315 research outputs found

    Labour induction near term for women aged 35 or over: an economic evaluation

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    Objective Induction of labour at 39 weeks for nulliparous women aged 35 years and over may prevent stillbirths and does not increase caesarean births, so it may be popular. But the overall costs and benefits of such a policy have not been compared. Design A cost–utility analysis alongside a randomised controlled trial (the 35/39 trial). Setting Obstetric departments of 38 UK National Health Service hospitals and one UK primary-care trust. Population Nulliparous women aged 35 years or over on their expected due date, with a singleton live fetus in a cephalic presentation. Methods Costs were estimated from the National Health Service and Personal Social Services perspective and quality-adjusted life-years (QALYs) were calculated based on patient responses to the EQ-5D at baseline and 4 weeks. Main outcome measures Data on antenatal care, mode of delivery, analgesia in labour, method of induction, EQ-5D (baseline and 4 weeks postnatal) and participant-administered postnatal health resource use data were collected. Results The intervention was associated with a mean cost saving of £263 and a small additional gain in QALYs (though this was not statistically significant), even without considering any possible QALY gains from stillbirth prevention. Conclusion A policy of induction of labour at 39 weeks for women of advanced maternal age would save money

    Colon cancer risk and different HRT formulations: a case-control study

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    <p>Abstract</p> <p>Background</p> <p>Most studies have found no increased risk of colon cancer associated with hormone replacement therapy (HRT), or even a decreased risk. But information about the effects of different HRT preparations is lacking.</p> <p>Methods</p> <p>A case-control study was performed within Germany in collaboration with regional cancer registries and tumor centers. Up to 5 controls were matched to each case of colon cancer. Conditional logistic regression analysis was applied to estimate crude and adjusted odds ratios (OR) and 95% confidence intervals (95% CI). Stratified analyses were performed to get an impression of the risk associated with different estrogens and progestins.</p> <p>Results</p> <p>A total of 354 cases of colon cancer were compared with 1422 matched controls. The adjusted overall risk estimate for colon cancer (ColC) associated with ever-use of HRT was 0.97 (0.71 – 1.32). No clinically relevant trends for ColC risk were observed with increasing duration of HRT use, or increasing time since first or last HRT use in aggregate.</p> <p>Whereas the overall risk estimates were stable, the numbers in many of the sub-analyses of HRT preparation groups (estrogens and progestins) were too small for conclusions. Nevertheless, if the ColC risk estimates are taken at face value, most seemed to be reduced compared with never-use of HRT, but did not vary much across HRT formulation subgroups. In particular, no substantial difference in ColC risk was observed between HRT-containing conjugated equine estrogens (CEE) or medroxyprogesterone acetate (MPA) and other formulations more common in Europe.</p> <p>Conclusion</p> <p>Ever-use of HRT was not associated with an increased risk of colon cancer. In contrary, most risk estimates pointed non-significantly toward a lower ColC risk in HRT ever user. They did not vary markedly among different HRT formulations (estrogens, progestins). However, the small numbers and the overlapping nature of the subgroups suggest cautious interpretation.</p

    Hormone therapy after the Women's Health Initiative: a qualitative study

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    BACKGROUND: Publication of results from the Women's Health Initiative study in July 2002 was a landmark event in biomedical science related to postmenopausal women. The purpose of this study was to describe the impact of new hormone therapy recommendations on patients' attitudes and decision-making in a primary care practice. METHODS: A questionnaire including structured and open-ended questions was administered in a family practice office waiting room from August through October 2003. Rationale for taking or not taking hormone therapy was specifically sought. Women 50–70 years old attending for office visits were invited to participate. Data were analyzed qualitatively and with descriptive statistics. Chart review provided medication use rates for the entire practice cohort of which the sample was a subset. RESULTS: Respondents (n = 127) were predominantly white and well educated, and were taking hormone therapy at a higher rate (38%) than the overall rate (26%) for women of the same age range in this practice. Belief patterns about hormone therapy were, in order of frequency, 'use is risky', 'vindication or prior beliefs', 'benefit to me outweighs risk', and 'unaware of new recommendations'. Twenty-eight out of 78 women continued hormones use after July 2002. Of 50 women who initially stopped hormone therapy after July 2002, 12 resumed use. Women who had stopped hormone therapy were a highly symptomatic group. Responses with emotional overtones such as worry, confusion, anger, and grief were common. CONCLUSION: Strategies for decision support about hormone therapy should explicitly take into account women's preferences about symptom relief and the trade-offs among relevant risks. Some women may need emotional support during transitions in hormone therapy use

    Care during the third stage of labour: A postal survey of UK midwives and obstetricians

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    <p>Abstract</p> <p>Background</p> <p>There are two approaches to care during the third stage of labour: Active management includes three components: administration of a prophylactic uterotonic drug, cord clamping and controlled cord traction. For physiological care, intervention occurs only if there is clinical need. Evidence to guide care during the third stage is limited and there is variation in recommendations which may contribute to differences in practice. This paper describes current UK practice during the third stage of labour.</p> <p>Methods</p> <p>A postal survey of 2230 fellows and members of the Royal College of Obstetricians and Gynaecologists (RCOG) and 2400 members of the Royal College of Midwives was undertaken. Respondents were asked about care during the third stage of labour, for vaginal and caesarean births and their views on the need for more evidence to guide care in the third stage. The data were analysed in Excel and presented as descriptive statistics.</p> <p>Results</p> <p>1189 (53%) fellows and members of the RCOG and 1702 (71%) midwives responded, of whom 926 (78%) and 1297 (76%) respectively had conducted or supervised births in the last year. 93% (863/926) of obstetricians and 73% (942/1297) of midwives report 'always or usually' using active management. 66% (611/926) of obstetricians and 33% (430/1297) of midwives give the uterotonic drug with delivery of the anterior shoulder; this was intramuscular Syntometrine<sup>® </sup>for 79% (728/926) and 86% (1118/1293) respectively. For term births, 74% (682/926) of obstetricians and 41% (526/1297) of midwives clamp the cord within 20 seconds, as do 57% (523/926) and 55% (707/1297) for preterm births. Controlled cord traction was used by 94% of both obstetricians and midwives. For caesarean births, intravenous oxytocin was the uterotonic used by 90% (837/926) of obstetricians; 79% (726/926) clamp the cord within 20 seconds for term births as do 63% (576/926) for preterm births.</p> <p>Physiological management was used 'always or usually' by 2% (21/926) of obstetricians and 9% (121/1297) of midwives. 81% (747/926) of obstetricians and 89% (1151/1297) of midwives thought more evidence from randomised trials was needed; the most popular question was when is best to clamp the cord.</p> <p>Conclusions</p> <p>Active management of the third stage of labour is widely used by both obstetricians and midwives in the UK. Syntometrine<sup>® </sup>is usually used for vaginal births and oxytocin for caesarean births; when this is given and when the cord is clamped varies.</p

    Displacement and disease: The Shan exodus and infectious disease implications for Thailand

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    Decades of neglect and abuses by the Burmese government have decimated the health of the peoples of Burma, particularly along her eastern frontiers, overwhelmingly populated by ethnic minorities such as the Shan. Vast areas of traditional Shan homelands have been systematically depopulated by the Burmese military regime as part of its counter-insurgency policy, which also employs widespread abuses of civilians by Burmese soldiers, including rape, torture, and extrajudicial executions. These abuses, coupled with Burmese government economic mismanagement which has further entrenched already pervasive poverty in rural Burma, have spawned a humanitarian catastrophe, forcing hundreds of thousands of ethnic Shan villagers to flee their homes for Thailand. In Thailand, they are denied refugee status and its legal protections, living at constant risk for arrest and deportation. Classified as "economic migrants," many are forced to work in exploitative conditions, including in the Thai sex industry, and Shan migrants often lack access to basic health services in Thailand. Available health data on Shan migrants in Thailand already indicates that this population bears a disproportionately high burden of infectious diseases, particularly HIV, tuberculosis, lymphatic filariasis, and some vaccine-preventable illnesses, undermining progress made by Thailand's public health system in controlling such entities. The ongoing failure to address the root political causes of migration and poor health in eastern Burma, coupled with the many barriers to accessing health programs in Thailand by undocumented migrants, particularly the Shan, virtually guarantees Thailand's inability to sustainably control many infectious disease entities, especially along her borders with Burma

    Changes in elderly women's health-related quality of life following discontinuation of hormone replacement therapy

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    BACKGROUND: Many women have discontinued hormone replacement therapy (HRT) in view of recent findings. The goal of this study was to determine if HRT discontinuation is associated with changes in health-related quality of life (HRQOL) in elderly women. METHODS: We studied women enrolled in Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) program, linking prescription claims with data from a longitudinal mail survey. HRQOL measures included the number of days out of the last 30 that physical health was not good and analogous measures for mental health, pain, and interference with activities, as well as a composite "healthy days" measure developed by CDC. Longitudinal analyses focused on 2,357 women who completed surveys in both 2002 and 2003, and who used HRT at baseline (mean age = 75.5, range = 65–102). Propensity scores were used to match HRT continuers and discontinuers according to HRT type, demographics, and baseline HRQOL. Analysis of covariance was used to compare HRQOL change in continuers and discontinuers. RESULTS: Between 2002 and 2003, 43% of HRT users discontinued therapy. Analysis of covariance to examine HRQOL change revealed complex interactions with age. Discontinuers aged 65–74 reported greater increases in days in which mental health was not good (p < .05), fewer "healthy days" (p < .05), more days in which health interfered with activities (p < .01), and more days with pain (p < .01). Among women aged 75–84, HRT discontinuers reported more days in which physical health was not good (p < .01); no other significant effects were observed in this group. Relative to HRT continuers, discontinuers aged 85 and older experienced apparent HRQOL improvements following cessation, with fewer days in which physical health was not good (p < .01), fewer days of poor mental health (p < .05), and more "healthy days" (p < .01). CONCLUSIONS: These results suggest that there are substantial age differences in response to HRT discontinuation. While women aged 65–74 experienced apparent declines in HRQOL following HRT cessation, women aged 85 and older experienced relative improvements. The HRQOL declines observed among younger women underscore the importance of communication between clinicians and patients throughout the discontinuation process. These results also demonstrate the value of HRQOL surveillance as a component of health program administration

    The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial

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    BACKGROUND: At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. DESIGN: Randomised, placebo, controlled, trial. METHODS: The trial was set in general practices in the UK (384), Australia (94), and New Zealand (24). In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. RESULTS: The trial was prematurely closed during recruitment following publication of early results from the Women's Health Initiative. At the time of closure, 56583 had been screened, 8980 entered run-in, and 5694 (26% of target of 22,300) randomised. Those women randomised had received a mean of one year of therapy, mean age was 62.8 years and total follow-up time was 6491 person years. DISCUSSION: The WISDOM experience leads to some simple messages. The larger a trial is the more simple it needs to be to ensure cost effective and timely delivery. When a trial is very costly and beyond the resources of one country, funders and investigators should make every effort to develop international collaboration with joint funding

    Are health care professionals able to judge cancer patients' health care preferences correctly? A cross-sectional study

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    Background: Health care for cancer patients is primarily shaped by health care professionals. This raises the question to what extent health care professionals are aware of patients' preferences, needs and values. The aim of this study was to explore to what extent there is concordance between patients' preferences in cancer care and patients' preferences as estimated by health care professionals. We also examined whether there were gender differences between health care professionals with regard to the degree in which they can estimate patients' preferences correctly. Methods: To obtain unbiased insight into the specific preferences of cancer patients, we developed the 'Cancer patients' health care preferences' questionnaire'. With this questionnaire we assessed a large sample of cancer patients (n = 386). Next, we asked health care professionals (medical oncologists, nurses and policymakers, n = 60) to fill out this questionnaire and to indicate preferences they thought cancer patients would have. Mean scores between groups were compared using Mann-Whitney tests. Effect sizes (ESs) were calculated for statistically significant differences. Results: We found significant differences (ESs 0.31 to 0.90) between patients and professionals for eight out of twenty-one scales and two out of eight single items. Patients valued care aspects related to expertise and attitude of health care providers and accessibility of services as more important than the professionals thought they would do. Health care professionals overestimated the value that patients set on particularly organisational and environmental aspects. We found significant gender-related differences between the professionals (ESs 0.69 to 1.39) for eight out of twenty-one scales and two out of eight single items. When there were significant differences between male and female healthcare professionals in their estimation of patients health care preferences, female health care professionals invariably had higher scores. Generally, female health care professionals did not estimate patients' preferences and needs better than their male colleagues. Conclusions: Health care professionals are reasonably well able to make a correct estimation of patients preferences, but they should be aware of their own bias and use additional resources to gain a better understanding of patients' specific preferences for each patient is different and ultimately the care needs and preferences will also be unique to the person

    Pharmacokinetics of isoflavones, daidzein and genistein, after ingestion of soy beverage compared with soy extract capsules in postmenopausal Thai women

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    BACKGROUND: Isoflavones from soybeans may provide some beneficial impacts on postmenopausal health. The purpose of this study was to compare the pharmacokinetics and bioavailability of plasma isoflavones (daidzein and genistein) after a single dose of orally administered soy beverage and soy extract capsules in postmenopausal Thai women. METHODS: We conducted a randomized two-phase crossover pharmacokinetic study in 12 postmenopausal Thai women. In the first phase, each subject randomly received either 2 soy extract capsules (containing daidzin : genistin = 7.79 : 22.57 mg), or soy beverage prepared from 15 g of soy flour (containing daidzin : genistin = 9.27 : 10.51 mg). In the second phase, the subjects received an alternative preparation in the same manner after a washout period of at least 1 week. Blood samples were collected immediately before and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24 and 32 h after administration of the soy preparation in each phase. Plasma daidzein and genistein concentrations were determined by using high performance liquid chromatography (HPLC). The pharmacokinetic parameters of daidzein and genistein, i.e. maximal plasma concentration (C(max)), time to maximal plasma concentration (T(max)), area under the plasma concentration-time curve (AUC) and half-life (t(1/2)), were estimated using the TopFit version 2.0 software with noncompartmental model analysis. RESULTS: There were no significant differences in the mean values of C(max)/dose, AUC(0–32)/dose, AUC(0-∝)/dose, T(max), and t(1/2 )of genistein between both preparations. For pharmacokinetic parameters of daidzein, the mean values of C(max)/dose, T(max), and t(1/2 )did not significantly differ between both preparations. Nonetheless, the mean AUC(0–32)/dose and AUC(0-∝)/dose after administration of soy extract capsules were slightly (but significantly, p < 0.05) higher than those of soy beverage. CONCLUSION: The bioavailability of daidzein, which was adjusted for the administered dose (AUC/dose), following a single oral administration of soy beverage was slightly (but significantly) less than that of soy extract capsules, whereas, the bioavailability adjusted for administered dose of genistein from both soy preparations were comparable. The other pharmacokinetic parameters of daidzein and genistein, including C(max )adjusted for the dose, T(max )and t(1/2), were not different between both soy preparations
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