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Dissections OBSERVATIONAL

20 April 2009
Evidence-based Medicine for Surgeons

A prognostic score estimating probability of healing in chronic lower extremity wounds


Authors: Beckert S, Pietsch AM, Kuper M, et al
Journal: Annals of Surgery 2009; 249:677-681
Centre: University of Tubingen, Tubingen, Germany
Diabetes mellitus, chronic venous insufficiency and peripheral arterial disease are the three main
causes of ulceration of the lower limb. Several classification systems exist that permit
BACKGROUND categorization of ulcers in an objective manner. However, they do not offer a scoring system that
can predict the probability of ulcer healing.
Authors' claim(s): “This new chronic lower extremity ulcer score provides a
RESEARCH QUESTION valuable diagnostic tool for anticipating probability of healing by combining 4
clinically assessable parameters namely wound duration, wound area,
Population presence/absence of pedal pulses, and presence/ absence of multiple ulcers.”
Patients seen at a referral centre
with leg and foot ulcers of various IN SUMMARY
etiologies.
The "MAID" scoring system of lower extremity ulcers
Indicator variable Clinical characteristic 0 points 1 point
An objective scoring system of the Multiple ulcers (M) No Yes
ulcer using 4 variables - the
2
"MAID" score Area of ulceration (A) < 4 cm > 4 cm2

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

THE BOTTOM LINE


The glaring error in this paper is the decision to club all three etiological groups -- arterial, venous and diabetic -- when the scoring
system should have been applied to each of them separately. The impact of each one of the mechanisms on the overall outcome -
confounding effect - has not been carefully examined. The study would be valuable if it showed the same consistent correlation in all
three groups. Overall, the study merely confirms popular wisdom: large, multiple, chronic ulcers in limbs with circulatory compromise
do poorly. Although the authors give probability figures for healing, they are of no practical value in terms of dictating management
pathways to achieve healing. The authors throw up a smoke screen of complex statistical multivariate analysis which really does little of
clinical value.

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

The devil is in the details (more on the paper) ... 

© 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

 = Reasonable | ? = Arguable |  = Questionable

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.

Device suited to task


Training

Scoring

Blinding
Repetition

Protocols

Y ? N

1.Foot pulse assessment Y N Y Y - N -


2.Wound area assessment (photoplanimetry) Y Y - - - -

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