Total-body screening: preliminary results of a pilot randomized controlled trial.
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.
Obuchowski
Nancy A
NA
Division of Radiology, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. obuchon@ccf.org
Holden
Darlene
D
Modic
Michael T
MT
Cheah
Grace
G
Fu
Alex Zhenghong
AZ
Brant-Zawadzki
Michael
M
Seballos
Raul
R
Mohammed
Tan-Lucien
TL
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*