Randomised control trials are studies that randomly assign people to different drugs whereby the researchers do not know what drugs people are on during the course of the study. These studies investigate how well a drug performs in populations of people who have enrolled to these studies. These studies are seen as the best way to investigate how well drugs perform however, they tend to include very specific types of people who are not always generalisable to the wider population of people seen in the UK. In order to better understand the types of people who are enrolled into these studies, we searched the literature for randomised control trials that specifically compared people with chronic obstructive pulmonary disease (COPD), a type of lung disease, who were given a combination of drugs known as “triple therapy” with COPD patients who were not given triple therapy. We determined what inclusion and exclusion criteria were used in these studies identified in the literature and now aim to apply these criteria to a population of people with COPD seen in the real world to better understand the proportion of people who would be enrolled to these randomised control trials.
Whilst randomised controlled trials remain the gold standard for treatment efficacy, many have quite strict inclusion and exclusion criteria and do not necessarily represent patients more commonly seen in routine clinical practice. The aim of this study will be to determine the proportion of the general UK patient population with COPD who would be eligible for inclusion in randomised controlled trials investigating triple therapy. Triple therapy is a combination of a long-acting beta agonist, a long-acting muscarinic antagonist and an inhaled corticosteroid. Having searched the literature and clinicaltrails.gov for eligibility criteria for trials in COPD that involve triple therapy, we will investigate a general UK COPD population relative to the randomised controlled trial inclusion and exclusion criteria and describe characteristics of these selection criteria in this population. This will allow us to determine the proportion of patients with COPD in the CPRD Aurum database (a generalisable primary care database) who would meet the eligibility criteria for randomised controlled trials of triple therapy. Numbers can then be scaled up to a UK population. We will use CPRD Aurum linked with HES (to determine exacerbations). Analyses will be descriptive and will include proportions (%) of individuals eligible for each trial and demographics of people eligible and not eligible will be summarised using n(%), means (sd), and medians (IQR).
Our outcome of interest will be the proportion of patients with COPD who meet the most common inclusion and exclusion criteria of RCTs investigating triple therapy.
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
HES Admitted Patient Care;Patient Level Index of Multiple Deprivation