The Impact of COVID-19 on care for UK patients with chronic obstructive pulmonary disease (COPD) and patients with asthma

Date of Approval
Application Number
21_000556
Technical Summary

Aim: To assess the indirect and clinical impact of COVID-19 on patients with chronic obstructive pulmonary disease (COPD) and asthma in the years during and surrounding the UK COVID-19 epidemic, to inform and contextualize future research.

Objectives: For patients with asthma or COPD in the UK to describe over time: i) demographic and clinical characteristics; ii) changes in ICS dose, triple therapy use, and medication adherence; iii) factors relating to exacerbation frequency and lung function testing frequency and results; iv) all-cause, disease-related healthcare resource utilisation (HCRU) and direct medical costs; v) all-cause and COVID-19-specific mortality; vi) rate of SARS-CoV-2 infection; vii) hospitalization due to COVID-19.

Primary exposures: Treatment class, disease severity, ever diagnosed with COVID-19.

Outcomes: Change in ICS dose; Triple therapy use; Adherence; Disease-specific exacerbations; Lung function testing frequency and results; HCRU/ costs; Rate of COVID-19 diagnosis; COVID-19-related and all-cause HCRU/ costs; COVID-19-related/all-cause mortality.

Methods: A longitudinal retrospective dynamic cohort study using existing electronic primary and secondary care data of patients diagnosed with COPD or asthma. COPD and asthma cohorts will be analysed separately. The baseline period will be defined as the 12 months prior to the index date. After index, outcomes will be observed in monthly and yearly intervals until either the end of the study period, when the patients dies, or when data are no longer available.

Linked secondary care datasets will be used to describe HCRU and asthma/COPD exacerbations, and Office for National Statistics (ONS) data will be used to describe mortality.

Data Analysis: Counts, means, medians, standard deviation (SD), 25th and 75th percentile values will be reported for numeric variables, whilst relative frequencies and proportions/ percentages will be reported for nominal variables. HCRU and costs will be derived by observing consultations and medications in primary care, and Healthcare Resource Group for secondary care.

Health Outcomes to be Measured

Change in inhaled corticosteroid dose (ICS) dose; Triple therapy use; Adherence to therapy (via proportion days covered [PDC]); Rate of COPD exacerbations; Rate of severe asthma exacerbations; FEV1% predicted (COPD cohort only); Lung function testing frequency; All-cause and COPD/asthma-related HCRU; All-cause and COPD/asthma-related direct medical costs; Rate of diagnosed COVID-19; COVID-19-related HCRU; COVID-19-related direct medical costs; All-cause/COVID-19-related mortality.

Collaborators

Afisi Ismaila - Chief Investigator - GSK
Alexander Ford - Corresponding Applicant - Adelphi Real World
Eileen Han - Collaborator - GSK
Kieran Rothnie - Collaborator - GlaxoSmithKline - UK
Lucy Massey - Collaborator - Adelphi Real World
Qinggong Fu - Collaborator - GSK
Theo Tritton - Collaborator - Adelphi Real World
Tim Holbrook - Collaborator - Adelphi Real World

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation