The effect of hormone therapy on women's quality of life in the first year of the Estonian Postmenopausal Hormone Therapy trial.

BACKGROUND: For postmenopausal women, the main reason to start hormone therapy (HT) is to reduce menopausal symptoms and to improve quality of life (QOL). The aim of this study was to analyse the impact of HT on different aspects of symptom experience and QOL during a randomised trial. A total of 1823 postmenopausal women were recruited into the Estonian Postmenopausal Hormone Therapy (EPHT) trial in 1999-2001. Women were randomised to blind HT, open-label HT, placebo or non-treatment arm. After one year in the trial, a questionnaire was mailed and 1359 women (75%) responded, 686 in the HT arms and 673 in the non-HT arms. Mean age at filling in the questionnaire was 59.8 years. The questionnaire included Women's Health Questionnaire (WHQ) to assess menopause specific QOL of middle-aged women together with a 17-item questionnaire on symptoms related to menopause, a question about painful intercourse, and a question about women's self-rated health. RESULTS: After one year in the trial, fewer women in the HT arms reported hot flashes, trouble sleeping, and sweating on the symptom questionnaire. According to WHQ, women in the HT arms had fewer vasomotor symptoms, sleep problems, and problems with sexual behaviour, but more menstrual symptoms; HT had no effect on depression, somatic symptoms, memory, attractiveness, or anxiety. A smaller proportion of women reported painful intercourse in the HT arms. There were no significant differences between the trial arms in women's self-rated subjective health. CONCLUSIONS: The results from the EPHT trial confirm that HT is not justified for treating symptoms, other than vasomotor symptoms, among postmenopausal women. WHQ proved to be a useful and sensitive tool to assess QOL in this age group of women.

Increase in the duration of antidepressant treatment from 1994 to 2003: a nationwide population-based study from Finland.

OBJECTIVE: We examined the length and continuity of antidepressant treatment and factors associated with long-term of treatment among adults. METHODS: Nationwide data from all reimbursed antidepressant prescriptions in 1994-2003 were linked with patients' data retrieved from Statistics Finland and the Finnish Hospital Discharge Register. Logistic regression models were used to analyse long term use of antidepressants. RESULTS: The annual prevalence of antidepressant use increased from 3.6% in 1994 to 7.3% in 2003. Short-term use (<3 months) decreased from 58% in 1995 to 51% in 2000 and long-term treatment (≥12 months) increased from 18 to 21%. In 2000, 31% of treatment periods lasted ≥6 months and 24% ≥9 months. Long-term treatment correlated to the purchase of other psychotropics, in-patient psychiatric care, and prescription by a psychiatrist. CONCLUSIONS: Treatment periods with antidepressants have become longer over time. Clinical factors related to mental disorder severity predict long-term use. Only a quarter had the treatment duration recommended by clinical guidelines for depression.

Health of children born after ovulation induction.

OBJECTIVE: To study the health of children born after ovulation induction (OI). DESIGN: Nationwide register-based study. SETTING: The OI children were followed up to the age of 4 years and compared with other children. PATIENT(S): The OI children (N = 4,467). Two control groups: all other children (excluding children born after IVF, N = 190,398) and a random sample of those children (n = 26,877). INTERVENTION(S): Ovulation induction treatment in ordinary practice. MAIN OUTCOME MEASURE(S): Mortality rates and adjusted odds ratios for perinatal outcomes, hospitalizations, health-related benefits, and long-term medication use. RESULT(S): A total of 12% of OI and 2% of control children were multiples. Even after stratifying for multiplicity and adjusting for the available confounding factors (region, smoking, maternal age, socioeconomic position, and parity for perinatal health and mother's socioeconomic position for other indicators), most indicators showed worse health among OI children compared with control children. The OI children had poorer perinatal health and more episodes of long hospitalization than the control children. Singleton OI children had more long-term illnesses in childhood, as measured by child disability allowance, long-term medication use, and hospital care episodes. CONCLUSION(S): Either OI treatment or the reasons for the treatment increase the risk of health problems in early childhood.

Sexual behaviour and lifestyles of young men in Finland, 1998-2005. Cross-sectional survey of military conscripts.

OBJECTIVE: To reveal sexual risk behaviour over time and to explore the associations of sexual risk behaviour, HIV-testing and socio-demographic and lifestyle characteristics, including alcohol and drug use among young men. METHODS: Cross-sectional, structured health and lifestyle survey carried out during the beginning of the mandatory military service. Data were collected from 10,446 randomized conscripts in 1998-2005, with a response rate of 95%. RESULTS: There was a minor increase in the prevalence of those reporting early sexual intercourse and multiple lifetime partners between 1998 and 2005 (age adjusted odds ratios [ORs] 0.68 [95% confidence interval (CI) 0.54-0.87] and 0.83 [0.70-0.99]), and a minor decrease in multiple partners over the past 12 months or engaging in high risk sex between 2000 and 2005 (ORs: 1.20 [95% CI: 1.08-1.41] and 1.45 [1.13-1.86]). No significant differences were observed in non-condom use and HIV-testing over the study period. Alcohol consumption had an independent, strong dose-contingent relationship with sexual risk behaviour. Illegal drug use showed a trend for similar but weaker association with risky sex as alcohol use. CONCLUSIONS: This study shows minor change in the risk indicators over time, yet the prevalence of sexually transmitted infections has risen. More in-depth research to identify groups with risky sexual behaviour and multiple risk factors related to sex, alcohol and drugs is a matter of public health importance.

Special features of health services and register based trials - experiences from a randomized trial of childbirth classes.

BACKGROUND: Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. METHODS: The example intervention was education to public health nurses (PHN) (childbirth classes) to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC) were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers). The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR). Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. RESULTS: It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. CONCLUSION: Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health service providers is a challenging intervention. TRIAL REGISTRATION NUMBER: not registered (see Results).

Resource allocation of in vitro fertilization: a nationwide register-based cohort study.

BACKGROUND: Infertility is common and in vitro fertilization (IVF) is a widely used treatment. In IVF the need increases and the effectiveness and appropriateness decrease by age. The purpose of this study was to describe allocation of resources for IVF by women's age, socioeconomic position, area of residence and treatment sector (public vs. private) and to discuss how fairly the IVF resources are allocated in Finland. METHODS: Women who received IVF between 1996 and 1998 (N = 9175) were identified from the reimbursement records of the Social Insurance Institution (SII). Information on IVF women's background characteristics came from the Central Population Register and the SII, on treatment costs from IVF clinics and the SII, and on births from the Medical Birth Register. The main outcome measures were success of IVF by number of cycles and treated women, expenditures per IVF cycles, per women, per live-birth, and per treatment sector, and private and public expenditures. Expenditures were estimated from health care visits and costs. RESULTS: During a mean period of 1.5 years, older women (women aged 40 or older) received 1.4 times more IVF treatment cycles than younger women (women aged below 30). The success rate decreased by age: from 22 live births per 100 cycles among younger women to 6 per 100 among older women. The mean cost of a live birth increased by age: compared to younger women, costs per born live birth of older women were 3-fold. Calculated by population, public expenditure was allocated most to young women and women from the highest socioeconomic position. Regional differences were not remarkable. CONCLUSION: Children of older infertile women involve more expense due to the lower success rates of IVF. Socioeconomic differences suggest unfair resource allocation in Finland.

Health of children born as a result of in vitro fertilization.

OBJECTIVE: The purpose of this study was to use nationwide registries to examine the health of children up to 4 years of age who were born as a result of in vitro fertilization. METHODS: Children born after in vitro fertilization (N = 4559) from 1996 to 1999 were monitored until 2003. Two control groups were selected from the Finnish Medical Birth Register as follows: all other children (excluding children born after ovulation induction) from the same period (N = 190,398, for study of perinatal health and hospitalizations) and a random sample of those children (n = 26,877, for study of health-related benefits). Mortality rates and odds ratios for perinatal outcomes, hospitalizations, health-related benefits, and long-term medication use were calculated. RESULTS: Although the health of most in vitro fertilization children was good, such children had more health problems than other children. A total of 35.7% of in vitro fertilization children and 2.2% of control children were multiple births, and the health of multiple births was worse than that of singletons. Perinatal outcomes of in vitro fertilization children were worse and hospital episodes were more common than among control children. Risks for cerebral palsy and psychological and developmental disorders were increased. Among in vitro fertilization singletons, worse results for perinatal outcomes and hospitalizations, but no increased risk for specific diseases, were found. The health of in vitro fertilization multiple births was comparable to the health of control multiple births. CONCLUSIONS: Reducing the number of transferred embryos would improve the health of in vitro fertilization children. Additional studies are needed to explain the poorer health of in vitro fertilization singletons, as well as follow-up studies to examine the health of in vitro fertilization children from 4 years onward.

