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ICS-RECODE: Predictors of treatment REsponse to inhaled corticosteroids (ICS) in COPD: randomised COntrolled trials individual participant Data re-Evaluation.

ICS-RECODE: Predictors of treatment REsponse to inhaled corticosteroids (ICS) in COPD: randomised COntrolled trials individual participant Data re-Evaluation.

Alexander G Mathioudakis

1. North West Lung Centre, Manchester University NHS Foundation Trust. 2. Division of Immunology, Immunity to Infection & Respiratory Medicine, The University of Manchester.

16 November 2023

Chronic obstructive pulmonary disease, or COPD, affects over 3 million people in the UK. It is a long-term lung condition that makes it difficult to breathe, because the lungs have become damaged. People with COPD experience flare-ups (called exacerbations), that cause poor health and often need treatment in a hospital. As a result, COPD can cause early death and a huge reduction in quality of life.Some people with COPD benefit from a treatment called “inhaled steroids”. These can help to ease symptoms, improve quality of life, prevent flare-ups, and prolong life. However, they also cause side effects like pneumonia (severe chest infection) and osteoporosis (bone thinning). For this reason, we should only offer inhaled steroids to specific people who will gain the most benefit at a low risk of side effects; this is sometimes called “personalised medicine”. The National Institute for Health and Care Excellence (NICE) recently requested further research to find the best tests to help us identify people who will benefit from inhaled steroids.Aim: To find out which are the best tests to help us personalise the use of inhaled steroids. We will use data from existing research studies (“clinical trials”) about inhaled steroids in people with COPD.Design: Many clinical trials have assessed whether inhaled steroids are safe and effective for people with COPD. However, most studies are not big enough to identify the specific characteristics that make a person more or less likely to benefit from inhaled steroids. To overcome this problem, we will collect anonymous information about all the individual people in these trials and combine the results together. Clinical trials are the best source of information for our study because they collect very detailed information about the people who take part. We are confident that by combining so much information we will find an effective test.We have already performed a thorough search to find all clinical trials that assessed inhaled steroids for COPD. We are now requesting to gain access to the information from all these trials. Once we gain access to data from all these trials, we will first check the results carefully. We will change all the data into a similar format so that we can combine the results. We will assess if the trials were done properly. We will use a cutting edge and complex statistical method to analyse all the data together. This method is called individual participant data (IPD) meta-analysis. We will focus on finding tests that can help us personalise the use of inhaled steroids.It is very complex to access, merge and analyse all data together. It needs commitment, time and skills. If it is not done properly, it could easily reach wrong conclusions. For this reason, we have brought together a group of experts in COPD, clinical trials, statistics, and IPD meta-analyses. It will take us 2 years to fully process and analyse the data.Patient and public involvement (PPI): The views of people who are living with COPD are central to our work. For this reason, we included a patient advocate and our PPI lead to join our group. We will involve more patients and other stakeholders in an advisory group. The lay advisory group members will deliver patients' perspectives on the analyses throughout the study. Upon completion of the analyses, we will organise a focus group with COPD patients, to inform the next steps of our research.

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Statistical Analysis Plan