Sequential case series analysis for pharmacovigilance

Summary.  The self-controlled case series method is used to evaluate drug safety, particularly the safety of paediatric vaccines with respect to rare adverse reactions. We propose a group sequential version of the method for prospective surveillance of drug safety. We focus on the surveillance of new vaccines. We develop methods that are based on the sequential probability ratio test applied at predetermined surveillance intervals, using both simple and composite alternative hypotheses. We investigate the properties of the methods analytically in a simple setting and by simulations in more realistic scenarios. The methods are applied to data on influenza vaccine and Bell's palsy, and to data on measles, mumps and rubella vaccine and bleeding disorders.     

Does poor weight gain identify children in need?

To determine the socioeconomic variables in children with slow growth (failure to thrive), a case–control study was carried out in two economically deprived areas of Newcastle upon Tyne. Three hundred and six children, aged 12–24 months, registered at two health authority clinics, were studied by reviewing their growth charts. Sixty-three had poor growth (weight deviating downwards across two major centiles from the maximum centile attained at 4–8 weeks of age). Five children were excluded because of known organic disease. A matched control group of normally growing children was selected from the same clinics. Study children and controls were examined and their parents interviewed on a range of socioeconomic, health and interactional factors. A health visitor assessment and a record of social work contact was obtained. The slowly growing children differed significantly from controls in being lighter and shorter, while their mothers spent less on food, needed more help with the child, had a poorer home environment and expressed greater concern over their child's health. Four different patterns of poor growth were identified by inspection of the charts: early onset (before 6 months but sustained), late onset (after 6 months), temporary and recurrent. The ‘recurrent’ group was associated with parenting difficulties and the ‘late onset’ group with adverse socioeconomic factors. Slow growth patterns in children under 2 years may be used as a screening tool to identify ‘children in need’ and should be sought on a population basis. Those identified can then be assessed further to ascertain the area where underlying difficulties lie, for intervention to follow as appropriate.     

Habitus,social elevation,and the channel of shame‐fear: The decision to expand Guinness advertising

This article explains the relationship between social habitus, social mobility and shame feelings using Elias's theoretical frame of figurational sociology. Much work to date has centred on Bourdieu's theoretical formulations and while there are clear parallels with Elias, significant differences exist. Elias identified how shame functions as a key channel for the transmission of social tensions generated by the structure of social relations into the social habitus of individuals. We explain how apparently rational decision‐making in organisations obscures the emotional dynamics of shame and fear connected with processes of social elevation, habitus change and shifting power relations between social classes. Our empirical case concerns the brewer Arthur Guinness & Sons Ltd and the decision in 1927 to sanction a direct advertising campaign in Britain for the first time.     

The civilizing and sportization of Gaelic football in Ireland: 1884–2009

Over the course of the last 125 years the sport of Gaelic football in Ireland has undergone a sportization and civilizing process as the rules governing the sport became stricter and players developed greater levels of self-control. However, the civilizing of Gaelic football was a particularly fragile and uneven process. The growing social desire to diminish displays of violence was moderated by ambivalence towards violence. Gradually the external social controls on players increased and, greater and more stable levels of internalization occurred reflected by more advanced levels of player self-restraint in the control of violence. At the same time the threshold of shame toward displays of violence advanced. This transformation was shaped by lengthening chains of social interdependencies in Ireland.