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Appropriately designed randomized controlled studies (RCTs) are pivotal for the clinical evaluation of new treatments, but also of new diagnostic tests. Before addressing RCTs, this chapter describes the observational study designs. A case-control study has a retrograde direction of enquiry, it starts with the outcome and looks back at the exposure. Cross-sectional studies are most appropriate for obtaining clinical information before embarking on more elaborate types of study. In an RCT two randomization procedures take place, the first (r1) is the random drawing of a representative sample from the general population, and the second (r2) random allocation of these individuals to either of (most often) two treatment arms. Next, the outcome of treatment is studied and compared between arms. Generation of a proper randomization sequence takes little time and effort but affords big rewards in scientific accuracy and credibility.
Objectives: Even when policy makers show interest and evidence-informed and convincing HTA studies are available, use of assessment products is not guaranteed. In this article, we report our experience with knowledge brokering to foster evidence-informed policy making on cost-effective treatment and reimbursement of assisted reproduction in The Netherlands.
Methods: From earlier work in the field of knowledge brokering, we foresaw the need for a deliberative strategy to manage the inherent tension between scientific rigor demanded by researchers and responsiveness to real-time needs demanded by policy makers. Therefore, we structured the process in three distinct steps: (i) agreement about the main messages from the research, (ii) analysis of the policy context and of the meaning of the main messages for the actors involved, and (iii) an invitational meeting to make recommendations for action.
Results: One of the recommendations that would require changes in ministerial policy was followed up instantly, whereas the other recommendation is still under debate. The Dutch Society of Obstetrics and Gynecology activated the revision of two guidelines. The patient organization uses the new scientific insights in informing members and the public. Closing the loop, The Netherlands Organisation for Health Research and Development (ZonMw) funded research to close knowledge gaps that became apparent in the process.
Conclusions: Knowledge brokering is a promising approach to bring HTA into practice. We conclude that the methodologies to feed research results into the policy process are still in an incipient stage and need further development.
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