title: Consensus on the criteria needed for creating a rare-disease patient registry. A Delphi study.
abstract: Patient registries (PRs) are important tools for public-health surveillance and rare-disease research. The purpose of this study is to identify the most important criteria for the creation of a rare-disease PR that could be used by public-health authorities to develop health policies.
  
  
  
  A consensus-development Delphi study was used, with participants selected for their expertize in rare diseases and registries. Participants were asked to complete a questionnaire on the most important criteria for creating PRs. Three rounds were performed.
  
  
  
  Agreement was reached on half the questions in the first round and on 89% of questions in the final round, with a total expert participation rate of around 60% by the final stage. This study made it possible to reach a broader consensus starting from experts' initial assessment of the features that should be considered for the creation of a rare-disease PR.
  
  
  
  The consensus method used made it possible to define the characteristics of a PR based on expert opinion within a rare-disease framework. This study may serve as a guide for helping other researchers plan and build a rare-disease PR.
authors: Rare Diseases Research Area, FISABIO-Public Health, Valencia, Spain.
authors: Clara
authors: C
authors: Cavero-Carbonell
authors: Rare Diseases Research Area, FISABIO-Public Health, Valencia, Spain.
authors: Elena
authors: E
authors: Gras-Colomer
authors: Public Health Center, Valencia, Spain.
authors: Rosana
authors: R
authors: Guaita-Calatrava
authors: Inequalities Research Area, FISABIO-Public Health, Valencia, Spain.
authors: Carmen
authors: C
authors: López-Briones
authors: Inequalities Research Area, FISABIO-Public Health, Valencia, Spain.
authors: Rubén
authors: R
authors: Amorós
authors: Institute of Rare Diseases Research (IIER), Madrid, Spain SpainRDR and CIBERER, Madrid, Spain Instituto de Salud Carlos III (ISCIII), Madrid, Spain.
authors: Ignacio
authors: I
authors: Abaitua
authors: Institute of Rare Diseases Research (IIER), Madrid, Spain SpainRDR and CIBERER, Madrid, Spain Instituto de Salud Carlos III (ISCIII), Madrid, Spain.
authors: Manuel
authors: M
authors: Posada
authors: Rare Diseases Research Area, FISABIO-Public Health, Valencia, Spain Subdirección General de Epidemiología y Vigilancia de la Salud, Conselleria de Sanitat, Valencia, Spain Spanish Consortium of Epidemiology and Public Health Research (CIBERESP), Madrid, Spain.
authors: Oscar
authors: O
authors: Zurriaga
mesh_terms: D032921:Consensus; D003697:Delphi Technique; D004812:Epidemiologic Methods; D006801:Humans; D007400:Interprofessional Relations; D035583:Rare Diseases / Q000453:epidemiology*; D012042:Registries / Q000592:standards; D013030:Spain / Q000453:epidemiology; D011795:Surveys and Questionnaires / Q000592:standards*
keywords: Delphi technique; expert opinion; rare diseases; registry