title: Reducing drug self-injection errors: a randomized trial comparing a "standard" versus "plain language" version of Patient Instructions for Use.
abstract: BACKGROUND
  Many American adults struggle to use and interpret medical-related instructions. Plain language materials have been shown to improve patient understanding and adherence.
  
  
  OBJECTIVE
  The study objective was to compare the effectiveness of a "standard" Patient Instructions for Use (PIFU-standard) with a "plain language" Patient Instructions for Use (PIFU-PL) by testing user comprehension and ability to administer a biologic agent with an auto-injector ("pen").
  
  
  METHODS
  A trained research assistant administered sociodemographic items and the Rapid Estimate of Adult Literacy in Medicine to study participants (n = 50). Next, using a priori random assignment, participants received either PIFU-PL or PIFU-standard. Participants' knowledge of preparation (6 steps) and pre-injection (3 steps) procedures, and demonstrated correctness of self-administration (15 steps) were then evaluated.
  
  
  RESULTS
  Participants receiving the PIFU-PL were more likely to correctly describe a greater number of both preparation (4.5 ± 1.3 versus 3.1 ± 1.5, P = 0.01) and pre-injection steps (2.4 ± 0.8 versus 1.6 ± 0.6, P = 0.01), and demonstrated more correct self-injection steps (13.1 ± 2.1 versus 10.8 ± 4.4, P = 0.05) as compared to participants receiving the PIFU-standard.
  
  
  CONCLUSIONS
  Participants given "plain language" instructions had a significantly better understanding of how to prepare for and self-administer medication with a pen and were consistently more accurate in demonstrating how to self-inject.
authors.affiliation: Risk Management, Abbott Laboratories, Bldg AP6C\Dept NJ44, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Electronic address: Meredith.Smith@abbott.com.
authors.forename: Meredith Y
authors.initials: MY
authors.lastname: Smith
authors.forename: Lorraine S
authors.initials: LS
authors.lastname: Wallace
mesh_terms: D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D001685:Biological Factors / Q000008:administration & dosage*; D032882:Comprehension; D003424:Crohn Disease / Q000188:drug therapy; D004348:Drug Labeling; D005260:Female; D057220:Health Literacy; D006801:Humans; D007267:Injections; D008297:Male; D008508:Medication Errors / Q000517:prevention & control*; D008875:Middle Aged; D010353:Patient Education as Topic; D012646:Self Administration
chemical_list: D001685:Biological Factors
keywords: Comprehension; Drug labeling; Health literacy; Medication errors; Patient education as topic/methods; Prescription drugs/administration; Risk reduction behavior