title: The OxVALVE population cohort study (OxVALVE-PCS)-population screening for undiagnosed valvular heart disease in the elderly: study design and objectives.
abstract: Valvular heart disease (VHD) is an increasingly important cardiac condition, driven by an ageing population and lack of progress in the development of medical therapies. There is a dearth of accurate information to guide decision-makers in the development of strategies to combat VHD, and no population-based study has been performed specifically to investigate its contemporary epidemiology. This document describes the design and methodology of the OxVALVE population cohort study (OxVALVE-PCS), which was conceived to address this need.
  
  
  
  Participants aged 65 years and older attending a participating general practice in Oxfordshire, UK, are invited to attend a screening examination. Exclusion criteria include previously diagnosed VHD, inability to provide consent, terminal illness or excessive frailty. Demographics, a focused cardiovascular history and vital signs are recorded at the initial screening examination, accompanied by an echocardiogram. Any finding of significant VHD triggers a separate, more formal echocardiographic assessment (including acquisition of a three-dimensional dataset) and collection of blood samples for future genetic and biomarker analysis. Participants provide consent for longitudinal follow-up and enrolment in future cohort substudies. We also assess the acceptability of community-based echocardiographic examination and compare self-assessed quality of life between those with and without VHD.
  
  
  
  OxVALVE-PCS will provide contemporary epidemiological data concerning the community prevalence of undiagnosed VHD, facilitate accurate deployment of scarce resources to meet the anticipated increase in demand for VHD-associated healthcare and create a series of subcohorts with carefully defined genotypes and echocardiographic phenotypes for long overdue clinical studies.
  
  
  
  This study was approved by the local research ethics committee (Southampton, UK; REC Ref: 09/H0502/58).
  
  
  
  Results will be submitted for publication in peer-reviewed scientific journals.
authors.affiliation: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust , Oxford , UK.
authors.forename: Sean
authors.identifier: 0000-0003-2312-4666
authors.initials: S
authors.lastname: Coffey
authors.affiliation: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust , Oxford , UK.
authors.forename: Joanna L
authors.initials: JL
authors.lastname: d'Arcy
authors.affiliation: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust , Oxford , UK.
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Loudon
authors.affiliation: Department of Primary Care Health Sciences , NIHR School for Primary Care Research, University of Oxford , Oxford , UK.
authors.forename: David
authors.initials: D
authors.lastname: Mant
authors.affiliation: Department of Primary Care Health Sciences , NIHR School for Primary Care Research, University of Oxford , Oxford , UK.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Farmer
authors.affiliation: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust , Oxford , UK.
authors.forename: Bernard D
authors.initials: BD
authors.lastname: Prendergast
keywords: Valvular Disease