Juha Teperi

Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial

BACKGROUND Heavy menstrual blood loss is a common reason for women to seek medical care. The levonorgestrel-releasing intrauterine system (IUS) is an effective medical treatment for menorrhagia. We report a randomised comparison of this approach with hysterectomy in terms of the quality of life of women with menorrhagia and cost-effectiveness. METHODS Of 598 women referred with menorrhagia to five university hospitals in Finland, 236 were eligible and agreed to take part. They were randomly assigned treatment with the levonorgestrel-releasing IUS (n=119) or hysterectomy (n=117). The amount of menstrual blood loss was objectively measured. The primary outcome measure was health-related quality of life at 12-month follow-up. Analyses were by intention to treat. FINDINGS In the group assigned the levonorgestrel-releasing IUS, 24 (20%) women had had hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation. Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change 0.10 [95% CI 0.06-0.14] in both groups) as did other indices of psychological wellbeing. There were no significant differences between the treatment groups except that women with hysterectomy suffered less pain. Overall costs were about three times higher for the hysterectomy group than for the IUS group. INTERPRETATION The significant improvement in health-related quality of life highlights the importance of treating menorrhagia. During the first year the levonorgestrel-releasing IUS was a cost-effective alternative to hysterectomy in treatment of this disorder.

Menstrual pain, health and behaviour in girls.

Prevalence of menstrual pain, use of medication and school absenteeism due to the pain were studied by means of a mailed questionnaire in a sample representing 12-18-year-old girls in Finland (n = 3370, response rate 87%). Prevalence of menstrual pain was 48% among 12-year-old post-menarcheal girls and 79% among 18-year-olds. Thirty percent of the 16-year-old girls had used medication and 21% had stayed at home due to menstrual pain in the last 6 months; 3% had both been absent and used medication several times. Three types of factors were associated with menstrual pain: (1) physiological (gynaecological age, duration of menstrual flow); (2) indicators of poor self-rated health (not feeling active in the morning, bad physical condition, number of common colds); (3) unhealthy practices (consumption of alcohol, low physical activity, smoking). The prevalence of menstrual pain did not correlate with the variables describing the place of residence or the socio-economic status of the family. The determinants of menstrual pain are supposed to lie more in the biological construct and micro-environment of the girls than in macro-level structures of the society. The experience of pain seems to be related to self-rated health as a whole and to lifestyle rather than to specific disorders and health practices.

Hysterectomy trends in Finland in 1987-1995--a register based analysis.

BACKGROUND The study objective was to identify trends in the use of hysterectomy by nationwide register based analysis in Finland. METHODS All women (n=89,069) undergoing hysterectomy in 1987-1995 according to the Finnish Hospital Discharge Register were the numerator. The annual denominator data were obtained from the population database of Statistics Finland. RESULTS From 1987 to 1992 the hysterectomy rate increased by 22%, from 340 to 414 per 100,000 females, almost half of this being attributable to the changing age structure. From 1993 on, ambiguity in coding laparoscopically assisted vaginal hysterectomies prohibited detailed analyses. However, the overall trend continued at least among women 50 years and over until 1995. The age-adjusted 12% increase from 1987 to 1992 coincided with a rapid increase in operation rates in postmenopausal groups (60% or more among women aged 55 59 and 70-79 years). Among women aged 55-64 years, operations for fibroids and uterine bleeding more than doubled, suggesting an influence of increased use of estrogen replacement therapy. Among all women, operations due to bleeding disorders and genital prolapse showed the largest increase (41% and 42% respectively). Bilateral oophorectomy became more common in all age groups over 46 years. CONCLUSIONS There was a modest increase in the overall hysterectomy rate. However, the operation became far more common in postmenopausal women, possibly due to the growing use of estrogen replacement therapy. Register data can be used for describing changes in clinical practice, but other methods are needed to confirm the causal relationships underlying the changes.

