Professional Documents
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16 May 2009
Evidence-based Medicine for Surgeons
EBM-O-METER
Evidence level Overall rating Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interestingl | Novel l | Feasible l
Case series - retrospective Ethical l | Resource saving l
© Dr Arjun Rajagopalan
SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random All "major" trauma Age < 15 years
patients who
Stratified random Target ?
received a spiral CT
Cluster scan Accessible ?
Consecutive Intended 3246
Convenience Drop outs 154
Judgmental Study 3092
Sampling bias: The criteria for "major" trauma is left undefined. The sample population represents the experience
of a single, referral, Level I trauma centre in the USA.
COMPARISON
Randomized Case-control Non-random Historical None
Controls - details
Allocation details The study was carried out as a retrospective chart review using a detailed, objective
methodology. A complete s[iral CT was defined as imaging of the head, cervical spine, chest,
abdomen, and pelvis, thoracic, and lumbar spine. An "incidental" finding was defined as an
unexpected finding seen on CT, not related to trauma, that potentially could pose danger to
the patient's present or future health. All findings were classifed as: type 1 findings -
potentially serious results that necessitate further evaluation and close follow-up, and type 2
findings - requiring informing the patient but do not mandate urgent follow-up.
Comparability -
Disparity -
Comparison bias: Although the authors differentiate the characteristic of those with and without significant CT
findings, this was not the primary intention of the study. Attempting to delineate associations between the CT
findings and baseline data differences is not valid.
MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.
Scoring
Blinding
Repetition
Protocols
Y ? N
A 2-month, pilot period preceded the actual study. Four chart reviewers (2 faculty physicians and 2 resident physicians)
conducted a 2-month pilot study reviewing the charts of trauma patients and a uniform method of data recording was
established. A uniform data abstraction form was designed that clearly listed examples of types 1 and 2 incidental
findings in addition to examples of findings not considered of clinical significance. Two independent case manager
reviewers recorded the age, sex, mechanism of trauma, and final patient disposition. The physician reviewers were
blinded to these patient characteristics to limit potential bias.
Measurement bias: Only thirteen percent of the charts were reviewed by two observers. The inter-observer
variability was estimated at a Kappa value of 0.67. The chart review relied upon the attending radiologist's
interpretation of the CT scan. The level of detail in the report varied considerably between the various radiologists.
© Dr Arjun Rajagopalan