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To determine treatment options (myomectomy vs uterine artery embolization [UAE]) for women wishing to avoid hysterectomy.A multicenter randomized controlled trial was conducted on 254 women and data were collected on fibroid-specific quality of life (UFS-QOL), loss of menstrual blood, and pregnancy.At 4 years, the mean difference in the UFS-QOL was 5.0 points (95% confidence interval [CI] -1.4 to 11.5; P=0.13) in favor of myomectomy. This was not statistically significant as it was at 2 years. There were no differences in bleeding scores, rates of amenorrhea, or heavy bleeding. Of those who were still menstruating, the majority reported regular or fairly regular periods: 36 of 48 (75%) in the UAE group and 30 of 39 (77%) in the myomectomy group. Twelve women after UAE and six women after myomectomy became pregnant (4 years) with seven and five live births, respectively (hazard ratio 0.48, 95% CI 0.18-1.28). There was no difference between the levels of hormones associated with the uterine reserve in each group.Leiomyoma are common in reproductive-aged women, causing heavy menses and subfertility. Among women with uterine fibroids, myomectomy resulted in better fibroid-related quality of life at 4 years, compared with UAE but the treatments decreased menstrual bleeding equally. There was also no significant difference in the impact of treatment on ovarian reserve.

Objectives To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. Design Economic evaluation alongside the FEMME randomised controlled trial. Setting 29 UK hospitals. Population Premenopausal women who had symptomatic uterine fibroids amenable to UAE or myomectomy wishing to avoid hysterectomy. 254 women were randomised to UAE (127) and myomectomy (127). Methods A within-trial cost-utility analysis was conducted from the perspective of the UK NHS. Main outcome measures Quality-adjusted life years (QALYs) measured using the EuroQoL EQ-5D-3L, combined with costs to estimate cost-effectiveness over 2 and 4 years of follow-up. Results Over a 2-year time horizon, UAE was associated with higher mean costs (difference £645; 95% CI -1381 to 2580) and lower QALYs (difference -0.09; 95% CI -0.11 to -0.04) when compared with myomectomy. Similar results were observed over the 4-year time horizon. Thus, UAE was dominated by myomectomy. Results of the sensitivity analyses were consistent with the base case results for both years. Over 2 years, UAE was associated with higher costs (difference £456; 95% CI -1823 to 3164) and lower QALYs (difference -0.06; 95% CI -0.11 to -0.02). Conclusions Myomectomy is a cost-effective option for the treatment of uterine fibroids. The differences in costs and QALYs are small. Women should be fully informed and have the option to choose between the two procedures. Tweetable abstract Fully informed women with uterine fibroids should have a choice between uterine artery embolisation or myomectomy.

Background: \ud Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.\ud Methods: \ud We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.\ud Results: \ud A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P=0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.\ud Conclusions: \ud Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394).

PURPOSE To critically review the evidence and opinions expressed about mammographic screening (MS) in research reports on breast cancer in the occupied Palestinian territory (oPt) and to assess whether benefits and harms in MS are presented in a balanced way. METHODS Searches of PubMed, Cochrane, MEDLINE, EMBASE, CINAHL, and gray literature identified 14 eligible research reports relating to the oPt. We reviewed these documents and then used a thematic analysis to describe and analyze the evidence and the opinions about MS expressed in them. RESULTS All 14 research reports mentioned that MS would improve survival rates in the oPt. Only three gave information on major harmful effects, and only two emphasized that MS must be accompanied by effective treatment to have any beneficial effects on population mortality. There was no consistency in the recommended frequency of MS. CONCLUSION Most information presented by Palestinian health researchers was selective and failed to address the important established harms of MS. Thus, calls to support MS in the oPt are not based on a measured discussion of the risks and benefits for women or grounded in the systemic readiness of health care necessary for its effectiveness. As long as diagnostic and treatment facilities remain deficient, screening cannot lead to reduced mortality from breast cancer.

