Key Learnings from Running an Extension Study to a Real-World Effectiveness Trial: The Extended Salford Lung Study.

ABSTRACT:

Introduction

The Salford Lung Studies (SLS) were real-world randomised controlled trials set within UK primary care that assessed the effectiveness and safety of initiating once-daily fluticasone furoate/vilanterol versus continuing usual care in patients with chronic obstructive pulmonary disease or asthma. Data were collected for a relatively short period, limiting the study of long-term outcomes. To broaden the capture of SLS patients' data, we undertook the Extended SLS (Ext-SLS), aiming to better understand the patient disease journey and the effects of treatment in a real-world setting, through collection of patient-level data. Here, we present study design information and the challenges and learnings gathered in creating the Ext-SLS.

Methods

The Ext-SLS was intended t

SUBMITTER: Meeraus W 

PROVIDER: S-EPMC8344325 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature