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Biomedical subjects

I Pigeot

Publications and source records attributed to I Pigeot.

9 recordsLinked to original sources
PubMed2006

Understanding and preventing childhood obesity and related disorders--IDEFICS: a European multilevel epidemiological approach.

The environment of children has drastically changed in Europe during the last decades as reflected in unhealthy dietary habits and sedentary lifestyle. Nutrition obviously plays a part in the development of overweight in childhood. However, dietary factors and physical activity are also involved in the development of metabolic syndrome, type II diabetes, cardiovascular diseases, osteoporosis, and postural deformities like scoliosis, effects related in part to excessive weight gain. To stop the resulting epidemic of diet- and lifestyle-induced morbidity, efficient evidence-based approaches are needed. These issues are the focus of IDEFICS (Identification and prevention of dietary- and lifestyle-induced health effects in children and infants), a five-year project proposed under the sixth EU framework. The IDEFICS consortium comprises 25 research centres and SMEs across Europe. The planned prospective study will identify risk profile inventories for children susceptible to any of these disorders with emphasis on obesity and its co-morbid conditions. Genetic and non-genetic factors, psychosocial factors and social settings will be considered. The project will devise tailored prevention strategies that are effective, easy to implement and that account for the needs of different social groups. Population-based studies will investigate the impact of sensory perception and provide results concerning internal and external triggers of food choices and children's consumer behaviour. The ethical implications of a "right not to know" of genetic factors will be addressed. We will propose knowledge-based guidelines on dietary and lifestyle activities for health promotion and disease prevention in children for health professionals, stakeholders and consumers.

Adolescent↗
PubMed2006

[Data sources in epidemiology].

The use of large databases has a high potential for future epidemiological research. Databases consisting of primary data as well as routine data that are mainly collected for administrative purposes will be of interest. This paper presents some large databases and some that are most relevant for epidemiological research, respectively, and shows how they might be exploited for research purposes. To make better use of large databases there are new requirements and challenges that we have to face regarding appropriate methods for their analysis. Some examples of such methods are given. An example of pharmaco-epidemiology illustrates linkage of several administrative databases and specific problems that have to be solved in this context. Finally, future challenges are discussed that have to be overcome on the way towards establishment, maintenance and analysis of large databases, especially regarding data protection, data quality and regular updates.

Computer Security↗
PubMed2005

[Post-marketing surveillance studies].

Approval of a drug on the market is typically considered as the successful endpoint of a long development phase. This often leads to reduced interest in further research for the indication approved, while in contrast the patient's as well as physician's interest in further research increases. This paper discusses the main areas of effectiveness, safety and post-marketing practice regarding sensible study types for the specific area and the potential gain of knowledge.

Aged↗
PubMed2005

[Biometrical methods for the proof of efficacy in regulatory submissions. Non-inferiority in clinical studies].

The increasing number of approved efficacious therapies for various indications raises the question of whether the inclusion of a placebo group is still justified. In addition, pharmaceutical companies and regulatory agencies acknowledge that it may be sufficient to prove that a new therapy is comparable to an approved reference therapy regarding efficacy and safety in some situations. This becomes especially striking for the approval to market a generic drug. Another, perhaps even more important example is the increasing resistance of bacteria which calls for new antibiotics based on new therapeutic principles without having the claim for better efficacy. In these situations, a comparable efficacy would constitute progress. In the present paper, we discuss the numerous methodological challenges and approaches to overcome these problems that occur when it is not possible or even not wanted to use the classic approach of a randomized placebo-controlled superiority trial. Here, the field of medical biometry, which has proved in the last 25 years to be an integral part of the development of new drugs, demonstrates its suitability as a flexible and scientifically based means to fulfil the requirements resulting from clinical practice. Starting from the fact that statistical methods are not able to prove "equality" of two treatments, "shifted" hypotheses are considered and their importance for the different study designs is discussed. We show how the classic hypotheses known from placebo-controlled clinical trials can be embedded in this concept. The implications of this approach for the analysis and interpretation of study results is further discussed. The relevant guidelines of the European and US regulatory agencies are taken into account.

Biometry↗
PubMed2004

[Programs for primary prevention of obesity and overweight in childhood].

The prevalence of obesity and overweight in childhood and among adolescents is dramatically increasing worldwide with high impact on their self-esteem and on their health as adults. Therefore, effective programs for primary prevention are urgently required. The focus of these programs should not only be on nutrition but also account for the complete sociocultural environment of the child. This paper will describe some of the more important programs on the one hand and present an exemplary concept for a scientifically observed program for prevention of obesity in preschool children on the other hand. The discussion will be completed by a short overview of programs for secondary prevention. In summary, it can be concluded that no sufficiently evaluated programs for primary prevention of obesity in childhood currently exist in Germany.

Age Factors↗
PubMed2004

[Databases as a source for monitoring systems of drug safety].

Clinical trials only allow for a limited assessment of adverse drug reactions (ADRs) due to their restricted number of patients, their short duration, and their narrow inclusion criteria. To assess potential ADRs in the population actually treated after drug approval, different systems for signal generation such as spontaneous reporting systems have been established and are required by drug laws in many countries. As of today epidemiological methods for signal confirmation for rare adverse events or events with long induction periods use record linkage databases such as the United Health Care (Ingenix) in the USA or the practice databases such as the General Practice Research Database in Great Britain. However, this approach also has its limitations. This type of database will be presented in this paper. In addition, databases operated by German public health insurance will be described. The topic of linking different data sources in Germany to support pharmaco-vigilance activities will be addressed.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

CORA--a knowledge-based system for the analysis of case-control studies.

Carrying out a statistical analysis, the researcher is concerned with the problem of choosing an appropriate statistical technique from a large number of competing methods. Most common statistical software offer different methods for analysing the data without giving any support regarding the adequacy of a method for a particular data set. This paper outlines the main features of the computer system CORA which provides a statistical analysis of stratified contingency tables and additionally supports the researcher at the different steps of this analysis. Here, the support given by the system consists of two different aspects. On the one hand, the help system of CORA contains general information on the implemented statistical methods which can be obtained on request. On the other hand, an advice tool recommends an adequate statistical method which depends on the actual empirical case-control data to be analysed. To build up the advice tool, a set of rules being discovered by machine learning from simulation studies is integrated into the system CORA.

Case-Control Studies↗