Should Research Ethics Encourage the Production of Cost-Effective Interventions?

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs

Temperature Modulation of Electric Fields in Biological Matter

Pulsed electric fields (PEF) have become an important minimally invasive surgical technology for various applications including genetic engineering, electrochemotherapy and tissue ablation. This study explores the hypothesis that temperature dependent electrical parameters of tissue can be used to modulate the outcome of PEF protocols, providing a new means for controlling and optimizing this minimally invasive surgical procedure. This study investigates two different applications of cooling temperatures applied during PEF. The first case utilizes an electrode which simultaneously delivers pulsed electric fields and cooling temperatures. The subsequent results demonstrate that changes in electrical properties due to temperature produced by this configuration can substantially magnify and confine the electric fields in the cooled regions while almost eliminating electric fields in surrounding regions. This method can be used to increase precision in the PEF procedure, and eliminate muscle contractions and damage to adjacent tissues. The second configuration considered introduces a third probe that is not electrically active and only applies cooling boundary conditions. This second study demonstrates that in this probe configuration the temperature induced changes in electrical properties of tissue substantially reduce the electric fields in the cooled regions. This novel treatment can potentially be used to protect sensitive tissues from the effect of the PEF. Perhaps the most important conclusion of this investigation is that temperature is a powerful and accessible mechanism to modulate and control electric fields in biological tissues and can therefore be used to optimize and control PEF treatments

Length of stay and associated costs of obesity related hospital admissions in Ireland

BACKGROUND: Obesity is the cause of other chronic diseases, psychological problems, obesity shortens the lifespan and puts strain on health systems. The risk associated with childhood obesity in particular, which will accelerate the development of adult morbidity and mortality, has been identified as an emerging public health problem. METHODS: To estimate the length of stay and associated hospital costs for obesity related illnesses a cost of illness study was set up. All discharges from all acute hospitals in the Republic of Ireland from 1997 to 2004 with a principal or secondary diagnostic code for obesity for all children from 6 to 18 years of age and for adults were collected.A discharge frequency was calculated by dividing obesity related discharges by the total number of diagnoses (principal and secondary) for each year. The hospital costs related to obesity was calculated based on the total number of days care. RESULTS: The discharge frequency of obesity related conditions increased from 1.14 in 1997 to 1.49 in 2004 for adults and from 0.81 to 1.37 for children. The relative length of stay (number of days in care for obesity related conditions per 1000 days of hospital care given) increased from 1.47 in 1997 to 4.16 in 2004 for children and from 3.68 in 1997 to 6.74 in 2004 for adults.Based on the 2001 figures for cost per inpatient bed day, the annual hospital cost was calculated to be 4.4 Euromillion in 1997, increasing to 13.3 Euromillion in 2004. At a 20% variable hospital cost the cost ranges from 0.9 Euromillion in 1997 to 2.7 Euromillion in 2004; a 200% increase. CONCLUSION: The annual increase in the proportion of hospital discharges related to obesity is alarming. This increase is related to a significant increase in economic costs. This paper emphasises the need for action at an early stage of life. Health promotion and primary prevention of obesity should be high on the political agenda

Measuring affective well-being at work using short-form scales : implications for affective structures and participant instructions

Measuring affective well-being in organizational studies has become increasingly widespread, given its association with key work-performance and other markers of organizational functioning. As such, researchers and policy-makers need to be confident that well-being measures are valid, reliable and robust. To reduce the burden on participants in applied settings, short-form measures of affective well-being are proving popular. However, these scales are seldom validated as standalone, comprehensive measures in their own right. In this article, we used a short-form measure of affective well-being with 10 items: the Daniels five-factor measure of affective well-being (D-FAW). In Study 1, across six applied sample groups (N = 2624), we found that the factor structure of the short-form D-FAW is robust when issued as a standalone measure, and that it should be scored differently depending on the participant instruction used. When participant instructions focus on now or today, then affect is best represented by five discrete emotion factors. When participant instructions focus on the past week, then affect is best represented by two or three mood-based factors. In Study 2 (N = 39), we found good construct convergent validity of short-form D-FAW with another widely used scale (PANAS). Implications for the measurement and structure of affect are discussed

Racial differences in central adiposity in a longitudinal cohort of black and white adolescent females

