Understanding non-recovery after an exacerbation of chronic pulmonary obstructive disease

Study type
Protocol
Date of Approval
Study reference ID
20_144
Lay Summary

Many patients in the UK have chronic obstructive pulmonary disease (COPD), a lung disease usually caused by smoking that typically causes symptoms such as cough or breathlessness. Sudden worsening of lung symptoms requiring urgent treatment are called exacerbations. These are usually treated with oral steroids and/or antibiotics and sometimes require admission to hospital. Some patients after completing treatment for an exacerbation suffer from a period of suboptimal recovery with ongoing symptoms such as breathlessness, cough or tiredness that were not present before the exacerbation. Patients with such symptoms may be given antibiotics as it is thought there is still residual bacterial infection. Some patients will exacerbate again within a few weeks, exhibiting severe symptoms and requiring further course of steroids and antibiotics. In this study we wish to understand the pattern of suboptimal recovery and repeat exacerbations and how they are managed within primary care. A recent trial found no improvement in patients with suboptimal recovery that were given antibiotics compared to patients that were not, we wish to assess this in the real-world.

Technical Summary

We will draw a cohort of COPD patients and measure the incidence rates of exacerbations, nonrecovery and re-exacerbations. Nonrecovery in this study will be defined as non-resolution of symptoms back to a patientÂ’s pre-exacerbation baseline level within 21 days after the primary exacerbation. Re-exacerbations will be defined as another exacerbation within 31 days after the primary exacerbation. An open cohort will be used to assess the effect of antibiotics and/or oral corticosteroids as compared to no treatment during a period of nonrecovery, on the risk of a re-exacerbation. The risk will be estimated using propensity score methodology and multivariable Cox regression, with stratification on disease severity. Covariates will include age, gender, smoking history, BMI, socioeconomic status (through IMD linkage), disease severity, past history of exacerbations, comorbidities. HES and ONS linkage will be required as exacerbations can be managed by hospital admission, or can result in death; these outcomes also indicate a more severe exacerbation.

Health Outcomes to be Measured

COPD exacerbations, respiratory symptoms and antibiotics

Collaborators

Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Andy Ritchie - Collaborator - Imperial College London
Gavin Donaldson - Collaborator - Imperial College London
Wisia Wedzicha - Collaborator - Imperial College London

Linkages

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