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Review
. 2023 Jan 18;33(1):4.
doi: 10.1038/s41533-022-00322-7.

Extending the data collection from a clinical trial: The Extended Salford Lung Study research cohort

Wilhelmine Meeraus  1 , Qinggong Fu  2 , George Mu  2 , Mark Fry  3 , Lucy Frith  1 , Jeanne M Pimenta  1
Affiliations
Review

Extending the data collection from a clinical trial: The Extended Salford Lung Study research cohort

Wilhelmine Meeraus et al. NPJ Prim Care Respir Med. .

Abstract

The Extended Salford Lung Study (Ext-SLS) is an extension of the Salford Lung Studies (SLS) in asthma and chronic obstructive pulmonary disease (COPD) through retrospective and prospective collection of patient-level electronic health record (EHR) data. We compared the Ext-SLS cohort with the SLS intention-to-treat populations using descriptive analyses to determine if the strengths (e.g. randomization) of the clinical trial were maintained in the new cohort. Historical and patient-reported outcome data were captured from asthma-/COPD-specific questionnaires (e.g., Asthma Control Test [ACT]/COPD Assessment Test [CAT]). The Ext-SLS included 1147 participants (n = 798, SLS asthma; n = 349, SLS COPD). Of participants answering the ACT, 39% scored <20, suggesting poorly controlled asthma. For COPD, 61% of participants answering the CAT scored ≥21, demonstrating a high disease burden. Demographic/clinical characteristics of the cohorts were similar at SLS baseline. EHR data provided a long-term view of participants' disease, and questionnaires provided information not typically captured. The Ext-SLS cohort is a valuable resource for respiratory research, and ongoing prospective data collection will add further value and ensure the Ext-SLS is an important source of patient-level information on obstructive airways disease.

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Conflict of interest statement

The authors declare no competing non-financial interests but the following competing financial interests: Wilhelmine Meeraus: Employment with GSK at the time of study and stock/share ownership in GSK. Qinggong Fu: Employment and stock/share ownership in GSK. George Mu: Employment and stock/share ownership in GSK. Mark Fry: Employment and stock/share ownership in GSK. Lucy Frith: Employment and stock/share ownership in GSK. Jeanne. M. Pimenta: Employment with GSK at the time of study and stock/share ownership in GSK.

Figures

Fig. 1
Fig. 1. Disease impact on sleep among participants with asthma and COPD as reported at the time of Ext-SLS consent.
CASIS COPD and Asthma Sleep Impact Scale, COPD chronic obstructive pulmonary disease, Ext-SLS extended Salford Lung Study. Note: aOne week look-back period for all seven questions. Asthma responders n = 783–792, COPD responders n = 335–343, variable per question.
Fig. 2
Fig. 2. Common symptom triggers as reported by Ext-SLS participants with asthma at the time of Ext-SLS consent.
Ext-SLS extended Salford Lung Study. Note: aOf the airway. Responders providing a “Yes” or “No” answer n = 589–760 variable per question.
Fig. 3
Fig. 3. Self-reported working environments for participants with COPD in the Ext-SLS who reported working outside the home.
COPD chronic obstructive pulmonary disease, Ext-SLS Extended Salford Lung Study. Note: Responders n = 337–346 variable per question.
See this image and copyright information in PMC

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