title: Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study.
abstract: 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
  Prospective observational study with two consecutive cohorts of patients.
  
  
  METHODS
  A high-volume, academic, supra-regional trauma centre in Germany.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  (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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN74557102.
authors.affiliation: Centre for Clinical Research, Unfallkrankenhaus Berlin Trauma Centre, Warener Str, 7, Berlin 12683, Germany. dirk.stengel@ukb.de.
authors.forename: Dirk
authors.initials: D
authors.lastname: Stengel
authors.forename: Caspar
authors.initials: C
authors.lastname: Ottersbach
authors.forename: Thomas
authors.initials: T
authors.lastname: Kahl
authors.forename: Constanze
authors.initials: C
authors.lastname: Nikulka
authors.forename: Claas
authors.initials: C
authors.lastname: Güthoff
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartel
authors.forename: Sophia
authors.initials: S
authors.lastname: Hünnebeck
authors.forename: Axel
authors.initials: A
authors.lastname: Ekkernkamp
authors.forename: Sven
authors.initials: S
authors.lastname: Mutze
mesh_terms: D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D021621:Imaging, Three-Dimensional; D008297:Male; D061330:Multidetector Computed Tomography / Q000379:methods* / Q000592:standards; D009104:Multiple Trauma / Q000000981:diagnostic imaging*; D010865:Pilot Projects; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D015203:Reproducibility of Results; D012449:Safety; D015599:Trauma Severity Indices; D051598:Whole Body Imaging / Q000379:methods* / Q000592:standards