The COVID-19 epidemic can probably be ended and normal life restored, perhaps quite quickly, by weekly SARS-CoV-2 RNA testing together with household quarantine and systematic contact tracing. Isolated outbreaks could then be contained by contact tracing, supplemented if necessary by temporary local reintroduction of population testing or lockdown. Leading public health experts have recommended that this should be tried in a demonstration project in which a medium-sized city introduces weekly testing and lifts lockdown completely. The idea was not considered by the groups whose predictions have guided UK policy, so we have examined the statistical case for such a study. The combination of regular testing with strict household quarantine, which was not analysed in their models, has remarkable power to reduce transmission to the community from other household members as well as providing earlier diagnosis and facilitating rapid contact tracing.

Healthcare alone cannot improve population health. Laura Webber and colleagues advocate a “health in all policies” approach, with protected funding for preventive interventions

Economic evaluation of type 2 diabetes prevention programmes: does the type of pre-diabetes and intensity of intervention matter? Appendices [42, 43]. (DOCX 3780Â kb)

BackgroundNational guidance on preventing type 2 diabetes mellitus (T2DM) in the UK recommends low-intensity lifestyle interventions for individuals with intermediate categories of hyperglycaemia defined in terms of impaired fasting glucose (IFG) or ‘at-risk’ levels of HbA1c. In a recent systematic review of economic evaluations of such interventions, most studies had evaluated intensive trial-based lifestyle programmes in participants with impaired glucose tolerance (IGT). This study examines the costs and effects of different intensity lifestyle programmes and metformin in participants with different categories of intermediate hyperglycaemia. MethodsWe developed a decision tree and Markov model (50-year horizon) to compare four approaches, namely (1) a low-intensity lifestyle programme based on current NICE guidance, (2) a high-intensity lifestyle programme based on the US Diabetes Prevention Program, (3) metformin, and (4) no intervention, modelled for three different types of intermediate hyperglycaemia (IFG, IGT and HbA1c). A health system perspective was adopted and incremental analysis undertaken at an individual and population-wide level, taking England as a case study. ResultsLow-intensity lifestyle programmes were the most cost-effective (£44/QALY, £195/QALY and £186/QALY compared to no intervention in IGT, IFG and HbA1c, respectively). Intensive lifestyle interventions were also cost-effective compared to no intervention (£2775/QALY, £6820/QALY and £7376/QALY, respectively, in IGT, IFG and HbA1c). Metformin was cost-effective relative to no intervention (£5224/QALY, £6842/QALY and £372/QALY in IGT, IFG and HbA1c, respectively), but was only cost-effective relative to other treatments in participants identified with HbA1c. At a willingness-to-pay threshold of £20,000/QALY, low- and high-intensity lifestyle programmes were cost-effective 98%, 99% and 98% and 81%, 81% and 71% of the time in IGT, IFG and HbA1c, respectively. An England-wide programme for 50–59 year olds could reduce T2DM incidence by  DiscussionThis analysis suggests that current English national policy of low-intensity lifestyle programmes in participants with IFG or HbA1c will be cost-effective and have the most favourable budget impact, but will prevent only a fraction of cases of T2DM. Additional approaches to prevention need to be investigated urgently.

Obesity has escalated to epidemic proportions over the past 30 years resulting in increased disease burden and healthcare costs. The aim of this paper was to analyse different costing methods for obesity. Several databases have been searched to identify eligible literature estimating obesity cost. These were categorized into databases, patient-attributable fraction (PAF) and modelling studies. Studies from the United States were used to explore effects of study designs on cost outcomes. Our results show that cost outcomes are largely affected by underlying study designs, such as population size, age, cost categories (medical expenditure vs. total costs), length of the data collection and body mass index cut-offs. Three study types are likely to have an impact on reported costs, with modelling studies providing the most conservative estimates. Database studies can help to increase the overall awareness of the economic burden of obesity. PAF studies can make the obesity disease more tangible by drawing connections to diseases. Decision makers need to be aware of the different purposes and weaknesses of the studies when interpreting cost outcomes. Further research is needed to refine the existing methods and provide high-quality data accounting for the complexity of the disease.

