linkages

HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation