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1.  Advances in hormone replacement therapy: making the menopause manageable 
BMC Women's Health  2008;8:22.
The importance of the results of some large, randomized controlled trials (RCTs) on Hormone Replacement Therapy (HRT) has modified the risk/benefit perception of HRT. Recent literature review supports a different management.
The differences in age at initiation and the duration of HRT are key points. HRT appears to decrease coronary disease in younger women, near menopause; yet, in older women, HRT increases risk of a coronary event. Although HRT is a recognized method in the prevention and treatment of osteoporosis, it is not licensed for the prevention of osteoporosis as a first-line treatment. The effectiveness of low and ultra-low estrogen doses has been demonstrated for the treatment of vasomotor symptoms, genital atrophy and the prevention of bone loss, with fewer side-effects than the standard dose therapy. Further research, however, is needed to determine the effect both on fractures, as well as on cardiovascular and breast diseases. Newer progestins show effects that are remarkably different from those of other assays. The effectiveness of testosterone at improving both sexual desire and response in surgically and naturally postmenopausal women is shown by the testosterone patch.
The intention, dose and regimen of HRT need to be individualized, based on the principle of choosing the lowest appropriate dose in relation to the severity of symptoms and the time and menopause age.
doi:10.1186/1472-6874-8-22
PMCID: PMC2605606  PMID: 19038018
2.  Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates 
BMC Women's Health  2008;8:24.
Background
Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis.
Methods
This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan®). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate.
Results
Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model.
Conclusion
In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.
doi:10.1186/1472-6874-8-24
PMCID: PMC2642779  PMID: 19105828
3.  New paradigms in cervical cancer prevention: opportunities and risks 
BMC Women's Health  2008;8:23.
Testing for the DNA of high-risk types of papilloma virus (HPV) is more sensitive than cytology in detecting pre-cancerous lesions. One of the main advantages will be the possibility of applying prolonged screening intervals. However adequate screening protocols (age of start and stop, screening intervals, management of HPV positive women) need to be applied in order to avoid over-referral to colposcopy and over-treatment and to maintain sustainable costs. Further follow-up of running trials and research on molecular markers will better define these parameters. The new situation will require organised screening programmes with rigorous protocols and monitoring. This will be even more needed when women vaccinated for HPV 16 and 18 will be screened. Research on how to best screen vaccinated women is a priority. This paper proposes an overview of the plausible impact of new technologies in cervical cancer screening in the near future and in the vaccinated cohorts.
doi:10.1186/1472-6874-8-23
PMCID: PMC2627833  PMID: 19091066
4.  Preliminary development of a scale to measure stigma relating to sexually transmitted infections among women in a high risk neighbourhood 
BMC Women's Health  2008;8:21.
Background
As stigma is a socially constructed concept, it would follow that stigma related to sexual behaviours and sexually transmitted infections would carry with it many of the gender-based morals that are entrenched in social constructs of sexuality. In many societies, women tend to be judged more harshly with respect to sexual morals, and would therefore have a different experience of stigma related to sexual behaviours as compared to men. While a variety of stigma scales exist for sexually transmitted infections (STIs) in general; none incorporate these female-specific aspects. The objective of this study was to develop a scale to measure the unique experience of STI-related stigma among women.
Methods
A pool of items was identified from qualitative and quantitative literature on sexual behaviour and STIs among women. Women attending a social evening program at a local community health clinic in a low-income neighbourhood with high prevalence of substance use were passively recruited to take part in a cross-sectional structured interview, including questions on sexual behaviour, sexual health and STI-related stigma. Exploratory factor analysis was used to identify stigma scales, and descriptive statistics were used to assess the associations of demographics, sexual and drug-related risk behaviours with the emerging scales.
Results
Three scales emerged from exploratory factor analysis – female-specific moral stigma, social stigma (judgement by others) and internal stigma (self-judgement) – with alpha co-efficients of 0.737, 0.705 and 0.729, respectively. In this population of women, internal stigma and social stigma carried higher scores than female-specific moral stigma. Aboriginal ethnicity was associated with higher internal and female-specific moral stigma scores, while older age (>30 years) was associated with higher female-specific moral stigma scores.
Conclusion
Descriptive statistics indicated an important influence of culture and age on specific types of stigma. Quantitative researchers examining STI-stigma should consider incorporating these female-specific factors in order to tailor scales for women.
doi:10.1186/1472-6874-8-21
PMCID: PMC2610028  PMID: 19021915
5.  Mammography screening: views from women and primary care physicians in Crete 
BMC Women's Health  2008;8:20.
