Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B

Background and Aims:In the REALM (Randomized, Obser-vational Study of Entecavir to Assess Long-Term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Pa-tients with Chronic HBV Infection) study, 12,378 patients with chronic hepatitis B virus (HBV) infection received up to 10 years of randomized therapy with entecavir or another HBV nucleos(t)ide analogue. Monitored clinical outcome events (COEs) included malignant neoplasms, HBV disease progres-sion events, and deaths. An external event adjudication com-mittee (EAC) was convened to provide real-time review of reported COEs to optimize data quality, and minimize poten-tial adverse effects of the large cohort, interdisciplinary out-come assessments, geographic scope, and long duration. Methods:The EAC comprised an international group of hep-atologists and oncologists with expertise in diagnosis of tar-geted COEs. The EAC reviewed and adjudicated COEs according to prospectively defined diagnostic criteria cap-tured in the EAC charter. Operational processes, including da-ta collection and query procedures, were implemented to optimize efficiency of data recovery to maximize capture of adjudicated COEs, the primary study outcome measure. Results: A total of 1724 COEs were reported and 1465 of these events were adjudicated by the EAC as reported by the investigators (85.0% overall concordance). Concordance by COE type varied: deaths, 99.6%;hepatocellular carcino-ma (HCC), 83.3%;non-HCC malignancies, 88.0%;non-HCC HBV disease progression, 68.2%. Reasons for lack of con-cordance were most commonly lack of adequate supporting data to support an adjudicated diagnosis or evidence that the event pre-dated the study. Conclusions: The REALM EAC performed a critical role in ensuring data quality and consis-tency;EAC performance was facilitated by well-defined diag-nostic criteria, effective data capture, and efficient operational processes. Trial registration: ClinicalTrials.gov NCT00388674.

Exploring Paths for Substantive Settlement of Administrative Disputes:An Empirical Analysis Based on Practice in Weiyuan County,Sichuan Province

As an effective means of addressing social contradictions,the substantive settlement of administrative disputes refers to the timely,impartial,and effective handling of such disputes.It embodies the essence of the modern governance system enabled by the principles and methodologies of the rule of law.Administrative reconsideration,the main channel for settling administrative disputes,is an inevitable consequence of its effective role in settling such disputes.The efficient adjudication of administrative litigation is an indispensable prerequisite for achieving the substantive settlement of administrative disputes,while the diverse approaches employed in settling these disputes contribute to achieving source governance of such disputes.Along with the efficient adjudication of administrative litigation and the multiple approaches to settling administrative disputes,the effectiveness of administrative reconsideration decisions constitutes a comprehensive system that ensures the substantive settlement of administrative disputes.

Outpatient competence restoration: A model and outcomes

AIM: To describe a model outpatient competencerestoration program(OCRP) and provide data on time to restoration of adjudicative competence.METHODS: The authors tracked the process by which individuals are referred for outpatient competence restoration(OCR) by courts in the United States capital, describing the unique requirements of American law, and the avenues available for compelling adherence. Competence to stand trial is a critical gate-keeping function of the judicial and forensic communities and assures that defendants understand courtroom procedures. OCR is therefore an effort to assure fairness and protection of important legal rights. Multimedia efforts are described that educate patients and restore competence to stand trial. These include resources such as group training, use of licensed clinicians, visual aids, structured instruments, and cinema. Aggregate data from the OCRP's previous 4 years of OCR efforts were reviewed for demographic characteristics, restoration rate, and time to restoration. Poisson regression modeling identified the differences in restoration between sequential 45-d periods after entrance into the program.RESULTS: In the past 4 years, the DC OCRP has been successful in restoring 55 of 170 participants(32%), with an average referral rate of 35 persons per year. 76% are restored after the initial 45 d in the program. Demographics of the group indicate a predominance of African-American men with a mean age of 42. Thought disorders predominate and individuals in care face misdemeanor charges 78% of the time. Poisson regression modeling of the number attaining competence during four successive 45-d periods showed a substantial difference among the time periods for the rate of attaining competence(P = 0.0011). The three time periods after 45 d each showed a significant decrease in the restoration rate when compared to the initial 0 to 45 d period- their relative rates were only 22% to 33% as high as the rate for 0-45 d(all P-values, compared to the 0-45 d rate, were 0.013 or smaller). However, the three periods from day 45 to day 135 showed no difference among themselves(P = 0.87).CONCLUSION: The majority of restored participants were restored after 45 d, suggesting a model that may identify an optimal length of time to restoration.

An Alternative to the Adversarial:Studies on Challenges of Court-appointed Experts

At present,experts have become a mainstay of modern litigation,although criticisms suggest that the problems of how to fit expert knowledge comfortably into the method of adversarial fact-finding are numerous,significant,and without simple solutions.Concerns about partisanship and lack of scientific competence by adjudicators to evaluate contradictory expert testimony have been widely recognized in the traditional use of party-called expert witnesses.While such concerns cannot be wholly ameliorated,there may be alternative mechanisms that can help.One solution would be to call for the use of neutral court-appointed experts,to create a nonpartisan source of expert knowledge.A system of neutral court-appointed experts is an advisory tribunal to the court that could deliver“those general truths,applicable to the issue,which they may treat as final and decisive.”However,no matter in which country,the choice of appointing neutral experts still seems to be a rare option for trial judges to consider and exercise.An obvious question would be:Why are neutral experts not used more frequently at trial?This paper did a study on court-appointed experts,with a focus on challenges that such mechanism faces.Part Ⅰ examines problems in the traditional use of expert witnesses in an adversarial system.Part Ⅱ discusses the incentives to make greater use of court-appointed experts in a typical adversarial system and to what extent such mechanism would solve difficulties within the traditional use of party-called expert witnesses.Part Ⅲ further explores and analyzes obstacles that a typical neutral expert system nowadays encounters when it operates in practice.Taking all analysis together,Part IV makes an overall evaluation of the mechanism of court-appointed experts.