Chronic obstructive pulmonary disease exacerbation episodes derived from electronic health record data validated using clinical trial data

Matthew Sperrin, David J Webb, Pinal Patel, Kourtney J Davis, Susan Collier, Alexander Pate, David A Leather, Jeanne M Pimenta, Matthew Sperrin, David J Webb, Pinal Patel, Kourtney J Davis, Susan Collier, Alexander Pate, David A Leather, Jeanne M Pimenta

Abstract

Purpose: To validate an algorithm for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) episodes derived in an electronic health record (EHR) database, against AECOPD episodes collected in a randomized clinical trial using an electronic case report form (eCRF).

Methods: We analyzed two data sources from the Salford Lung Study in COPD: trial eCRF and the Salford Integrated Record, a linked primary-secondary routine care EHR database of all patients in Salford. For trial participants, AECOPD episodes reported in eCRF were compared with algorithmically derived moderate/severe AECOPD episodes identified in EHR. Episode characteristics (frequency, duration), sensitivity, and positive predictive value (PPV) were calculated. A match between eCRF and EHR episodes was defined as at least 1-day overlap.

Results: In the primary effectiveness analysis population (n = 2269), 3791 EHR episodes (mean [SD] length: 15.1 [3.59] days; range: 14-54) and 4403 moderate/severe AECOPD eCRF episodes (mean length: 13.8 [16.20] days; range: 1-372) were identified. eCRF episodes exceeding 28 days were usually broken up into shorter episodes in the EHR. Sensitivity was 63.6% and PPV 71.1%, where concordance was defined as at least 1-day overlap.

Conclusions: The EHR algorithm performance was acceptable, indicating that EHR-derived AECOPD episodes may provide an efficient, valid method of data collection. Comparing EHR-derived AECOPD episodes with those collected by eCRF resulted in slightly fewer episodes, and eCRF episodes of extreme lengths were poorly captured in EHR. Analysis of routinely collected EHR data may be reasonable when relative, rather than absolute, rates of AECOPD are relevant for stakeholders' decision making.

Trial registration: ClinicalTrials.gov NCT01551758.

Keywords: algorithms; chronic obstructive; electronic health records; pharmacoepidemiology; pulmonary disease; validation.

Conflict of interest statement

David J. Webb, Pintal Patel, Susan Collier, David A. Leather, and Jeanne M. Pimenta are employee of GlaxoSmithKline plc. and hold stocks/shares in GlaxoSmithKline plc.; Kourtney J. Davis was a former employee of GlaxoSmithKline plc. (employee of GlaxoSmithKline plc. at time of writing) and is a current employee of Janssen/J&J. Matthew Sperrin and Alexander Pate declare no conflict of interest.

© 2019 John Wiley & Sons, Ltd.

Figures

Figure 1
Figure 1
Visualization of approach to EHR‐identified AECOPD episode algorithm construction. Areas enclosed by braces are 14‐day (2‐week) periods. The grey brackets for episode duration show the start and end times of the two episodes deduced by applying the algorithm to these codes. Abbreviations: AECOPD, acute exacerbation of chronic obstructive pulmonary disease; EHR, electronic health record [Colour figure can be viewed at http://wileyonlinelibrary.com]
Figure 2
Figure 2
Visualization of agreement between eCRF and EHR‐derived AECOPD episodes Top panel shows how FN, TP, and FP are derived for the main analysis. Bottom panel shows the same for the sensitivity analysis. Here, the first eCRF episode becomes a TP because there is an EHR episode within 15 days as an example (15‐day window shown striped in grey). Abbreviations: AECOPD, acute exacerbation of chronic obstructive pulmonary disease; eCRF, electronic case report form; EHR, electronic health record; FN, false negative; FP, false positive, TP, true positive [Colour figure can be viewed at http://wileyonlinelibrary.com]
Figure 3
Figure 3
Frequency of AECOPD episodes per patient in eCRF compared with EHR (primary and secondary care). Abbreviations: AECOPD, acute exacerbation of chronic obstructive pulmonary disease; eCRF, electronic case report form; EHR, electronic health record [Colour figure can be viewed at http://wileyonlinelibrary.com]
Figure 4
Figure 4
Length of AECOPD episodes in eCRF compared with EHR (primary and secondary care). Abbreviations: AECOPD, acute exacerbation of chronic obstructive pulmonary disease; eCRF, electronic case report form; EHR, electronic health record. [Colour figure can be viewed at http://wileyonlinelibrary.com]

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