Abstract
BackgroundRoutinely recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs). However, limitations with access and accuracy have been identified. Objective: Using epilepsy as an exemplar condition, we assessed the attributes and agreement of routinely recorded data compared to data collected using case report forms in a UK RCT assessing antiepileptic drug treatments for individuals newly diagnosed with epilepsy.MethodsThe case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK multicentre RCT assessing the clinical and cost-effectiveness of antiepileptic drugs as treatments for epilepsy. Ninety-eight of 470 eligible participants provided consent for access to routinely recorded secondary care data that were retrieved from NHS Digital Hospital Episode Statistics (N=71) and primary and secondary care data from The Secure Anonymised Information Linkage Databank (N=27). We assessed data items relevant to the identification of individuals eligible for inclusion in SANAD II, baseline and follow-up visits. The attributes of routinely recorded data were assessed including the degree of missing data. The agreement between routinely recorded data and data collected on case report forms in SANAD II was assessed using calculation of Cohen’s kappa for categorical data and construction of Bland-Altman plots for continuous data.ResultsThere was a significant degree of missing data in the routine record for 15 of the 20 variables assessed, including all clinical variables. Agreement was poor for the majority of comparisons, including the assessments of seizure occurrence and adverse events. For example, only 23/62 (37%) participants had a date of first-ever seizure identified in routine datasets. Agreement was satisfactory for the date of prescription of antiepileptic drugs and episodes of healthcare resource use.ConclusionsThere are currently significant limitations preventing the use of routinely recorded data for participant identification and assessment of clinical outcomes in epilepsy, and potentially other chronic conditions. Further research is urgently required to assess the attributes, agreement, additional benefits, cost-effectiveness and ‘optimal mix’ of routinely recorded data compared to data collected using standard methods such as case report forms at clinic visits for people with epilepsy.Trial registrationStandard and New Antiepileptic Drugs II (SANAD II (EudraCT No: 2012-001884-64, registered 05/09/2012; ISRCTN Number: ISRCTN30294119, registered 03/07/2012))
Highlights
Recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs)
It is vital that we understand their utility in clinical trials in common chronic diseases, epilepsy being the exemplar in this paper
To assess the attributes and agreement between routinely recorded data and data collected using case report forms in a UK pragmatic RCT assessing antiepileptic drug treatments for individuals newly diagnosed with epilepsy
Summary
Recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs). Objective: Using epilepsy as an exemplar condition, we assessed the attributes and agreement of routinely recorded data compared to data collected using case report forms in a UK RCT assessing antiepileptic drug treatments for individuals newly diagnosed with epilepsy. Recorded data have established use in retrospective observational studies such as record linkage population studies, but their use in randomised controlled trials (RCTs) is less well established. RCTs remain the gold standard for assessing the efficacy and effectiveness of treatments in healthcare [6] and publicly funded, pragmatic RCTs typically provide longer-term outcome data to inform chronic disease management. The majority of RCTs are time-consuming and resource-intensive as clinicians typically assess participants at clinic visits and record trial data on case report forms. If a trial is assessing outcomes that are important to participants, such as a core outcome set [7, 8], one might expect relevant data to be recorded routinely
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