An Assessment of Data from Routine Sources Applied to a RCT
Research type
Research Study
Full title
An Assessment of Data from Routine Sources Applied to a Randomised Controlled Trial
IRAS ID
189002
Contact name
Graham Powell
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 11 months, 1 days
Research summary
Randomised Controlled Trials (RCTs) are regarded as the 'gold standard' when assessing new treatments. Participants are assigned a specific treatment and a 'follow-up' period over a number of months or years occurs where patients return for assessments, investigations or to complete questionnaires. This process can be time consuming, costly and onerous for participants.
An electronic medical record is kept for all individuals in the UK in a number of ‘routine data sources’. For example, medical information is recorded to inform patient treatment and NHS Trust reimbursement. Routinely recorded information (‘routine data’) can be useful for secondary purposes such as clinical research. Electronic medical records recording information about General Practice and hospital care are frequently used in retrospective clinical studies and may be cost and resource-effective when used in prospective studies, improving the efficiency of the study and reducing the burden for participants, for example the number of follow up appointments and questionnaires may be reduced.
This study will assess the attributes of information obtained from electronic medical records when used to inform a RCT. The Standard and New Antiepileptic Drugs Trial II is a RCT that is assessing antiepileptic drugs used for the treatment of epilepsy. Participants are assigned a treatment and followed up with appointments, telephone calls and questionnaire completion for up to 5.5 years. This study will assess if information from electronic medical records can be used to measure the outcomes of SANAD II and if there are any additional benefits compared to information collected during SANAD II. Individuals will be invited to consent to allow information from their electronic medical records to be collected for the time period they have been taking part in SANAD II. Information from electronic medical records will then be compared to information collected during SANAD II.
REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0007
Date of REC Opinion
29 Jan 2016
REC opinion
Further Information Favourable Opinion