Regional variation in surgical procedure rates in Finland

The aim was to describe the regional variation of population based surgery rates in Finland with special reference to the comparison of surgical activities in individual hospitals. Data on 11 common procedures covering all Finnish hospitals were obtained from the Finnish Hospital Discharge Register and the Finnish Medical Birth Register of the years 1987 and 1988. The variations of age and sex standardized procedure rates were studied across the procedure specific hospital service areas. The variation was estimated by three methods: extremal quotient, coefficient of variation, and systematic component of variation. The statistical significance of the variation measures was tested with a computerized simulation model. The variation was small for mastectomy, inguinal hernia repair, and hip replacement due to fracture, and large for lumbar disc operations, haemorrhoidectomies, and uterus operations. The results are similar to those of comparable studies elsewhere. The results indicate that there are clear differences in surgical activities between Finnish hospitals.

Short Communication: Data Quality after Restructuring a National Medical Registry

The validity of the 1991 Finnish Medical Birth Registry data was assessed, with special emphasis on the effects of changes made to the data collection form in 1990. Data abstracted from medical records for all births occurring in 49 hospitals during a five-day sample period (n = 865) were compared to the register information. Good or satisfactory validity was found for 32 of 33 variables, when minor error was tolerated in variables with continuous scales. For diagnoses and procedures, recorded in check-box format, satisfactory validity was found for 10 of 45 variables. Validity could not be assessed for 18 variables because of insufficient number of cases (13 items) or definition problems (5 items). When the results were compared to a 1987 data quality study, many of the variables that had been changed to the check-box format showed improvement in validity. In addition, in some cases a small change in question alternatives or instructions caused a noticeable change in validity.

Combined laboratory and diary method for objective assessment of menstrual blood loss

BACKGROUND To develop an objective measurement system for menstrual blood loss applicable in clinical practice. METHODS One hundred and fifty-six patients were enrolled in a randomized trial of the treatment of menorrhagia in all five gynecology departments of the university teaching hospitals in Finland. Correlation between venous blood hemoglobin concentration (Hb) and absorbance at 564 nm (A564) was investigated in experiments with blood samples. Amount of collected menstrual blood and menstrual diary data were analyzed. RESULT Hb concentration and A564 of the blood were linearly correlated (r=0.99). One hundred and fifty-four women (99%) returned used sanitary protection and menstrual diaries. On average, 12% (range 0-57%) of menstrual blood was lost during collection. The median amount of blood recovered from sanitary protection was 89 ml (range 14-724 ml), with 58% (n=90) of the women exceeding 80 ml per cycle. When the spilled blood was taken into account, the corresponding figures were 104 ml (range 15-724 ml) and 66% (n= 101). CONCLUSIONS The spectrophotometric measurement of venous blood in the conventional alkaline hematin method can be replaced by measurement of Hb concentration. All blood incompletely collected should be recorded. Objective measurement of menstrual blood loss can be applied in routine clinical practice.

Levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of essential menorrhagia: predictors of outcome

Levonorgestrel‐releasing intrauterine system (LNG‐IUS) has been advocated as an effective alternative to hysterectomy in the treatment of menorrhagia. The outcome predictors have been poorly known. In this study the amount of menstrual blood loss (MBL) turned out to be the single most important outcome predictor of these treatments. However, the treatment with LNG‐IUS seemed to be an appropriate alternative to hysterectomy for all women who perceived their MBL heavy.

Impact of patient information booklet on treatment decision--a randomized trial among women with heavy menstruation.

Objective  Does a patient information booklet influence treatment for menorrhagia?

Psychosocial and other characteristics of women complaining of menorrhagia, with and without actual increased menstrual blood loss

Objective To discover whether psychosocial factors can explain why many women with normal menstrual blood loss seek care for menorrhagia.

A randomized trial among women with heavy menstruation – impact of a decision aid on treatment outcomes and costs

Objective  To evaluate the effects of a decision aid for menorrhagia on treatment outcomes and costs over a 12‐month follow‐up.