Modelling and simulation to improve decision‐making in clinical development

Modelling and simulation are buzz words in clinical drug development. But is clinical trial simulation (CTS) really a revolutionary technique? There is not much more to CTS than applying standard methods of modelling, statistics and decision theory. However, doing this in a systematic way can mean a significant improvement in pharmaceutical research. This paper describes in simple examples how modelling could be used in clinical development. Four steps are identified: gathering relevant information about a drug and the disease; building a mathematical model; predicting the results of potential future trials; and optimizing clinical trials and the entire clinical programme. We discuss these steps and give a number of examples of model components, demonstrating that relatively unsophisticated models may also prove useful. We stress that modelling and simulation are decision tools and point out the benefits of integrating them with decision analysis. Copyright © 2005 John Wiley & Sons, Ltd.     

Pilot Study Sleepiness in physicians on night call duty

Little is known about how physicians' feelings of sleepiness and sleep patterns are affected by night call duties. In the present pilot study, the authors followed a group of staff (hospital) physicians during and following night call duties. They recorded feelings of sleepiness and sleep patterns every third hour. Results show measurable effects on the sleepiness scale with residual effects lasting up to two days after the actual night call duty. The authors suggest that increased attention should now be given to studies of the psychophysiological effects of both present and alternative work schedules for physicians.     

Attitudes towards the unemployed. An analysis of Swedish survey data

To be unemployed is often associated with being stigmatised by others. People may blame the unemployed themselves, insist that they could find a job if they tried harder, maintain that too little is demanded from recipients of unemployment benefits and consider differences in standard of living between the unemployed and the employed too small. This article is aimed at studying the prevalence of such negative attitudes and to examine the determinants behind them. In May 2000, questions were added on to a randomly selected subsample in the regular Swedish labour force survey. The results indicate that own unemployment experience and perceived risks of becoming unemployed make people less apt to blame the unemployed. Having family members or close friends with unemployment experience tends to have a similar impact. In contrast, young people more often express stigmatising attitudes. With respect to social class position the results are divided.     

A comparison of perceived health, attitudes to work, leisure time, and social welfare systems among people in a rural area in the north of Sweden and among people in the city of Stockholm

A problem attracting considerable attention in Sweden today is the substantial regional differences in sickness absence. The aim of the study was to investigate and compare how people, from a random sample of the population in both a rural area in the north of Sweden and the Swedish capital Stockholm, perceive their health, and what their attitudes are to work, leisure time and social welfare systems. Results showed that a larger proportion of those answering in Stockholm considered their health status to be "very good", compared with those in the rural area (p<0.0001). A majority in the rural area compared to the city of Stockholm reported a high or very high level of aches/pain (p<0.0001) and that work causes them physical problems p<0.0001). The population in both Stockholm and the rural area is of the opinion that the increase in sickness absence is mainly due to deterioration in the work environment. Almost half of the individuals in both the rural area and in Stockholm are of the opinion that many of those sick-listed are not actually ill. It may be that in the rural area in north Sweden people are more inclined to put their opinions to practice than those in Stockholm are.     

What difference do different settings in residential care make for young people? A comparison of family‐style homes and institutions in Sweden

Residential care in Sweden has undergone great change in recent decades. With new small family-style institutions, the boundaries between residential care and foster care have been blurred. Almost all residential care used to be run by the public sector. Today about 80 per cent is privately run. This study compares three different settings in residential care: institutions run by the public sector, privately run institutions and family-style homes. Among other things, it is found that the institutions run by the public sector have better educated staff and a higher staff–resident ratio than privately run institutions. Despite this, they are more restrictive in their intake and they have youths with fewer problems, especially delinquency and other antisocial behaviour. The results are discussed in relation to developments in the residential care sector in Sweden and in relation to the balance between care and treatment.     

Financial Stress,Shaming Experiences and Psychosocial Ill-Health: Studies into the Finances-Shame Model

The aim of the study was to test the Finances-Shame model and its explanatory power regarding the prevalence of psychosocial ill-health. The Finances-Shame model postulates that (i) the greater the financial stress and the more experiences of having been shamed, the greater the risk for psychosocial ill-health, (ii) the lesser the financial stress and the fewer experiences of having been shamed, the lower the risk for psychosocial ill-health. The study was based upon a survey carried out during the period March 2000–May 2000 in a mid-Swedish region (n = 5,666). The response rate was 69%. The results of the study supported the hypotheses.     

The independence condition in the theory of social choice

Arrow's theorem is really a theorem about the independence condition. In order to show the very crucial role that this condition plays, the theorem is proved in a refined version, where the use of the Pareto condition is almost avoided.A distinction is made between group preference functions and group decision functions, yielding respectively preference relations and optimal subsets as values. Arrow's theorem is about the first kind, but some ambiguities and mistakes in his book are explained if we assume that he was really thinking of decision functions. The trouble then is that it is not clear how to formulate the independence condition for decision functions. Therefore the next step is to analyse Arrow's argument for accepting the independence condition.The most frequent ambiguity depends on an interpretation of A as the set of all conceivable alternatives, while the variable subset B is the set of all feasible or available alternatives. He then argues that preferences between alternatives that are not feasible shall not influence the choice from the set of available alternatives. But even if this principle is accepted, it only forces us to require independence with respect to some specific set B and not to every B simultaneously. Therefore the independence condition cannot be accepted on these grounds.Another argument is about an election where one of the candidates dies. On one interpretation this argument can be taken to support an independence requirement which leads to a contradiction. On another interpretation it is a condition about connexions between choices from different sets.The so-called problem of binary choice is found to be different from the independence problem and it plays no essential role in Arrow's impossibility result. Other impossibility results by Sen, Batra and Pattanaik and by Schwartz are of a different character.In the last section, several weaker independence conditions are presented. Their relations to Arrow's condition are stated and the arguments supporting them are discussed.     

Unemployment and Health in Sweden: Public Issues and Private Troubles

The unemployment rate for a country seems to reflect unemployment policies rather than economic conditions. Variations in employment rates for selected Western countries are presented as a background for a discussion of unemployment and its individual and societal consequences in Sweden. Unemployment is both a private trouble—where individuals see the possibility of controlling their own lives diminishing, which leads to increased risk for psychological and physiological stress—and a public issue, for increased unemployment is associated with societal vulnerability, social polarization, and the breakdown of community ties, which lead to increased societal stress and increased mortality on the national and the community levels. However, for the large majority of workers, the Swedish welfare system buffers first against unemployment, and second against its negative economic effects. Less than 2% of the workforce are exposed to unemployment, and a minority of the unemployed seem negatively affected by the unemployment experience. An empirical longitudinal study of unemployed blue-collar workers and two employed control groups indicated that a coping orientation involving an attitude of mastery or perceived control buffered against psychological and physiological stress reactions.