Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops

International audienceBACKGROUND: Treatment decisions in kidney transplantation requires patients and clinicians to weigh the benefits and harms of a broad range of medical and surgical interventions, but the heterogeneity and lack of patient-relevant outcomes across trials in transplantation makes these trade-offs uncertain, thus, the need for a core outcome set that reflects stakeholder priorities. METHODS: We convened 2 international Standardized Outcomes in Nephrology-Kidney Transplantation stakeholder consensus workshops in Boston (17 patients/caregivers; 52 health professionals) and Hong Kong (10 patients/caregivers; 45 health professionals). In facilitated breakout groups, participants discussed the development and implementation of core outcome domains for trials in kidney transplantation. RESULTS: Seven themes were identified. Reinforcing the paramount importance of graft outcomes encompassed the prevailing dread of dialysis, distilling the meaning of graft function, and acknowledging the terrifying and ambiguous terminology of rejection. Reflecting critical trade-offs between graft health and medical comorbidities was fundamental. Contextualizing mortality explained discrepancies in the prioritization of death among stakeholders-inevitability of death (patients), preventing premature death (clinicians), and ensuring safety (regulators). Imperative to capture patient-reported outcomes was driven by making explicit patient priorities, fulfilling regulatory requirements, and addressing life participation. Specificity to transplant; feasibility and pragmatism (long-term impacts and responsiveness to interventions); and recognizing gradients of severity within outcome domains were raised as considerations. CONCLUSIONS: Stakeholders support the inclusion of graft health, mortality, cardiovascular disease, infection, cancer, and patient-reported outcomes (ie, life participation) in a core outcomes set. Addressing ambiguous terminology and feasibility is needed in establishing these core outcome domains for trials in kidney transplantation

The Limits of the European Union’s Transformative Power: Pathologies of Europeanization and Rule of Law Reform in Central and Eastern Europe

This thesis examines the impact of the European Union (EU) on the development of the rule of law in Central and Eastern Europe. The topic is addressed through a mixed methods study which consists of a quantitative comparative analysis of three country groups from Central and Eastern Europe (1. Central Europe and the Baltics, CEB; 2. South Eastern Europe, SEE; 3. Commonwealth of Independent States, CIS) and three qualitative case studies on Poland, Romania and Moldova. The empirical analysis is based on an innovative set of indicators and revealing insights from numerous qualitative interviews. The findings of the study suggest that the impact of the EU is differential, both healthy and pathological. While EU-driven judicial reforms increase judicial capacity and align domestic legislation with European and international standards (substantive legality), they do not improve and even lead to a deterioration of judicial impartiality and formal legality, resulting in several reform pathologies, such as instable, incoherent and non-enforced laws and in more politicized and incoherent judicial systems, which undermine the development of the rule of law. These pathological effects occur mostly in weak rule of law countries from SEE (Romania) and CIS (Moldova), in contrast to more healthy effects in advanced, strong rule of law countries from CEB (Poland). The dissimilar development in the rule of law across countries is explained in relation to the conduct of reforms. Successful reformers like Poland, which consolidate the rule of law, have strong and independent horizontal accountability institutions (e.g. Constitutional Court, Ombudsman, judiciary), which mitigate or alleviate reform pathologies and ensure that reforms are conducted in an accountable, gradual and non-politicized way. Unsuccessful reformers, like Romania and Moldova, lack these independent checks on reformers and thus fail to establish the rule of law. Based on the findings from the case studies an original typology of healthy and pathological reform paths is proposed, which draws on the logic of circular and cumulative causation and emphasizes the mutual reinforcement between domestic conditions and the reform approach of transnational coalitions. The proposed typology implies that EU conditionality is not transformative, but rather reinforces existing healthy and pathological reform paths, thus cementing the existing divergence in the rule of law across post-communist countries. This thesis further makes several policy recommendations to remedy the pathological impact of donor-driven reforms