ADDIS: A decision support system for evidence-based medicine

摘要

Clinical trials are the main source of information for the efficacy and safety evaluation of medical treatments. Although they are of pivotal importance in evidence-based medicine, there is a lack of usable information systems providing data-analysis and decision support capabilities for aggregate clinical trial results. This is partly caused by unavailability (i) of trial data in a structured format suitable for re-analysis, and (ii) of a complete data model for aggregate level results. In this paper, we develop a unifying data model that enables the development of evidence-based decision support in the absence of a complete data model. We describe the supported decision processes and show how these are implemented in the open source ADDIS software. ADDIS enables semi-automated construction of meta-analyses, network meta-analyses and benefit–risk decision models, and provides visualization of all results.

论文关键词：OCRe,Ontology of Clinical Research,OBX,Ontology Based Extensible Conceptual Model,DED,Data Element Definitions,OWL,Web Ontology Language,ADaM,Analysis Data Model,ADE,Adverse Drug Event (an injury resulting from a medication),ADR,Adverse Drug Reaction (any unexpected, unintended, undesired or excessive response to a drug, with or without an injury),AMIA,American Medical Informatics Association,ANSI,American National Standards Institute,BRIDG,Biomedical Research Integrated Domain Group,caBIG,Cancer Biomedical Informatics Grid,CDASH,Clinical Data Acquisition Standards Harmonization,CDISC,Clinical Data Interchange Standards Consortium,CDMS,Clinical Data Management System (sophisticated EDC system),CHMP,Committee for Medicinal Products for Human Use (EMA),CPOE,Computerized Physician Order Entry,CRF,Case Report Form,CRO,Clinical Research Organization,CTIS,Clinical Trial Information System,CTMS,Clinical Trial Management System (sophisticated CDMS),DB,Database,DIS,Drug Information System,DSS,Decision Support System,EAV,Entity Attribute Value,EBM,Evidence-Based Medicine,eCRF,Electronic Case Report Form,EDC,Electronic Data Capture,EHR,Electronic Health Record,eLab,Electronic Laboratory Data,EMA,European Medicines Agency (EU, formerly EMEA),EPAR,European Public Assessment Report,ePRO,Electronic Patient Reported Outcome,FDAAA,FDA Amendments Act of 2007,FDA,Food and Drug Administration (US),GCP,Good Clinical Practice,HL7,Health Level 7,HSDB,Human Studies Database,ICMJE,International Committee of Medical Journal Editors,ICTRP,International Clinical Trials Registry Platform,JAMA,Journal of the American Medical Association,LAB,Laboratory Data Model,NCI,National Cancer Institute (US),NDA,New Drug Application,NIHUS,National Institutes of Health,ODM,Operational Data Model,PhRMA,Pharmaceutical Research and Manufacturers of America,PIM,Product Information Management (EMA),PMDA,Pharmaceuticals and Medical Devices Agency (Japan),PRM,Protocol Representation Model,QRD,Quality Review of Documents (EMA),RIM,Reference Information Model,SDTM,Study Data Tabulation Model,SEND,Standards for Exchange of Nonclinical Data,SmPC,Summary of Product Characteristics,SPL,Structured Product Labeling (FDA),TDM,Trial Design Model,WHO,World Health Organization,GUI,Graphical User Interface,DOI,Digital Object Identifier,MCDA,Multi-criteria Decision Analysis,ICD,International Classification of Diseases,MedDRA,Medical Dictionary for Regulatory Activities,MeSH,Medical Subject Headings,SNOMEDCT,Systematized Nomenclature of Medicine, Clinical Terms,UMLS,Unified Medical Language System,ATC,Anatomical Therapeutic Chemical Classification System,SMAA,Stochastic Multi-criteria Acceptability Analysis,Evidence-based medicine,Evidence synthesis,Data model,Clinical trial,Decision analysis