Chronic obstructive pulmonary disease (COPD) is a chronic lung disease which commonly presents with breathing difficulties, often with cough and sometimes chest infections. Steroid tablets are prescribed to treat patients that have flare ups of COPD. Although steroids are relatively cheap to prescribe, they are associated with short- and long-term side effects that increase costs and use of health care resources. Previous studies have examined side effects over a period of up to six months, however, the impact of steroids on the onset of side effects over long periods of time in COPD patients is not fully known. There is also little evidence about the patterns of steroid and steroid-related use on health care resources and costs in these patients.
The proposed study will use information observed in longitudinal anonymous primary and secondary care records of COPD patients to describe the short- and long-term patterns of SCS use in patients with COPD, including the use of SCS before and after diagnosis and how various factors (treatment, biology) impact on these patterns. The study will then compare the onset, worsening and recurrence of side effects in COPD patients with and without SCS prescriptions and their impact on health care resources and costs. This information is key to identify when patients should be evaluated and considered for alternative treatment strategies.
This study will use a historical cohort study design to describe and quantify the utilisation patterns of SCS use, as well as the risk of SCS-associated comorbidities, healthcare resource utilisation and associated costs among COPD patients. The descriptive component of the study will examine records of SCS prescriptions (cumulative exposure, mean daily exposure) in general practice and the relationship to other baseline variables (maintenance treatment changes, blood eosinophil counts, exacerbations rates).
The hypothesis-testing component of this study will compare the onset or worsening of SCS-related morbidities (side effects) in those initiating SCS (SCS arm) with those not exposed to SCS (non-SCS arm) The two patient groups will be matched, according to relevant demographic and clinical characteristics. A one-year baseline period will be used to identify variables for matching, and patients will be followed up during the available outcome period. The incidence rate of each comorbid outcome in patients exposed to SCS and patients not exposed to SCS, as cases per 100 patient-years of follow-up (100 patient-year), will be compared using the incidence rate difference and the incidence rate ratio (IRR) with 95% confidence intervals (CIs). To account for all HCRU outcomes, the study will include only the subset of COPD patients with HES linkage in the final study population. HCRU and associated costs will be assessed annually, and annual averages for the entire follow?up period will be calculated. The aim of these analyses will be to identify potential SCS dose thresholds at which the onset, recurrence or worsening of comorbid conditions occurs in patients with COPD and HCRU increases.
The following outcomes will be measured:
Utilisation pattern of COPD-related or all-cause SCS use (SCS use and non-SCS use; SCS-arm only: cumulative dose (g); average daily dose (mg/day); long-term maintenance treatment; number of acute courses; Intermittent SCS use); incidence, recurrence or worsening of comorbidity outcomes: type 2 diabetes mellitus, hypertension, cardio-/cerebrovascular disease (myocardial infarction, dyslipidaemia, congestive heart failure, cerebrovascular accident), osteoporosis, osteoporotic fracture, weight gain, sleep disorders, sleep apnoea, peptic ulcer, cataracts, glaucoma, depression/anxiety, psychosis, pneumonia, antibiotic treated infections, sudden death, and renal impairment; HCRU and associated costs (general practitioner (GP) consultations, outpatient visits (i.e. specialist consultations), inpatient hospital admissions, Accident and Emergency (A&E) attendances, primary care medication prescriptions, or use of continuous Positive Airway Pressure (CPAP) device for sleep apnoea (if data are available in Hospital Episode Statistics (HES)) for SCS-related all-cause and specified comorbid conditions); number of moderate or severe exacerbations; number of patients not on maintenance treatment for COPD (preceding and post diagnosis of COPD); change in maintenance treatment; change blood eosinophil counts after SCS use.
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Victoria Carter - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Abyramy Kadayam Srikanth - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Alberto Papi - Collaborator - University of Ferrara
Benjamin Emmanuel - Collaborator - AstraZeneca Ltd - UK Headquarters
Derek Skinner - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Hana Mullerova - Collaborator - AstraZeneca Ltd - UK Headquarters
Hilda de Jong - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marianna Alacqua - Collaborator - Astra Zeneca Inc - USA
Marjan Kerkhof - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Mona Bafadhel - Collaborator - University of Oxford
Shay Soremekun - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Xiao Xu - Collaborator - Astra Zeneca Inc - USA
Jaco Voorham - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Practice Level Index of Multiple Deprivation