Radiofrequency volumetric thermal ablation of fibroids: A prospective, clinical analysis of two years' outcome from the Halt trial

Background: Although most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up.Methods: Prospective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant.Results: One hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was -35.7 (95% CI, -40.1 to -31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124).Conclusion: Radiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.Trial registration: ClinicalTrials.gov: NCT00874029. © 2013 Guido et al.; licensee BioMed Central Ltd

Experts' attitudes towards medical futility: an empirical survey from Japan

BACKGROUND: The current debate about medical futility is mostly driven by theoretical and personal perspectives and there is a lack of empirical data to document experts and public attitudes towards medical futility. METHODS: To examine the attitudes of the Japanese experts in the fields relevant to medical futility a questionnaire survey was conducted among the members of the Japan Association for Bioethics. A total number of 108 questionnaires returned filled in, giving a response rate of 50.9%. Among the respondents 62% were healthcare professionals (HCPs) and 37% were non-healthcare professionals (Non-HCPs). RESULTS: The majority of respondents (67.6 %) believed that a physician's refusal to provide or continue a treatment on the ground of futility judgment could never be morally justified but 22.2% approved such refusal with conditions. In the case of physiologically futile care, three-quarters believed that a physician should inform the patient/family of his futility judgment and it would be the patient who could decide what should be done next, based on his/her value judgment. However more than 10% said that a physician should ask about a patient's value and goals, but the final decision was left to the doctor not the patient. There was no statistically significant difference between HCPs and Non-HCPs (p = 0.676). Of respondents 67.6% believed that practical guidelines set up by the health authority would be helpful in futility judgment. CONCLUSION: The results show that there is no support for the physicians' unilateral decision- making on futile care. This survey highlights medical futility as an emerging issue in Japanese healthcare and emphasizes on the need for public discussion and policy development

Surrogacy tourism: the ethical and legal challenges

Although surrogacy seemed to have been practised since ancient times, its resurgence in the contemporary era has been nothing short of phenomenal. With advances made in reproductive technology, it is now possible to fertilise eggs and sperms in laboratories and have the embryo transferred into the womb of a surrogate mother for gestation. Through a combination of push and pull factors, this possibility of gestational surrogacy has led to the meteoric rise of cross-border surrogacy. This paper seeks to highlight the ethical and legal challenges associated with the practice, and calls for better legal oversight at international level

The ethical desirability of moral bioenhancement: A review of reasons

Background: The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and against moral bioenhancement. Discussion: A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don't) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. Summary: Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing 'the whole of humanity', we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise

The International HapMap Project

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/62838/1/nature02168.pd

A second generation human haplotype map of over 3.1 million SNPs

We describe the Phase II HapMap, which characterizes over 3.1 million human single nucleotide polymorphisms (SNPs) genotyped in 270 individuals from four geographically diverse populations and includes 25-35% of common SNP variation in the populations surveyed. The map is estimated to capture untyped common variation with an average maximum r(2) of between 0.9 and 0.96 depending on population. We demonstrate that the current generation of commercial genome-wide genotyping products captures common Phase II SNPs with an average maximum r(2) of up to 0.8 in African and up to 0.95 in non-African populations, and that potential gains in power in association studies can be obtained through imputation. These data also reveal novel aspects of the structure of linkage disequilibrium. We show that 10-30% of pairs of individuals within a population share at least one region of extended genetic identity arising from recent ancestry and that up to 1% of all common variants are untaggable, primarily because they lie within recombination hotspots. We show that recombination rates vary systematically around genes and between genes of different function. Finally, we demonstrate increased differentiation at non-synonymous, compared to synonymous, SNPs, resulting from systematic differences in the strength or efficacy of natural selection between populations.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/62863/1/nature06258.pd