Background
Breast cancer is the most commonly diagnosed cancer among women and a leading cause of death from cancer in women in Europe. Although breast cancer incidence is on the rise worldwide, breast cancer mortality over the past 25 years has been stable or decreasing in some countries and a fall in breast cancer mortality rates in most European countries in the 1990s was reported by several studies, in contrast, in Greece have not reported these favourable trends. In Greece, the age-standardised incidence and mortality rate for breast cancer per 100.000 in 2006 was 81,8 and 21,7 and although it is lower than most other countries in Europe, the fall in breast cancer mortality that observed has not been as great as in other European countries. There is no national strategy for screening in this country. This study reports on the use of mammography among middle-aged women in rural Crete and investigates barriers to mammography screening encountered by women and their primary care physicians.
Methods
Design: Semi-structured individual interviews. Setting and participants: Thirty women between 45–65 years of age, with a mean age of 54,6 years, and standard deviation 6,8 from rural areas of Crete and 28 qualified primary care physicians, with a mean age of 44,7 years and standard deviation 7,0 serving this rural population. Main outcome measure: Qualitative thematic analysis.
Results
Most women identified several reasons for not using mammography. These included poor knowledge of the benefits and indications for mammography screening, fear of pain during the procedure, fear of a serious diagnosis, embarrassment, stress while anticipating the results, cost and lack of physician recommendation. Physicians identified difficulties in scheduling an appointment as one reason women did not use mammography and both women and physicians identified distance from the screening site, transportation problems and the absence of symptoms as reasons for non-use.
Conclusion
Women are inhibited from participating in mammography screening in rural Crete. The provision of more accessible screening services may improve this. However physician recommendation is important in overcoming women's inhibitions. Primary care physicians serving rural areas need to be aware of barriers preventing women from attending mammography screening and provide women with information and advice in a sensitive way so women can make informed decisions regarding breast caner screening.
doi:10.1186/1472-6874-8-20
PMCID: PMC2588567  PMID: 18990253
6.  Hormonal contraception, sexual behaviour and HIV prevalence among women in Cameroon 
BMC Women's Health  2008;8:19.
Background
Data on the effect of contraceptive methods, other than the condom, on HIV acquisition is not clear. The aim of this study was to describe hormonal contraceptive use, sexual behaviour and HIV prevalence among women in Cameroon in order to provide baseline information for future analytical studies.
Methods
This is a cross-sectional descriptive study based a nationally representative sample of 4486 sexually active women aged 15–49 years who participated in the 2004 Cameroon Demographic and Health Survey.
Results
The overall HIV prevalence was 7.4% (332/4486). The HIV prevalence was higher in the 25–35 year age group (10.03%), urban residents (9.39%), and formerly married (18.48%), compared to their compatriots. The prevalence was lower in women with five or more living child (3.67%), women in the low wealth index category (3.79%) and women who had no formal education (3.37%). The HIV prevalence was higher among women who had two or more partners in the last 12 months (10.26%) and women who reported to have had four or more partners in their lifetime (12.40%). The prevalence of HIV was higher among current hormonal contraceptive users (6.63%) compared to the current non-users (3.06%), among ever users of hormonal contraception (13.27%) compared to the never users (7.11%).
Conclusion
We conclude that the prevalence of HIV among sexually active women in Cameroon varies according to sociodemographic characteristics, sexual behaviour and hormonal contraceptive use. Our findings underscore the need to counsel women using hormonal contraception to be aware that hormonal methods do not protect against HIV infection. Given the biologic plausibility of the link between hormonal contraception and HIV infection, future research should focus on carefully designed prospective studies to establish the temporal relationship and estimate the incidence of HIV infection among women using and not using hormonal contraceptive methods.
doi:10.1186/1472-6874-8-19
PMCID: PMC2584627  PMID: 18973697
7.  Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial 
BMC Women's Health  2008;8:18.
Background
Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception.
Methods
We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group) or bar graph plus a frequency format diagram (BG+FF group), which was assessed by previsit and postvisit questionnaires.
Results
Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67%) was not significantly different between the 2 groups (P = .10). Among women who inaccurately perceived very high risk (≥ 50% risk), inaccurate risk perception decreased significantly in the BG+FF group (22% to 3%) compared with the BG group (28% to 19%) (P = .004).
Conclusion
Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.
doi:10.1186/1472-6874-8-18
PMCID: PMC2576054  PMID: 18937844
8.  Intimate partner violence among pregnant women in Rwanda 
BMC Women's Health  2008;8:17.
Background
Intimate partner violence (IPV), defined as actual or threatened physical, sexual, psychological, and emotional abuse by current or former partners is a global public health concern. The prevalence and determinants of intimate partner violence (IPV) against pregnant women has not been described in Rwanda. A study was conducted to identify variables associated with IPV among Rwandan pregnant women.
Methods
A convenient sample of 600 pregnant women attending antenatal clinics were administered a questionnaire which included items on demographics, HIV status, IPV, and alcohol use by the male partner. Mean age and proportions of IPV in different groups were assessed. Odds of IPV were estimated using logistic regression analysis.
Results
Of the 600 respondents, 35.1% reported IPV in the last 12 months. HIV+ pregnant women had higher rates of all forms of IVP violence than HIV- pregnant women: pulling hair (44.3% vs. 20.3%), slapping (32.0% vs. 15.3%), kicking with fists (36.3% vs. 19.7%), throwing to the ground and kicking with feet (23.3% vs. 12.7%), and burning with hot liquid (4.1% vs. 3.5%). HIV positive participants were more than twice likely to report physical IPV than those who were HIV negative (OR = 2.38; 95% CI [1.59, 3.57]). Other factors positively associated with physical IPV included sexual abuse before the age of 14 years (OR = 2.69; 95% CI [1.69, 4.29]), having an alcohol drinking male partner (OR = 4.10; 95% CI [2.48, 6.77] for occasional drinkers and OR = 3.37; 95% CI [2.05, 5.54] for heavy drinkers), and having a male partner with other sexual partners (OR = 1.53; 95% CI [1.15, 2.20]. Education was negatively associated with lifetime IPV.
Conclusion
We have reported on prevalence of IPV violence among pregnant women attending antenatal care in Rwanda, Central Africa. We advocate that screening for IPV be an integral part of HIV and AIDS care, as well as routine antenatal care. Services for battered women should also be made available.
doi:10.1186/1472-6874-8-17
PMCID: PMC2570659  PMID: 18847476
9.  Reference population for international comparisons and time trend surveillance of preterm delivery proportions in three countries 
BMC Women's Health  2008;8:16.
Background
International comparison and time trend surveillance of preterm delivery rates is complex. New techniques that could facilitate interpretation of such rates are needed.
Methods
We studied all live births and stillbirths (≥ 28 weeks gestation) registered in the medical birth registers in Sweden, Denmark and Norway from 1995 through 2004. Gestational age was determined by best estimate. A reference population of pregnant women was designed using the following criteria: 1) maternal age 20–35, 2) primiparity, 3) spontaneously conceived pregnancy, 4) singleton pregnancy and 5) mother born in the respective country. National preterm delivery rate, preterm delivery rate in the reference population and rate of spontaneous preterm delivery in the reference population were calculated for each country.
Results
The total national preterm delivery rate (< 37 completed gestational weeks), increased in both Denmark (5.3% to 6.1%, p < 0.001) and Norway (6.0% to 6.4%, p = 0.006), but remained unchanged in Sweden, during 1995–2004. In Denmark, the preterm delivery rate in the reference population (5.3% to 6.3%, p < 0.001) and the spontaneous preterm delivery rate in the reference population (4.4% to 6.8%, p < 0.001) increased significantly. No similar increase was evident in Norway. In Sweden, rates in the reference population remained stable.
Conclusion
Reference populations can facilitate overview and thereby explanations for changing preterm delivery rates. The model also permits comparisons over time. This model may in its simplicity prove to be a valuable supplement to assessments of national preterm delivery rates for public health surveillance.
doi:10.1186/1472-6874-8-16
PMCID: PMC2566973  PMID: 18817549
10.  Factors associated with wife beating in Egypt: Analysis of two surveys (1995 and 2005) 
BMC Women's Health  2008;8:15.
Background
Wife beating is an important public health problem in many developing countries. We assessed the rates of wife beating and examined factors associated with wife beating in 1995 and 2005 in Egypt.
Methods
We used data from two Demographic and Health Surveys (DHS) conducted in Egypt in 1995 and 2005 using multistage household sampling. Data related to wife beating included information from 7122 women in 1995 and 5612 women in 2005. Logistic regression was used to analyze factors independently associated with wife beating. Special weights were used to obtain nationally representative estimates.
Results
In 1995 17.5% of married women in Egypt experienced wife beating in the last 12 months, in 2005 – 18.9% or 16.0%, using different measures. The association between socio-demographic differentials and wife beating was weaker in the newer survey. The 12-month prevalence of wife beating was lower only when both partners were educated, but the differences across education levels were less pronounced in 2005. Based on the information available in the 2005 survey, more educated women experienced less severe forms of wife beating than less educated women.
Conclusion
Different measures used in both surveys make a direct comparison difficult. The observed patterns indicate that the changes in prevalence may be masked by two opposite processes occurring in the society: a decrease in (severe forms of) wife beating and an increase in reporting of wife beating. Improving the access to education for women and raising education levels in the whole society may help reducing wife beating.
doi:10.1186/1472-6874-8-15
PMCID: PMC2556994  PMID: 18801155
11.  Physical activity counseling in maternity and child health care – a controlled trial 
BMC Women's Health  2008;8:14.
Background
The purpose of the study is to examine the effects and feasibility of individual physical activity (PA) counseling in maternity and child health clinics in Finland.
Methods
Three clinics including both maternity and child health care signed up for the experimental (EXP) and three for the control group (CON). The participants were 132 pregnant and 92 postpartum primiparas. The nurses in EXP integrated a primary and four booster PA counseling sessions into routine visits. An option for supervised group exercise was offered. In CON former practices, usually including brief PA advice, were continued. Leisure-time PA (LTPA) prior to pregnancy was elicited by questionnaire and followed 16–18 and 36–37 weeks' gestation in maternity clinics and 5 and 10 months postpartum in child health clinics. Feasibility included safety, participant responsiveness, realization of counseling and applicability.
Results
According to analysis of covariance adjusted for baseline LTPA and possible confounders, no relative between-group differences in LTPA were found at the first follow-up in either maternity or child health clinics. At the last follow-up in maternity clinics the weekly number of at least moderate-intensity LTPA days was 43% (95% CI: 9, 87) higher and the weekly duration of at least moderate-intensity LTPA 154% (95% CI: 16, 455) higher in EXP compared with CON. Counseling proved feasible in both maternity and child health clinics.
Conclusion
Counseling encouraged pregnant women to sustain their moderate-intensity LTPA and was feasible in routine practices. No effects were observed if counseling was initiated postpartum.
Trial registration
Current Controlled Trials ISRCTN21512277
doi:10.1186/1472-6874-8-14
PMCID: PMC2527301  PMID: 18702803
12.  A Prospective study of the association between weight changes and self-rated health 
BMC Women's Health  2008;8:13.
Background
Obesity and self-rated health (SRH) are strong predictors of morbidity and mortality but their interrelation is sparsely studied. The aim of this study was to analyse the association between weight changes and changes in SRH among women. We also examined if poor SRH at baseline was associated with later weight gain.
Methods
The Danish Nurse Cohort Study is a prospective population study (1993–1999) and comprises 13,684 female nurses aged 44 to 69 years. Logistic regression analyses were used to examine the association between weight changes and changes in SRH.
Results
Women who gained weight during the study period had higher odds of reporting poorer self-rated health (Odds Ratio (OR): 1.18, 95% CI: 1.04–1.35). Weight loss among overweight women, did not result in an increase in self-rated health ratings, in fully adjusted analyses (0.96 (95% CI: 0.76–1.23). Poor self-rated health combined with normal weight at first examination was associated with higher odds of later weight gain (OR: 1.29, 95% CI: 1.10–1.51).
Conclusion
Weight changes may result in lower SRH. Further, poor self-rated health at baseline seems to predict an increase in weight, among women without any longstanding chronic diseases. Future obesity prevention may focus on normal weight individuals with poor SRH.
doi:10.1186/1472-6874-8-13
PMCID: PMC2532681  PMID: 18691402
13.  Study of knowledge, perception and attitude of adolescent girls towards STIs/HIV, safer sex and sex education: (A cross sectional survey of urban adolescent school girls in South Delhi, India) 
BMC Women's Health  2008;8:12.
Background
Sexually Transmitted Infections (STI's), including HIV (Human Immunodeficiency Virus) mainly affects sexually active young people. Young adults aged 15–29 years, account for 32% of AIDS (Acquired Immunodeficiency Syndrome) cases reported in India and the number of young women living with HIV/AIDS is twice that of young men. The aim of the study was to evaluate adolescent school girls' knowledge, perceptions and attitudes towards STIs/HIV and safer sex practice and sex education and to explore their current sexual behaviour in India.
Methods
A cross sectional study was carried out in 2007 in South Delhi, India to investigate the perception, knowledge and attitude of adolescent urban schoolgirls towards sexually transmitted Infections (STIs), HIV/AIDS, safer sex practice and sex education. the self-administered questionnaire was completed by 251 female students from two senior secondary schools.
Results
More than one third of students in this study had no accurate understanding about the signs and symptoms of STIs other than HIV/AIDS. About 30% of respondents considered HIV/AIDS could be cured, 49% felt that condoms should not be available to youth, 41% were confused about whether the contraceptive pill could protect against HIV infection and 32% thought it should only be taken by married women.
Conclusion
Though controversial, there is an immense need to implement gender-based sex education regarding STIs, safe sex options and contraceptives in schools in India
doi:10.1186/1472-6874-8-12
PMCID: PMC2490677  PMID: 18647417
14.  The ESEP study: Salpingostomy versus salpingectomy for tubal ectopic pregnancy; The impact on future fertility: A randomised controlled trial 
BMC Women's Health  2008;8:11.
Background
For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP.
Methods/Design
International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation.
The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on costs per live birth, including IVF treatment whenever a spontaneous pregnancy does not occur. Patients' preferences will be assessed using a discrete choice experiment.
