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Feasibility of data linkage in the PARAMEDIC Trial : a cluster randomised trial of mechanical chest compression in out of hospital cardiac arrest

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Ji, Chen, Quinn, Tom, Gavalova, Lucia, Lall, Ranjit, Scomparin, Charlotte, Horton, Jessica, Deakin, Charles D., Pocock, Helen, Smyth, Michael A., Rees, Nigel, Brace-McDonnell, Samantha J., Gates, Simon and Perkins, Gavin D. (2018) Feasibility of data linkage in the PARAMEDIC Trial : a cluster randomised trial of mechanical chest compression in out of hospital cardiac arrest. BMJ Open, 8 . e021519. doi:10.1136/bmjopen-2018-021519 ISSN 2044-6055.

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Official URL: https://doi.org/10.1136/bmjopen-2018-021519

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Abstract

Objectives: There is considerable interest in reducing the cost of clinical trials. Linkage of trial data to administrative datasets and disease-specific registries may improve trial efficiency, but has not been reported in resuscitation trials conducted in the UK. To assess the feasibility of utilising national administrative and clinical datasets to follow up patients transported to hospital following attempted resuscitation in a cluster randomised trial of a mechanical chest compression device in out of hospital cardiac arrest (OHCA).
Methods: Hospital data on trial participants were requested from Hospital Episode Statistics (HES); the Intensive Care National Audit and Research Centre (ICNARC); and Myocardial Ischaemia National Audit Project (MINAP) and National Audit of Percutaneous Coronary Intervention (NAPCI), using unique patient identifiers. Linked data were received between June 2014 and June 2015.
Results: Of 4471 patients randomised in the PARAMEDIC trial, 2398 (53.6%) were not known to be deceased at emergency department arrival and were eligible for linkage. We achieved an overall match rate of 86.7% in the combined HES A&E, inpatient and Critical care dataset, with variable match rates (4.2-80.4%) in individual datasets. Patient demographics, cardiac arrest related characteristics and major outcomes were predominantly similar between HES matched and unmatched groups, in the linkage apart from location, response time and ROSC at handover.
Conclusions: This study shows that it is feasible to track patients from the pre-hospital setting through to hospital admission using routinely available administrative datasets with a moderate to high degree of success. This approach has the potential to complement the trial data with the demographic and clinical management information about the studied cohort, as well as to improve the efficiency and reduce the costs of follow-up in cardiac arrest trials.

Item Type: Journal Article
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title: BMJ Open
Publisher: BMJ
ISSN: 2044-6055
Official Date: 28 July 2018
Dates:
DateEvent
28 July 2018Published
25 June 2018Accepted
Volume: 8
Article Number: e021519
DOI: 10.1136/bmjopen-2018-021519
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 26 June 2018
Date of first compliant Open Access: 25 September 2018
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