부산대학교 도서관

Timely recruitment and comprehensive follow-up of patients are vital to the success of randomised controlled trials (RCTs) but both present issues. This thesis aims to investigate how routine data can be used for recruitment to clinical trials, whether there are any biases introduced by using routine data, and to determine whether routine data can be used as a follow-up method in clinical trials. The literature on the use of routine data for recruitment and follow-up are explored in two systematic literature searches. Both reviews highlight that routine data can be used for recruitment and follow-up in RCTs. One finding is that these methodological aspects of RCTs, particularly when not pertaining to the results, are often not reported. Using data from two large cardiovascular disease trials, the Heart Protection Study (HPS) and the Randomized EValuation of the Effects of Anacetrapib through Lipid-modification trial (REVEAL), that used electronic health records to recruit patients, the demographics of those entering the trial and declining to participate are investigated. A significant sex difference is observed, with females being less likely than males to progress through the recruitment pathway of both clinical trials. Attendance at follow-up visits and adherence to treatment were also significantly worse in females than in males. This disparity may leave studies underpowered for sex specific effects. These factors potentially limit the ability to establish the safety and efficacy of interventions in females and have the potential to have serious adverse public health consequences. The use of routine data for follow-up is investigated by comparing the outcomes from HPS (non-fatal myocardial infarction, non-fatal stroke, revascularisation, and major vascular event) and the outcomes reported in Hospital Episode Statistics (HES) during the same time period. All of the trial outcomes were well recorded in the HES dataset, with no significant differences between males and females in their reporting of events. The use of routine data for follow-up in RCTs could reduce the frequency of study visits, which may aid recruitment. Routine health records contain a wealth of information about patients that can be used to optimise both recruitment to trials and the follow-up of patients. The use of electronic health records (EHR) has the potential to provide more cost-effective and efficient methods for research.