title: Understanding and assessing potential serious adverse events: a practical approach to understanding the benefits and harm of psoriasis treatments.
abstract: BACKGROUND
  Any therapeutic intervention carries with it the potential for benefit and harm. Generally, benefit is far more common than risk; however, risk aversion drives many of the treatment decisions made by patients and their physicians.
  
  
  OBJECTIVE
  To provide guidelines to help clinicians improve their understanding of causality and the interpretation of harm.
  
  
  METHODS
  A group of dermatologists involved in data safety monitoring boards, clinical trial investigators, and a clinical epidemiologist identified the need for practical advice on how to understand and explain causality and harm and combined to share their knowledge.
  
  
  RESULTS
  An explanation of how data are collected and the environment that shapes the data seen by clinicians is presented. The article spans an overview of the regulatory environment that informs trial design for regulatory approval to a description of types of designs that inform safety and techniques, such as the rule of three, to provide guidance to clinicians in interpreting the data.
  
  
  CONCLUSIONS
  Communicating the potential for harm to patients is critical. Placing the potential for rare and serious risks into perspective for the patient is as important as discussing the potential benefits of medication.
authors.affiliation: Probity Medical Research, Waterloo, ON, Canada.
authors.forename: Kim
authors.initials: K
authors.lastname: Papp
authors.forename: Lyn
authors.initials: L
authors.lastname: Guenther
authors.forename: Neil
authors.initials: N
authors.lastname: Shear
authors.forename: Carin
authors.initials: C
authors.lastname: Binder
authors.forename: Jerry
authors.initials: J
authors.lastname: Tan
authors.forename: Charles
authors.initials: C
authors.lastname: Lynde
authors.forename: Wayne
authors.initials: W
authors.lastname: Gulliver
authors.forename: Paul
authors.initials: P
authors.lastname: Stang
mesh_terms: D003880:Dermatology / Q000379:methods*; D019468:Disease Management; D014943:Global Health; D006801:Humans; D015994:Incidence; D017410:Practice Guidelines as Topic; D011565:Psoriasis / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D012107:Research Design; D018570:Risk Assessment / Q000379:methods*