Use of private gynaecologist does not relate to better prevention outcomes - an ecological analysis from Finland.

BACKGROUND: Control of reproduction and prevention of reproductive health problems are important reasons for women to use health services, but the proper organisational level of service provision is not clear. The purpose of this study was to investigate whether visits to private gynaecologists correlate with better health outcomes and worse participation in organised screening for cancer programs. METHODS: This is an ecological analysis using municipalities and groups of women at 5-year age intervals within municipalities as study units. First, the Finnish municipalities (n = 452) were classified into three groups by the age-adjusted level of use of private gynaecologists. Secondly, each age group within municipalities was classified into tertiles by the level of private gynaecologist use. The outcomes were participation in cervical and organised breast cancer screening for cancer programmes, stage of gynaecological and breast cancers at diagnosis, and abortion rates and ratios. All data were obtained from national registers by groups at 5-year age intervals and by municipality. Raw and adjusted (age groups, and in some analyses, municipality social class index) odds ratios, total and by urbanity, were calculated. RESULTS: The proportions of women participating in cervical cancer and organised breast cancer screening for cancer were somewhat higher in the groups having a low use of private gynaecologists. The proportions of local cancers of all cervical, uterine, ovarian and breast cancers were similar in the three groups, even though the first analysis method suggested somewhat better results for the low-use group in case of cervical cancer and for the high-use group in case of uterine and breast cancer. The rates of induced abortion were higher in municipalities having a high use of private gynaecologists than in those having lower use. CONCLUSION: This ecological analysis suggests that frequent use of private gynaecologists relates somewhat to lower organised screening for cancer participation, and is not better in preventing abortions or in detecting cancer earlier. Our results suggest that a planned system relying mainly on general practitioners and public health nurses as the first line care providers is equally good for women's reproductive health as that in which specialists are used.

Children born after assisted fertilization have an increased rate of major congenital anomalies.

OBJECTIVE: To study the occurrence of major congenital anomalies (CAs) among children born after IVF (IVF, microinjections, and frozen embryo transfers) and after ovulation inductions with or without insemination (other assisted reproductive technologies [ART]). DESIGN: Register-based study. SETTING: Data regarding CAs were obtained from the Register of Congenital Malformations. PATIENT(S): Children from IVF (n = 4,559), children from other ART (n = 4,467), and controls (n = 27,078, a random sample of naturally conceived children) from the Medical Birth Register. INTERVENTION(S): In vitro fertilization and other ART treatment in ordinary practice. MAIN OUTCOME MEASURE(S): Rate of major CAs. Children from IVF and other ART were compared with control children, both overall and by plurality, controlling for confounding factors by logistic regression. RESULT(S): For IVF children, the adjusted odds ratio (OR) was 1.3 (95% confidence interval [CI], 1.1-1.6). Stratifying by gender and plurality showed that the risk was only increased for boys, and the risk was decreased for multiple IVF girls (OR = 0.5, 95% CI 0.2-0.9). The crude OR of major CA for other ART children was 1.3 (95% CI 1.1-1.5), but adjusted differences by gender and plurality were statistically insignificant. CONCLUSION(S): In vitro fertilization was associated with an increased risk for major CAs among singleton boys and a decreased risk among multiple girls. The risk after other ART was only slightly increased.

Complications of IVF and ovulation induction.

