EMA Self-Controlled Case Study of Fluoroquinolones and Retinal Detachment in The Health Improvement Network database

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01M) QUINOLONE ANTIBACTERIALS

  QUINOLONE ANTIBACTERIALS
• Medical condition to be studied:
  Retinal detachment

Population studied

• Short description of the study population:
  All patients in THIN who had a code for retinal detachment (RD) and for a fluoroquinolones (FQ) in the interval from 1 Jan 1990 to 31 Dec 2012
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Retinal detachment patients
• Estimated number of subjects:
  2584

Study design details

• Main study objective:
  To determine whether there is an increased risk of retinal detachment in patients treated with systemic (fluoro)quinolones
• Outcomes:
  Retinal detachment, To determine whether discrepancies between the studies can be explained by failure of assumptions underlying the basic SCCS model.
• Data analysis plan:
  The primary risk estimation analysis was carried out both in SAS and in STATA using the methods available from the Open University http://statistics.open.ac.uk/sccs/sas.htm.