Professional Documents
Culture Documents
20 April 2009
Evidence-based Medicine for Surgeons
Outcome variable Pedal pulses (I) At least one felt None felt
Ulcer healing at one year of follow Duration of ulceration (D) < 130 days > 130 days
up. MAID score and probability of healing (%) at 1 year
Comparison 0 84
None 1 79
2 64
3 48
4 31
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 patients seen with Not stated Study
leg and foot ulcers, of
Stratified random Target ?
non-traumatic etiology,
Cluster that were present for at Accessible ?
least 14 days without
Consecutive clinical signs of healing Intended ?
Convenience despite adequate local Drop outs ?
therapy
Judgmental Study 2019
Sampling bias: The study was carried out at a referral centre in Germany. Details of sampling are skimpy.
COMPARISON
Randomized Case-control Non-random Historical None
Controls - details
Allocation details Wounds were treated according to a comprehensive wound care protocol. In brief, wound care
consisted of sharp debridement, moist wound therapy, and adequate pressure off-loading if
necessary. Venous ulcers received elastic pressure bandages.
Comparability No description is given of the patient baseline demographics on the basis of the etiology of the
ulcer. All details are clubbed together for the whole cohort.
Disparity -
Comparison bias: When a patient cohort is made up of several distinct subsets, each with different behavior
patterns, it is necessary that they be analyzed as separate groups and homogeneity or disparity demonstrated.
Despite the well known fact, and the authors' own admission, that there are three distinct causes for lower extremity
ulcer (arterial, venous and diabetic), the whole cohort is analyzed as a homogeneous group: apples, oranges and
bananas being treated all together as "fruit". Not acceptable.
MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.
Scoring
Blinding
Repetition
Protocols
Y ? N
Measurement bias: Ulcers were classified using the "MAID" scoring system described in the table on the previous
page. Four objective criteria were used and the score entered on a scale from 0 to 4. Since three of the four items on
the score are simple, reproducible, clinical data, there is little scope for observer or device-induced bias. The ulcer
size was estimated using a technique called photoplanimetry which eliminates the need for an observer to calculate
the area of the ulcer.
© Dr Arjun Rajagopalan