Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study.

Background: Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that the same studies often need to be registered in different registries with different data entry requirements and interfaces.

Objective: This study investigates how Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records.

Extractive summarization of clinical trial descriptions.

Purpose: Text summarization of clinical trial descriptions has the potential to reduce the time required to familiarize oneself with the subject of studies by condensing long-form detailed descriptions to concise, meaning-preserving synopses. This work describes the process and quality of automatically generated summaries of clinical trial descriptions using extractive text summarization methods.

Methods: We generated a novel dataset from the detailed descriptions and brief summaries of trials registered on clinicaltrials.

Design and Implementation of a Single Source Multipurpose Hospital-Wide Clinical Trial Registry.

IT-supported patient recruitment, serious adverse event reporting as well as making information about clinical trials accessible to the public on websites, are still major challenges in clinical trials. Too often the distribution of information about trials being performed within a hospital across numerous institutions and IT systems is a barrier to provide efficient IT support for such scenarios. Thus, the essential prerequisite to mastering those challenges is to achieve one single point of truth with adequate, complete, accurate and up-to-date information about all clinical trials running at a hospital.

Application of the Pareto principle to identify and address drug-therapy safety issues.

Purpose: Adverse drug events (ADE) and medication errors (ME) are common causes of morbidity in patients presenting at emergency departments (ED). Recognition of ADE as being drug related and prevention of ME are key to enhancing pharmacotherapy safety in ED. We assessed the applicability of the Pareto principle (~80 % of effects result from 20 % of causes) to address locally relevant problems of drug therapy.

Medication safety and knowledge-based functions: a stepwise approach against information overload.

Aims: The aim was to improve medication safety in an emergency department (ED) by enhancing the integration and presentation of safety information for drug therapy.

Methods: Based on an evaluation of safety of drug therapy issues in the ED and a review of computer-assisted intervention technologies we redesigned an electronic case sheet and implemented computer-assisted interventions into the routine work flow. We devised a four step system of alerts, and facilitated access to different levels of drug information.

Comparative evaluation of different medication safety measures for the emergency department: physicians' usage and acceptance of training, poster, checklist and computerized decision support.

Background: Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital.

Adverse drug events in older patients admitted as an emergency: the role of potentially inappropriate medication in elderly people (PRISCUS).

Background: Lists of potentially inappropriate medications (PIMs) for the elderly, such as the German PRISCUS list, have been published as expert recommendations with the aim of improving drug safety for this patient group. In this study, we tried to determine how often adverse drug events occur in the emergency department and what role PRISCUS medications might play in these events.

Methods: We prospectively reviewed the medical records of 752 patients who were treated in the emergency department (ED) of a level III hospital in Germany for adverse drug events due to medication errors (MEs) and for adverse drug reactions (ADRs).

Building the technical infrastructure to support a study on drug safety in a general hospital.

We describe reorganization steps and the required technical infrastructure to support a multidisciplinary research project aimed at improving the safety of drug therapy in an emergency department (ED) of a community hospital. Assessment of drug safety required consolidation of data from various sources in a single source approach. We solved this by transferring digital data from the hospital information system (HIS) and attached clinical systems into a pseudonymized study database (secuTrial), which is also used as a web based data capturing tool to rate drug associated risk situations, extended by a technical extension for dynamic upload of further data.