ObjectiveThe present study aimed to model obesity trends and future obesity-related disease for nine countries in the Middle East; in addition, to explore how hypothetical reductions in population obesity levels could ameliorate anticipated disease burdens.DesignA regression analysis of cross-sectional data v. BMI showed age- and sex-specific BMI trends, which fed into a micro simulation with a million Monte Carlo trials for each country. We also examined two alternative scenarios where population BMI was reduced by 1 % and 5 %.SettingStatistical modelling of obesity trends was carried out in nine Middle East countries (Bahrain, Egypt, Iran, Jordan, Kuwait, Lebanon, Oman, Saudi Arabia and Turkey).SubjectsBMI data along with disease incidence, mortality and survival data from national and sub-national data sets were used for the modelling process.ResultsHigh rates of overweight and obesity increased in both men and women in most countries. The burden of incident type 2 diabetes, CHD and stroke would be moderated with even small reductions in obesity levels.ConclusionsObesity is a growing problem in the Middle East which requires government action on the primary prevention of obesity. The present results are important for policy makers to know the effectiveness of obesity interventions on future disease burden.

Part I of this report appeared in the previous issue (Br. J. Cancer (1976) 34,585), and discussed the design of randomized clinical trials. Part II now describes efficient methods of analysis of randomized clinical trials in which we wish to compare the duration of survival (or the time until some other untoward event first occurs) among different groups of patients. It is intended to enable physicians without statistical training either to analyse such data themselves using life tables, the logrank test and retrospective stratification, or, when such analyses are presented, to appreciate them more critically, but the discussion may also be of interest to statisticians who have not yet specialized in clinical trial analyses.

We have assessed the relative value of various outcome measures after THR, by the analysis of follow-up data from over 2000 patients. They had been reviewed clinically and radiologically six months after operation, at one year, and then every two years, some for 16 years. At each review their pain level, stiffness and opinion of progress were scored and a radiograph taken. We found that pain level was the most informative outcome as a predictor of revision and correlated well with the patients’ opinions. We made a comparison between the six types of implant in the series, using survival analysis and log-rank testing with different pain levels as endpoints. This analysis revealed differences which were not detected by survival analysis using the traditional endpoint of revision. We therefore recommend the use of different levels of pain as the main outcome measures after total hip replacement.

Background. The Collaborative Group on Hormonal Factors in Breast Cancer has brought together and reanalysed about 90% of the worldwide epidemiological evidence on the relation between risk of breast cancer and use of hormone replacement therapy (HRT). Methods. Individual data on 52,705 women with breast cancer and 108,411 women without breast cancer from 51 studies in 21 countries were collected, checked, and analysed centrally. The main analyses are based on 53,865 postmenopausal women with a known age at menopause, of whom 17,830 (33%) had used HRT at some time. The median age at first use was 48 years, and 34% of ever-users had used HRT for 5 years or longer. Estimates of the relative risk of breast cancer associated with the use of HRT were obtained after stratification of all analyses by study, age at diagnosis, time since menopause, body-mass index, parity, and the age a woman was when her first child was born. Findings. Among current users of HRT or those who ceased use 1-4 years previously, the relative risk of having breast cancer diagnosed increased by a factor of 1.023 (95% CI 1.011-1.036; 2p = 0.0002) for each year of use; the relative risk was 1.35 (1.21-1.49; 2p = 0.00001) for women who had used HRT for 5 years or longer (average duration of use in this group 11 years). This increase is comparable with the effect on breast cancer of delaying menopause, since among never-users of HRT the relative risk of breast cancer increases by a factor of 1.028 (95% CI 1.021-1.034) for each year older at menopause. 5 or more years after cessation of HRT use, there was no significant excess of breast cancer overall or in relation to duration of use. These main findings did not vary between individual studies. Of the many factors examined that might affect the relation between breast cancer risk and use of HRT, only a woman's weight and body-mass index had a material effect: the increase in the relative risk of breast dancer associated with long durations of use in current and recent users was greater for women of lower than of higher weight or body-mass index. There was no marked variation in the results according to hormonal type or dose but little information was available about long durations of use of any specific preparation. Cancers diagnosed in women who had ever used HRT tended to be less advanced clinically than those diagnosed in never-users. In North America and Europe the cumulative incidence of breast cancer between the ages of 50 and 70 in never-users of HRT is about 45 per 1000 women. The cumulative excess numbers of breast cancers diagnosed between these ages per 1000 women who began use of HRT at age 50 and used it for 5, 10, and 15 years, respectively, are estimated to be 2 (95% CI 1-3), 6 (3-9), and 12 (5-20). Whether HRT affects mortality from breast cancer is not known. Interpretation. The risk of having breast cancer diagnosed is increased in women using HRT and increases with increasing duration of use. This effect is reduced after cessation of use of HRT and has largely, if not wholly, disappeared after about 5 years. These findings should be considered in the context of the benefits and other risks associated with the use of HRT.

Objective To assess the efficacy of an intervention designed to improve the mother-infant relationship and security of infant attachment in a South African peri-urban settlement with marked adverse socioeconomic circumstances. Design Randomised controlled trial. Setting Khayelitsha, a peri-urban settlement in South Africa. Participants 449 pregnant women. Interventions The intervention was delivered from late pregnancy and for six months postpartum. Women were visited in their homes by previously untrained lay community workers who provided support and guidance in parenting. The purpose of the intervention was to promote sensitive and responsive parenting and secure infant attachment to the mother. Women in the control group received no therapeutic input from the research team. Main outcome measures Primary outcomes: quality of mother-infant interactions at six and 12 months postpartum; infant attachment security at 18 months. Secondary outcome: maternal depression at six and 12 months. Results The intervention was associated with significant benefit to the mother-infant relationship. At both six and 12 months, compared with control mothers, mothers in the intervention group were significantly more sensitive (6 months: mean difference=0.77 (SD 0.37), t=2.10, P

Obesity has increased at an alarming rate across the world and, in turn, rates of non-communicable diseases have escalated. In Eastern Europe, this epidemic has probably occurred at a later stage than the West due to the economic transition following the demise of communism. Knowing how these trends will change is important. We used a micro-simulation model to project obesity trends and related incidence of coronary heart disease and stroke, cancer and type 2 diabetes 20 and 40 years into the future. Where nationally representative data were available, obesity levels were shown to increase with most prominent increases seen amongst men in Latvia and Estonia, and amongst women in Croatia and Latvia. The exception was Lithuania where a decrease in overweight and obesity was observed in both men and women. We showed that interventions effective in reducing obesity would have a significant impact upon the number of new cases of each disease. It is necessary to improve surveillance of obesity and disease incidence as well as implement policies that are effective in reducing body fat.

Similar to most developed countries, obesity rates inRussiahave been steadily increasing. This has led to a high burden of obesity related diseases and associated healthcare costs. The micro-simulation model has been utilized to project body mass index (BMI) and BMI related disease burden and healthcare costs. Incidence, mortality, survival and healthcare costs were collected for thirteen diseases. The results have been simulated for 3 hypothetical scenarios to project a potential impact of policy interventions: 1) assuming no reduction in BMI; 2) 1% reduction in mean BMI across the population; 3) 5% reduction in mean BMI across the population. Nearly 58% of the female population was obese (BMI ≥30 kg/m2) or overweight (BMI 25 -29.9 kg/m2) in 2010, and the prevalence is projected to decrease to 54% in 2050. The rates are predicted to increase for men from 51% in 2010 to 76% in 2050. The prevalence rates will triple for some obesity-related diseases. A one percent decrease in BMI across the population will save more than two billion US Dollars in 2030 and 2050. Despite female obesity prevalence starting at a higher point than the men, obesity is predicted to increase in males but not females. Disease and economic burden attributed to these obesity rates are still severe and the country should implement strong policies to tackle the obesity epidemic.

Summary Rising prevalence of obesity is a worldwide health concern because excess weight gain within populations forecasts an increased burden from several diseases, most notably cardiovascular diseases, diabetes, and cancers. In this report, we used a simulation model to project the probable health and economic consequences in the next two decades from a continued rise in obesity in two ageing populations—the USA and the UK. These trends project 65 million more obese adults in the USA and 11 million more obese adults in the UK by 2030, consequently accruing an additional 6–8·5 million cases of diabetes, 5·7–7·3 million cases of heart disease and stroke, 492 000–669 000 additional cases of cancer, and 26–55 million quality-adjusted life years forgone for USA and UK combined. The combined medical costs associated with treatment of these preventable diseases are estimated to increase by $48–66 billion/year in the USA and by £1·9–2 billion/year in the UK by 2030. Hence, effective policies to promote healthier weight also have economic benefits.

The statin saga is iconic, because it highlights the need for clinical data sharing and the constant need for proper assessment of side effects.1 Apparently the Cochrane review group is not interested in seeking the data on adverse events, …

The prevalence of childhood overweight and obesity has risen substantially worldwide in less than one generation. In the USA, the average weight of a child has risen by more than 5 kg within three decades, to a point where a third of the country's children are overweight or obese. Some low-income and middle-income countries have reported similar or more rapid rises in child obesity, despite continuing high levels of undernutrition. Nutrition policies to tackle child obesity need to promote healthy growth and household nutrition security and protect children from inducements to be inactive or to overconsume foods of poor nutritional quality. The promotion of energy-rich and nutrient-poor products will encourage rapid weight gain in early childhood and exacerbate risk factors for chronic disease in all children, especially those showing poor linear growth. Whereas much public health effort has been expended to restrict the adverse marketing of breastmilk substitutes, similar effort now needs to be expanded and strengthened to protect older children from increasingly sophisticated marketing of sedentary activities and energy-dense, nutrient-poor foods and beverages. To meet this challenge, the governance of food supply and food markets should be improved and commercial activities subordinated to protect and promote children's health.

Mental illness is associated with physical illness and mortality from a variety of causes including cancer. There is little information on screening attendance among the mentally ill population. An audit was conducted of a breast screening service in inner London to determine uptake rates in women with mental illness.Cross sectional data linkage study of the local screening register and patients of the local psychiatric units. Screening uptake rates in all patients, those with a history of multiple detention in hospital, and those with psychosis were compared with the local reference population.Women in three inner London boroughs.Screening records for 933 psychiatric patients and 44 195 women without mental health problems aged 50 to 64 years.Overall, psychiatric patients were as likely as the reference group to attend breast screening. Patients with a history of multiple detention were significantly less likely to attend (OR = 0.40, 0.29 to 0.55; p0.001), as were patients with a diagnosis of psychosis (OR = 0.33, 0.18 to 0.61; p0.01). Increasing age, a history of detention in hospital, and social deprivation remained independent predictors for non-attendance.Women with severe mental health problems may be less likely to attend national screening programmes such as breast screening, and action should be taken to overcome the barriers to attendance.

Objectives: To investigate the readmission experience of a large national prospective cohort of women up to 5 years after undergoing either transcervical resection of the endometrium (TCRE) or hysterectomy to assess reasons for readmission and whether TCRE can be viewed as a definitive substitute for hysterectomy. Design and participants: Data are from the VALUE/MISTLETOE prospective national cohort studies of hysterectomy and TCRE respectively. 5294 women who underwent hysterectomy for dysfunctional uterine bleeding in 1994/5 and 4032 women who underwent TCRE in 1993/4 and who responded to postal questionnaires were included. Surgeons gathered operative details. Women completed postal follow up questionnaires at 3 and 5 years after surgery asking about readmission to hospital and reasons for readmission. Adjusted proportional hazard ratios were calculated for likelihood of readmission in each category comparing types of surgery. Results: 41.7% of women undergoing hysterectomy and 44.6% of women undergoing TCRE experienced one or more readmissions to hospital overall within 5 years (adjusted hazard ratio for all readmissions (AHR) 0.87 (95% confidence interval (CI) 0.80 to 0.95)). 12.6% of hysterectomy patients and 30.3% of TCRE patients were readmitted for gynaecological reasons (AHR 0.40 (95% CI 0.33 to 0.48)). Rates of readmission for gynaecological reasons were similar up to 6 months but were markedly reduced for hysterectomy compared with TCRE patients towards the end of the follow up period (AHR for readmission at 3–5 years 0.28 (95% CI 0.20 to 0.39)). Conclusions: There are differences in the pattern of readmission to hospital after hysterectomy and TCRE for dysfunctional uterine bleeding. Women undergoing a hysterectomy are less likely to be readmitted to hospital up to 5 years after their operation overall, and are significantly less likely to be readmitted for reasons related to their operation, particularly for gynaecological reasons. Hysterectomy appears to be a more definitive operation. The different options for surgery for dysfunctional uterine bleeding are not interchangeable; they represent different patterns of care. Information should be available to women and practitioners to inform choices between these options.

This paper examines the current status of qualitative and quantitative research in the context of UK (public) health research in cancer. It is proposed that barren competition between qualitative and quantitative methods is inevitable, but that effective synergy between them continues to be essential to research excellence. The perceived methodological utility, with respect to understanding residual uncertainties, can account for the status accorded various research techniques and these will help to explain shifts witnessed in recent years and contribute towards an understanding of what can be realistically expected in terms of future progress. It is argued that the methodological debate, though familiar to many, is worthy of rearticulation in the context of cancer research where the psychosocial aspects of living with a cancer and the related complexity of providing appropriate cancer care are being addressed across Europe, as evidenced in recent directions in policy and research.

Objective Non-communicable diseases (NCDs) are the biggest cause of death in Europe putting an unsustainable burden on already struggling health systems. Increases in obesity are a major cause of NCDs. This paper projects the future burden of coronary heart disease (CHD), stroke, type 2 diabetes and seven cancers by 2030 in 53 WHO European Region countries based on current and past body mass index (BMI) trends. It also tests the impact of obesity interventions on the future disease burden. Setting and participants Secondary data analysis of country-specific epidemiological data using a microsimulation modelling process. Interventions The effect of three hypothetical scenarios on the future burden of disease in 2030 was tested: baseline scenario, BMI trends go unchecked; intervention 1, population BMI decreases by 1%; intervention 2, BMI decreases by 5%. Primary and secondary outcome measures Quantifying the future burden of major NCDs and the impact of interventions on this future disease burden. Results By 2030 in the whole of the European region, the prevalence of diabetes, CHD and stroke and cancers was projected to reach an average of 3990, 4672 and 2046 cases/100 000, respectively. The highest prevalence of diabetes was predicted in Slovakia (10 870), CHD and stroke—in Greece (11 292) and cancers—in Finland (5615 cases/100 000). A 5% fall in population BMI was projected to significantly reduce cumulative incidence of diseases. The largest reduction in diabetes and CHD and stroke was observed in Slovakia (3054 and 3369 cases/100 000, respectively), and in cancers was predicted in Germany (331/100 000). Conclusions Modelling future disease trends is a useful tool for policymakers so that they can allocate resources effectively and implement policies to prevent NCDs. Future research will allow real policy interventions to be tested; however, better surveillance data on NCDs and their risk factors are essential for research and policy.

Background Uterine fibroids are the most common tumour in women of reproductive age. By the time they are 50-years-old around 80% of women will have developed one. Of these, around half will experience symptoms which will impact negatively on their quality of life. Hysterectomy is the traditional treatment for women with symptomatic fibroids. For women who do not wish to undergo a hysterectomy, two invasive treatments are commonly available: myomectomy or uterine artery embolization (UAE). Design FEMME is a pragmatic, randomised, open, multi-centre trial examining the quality of life menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Methods After providing informed consent, 216 women with symptomatic fibroids from 43 NHS Hospital Trusts and Health Boards across the United Kingdom will undergo randomisation by a centralised computer system to treatment by either UAE or myomectomy. A minimisation algorithm will be used in order to balance the groups with respect to the following three parameters: the longest dimension of the largest fibroid, the number of fibroids present, and whether the woman currently desires pregnancy. Using validated questionnaires the women’s quality of life will be compared between groups at six months, one year, two years and four years post-procedure, taking into account pre-procedure scores. An economic evaluation will be conducted alongside the trial to determine the cost-effectiveness of UAE compared with myomectomy. Validated diaries will also be used to compare menstrual blood loss at the same time-points. The plasma concentration of Anti-Müllerian hormone (AMH), which will act as a proxy measurement of ovarian reserve, will be recorded before the woman has her procedure and then again at six weeks, six months, and twelve months afterwards. Re-intervention rates will be recorded. Discussion The FEMME trial’s primary outcome is the quality of life women with symptomatic uterine fibroids experience two years after they have been treated with either UAE or myomectomy, as measured by the disease-specific Uterine Fibroid Symptom Quality-of-Life (UFS-QoL) questionnaire. Trial registration Current Controlled Trials registration number: ISRCTN70772394, registered on 2 March 2013.

The first objective is to project obesity trends to 2030 based on the current data from Poland. The second objective is to test the effect of a 1% or 5% decrease in population BMI upon future incidence and prevalence of related non-communicable diseases. A two-stage modelling design projecting overweight and obesity trends and related diseases in a microsimulation model was developed. Epidemiological data for entry into a microsimulation model were gathered from Poland. This study used population level data from Poland creating a virtual population within a microsimulation model. Obesity and overweight in Poland was found to increase to very high levels in men while trends remained unchanged in women. In a country that currently has about 38 million inhabitants, it is anticipated that by 2030, there might be more than 9 million new cancer cases; 10 million CHD and stroke cases, and 7 million new cases of type 2 diabetes. These findings have policy implications highlighting the need for action to curb trends and to reduce increases in the rates of diet-related non-communicable disease.

Public health does not need to be led by doctors {#article-title-2} For years lead positions in public health have been restricted to those with a medical background, and it is still impossible for individuals to be accredited as specialists in public health without medical training. But does such exclusivity have repercussions? Here a professor of epidemiology and two directors of public health present their views. # For {#article-title-3} Public health is the science and art of promoting, protecting, and improving health and wellbeing through organised efforts of society.1 It encompasses all influences throughout life and, because the diversity is crucial, must be multidisciplinary.2 Whether medical training enables unique qualities for leadership in public health is certainly plausible but unproved, and justifications have so far been little more than special pleading. Public health in the United Kingdom is, and has been, led by many people from several core disciplines: Chadwick, Chalmers, Cochrane, Day, Davey Smith, Doll, Farr, Greenwood, Hill, Morris, Nightingale, Peto, Rose, Titmus, Stacey to name but a few. It will surely continue to do so. Yet for half a century a medical hegemony (legitimate or otherwise) has implied medical ownership and protection of careers, training, and accreditation in public health. All top public health jobs in the NHS and elsewhere from the chief medical officer down are protected, if not by law, by the BMA. It remains impossible to be accredited as a specialist in public health and, until quite recently, to attend postgraduate public health courses without a medical training. Funding for training and career opportunities are still grossly unequal and all this has clearly tended to confine others to roles different from, or ancillary to, public health. Until the need for this is satisfactorily justified it is a scandal. The academic sector is only now becoming an exception, where for too long the research, the teaching (exclusively of doctors), … Correspondence to: Edward Coyle

Summary Background In a previous study of pooled data from published trials, we found no evidence to support the claim that postmenopausal hormone therapy (PHT) is associated with a decrease in cardiovascular disease. The purpose of this study was to see whether reports of clinical trials attached to drug-licensing applications in Finland could be obtained for scientific purposes, whether they are useful for studying cardiovascular events resulting from PHT, and if so, whether these unpublished reports corroborate the results of published reports. Methods Since clinical trials in drug-licensing documents are confidential, we had to obtain special permission from the Ministry of Social Affairs and Health to use the data for research purposes. After permission was granted, we studied the clinical sections of licensing documents for PHT drugs sent by drug companies to the Finnish Drug Agency. We aimed to identify trials that compared PHT and a placebo (or no therapy, or vitamin-mineral drugs), and that reported on cardiovascular and thromboembolic events or superficial phlebitis. New trials were identified and their data were pooled with those of published trials. Findings 17 licensing applications for drugs used as PHT were found. The number, type, and quality of reporting of clinical trials varied widely between applications. The trials and their reporting of unanticipated adverse events were mostly inadequate. Six new trials (ie, those fulfilling the inclusion criteria and not included in our earlier report) were found. The new trials added little to the conclusions of previously published studies: the calculated odds ratios of cardiovascular and thromboembolic events for women taking PHT versus those not taking it was 1.97 (95% Cl 0.84-4.63), compared with 1.65 (0.65-4.21) in our previous study. Interpretation In this case, unpublished trials added only a little to the data available from published trials, mainly due to the type of clinical data used in the licensing applications. The new data did not change the previous conclusion that clinical trials do not support a beneficial effect of PHT on cardiovascular diseases.

Background The existence of a U-shaped relationship between alcohol consumption and all-cause mortality complicates the calculation and interpretation of mortality attributable to alcohol consumption. Methods We used the relationships between all-cause mortality and alcohol consumption from four British cohort studies. For each study we defined a ‘sensible drinking level’ as the level with lowest observed mortality. We estimated the fractions of deaths that were attributable to (1) any drinking (compared with not drinking), (2) drinking more than the ‘sensible level’, and (3) drinking less than the ‘sensible level’. Results Data from the Doctors’ study suggest that on balance 22.3 per cent of deaths are prevented by alcohol consumption, yet the fractions of deaths attributable to drinking more than 8‐14 units per week and less than 8‐14 units per week are nearly equal (6.5 per cent and 6.4 per cent, respectively). In a sensitivity analysis we show that it is possible for alcohol consumption to prevent deaths overall yet for more deaths to be attributable to drinking above a sensible level than are attributable to drinking below the sensible level. Conclusions The balance of deaths attributable to or prevented by alcohol consumption provides no information about the deaths attributable to drinking above or below sensible levels. Using all-cause data in this way is likely to exaggerate the protective effect of alcohol consumption, so our results are only illustrative.

BackgroundIn a recent study, 20% of the variance in the weight of infants of mothers with eating disorders was accounted for by mealtime conflict.AimsTo investigate the antecedents and interactive processes involved in the development of such conflict.MethodMothers with eating disorders and their 12-month-old infants (n=34) and a comparison group (n=24) were videotaped during infant mealtimes. Specific classes of antecedents to conflict episodes were identified. An examination was then made of all such antecedents not leading to conflict and the mother–infant responses to each antecedent.ResultsWithin the index group, conflict was less likely when mothers acknowledged infants' cues and were able to put aside their own concerns. The relationship between maternal responses and the evolution of conflictual interaction was confirmed in multiple regression analyses including both index and comparison groups.ConclusionsMothers' and infants' responses to potential antecedents to conflict had an impact on whether mealtime conflict ensued. Conflict arose because maternal eating disorder psychopathology interfered with aspects of responsive parenting.

We combined data from 5 prospective studies to compare the death rates from common diseases of vegetarians with those of nonvegetarians with similar lifestyles. A summary of these results was reported previously; we report here more details of the findings. Data for 76172 men and women were available. Vegetarians were those who did not eat any meat or fish (n = 27808). Death rate ratios at ages 16-89 y were calculated by Poisson regression and all results were adjusted for age, sex, and smoking status. A random-effects model was used to calculate pooled estimates of effect for all studies combined. There were 8330 deaths after a mean of 10.6 y of follow-up. Mortality from ischemic heart disease was 24% lower in vegetarians than in nonvegetarians (death rate ratio: 0.76; 95% CI: 0.62, 0.94; P5 y. Further categorization of diets showed that, in comparison with regular meat eaters, mortality from ischemic heart disease was 20% lower in occasional meat eaters, 34% lower in people who ate fish but not meat, 34% lower in lactoovovegetarians, and 26% lower in vegans. There were no significant differences between vegetarians and nonvegetarians in mortality from cerebrovascular disease, stomach cancer, colorectal cancer, lung cancer, breast cancer, prostate cancer, or all other causes combined.

A retrospective comparison of cancer incidence data and, where relevant, population data with 16 955first-time users (patients, relatives and friends) of a national cancer information service (CancerBACUP) during the period April1995 to March 1996 is presented. The number of events observed was compared with the number of events expected, were the nationalrates of cancer incidence and population demographics apply. Standardized incidence ratios (SIRs) (observed – expectedratios) were used to indicate any differences. Statistically significant differences (P< 0.001) in the observed andexpected sex, age and primary site distribution of patients enquired about were found. Statistically significant differences(P< 0.001) were also identified for the age, employment status, socioeconomic class and geographical location offirst-time enquirers (patients, relatives and friends). Enquiries about brain, testis and breast cancers and non-Hodgkin'slymphoma (NHL) were substantially higher than expected; enquiries about bladder, lung, stomach and colorectal cancers were muchlower than expected. As the service is provided via a freephone number, it is available to all, and users might be expected to berandomly distributed across the variables listed. The underlying reasons for the differences identified need to be investigated,and the role of information in the care of cancer patients should be formally evaluated. © 1999 Cancer Research Campaign