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.

Computerizing the welfare state: An international comparison of computerization in social security

Although computer technology is central to the operation of the modern welfare state, there has been little analysis of its role or of the factors shaping the way in which it is used. Using data generated by expert informants from 13 OECD countries, this paper provides an indicative comparison of the aims of computerization in national social security systems over a 15-year period from 1985 to 2000. The paper seeks to identify and explain patterns in the data and outlines and examines four hypotheses. Building on social constructivist accounts of technology, the first three hypotheses attribute variations in the aims of computerization to different welfare state regimes, forms of capitalism, and structures of public administration. The fourth hypothesis, which plays down the importance of social factors, assumes that computerization is adopted as a means of improving operational efficiency and generating expenditure savings. The findings suggest that, in all 13 countries, computerization was adopted in the expectation that it would lead to increased productivity and higher standards of performance, thus providing most support for the fourth hypothesis. However, variations between countries suggest that the sociopolitical values associated with different welfare state regimes have also had some effect in shaping the ways in which computer technology has been used in national social security systems.

Diabetes as a tracer condition in international benchmarking of health systems

OBJECTIVE - To assess the performance of health systems using diabetes as a tracer condition. RESEARCH DESIGN AND METHODS - We generated a measure of case-fatality among young people with diabetes Using the mortalily-to-incidence ratio (M/I ratio) for 29 industrialized countries using published data on diabetes incidence and mortality. Standardized incidence rates for ages 0-14 years were extracted from the World Health Organization DiaMond Study for the period 1990-1994; data on death from diabetes for ages 0-39 years were obtained from the World Health Organization Mortality database and converted into age-standardized death rates for the period 1994-1998, using the European standard population. RESULTS - The MA ratio varied > 10-fold. These relative differences appear similar to those observed in cohort studies of mortality among young people with type I diabetes in five countries. A sensitivity analysis showed that using plausible assumptions about potential overestimation of diabetes as a cause of death and underestimation of incidence rates in the U.S. yields an M/I ratio that would still be twice as high as in the U.K. or Canada. CONCLUSIONS - The M/I ratio for diabetes provides a means of differentiating countries on quality of care for people with diabetes. It is solely an indicator of potential problems, a basis for Stimulating more detailed assessments of whether such problems exist, and what can be done to address them.

Predictors of cultural adjustment: Intergroup status relations and boundary permeability

We examined intergroup predictors of cultural adjustment among Asian international students in Australia. Sociostructural beliefs (status, legitimacy, and permeability) and initial adjustment were assessed (N = 113) at Time 1, and measures of adjustment were obtained (N = 80) at Time 2 eight weeks later. International students who perceived their cultural group to be relatively low in status experienced lower levels of psychological adjustment. Also, as expected, the effects of status were moderated by perceptions of both the permeability of intergroup boundaries and the legitimacy of the status differential. At high levels of legitimacy, perceptions of permeable group boundaries were associated with better psychological, sociocultural, and academic adjustment among international students perceiving their group to be low in status, but lower levels of adjustment among students who perceived their group to be high in status. At low levels of legitimacy, irrespective of group status position, perceived permeability was not related to adjustment.