Discussion
This trial will provide evidence on the trade off between salpingostomy and salpingectomy for tubal EP in view of the pros and cons of both interventions and will offer guidance to clinicians in making the right treatment choice.
Trial registration
Current Controlled Trials ISRCTN37002267
doi:10.1186/1472-6874-8-11
PMCID: PMC2464580  PMID: 18582372
15.  The METEX study: Methotrexate versus expectant management in women with ectopic pregnancy: A randomised controlled trial 
BMC Women's Health  2008;8:10.
Background
Patients with ectopic pregnancy (EP) and low serum hCG concentrations and women with a pregnancy of unknown location (PUL) and plateauing serum hCG levels are commonly treated with systemic methotrexate (MTX). However, there is no evidence that treatment in these particular subgroups of women is necessary as many of these early EPs may resolve spontaneously. The aim of this study is whether expectant management in women with EP or PUL and with low but plateauing serum hCG concentrations is an alternative to MTX treatment in terms of treatment success, future pregnancy, health related quality of life and costs.
Methods/Design
A multicentre randomised controlled trial in The Netherlands. Hemodynamically stable patients with an EP visible on transvaginal ultrasound and a plateauing serum hCG concentration < 1,500 IU/L or with a persisting PUL with plateauing serum hCG concentrations < 2,000 IU/L are eligible for the trial. Patients with a viable EP, signs of tubal rupture/abdominal bleeding, or a contra-indication for MTX will not be included. Expectant management is compared with systemic MTX in a single dose intramuscular regimen (1 mg/kg) in an outpatient setting. Serum hCG levels are monitored weekly; in case of inadequately declining, systemic MTX is installed or continued. In case of hemodynamic instability and/or signs of tubal rupture, surgery is performed. The primary outcome measure is an uneventful decline of serum hCG to an undetectable level by the initial intervention. Secondary outcomes are (re)interventions (additional systemic MTX injections and/or surgery), treatment complications, health related quality of life, financial costs, and future fertility. Analysis is performed according to the intention to treat principle. Quality of life is assessed by questionnaires before and at three time points after randomisation. Costs are expressed as direct costs with data on costs and used resources in the participating centres. Fertility is assessed by questionnaires after 6, 12, 18 and 24 months. Patients' preferences will be assessed using a discrete choice experiment.
Discussion
This trial will provide guidance on the present management dilemmas in women with EPs and PULs with low and plateauing serum hCG concentrations.
Trial registration
Current Controlled Trials ISRCTN 48210491
doi:10.1186/1472-6874-8-10
PMCID: PMC2453103  PMID: 18565217
16.  Cervical dysplasia and cancer and the use of hormonal contraceptives in Jamaican women 
BMC Women's Health  2008;8:9.
Background
This study was conducted to determine whether use of hormonal contraceptives is associated with cervical dysplasia and cancer in a population where there is widespread use of hormonal contraception and the rates of cervical cancer remain high at 27.5/100,000.
Methods
A case-control study was conducted among women visiting the colposcopy and gynaelogical clinics at a tertiary referral hospital. Two hundred and thirty six cases CIN I (72), II (59), III (54), cancer (51) and 102 controls, consented and were interviewed on use of contraceptives using a structured questionnaire. Logistic regression was used to determine odds ratios (ORs) and 95% confidence intervals (CIs) associated with use of hormonal contraception in cases and controls and in low and high risk cases. Recruitment was carried out from 2001–2002.
Results
Contraceptives used were: oral contraceptives – 35%, injections (depot medroxy progesterone acetate (Depo-provera) – 10%, Intrauterine devices – 2%, combinations of these and tubal ligation – 30%. 23% reported use of 'other' methods, barrier contraceptives or no form of contraception. Barrier contraceptive use was not significantly different between cases and controls. Current and/or past exposure to hormonal contraceptives (HC) by use of the pill or injection, alone or in combination with other methods was significantly higher in the cases. In multivariate analysis with age and number of sexual partners as co-variates, use of hormonal contraception was associated both with disease, [OR, 1.92 (CI 1.11, 3.34; p = 0.02] and severity of the disease [OR, 2.22 (CI 1.05, 4.66) p = 0.036]. When parity and alcohol consumption were added to the model, hormonal contraception was no longer significant. The significant association with high risk disease was retained when the model was controlled for age and number of sexual partners. Depo-provera use (with age and number of sexual partners as covariates) was also associated with disease [OR, 2.43 (CI 1.39, 4.57), p = 0.006] and severity of disease [OR 2.51 (1.11, 5.64) p = 0.027]. With parity and alcohol added to this model, depo-provera use retained significance. Exposure to HC > 4 years conferred more risk for disease and severity of disease.
