Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

Society's search for a legal and ethical basis of physician-assisted suicide

A review of the way physician-assisted suicide (PAS) is being addressed in the United States reveals three models, each functioning out of distinctive concepts of autonomy: (1) litigation, which utilizes philosophical autonomy; (2) legislation, which utilizes political autonomy; and (3) act of conscience by a physician, which utilizes consumer autonomy. Each model raises a correspondingly distinct set of ethical questions and challenges centered around their point of reference-the judicial system, voters, or the doctor-patient relationship. In the end, however, efforts to resolve the challenge of PAS will falter if they do not go beyond these models of autonomy. Religious institutions offer a more constructive setting for facing the life and death decisionmaking of PAS. The challenge for religion is to address PAS in solidarity with sufferers, physicians, and the community, rather than retreating into iconoclastic dogmas.     

Factors influencing Soay sheep survival

We present a survival analysis of Soay sheep mark recapture and recovery data. Unlike previous conditional analyses, it is not necessary to assume equality of recovery and recapture probabilities; instead these are estimated by maximum likelihood. Male and female sheep are treated separately, with the higher numbers and survival probabilities of the females resulting in a more complex model than that used for the males. In both cases, however, age and time aspects need to be included and there is a strong indication of a reduction in survival for sheep aged 7 years or more. Time variation in survival is related to the size of the population and selected weather variables, by using logistic regression. The size of the population significantly affects the survival probabilities of male and female lambs, and of female sheep aged 7 or more years. March rainfall and a measure of the North Atlantic oscillation are found to influence survival significantly for all age groups considered, for both males and females. Either of these weather variables can be used in a model. Several phenotypic and genotypic individual covariates are also fitted. The only covariate which is found to influence survival significantly is the type of horn of first-year female sheep. There is a substantial variation in the recovery probabilities over time, reflecting in part the increased effort when a population crash was expected. The goodness of fit of the model is checked by using graphical procedures.     

USING DUMMY VARIABLES TO CHECK FOR ROUNDING ERROR IN COMPUTERIZED REGRESSION PROGRAMS*

After a brief review of the role of dummy variables in regression analysis and the current state-of-the art in rounding/truncation error detection in computerized least squares programs, this paper presents a theorem that can be used to detect this type of error whenever an analyst is running a regression program that has one (or more) dummy variables as independent variables.     

“Thank You for Including Us!” – Introducing a Community‐Based Collaborative Approach to Translating Clinic Materials

When working with clients in another language, having culturally relevant and properly translated clinic materials is vital to effective clinical practice. Not having them presents a barrier for bilingual therapists and their clients. This paper reviews common translation methods and introduces a multi‐level, community‐based approach for translating clinic materials for non‐English speaking clients. Informed by decolonizing practices, this five‐tier method includes members from the target community as cultural brokers to verify the accuracy and nuances of language for their cultural group, as well as a constant comparative method to ensure methodological rigor in the process of inclusion. We present community member's feedback and recommendations, as well as discuss advantages and challenges of using this collaborative culturally responsive translation method.     

ASSOCIATIONS BETWEEN AIR POLLUTION AND HOSPITAL VISITS FOR CARDIOVASCULAR DISEASES IN THE ELDERLY IN SYDNEY USING BAYESIAN STATISTICAL METHODS

Using generalized linear models (GLMs), Jalaludin  et al. (2006;  J. Exposure Analysis and Epidemiology   16 , 225–237) studied the association between the daily number of visits to emergency departments for cardiovascular disease by the elderly (65+) and five measures of ambient air pollution. Bayesian methods provide an alternative approach to classical time series modelling and are starting to be more widely used. This paper considers Bayesian methods using the dataset used by Jalaludin  et al.  (2006) , and compares the results from Bayesian methods with those obtained by Jalaludin  et al.  (2006) using GLM methods.     

Observational sketching as method

This paper explores the potential of observational sketching as a social science research tool, informed by our own recent experiments with observational sketching techniques and approaches. We first outline the historical roots of academic sketching and note a recent resurgence of interest in sketching in certain disciplines. We then introduce our own explorations in sketching as method, based on a year-long collaboration between an observational artist and a group of qualitative researchers with interests in creative methods. The paper outlines some of the lessons we learnt from our partnership, focusing on three themes: (i) ‘sketchiness’; (ii) ‘concentrated seeing’ and (iii) sketching as interaction. We conclude that observational sketching generates a refreshingly different form of visual data which has considerable potential to be used as a complement to other methods, including as a participatory method and as a useful tool for thinking.