Validity of MRS as outcome measure
How is the quality of the MRS scale to reliably measure treatment
effects on HRQoL - even if symptoms are not so impressive? Can
the result of the scale the judgment of the treating physician
concerning treatment success predict? To this end, many clinicians
use the term "validity" and mean high utility for clinical
work or research. In so far it is important to address this issue.
Recently, we analyzed data of 9300 women with pre- and post- treatment
data of the MRS scale [ 13
]. The data came from an open post-marketing study in Germany
with a product for hormone replacement therapy and the MRS scale
was used as outcome measure (before an 6 months after hormone
treatment). This was the basis to critically evaluate whether
the scale is sensitive enough to measure the effect of hormone
treatment independent from the severity of complaints.
The improvement of symptoms during treatment was equivalent to
36% of the baseline score, and similar also for all three subscales.
An improvement of complaints/QoL was seen in an increasing degree
of severity of symptoms. An improvement of menopausal complaints
during/after treatment was observed. The change relative to the
baseline score was 36% in average. As can be seen in Figure
1, patients with little/no complaints before therapy improved
by 11%, those with mild complaints at entry by 32%, with moderate
by 44%, and with severe symptoms by 55% - compared with the baseline
score. The scale is sensitive enough to detect even positive treatment
effects in women with little complaints – although to a
This can be illustrated also with a different approach –
the comparison with norm values for the population (Table
1). The percentage of women with no/little symptoms is much
higher than those with severe complains in the normal population.
Women eligible for therapy depict a much lower proportion with
little or mild complaints and a much higher proportion of moderate
or sever complaints as compared with the normal population. After
6 months of hormone treatment, however, the frequency distribution
of patients with a certain severity of complaints returned towards
a similar distribution as observed in the general population.
The extreme proportion of patients with no/ little complaints
after therapy should be interpreted with reservation, because
of a possible patient selection that may have led to an overestimation
of the treatment effect. Such an visual comparison (as in table
1) should be used only to get a crude idea for the interpretation
of results because patients are usually differ from the general
population, a difference hard to adjust for.
That means that the MRS scale showed a convincing ability to measure
treatment effects on quality of life across the full range of
severity of menopausal complaints. The MRS scale was also tested
whether it predicts the subjective, clinical impression/opinion
of the treating physician. At face value, the individually assessed
efficiency of hormone treatment by the treating gynaecologists
was comparable with the assessment by the MRS scale, i.e. using
a simple dichotomization of the treatment effect in “successful”
and “not successful” for both the subjective opinion
of the physician and the result of the MRS scale (Table
2): The sensitivity (correct prediction of a positive assessment
by the physician) was 70.8% and specificity (correct prediction
of a negative assessment by the physician) 73.5%. In other words,
the MRS scale fits well with the subjective assessment of the
treatment by the physician. Both, sensitivity & specificity
however might be over-estimated, because it is hard to estimate
to which degree "clinical judgment" and "MRS assessment
were really independent.
The attached poster
presented in 2005 at the Congress of the International Society
of Pharamacoepidemiology (Nashville, USA) provides some additional
A new study based on 3282 women with pre- and post- hormone -
treatment data was published 2006 [
17 ]. The application of the MRS scale differed compared to
the previous study [13
]: self-administered vs. interview by physician. The hormone-therapy
related improvement of complaints relative to the baseline score
was about or less than 30% in total or domain scores, whereas
it exceeded 30% improvement in the old study [ 13
Similarly, the relative improvement after therapy, stratified
by the degree of severity at baseline, was lower in the new than
in the old study, but had the same slope.
Although one cannot exclude different treatment effects with the
study method used, this supports our hypothesis that the individual
MRS interviews performed by the physician obviously biased the
results towards over-estimation of the treatment effects.
This hypothesis was underlined by the degree of concordance of
physician’s assessment and patient’s perception of
treatment success (MRS results): Sensitivity (correct prediction
of the positive assessment by the treating physician) of the MRS
and specificity (correct prediction of a negative assessment by
the physician) were lower than the results obtained with the interview-based
MRS scale in the previous publication.
Although the new study confirmed evidence for the capacity of
the MRS scale to measure treatment effects on quality of life
across the full range of severity of complaints before treatment,
the authors concluded that the MRS scale should be used as self-administered
instrument in clinical studies to avoid overestimation of treatment
. Heinemann LAJ, DoMinh T, Strehlow F, Gerbsch S, Schnitker
J, Schneider HPG. Validity of the Menopause Rating Scale as outcome
measure. A clinical outcome study. Health and Quality of Life
Outcomes 2004;2:45 (2 September 2004). www.hqlo.com/content/2/1/67
 Dinger J, Zimmermann T, Heinemann LAJ, Stoehr D. Quality
of life and hormone use: new validation results of MRS scale.
Health and Quality of Life Outcomes, 2006;4:32. www.hqlo.com/content/4/1/32.