title: Feedback for patients reporting adverse drug reactions; satisfaction and expectations.
abstract: OBJECTIVE
  Due to the rising number of patient reports in pharmacovigilance, the manner in which feedback is provided to patients is an element to be considered. The objective is to explore the satisfaction of patients towards personalized and general feedback in response to their reported adverse drug reactions (ADRs).
  
  
  METHODS
  Patients who reported an ADR to the Dutch Pharmacovigilance Centre for the first time in the period between October 2012 and April 2013 were included. Reporters received personalized feedback or a general acknowledgement letter. Satisfaction towards the received feedback, expressed on a 5-point Likert scale (1 very good to 5 very poor), was studied using a web-based questionnaire. Data were analyzed using Pearson Chi-square test and linear regression analysis. Statistical significance was based on p < 0.05.
  
  
  RESULTS
  A total of 471 patient-reporters were contacted with a total response of 52.5%. Respondents of both groups were satisfied with the received feedback, average score 2 (good). Respondents of the personalized feedback-group were however more satisfied score 2.0 versus 2.5 (p < 0.001) and considered the feedback more clear and useful compared with respondents of the acknowledgement letter-group, respectively score 1.6 versus 1.7 (p = 0.01) and score 2.1 versus 2.5 (p < 0.001).
  
  
  CONCLUSIONS
  Patients reporting ADRs are satisfied with feedback received from the pharmacovigilance centre, whether this is a personalized feedback or a general acknowledgment letter. They find it clear, useful and it meets their expectation. Although differences were found between the two types of feedback, these differences did not indicate dissatisfaction towards the received feedback.
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb , Goudsbloemvallei 7, 's-Hertogenbosch , The Netherlands +31 73 6469700 ; +31 73 6426136 ; l.rolfes@lareb.nl.
authors.forename: Leàn
authors.initials: L
authors.lastname: Rolfes
authors.forename: Florence
authors.initials: F
authors.lastname: van Hunsel
authors.forename: Kees
authors.initials: K
authors.lastname: van Grootheest
authors.forename: Eugène
authors.initials: E
authors.lastname: van Puijenbroek
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions; D005246:Feedback; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017060:Patient Satisfaction; D060735:Pharmacovigilance; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: adverse drug reactions; feedback; patient reporting; pharmacovigilance