title: How much information about the benefits of medicines is included in patient leaflets in the European Union? - A survey.
abstract: BACKGROUND
  Patient information leaflets (PILs) are required with all licensed medicines throughout the European Union (EU) and they must include information about all side effects and their likelihood. This has led to criticism of a lack of balance, with little information included about potential benefits. Recent European Medicines Agency guidance proposed the inclusion of benefit information, and this study examined the current prevalence and type of such information in PILs in the EU.
  
  
  METHODS
  A survey and content analysis of the English translation of PILs in the EUwas carried out. Random quota sampling was used on the most frequently dispensed (n = 50) and newly licensed medicines (n = 50) in 2011/2. Leaflets were searched for benefit information meeting predefined criteria, and data synthesised and categorised into 10 categories.
  
  
  RESULTS
  Eighty-five (85%) leaflets described how the medicine works, with 45 providing information about the rationale for treatment (more commonly for newly licensed (32/50) than most commonly dispensed medicines (13/50; P < 0.001). Nearly half (47) did not describe whether the medicine was curative, symptomatic or preventative. The terms used to communicate uncertainty were imprecise (such as 'may help'). None communicated numerical benefit information.
  
  
  CONCLUSIONS
  Current PILs do not appropriately communicate information about benefit. At the basic level, around a half did not include information about treatment rationale or whether the treatment was to treat symptoms, curative or preventative. However, for true informed decision making, patients need quantitative information about benefits and none of the leaflets provided this.
authors.affiliation: School of Healthcare, University of Leeds, Leeds, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Dickinson
authors.affiliation: School of Healthcare, University of Leeds, Leeds, UK.
authors.forename: David K
authors.initials: DK
authors.lastname: Raynor
authors.affiliation: Hull York Medical School, York, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Knapp
authors.affiliation: Medicines and Healthcare products Regulatory Agency, London, UK.
authors.forename: Jan
authors.initials: J
authors.lastname: MacDonald
mesh_terms: D003142:Communication; D003657:Decision Making; D004348:Drug Labeling / Q000379:methods* / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005062:European Union; D006801:Humans; D010174:Pamphlets; D011795:Surveys and Questionnaires