Regulatory Futures in Retrospect

In our 1998 volume ‘The Politics of Chemical Risk: Scenarios for a regulatory Future’ we envisioned four ideal typical scenarios for the future of European chemicals policies. The scenarios focused on the nature of expertise (seen either as a universal or a localised phenomenon) and the organisation of the boundary between science and policy (as either diverging or converging). The four scenarios were titled International Experts, European Risk Consultation, European Coordination of Assessment, and Europe as a Translator. For all four scenarios, we hypothesized internal dynamics and articulated dilemmas related to the development of the sciences contributing to chemical assessment, the relation between the EU and member states and the role of the public. In this contribution, we look back on our four scenarios fifteen years later, to see which ones have materialized and to explore whether the dilemmas we saw have indeed surfaced. We conclude that the International Experts scenario by and large has materialized and explore some of the underlying tensions and dynamics in this development

Evaluation design of a systematic, selective, internet-based, Chlamydia screening implementation in the Netherlands, 2008-2010: implications of first results for the analysis

A selective, systematic, Internet-based, Chlamydia Screening Implementation for 16 to 29-year-old residents started in three regions in the Netherlands in April 2008: in the cities of Amsterdam and Rotterdam and a more rural region, South Limburg. This paper describes the evaluation design and discusses the implications of the findings from the first screening round for the analysis. The evaluation aims to determine the effects of screening on the population prevalence of Chlamydia trachomatis after multiple screening rounds. A phased implementation or 'stepped wedge design' was applied by grouping neighbourhoods (hereafter: clusters) into three random, risk-stratified blocks (A, B and C) to allow for impact analyses over time and comparison of prevalences before and after one or two screening rounds. Repeated simulation of pre- and postscreening Chlamydia prevalences was used to predict the minimum detectable decline in prevalence. Real participation and positivity rates per region, block, and risk stratum (high, medium, and low community risk) from the 1st year of screening were used to substantiate predictions. The results of the 1st year show an overall participation rate of 16% of 261,025 invitees and a positivity rate of 4.2%, with significant differences between regions and blocks. Prediction by simulation methods adjusted with the first-round results indicate that the effect of screening (minimal detectable difference in prevalence) may reach significance levels only if at least a 15% decrease in the Chlamydia positivity rate in the cities and a 25% decrease in the rural region after screening can be reached, and pre- and postscreening differences between blocks need to be larger. With the current participation rates, the minimal detectable decline of Chlamydia prevalence may reach our defined significance levels at the regional level after the second screening round, but will probably not be significant between blocks of the stepped wedge design. Evaluation will also include other aspects and prediction models to obtain rational advice about future Chlamydia screening in the Netherland

Virology Experts in the Boundary Zone Between Science, Policy and the Public: A Biographical Analysis

This article aims to open up the biographical black box of three experts working in the boundary zone between science, policy and public debate. A biographical-narrative approach is used to analyse the roles played by the virologists Albert Osterhaus, Roel Coutinho and Jaap Goudsmit in policy and public debate. These figures were among the few leading virologists visibly active in the Netherlands during the revival of infectious diseases in the 1980s. Osterhaus and Coutinho in particular are still the key figures today, as demonstrated during the outbreak of novel influenza A (H1N1). This article studies the various political and communicative challenges and dilemmas encountered by these three virologists, and discusses the way in which, strategically or not, they handled those challenges and dilemmas during the various stages of the field’s recent history. Important in this respect is their pursuit of a public role that is both effective and credible. We will conclude with a reflection on the H1N1 pandemic, and the historical and biographical ties between emerging governance arrangements and the experts involved in the development of such arrangements

Risk of upper limb complaints due to computer use in older persons: a randomized study

Abstract Background We studied whether the twelve-month use of a standard computer would induce complaints of upper limb pain or functional limitations in older novice computer users. Methods Participants between 64 and 76 of age were randomly assigned to an Intervention group (n = 62), whose members received a personal computer and fast Internet access at their homes, or a No Intervention control group (n = 61), whose members refrained from computer use during the twelve month study period. Results Difference scores between baseline and twelve months assessments on both complaint (SFS) and functional health scales (SF-36) did not differ between groups (all p > .05). Conclusion Prolonged, self-paced use of a standard computer interface does not put older persons at a risk of upper limb complaints or reduce functional health in older adults.</p

Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence

<p>Abstract</p> <p>Background</p> <p>Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial.</p> <p>Methods/Design</p> <p>A multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands</p> <p>Trial registration</p> <p>Nederlands trial register: NTR 1248</p

Medico-legal reasoning in disability assessment: A focus group and validation study

<p>Abstract</p> <p>Background</p> <p>Decisions on disability pensions are based, among others, on medical reports. The way these medical assessments are performed is largely unclear. The aim of the study was to determine which grounds are used by social insurance physicians (SIPs) in these assessments and to determine if the identification of these grounds can help improve the quality of assessments in social insurance practice. The article describes a focus group study and a questionnaire study with SIPs in four different countries.</p> <p>Method</p> <p>Using focus group discussions of SIPs discussing the same case in Belgium, the Netherlands, Norway and Slovenia (N = 29) we determined the arguments and underlying grounds as used by the SIP's. We used a questionnaire study among other SIPs (N = 60) in the same countries to establish a first validation of these grounds.</p> <p>Results</p> <p>Grounds in the focus groups were comparable between the countries studied. The grounds were also recognized by SIPs who had not participated in the focus groups. SIPs agreed most on grounds with regard to the claimant's health condition, and about the claimant's duty to explore rehabilitation and work resumption, but less on accepting permanent incapacity when all options for treatment were exhausted.</p> <p>Conclusion</p> <p>Grounds that SIPs use refer to a limited group of key elements of disability evaluation. SIPs interpret disability in social insurance according to the handicapped role and strive at making their evaluation fair trials. ICF is relevant with regard to the health condition and to the process of evaluation. Identification of grounds is a valuable instrument for controlling the quality of disability evaluation. The grounds also appear to be internationally comparable which may enhance scientific study in this area.</p

Informed decision making about predictive DNA tests: arguments for more public visibility of personal deliberations about the good life

Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes to supporting positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories