title: Total-body screening: preliminary results of a pilot randomized controlled trial.
abstract: OBJECTIVE
  The authors performed a pilot randomized controlled trial of total-body screening to assess the feasibility of a full-scale study.
  
  
  METHODS
  After informed consent, 50 asymptomatic people were randomized to either the intervention arm (total-body screening with multidetector computed tomography) or the control arm (no screening for 3 years). The study was approved by our institutional review board and was compliant with the Health Insurance Portability and Accountability Act. Images were interpreted independently by 6 radiologists from 2 institutions. Subjects in both study arms completed periodic health questionnaires and medical utilization forms over 2 years. Key outcome variables were the incidence of symptomatic disease, medical costs, and patient-reported health.
  
  
  RESULTS
  Sixteen screened subjects (64%) had abnormal findings on screening. A second interpretation of the images yielded a similar overall rate but with considerable variability at the subject level. No cancers were detected. Ninety percent of subjects were compliant at 2 years. Medical costs were twice as high for screened subjects, with considerable between-subject variability. Screened subjects reported fewer physical limitations than unscreened subjects.
  
  
  CONCLUSIONS
  A full-scale randomized controlled trial of total-body screening will need to account for the large interreader variability in interpreting the images, the high rate of incidental findings, and the low prevalence of cancers. A full-scale study using mortality as the endpoint does not seem feasible at this time.
authors.affiliation: Division of Radiology, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. obuchon@ccf.org
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Obuchowski
authors.forename: Darlene
authors.initials: D
authors.lastname: Holden
authors.forename: Michael T
authors.initials: MT
authors.lastname: Modic
authors.forename: Grace
authors.initials: G
authors.lastname: Cheah
authors.forename: Alex Zhenghong
authors.initials: AZ
authors.lastname: Fu
authors.forename: Michael
authors.initials: M
authors.lastname: Brant-Zawadzki
authors.forename: Raul
authors.initials: R
authors.lastname: Seballos
authors.forename: Tan-Lucien
authors.initials: TL
authors.lastname: Mohammed
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D003365:Costs and Cost Analysis; D005240:Feasibility Studies; D005260:Female; D006306:Health Surveys; D006801:Humans; D033162:Incidental Findings; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012307:Risk Factors; D014057:Tomography, X-Ray Computed / Q000191:economics / Q000379:methods*; D051598:Whole Body Imaging / Q000191:economics / Q000379:methods*