PURPOSE: The authors performed a pilot randomized controlled trial of total-body screening to assess the feasibility of a full-scale study. MATERIALS AND 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. CONCLUSION: 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.
RCT Entities:
PURPOSE: The authors performed a pilot randomized controlled trial of total-body screening to assess the feasibility of a full-scale study. MATERIALS AND 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. CONCLUSION: 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: Nicolas Rodondi; Reto Auer; Vanessa de Bosset Sulzer; William A Ghali; Jacques Cornuz Journal: J Gen Intern Med Date: 2011-09-01 Impact factor: 5.128
Authors: Seamus P Whelton; Khurram Nasir; Michael J Blaha; Heidi Gransar; Thomas S Metkus; Josef Coresh; Daniel S Berman; Roger S Blumenthal Journal: Circ Cardiovasc Qual Outcomes Date: 2012-07-01
Authors: Ankur Gupta; Emily Lau; Ravi Varshney; Edward A Hulten; Michael Cheezum; Marcio S Bittencourt; Michael J Blaha; Nathan D Wong; Roger S Blumenthal; Matthew J Budoff; Craig A Umscheid; Khurram Nasir; Ron Blankstein Journal: JACC Cardiovasc Imaging Date: 2017-08