Brief reportUse of a patient linked data warehouse to facilitate diabetes trial recruitment from primary care
Introduction
Recruitment of patients into diabetes clinical trials remains poor [1], [2] compared to recruitment for other life threatening conditions such as cancer [3]. There are benefits to being a trial participant. For example improved glycaemic control has been consistently demonstrated amongst research participants [4], [5]. Within recent years there has been a shift of diabetes care from the secondary to the primary care setting. Of interest much of the recruitment of participants to diabetes (and other) studies still occurs within secondary care. This may result in a potential obstacle to trial recruitment. It may also be argued that this is a particular problem at the present time, since many of the current studies are looking to recruit treatment-naive suboptimally controlled patients with diabetes or those free from macrovascular or microvascular complications. Therefore, the routine care for these patients tends to be provided by the general practitioner and primary care [3].
The increased use of electronic resources and databases [6], [7] in the routine management of patients’ care provides an opportunity to facilitate participant recruitment into diabetes (and other) studies. The Secure Anonymised Information Linkage (SAIL) databank [8] has already been used to estimate the denominator of the number of newly diagnosed diabetic adults for the calculation of prevalence and incidence of latent autoimmune diabetes in adults (LADA) [9]. Our aim was to examine the use the databank [8] as a tool to identify potential participants for two factitious exemplar trial protocols with specific inclusion and exclusion criteria.
Section snippets
The SAIL database
The SAIL databank [8] containing patient data from 35 primary care clinical systems for the Swansea area (250,086 individuals) was utilised. In brief, this consists of coded (Read codes version 2) data of all the diagnoses, investigations, results and medications relating to a practice's patients, building an anonymised but individualised health record. Each health record can be queried for specified Read codes to identify relevant criteria (//www.pcc.nhs.uk/uploads/QOF/Business%20rules%20v13/diabetes_ruleset_v13_0.pdf
Results
In total, 10,205 individuals with a diagnosis of type 2 diabetes were identified from a population of 250,086 from the SAIL databank, a crude prevalence of 4.1%.
Conclusions
Trial recruitment in the UK is poor for many chronic diseases (with the exception of cancer) [12]. Less than one-third of clinical trials achieve the recruitment target in the UK [13]. We demonstrate the use of a routine data source (SAIL) to identify potential research participants for complex clinical trials. Both factitious studies were designed to reflect the complexity of current trials with inclusion and exclusion criteria, and with a focus on patients managed in the primary care setting
Conflict of interest statement
None.
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These authors contributed equally.