Detection of treatment effect
The results of the first clinical study where the AMS scale was applied
as outcome measure for testosterone treatment in patients with androgen
deficiency. [
20 ]
The absolute improvement of symptoms during treatment was 15 scoring
points of the AMS in average. This is equivalent to 32% of the baseline
score on average.
The relative
improvement increases with the degree of severity of symptoms at
baseline, what fits the general expectation: 11% relative improvement,
24%, 31%, and 39% improvement in males with little, mild, moderate,
and severe complaints at baseline. That means, there was still a positive
treatment effect detectable with the AMS scale in men with moderate
or even mild symptoms.
The next Figure
shows the capacity of the AMS scale to detect therapeutic efficiency
from another angle: the comparison with norm values of the population
[
5 ]. One can see that the level of complaints in elderly patients
before therapy is very much shifted toward higher degree of severity
(higher AMS total score).
After 12 weeks of testosterone treatment the frequency distribution
of patients with a certain severity of complaints became similar to
the distribution in the general population of aging males. This is re-assuring
and indicates that comparisons with norm values could be helpful for
interpreting results of intervention studies. It is another way to look
at therapeutic efficiency with the assistance of the AMS scale.
Prediction of expert assessment
The AMS scale was also able to predict the independent judgment of
the urologists regarding the therapeutic effect. The treating urologist
assessed individually the effectiveness of the hormone treatment in
the above mentioned intervention study - without knowledge of the results
of the self-administered AMS questionnaire which was only later analysed.
Grouping the urologist's expert opinion regarding treatment efficiency
into two categories: effective (very effective and effective) and not
effective (little, no or negative effect). Similarly grouped were the
AMS results - namely effective (at least 5% improvement) and not effective
(less than 5% improvement).
The positive predictive value was 89%, the negative predictive value
59%, sensitivity (correct prediction of a positive assessment by the
physician) 96% and specificity (correct prediction of a negative assessment
by the physician) 30% [
20 ].
In other words, the change of the AMS score fits well with a positive
judgment of the physician concerning therapy efficiency, however predicts
not very good a negative therapy assessment of the physician. This
means,
using the total AMS score as criterion, it would result in a high positive
predictive value but a less satisfactory negative predictive value,
very high sensitivity but low specificity.
A new
publication from another treatment study (2006) basically confirmed
the findings. The
conclusion of the authors was that the AMS scale showed a convincing
ability to measure treatment effects on quality of life across the
full range of severity of complaints. Effect modification by other
variables at baseline was not observed. In addition, results of the
scale could predict the subjective clinical expert opinion on the
treatment efficiency.
[5]. Heinemann LAJ, Zimmermann T, Vermeulen A, Thiel C. A New 'Aging
Male's Symptoms' (AMS) Rating Scale. The Aging Male 1999; 2:105-114.
[20]. Moore C, Huebler D, Zimmermann T, Heinemann LAJ, Saad F, and
Do Minh T. The AMS scale as outcome measure for treatment of androgen
deficiency. Eur Urology 2004 ; in press.