Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submi...

HL7 Templates and EN/ISO 13606 Archetypes are essential components for a semantically interoperable exchange of electronic health record (EHR) data. In this article the underlying models from which Templates and Archetypes are instantiated, namely the HL7 Template Model and the EN/ISO 13606 Archetype Object Model will be compared to identify discrepancies and analogies.

OBJECTIVES The goal of this survey is to discuss the impact of the growing availability of electronic health record (EHR) data on the evolving field of Clinical Research Informatics (CRI), which is the union of biomedical research and informatics. RESULTS Major challenges for the use of EHR-derived data for research include the lack of standard methods for ensuring that data quality, complete...

The research world is undergoing a transformation into one in which data, on massive levels, is freely shared. In the clinical world, the capture of data on a consistent basis has only recently begun. We propose an operational vision for a digitally based care system that incorporates data-based clinical decision making. The system would aggregate individual patient electronic medical data in t...

BACKGROUND Pharmaceutical clinical trials are primarily conducted across many countries, yet recruitment numbers are frequently not met in time. Electronic health records store large amounts of potentially useful data that could aid in this process. The EHR4CR project aims at re-using EHR data for clinical research purposes. OBJECTIVE To evaluate whether the protocol feasibility platform prod...

Background The CREAM Study aimed to address the uncertainty around the effect of using antibiotics to treat clinically infected eczema on subjective eczema severity in children in primary care. Children were identified by GP practices and referred to the CREAM Study. A software package (Trial Torrent) that sits on primary care electronic medical record systems and can deliver pop-up reminders a...

OBJECTIVES (1) To determine the proportion of hospitals with and without implementation of electronic health records (EHRs). (2) To examine characteristics of hospitals that report implementation of EHRs partially or completely versus those that report no implementation. (3) To identify hospital characteristics associated with nonimplementation to help devise future policy initiatives. METHOD...

BACKGROUND Data collection by electronic medical record (EMR) systems have been proven to be helpful in data collection for scientific research and in improving healthcare. For a multi-centre trial in Indonesia and the Netherlands a web based system was selected to enable all participating centres to easily access data. This study assesses whether the introduction of a clinical trial data manag...

For cost-effectiveness and efficiency, many large-scale general-purpose cohort studies are being assembled within large health-care providers who use electronic health records. Two key features of such data are that incident disease is interval-censored between irregular visits and there can be pre-existing (prevalent) disease. Because prevalent disease is not always immediately diagnosed, some...

BACKGROUND Computerized medical records (CMR) are used in most Australian general practices. Although CMRs have the capacity to amalgamate and provide data to the clinician about their standard of care, there is little research on the way in which they may be used to support clinical governance: the process of ensuring quality and accountability that incorporates the obligation that patients ar...