title: Construct validity in a high-fidelity prostate exam simulator.
abstract: BACKGROUND
  All health care practitioners should be facile in the digital rectal exam (DRE) as it provides prostate, rectal and neurological information. The purpose of this study was first to justify our hypothesis that tissue elasticity is indicative of carcinomatous changes. Second, we employed urological surgeons to evaluate our prostate simulator in three ways: (1) authenticate that the elasticity of the simulated prostates accurately represents the range of normal prostate stiffness, (2) determine the range of nodule size reasonably palpable by DRE and (3) discern what degree of elasticity difference within the same prostate suggests malignancy.
  
  
  METHODS
  Institutional Review Board-approved materials characterization, human-subjects experiments, histopathology and chart abstraction of clinical history were performed. Material characterization of 21 ex-vivo prostatectomy specimens was evaluated using a custom-built, portable spherical indentation device while a novel prostate simulator was employed to measure human-subject perception of prostatic state.
  
  
  RESULTS
  From the materials characterization, the measurements of the 21 gross prostates and 40 cross-sections yielded 306 data points. Within the same prostate, cancer was always stiffer. Of the seven cases with an abnormal DRE, the DRE accurately identified adenocarcinoma in 85%. From the human-subjects experiments, the simulated prostates evaluated by urologists ranged in stiffness from 8.9 to 91 kPa, mimicking the range found on ex vivo analysis of 4.6-236.7 kPa. The urological surgeons determined the upper limit of stiffness palpated as realistic for a healthy prostate was 59.63 kPa while the lower limit of stiffness was 27.1 kPa. Nodule size less than 7.5 mm was felt to be too small to reasonably palpate.
  
  
  CONCLUSIONS
  We found it is not the absolute elasticity of the nodule, but rather the relationship of the nodule with the background prostate elasticity that constitutes the critical tactile feedback. Prostate simulator training may lead to greater familiarity with pertinent diagnostic cues and diagnosis of prostate cancer.
authors.affiliation: Department of Urology, Lahey Clinic Medical Center, Boston, MA 22908, USA.
authors.forename: C G
authors.initials: CG
authors.lastname: Kowalik
authors.forename: G J
authors.initials: GJ
authors.lastname: Gerling
authors.forename: A J
authors.initials: AJ
authors.lastname: Lee
authors.forename: W C
authors.initials: WC
authors.lastname: Carson
authors.forename: J
authors.initials: J
authors.lastname: Harper
authors.forename: C A
authors.initials: CA
authors.lastname: Moskaluk
authors.forename: T L
authors.initials: TL
authors.lastname: Krupski
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis* / Q000473:pathology; D000328:Adult; D000368:Aged; D051517:Digital Rectal Examination; D004502:Education, Medical, Continuing / Q000379:methods; D055119:Elastic Modulus; D005260:Female; D006801:Humans; D057230:Limit of Detection; D008297:Male; D008875:Middle Aged; D008953:Models, Anatomic; D011467:Prostate / Q000473:pathology; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000473:pathology; D047368:Tumor Burden