Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM).

Background: The symptom of heavy menstrual bleeding (HMB) diminishes quality-of-life for many mid-age women and imposes substantial societal burden. We investigated our hypothesis that HMB reflects impaired endometrial vasoconstriction due to endometrial glucocorticoid deficiency. Does reversing this deficiency, by short-term luteal-phase treatment with exogenous glucocorticoid (dexamethasone), ameliorate HMB?

Methods: In our Bayesian response-adaptive parallel-group placebo-controlled randomised trial, five pre-planned interim analyses used primary outcome data to adjust randomisation probabilities to favour doses providing most dose-response information.

A practical guide to pre-trial simulations for Bayesian adaptive trials using SAS and BUGS.

It is often unclear what specific adaptive trial design features lead to an efficient design which is also feasible to implement. Before deciding on a particular design, it is generally advisable to carry out a simulation study to characterise the properties of candidate designs under a range of plausible assumptions. The implementation of such pre-trial simulation studies presents many challenges and requires considerable statistical programming effort and time.

Development of a Bayesian response-adaptive trial design for the Dexamethasone for Excessive Menstruation study.

It is often unclear what specific adaptive trial design features lead to an efficient design which is also feasible to implement. This article describes the preparatory simulation study for a Bayesian response-adaptive dose-finding trial design. Dexamethasone for Excessive Menstruation aims to assess the efficacy of Dexamethasone in reducing excessive menstrual bleeding and to determine the best dose for further study.

Contraceptive practices, sexual and reproductive health needs of HIV-positive and negative female sex workers in Goa, India.

Objectives: In India, female sex workers (FSWs), suffer from high HIV prevalence and abortions. Contraceptive use among general population women is well understood. However, FSWs contraceptives practices and reproductive health needs are under-researched.

Physiological versus standard sex steroid replacement in young women with premature ovarian failure: effects on bone mass acquisition and turnover.

Background: The aim of this exploratory study was to establish whether we could improve skeletal health with a physiological regimen of SSR in young women with premature ovarian failure (POF).

Patients And Methods: In an open-label randomized controlled crossover trial, 34 women with POF were randomized to 4-week cycles of pSSR (transdermal oestradiol, 100 μg daily for week 1, 150 μg for weeks 2-4; vaginal progesterone, 200 mg twice daily for weeks 3-4) or standard hormone replacement treatment (sHRT) (oral ethinyloestradiol 30 μg and 1·5 mg norethisterone daily for weeks 1-3, week 4 'pill-free') for 12 months. Bone mineral density (BMD) was measured by DEXA at study entry and after each 12-month treatment period.

A review of methods used in comprehensive, descriptive studies that relate red blood cell transfusion to clinical data.

Background: Red blood cell (RBC) use varies greatly between countries but the underlying reasons are not well understood. Some insight might be gained from blood utilization studies that provide a complete view of the clinical conditions that place individuals at risk of transfusion. This review considers the methodology of published studies that might provide such information and proposes requirements for future studies.

Cardiovascular effects of physiological and standard sex steroid replacement regimens in premature ovarian failure.

Current hormone replacement therapy may not optimize cardiovascular health in women with premature ovarian failure. We compared the effects of physiological and standard sex steroid replacement regimens on cardiovascular health in these women. In an open-label, randomized, controlled crossover trial, 34 women with premature ovarian failure were randomly assigned to 4-week cycles of physiological (transdermal estradiol and vaginal progesterone) and standard (oral ethinylestradiol and norethisterone) therapy for 12 months.

Why are rates of sterilization in decline? A pilot study designed to explore reasons for declining female sterilization in Scotland.

Background: In the last decade, female sterilization had been in decline throughout the UK. It is not clear whether fewer women are requesting sterilization or whether the universal enthusiasm for long-acting reversible methods is leading health professionals to discourage women from being sterilized. Since correct and consistent use of alternative, reversible contraceptive methods depends somewhat on their acceptability, it is important to determine whether women are being refused sterilization or whether they are freely choosing other methods.

What aspects of periods are most bothersome for women reporting heavy menstrual bleeding? Community survey and qualitative study.

Background: Heavy menstrual bleeding is a common symptom amongst women of reproductive age, yet questions remain about why some women experience this as a problem while others do not. We investigated the concerns of women who reported heavy menstrual bleeding on questionnaire.

Methods: A cross-sectional postal survey and qualitative interviews were carried out amongst a community-based sample of women in Lothian, Scotland.

Inside the Premier/CMS Pay-for-Performance Project.

In an H&HN exclusive roundtable discussion, representatives from the five top-performing hospitals describe what they've learned so far from the Premier/CMS Pay-for-Performance Project. For hospitals around the country, so-called value-based ent will soon be the primary way they get paid by both public and commercial insurers. The Premier/CMS participants offer valuable insights--and warnings--about the challenges ahead.

Descriptors and accounts of alcohol consumption: methodological issues piloted with female undergraduate drinkers in Scotland.

Excessive drinking among young women continues to attract adverse media attention and is the target of UK government-led initiatives. Reliable research on alcohol consumption is needed to inform/evaluate public health interventions. This pilot study, investigating descriptors of alcohol drinking in female Scottish undergraduate students, comprised: (i) self-completed questionnaire survey (n = 95) and (ii) interview plus test pouring of a 'drink' (n = 19).

A Scottish postal survey suggested that the prevailing clinical preoccupation with heavy periods does not reflect the epidemiology of reported symptoms and problems.

Objective: To determine the prevalence of self-reported menstrual symptoms and problem periods and explore their relationship with sociodemographic factors, parity, long-standing illness, and hormonal contraceptive use.

Study Design And Setting: Postal questionnaire survey of 4,610 women aged 25-44 registered with 19 general practices in Lothian, Scotland.

Results: Among menstruating women, 30% reported heavy periods, a further 5% very heavy periods and 15% severe period pain.

Menorrhagia II: is the 80-mL blood loss criterion useful in management of complaint of menorrhagia?

Objective: Menorrhagia is defined in terms of statistical"abnormality"as blood loss of >80 mL. We examined the usefulness of this definition in women who were referred to gynecology clinics with heavy periods.

Study Design: A questionnaire survey of 952 menstrual complaint referrals at 3 hospital gynaecology clinics in Glasgow and Edinburgh included 226 women with heavy periods who had also consented to the measurement of their blood loss.