Biomaterial Database

Common data elements for clinical research in Friedreich's ataxia. 2013

David R Lynch, and Massimo Pandolfo, and Jorg B Schulz, and Susan Perlman, and Martin B Delatycki, and R Mark Payne, and Robert Shaddy, and Kenneth H Fischbeck, and Jennifer Farmer, and Paul Kantor, and Subha V Raman, and Lisa Hunegs, and Joanne Odenkirchen, and Kristy Miller, and Petra Kaufmann

Department of Neurology, University of Pennsylvania and the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA. lynchd@mail.med.upenn.edu

To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.

UI	MeSH Term	Description	Entries
D007391	International Cooperation	The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.	Foreign Aid,Treaties,Aid, Foreign,Cooperation, International,Treaty
D009316	National Institutes of Health (U.S.)	An operating division of the US Department of Health and Human Services. It is concerned with the overall planning, promoting, and administering of programs pertaining to health and medical research.	United States National Institutes of Health,National Institutes of Health
D009460	Neurologic Examination	Assessment of sensory and motor responses and reflexes that is used to determine impairment of the nervous system.	Examination, Neurologic,Neurological Examination,Examination, Neurological,Examinations, Neurologic,Examinations, Neurological,Neurologic Examinations,Neurological Examinations
D009462	Neurology	A medical specialty concerned with the study of the structures, functions, and diseases of the nervous system.
D009626	Terminology as Topic	Works about the terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.	Etymology,Nomenclature as Topic,Etymologies
D011597	Psychomotor Performance	The coordination of a sensory or ideational (cognitive) process and a motor activity.	Perceptual Motor Performance,Sensory Motor Performance,Visual Motor Coordination,Coordination, Visual Motor,Coordinations, Visual Motor,Motor Coordination, Visual,Motor Coordinations, Visual,Motor Performance, Perceptual,Motor Performance, Sensory,Motor Performances, Perceptual,Motor Performances, Sensory,Perceptual Motor Performances,Performance, Perceptual Motor,Performance, Psychomotor,Performance, Sensory Motor,Performances, Perceptual Motor,Performances, Psychomotor,Performances, Sensory Motor,Psychomotor Performances,Sensory Motor Performances,Visual Motor Coordinations
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D003625	Data Collection	Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.	Data Collection Methods,Dual Data Collection,Collection Method, Data,Collection Methods, Data,Collection, Data,Collection, Dual Data,Data Collection Method,Method, Data Collection,Methods, Data Collection
D003627	Data Interpretation, Statistical	Application of statistical procedures to analyze specific observed or assumed facts from a particular study.	Data Analysis, Statistical,Data Interpretations, Statistical,Interpretation, Statistical Data,Statistical Data Analysis,Statistical Data Interpretation,Analyses, Statistical Data,Analysis, Statistical Data,Data Analyses, Statistical,Interpretations, Statistical Data,Statistical Data Analyses,Statistical Data Interpretations
D003710	Demography	Statistical interpretation and description of a population with reference to distribution, composition, or structure.	Demographer,Demographic,Demographic and Health Survey,Population Distribution,Accounting, Demographic,Analyses, Demographic,Analyses, Multiregional,Analysis, Period,Brass Technic,Brass Technique,Demographers,Demographic Accounting,Demographic Analysis,Demographic Factor,Demographic Factors,Demographic Impact,Demographic Impacts,Demographic Survey,Demographic Surveys,Demographic and Health Surveys,Demographics,Demography, Historical,Demography, Prehistoric,Factor, Demographic,Factors, Demographic,Family Reconstitution,Historical Demography,Impact, Demographic,Impacts, Demographic,Multiregional Analysis,Period Analysis,Population Spatial Distribution,Prehistoric Demography,Reverse Survival Method,Stable Population Method,Survey, Demographic,Surveys, Demographic,Analyses, Period,Analysis, Demographic,Analysis, Multiregional,Demographic Analyses,Demographies, Historical,Demographies, Prehistoric,Distribution, Population,Distribution, Population Spatial,Distributions, Population,Distributions, Population Spatial,Family Reconstitutions,Historical Demographies,Method, Reverse Survival,Method, Stable Population,Methods, Reverse Survival,Methods, Stable Population,Multiregional Analyses,Period Analyses,Population Distributions,Population Methods, Stable,Population Spatial Distributions,Prehistoric Demographies,Reconstitution, Family,Reconstitutions, Family,Reverse Survival Methods,Spatial Distribution, Population,Spatial Distributions, Population,Stable Population Methods,Technic, Brass,Technique, Brass