title: A systematic review of the methodological quality and extent to which evaluation studies measure the usability of orthopaedic shoes.
abstract: OBJECTIVE
  To determine the methodological quality of studies evaluating orthopaedic shoes and orthopaedic shoe provisions. To what extent do studies evaluating orthopaedic shoes prescribed for patients with degenerative disorders of the foot, rheumatoid arthritis, diabetes mellitus and neurological foot disorders, focus on the aspects of the International Organization for Standardization (ISO) definition of usability, i.e., effectiveness, efficiency, satisfaction, and context of use?
  
  
  METHODS
  Systematic review.
  
  
  METHODS
  A systematic literature search was performed to identify randomized controlled trials (RCTs) concerning orthopaedic shoes and orthopaedic shoe inserts. The methodological quality of the studies was assessed independently by two raters, based on the 19 items of the 'Maastricht-Amsterdam criteria list'. The studies were assessed against the parameters of the ISO definition of usability.
  
  
  RESULTS
  Eleven RCTs were included. The methodological scores ranged from 8 to 14 out of 19 possible points. Eleven studies focused on the effectiveness of the orthopaedic shoes and orthopaedic shoe inserts, two of which reported outcome measures and conclusions related to the efficiency of the studied orthopaedic shoes and orthopaedic shoe inserts. Four studies reported some form of patient satisfaction and only three studies paid attention to the context of use.
  
  
  CONCLUSIONS
  The methodological quality of the RCTs as assessed according to the 19 different criteria varied considerably. The present review shows that current scientific literature concerning the usability of orthopaedic shoes focuses mainly on effectiveness at the expense of the other domains of usability, i.e., efficiency, satisfaction and context of use.
authors.affiliation: Roessingh Research and Development, Enschede, The Netherlands. m.jannink@rrd.nl
authors.forename: Michiel J A
authors.initials: MJ
authors.lastname: Jannink
authors.forename: Henk
authors.initials: H
authors.lastname: van Dijk
authors.forename: Jaap
authors.initials: J
authors.lastname: de Vries
authors.forename: Johan W
authors.initials: JW
authors.lastname: Groothoff
authors.forename: Gustaaf J
authors.initials: GJ
authors.lastname: Lankhorst
mesh_terms: D005069:Evaluation Studies as Topic; D006801:Humans; D009989:Orthotic Devices / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D012775:Shoes / Q000592:standards*