Björn Bergh

Evaluation of data completeness in the electronic health record for the purpose of patient recruitment into clinical trials: a retrospective analysis of element presence

BackgroundComputerized clinical trial recruitment support is one promising field for the application of routine care data for clinical research. The primary task here is to compare the eligibility criteria defined in trial protocols with patient data contained in the electronic health record (EHR). To avoid the implementation of different patient definitions in multi-site trials, all participating research sites should use similar patient data from the EHR. Knowledge of the EHR data elements which are commonly available from most EHRs is required to be able to define a common set of criteria. The objective of this research is to determine for five tertiary care providers the extent of available data compared with the eligibility criteria of randomly selected clinical trials.MethodsEach participating study site selected three clinical trials at random. All eligibility criteria sentences were broken up into independent patient characteristics, which were then assigned to one of the 27 semantic categories for eligibility criteria developed by Luo et al. We report on the fraction of patient characteristics with corresponding structured data elements in the EHR and on the fraction of patients with available data for these elements. The completeness of EHR data for the purpose of patient recruitment is calculated for each semantic group.Results351 eligibility criteria from 15 clinical trials contained 706 patient characteristics. In average, 55% of these characteristics could be documented in the EHR. Clinical data was available for 64% of all patients, if corresponding data elements were available. The total completeness of EHR data for recruitment purposes is 35%. The best performing semantic groups were ‘age’ (89%), ‘gender’ (89%), ‘addictive behaviour’ (74%), ‘disease, symptom and sign’ (64%) and ‘organ or tissue status’ (61%). No data was available for 6 semantic groups.ConclusionsThere exists a significant gap in structure and content between data documented during patient care and data required for patient eligibility assessment. Nevertheless, EHR data on age and gender of the patient, as well as selected information on his disease can be complete enough to allow for an effective support of the manual screening process with an intelligent preselection of patients and patient data.

Design and multicentric Implementation of a generic Software Architecture for Patient Recruitment Systems re-using existing HIS tools and Routine Patient Data

OBJECTIVE (1) To define features and data items of a Patient Recruitment System (PRS); (2) to design a generic software architecture of such a system covering the requirements; (3) to identify implementation options available within different Hospital Information System (HIS) environments; (4) to implement five PRS following the architecture and utilizing the implementation options as proof of concept. METHODS Existing PRS were reviewed and interviews with users and developers conducted. All reported PRS features were collected and prioritized according to their published success and users request. Common feature sets were combined into software modules of a generic software architecture. Data items to process and transfer were identified for each of the modules. Each site collected implementation options available within their respective HIS environment for each module, provided a prototypical implementation based on available implementation possibilities and supported the patient recruitment of a clinical trial as a proof of concept. RESULTS 24 commonly reported and requested features of a PRS were identified, 13 of them prioritized as being mandatory. A UML version 2 based software architecture containing 5 software modules covering these features was developed. 13 data item groups processed by the modules, thus required to be available electronically, have been identified. Several implementation options could be identified for each module, most of them being available at multiple sites. Utilizing available tools, a PRS could be implemented in each of the five participating German university hospitals. CONCLUSION A set of required features and data items of a PRS has been described for the first time. The software architecture covers all features in a clear, well-defined way. The variety of implementation options and the prototypes show that it is possible to implement the given architecture in different HIS environments, thus enabling more sites to successfully support patient recruitment in clinical trials.

From SOMDA to application – integration strategies in the OR.NET demonstration sites

Abstract The effective development and dissemination of the open integration for the next generation of operating rooms require a comprehensive testing environment. In this paper, we present the various challenges to be addressed in demonstration applications, and we discuss the implementation approach, the foci of the demonstration sites and the evaluation efforts. Overall, the demonstrator setups have proven the feasibility of the service-oriented medical device architecture (SOMDA) and real-time approaches with a large variety of example applications. The applications demonstrate the potentials of open device interoperability. The demonstrator implementations were technically evaluated as well as discussed with many clinicians from various disciplines. However, the evaluation is still an ongoing research at the demonstration sites. Technical evaluation focused on the properties of a network of medical devices, latencies in data transmission and stability. A careful evaluation of the SOMDA design decisions and implementations are essential to a safe and reliable interoperability of integrated medical devices and information technology (IT) system in the especially critical working environment. The clinical evaluation addressed the demands of future users and stakeholders, especially surgeons, anesthesiologists, scrub nurses and hospital operators. The opinions were carefully collected to gain further insights into the potential benefits of the technology and pitfalls in future work.

Intelligente Vernetzung in der Gesundheitsregion Rhein-Neckar

Die Gesundheitsregion Rhein-Neckar hat ihre Schwerpunkte in den Bereichen Gesundheitswirtschaft, Versorgung, Pravention, Forschung und Innovation. Digitalisierung und intelligente Vernetzung spielen eine zunehmende Rolle im Gesundheitswesen. Sie konnen helfen, aktuelle und zukunftige Herausforderungen im Bereich Versorgung, Pravention und Verwaltung zu meistern. Mit strategischen Projekten im Bereich elektronische Patientenakten wird die Basis fur eine intelligente Vernetzung der Gesundheitsregion gelegt, sowie ein Beitrag zur Wettbewerbsfahigkeit, Daseinsvorsorge und Lebensqualitat geleistet.

Persönliche einrichtungsübergreifende Gesundheits- und Patientenakten (PEPA) als zentrale Infrastrukturkomponente einer patientenzentrierten Gesundheitsversorgung

Das Gesundheitswesen in Deutschland ist in den letzten Jahren gepragt durch eine immer aktivere Einbindung des Patienten in Prozesse der Gesundheitsversorgung. Die Grunde hierfur sind vielfaltig. Eine Ursache ist die Entstehung neuer Behandlungsmodelle wie der integrierten Versorgung, die darauf ausgelegt ist, bei gleicher Qualitat die Kosten der Gesundheitsversorgung nicht weiter steigen zu lassen.

Interoperabilität als Basis für die Vernetzung von Gesundheitsregionen

Das Gesundheitssystem steht vor grosen Herausforderungen, wie zum Beispiel die Bewaltigung zunehmender multimorbider Patienten mit chronischen Erkrankungen im Rahmen des demografischen Wandels. Es gilt neue Versorgungsmodelle zu finden, die jedoch ohne adaquate Unterstutzung durch telemedizinische Verfahren und Einfuhrung von Interoperabilitatsstandards nicht effizient durchfuhrbar sind. Die Digitalisierung im Gesundheitswesen kann zugleich als Basis und Motor fur die Vernetzung aller Akteure dienen. In diesem Beitrag beleuchten wir die Moglichkeiten, die Integrating the Healthcare Enterprise (IHE) und die personliche elektronische Patientenakte (PEPA) fur die Vernetzung von Gesundheitsregionen bieten. Wir beschreiben, welche Komponenten von IHE relevant sind und welche in der Gesundheitsregion Rhein Neckar Anwendung finden. Abschliesend betrachten wir Mehrwerte der Umsetzungsperspektive fur eine Gesundheitsregion und daruber hinaus.

Developing a Process Quality Improvement Questionnaire – A Case Study on Writing Discharge Letters

Business process quality assessment plays an important role in business process management. Business process quality is often assessed by identifying potentials for improvement. In practice, a questionnaire is a commonly used means. However, creating a questionnaire requires a high expertise because systematic approaches are missing. Moreover, questionnaires for process improvement often focus on single quality aspects. In this paper, we describe a systematic approach to create a questionnaire to identify business process quality problems. The approach is based on a comprehensive business process quality model. We applied the approach in a case study at a German university hospital and present results of the preliminary evaluation phase.