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Real world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results

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Title: Real world effects of medications for chronic obstructive pulmonary disease: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results
Authors: Wing, K
Williamson, E
Carpenter, J
Wise, L
Schneeweiss, S
Smeeth, L
Quint, JK
Douglas, I
Item Type: Journal Article
Abstract: Introduction: Chronic obstructive pulmonary disease (COPD) is a progressive disease affecting 3 million people in the UK, in which patients exhibit airflow obstruction that is not fully reversible. COPD treatment guidelines are largely informed by randomised controlled trial (RCT) results, but it is unclear if these findings apply to large patient populations not studied in trials. Non-interventional studies could be used to study patient groups excluded from trials, but the use of these studies to estimate treatment effectiveness is in its infancy. In this study we will use individual trial data to validate non-interventional methods for assessing COPD treatment effectiveness, before applying these methods to the analysis of treatment effectiveness within people excluded from, or under-represented in COPD trials. Methods and analysis: Using individual patient data from the landmark COPD TORCH trial and validated methods for detecting COPD and exacerbations in routinely collected primary care data, we will assemble a cohort in the UK Clinical Practice Research Datalink (selecting people from between the dates of 1st January 2004 and 1st January 2017) with similar characteristics to TORCH participants and test whether non-interventional data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. We will then use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (>80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Ethics and dissemination: Ethical approval has been granted by the LSHTM Medicines Ethics Committee (Ref: 11997). The study is under review by the Independent Scientific Advisory Committee (ISAC) of the UK Medicines and Healthcare Products Regulatory Agency (MHRA). An application to use the TORCH trial data made to clinicalstudydatarequest.com has been approved. In addition to scientific publications, dissemination methods will be developed based on discussions with COPD patient groups.
Issue Date: 25-Mar-2018
Date of Acceptance: 19-Feb-2018
URI: http://hdl.handle.net/10044/1/57303
DOI: https://dx.doi.org/10.1136/bmjopen-2017-019475
ISSN: 2044-6055
Publisher: BMJ Journals
Journal / Book Title: BMJ Open
Volume: 8
Copyright Statement: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Keywords: chronic airways disease
clinical pharmacology
epidemiology
primary care
public health
Publication Status: Published
Article Number: e019475
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine



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