title: Oncology thinking cap: scaffolded use of a simulation to learn clinical trial design.
abstract: BACKGROUND
  Physicians often are called on to participate in and interpret clinical trials, but their training in this area may not provide them with the inquiry skills that are needed. Simulations have the potential to be a promising tool for helping medical students learn the skills involved in clinical trial design. However, simulations may be complex and require additional scaffolding to support learning.
  
  
  METHODS
  The goal of this study was to teach aspects of cancer clinical trial design through the scaffolded use of a simulation, the Oncology Thinking Cap. The software-based scaffolding provided guidance in designing the trial. Subsequently, the simulation allowed students to run the designed trial, which produces detailed patient histories. This feedback then could be used to redesign the trial.
  
  
  RESULTS
  Twenty-four 4th-year medical students were asked to design a clinical trial in advance, on paper, to test a new anticancer drug. Student groups then designed and simulated running the clinical trial assisted by the software environment. Instructional effectiveness was measured using a pretest-posttest design that included having students (a) write a group research proposal and (b) individually critique a flawed proposal. At the group level (N = 6 groups), students demonstrated a 34% increase in the number of elements of a clinical trial that they included in their research proposals. At the individual level (N = 24), students improved by 48% in their critiques of flawed proposals.
  
  
  CONCLUSIONS
  Scaffolding embedded in the simulator is a promising approach to helping students learn about clinical trial design.
authors.affiliation: Department of Educational Psychology, Graduate School of Education, Rutgers University, 10 Seminary Place, New Brunswick, NJ 08901-1183, USA. chmelo@rci.rutgers.edu
authors.forename: C E
authors.initials: CE
authors.lastname: Hmelo
authors.forename: S
authors.initials: S
authors.lastname: Ramakrishnan
authors.forename: R S
authors.initials: RS
authors.lastname: Day
authors.forename: W E
authors.initials: WE
authors.lastname: Shirey
authors.forename: A
authors.initials: A
authors.lastname: Brufsky
authors.forename: C
authors.initials: C
authors.lastname: Johnson
authors.forename: J
authors.initials: J
authors.lastname: Baar
authors.forename: Q
authors.initials: Q
authors.lastname: Huang
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003198:Computer Simulation; D004501:Education, Medical / Q000379:methods*; D006801:Humans; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents