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Comparative Study
. 2023 May:128:107162.
doi: 10.1016/j.cct.2023.107162. Epub 2023 Mar 16.

Healthcare systems data in the context of clinical trials - A comparison of cardiovascular data from a clinical trial dataset with routinely collected data

Archie Macnair  1 , Matthew Nankivell  2 , Macey L Murray  3 , Stuart D Rosen  4 , Sally Appleyard  5 , Matthew R Sydes  6 , Sylvia Forcat  2 , Andrew Welland  2 , Noel W Clarke  7 , Stephen Mangar  8 , Howard Kynaston  9 , Roger Kockelbergh  10 , Abdulla Al-Hasso  11 , John Deighan  12 , John Marshall  12 , Mahesh Parmar  2 , Ruth E Langley  2 , Duncan C Gilbert  13
Affiliations
Comparative Study

Healthcare systems data in the context of clinical trials - A comparison of cardiovascular data from a clinical trial dataset with routinely collected data

Archie Macnair et al. Contemp Clin Trials. 2023 May.

Abstract

Background: Routinely-collected healthcare systems data (HSD) are proposed to improve the efficiency of clinical trials. A comparison was undertaken between cardiovascular (CVS) data from a clinical trial database with two HSD resources.

Methods: Protocol-defined and clinically reviewed CVS events (heart failure (HF), acute coronary syndrome (ACS), thromboembolic stroke, venous and arterial thromboembolism) were identified within the trial data. Data (using pre-specified codes) was obtained from NHS Hospital Episode Statistics (HES) and National Institute for Cardiovascular Outcomes Research (NICOR) HF and myocardial ischaemia audits for trial participants recruited in England between 2010 and 2018 who had provided consent. The primary comparison was trial data versus HES inpatient (APC) main diagnosis (Box-1). Correlations are presented with descriptive statistics and Venn diagrams. Reasons for non-correlation were explored.

Results: From 1200 eligible participants, 71 protocol-defined clinically reviewed CVS events were recorded in the trial database. 45 resulted in a hospital admission and therefore could have been recorded by either HES APC/ NICOR. Of these, 27/45 (60%) were recorded by HES inpatient (Box-1) with an additional 30 potential events also identified. HF and ACS were potentially recorded in all 3 datasets; trial data recorded 18, HES APC 29 and NICOR 24 events respectively. 12/18 (67%) of the HF/ACS events in the trial dataset were recorded by NICOR.

Conclusion: Concordance between datasets was lower than anticipated and the HSD used could not straightforwardly replace current trial practices, nor directly identify protocol-defined CVS events. Further work is required to improve the quality of HSD and consider event definitions when designing clinical trials incorporating HSD.

Keywords: Cardiovascular disease; Clinical trials; Healthcare systems data; Prostate cancer.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Three-way comparison between clinical trial data, HES APC and NICOR data for the combined outcomes of inpatient ACS and Heart Failure; a) using HES box 1 data only and b) using HES boxes 1−5; 1a − Clinical Trial Data, NICOR and HES (APC box 1 only) ACS and Heart Failure. 1b − Clinical Trial Data, NICOR and HES (APC boxes 1−5) ACS and Heart Failure.
See this image and copyright information in PMC

References

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