Framework for the quantitative weight-of-evidence analysis of 'omics data for regulatory purposes.

A framework for the quantitative weight-of-evidence (QWoE) analysis of 'omics data for regulatory purposes is presented. The QWoE framework encompasses seven steps to evaluate 'omics data (also together with non-'omics data): (1) Hypothesis formulation, identification and weighting of lines of evidence (LoEs). LoEs conjoin different (types of) studies that are used to critically test the hypothesis. As an essential component of the QWoE framework, step 1 includes the development of templates for scoring sheets that predefine scoring criteria with scores of 0-4 to enable a quantitative determination of study quality and data relevance; (2) literature searches and categorisation of studies into the pre-defined LoEs; (3) and (4) quantitative assessment of study quality and data relevance using the respective pre-defined scoring sheets for each study; (5) evaluation of LoE-specific strength of evidence based upon the study quality and study relevance scores of the studies conjoined in the respective LoE; (6) integration of the strength of evidence from the individual LoEs to determine the overall strength of evidence; (7) characterisation of uncertainties and conclusion on the QWoE. To put the QWoE framework in practice, case studies are recommended to confirm the relevance of its different steps, or to adapt them as necessary.

Outsourcing medical data analyses: can technology overcome legal, privacy, and confidentiality issues?

BACKGROUND: Medical data are gold mines for deriving the knowledge that could change the course of a single patient's life or even the health of the entire population. A data analyst needs to have full access to relevant data, but full access may be denied by privacy and confidentiality of medical data legal regulations, especially when the data analyst is not affiliated with the data owner. OBJECTIVE: Our first objective was to analyze the privacy and confidentiality issues and the associated regulations pertaining to medical data, and to identify technologies to properly address these issues. Our second objective was to develop a procedure to protect medical data in such a way that the outsourced analyst would be capable of doing analyses on protected data and the results would be comparable, if not the same, as if they had been done on the original data. Specifically, our hypothesis was there would not be a difference between the outsourced decision trees built on encrypted data and the ones built on original data. METHODS: Using formal definitions, we developed an algorithm to protect medical data for outsourced analyses. The algorithm was applied to publicly available datasets (N=30) from the medical and life sciences fields. The analyses were performed on the original and the protected datasets and the results of the analyses were compared. Bootstrapped paired t tests for 2 dependent samples were used to test whether the mean differences in size, number of leaves, and the accuracy of the original and the encrypted decision trees were significantly different. RESULTS: The decision trees built on encrypted data were virtually the same as those built on original data. Out of 30 datasets, 100% of the trees had identical accuracy. The size of a tree and the number of leaves was different only once (1/30, 3%, P=.19). CONCLUSIONS: The proposed algorithm encrypts a file with plain text medical data into an encrypted file with the data protected in such a way that external data analyses are still possible. The results show that the results of analyses on original and on protected data are identical or comparably similar. The approach addresses the privacy and confidentiality issues that arise with medical data and is adherent to strict legal rules in the United States and Europe regarding the processing of the medical data.

Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the ambulatory glucose profile.

Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes mellitus. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardizing the analysis and presentation of glucose monitoring data, with the initial focus on data derived from continuous glucose monitoring systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile, and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings. This article provides a summary of the topics and issues discussed during the meeting and presents recommendations from the expert panel regarding the need to standardize glucose profile summary metrics and the value of a uniform glucose report to aid clinicians, researchers, and patients.

Child-care availability and fertility in Norway.

The child-care and fertility hypothesis has been in the literature for a long time and is straightforward: As child care becomes more available, affordable, and acceptable, the antinatalist effects of increased female educational attainment and work opportunities decrease. As an increasing number of countries express concern about low fertility, the child-care and fertility hypothesis takes on increased importance. Yet data and statistical limitations have heretofore limited empirical tests of the hypothesis. Using rich longitudinal data and appropriate statistical methodology, We show that increased availability of child care increases completed fertility. Moreover, this positive effect of child-care availability is found at every parity transition. We discuss the generalizability of these results to other settings and their broader importance for understanding variation and trends in low fertility.

An evolutionary view of chromatography data systems used in bioanalysis.

This is a personal view of how chromatographic peak measurement and analyte quantification for bioanalysis have evolved from the manual methods of 1970 to the electronic working possible in 2010. In four decades there have been major changes from a simple chart recorder output (that was interpreted and quantified manually) through simple automation of peak measurement, calculation of standard curves and quality control values and instrument control to the networked chromatography data systems of today that are capable of interfacing with Laboratory Information Management Systems and other IT applications. The incorporation of electronic signatures to meet regulatory requirements offers a great opportunity for business improvement and electronic working.

The effects of racial/ethnic segregation on Latino and Black homicide.

