Quality of life and hormone use: new validation results of MRS scale.
BACKGROUND
The Menopause Rating Scale is a health-related Quality of Life scale developed in the early 1990s and step-by-step validated since then. Recently the MRS scale was validated as outcomes measure for hormone therapy. The suspicion however was expressed that the data were too optimistic due to methodological problems of the study. A new study became available to check how founded this suspicion was.


METHODS
An open post-marketing study of 3282 women with pre- and post- treatment data of the self-administered version of the MRS scale was analyzed to evaluate the capacity of the scale to detect hormone treatment related effects with the MRS scale. The main results were then compared with the old study where the interview-based version of the MRS scale was used.


RESULTS
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. 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 we cannot exclude different treatment effects with the study method used, this supports our hypothesis that the individual MRS interviews performed by the physician biased the results towards over-estimation of the treatment effects. This hypothesis is 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.


CONCLUSIONS
The 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 difference of the relative improvement after therapy between the old and current study as well as the observed different sensitivity/specificity is--as a matter of probability--more likely to be caused by a bias introduced by the different application of the MRS scale than by real differences in the efficacy of the therapy. A randomized clinical trial would be needed to test the impact of the latter. The message for future studies is: The MRS scale should be only used as self-administered tool where the suggestive effect of questions raised by health professionals ("therapeutic optimism") can be largely excluded.
Dinger
Jürgen
J
Center for Epidemiology & Health Research Berlin, Invalidenstr, 115, 10115 Berlin, Germany. dinger@zeg-berlin.de
Zimmermann
Thomas
T
Heinemann
Lothar Aj
LA
Stoehr
Diana
D
D015914:Estrogen Replacement Therapy; D005260:Female; D005858:Germany; D006176:Gynecology / Q000295:instrumentation*; D006305:Health Status Indicators; D006801:Humans; D008593:Menopause / Q000187:drug effects* / Q000502:physiology / Q000523:psychology; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011358:Product Surveillance, Postmarketing; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life / Q000523:psychology*; D012647:Self-Assessment; D012680:Sensitivity and Specificity