<p>Abstract</p> <p>Background</p> <p>Central adiposity is related to chronic disease risk in adolescents. Racial differences in waist circumference have been identified using cross-sectional data from this age group. We tested for racial differences in age-related growth in waist circumference in a longitudinal cohort of black and white adolescent girls.</p> <p>Methods</p> <p>We analyzed 9 years of publicly available data from the National Heart, Lung, and Blood Institute Growth and Health Study, for 2379 girls (1213 black and 1166 white) enrolled at age 9-10 years in 1987-1988 and followed annually. Individual growth trajectories of waist circumference were constructed for girls with >3 annual measures. Mixed models were used to compare changes in waist circumference during adolescence between black and white females. BMI and age at menarche were included in the models.</p> <p>Results</p> <p>At each age, black females had significantly higher waist circumference. Mean annual increase in waist circumference was significantly higher for black females compared to white females (1.46 cm/yr vs. 1.36 cm/yr, respectively). After adjusting for BMI, the mean annual increase in waist circumference for white females was significantly higher than for black females (0.08 cm/yr vs. -0.07 cm/yr, respectively). These relationships remained significant after adjusting for age at menarche.</p> <p>Conclusions</p> <p>Black females had significantly steeper increases in waist circumference over adolescence than white females. After adjusting for BMI and age at menarche, however, the annual increase in waist circumference for black females was significantly shallower than for their white peers. These data suggest racial differences in the deposition of fat over the adolescent period.</p

The Early Prevention of Obesity in CHildren (EPOCH) Collaboration - an Individual Patient Data Prospective Meta-Analysis

BackgroundEfforts to prevent the development of overweight and obesity have increasingly focused early in the life course as we recognise that both metabolic and behavioural patterns are often established within the first few years of life. Randomised controlled trials (RCTs) of interventions are even more powerful when, with forethought, they are synthesised into an individual patient data (IPD) prospective meta-analysis (PMA). An IPD PMA is a unique research design where several trials are identified for inclusion in an analysis before any of the individual trial results become known and the data are provided for each randomised patient. This methodology minimises the publication and selection bias often associated with a retrospective meta-analysis by allowing hypotheses, analysis methods and selection criteria to be specified a priori.Methods/DesignThe Early Prevention of Obesity in CHildren (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine if early intervention for childhood obesity impacts on body mass index (BMI) z scores at age 18-24 months. Additional research questions will focus on whether early intervention has an impact on children\u27s dietary quality, TV viewing time, duration of breastfeeding and parenting styles. This protocol includes the hypotheses, inclusion criteria and outcome measures to be used in the IPD PMA. The sample size of the combined dataset at final outcome assessment (approximately 1800 infants) will allow greater precision when exploring differences in the effect of early intervention with respect to pre-specified participant- and intervention-level characteristics.DiscussionFinalisation of the data collection procedures and analysis plans will be complete by the end of 2010. Data collection and analysis will occur during 2011-2012 and results should be available by 2013.<br /

Does the perception of fairness and standard of care in the health system depend on the field of study? Results of an empirical analysis

Background: The main challenge in the context of health care reforms and priority setting is the establishment and/or maintenance of fairness and standard of care. For the political process and interdisciplinary discussion, the subjective perception of the health care system might even be as important as potential objective criteria. Of special interest are the perceptions of academic disciplines, whose representatives act as decision makers in the health care sector. The aim of this study is to explore and compare the subjective perception of fairness and standard of care in the German health care system among students of medicine, law, economics, philosophy, and religion. Methods: Between October 2011 and January 2012, we asked freshmen and advanced students of the fields mentioned above to participate in a paper and pencil survey. Prior to this, we formulated hypotheses. The data were analysed by micro econometric regression techniques. Results: Data from 1,088 students were included in the study. Medical students, freshmen, and advanced students perceive the standard of care significantly as being better than non-medical students. Differences in the perception of fairness are not significant between the freshmen of the academic disciplines; however, they increase with the number of study terms. Besides the field of study, further variables such as gender and health status have a significant impact on perceptions. Conclusions: Our results show that there are differences in the perception of fairness and standard of care between academic disciplines, which might influence the interdisciplinary discussion on health care reforms and priority setting.Leibniz University Hannover/Wege in die Forschung I

Search for a Technicolor omega_T Particle in Events with a Photon and a b-quark Jet at CDF

If the Technicolor omega_T particle exists, a likely decay mode is omega_T -> gamma pi_T, followed by pi_T -> bb-bar, yielding the signature gamma bb-bar. We have searched 85 pb^-1 of data collected by the CDF experiment at the Fermilab Tevatron for events with a photon and two jets, where one of the jets must contain a secondary vertex implying the presence of a b quark. We find no excess of events above standard model expectations. We express the result of an exclusion region in the M_omega_T - M_pi_T mass plane.Comment: 14 pages, 2 figures. Available from the CDF server (PS with figs): http://www-cdf.fnal.gov/physics/pub98/cdf4674_omega_t_prl_4.ps FERMILAB-PUB-98/321-