Sample sizes for estimation in clinical research

A sample size justification should be given for all clinical investigations. However, sometimes the objective of a trial is to estimate an effect with a view to planning a later definitive study. This paper describes the calculations for designing studies where one wishes to adopt an estimation approach through using confidence intervals around the overall response. Calculations are given for data anticipated to take a Normal form. Copyright © 2004 John Wiley & Sons, Ltd.     

A Bayesian Adjustment for Covariate Misclassification with Correlated Binary Outcome Data

Estimated associations between an outcome variable and misclassified covariates tend to be biased when the methods of estimation that ignore the classification error are applied. Available methods to account for misclassification often require the use of a validation sample (i.e. a gold standard). In practice, however, such a gold standard may be unavailable or impractical. We propose a Bayesian approach to adjust for misclassification in a binary covariate in the random effect logistic model when a gold standard is not available. This Markov Chain Monte Carlo (MCMC) approach uses two imperfect measures of a dichotomous exposure under the assumptions of conditional independence and non-differential misclassification. A simulated numerical example and a real clinical example are given to illustrate the proposed approach. Our results suggest that the estimated log odds of inpatient care and the corresponding standard deviation are much larger in our proposed method compared with the models ignoring misclassification. Ignoring misclassification produces downwardly biased estimates and underestimate uncertainty.     

Generations,Identities, and the Collective Memory of Che Guevara1

Has the image of Che Guevara lost its power to evoke radical politics in the face of pervasive commodification? The commercialization of this 1960s political icon has called into question the power of the market to shape collective memories. Meanwhile, antisystemic movements of the left continue to erect his image at protest events. In light of this contest over how Che Guevara is remembered, we investigate, using data from a survey of Spanish citizens, who is most likely to recall him. We find qualified support for the theory of generational imprinting—Che is more often recalled by those generations who saw him rise to prominence during their formative years, although prominent as a collective symbol rather than as a living person. Our results also corroborate the claim that historical figures or events are more salient for, and therefore more likely to be remembered by, some subgenerational units than others. Thus, although the younger generations are in general more likely than their elders to recall Che, he is most frequently remembered by the highly educated leftists who espouse postmaterialist and posttraditionalist values and identify more with their local regions than with the nation of Spain. These patterns suggest that, in contrast to the dire predictions of mass culture theorists, the memory of Che Guevara has become increasingly tied to markers of social, ethnic‐regional, and political identity.     

Social Antecedents of Medical Fraud and Over-Servicing: What Makes A Doctor Criminal?

Medical fraud and overservicing are estimated to cost the Australian community between $130 and $200 million per annum, a figure far greater than the national cost of burglary and almost the same as the total property loss from all conventional crime. An examination of the social antecedents of medical fraud and overservicing suggests that the predisposition of some doctors to engage in these practices occurs because of the following: (1) medical training and professional socialization that orientate student doctors away from altruistic health issues towards narrower self-interested professional concerns; (2) career expectations of a high pattern of material consumption that are often frustrated by an increasingly competitive medical market place; and (3) professional medical organizations that lobby for national health policies which reflect the mercenary self-interest of doctors rather than the health interest of the nation.     

Non-ignorable missing covariate data in survival analysis: a case-study of an International Breast Cancer Study Group trial

Summary.  Non-ignorable missing data, a serious problem in both clinical trials and observational studies, can lead to biased inferences. Quality-of-life measures have become increasingly popular in clinical trials. However, these measures are often incompletely observed, and investigators may suspect that missing quality-of-life data are likely to be non-ignorable. Although several recent references have addressed missing covariates in survival analysis, they all required the assumption that missingness is at random or that all covariates are discrete. We present a method for estimating the parameters in the Cox proportional hazards model when missing covariates may be non-ignorable and continuous or discrete. Our method is useful in reducing the bias and improving efficiency in the presence of missing data. The methodology clearly specifies assumptions about the missing data mechanism and, through sensitivity analysis, helps investigators to understand the potential effect of missing data on study results.     

Efficient designs based on orthogonal arrays of type I and type II for experiments using units ordered over time or space

For a wide variety of applications, experiments are based on units ordered over time or space. Models for these experiments generally may include one or more of: correlations, systematic trends, carryover effects and interference effects. Since the standard optimal block designs may not be efficient in these situations, orthogonal arrays of type I and type II, which were introduced in 1961 by C.R. Rao [Combinatorial arrangements analogous to orthogonal arrays, Sankhya A 23 (1961) 283–286], have been recently used to construct optimal and efficient designs for many of these experiments. Results in this area are unified and the salient features are outlined.     

Secondary analysis of dangerousness among death sentenced capital murderers

The theory of incapacitation involves reducing an offender's ability or capacity to commit further crimes. Capital punishment accomplishes this goal. An executed murderer never murders again. However, we do not execute all murderers, only capital murderers. This policy produces several research questions. Do capital murderers present a special risk to society? Are capital murderers more likely to murder or commit other violent crimes again than other murderers or the average citizen? To answer these questions, many states require a prediction of future dangerousness of a newly convicted murderer. To what extent has the judgment of future dangerousness matched actuarial data of subsequent murders and serious crimes? Using a secondary analysis, this investigation attempted to assemble available data of postconviction dangerousness of death sentenced capital murderers to create a more comprehensive actuarial account of subsequent dangerousness and to present the data in a common format used by the Federal Bureau of Investigation and the Bureau of Justice Statistics. Across 14 studies identified with relevant data, there were 13 instances of subsequent murder and 462 serious crime or prison rule violations.