edify Requirements for Evidence-based Templates in Electronic Case Report Forms Marco Schweitzer, Stefan Oberbichler
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1 edify Requirements for Evidence-based Templates in Electronic Case Report Forms Marco Schweitzer, Stefan Oberbichler ehealth Research and Innovation Unit, UMIT - University for Health Sciences, Medical Informatics and Technology ehealth conference - Vienna
2 Registered Studies Electronic Data Capture Total Number of Registered Studies Year 1 according to ehealth Research and Innovation Unit 2
3 Electronic Data Capture Systematically use clinical and epidemiological research Collect patient-related data Support data integration Reduce costs and time for clinical trials Medical Data Registries Different ways to capture data o Primary data (Prospective) collection: e.g. ecrfs o Secondary data (Retrospective) collection: e.g. EHR records ehealth Research and Innovation Unit 3
4 Electronic Case Report Forms (ecrf) Electronic form aiming to collect patient-related information for clinical trials, etc. Structured forms Originally evolved from paper based CRFs Main items: Data Elements (Metadata) ehealth Research and Innovation Unit 4
5 Metadata Patient information Given Name: John Family Name: Doe Birthdate (DD-MM-YYYY): Metadata Vital Signs Body Weight (kg): 95 Data Body Height (cm): 190 Blood pressure systolic (mm Hg): 95 Blood pressure diastolic (mm Hg): 70 Medication Currently Prescribed: Metformin ehealth Research and Innovation Unit 5
6 Metadata Metadata: data that defines and describes other data (ISO/IEC11179) Data about the containers of data Data Elements need to have maximum interoperability Defined Semantics o Identification / data element name [1..1] o Definition [1..1] o Representation term [1..*] o Value properties [0..*] o Relation (hierarchy, synonyms, ) [0..*] ehealth Research and Innovation Unit 6
7 ecrf Design creating ecrfs: tedious task Selection of data elements research question Data collection o unambiguously and in sufficient detail o avoid redundancy and unwanted details Re-use of existing ecrfs or data elements Metadata Repository Problem: Metadata repositories usually don t link the evidence based information about data elements ehealth Research and Innovation Unit 7
8 edify Templates Data element 1 Data element 2 Data element 3 ecrf 1 ecrf 2 ecrf 3 edify: evidence-based Design of Electronic Case Report Forms Link ecrfs and data elements to existing sources Derive templates for evidence-based ecrfs Benefits o o Reference Docs Decrease needed effort for ecrf creation Enable/increase comparability between clinical studies Funded by TWF (Tyrolean Science Foundation) ehealth Research and Innovation Unit 8
9 Objectives Existing standards edify requirements Analyze existing ecrf design approaches: ecrf/data element standards Identify requirements to build templates for evidence-based ecrfs Concept Correlate and map defined standards and requirements ehealth Research and Innovation Unit 9
10 Methods - Requirements Engineering Literature review o Get an overview of existing standards for ecrfs & Data elements Use case definition o Define and identify necessary functions for the users Derive edify requirements Literature results edify requirements Use-cases ehealth Research and Innovation Unit 10
11 Results - edify Use cases edify Create ecrf templates <<includes>> Conductor of medical study or Medical Data Registry Compare medical studies <<includes>> <<includes>> Manage annotations Annotating actor Annotate with evidence-based information ecrf / data element repository ehealth Research and Innovation Unit 11
12 Results - Available Standards ISO/IEC o Describing Metadata within Metadata repositories o Exmples: Cancer Data Standards Registry and Repository (cadsr), Australian Metadata Online Registry (METeOR), body weight Object Class Property Conceptual Level body weight Data Element Concept 1 0..* 0..* Conceptual Domain 1 Weight Measurement Representational Level body weight in kg 0..* Data Element 0..* 1 0..* Value Domain data unit: kg Data type: numeber Data type: number ehealth Research and Innovation Unit 12
13 Results - Derived Requirements Standards conformity Define a proper structure for ecrfs and its items Utilize a semantic enabled structure Link existing information repositories Edify Requirements Link ecrf content with evidence based information ehealth Research and Innovation Unit 13
14 Discussion Literature review: informal overview on existing standards No universal standard for ecrf and data element available ISO/IEC 11179: offers high flexibility in modification by using a combination of conceptual and representation models DEFINE-XML 1 : recommendation by FDA Existing metadata repositories don t provide related evidence-based information on data element level 1 CDISC DEFINE-XML: ehealth Research and Innovation Unit 14
15 Use requirements for: o Ontology o Prototype Outlook & Conclusion Sharing ecrfs with scientific community and annotate the elements within existing literature ehealth Research and Innovation Unit 15
16 Thank you for your attention! Contact: Marco Schweitzer more Information: edify Project ehealth Research and Innovation Unit 16
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