title: Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.
abstract: OBJECTIVE
  The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making.
  
  
  METHODS
  A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance.
  
  
  RESULTS
  The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials.
  
  
  CONCLUSIONS
  Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.
authors.affiliation: a Swedish Medical Products Agency , Uppsala , Sweden.
authors.forename: Nils
authors.initials: N
authors.lastname: Feltelius
authors.affiliation: a Swedish Medical Products Agency , Uppsala , Sweden.
authors.forename: Rolf
authors.initials: R
authors.lastname: Gedeborg
authors.affiliation: a Swedish Medical Products Agency , Uppsala , Sweden.
authors.forename: Lennart
authors.initials: L
authors.lastname: Holm
authors.affiliation: a Swedish Medical Products Agency , Uppsala , Sweden.
authors.forename: Björn
authors.initials: B
authors.lastname: Zethelius
mesh_terms: D003362:Cost-Benefit Analysis; D003657:Decision Making; D006760:Hospitalization; D006801:Humans; D040541:Marketing; D017063:Outcome Assessment, Health Care; D011358:Product Surveillance, Postmarketing; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D011795:Surveys and Questionnaires; D013548:Sweden; D016896:Treatment Outcome
keywords: Drug regulation; health technology assessment; medical devices; pharmacoepidemiology; quality registries; real world data