EMR-integrated minimal core dataset for routine health care and multiple research settings: A case study for neuroinflammatory demyelinating diseases

Abstract

Although routine health care and clinical trials usually require the documentation of similar information, data collection is performed independently from each other, resulting in redundant documentation efforts. Standardizing routine documentation can enable secondary use for medical research. Neuroinflammatory demyelinating diseases (NIDs) represent a heterogeneous group of diseases requiring further research to improve patient management. The aim of this work is to develop, implement and evaluate a minimal core dataset in routine health care with a focus on secondary use as case study for NIDs. Therefore, a draft minimal core dataset for NIDs was created by analyzing routine, clinical trial, registry, biobank documentation and existing data standards for NIDs. Data elements (DEs) were converted into the standard format Operational Data Model, semantically annotated and analyzed via frequency analysis. The analysis produced 1958 DEs based on 864 distinct medical concepts. After review and finalization by an interdisciplinary team of neurologists, epidemiologists and medical computer scientists, the minimal core dataset (NID CDEs) consists of 46 common DEs capturing disease-specific information for reuse in the discharge letter and other research settings. It covers the areas of diagnosis, laboratory results, disease progress, expanded disability status scale, therapy and magnetic resonance imaging findings. NID CDEs was implemented in two German university hospitals and a usability study in clinical routine was conducted (participants n = 16) showing a good usability (Mean SUS = 75). From May 2017 to February 2018, 755 patients were documented with the NID CDEs, which indicates the feasibility of developing a minimal core dataset for structured documentation based on previously used documentation standards and integrating the dataset into clinical routine. By sharing, translating and reusing the minimal dataset, a transnational harmonized documentation of patients with NIDs might be realized, supporting interoperability in medical research.

Chances and challenges of a long-term data repository in multiple sclerosis: 20th birthday of the German MS registry

“…It could furthermore establish a documentation system for several different prospective studies and reduce time and costs expenditure in the future. Despite its positive effects, the reuse and integration of electronic healthcare records for research purposes is still in its early stages 37 .…”

A simple core dataset and disease severity score for hereditary transthyretin (ATTRv) amyloidosis

“…Interventional clinical trials are the gold standard for regulators in determining the efficacy and safety of medicines in a highly selected patient population under arguably artificial conditions. As a result, they are limited in their generalisability to answering the questions of other relevant groups such as prescribers and payors who are interested in patients seen in everyday practice [10,11]. In contrast, observational studies or patient registries are more inclusive, less intrusive, and therefore their findings are more representative of patients in this 'real-world' [12,13].…”

“…The data format must also be standardised to ensure that the contributing datasets can be reliably combined into a single, uniform aggregated dataset. Meeting these criteria will guarantee the collection of a unified dataset of optimal quality to form a successful ATTRv CD [11]. Currently, no ATTRv-specific CD exists, and existing ATTRv disease assessments typically utilise clinical tools such as the Familial Amyloid Polyneuropathy (FAP) staging system and the Polyneuropathy Disability (PND) score [6].…”

Developing a Transnational Health Record Framework with Level-Specific Interoperability Guidelines Based on a Related Literature Review

“…The need for interoperability has already been recognized for a long time, and many related studies have also been conducted [ 5 ]. However, previous studies have mostly focused on technical interoperability, such as with data formats [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. Interoperability includes not only the technical aspects, but also business processes, workflows, and policies.…”

“…The inclusion criteria for the selection of previous studies were: (1) published any time in or after 2016, (2) limited to articles and conference papers, (3) full free text available in a digital database, (4) present a framework, a model, or a system architecture, and ( 5) written in English. Finally, nine articles were selected to review the interoperability issues [19][20][21][22][23][24][25][26][27].…”