Conclusion
Hormonal contraception did confer some risk of dysplasia and women using HC should therefore be encouraged to do regular Pap smear screening.
doi:10.1186/1472-6874-8-9
PMCID: PMC2430195  PMID: 18513406
17.  A systematic review of tests for lymph node status in primary endometrial cancer 
BMC Women's Health  2008;8:8.
Background
The lymph node status of a patient is a key determinate in staging, prognosis and adjuvant treatment of endometrial cancer. Despite this, the potential additional morbidity associated with lymphadenectomy makes its role controversial. This study systematically reviews the accuracy literature on sentinel node biopsy; ultra sound scanning, magnetic resonance imaging (MRI) and computer tomography (CT) for determining lymph node status in endometrial cancer.
Methods
Relevant articles were identified form MEDLINE (1966–2006), EMBASE (1980–2006), MEDION, the Cochrane library, hand searching of reference lists from primary articles and reviews, conference abstracts and contact with experts in the field. The review included 18 relevant primary studies (693 women). Data was extracted for study characteristics and quality. Bivariate random-effect model meta-analysis was used to estimate diagnostic accuracy of the various index tests.
Results
MRI (pooled positive LR 26.7, 95% CI 10.6 – 67.6 and negative LR 0.29 95% CI 0.17 – 0.49) and successful sentinel node biopsy (pooled positive LR 18.9 95% CI 6.7 – 53.2 and negative LR 0.22, 95% CI 0.1 – 0.48) were the most accurate tests. CT was not as accurate a test (pooled positive LR 3.8, 95% CI 2.0 – 7.3 and negative LR of 0.62, 95% CI 0.45 – 0.86. There was only one study that reported the use of ultrasound scanning.
Conclusion
MRI and sentinel node biopsy have shown similar diagnostic accuracy in confirming lymph node status among women with primary endometrial cancer than CT scanning, although the comparisons made are indirect and hence subject to bias. MRI should be used in preference, in light of the ASTEC trial, because of its non invasive nature.
doi:10.1186/1472-6874-8-8
PMCID: PMC2409306  PMID: 18457596
18.  Abnormal vaginal bleeding in women of reproductive age: a descriptive study of initial management in general practice 
BMC Women's Health  2008;8:7.
Background
Abnormal vaginal bleeding (AVB) in women of reproductive age is a common reason for consulting a general practitioner. Nevertheless, how general practitioners (GPs) choose to initially manage AVB is largely unknown, as is the prevalence of underlying pathology of AVB in primary care.
Methods
To investigate the initial diagnostic procedures and treatment for AVB used in general practice, we performed a descriptive study based on computerised medical records. New consultations for AVB in 2000 and 2001 were selected. Patient characteristics, diagnostic procedures and treatment were analysed.
Results
In total, 270 new consultations were included. The majority of patients (75%) consulted the GP for AVB only once. GPs performed diagnostic procedures in 54% of all consultations. Overall, additional diagnostic procedures revealed abnormalities in 11% of women. However, the diagnostic procedures implemented by the GPs varied widely per bleeding type and contraceptive use. Anaemia was found in 36% of 45 women tested. Uterine fibroids were found in 41% of 27 women examined by ultrasound. Medication was prescribed in 34% of all consultations. A gynaecological referral was registered in 4% of all contacts.
Conclusion
Initially, GPs tend to follow a policy of expectant management in women of reproductive age with AVB. However, when additional diagnostic procedures were performed, anaemia and uterine fibroids were found in a considerable number of women.
doi:10.1186/1472-6874-8-7
PMCID: PMC2358883  PMID: 18412967
19.  Variation in NHS utilisation of vault smear tests in women post-hysterectomy: A study, using routinely collected datasets 
BMC Women's Health  2008;8:6.
Background
20% of women living in the UK have a hysterectomy during their lifetime, levels are higher in the USA, making it one of the most commonly performed major surgical procedures. Understanding of the indications for hysterectomy and of the rationale for follow-up of women post hysterectomy is currently limited. Guidelines concerning follow-up by means of vaginal vault cytology tests exist but these are not based on 'gold standard' evidence. Furthermore, the extent to which current practice reflects these guidelines is unclear. This study aims to determine the factors associated with variability in hysterectomy rates and subsequent follow-up after surgery by use of the vaginal vault smear cytology test.
Methods/Design
All women resident in the West Midlands region, of the United Kingdom, who had a hysterectomy operation between 1st April 2002 and 30th March 2003 will be identified from the Hospital Episodes Statistics database which also contains proxy data on deprivation status, derived from postcode and self declared ethnicity. These data will be linked to regional cervical screening records for each woman and histopathology laboratory records from the relevant hospitals. Study objectives are to describe: Indications for the hysterectomy operation, histology at hysterectomy, subsequent follow-up by use or non-use of vaginal vault cytology tests and variation between histological groups. Additionally the data will be categorised according to a woman's cytology screening history prior to surgery (i.e. always normal, borderline, resolved abnormalities, CIN etc) and these different groups compared. Variations in these outcomes according to age, deprivation and ethnic group will also be examined. Analysis will be undertaken using SPSS.
