User Requirements for an Electronic Patient Recruitment System: Semistructured Interview Analysis After First Implementation in 3 German University Hospitals.

Background: Clinical trials are essential for medical research and medical progress. Nevertheless, trials often fail to reach their recruitment goals. Patient recruitment systems aim to support clinical trials by providing an automated search for eligible patients in the databases of health care institutions like university hospitals.

recruIT: A cloud-native clinical trial recruitment support system based on Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM).

Background: Clinical trials (CTs) are foundational to the advancement of evidence-based medicine and recruiting a sufficient number of participants is one of the crucial steps to their successful conduct. Yet, poor recruitment remains the most frequent reason for premature discontinuation or costly extension of clinical trials.

Methods: We designed and implemented a novel, open-source software system to support the recruitment process in clinical trials by generating automatic recruitment recommendations.

Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals.

Background: As part of the German Medical Informatics Initiative, the MIRACUM project establishes data integration centers across ten German university hospitals. The embedded MIRACUM Use Case "Alerting in Care - IT Support for Patient Recruitment", aims to support the recruitment into clinical trials by automatically querying the repositories for patients satisfying eligibility criteria and presenting them as screening candidates. The objective of this study is to investigate whether the developed recruitment tool has a positive effect on study recruitment within a multi-center environment by increasing the number of participants.

Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis.

Background: Clinical trials (CTs) are crucial for medical research; however, they frequently fall short of the requisite number of participants who meet all eligibility criteria (EC). A clinical trial recruitment support system (CTRSS) is developed to help identify potential participants by performing a search on a specific data pool. The accuracy of the search results is directly related to the quality of the data used for comparison.

Implementation of inclusion and exclusion criteria in clinical studies in OHDSI ATLAS software.

Clinical trials are essential parts of a medical study process, but studies are often cancelled due to a lack of participants. Clinical Trial Recruitment Support Systems are systems that help to increase the number of participants by seeking more suitable subjects. The software ATLAS (developed by Observational Health Data Sciences and Informatics) can support the launch of a clinical trial by building cohorts of patients who fulfill certain criteria.

RD-MON - Building a Rare Disease Monitor to Enhance Awareness for Patients with Rare Diseases in Intensive Care.

Rare diseases are commonly defined by an incidence of less than 5/10000 inhabitants. There are some 8000 different rare diseases known. So even if a single rare disease is seldom, together they pose a relevant problem for diagnosis and treatment.

Building a Comprehensive Clinical Data Repository Using FHIR, LOINC and SNOMED.

In 2018 the University Hospital of Giessen (UHG) moved its hospital information system from an in-house solution to commercial software. The introduction of MEONA and Synedra-AIM allowed for the successful migration of clinical documents. The large pool of structured clinical data has been addressed in a second step and is now consolidated in a HAPI-FHIR server and mapped to LOINC and SNOMED for semantic interoperability in multicenter research projects, especially the German Medical Informatics Initiative (MII) and the Medical Informatics in Research and Care in University Medicine (MIRACUM) consortium.

Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals.

Background: Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials.

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.

Design for a Modular Clinical Trial Recruitment Support System Based on FHIR and OMOP.

The MIRACUM consortium is developing a Clinical Trials Recruitment Support System to support the data-driven recruitment of patients for clinical trials. The design of the prototype includes both open source solutions (OMOP CDM, Atlas) and open standards for interoperability (FHIR). The aim of the prototype is to create a patient screening list of potential participants for a clinical study.