OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited.

Background: The OARSI Standing Committee for Clinical Trials Response Criteria Initiative had developed two sets of responder criteria to present the results of changes after treatment in three symptomatic domains (pain, function, and patient's global assessment) as a single variable for clinical trials (1). For each domain, a response was defined by both a relative and an absolute change, with different cut-offs with regard to the drug, the route of administration and the OA localization. Objective: To propose a simplified set of responder criteria with a similar cut-off, whatever the drug, the route or the OA localization. Methods: Data driven approach: (1) Two databases were considered The 'elaboration' database with which the formal OARSI sets of responder criteria were elaborated and The 'revisit' database. (2) Six different scenarios were evaluated: The two formal OARSI sets of criteria Four proposed scenarios of simplified sets of criteria Data from clinical randomized blinded placebo controlled trials were used to evaluate the performances of the two formal scenarios with two different databases ('elaboration' versus 'revisit') and those of the four proposed simplified scenarios within the 'revisit' database. The placebo effect, active effect, treatment effect, and the required sample arm size to obtain the placebo effect and the active treatment effect observed were the performances evaluated for each of the six scenarios. Experts' opinion approach: Results were discussed among the participants of the OMERACT VI meeting, who voted to select the definite OMERACT-OARSI set of criteria (one of the six evaluated scenarios). Results: Data driven approach: Fourteen trials totaling 1886 CA patients and fifteen studies involving 8164 CA patients were evaluated in the 'elaboration' and the 'revisit' databases respectively. The variability of the performances observed in the 'revisit' database when using the different simplified scenarios was similar to that observed between the two databases ('elaboration' versus 'revisit') when using the formal scenarios. The treatment effect and the required sample arm size were similar for each set of criteria. Experts' opinion approach: According to the experts, these two previous performances were the most important of an optimal set of responder criteria. They chose the set of criteria considering both pain and function as evaluation domain and requiring an absolute change and a relative change from baseline to define a response, with similar cut-offs whatever the drug, the route of administration or the CA localization. Conclusion: This data driven and experts' opinion approach is the basis for proposing an optimal simplified set of responder criteria for CA clinical trials. Other studies, using other sets of CA patients, are required in order to further validate this proposed OMERACT - OARSI set of criteria. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

A political analysis of the PRSP initiative: Social struggles and the organization of persistent relations of inequality

The current global development project appears to be premised on the assumption that underlying political debates over development have been settled. An upshot of this is that development is reduced to the theoretical, ideological and legal framework of a neo-liberal political order. However, implicit, and sometimes explicit, political dynamics of development can be rendered from a perspective that foregrounds social struggles. I offer a political analysis of the PRSP initiative by examining its evolution and implications considered within social and political contexts, and by specific reference to the 'poverty reduction' interventions that emerged in the 1980s. I argue that the PRSP initiative is best understood as the formation of a comprehensive extension of neo-liberal strategic responses that emerged in the 1980s. In this context, I discuss the example of microcredit schemes in relation to the PRSP process and demonstrate the analytical significance of micro-political social relations for political analyses of development. The approach I adopt reveals social struggles as relationally constitutive of formations of a hegemonic development discourse otherwise ostensibly rendered in de-contextualized terms. From the perspective of critical development analysis such struggles are the concrete expressions of the contradictions immanent to the dialectic of development through inequality and immiseration in the (re)production of social power.