Discussion
This study will clarify patterns of current practice in one large English region and determine whether this practice reflects existing guidelines. The study will also strengthen the evidence base for future guidelines.
Study registration
National Research Register N0138173331
doi:10.1186/1472-6874-8-6
PMCID: PMC2329610  PMID: 18373859
20.  Symptom reporting and quality of life in the Estonian Postmenopausal Hormone Therapy Trial 
BMC Women's Health  2008;8:5.
Background
The aim of the study was to determine the effect of postmenopausal hormone therapy on women's symptom reporting and quality of life in a randomized trial.
Methods
1823 women participated in the Estonian Postmenopausal Hormone Therapy (EPHT) Trial between 1999 and 2004. Women were randomized to open-label continuous combined hormone therapy or no treatment, or to blind hormone therapy or placebo. The average follow-up period was 3.6 years. Prevalence of symptoms and quality of life according to EQ-5D were assessed by annually mailed questionnaires.
Results
In the hormone therapy arms, less women reported hot flushes (OR 0.20; 95% CI: 0.14–0.28), sweating (OR 0.56; 95% CI: 0.44–0.72), and sleeping problems (OR 0.66; 95% CI: 0.52–0.84), but more women reported episodes of vaginal bleeding (OR 19.65; 95% CI: 12.15–31.79). There was no difference between the trial arms in the prevalence of other symptoms over time. Quality of life did not depend on hormone therapy use.
Conclusion
Postmenopausal hormone therapy decreased vasomotor symptoms and sleeping problems, but increased episodes of vaginal bleeding, and had no effect on quality of life.
Trial registration number
ISRCTN35338757
doi:10.1186/1472-6874-8-5
PMCID: PMC2330032  PMID: 18366766
21.  How does social integration influence breast cancer control among urban African-American women? Results from a cross-sectional survey 
BMC Women's Health  2008;8:4.
Background
Although social integration is a well-established influence on health, less is known about how the specific types of social connection (social roles, social networks, and social support) influence knowledge, attitudes, and practices for specific prevention goals, and how to utilize these influences in interventions with priority populations. This research examined the prevalence of social roles, networks and support among 576 urban African-American women age 45–93 in East Baltimore, Maryland, and the association of these social factors with breast cancer related knowledge, attitudes, and practices.
Methods
Using data from 1997–1998 in-home interviews, we developed indices of six possible social roles, social networks of family, neighborhood and church, and instrumental and emotional social support. In multivariate models adjusting for age, education, and medical care, we examined the association of each social influence on breast cancer knowledge, attitudes, screening recency and intention, and treatment preferences.
Results
We found substantial variation in social integration among these women, with social integration positively associated with overall health and well-being. Social roles and networks were positively associated with screening knowledge, and emotional support and church networks were positively associated with attitudes conducive to early detection and treatment. In regard to screening behaviors, family networks were associated with both screening recency and intention. Women with greater church networks and emotional support held more conservative attitudes towards lumpectomy, reconstruction, and clinical trials.
Conclusion
Overall, social integration is a positive influence on breast cancer control and should be utilized where possible in interventions, including identifying surrogate mechanisms for support for subgroups without existing social resources.
doi:10.1186/1472-6874-8-4
PMCID: PMC2262880  PMID: 18254967
22.  Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study 
BMC Women's Health  2008;8:3.
Background
The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure.
Methods
Women (n = 100) with bacterial vaginosis diagnosed by Amsel criteria were after informed consent offered vaginal clindamycin therapy followed by vaginal gelatine capsules containing either 109 freeze-dried lactobacilli or identical placebo capsules for 10 days during 3 menstrual cycles in a double-blind, randomized, placebo-controlled trial.
Results
The initial intent to treat (ITT) analysis for the one-month cure rate was 64% in the lactobacilli group and 78% in the placebo group (p > 0.05). However, any patient with missing or unclassified smears at the initial visit who continued the study and whose next smear indicated a cure was included in the cured group; the study also excluded two of the patients in the lactobacilli group who reported that they did not take any vaginal capsules. With consideration to these population changes, the initial cure rate would be 77% in the lactobacilli group. The 76 cured women were followed for 6 menstrual cycles or until relapse within that time span. At the end of the study, 64.9% (24/37) of the lactobacilli treated women were still BV-free compared to 46.2% (18/39) of the placebo treated women. Comparison of the two groups regarding "Time from cure to relapse" was statistically significant (p = 0.027) in favour of the lactobacilli treatment. Adjuvant therapy with lactobacilli contributed significantly to avoidance of relapse with a proportional Hazard Risk ratio (HR) of 0.73 (0.54–0.98) (p < 0.05)
Conclusion
The study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment, but for women initially cured, adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up.
