http://repub.eur.nl/res/aut/12534/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/34731/ 2012-01-01T00:00:00Z Objectives To identify appropriate screening conditions, stratified according to age and vulnerability, to prevent functional decline in older people. Design A RAND/University of California at Los Angeles appropriateness method. Setting The Netherlands. Participants A multidisciplinary panel of 11 experts. Measurements The panelists assessed the appropriateness of screening for 29 conditions mentioned in guidelines from four countries, stratified according to age (60-74, 75-84, ≥85) and health status (general, vital, and vulnerable) and received a literature overview for each condition, including the guidelines and up-to-date literature. After an individual rating round, panelists discussed disagreements and performed a second individual rating. The median of the second ratings defined the appropriateness of screening. Results The panel rated screening to be appropriate in three of the 29 conditions, indicating that screening was expected to prevent functional decline. Screening for insufficient physical activity was considered appropriate for all three age and health groups. Screening for cardiovascular risk factors and smoking was considered appropriate for the general and vital population aged 60 to 74. Of the 261 ratings, 63 (24%) were classified as uncertain, of which 42 (67%) concerned the vulnerable population. The panelists considered conditions inappropriate mainly because of lack of an adequate screening tool or lack of evidence of effective interventions for positive screened persons. Conclusion The expert panel considered screening older people to prevent functional decline appropriate for insufficient physical activity and smoking and cardiovascular risk in specific groups. For other conditions, sufficient evidence does not support screening. Based on their experience, panelists expected benefit from developing tests and interventions, especially for vulnerable older people. © 2011, Copyright the Authors Journal compilation http://repub.eur.nl/res/pub/18292/ 2009-04-01T00:00:00Z Background and Objective: Although in effectiveness studies, the conventional randomized trial, in which informed consent is obtained before randomization, is the first choice, this design is not the panacea for all research questions. To counter contamination problems, prerandomization designs might be an alternative. Prerandomization implies that the randomization takes place before seeking informed consent, and because of this, prerandomization designs are controversial among ethicists, health lawyers, methodologists, and clinicians. However, in the Netherlands, these designs are becoming more accepted since the Dutch State Secretary of Health, Welfare and Sport decided that, under certain circumstances, prerandomization is admissible and not in conflict with the law. Results: Based on well-defined indications and requirements, guidelines for the optimal application of prerandomization designs are presented. Designs in which prerandomization is used are outlined; methodological considerations useful when conducting trials using conventional designs or prerandomization designs are discussed, in addition to ethical and judicial aspects. Conclusion: In certain situations, prerandomization designs have an essential contribution to achieve evidence-based medicine. Banning prerandomization a priori implies that information about the effectiveness of numerous public health and medical interventions will not be forthcoming. Therefore, every design should be based on a balance between maximizing the potential for patient autonomy and minimizing the bias caused by contamination. This balance cannot be reached by formulating general rules, but an independent group of experts, like members of research ethics committee (REC), should decide whether this balance is acceptable. http://repub.eur.nl/res/pub/14724/ 2008-01-01T00:00:00Z In October 2006 the Dutch Ministry of Health, Welfare and Sport announced that the use of pre-randomisation in study designs is admissible and not in conflict with the Dutch Medical Research in Human Subjects Act. With pre-randomisation, the conventional sequence of obtaining informed consent followed by randomisation is reversed. According to the original pre-randomisation design (Zelen design), participants are randomised before they are asked to consent; after randomisation, only participants in the experimental group are asked to consent to treatment and effect measurement. In the past, pre-randomisation has seldom been used, and when it was, it was often under the wrong circumstances. Awareness regarding the ethical, legal and methodological objections to prerandomisation is increasing. About a decade ago, we illustrated the applicability and acceptability of pre-randomisation by means of a fictitious heroin provision trial. In general, pre-randomisation is justified if valid evaluation of the effects of an intervention is impossible using a conventional randomised design, e.g. if knowledge of the intervention may lead to non-compliance or drop-out in the control group, or when the intervention is an educational programme. Other requirements for pre-randomisation include the following: the study has a clinically relevant objective, it is likely that the study will lead to important new insights, the informed consent procedure bears no potential harm to participants, at least standard care is offered to participants in the control group, and the approval of an independent research ethics committee is obtained. http://repub.eur.nl/res/pub/7486/ 1998-06-18T00:00:00Z