Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data

Dugas, Martin

doi:10.1186/s13063-016-1691-8

Cited by 7 publications

(5 citation statements)

References 8 publications

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“…Standardized data formats result in syntactic compatibility and facilitate integration and interpretation of clinical research data without the need to apply a proprietary data format [ 34 ]. Moreover, it allows the reuse of metadata elements from previous subject-related studies, leading to a simplified metadata development process and data compatibility at the design stage [ 10 ]. We agreed to support the regulatory-compliant and well-established CDISC ODM standard, which is “a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information” [ 16 ].…”

Section: Resultsmentioning

confidence: 99%

“…We agreed to support the regulatory-compliant and well-established CDISC ODM standard, which is “a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information” [ 16 ]. It is the fundamental part of Define-XML [ 35 ], which is included in the United States Food and Drug Administration Data Standards Catalog [ 10 , 36 ]. See the Discussion section for comparison with other medical data standards.…”

Section: Resultsmentioning

confidence: 99%

“…However, proprietary or customized data formats used by EDC vendors render this endeavor a major point of concern. As a result, incompatible electronic case report form (eCRF) data structures impede data integration and analysis from different sources and, hence, the full potential of captured information [ 10 ]. A system that fosters compatible data structures through standardization could pave the way toward more open science to improve scientific understanding and enhance patient care [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study

Greulich¹,

Hegselmann²,

Dugas³

2021

JMIR Med Inform

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Background Medical research and machine learning for health care depend on high-quality data. Electronic data capture (EDC) systems have been widely adopted for metadata-driven digital data collection. However, many systems use proprietary and incompatible formats that inhibit clinical data exchange and metadata reuse. In addition, the configuration and financial requirements of typical EDC systems frequently prevent small-scale studies from benefiting from their inherent advantages. Objective The aim of this study is to develop and publish an open-source EDC system that addresses these issues. We aim to plan a system that is applicable to a wide range of research projects. Methods We conducted a literature-based requirements analysis to identify the academic and regulatory demands for digital data collection. After designing and implementing OpenEDC, we performed a usability evaluation to obtain feedback from users. Results We identified 20 frequently stated requirements for EDC. According to the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 25010 norm, we categorized the requirements into functional suitability, availability, compatibility, usability, and security. We developed OpenEDC based on the regulatory-compliant Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) standard. Mobile device support enables the collection of patient-reported outcomes. OpenEDC is publicly available and released under the MIT open-source license. Conclusions Adopting an established standard without modifications supports metadata reuse and clinical data exchange, but it limits item layouts. OpenEDC is a stand-alone web app that can be used without a setup or configuration. This should foster compatibility between medical research and open science. OpenEDC is targeted at observational and translational research studies by clinicians.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study

Greulich¹,

Hegselmann²,

Dugas³

2021

JMIR Med Inform

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“…Storing metadata in this standard format and supporting semantic annotation, i.e. mapping of codes of a terminology to medical concepts, may facilitate data integration from various sources [30, 31].…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2019

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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.

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“…As a remedy, the unambiguous interpretation and, thus, integration of such “instance data” can be facilitated by describing their variety and characteristics using “metadata”. If curated and semantically annotated, metadata is instrumental in data integration [ 2 ]. For example, metadata can be used for validation and transformation of instance data: Having harmonized metadata at the schema level, matchings and mappings between different metadata sets can be used to generate the transformation of instance data, as conceptually shown in Fig.…”

Section: Introductionmentioning

confidence: 99%

QL4MDR: a GraphQL query language for ISO 11179-based metadata repositories

Ulrich

Kern

Tas

et al. 2019

BMC Med Inform Decis Mak

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BackgroundHeterogeneous healthcare instance data can hardly be integrated without harmonizing its schema-level metadata. Many medical research projects and organizations use metadata repositories to edit, store and reuse data elements. However, existing metadata repositories differ regarding software implementation and have shortcomings when it comes to exchanging metadata. This work aims to define a uniform interface with a technical interlingua between the different MDR implementations in order to enable and facilitate the exchange of metadata, to query over distributed systems and to promote cooperation. To design a unified interface for multiple existing MDRs, a standardized data model must be agreed on. The ISO 11179 is an international standard for the representation of metadata, and since most MDR systems claim to be at least partially compliant, it is suitable for defining an interface thereupon. Therefore, each repository must be able to define which parts can be served and the interface must be able to handle highly linked data. GraphQL is a data access layer and defines query techniques designed to navigate easily through complex data structures.ResultsWe propose QL4MDR, an ISO 11179-3 compatible GraphQL query language. The GraphQL schema for QL4MDR is derived from the ISO 11179 standard and defines objects, fields, queries and mutation types. Entry points within the schema define the path through the graph to enable search functionalities, but also the exchange is promoted by mutation types, which allow creating, updating and deleting of metadata. QL4MDR is the foundation for the uniform interface, which is implemented in a modern web-based interface prototype.ConclusionsWe have introduced a uniform query interface for metadata repositories combining the ISO 11179 standard for metadata repositories and the GraphQL query language. A reference implementation based on the existing Samply.MDR was implemented. The interface facilitates access to metadata, enables better interaction with metadata as well as a basis for connecting existing repositories. We invite other ISO 11179-based metadata repositories to take this approach into account.

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Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data

Cited by 7 publications

References 8 publications

An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study

An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study

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

QL4MDR: a GraphQL query language for ISO 11179-based metadata repositories

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