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

Area of Science:

• Respiratory Medicine
• Clinical Trials
• Real-World Evidence

Background:

• The Salford Lung Studies (SLS) provided real-world data on asthma and COPD treatments but had limited long-term outcome data.
• Extending the SLS aimed to capture a more comprehensive patient disease journey and treatment effects.

Purpose of the Study:

• To design and implement the Extended Salford Lung Studies (Ext-SLS) for collecting long-term patient-level data.
• To present the study design, challenges, and learnings from creating the Ext-SLS.

Main Methods:

• Collected retrospective and prospective electronic health record (EHR) data and patient questionnaires for up to 10 years.
• Utilized a novel EHR-based approach for patient identification and remote consent acquisition by general practitioners (GPs).
• Extracted primary care data from GP systems and secondary care data from the UK National Health Service (NHS).

Main Results:

• 35 out of 75 (47%) original GP sites declined participation.
• 1189 out of 2989 (40%) invited patients consented to participate in the Ext-SLS.
• A significant number of potentially eligible patients were excluded due to confirmation issues or incapacity.

Conclusions:

• The Ext-SLS was successfully developed as a valuable real-world research resource.
• Leveraging EHRs and technology reduced the burden on GPs and facilitated patient participation.
• Initiating extension studies earlier could potentially improve participation rates.