Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative

Objective To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in a study, and to evaluate a study's generalisability. Methods The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two day consensus meeting, with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. Results The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25 item checklist, by using evidence, whenever available. A prototype of a flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation and the reference standard, or both. Conclusions Evaluation of research depends on complete and accurate reporting. If medical journals adopt the STARD checklist and flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

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 framework of lessons learned from community-based marine reserves and its effectiveness in guiding a new coastal management initiative in the Philippines

Community-based coastal resource management has been widely applied within the Philippines. However, small-scale community-based reserves are often inefficient owing to management inadequacies arising because of a lack of local support or enforcement or poor design. Because there are many potential pitfalls during the establishment of even small community-based reserves, it is important for coastal managers, communities, and facilitating institutions to have access to a summary of the key factors for success. Reviewing relevant literature, we present a framework of lessons learned during the establishment of protected areas, mainly in the Philippines. The framework contains summary guidance on the importance of (1) an island location, (2) small community population size, (3) minimal effect of land-based development, (4) application of a bottom-up approach, (5) an external facilitating institution, (6) acquisition of title, (7) use of a scientific information database, (8) stakeholder involvement, (9) the establishment of legislation, (10) community empowerment, (11) alternative livelihood schemes, (12) surveillance, (13) tangible management results, (14) continued involvement of external groups after reserve establishment, and (15) small-scale project expansion. These framework components guided the establishment of a community-based protected area at Danjugan Island, Negros Occidental, Philippines. This case study showed that the framework was a useful guide that led to establishing and implementing a community-based marine reserve. Evaluation of the reserve using standard criteria developed for the Philippines shows that the Danjugan Island protected area can be considered successful and sustainable. At Danjugan Island, all of the lessons synthesized in the framework were important and should be considered elsewhere, even for relatively small projects. As shown in previous projects in the Philippines, local involvement and stewardship of the protected area appeared particularly important for its successful implementation. The involvement of external organizations also seemed to have a key role in the success of the Danjugan Island project by guiding local decision-makers in the sociobiological principles of establishing protected areas. However, the relative importance of each component of the framework will vary between coastal management initiatives both within the Philippines and across the wider Asian region.

The importance of modelling heterogeneity in complex disease: application to NIMH Schizophrenia Genetics Initiative data

As for other complex diseases, linkage analyses of schizophrenia (SZ) have produced evidence for numerous chromosomal regions, with inconsistent results reported across studies. The presence of locus heterogeneity appears likely and may reduce the power of linkage analyses if homogeneity is assumed. In addition, when multiple heterogeneous datasets are pooled, intersample variation in the proportion of linked families ( a) may diminish the power of the pooled sample to detect susceptibility loci, in spite of the larger sample size obtained. We compare the significance of linkage. findings obtained using allele- sharing LOD scores ( LODexp) - which assume homogeneity - and heterogeneity LOD scores ( HLOD) in European American and African American NIMH SZ families. We also pool these two samples and evaluate the relative power of the LODexp and two different heterogeneity statistics. One of these ( HLOD- P) estimates the heterogeneity parameter a only in aggregate data, while the second ( HLOD- S) determines a separately for each sample. In separate and combined data, we show consistently improved performance of HLOD scores over LODexp. Notably, genome-wide significant evidence for linkage is obtained at chromosome 10p in the European American sample using a recessive HLOD score. When the two samples are combined, linkage at the 10p locus also achieves genome-wide significance under HLOD- S, but not HLOD- P. Using HLOD- S, improved evidence for linkage was also obtained for a previously reported region on chromosome 15q. In linkage analyses of complex disease, power may be maximised by routinely modelling locus heterogeneity within individual datasets, even when multiple datasets are combined to form larger samples.

Hormones down under: Hormone therapy use after the women's health initiative

Aims: The primary objective was to describe the usage pattern of hormone therapy (HT) in a sample of urban Australian women in 2001 and to assess the characteristics of users vs. non-users. The second objective was to determine whether there had been any change in usage since the publication of the results of the combined oestrogen plus progestagen arm of the Women's Health Initiative (WHI) in 2002. Methods: A cohort of 374 postmenopausal women aged 50-80 years participated in this substudy of the LAW (Longitudinal Assessment of Ageing in Women) project: a 5-year multidisciplinary, observational study. Participants completed an annual medical assessment including details of the use of HT and the reasons for use, as well as demographic and psychosocial data. Results: In December 2001, 30.8% of the participants were using HT, whereas 55.4% were ever users. The management of vasomotor symptoms and mood disturbance were the primary reasons for use. Of those who had been using HT in December 2001 (24.4%) women ceased using HT in the 3 months following publication of the WHI results. The percentage of women using HT in December 2003 (13.9%) was less than half of that of December 2001. Conclusion: The rate of HT use and the reasons for use, in 2001 in Brisbane was similar to that of other Australian regions. Usage of HT decreased since the publication of the WHI results in 2002 which may reflect changing attitudes by patients and practitioners regarding HT.

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.

Repurchase of renewal rights: A policy option for the National Water Initiative

Management of the Murray-Darling river system involves a large number of users with imprecisely defined rights, and an aggregate rate of resource use that is environmentally unsustainable. One possible policy response is to make formal or informal contracts with users, under which users receive current benefits in return for a commitment to forgo usage rights in future. In this paper, this issue is explored with specific reference to the possibility of repurchasing the renewal rights for irrigation licenses.