Cause-specific mortality adjudication in the UPLIFT® COPD trial:findings and recommendations

Mortality is an important endpoint in chronic obstructive pulmonary disease (COPD) trials, although accurately determining cause of death is difficult. In the Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT®) trial, a mortality adjudication committee (MAC) provided systematic, independent and blinded assessment of cause-specific mortality of all 981 reported deaths. Here we describe this process of mortality adjudication and methodological revisions introduced to help standardise the adjudication of two areas recognised to pose particular difficulty; firstly, the classification of fatal COPD exacerbations that occur in the setting of pneumonia and secondly, the categorisation of sudden death. In addition MAC determined cause of death was compared with that reported by site investigators (SIs). MAC-assigned causes of death were: respiratory, 35%; cancer, 25%; cardiovascular, 11%; sudden cardiac death, 4.4%; sudden death, 3.4%; other, 8.8%; unknown, 12.4%. Cancer/cardiac deaths were more common in Global Initiative for Chronic Obstructive Lung Disease stage II, respiratory deaths in stages III and IV. Agreement between MAC and SI regarding cause of death was complete (50.2%), incomplete (18.5%) or none (31.3%). The SI classified deaths as cardiac three-fold more frequently than MAC (incidence rate [IR]/100 patient-years 0.797 vs. 0.257), although IR ratios for cardiac deaths for tiotropium vs. control were similar between SI and MAC. Discrepancies between MAC- and SI-adjudicated causes of death are common, especially increased reporting of cardiac deaths by the SI. Future multicentre COPD trials should plan appropriate infrastructure before study initiation to ensure collection and interpretation of fatal events data.

NEC Contracting: Evaluation of the Inclusion of Dispute Review Boards in lieu of Adjudication in the Construction Industry in the United Kinddom

The construction industry is renowned for spending vast sums in the resolution of disputes, but never in the prevention. The purpose of this paper is to analyse the New Engineering Contract (NEC) to determine whether or not adjudication has become misaligned with the contract’s objective of promoting effective management. In doing so, the paper examines dispute review boards in order to ascertain if they could be a viable alternative to adjudication. A sequential mixed methodology is adopted including a detailed literature review, eight semi-structured interviews, culminating in the circulation and analysis of a questionnaire, to record the significance of the factors identified. The research concludes that the majority of individuals agree that dispute review boards would be more aligned with the NEC. The familiarity of members, the potential to curb rogue behaviour of parties and the proactive nature of the board are flagged as positive features, however the cost aspect requires further investigation. The reservations made in the study about adjudication, such as the priority given to speed over accuracy and also the adversarial nature of the process, suggest that a preventative step prior to proceeding to adjudication would coincide more with the three core themes of the NEC Contract and therefore, be a positive addition.

The Pluralism of Human Rights Adjudication

This chapter considers judicial reasoning in ‘human rights’ cases. Are there techniques that courts share, or are different techniques adopted, to decide how human rights, in this broader sense, are protected? The chapter aims to adopt a comparative approach to the examination of this reasoning, through a detailed examination of similar human rights issues in a range of jurisdictions. The aim of the chapter is to examine the similarities and divergences in the reasoning developed by courts when addressing comparable human rights questions. The chapter shows that human rights reasoning involves distinctive and particular forms of legal reasoning, but that its form and content differ significantly
from jurisdiction to jurisdiction, and over time within jurisdictions. Building upon these findings, the chapter explores what these similarities and differences tell us about the nature, and the direction of travel, of human rights law which comprises notionally universal norms.

Using Comparative Reasoning in Human Rights Adjudication:The Court of Justice of the European Union and the European Court of Human Rights Compared

This article examines the relationship between the methods that the European Court of Human Rights (ECtHR) and the Court of Justice of the European Union (CJEU) use to decide disputes that involve ‘human’ or ‘fundamental’ rights claims, and the substantive outcomes that result from the use of these particular methods. It has a limited aim: in attempting to understand the interrelationship between human rights methodology and human rights outcomes, it considers primarily the use of ‘comparative reasoning’ in ‘human’ and ‘fundamental’ rights claims by these courts. It is not primarily concerned with examining the extent to which the use of comparative reasoning is based on an appropriate methodology or whether there is a persuasive normative theory underpinning the use of comparative reasoning. The issues considered in this chapter do some of the groundwork, however, that is necessary in order to address these methodological and normative questions.

Analyse comparee des modes d'adjudication appliques aux bons du tresor.

Rapport de recherche

Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation

Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting.

Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review

OBJECTIVES Although the use of an adjudication committee (AC) for outcomes is recommended in randomized controlled trials, there are limited data on the process of adjudication. We therefore aimed to assess whether the reporting of the adjudication process in venous thromboembolism (VTE) trials meets existing quality standards and which characteristics of trials influence the use of an AC. STUDY DESIGN AND SETTING We systematically searched MEDLINE and the Cochrane Library from January 1, 2003, to June 1, 2012, for randomized controlled trials on VTE. We abstracted information about characteristics and quality of trials and reporting of adjudication processes. We used stepwise backward logistic regression model to identify trial characteristics independently associated with the use of an AC. RESULTS We included 161 trials. Of these, 68.9% (111 of 161) reported the use of an AC. Overall, 99.1% (110 of 111) of trials with an AC used independent or blinded ACs, 14.4% (16 of 111) reported how the adjudication decision was reached within the AC, and 4.5% (5 of 111) reported on whether the reliability of adjudication was assessed. In multivariate analyses, multicenter trials [odds ratio (OR), 8.6; 95% confidence interval (CI): 2.7, 27.8], use of a data safety-monitoring board (OR, 3.7; 95% CI: 1.2, 11.6), and VTE as the primary outcome (OR, 5.7; 95% CI: 1.7, 19.4) were associated with the use of an AC. Trials without random allocation concealment (OR, 0.3; 95% CI: 0.1, 0.8) and open-label trials (OR, 0.3; 95% CI: 0.1, 1.0) were less likely to report an AC. CONCLUSION Recommended processes of adjudication are underreported and lack standardization in VTE-related clinical trials. The use of an AC varies substantially by trial characteristics.

Special Adjudication for Enforcement (SAFE) - executive summary.

National Highway Traffic Safety Administration, Washington, D.C.

Special Adjudication for Enforcement (SAFE) - Volume II.

National Highway Traffic Safety Administration, Washington, D.C.

State of Rhode Island Special Adjudication for Enforcement - volume II: evaluation of driver retraining schools. Analytic study. Final report.

National Highway Traffic Safety Administration, Office of Driver and Pedestrian Programs, Washington, D.C.

State of Rhode Island Special Adjudication for Enforcement - volume III: analysis of the administrative adjudication of traffic offenses. Analytic study. Final report.

National Highway Traffic Safety Administration, Office of Driver and Pedestrian Programs, Washington, D.C.

State of Rhode Island Special Adjudication for Enforcement - technical summary. Final report.

National Highway Traffic Safety Administration, Office of Driver and Pedestrian Programs, Washington, D.C.