Trial registration number
ISRCTN62879834
doi:10.1186/1472-6874-8-3
PMCID: PMC3225869  PMID: 18197974
23.  Women's colposcopy experience and preferences: a mixed methods study 
BMC Women's Health  2008;8:2.
Background
The colposcopy service is a key component in the UK Cervical Screening Programme. Over 120,000 women are referred to the service annually, however up to 25% of women fail to attend their appointment. Little is known about patients' preferences for colposcopic investigation and treatment. This study aims to investigate women's experience of colposcopy, to identify patients' preferences for aspects of appointments within the colposcopy service, and to make suggestions for service improvement.
Methods/Design
This study has been designed as a two stage, mixed method project. Stage one will involve in-depth interviews with new colposcopy patients to ascertain their experience of colposcopy services. This qualitative stage will generate factors thought to be important by service users in their experience. Stage two will utilise a choice based quantitative technique to identify women's preferences and determine the representativeness of factors generated through the interviews.
The initial stage of in-depth interviews will be conducted with patients who are newly referred to colposcopy clinics to investigate the experience that they have of the referral process and appointment attendance. The outcome of these interviews will be analysed qualitatively using Framework analysis. Factors found to be important in women's experience will be extracted and used to construct a choice based questionnaire.
The discrete choice experiment (questionnaire) will apply a best-worst technique through scenario-based questions to find women's relative preferences for different aspects of the service. It will be offered to women attending follow-up appointments at two colposcopy clinics in the West Midlands. Women will complete the questionnaire whilst they wait for their appointment, or, if they prefer, will take it home to complete in private. Women who do not attend their appointment will be posted the research information and questionnaire. The questionnaire analysis will use a weighted least squares regression technique for each best/worst pair. The accept/reject 'would you attend this appointment' question will be analysed using a random effects logit model.
Discussion
Colposcopy is a common procedure and one that is associated with raised anxiety among women experiencing the service. Little is known about women's experience of the service or their preferences for service delivery. The outcomes of the study will comprise a description of women's experience of colposcopy and establishing their preferences for how aspects of the service should be provided. Women's preferences will be fed back to service providers to enable improvements to the service to be made.
doi:10.1186/1472-6874-8-2
PMCID: PMC2241588  PMID: 18194523
24.  Hormone replacement therapy use and plasma levels of sex hormones in the Norwegian Women and Cancer Postgenome Cohort – a cross-sectional analysis 
BMC Women's Health  2008;8:1.
Background
Hormone replacement therapy use (HRT) is associated with increased breast cancer risk. Our primary objective was to explore hormone levels in plasma according to HRT use, body mass index (BMI) and menopausal status. A secondary objective was to validate self-reported questionnaire information on menstruation and HRT use in the Norwegian Women and Cancer postgenome cohort (NOWAC).
Methods
We conducted a cross-sectional study of sex hormone levels among 445 women aged 48–62 who answered an eight-page questionnaire in 2004 and agreed to donate a blood sample. The samples were drawn at the women's local general physician's offices in the spring of 2005 and sent by mail to NOWAC, Tromsø, together with a two-page questionnaire. Plasma levels of sex hormones and Sex Hormone Binding Globulin (SHBG) were measured by immunometry. 20 samples were excluded, leaving 425 hormone measurements.
Results
20% of postmenopausal women were HRT users. The plasma levels of estradiol (E2) increased with an increased E2 dose, and use of systemic E2-containing HRT suppressed the level of Follicle Stimulating Hormone (FSH). SHBG levels increased mainly among users of oral E2 preparations. Vaginal E2 application did not influence hormone levels. There was no difference in BMI between HRT users and non-users. Increased BMI was associated with increased E2 and decreased FSH and SHBG levels among non-users. Menopausal status defined by the two-page questionnaire showed 92% sensitivity (95% CI 89–96%) and 73% specificity (95% CI 64–82%), while the eight-page questionnaire showed 88% sensitivity (95% CI 84–92%) and 87% specificity (95% CI 80–94%). Current HRT use showed 100% specificity and 88% of the HRT-users had plasma E2 levels above the 95% CI of non-users.
Conclusion
Users of systemic E2-containing HRT preparations have plasma E2 and FSH levels comparable to premenopausal women. BMI has an influence on hormone levels among non-users. NOWAC questionnaires provide valid information on current HRT use and menopausal status among Norwegian women who are between 48 and 62 years old.
doi:10.1186/1472-6874-8-1
PMCID: PMC2254595  PMID: 18194511

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