Racial/ethnic residential segregation has been shown to contribute to violence and have harmful consequences for minority groups. However, research examining the segregation­crime relationship has focused almost exclusively on blacks and whites while largely ignoring Latinos and other race/ethnic groups and has rarely considered potential mediators (e.g., concentrated disadvantage) in segregation­violence relationships. This study uses year 2000 arrest data for California and New York census places to extend segregation­crime research by comparing the effects of racial/ethnic residential segregation from whites on black and Latino homicide. Results indicate that (1) racial/ethnic segregation contributes to both Latino and black homicide, and (2) the effects for both groups are mediated by concentrated disadvantage. Implications for segregation­violence relationships, the racial-invariance position, and the Latino paradox are discussed.

China's below-replacement fertility: government policy or socioeconomic development?

The article challenges the notion that below-replacement fertility and its local variation in China are primarily attributable to the government's birth planning policy. Data from the 2000 census and provincial statistical yearbooks are used to compare fertility in Jiangsu and Zhejiang, two of the most developed provinces in China, to examine the relationship between socioeconomic development and low fertility. The article demonstrates that although low fertility in China was achieved under the government's restrictive one-child policy, structural changes brought about by socioeconomic development and ideational shifts accompanying the new wave of globalization played a key role in China's fertility reduction.

Population decline in Polish and Czech cities during post-socialism? Looking behind the official statistics.

The evolving debate on "urban shrinkage" mirrors an increasing interest in demographic phenomena on the part of urban scholars. This paper discusses ambiguous evidence about recent population decline in the large cities of Poland and the Czech Republic, with a particular focus on Lódz and Brno in general and their inner cities more specifically. By applying a mixed-method approach, the paper identifies indications of inner-city repopulation and socio-demographic diversification which are not yet apparent in register or census data. It is argued that there are indications of a silent transformation of traditional residential patterns and neighbourhoods in east central Europe. In the inner cities, this is reflected, amongst other things, by the presence of new households that may be called "transitory urbanites".

Who lives and dies on death row? Race, ethnicity, and post-sentence outcomes in Texas.

A substantial body of research has explored the extent to which the race of offenders and victims influences who receives a death sentence for capital crimes. Little is known about how race and ethnicity might pattern death-row outcomes. Drawing upon evidence from male offenders sentenced to death in Texas during the years 1974 through 2009, we extend recent research by examining whether the race and ethnicity of offenders and victims and a number of offender, victim, and crime attributes influence the likelihood of executions and sentence relief (whereby prisoners leave death row). Cox regression analyses are used in conjunction with a multiple-imputation method for handling a modest amount of missing data. The results show that cases involving minorities­with black or Latino offenders or victims­have lower hazards of execution than cases in which both offenders and victims are white. Victim and offender race and ethnicity have little to no independent effect upon the hazard of sentence relief.

All connected? Geographies of race, death, wealth, votes and births.

In January 2010 we learnt that within London the best-off 10th of the population each had recourse to 273 times the wealth of the worse-off 10th of that population (Hills et al. 2010, An anatomy of economic inequality in the UK Report of the National Equality Panel, Government Equalities Office, London). It is hard to find any city in an affluent country that is more unequal. This wealth gap did not include the assets of the UK super-rich, who mostly live in or near London. In April 2010 the Sunday Times newspaper reported the wealth of the richest 1000 people in the UK had risen by an average of £77 million each in just one year, to now stand at £335.5 billion. Today in the UK we are again as unequal as we were around 1918. For 60 years we became more equal, but for the last 30 years, more unequal. Looking at inequality trends it is very hard, initially, to notice when the party of government changed. However, closer inspection of the time series suggests there were key times when the trends changed direction, when the future was much less like the past and when how people voted and acted appeared to matter more than at other times. With all three main parties offering what may appear to be very similar solutions to the issue of reducing inequality it seems unlikely that voting in 2010 will make much of a difference. However, today inequalities are now at unsustainable extremes. Action has been taken such that some inequalities, especially in education, have begun to shrink. The last two times that the direction of trends in inequalities changed, in the 1920s and 1970s, there were several general elections held within a relatively short time period. Inequality is expensive. The UK is not as well-off as it once was. It could be time for a change again. Which way will we go?

The politics of hope and despair: the effect of presidential election outcomes on suicide rates.

OBJECTIVES: This article examines the effect of election outcomes on suicide rates by combining the theory of social integration developed by Durkheim with the models of rational choice used in economics. METHODS: Theory predicts that states with a greater percentage of residents who supported the losing candidate would tend to exhibit a relative increase in suicide rates. However, being around others who also supported the losing candidate may indicate a greater degree of social integration at the local level, thereby lowering relative suicide rates. We therefore use fixed-effects regression of state suicide rates from 1981 to 2005 on state election outcomes during presidential elections to determine which effect is stronger. RESULTS: We find that the local effect of social integration is dominant. The suicide rate when a state supports the losing candidate will tend to be lower than if the state had supported the winning candidate-4.6 percent lower for males and 5.3 percent lower for females. CONCLUSION: Social integration works at many levels; it not only affects suicide risk directly, but can mediate other shocks that influence suicide risk.