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. METHODS: We designed and prototypically implemented an open-source central trial registry containing records from university hospitals, which are automatically exported and updated by local study management systems. RESULTS: We provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format. CONCLUSIONS: The results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.

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.gov. We executed several text summarization algorithms on the detailed descriptions in this corpus and calculated the standard ROUGE metrics using the brief summaries included in the record as a reference. To investigate the correlation of these metrics with human sentiments, four reviewers assessed the content-completeness of the generated summaries and the helpfulness of both the generated and reference summaries via a Likert scale questionnaire. RESULTS: The filtering stages of the dataset generation process reduce the 277,228 trials registered on clinicaltrials.gov to 101,016 records usable for the summarization task. On average, the summaries in this corpus are 25% the length of the detailed descriptions. Of the evaluated text summarization methods, the TextRank algorithm exhibits the overall best performance with a ROUGE-1 F1 score of 0.3531, ROUGE-2 F1 score of 0.1723, and ROUGE-L F1 score of 0.3003. These scores correlate with the assessment of the helpfulness and content similarity by the human reviewers. Inter-rater agreement for the helpfulness and content similarity was slight and fair respectively (Fleiss' kappa of 0.12 and 0.22). CONCLUSIONS: Extractive summarization is a viable tool for generating meaning-preserving synopses of detailed clinical trial descriptions. Further, the human evaluation has shown that the ROUGE-L F1 score is useful for rating the general quality of generated summaries of clinical trial descriptions in an automated way.

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. We describe the design and implementation of such a single source clinical trial registry serving multiple purposes at a university 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. METHODS: In 752 cases consecutively admitted to the nontraumatic ED of a major regional hospital, ADE, ME, contributing drugs, preventability, and detection rates of ADE by ED staff were investigated. Symptoms, errors, and drugs were sorted by frequency in order to apply the Pareto principle. RESULTS: In total, 242 ADE were observed, and 148 (61.2 %) were assessed as preventable. ADE contributed to 110 inpatient hospitalizations. The ten most frequent symptoms were causally involved in 88 (80.0 %) inpatient hospitalizations. Only 45 (18.6 %) ADE were recognized as drug-related problems until discharge from the ED. A limited set of 33 drugs accounted for 184 (76.0 %) ADE; ME contributed to 57 ADE. Frequency-based listing of ADE, ME, and drugs involved allowed identification of the most relevant problems and development of easily to implement safety measures, such as wall and pocket charts. CONCLUSIONS: The Pareto principle provides a method for identifying the locally most relevant ADE, ME, and involved drugs. This permits subsequent development of interventions to increase patient safety in the ED admission process that best suit local needs.

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. System use was analyzed over a period of 6 months. In addition, physicians answered a survey based on the technology acceptance model TAM2. RESULTS: The new application was implemented in an informal manner to avoid work flow disruption. Log files demonstrated that step I, 'valid indication' was utilized for 3% of the recorded drugs and step II 'tooltip for well-known drug risks' for 48% of the drugs. In the questionnaire, the computer-assisted interventions were rated better than previous paper based measures (checklists, posters) with regard to usefulness, support of work and information quality. CONCLUSION: A stepwise assisting intervention received positive user acceptance. Some intervention steps have been seldom used, others quite often. We think that we were able to avoid over-alerting and work flow intrusion in a critical ED environment.

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. METHODS: A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. RESULTS: During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively "critical" orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. CONCLUSIONS: Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment.

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). The evaluation was performed in two steps by pharmacologists, clinical pharmacologists, and board-certified internists. RESULTS: Both clinically important MEs and ADRs became more common with advancing age. Among the 351 patients who were over age 65, 307 (87.5%) were taking at least one medication at home. Of these 307 patients, 16.6% (95% confidence interval [CI]: 12.9-21.2%) were taking at least one PIM, as defined by the German PRISCUS list. In relative terms, PIMs were more commonly associated with ADRs or MEs than other drugs (27.0% [95% CI: 17.5-39.1% versus 15.7% [95% CI: 14.1-17.4%], Odds ratio 1.99 [95% CI: 1.23-3.52: p = 0.018), but in absolute terms ADRs and MEs involved non-PIM more often than PIM. CONCLUSION: Elderly patients more frequently suffer from ADR and from the clinical consequences of medication errors. Elderly patients taking PIMs are more likely to suffer from ADRs and MEs, even though most drug-related events are still attributable to non-PIM.

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. Paper-based documentation in the ED was digitized using a digital pen technology.