Uterine-artery embolization versus surgery for symptomatic uterine fibroids.

BACKGROUND: The efficacy and safety of uterine-artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. METHODS: We conducted a randomized trial comparing uterine-artery embolization and surgery in women with symptomatic uterine fibroids. The primary outcome was quality of life at 1 year of follow-up, as measured by the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). RESULTS: Patients were randomly assigned in a 2:1 ratio to undergo either uterine-artery embolization or surgery, with 106 patients undergoing embolization and 51 undergoing surgery (43 hysterectomies and 8 myomectomies). There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year. The embolization group had a shorter median duration of hospitalization than the surgical group (1 day vs. 5 days, P<0.001) and a shorter time before returning to work (P<0.001). At 1 year, symptom scores were better in the surgical group (P=0.03). During the first year of follow-up, there were 13 major adverse events in the embolization group (12%) and 10 in the surgical group (20%) (P=0.22), mostly related to the intervention. Ten patients in the embolization group (9%) required repeated embolization or hysterectomy for inadequate symptom control. After the first year of follow-up, 14 women in the embolization group (13%) required hospitalization, 3 of them for major adverse events and 11 for reintervention for treatment failure. CONCLUSIONS: In women with symptomatic fibroids, the faster recovery after embolization must be weighed against the need for further treatment in a minority of patients. (ISRCTN.org number, ISRCTN23023665 [controlled-trials.com].)

Screening for thrombophilia in high-risk situations: a meta-analysis and cost-effectiveness analysis.

Laboratory testing for the identification of heritable thrombophilia in high-risk patient groups have become common practice; however, indiscriminate testing of all patients is unjustified. The objective of this study was to evaluate the cost-effectiveness of universal and selective history-based thrombophilia screening relative to no screening, from the perspective of the UK National Health Service, in women prior to prescribing combined oral contraceptives and hormone replacement therapy, women during pregnancy and patients prior to major orthopaedic surgery. A decision analysis model was developed, and data from meta-analysis, the literature and two Delphi studies were incorporated in the model. Incremental cost-effectiveness ratios (ICERs) for screening compared with no screening was calculated for each patient group. Of all the patient groups evaluated, universal screening of women prior to prescribing hormone replacement therapy was the most cost-effective (ICER 6824 pounds). In contrast, universal screening of women prior to prescribing combined oral contraceptives was the least cost-effective strategy (ICER 202,402 pounds). Selective thrombophilia screening based on previous personal and/or family history of venous thromboembolism was more cost-effective than universal screening in all the patient groups evaluated.

Oral contraceptives, hormone replacement therapy, thrombophilias and risk of venous thromboembolism: a systematic review. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) Study.

Combined oral contraceptives, oral hormone replacement therapy and thrombophilias are recognised risk factors for venous thromboembolism in women. The objective of this study was to assess the risk of thromboembolism among women with thrombophilia who are taking oral contraceptives or hormone replacement therapy, conducting a systematic review and metaanalysis. Of 201 studies identified, only nine met the inclusion criteria. Seven studies included pre-menopausal women on oral contraceptives and two studies included peri-menopausal women on hormone replacement therapy. For oral contraceptive use, significant associations of the risk of venous thromboembolism were found in women with factor V Leiden (OR 15.62; 95%CI 8.66 to 28.15); deficiencies of antithrombin (OR 12.60; 95%CI 1.37 to 115.79), protein C (OR 6.33; 95%CI 1.68 to 23.87), or protein S (OR 4.88; 95%CI 1.39 to 17.10), elevated levels of factor VIIIc (OR 8.80; 95%CI 4.13 to 18.75); and factor V Leiden and prothrombin G20210A (OR 7.85; 95%CI 1.65 to 37.41). For hormone replacement therapy, a significant association was found in women with factor V Leiden (OR 13.16; 95%CI 4.28 to 40.47). Although limited by the small number of studies, the findings of this study support the presence of interaction between thrombophilia and venous thromboembolism among women taking oral contraceptives. However, further studies are required to establish with greater confidence the associations of these, and other, thrombophilias with venous thromboembolism among hormone users.

An evaluation of economics and acceptability of screening for Chlamydia trachomatis infection, in women attending antenatal, abortion, colposcopy and family planning clinics in Scotland, UK.

OBJECTIVE: The aims of this study were to determine cost effectiveness of screening for Chlamydia trachomatis in hospital-based antenatal and gynaecology clinics, and community-based family planning clinics. Additionally, women's views of screening were determined in the hospital-based clinics. DESIGN: Cost effectiveness based on decision model. Model probabilities were generated for a hypothetical sample of 250 women in each age group in each setting, based on prevalence studies, published data and expert opinion. A prospective observational study was used to generate data on prevalence and acceptability. SETTING: Antenatal, gynaecology and family planning clinics in Aberdeen, Edinburgh and Glasgow. SAMPLE: Prevalence was estimated in 2817 women. Acceptability was determined in 484 women. METHODS: An economic evaluation was performed using prevalence data from this and a previous study, and using outcome data from the literature and observational work. Incremental cost effectiveness ratios were estimated for each age group and clinical setting. Sensitivity analyses were performed to determine the robustness of incremental cost effectiveness ratios to changes in the incidence of long term sequelae and costs. The prevalence of infection was determined by nucleic acid amplification of urine samples or endocervical swabs. Knowledge of C. trachomatis and women's views of screening were determined using structured questionnaires. MAIN OUTCOME MEASURES: Direct health service costs of screening, incidence and costs associated with adverse sequelae, women's views of screening and prevalence of infection. RESULTS: The estimated cost of screening 250 women in each age group in each the four sample populations (total population of 3750) is 49,367 UK pounds, while preventing 64 major sequelae. This represents a net cost of 771.36 UK pounds in preventing one major sequela. Selective screening of all women under 20 years and all patients attending abortion clinics were shown to be the most cost effective strategies. These results were relatively insensitive to changes in estimated parameters, such as uptake rate, probabilities and unit costs of all major sequelae averted. Prevalence (95% CI) of infection in the highest risk groups (those aged under 20 in both antenatal and abortion clinics) was 12.1% (8.6-16.7) and 12.7% (7.3-21.2), respectively. The majority (>95%) of women agreed with a policy of regular screening for C. trachomatis, and screening in the settings employed in this study was largely acceptable. CONCLUSIONS: A single episode of screening for C. trachomatis does not result in net cost savings. Currently recommended strategies of screening for C. trachomatis in women under 25 years of age in abortion clinics are supported by our data on prevalence and acceptability. These data also suggest that hospital-based screening strategies should be further extended to include younger women attending antenatal clinics and all women of reproductive age attending colposcopy clinics.

Cost-effectiveness of screening for the factor V Leiden mutation in pregnant women.

The factor V Leiden (FVL) mutation is associated with vascular complications in pregnancy, and routine screening of all pregnant women has been suggested. We did a prospective, unselected study in 967 pregnant women to evaluate the cost-effectiveness of screening all women, or only those with a personal or family history of venous thrombosis (n=113). When anticoagulant prophylaxis was assumed to effect a 50% reduction in vascular complications, we recorded an additional management cost of 3768 pounds sterling with selective screening and 39,841 pounds sterling with universal screening. This additional cost would result in prevention of less than one and three vascular events,respectively. Our findings, therefore, suggest that screening of pregnant women for the FVL mutation is not cost-effective.