BACKGROUND: The frequency and importance of complications of IVF and other ovulation induction (OI) are poorly known. We examined the occurrence of serious complications and miscarriages leading to hospitalization or operation after IVF (including microinjections and frozen embryo transfers) and OI treatment (with or without insemination). METHODS: Women who received IVF (n = 9175) or OI treatment (n = 10 254) 1996-1998 in Finland were followed by a register linkage study until 2000. RESULTS: After the first IVF treatment cycle, 14 per 1000 women had a serious case of OHSS (ovarian hyperstimulation syndrome), with 23 per 1000 throughout the study period (mean of 3.3 treatments). The corresponding values after OI were very low. The rates of registered ectopic pregnancies and miscarriages after IVF were nine and 42 respectively per 1000 women, with corresponding rates after OI of eight and 42. Infections and bleeding were not common after IVF and even rarer after OI. Overall, 15% of IVF and 8% of OI women had at least one hospital episode during the study period. CONCLUSIONS: Though there was a low risk of complications after each IVF treatment cycle, repeated attempts resulted in serious complications for many women, and these occurred much more often than after ovulation induction alone.

Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy.

PURPOSE: To compare the effect of blind design (active drug and placebo) and nonblind design (active drug and no treatment) on recruitment. SETTING: A primary prevention trial with postmenopausal hormone therapy in Estonia. METHODS: Women who were eligible and willing to participate on the basis of the questionnaire survey were randomized into blind and nonblind groups. Recruitment rates are based on record keeping, and reasons for participating were requested in the first-year follow-up. RESULTS: The recruitment was 30% higher in the nonblind group: of the 4,295 women invited, 37% (95% confidence interval CI=35-39%) in the blind group and 48% (95% CI=46-49%) in the nonblind group were recruited. In both groups, once randomized, most of the losses were women who did not attend the first clinical examination: 49% (blind; 95% CI=47-51%) and 40% (nonblind; 95% CI=38-42%). The rest were found ineligible or lost their interest during clinical examinations. The reasons for joining the trial were relatively similar in the two groups. CONCLUSIONS: Blinding decreased women's interest in joining a long-term preventive trial. Women's reasons for joining the trial were not influenced by blinding.

Births and perinatal health of infants among women who have had silicone breast implantation in Finland, 1967-2000.

BACKGROUND: Potential problems with breast implants have been widely discussed, but few data exist on the childbearing and offspring of women with implants. The purpose of this study was to investigate the occurrence and conditions of pregnancies of women who have had cosmetic breast implantation (exposed women), and the health of their newborns. METHODS: Women who had breast implants for cosmetic reasons in the period 1967-1999 (n = 2236) were identified from hospital surgical records. The births of the exposed women were identified through record linkage to the Population Register. The perinatal health of the infants was studied by the data in the Medical Birth Register in 1987-1999. For each birth to an exposed woman, 20 control mothers who gave birth in the same year were chosen randomly from the Medical Birth Register. Differences in mothers' background characteristics were adjusted by logistic regression. RESULTS: The women had received their first cosmetic breast implants at young ages (mean 31 years). By year 2000, 26% of the exposed women had one or more children. Half of these women had not had a liveborn child before getting implants. Of the 1661 exposed women who had not (yet) had children, 32% were less than 35 years of age at the end of follow-up. The women had children at a mean of 4.7 years after the implants. Some of the perinatal health indicators suggested poorer health and others better health for infants of exposed women, but only transfers to other hospitals and lower birthweight among infants of exposed multipara were statistically significant. CONCLUSIONS: The study shows that pregnancy and infant health are relevant considerations with regard to breast implants; further studies on implants are needed.

Monitoring of IVF birth outcomes in Finland: a data quality study.

BACKGROUND: The collection of information on infertility treatments is important for the surveillance of potential health consequences and to monitor service provision. STUDY DESIGN: We compared the coverage and outcomes of IVF children reported in aggregated IVF statistics, the Medical Birth Register (subsequently: MBR) and research data based on reimbursements for IVF treatments in Finland in 1996-1998. RESULTS: The number of newborns were nearly equal in the three data sources (N = 4331-4384), but the linkage between the MBR and the research data revealed that almost 40% of the reported IVF children were not the same individuals. The perinatal outcomes in the three data sources were similar, excluding the much lower incidence of major congenital anomalies in the IVF statistics (157/10 000 newborns) compared to other sources (409-422/10 000 newborns). CONCLUSION: The differences in perinatal outcomes in the three data sets were in general minor, which suggests that the observed non-recording in the MBR is most likely unbiased.