storing results data
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Storing Results Storing Results DataData
Clement McDonald, M.D.Clement McDonald, M.D.Director, Lister Hill Center National Center for Biomedical Director, Lister Hill Center National Center for Biomedical
CommunicationsCommunicationsNational Library of MedicineNational Library of Medicine
February 11, 2008February 11, 2008
Scope Scope
The focus is on summary data of The focus is on summary data of the kind one sees in publication the kind one sees in publication
Characteristics of patients at base Characteristics of patients at base lineline
Differences between the outcomes Differences between the outcomes of the various study armsof the various study arms
Not patient level data Not patient level data
GoalsGoals
Represent this data in a generalized Represent this data in a generalized but “structured” formatbut “structured” format
Take advantage of what is in the Take advantage of what is in the registry data base to ease entry of registry data base to ease entry of results dataresults data
Minimize entry workMinimize entry work Accommodate most study designsAccommodate most study designs
Three parts to the Three parts to the problem problem Define the variables - used in the Define the variables - used in the
study study To characterize populationTo characterize population To measure outcomes To measure outcomes Etc.Etc.
– E.g. Age, creatinine, PHQ-9 E.g. Age, creatinine, PHQ-9
For each variable For each variable
Name Name Description Description Data type (e.g. continuous, Data type (e.g. continuous,
categorical, time to event )categorical, time to event ) Additional information depending Additional information depending
upon data type e.g.:upon data type e.g.:– For categorical variables - the categoriesFor categorical variables - the categories– For continuous variables- the units of For continuous variables- the units of
measuremeasure
Define the study arms Define the study arms and phases. and phases. Name Name Description Description E.g.E.g.
– Arm 1 - treat with new drug or device Arm 1 - treat with new drug or device XX
– Arm 2 - placeboArm 2 - placebo Statistical analyses – as Statistical analyses – as
descriptive text. descriptive text.
Define tablesDefine tables
Rows variables Rows variables Columns study arm phase - and one Columns study arm phase - and one
column for statistical analysis. column for statistical analysis. List the discrete summary observations List the discrete summary observations
per cell depends on data type per cell depends on data type – E.g. for continuousE.g. for continuous
NN MeanMean Coefficient of variationCoefficient of variation (more)(more)
Data structuresData structures
XML for current testing phaseXML for current testing phase
As relational data base As relational data base - simplest incarnation - simplest incarnation Table for study – with record per study Table for study – with record per study Table for variables - one record per Table for variables - one record per
variablevariable Table for study arms/phases - one Table for study arms/phases - one
record per study arm phaserecord per study arm phase Table for overview of each tables – one Table for overview of each tables – one
record per cell record per cell Table to define each table - one record Table to define each table - one record
per cellper cell
Non trivial problemNon trivial problem
Especially for newer study Especially for newer study designsdesigns
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