Personalized cardiovascular medicine: concepts and methodological considerations.

The primary goals of personalized medicine are to optimize diagnostic and treatment strategies by tailoring them to the specific characteristics of an individual patient. In this Review, we summarize basic concepts and methods of personalizing cardiovascular medicine. In-depth characterization of study participants and patients in general practice using standardized methods is a pivotal component of study design in personalized medicine. Standardization and quality assurance of clinical data are similarly important, but in daily practice imprecise definitions of clinical variables can reduce power and introduce bias, which limits the validity of the data obtained as well as their potential clinical applicability. Changes in statistical methods with personalized medicine include a shift from dichotomous outcomes towards continuously measured variables, predictive modelling, and individualized medical decisions, subgroup analyses, and data-mining strategies. A variety of approaches to personalized medicine exist in cardiovascular research and clinical practice that might have the potential to individualize diagnostic and therapeutic procedures. For some of the emerging methods, such as data mining, the most-efficient way to use these tools is not yet fully understood. In addition, the predictive models-although promising-are far from mature, and are likely to be greatly improved by using available large-scale data sets.

Comparing different scientific approaches to personalized medicine: research ethics and privacy protection.

In this article, two different scientific approaches to personalized medicine are compared. Biorepository at Vanderbilt University (BioVU) is a genomic biorepository at Vanderbilt University Medical Center in Nashville, TN, USA. Genetic biosamples are collected from leftover clinical blood samples; medical information is derived from an electronic medical records. Greifswald Approach to Individualized Medicine is a research resource at the University of Greifswald, Germany, comprised of clinical records combined with biosamples collected for research. We demonstrate that although both approaches are based on the collection of clinical data and biosamples, different legal milieus present in the USA and Germany as well as slight differences in scientific goals have led to different 'ethical designs'. While BioVU can successfully operate with an 'opt-out' mechanism, an informed consent-based 'opt-in' model is indispensable to allow GANI_MED to reach its scientific goals.

An epidemiology of care approach to lab-on-a-chip systems in individualized medicine?

Lab-on-a-chip systems (LOCs) are microfluidic systems integrating several laboratory functions on a very small single chip. The identification and characterization of innovative biomarkers based on portable LOCs provides a valuable tool to implement individualized medicine. An analysis of the clinical potential, advantages and obstacles of portable diagnostic LOCs is urgently needed to evaluate the associated risks and opportunities from a healthcare perspective. A planned network project promoted by the federal ministry for education and research in Germany will systematically investigate the scope of LOCs and discuss the impact as well as the future demand, potentially adding to further evidence-based development.

Epidemiology of multi-resistant organisms - challenges to a regional data management system.

The health care region Baltic Coast is within the framework of the joint project HICARE (Health, Innovative Care & Regional Economy) to be developed from January 2011 to December 2014 into a model region to combat the spread of multi-resistant organisms (MRO). The concept of the project area "IT & Epidemiology" will be introduced here. An IT system is to be developed and implemented consisting of two interconnected elements, a central data management and a web-based support system for information and decision. Particular challenges are the consolidation of data decentrally collected from numerous and heterogeneous data sources, compliance with the data privacy protection laws and the complex management of patients' informed consent. The information collected by the central data management will be the basis of epidemiological evaluations. Prevalence and incidence of MRO in patients and staff of medical facilities, single risk factors as well as risk profiles, the range and extent of treatments including their effectiveness and sustainability will be investigated. Furthermore, cost and cost-utility analyses will be performed.