Background For many years it has been claimed that observational studies find stronger treatment effects than randomized, controlled trials We compared the results of observational studies with those of randomized, controlled trials Methods We searched the Abridged Index Medicus and Cochrane data bases to identify observational studies reported between 1985 and 1998 that compared two or more treatments or interventions for the same condition We then searched the Medline and Cochrane data bases to identify all the randomized, controlled trials and observational studies comparing the same treatments for these conditions For each treatment, the magnitudes of the effects in the various observational studies were combined by the Mantel-Haenszel or weighted analysis-of-variance procedure and then compared with the combined magnitude of the effects in the randomized, controlled trials that evaluated the same treatment Results There were 136 reports about 19 diverse treatments, such as calcium-channel-blocker therapy for coronary artery disease, appendectomy, and interventions for subfertility In most cases, the estimates of the treatment effects from observational studies and randomized, controlled trials were similar In only 2 of the 19 analyses of treatment effects did the combined magnitude of the effect in observational studies lie outside the 95 percent confidence interval for the combined magnitude in the randomized, controlled trials Conclusions We found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in randomized, controlled trials

https://www.nejm.org/doi/pdf/10.1056/NEJM200006223422506

A comparison of observational studies and randomized, controlled trials.

Endometriosis

Role of reactive oxygen species in male infertility.

A 30-year-old woman presents with a history of no menses since she stopped taking oral contraceptives 6 months ago in order to conceive. She had undergone puberty that was normal in both timing and development, with menarche at 12 years of age. At 18 years of age, she started taking oral contraceptives for irregular menses. She reports stress at work. Her weight is 59 kg, and her height 1.66 m; her body-mass index (the weight in kilograms divided by the square of the height in meters) is 21.3. There is no galactorrhea, hirsutism, or acne. The pelvic examination is normal, a pregnancy test is negative, the prolactin level is normal, and the follicle-stimulating hormone (FSH) level is in the menopausal range. How should she be evaluated and treated?

/pdf/primary-ovarian-insufficiency-5duisc0sk9.pdf

Primary Ovarian Insufficiency

Consensus on infertility treatment related to polycystic ovary syndrome

This paper compiles data from different sources to get a first comprehensive picture of psychometric and other methodological characteristics of the Menopause Rating Scale (MRS) scale. The scale was designed and standardized as a self-administered scale to (a) to assess symptoms/complaints of aging women under different conditions, (b) to evaluate the severity of symptoms over time, and (c) to measure changes pre- and postmenopause replacement therapy. The scale became widespread used (available in 10 languages). A large multinational survey (9 countries in 4 continents) from 2001/ 2002 is the basis for in depth analyses on reliability and validity of the MRS. Additional small convenience samples were used to get first impressions about test-retest reliability. The data were centrally analyzed. Data from a postmarketing HRT study were used to estimate discriminative validity. 
Reliability measures (consistency and test-retest stability) were found to be good across countries, although the sample size for test-retest reliability was small. 
Validity: The internal structure of the MRS across countries was astonishingly similar to conclude that the scale really measures the same phenomenon in symptomatic women. The sub-scores and total score correlations were high (0.7–0.9) but lower among the sub-scales (0.5–0.7). This however suggests that the subscales are not fully independent. Norm values from different populations were presented showing that a direct comparison between Europe and North America is possible, but caution recommended with comparisons of data from Latin America and Indonesia. But this will not affect intra-individual comparisons within clinical trials. The comparison with the Kupperman Index showed sufficiently good correlations, illustrating an adept criterion-oriented validity. The same is true for the comparison with the generic quality-of-life scale SF-36 where also a sufficiently close association has been shown. The currently available methodological evidence points towards a high quality of the MRS scale to measure and to compare HRQoL of aging women in different regions and over time, it suggests a high reliability and high validity as far as the process of construct validation could be completed yet.

/pdf/the-menopause-rating-scale-mrs-scale-a-methodological-review-3r7l8quv63.pdf

The Menopause Rating Scale (MRS) scale: A methodological review

Background
Symptom scales for aging women have clinically been used for years and the interest in measuring health-related quality of life (HRQoL) has increased in recent years. The Menopause Rating Scale (MRS) is a formally validated scale according to the requirements for quality of life instruments. The aim of this paper is to review the current state of the instrument particularly concerning versions of the scale in different languages.

/pdf/international-versions-of-the-menopause-rating-scale-mrs-2jgxl6jryl.pdf

International versions of the Menopause Rating Scale (MRS).

The timing of sexual intercourse in relation to ovulation strongly influences the chance of conception. Daily serum LH measurements or transvaginal ultrasonography are not practical to determine ovulation in consecutive cycles for an individual. A prospective study was initiated to test the home use performance of the ClearPlan Fertility Monitor (CPFM) in ovulation prediction compared with transvaginal ultrasonography and serum hormone measurements. A total of 53 women aged 18-39 years with a normal uterus and at least one ovary, cycle length between 21-42 days and not using medication which interferes with ovarian function contributed 150 cycles for analysis. One cycle was anovulatory and no LH surge, indicating peak fertility, was detected by the monitor. Of the remaining 149 cycles, 135 (90.6%) had a monitor LH surge and ultrasonographically confirmed ovulation. Ovulation was detected in 91.1% of cycles during the 2 days of CPFM peak fertility. Ovulation was observed in 51.1% of cycles 1 day and in 43.2% of cycles 2 days after the surge in serum LH. Ovulation never occurred before CPFM peak fertility or the serum LH surge day. CPFM can help women who desire pregnancy to time intercourse. It may also have potential as a diagnostic aid and for monitoring the treatment of infertility.

/pdf/prediction-of-ovulation-by-urinary-hormone-measurements-with-4ytqlzi0ni.pdf

Prediction of ovulation by urinary hormone measurements with the home use ClearPlan® Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements

Objective To analyze the reliability of scores of the recently developed self-administrative Menopause Rating Scale (MRS) in a follow-up investigation of a cohort after approximately one and a half years, and to look for possible reasons for variation.Method A follow-up investigation of a random sample of an initially representative survey of German women (aged 40–60), which dated back to early 1996, was performed in late 1997. A subsample of 306 women participated. The MRS scale, a self-administrative standardized questionnaire, was applied with additional, mainly health-related, questions.Results The MRS results at baseline and follow-up were significantly correlated (r = 0.60). The majority of women remained in the category ‘no or mild menopausal symptoms’. The κ statistics showed significant agreement of the various subscales (total, somatic, psychological and urogenital scales) between the two measurements. Neither age nor social factors contributed to a change of score according to a multiple regres...

The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints

The past decade has seen marked fluctuations in opinions concerning the merits and risks of postmenopausal hormone therapy. In July 2002, menopause management faced a major turning point when the f...

Hermann P.G. Schneider

Papers

The Menopause Rating Scale (MRS) scale: A methodological review

International versions of the Menopause Rating Scale (MRS).

Prediction of ovulation by urinary hormone measurements with the home use ClearPlan® Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements

The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints

IMS updated recommendations on postmenopausal hormone therapy.