ABSTRACT
Sufficient exercise and sleep, a balanced diet, moderate alcohol consumption and a good approach to handle stress have been known as lifestyles that protect health and longevity since the Middle Age. This traditional prevention quintet, turned into a sextet by smoking cessation, has been the basis of the "preventive personality" that formed in the twentieth century. Recent analyses of big data sets including genomic and physiological measurements have unleashed novel opportunities to estimate individual health risks with unprecedented accuracy, allowing to target preventive interventions to persons at high risk and at the same time to spare those in whom preventive measures may not be needed or even be harmful. To fully grasp these opportunities for modern preventive medicine, the established healthy life styles require supplementation by stratified prevention. The opportunities of these developments for life and health contrast with justified concerns: A "surveillance society", able to predict individual behaviour based on big data, threatens individual freedom and jeopardises equality. Social insurance law and the new German Disease Prevention Act (Präventionsgesetz) rightly stress the need for research to underpin stratified prevention which is accessible to all, ethical, effective, and evidence based. An ethical and acceptable development of stratified prevention needs to start with autonomous individuals who control and understand all information pertaining to their health. This creates a mandate for lifelong health education, enabled in an individualised form by digital technology. Stratified prevention furthermore requires the evidence-based development of a new taxonomy of cardiovascular diseases that reflects disease mechanisms. Such interdisciplinary research needs broad support from society and a better use of biosamples and data sets within an updated research governance framework.
Subject(s)
Cardiovascular Diseases/prevention & control , Exercise/physiology , Life Style , Patient Education as Topic , Primary Prevention/methods , Cardiovascular Diseases/physiopathology , HumansABSTRACT
BACKGROUND: Rules and regulations form the framework of Health Technology Assessments. Legal issues are directly associated with the technology (as patents/licenses) or to the patients and their basic rights (as autonomy). In order to identify the regulations of interest as well as the relevant publications in a systematic and transparent way a specific methodological approach is required. In the absence of adapted methods, our objective was to develop a methodological approach to the systematic retrieval of information on legal issues. RESULTS: No publications on adapted methods could be identified. We therefore developed a procedure following the workflow of information retrieval for effectiveness assessments. This workflow consists of 8 steps: 0. pre-search: identification of the relevant rules, regulations and patient-related issues, 1. translation of the search question, 2. concept building, 3. identification of synonyms, 4. selection of relevant information sources, 5. design of the search strategies, 6. execution and quality check, 7. saving the results and reporting. CONCLUSIONS: There are numerous publications on legal issues associated with health technologies. Specifically adapted procedures are qualified to identify them in a systematic and transparent manner using the appropriate sensitivity and precision. A wider application seems to be reasonable in order to further test its practicality against more topics and to modify the proposed method if indicated.
Subject(s)
Biomedical Technology/legislation & jurisprudence , Biomedical Technology/methods , Licensure/legislation & jurisprudence , Patents as Topic/legislation & jurisprudence , Patient Advocacy/legislation & jurisprudence , Technology Assessment, Biomedical/legislation & jurisprudence , Technology Assessment, Biomedical/methods , Biomedical Technology/economics , Cost-Benefit Analysis/legislation & jurisprudence , Equipment Safety/methods , Female , Germany , Humans , Information Storage and Retrieval , Pregnancy , Ultrasonography, Prenatal/methods , WorkflowABSTRACT
BACKGROUND: Advance Care Planning (ACP) is an emerging strategy to ensure that well-reflected, meaningful and clearly documented treatment preferences are available and respected when critical decisions about life-sustaining treatment need to be made for patients unable to consent. In Germany, recent legislation confirms that advance directives (AD) have to be followed if they apply to the medical situation, but implementation of ACP has not yet been described. METHODS/DESIGN: In a longitudinal controlled study, we compare 1 intervention region (4 nursing homes [n/hs], altogether 421 residents) with 2 control regions (10 n/hs, altogether 985 residents). Inclusion went from 01.02.09 to 30.06.09, observation lasted until 30.06.10. Primary endpoint is the prevalence of ADs at follow-up, 17 (12) months after the first (last) possible inclusion. Secondary endpoints compare relevance and validity of ADs, process quality, the rate of life-sustaining interventions and, in deceased residents, location of death and intensity of treatment before death. The regional multifaceted intervention on the basis of the US program Respecting Choices® comprises training of n/h staff as facilitators, training of General Practitioners, education of hospital and ambulance staff, and development of eligible tools, including Physician Orders for Life-Sustaining Treatment in case of Emergency (POLST-E). Participation data: Of 1406 residents reported to live in the 14 n/hs plus an estimated turnover of 176 residents until the last possible inclusion date, 645 (41%) were willing to participate. Response rates were 38% in the intervention region and 42% in the control region. Non-responder analysis shows an equal distribution of sex and age but a bias towards dependency on nursing care in the responder group. Outcome analysis of this study will become available in the course of 2011. DISCUSSION: Implementing an ACP program for the n/hs and related health care providers of a region requires a complex community intervention with the effect of nothing less than a cultural shift in this health care sector. This study is to our knowledge the first to develop a strategy for regional implementation of ACP, and to evaluate its feasibility in a controlled design.
Subject(s)
Advance Care Planning/organization & administration , Nursing Homes , Proxy , Aged , Aged, 80 and over , Female , Germany , Humans , Longitudinal Studies , Male , Program DevelopmentABSTRACT
In Germany orphan (or rare) diseases are not a major issue of healthcare-related social security law. Laws, regulations, courts and the legislature have so far not succeeded in shaping an adequate legal approach. The deficient legal framework seems to correlate to the lack of medical knowledge about orphan diseases. Consequently, equal access to treatment--one of the principles of the German healthcare system--for patients suffering from orphan diseases is not sufficiently assured. Therefore, German legislation is facing the urgent challenge to compensate for the lack of medical knowledge and healthcare resources in this field by defining new rules, by establishing specific health authorities and by reforming the allocation of research efforts. In a way, rare diseases are orphans that attract little public and scientific interest. Provision of an adequate legal framework for the treatment of and research into orphan diseases is likely to promote significant improvements for those affected.
