title: Quality, quantity and harmony: the DataSHaPER approach to integrating data across bioclinical studies.
abstract: 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.
authors.affiliation: Public Population Project in Genomics (P³G), Montreal, QC, Canada. ifortier@p3g.org
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authors.lastname: Fortier
authors.forename: Paul R
authors.initials: PR
authors.lastname: Burton
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Robson
authors.forename: Vincent
authors.initials: V
authors.lastname: Ferretti
authors.forename: Julian
authors.initials: J
authors.lastname: Little
authors.forename: Francois
authors.initials: F
authors.lastname: L'Heureux
authors.forename: Mylène
authors.initials: M
authors.lastname: Deschênes
authors.forename: Bartha M
authors.initials: BM
authors.lastname: Knoppers
authors.forename: Dany
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authors.lastname: Doiron
authors.forename: Joost C
authors.initials: JC
authors.lastname: Keers
authors.forename: Pamela
authors.initials: P
authors.lastname: Linksted
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Harris
authors.forename: Geneviève
authors.initials: G
authors.lastname: Lachance
authors.forename: Catherine
authors.initials: C
authors.lastname: Boileau
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Pedersen
authors.forename: Carol M
authors.initials: CM
authors.lastname: Hamilton
authors.forename: Kristian
authors.initials: K
authors.lastname: Hveem
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: Borugian
authors.forename: Richard P
authors.initials: RP
authors.lastname: Gallagher
authors.forename: John
authors.initials: J
authors.lastname: McLaughlin
authors.forename: Louise
authors.initials: L
authors.lastname: Parker
authors.forename: John D
authors.initials: JD
authors.lastname: Potter
authors.forename: John
authors.initials: J
authors.lastname: Gallacher
authors.forename: Rudolf
authors.initials: R
authors.lastname: Kaaks
authors.forename: Bette
authors.initials: B
authors.lastname: Liu
authors.forename: Tim
authors.initials: T
authors.lastname: Sprosen
authors.forename: Anne
authors.initials: A
authors.lastname: Vilain
authors.forename: Susan A
authors.initials: SA
authors.lastname: Atkinson
authors.forename: Andrea
authors.initials: A
authors.lastname: Rengifo
authors.forename: Robin
authors.initials: R
authors.lastname: Morton
authors.forename: Andres
authors.initials: A
authors.lastname: Metspalu
authors.forename: H Erich
authors.initials: HE
authors.lastname: Wichmann
authors.forename: Mark
authors.initials: M
authors.lastname: Tremblay
authors.forename: Rex L
authors.initials: RL
authors.lastname: Chisholm
authors.forename: Andrés
authors.initials: A
authors.lastname: Garcia-Montero
authors.forename: Hans
authors.initials: H
authors.lastname: Hillege
authors.forename: Jan-Eric
authors.initials: JE
authors.lastname: Litton
authors.forename: Lyle J
authors.initials: LJ
authors.lastname: Palmer
authors.forename: Markus
authors.initials: M
authors.lastname: Perola
authors.forename: Bruce H R
authors.initials: BH
authors.lastname: Wolffenbuttel
authors.forename: Leena
authors.initials: L
authors.lastname: Peltonen
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Hudson
mesh_terms: 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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