Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a
prospective cohort study
Sammanfattning
BACKGROUND:
Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as
the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms
showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims
at investigating whether the radiation dose can safely be reduced in trauma patients without
compromising the diagnostic accuracy and image quality.
METHODS/DESIGN:
Prospective observational study with two consecutive cohorts of patients.
SETTING:
A high-volume, academic, supra-regional trauma centre in Germany.
STUDY POPULATION:
Consecutive male and female patients who 1. had been exposed to a high-velocity trauma
mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury
Severity Score [ISS] ?16) and 3. are scheduled for primary MDCT based on the decision of the trauma
leader on call.Imaging protocols: In a before/after design, a consecutive series of 500 patients will
undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a
standard, as low as possible radiation dose. This will be followed by a consecutive series of 500
patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm.
DATA:
Routine administrative data and electronic patient records, as well as digital images stored in a
picture archiving and communications system will serve as the primary data source. The protocol
was approved by the institutional review board.
MAIN OUTCOMES:
(1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard
of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients' safety,
(4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently
radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality
(e.g., contrast-to-noise ratio).
ANALYSIS:
Multivariate regression will be employed to adjust and correct the findings for time and cohort effects.
An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to
assess whether this protocol is clearly inferior or superior to the current standard.
DISCUSSION:
Although non-experimental, this study will generate first large-scale data on the utility of imaging-
enhancing algorithms in whole-body MDCT for major blunt trauma.