Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable condition of the lungs that is typically characterised by persistent airflow limitation progressing over time. Currently, COPD is the second most prevalent lung disease, affecting approximately 1.2million people in the UK.
Exacerbations of COPD are defined as an increase in the severity of symptoms such as dyspnoea (breathlessness), coughing, and wheezing, and are typically triggered by bacterial/viral infections or air pollution. While exacerbations impact on patients' quality of life, they can also result in other severe complications, hospital admissions and mortality. Each year in the UK, COPD costs the National Health Service (NHS) approximately £1.9billion, which constitutes 29% of the total cost of respiratory illnesses.
With the continued advancement and interest in COPD, there is a wide range of drugs widely available for the treatment and management of COPD in the UK. In particular, the use of Multiple Inhaler Triple Therapy (MITT) has been observed within the current clinical practice. There is growing evidence suggesting potential overuse and mis-use of MITT; therefore, highlighting an urgent need to determine optimal timing of MITT therapies within the COPD patient treatment pathway.
This study will conduct data analysis using anonymised NHS data in order to understand whether the timing of MITT initiation post-exacerbation could influence future HCRU and direct healthcare cost. Results from this study may indicate that early initiation of MITT treatment for COPD patients could help to reduce the burden of COPD on the healthcare system.
Objectives: The primary objective of this study is to estimate all-cause and COPD-related healthcare resource utilisation (HCRU) and direct healthcare costs of patients with COPD initiating MITT early (</=30 days) versus delayed (31-180 days) following a moderate-to-severe exacerbation.
Methods: This study will be a retrospective, longitudinal cohort study of COPD patients who are initiated on MITT within 180 days of an exacerbation between July 2012 and June 2015, inclusive. The cohort of patients will be identified from the Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) data; specifically, the admitted patient care, outpatients and Accident & Emergency (A&E) data sets. Elements of HCRU that will be considered in this study include General Practitioner consultations, medication prescribed in primary care, outpatient appointments and hospitalisation, and the associated direct healthcare costs.
Data analysis: The study will be testing the hypothesis that patients who initiate MITT early utilise less HCRU and result in a lower cost to the healthcare system compared with patients with delayed MITT initiation. In addition, potential confounding factors will be adjusted for using regression models, and time-to-event analysis will be conducted to assess the influence of the delay of MITT initiation on future exacerbations.
All medications prescribed in primary care; COPD medications prescribed in primary care; All-cause GP appointments; COPD-related GP appointments; All-cause outpatient appointments; COPD-related outpatient appointments; All-cause hospitalisations; COPD-related hospitalisations; All-caused A&E visits; COPD-related A&E visits; Associated all-cause total direct healthcare costs; Associated COPD-related direct healthcare costs
Afisi Ismaila - Chief Investigator - GSK
Robert Wood - Corresponding Applicant - Adelphi Real World
- Collaborator -
- Collaborator -
Glenn Anley - Collaborator - GSK
Leah Sansbury - Collaborator - GlaxoSmithKline - UK
Olivia Massey - Collaborator - Adelphi Real World
Yein Nam - Collaborator - Adelphi Real World
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient