Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.

STUDY OBJECTIVE:To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. DESIGN:Uncontrolled clinical trial. SETTING:Five academic medical centers across California. PATIENTS:Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. INTERVENTIONS:Laparoscopic RFA of leiomyomas. MEASUREMENTS AND MAIN RESULTS:We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4-7.5) on a 10-point scale, and 89% of surgeons felt "very or somewhat" confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2-6) after the fourth procedure, with all gynecologists reporting surgical confidence. CONCLUSION:Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases

The menopause transition and women\u27s health at midlife: a progress report from the Study of Women\u27s Health Across the Nation (SWAN)

OBJECTIVE: Our initial understanding of the menopause transition (MT) has been framed by clinical samples of women seeking treatment rather than by population-based studies. The Study of Women\u27s Health Across the Nation (SWAN) initiated in 1996 with an overall goal to define the MT, to characterize its biological and psychosocial antecedents and sequelae in an ethnically and racially diverse sample of midlife women. METHODS: This review summarizes the central findings of SWAN to date that can inform women and their healthcare providers about the impact of the MT and midlife aging on overall health and well-being. RESULTS: SWAN characterized changes in reproductive axis and menstrual cycle patterns that informed the development of the reproductive aging staging system Staging of Reproductive Aging Workshop+10; MT-related symptoms and mental health (vasomotor symptoms, sleep complaints, psychological symptoms, cognitive performance, and urogenital and sexual health); and physiological systems and functions (cardiovascular and cardiometabolic health, bone health, physical function performance) that are influenced by the MT. SWAN demonstrated substantial interrelations among these changes and significant racial/ethnic differences in the rate and magnitude of change in multiple health indictors in midlife women. The findings point to midlife as a critical stage for adopting healthy behavior and preventive strategies. CONCLUSIONS: Over the past 23 years, SWAN has advanced our understanding of the impact of the MT and midlife aging on health and well-being in women. SWAN will be instrumental to determine whether MT-related changes during midlife are related to unfavorable health and well-being in early old age

Ionising radiation metrology for the metallurgical industry

Every year millions tons of steel are produced worldwide from recycled scrap loads. Although the detection systems in the steelworks prevent most orphan radioactive sources from entering the furnace, there is still the possibility of accidentally melting a radioactive source. The MetroMetal project, carried out in the frame of the European Metrology Research Programme (EMRP), addresses this problem by studying the existing measurement systems, developing sets of reference sources in various matrices (cast steel, slag, fume dust) and proposing new detection instruments. This paper presents the key lines of the project and describes the preparation of radioactive sources as well as the intercomparison exercises used to test the calibration and correction methods proposed within the project.JRC.D.4-Standards for Nuclear Safety, Security and Safeguard

The certification of the activity concentration of the radionuclides 137Cs, 90Sr and 40K in wild berries: IRMM-426

This report describes the production of CRM IRMM-426, a dried bilberry material certified for the radionuclide activity concentrations of 137Cs, 90Sr and 40K. The material was produced following ISO Guide 34:2009. Bilberry samples were collected in a woodland region of so-called “strontium hot spots” close to the Chernobyl reactor site. The samples were air-dried at the sampling site before transport to IRMM, where the raw material was oven-dried, cryo-milled, sieved, homogenised and bottled. The bottled material was sterilised by gamma-irradiation. Between-unit homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006. The material was characterised by an intercomparison among laboratories of demonstrated competence and adhering to ISO/IEC 17025. Technically invalid results were removed but no outlier was eliminated on statistical grounds only. Uncertainties of the certified values were calculated in compliance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible inhomogeneity and instability and to characterisation. The material is intended for the assessment of method performance and quality control. As any reference material, it can also be used for control charts or validation studies. The CRM is available in amber glass jars containing about 100 g of dried bilberry powder. The minimum amount of sample to be used for analysis is 50 g for 90Sr and 18 g for 137Cs and 40K.JRC.D.2-Standards for Innovation and sustainable Developmen

An instrument to determine the technological literacy levels of upper secondary school students

In this article, an instrument for assessing upper secondary school students’ levels of technological literacy is presented. The items making up the instrument emerged from a previous study that employed a phenomenographic research approach to explore students’ conceptions of technology in terms of their understanding of the nature of technology and their interaction with technological artefacts. The instrument was validated through administration to 1,245 students on completion of their 12 years of formal schooling. A factor analysis was conducted on the data and Cronbach alpha reliability coefficients determined. The results show that a five-dimension factor structure (namely, artefact, process, direction/instruction, tinkering, and engagement) strongly supported the dimensions as developed during the original phenomenographic study. The Cronbach alpha reliability co-efficient of each dimension was satisfactory. Based on these findings, the instrument has been shown to be valid and reliable and can be used with confidence

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

<p>Abstract</p> <p>Background</p> <p>Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.</p> <p>Methods/Design</p> <p>Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:</p> <p indent="1"><b>Stakeholders </b>- federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.</p> <p indent="1"><b>Ethics </b>- beneficence, non-maleficence, autonomy, justice.</p> <p indent="1"><b>Economics </b>- scarcity of resources, choices, opportunity costs.</p> <p>For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.</p> <p>Discussion</p> <p>The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.</p

Activity Measurements of the radionuclide V134 for the IRMM, Geel, PTB, Germany, OMH, Hungary, LNE-LNHB, France and NMIJ, Japan in the ongoing Comparison BIPM.RI(II)-K1.Cs-134

Since 2004, IRMM, PTB (Germany), OMH (Hungary), LNE-LNHB (France) and NMIJ (Japan) eacch submitted one sample of known activity of Vs-134 to the International Reference System (SIR). The key comparison results under the SIR have been added to the matrix of degrees of equivalence between NMIs for the activity determination of Cs-134, now containing 12 results, to which the remaining 10 eligible results of the CCRI key comparison of 1978 are linked.JRC.D.4-Isotope measurement

Contribution of urban expansion and a changing climate to decline of a butterfly fauna.

Butterfly populations are naturally patchy and undergo extinctions and recolonizations. Analyses based on more than 2 decades of data on California's Central Valley butterfly fauna show a net loss in species richness through time. We analyzed 22 years of phenological and faunistic data for butterflies to investigate patterns of species richness over time. We then used 18-22 years of data on changes in regional land use and 37 years of seasonal climate data to develop an explanatory model. The model related the effects of changes in land-use patterns, from working landscapes (farm and ranchland) to urban and suburban landscapes, and of a changing climate on butterfly species richness. Additionally, we investigated local trends in land use and climate. A decline in the area of farmland and ranchland, an increase in minimum temperatures during the summer and maximum temperatures in the fall negatively affected net species richness, whereas increased minimum temperatures in the spring and greater precipitation in the previous summer positively affected species richness. According to the model, there was a threshold between 30% and 40% working-landscape area below which further loss of working-landscape area had a proportionally greater effect on butterfly richness. Some of the isolated effects of a warming climate acted in opposition to affect butterfly richness. Three of the 4 climate variables that most affected richness showed systematic trends (spring and summer mean minimum and fall mean maximum temperatures). Higher spring minimum temperatures were associated with greater species richness, whereas higher summer temperatures in the previous year and lower rainfall were linked to lower richness. Patterns of land use contributed to declines in species richness (although the pattern was not linear), but the net effect of a changing climate on butterfly richness was more difficult to discern