Developing a UK registry to investigate the role of cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway: a multicentre, feasibility study linking routinely collected electronic patient data

Abstract

ObjectivesTo determine whether it is feasible to set up a national registry, linking routinely collected data from hospital information systems (HIS), to investigate the role of cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway.DesignFeasibility prospective cohort study, to establish whether: (1) consent can be implemented; (2) data linkage and extraction from multiple HIS can be achieved for >90% of consented patients; (3) local data can be successfully linked with hospital episode data (Hospital Episode Statistics, HES; Patient Episode Database for Wales, PEDW) for >90% of consented patients and (4) the proportion of patients activating the PPCI pathway who get a CMR scan is ≥10% in hospitals with dedicated CMR facilities.ParticipantsPatients from four 24/7 PPCI hospitals in England and Wales (two with and two without a dedicated CMR facility) who activated the PPCI pathway and underwent an emergency coronary angiogram.ResultsConsent was successfully implemented at all hospitals (consent rates ranged from 59% to 74%) and 1670 participants were recruited. Data submission was variable: all hospitals submitted clinical data (for ≥82% of patients); only three hospitals submitted biochemistry data (for ≥98% of patients) and echocardiography data (for 34%–87% of patients); only one hospital submitted medications data (for 97% of patients). At the two CMR centres, 14% and 20% of patients received a CMR scan. Data submitted by hospitals were linked with HES and PEDW for 99% of all consented patients.ConclusionWe successfully consented patients but obtaining individual, opt-in consent would not be feasible for a national registry. Linkage of data from HIS with hospital episode data was feasible. However, data from HIS are not uniformly available/exportable and, in centres with a dedicated CMR facility, some referrals for CMR were for research rather than clinical purposes.

Feasibility of identifying important changes in care management resulting from cardiovascular magnetic resonance (CMR) using hospital episode data in patients who activate the primary percutaneous coronary intervention (PPCI) pathway

“…exposure to tests) and consent (e.g. conventional ways of obtaining consent are too time consuming for a registry with no primary data collection [9]). However, this does not invalidate the concept of creating a composite outcome that reflects changes in management as a result of having an imaging test.…”

“…hospitals without access to a local dedicated CMR service. Patient identification, recruitment and consent have been described previously [9]. Patients entered the cohort at the point they activated the PPCI pathway (i.e.…”

“…We conducted a study to determine the feasibility of setting up a registry linking data collected during usual care to assess the clinical and cost-effectiveness of cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway [9]. Although a long-term objective of the registry would be to compare the incidence of MACE in patients who do or do not have CMR after the index event, the relatively low frequency of MACE after PPCI in this population (about 13% [9]) means that the study would have to accrue over 27,000 subjects to detect a clinically important (assumed to be 10%) relative reduction in the incidence of MACE with 90% power. Therefore, a key objective of the feasibility study was to define a primary composite outcome, acceptable to cardiologists and other stakeholders (e.g.…”

Evidence Review, Co-Production and Prototyping A Process of Creating a Consumer Research Contact List in a Paediatric Health Setting: The PARTICIPATE Project

“…Opportunities to involve children in research today are much greater [1], yet recruiting paediatric research participants remains challenging. Speci c challenges include ethical and practical concerns about overburdening parents in acute and emergency healthcare contexts where families may be experiencing intense emotional or psychological stress [3]. Recruiting insu cient research participants can be a barrier to conducting research and result in waste of research resources [4][5][6].…”

Cardiovascular magnetic resonance in emergency patients with multivessel disease or unobstructed coronary arteries: a cost-effectiveness analysis in the UK

“…In this paper, we present a health economic analysis based on a study that was designed to establish the feasibility of setting up a UK multicentre registry to document CMR use in patients who activate the PPCI pathway and determine its prognostic value and impact on patient management 23. Here, we present the results of two economic decision models which we designed to compare the cost-effectiveness of introducing CMR in two patient subgroups: patients with multivessel disease and those with unobstructed coronary arteries.…”