Quality, quantity and harmony: the DataSHaPER approach to integrating data across bioclinical studies.
BACKGROUND
Vast sample sizes are often essential in the quest to disentangle the complex interplay of the genetic, lifestyle, environmental and social factors that determine the aetiology and progression of chronic diseases. The pooling of information between studies is therefore of central importance to contemporary bioscience. However, there are many technical, ethico-legal and scientific challenges to be overcome if an effective, valid, pooled analysis is to be achieved. Perhaps most critically, any data that are to be analysed in this way must be adequately 'harmonized'. This implies that the collection and recording of information and data must be done in a manner that is sufficiently similar in the different studies to allow valid synthesis to take place.


METHODS
This conceptual article describes the origins, purpose and scientific foundations of the DataSHaPER (DataSchema and Harmonization Platform for Epidemiological Research; http://www.datashaper.org), which has been created by a multidisciplinary consortium of experts that was pulled together and coordinated by three international organizations: P³G (Public Population Project in Genomics), PHOEBE (Promoting Harmonization of Epidemiological Biobanks in Europe) and CPT (Canadian Partnership for Tomorrow Project).


RESULTS
The DataSHaPER provides a flexible, structured approach to the harmonization and pooling of information between studies. Its two primary components, the 'DataSchema' and 'Harmonization Platforms', together support the preparation of effective data-collection protocols and provide a central reference to facilitate harmonization. The DataSHaPER supports both 'prospective' and 'retrospective' harmonization.


CONCLUSIONS
It is hoped that this article will encourage readers to investigate the project further: the more the research groups and studies are actively involved, the more effective the DataSHaPER programme will ultimately be.
Fortier
Isabel
I
Public Population Project in Genomics (P³G), Montreal, QC, Canada. ifortier@p3g.org
Burton
Paul R
PR
Robson
Paula J
PJ
Ferretti
Vincent
V
Little
Julian
J
L'Heureux
Francois
F
Deschênes
Mylène
M
Knoppers
Bartha M
BM
Doiron
Dany
D
Keers
Joost C
JC
Linksted
Pamela
P
Harris
Jennifer R
JR
Lachance
Geneviève
G
Boileau
Catherine
C
Pedersen
Nancy L
NL
Hamilton
Carol M
CM
Hveem
Kristian
K
Borugian
Marilyn J
MJ
Gallagher
Richard P
RP
McLaughlin
John
J
Parker
Louise
L
Potter
John D
JD
Gallacher
John
J
Kaaks
Rudolf
R
Liu
Bette
B
Sprosen
Tim
T
Vilain
Anne
A
Atkinson
Susan A
SA
Rengifo
Andrea
A
Morton
Robin
R
Metspalu
Andres
A
Wichmann
H Erich
HE
Tremblay
Mark
M
Chisholm
Rex L
RL
Garcia-Montero
Andrés
A
Hillege
Hans
H
Litton
Jan-Eric
JE
Palmer
Lyle J
LJ
Perola
Markus
M
Wolffenbuttel
Bruce H R
BH
Peltonen
Leena
L
Hudson
Thomas J
TJ
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003625:Data Collection / Q000379:methods; D003627:Data Interpretation, Statistical; D004812:Epidemiologic Methods; D015438:Health Behavior; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods*; D015201:Meta-Analysis as Topic; D012111:Residence Characteristics; D012959:Socioeconomic Factors
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