Redeeming Justice

Approximately three decades ago, two of us, Terrell Carter and Kempis Songster, were sentenced to life in prison without the possibility of parole. The U.S. Supreme Court has said that this sentence, effectively an order to die in prison, represented a legal determination that we were irredeemable. In this Article, with insights from our coauthor and friend, human rights scholar Rachel López, we ask: What does it mean for the law to judge some human beings as incapable of redemption? Isn’t the capacity for change core to the human condition, and shouldn’t that be reflected in the law? This Article marries human rights law with our lived experience to argue that the capacity for redemption is an innate human characteristic. By documenting the dehumanizing effect of codified condemnation and the struggle for humanity after a person has been found irredeemable in a court of law, we seek to show why all humans should have a legal right to redemption—a right embedded in the Eighth Amendment through the latent concept of human dignity. The reading of the Eighth Amendment we call for would require a dramatic reimagination of the U.S. criminal legal system into one that elevates humanity, not deprives it. One that creates the opportunity for healing and human development, not denies it. One that facilitates the human capacity for redemption, not forbids it. One, in other words, that recognizes that change is always possible. Redeeming justice thus requires that legal systems not make unalterable decisions about a human being’s capacity for change. At a bare minimum, this means that all sentences should be reviewable, with release possible after someone redeems herself. No person should be permanently deprived of her hope for freedom

Bayesian Analysis of Econometrics Systems with Discrete Variables and Inequality Constraints

In econometric models, sign or inequality constraints on parameters arise in a wide variety of applications. In this paper, we incorporate linear and nonlinear inequality constraints into systems of equations with both discrete and continuous variables serving as the dependent variables. The posterior sample is generated using Gibbs and Metropolis algorithms with data augmentation. One illustrative example analyzes the choice between fixed and adjustable mortgage rates with inequality restrictions on the financial and borrower characteristics. A second application focuses on certification and performance of auditors.

Potentially Inappropriate Medication Utilization in the Emergency Department Visits by Older Adults: Analysis From a Nationally Representative Sample

The objectives were to determine the frequency of administration of potentially inappropriate medications (PIMs) to older emergency department (ED) patients and to examine recent trends in the rates of PIM usage.The data examined during the study were obtained from the National Hospital Ambulatory Medical Care Survey (NHAMCS). This study utilized the nationally representative ED data from 2000–2006 NHAMCS surveys. Our sample included older adults (age 65 years and greater) who were treated in the ED and discharged home. Estimated frequencies of PIM-associated ED visits were calculated. A multivariable logistic regression model was created to assess demographic, clinical, and hospital factors associated with PIM administration and to assess temporal trends.Approximately 19.5 million patients, or 16.8% (95% confidence interval [CI] = 16.1% to 17.4%) of eligible ED visits, were associated with one or more PIMs. The five most common PIMs were promethazine, ketorolac, propoxyphene, meperidine, and diphenhydramine. The total number of medications prescribed or administered during the ED visit was most strongly associated with PIM use. Other covariates associated with PIM use included rural location outside of the Northeast, being seen by a staff physician only (and not by a resident or intern), presenting with an injury, and the combination of female sex and age 65–74 years. There was a small but significant decrease in the proportion of visits associated with a PIM over the study period.Potentially inappropriate medication administration in the ED remains common. Given rising concerns about preventable complications of medical care, this area may be of high priority for intervention. Substantial regional and hospital type (teaching versus nonteaching) variability appears to exist.ACADEMIC EMERGENCY MEDICINE 2010; 17:231–237 © 2010 by the Society for Academic Emergency MedicinePeer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/79341/1/ACEM_667_sm_DataSupplementS3.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/79341/2/ACEM_667_sm_DataSupplementS2.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/79341/3/ACEM_667_sm_DataSupplementS1.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/79341/4/j.1553-2712.2010.00667.x.pd

Targeting Conservation Investments in Heterogeneous Landscapes: A distance function approach and application to watershed management

To achieve a given level of an environmental amenity at least cost, decision-makers must integrate information about spatially variable biophysical and economic conditions. Although the biophysical attributes that contribute to supplying an environmental amenity are often known, the way in which these attributes interact to produce the amenity is often unknown. Given the difficulty in converting multiple attributes into a unidimensional physical measure of an environmental amenity (e.g., habitat quality), analyses in the academic literature tend to use a single biophysical attribute as a proxy for the environmental amenity (e.g., species richness). A narrow focus on a single attribute, however, fails to consider the full range of biophysical attributes that are critical to the supply of an environmental amenity. Drawing on the production efficiency literature, we introduce an alternative conservation targeting approach that relies on distance functions to cost-efficiently allocate conservation funds across a spatially heterogeneous landscape. An approach based on distance functions has the advantage of not requiring a parametric specification of the amenity function (or cost function), but rather only requiring that the decision-maker identify important biophysical and economic attributes. We apply the distance-function approach empirically to an increasingly common, but little studied, conservation initiative: conservation contracting for water quality objectives. The contract portfolios derived from the distance-function application have many desirable properties, including intuitive appeal, robust performance across plausible parametric amenity measures, and the generation of ranking measures that can be easily used by field practitioners in complex decision-making environments that cannot be completely modeled. Working Paper # 2002-01

Randomized, Controlled Trial of the Long Term Safety, Immunogenicity and Efficacy of RTS,S/AS02(D) Malaria Vaccine in Infants Living in a Malaria-Endemic Region.

The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02(D) vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02(D) or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02(D) (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02(D) and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02(D) and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02(D) group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95% CI: -41.9 to 48.4, p = 0.545). The acceptable safety profile and good tolerability of RTS,S/AS02(D) in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20 month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02(D) group remained significantly higher compared to control for the study duration. Over 18 months follow up, RTS,S/AS02(D) prevented approximately a quarter of malaria cases in the study population. CLINICAL TRIALS: Gov identifier: NCT00289185

A Randomized Trial Assessing the Safety and Immunogenicity of AS01 and AS02 Adjuvanted RTS,S Malaria Vaccine Candidates in Children in Gabon

Background:The malaria vaccine candidate antigen RTS,S includes parts of the pre-erythrocytic stage circumsporozoite protein fused to the Hepatitis B surface antigen. Two Adjuvant Systems are in development for this vaccine, an oil-in water emulsion – based formulation (AS02) and a formulation based on liposomes (AS01).Methods & Principal Findings:In this Phase II, double-blind study (NCT00307021), 180 healthy Gabonese children aged 18 months to 4 years were randomized to receive either RTS,S/AS01E or RTS,S/AS02D, on a 0–1–2 month vaccination schedule. The children were followed-up daily for six days after each vaccination and monthly for 14 months. Blood samples were collected at 4 time-points. Both vaccines were well tolerated. Safety parameters were distributed similarly between the two groups. Both vaccines elicited a strong specific immune response after Doses 2 and 3 with a ratio of anti-CS GMT titers (AS02D/AS01E) of 0.88 (95% CI: 0.68–1.15) post-Dose 3. After Doses 2 and 3 of experimental vaccines, anti-CS and anti-HBs antibody GMTs were higher in children who had been previously vaccinated with at least one dose of hepatitis B vaccine compared to those not previously vaccinated.Conclusions:RTS,S/AS01E proved similarly as well tolerated and immunogenic as RTS,S/AS02D, completing an essential step in the age de-escalation process within the RTS,S clinical development plan

Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

BACKGROUND\ud \ud A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres.\ud \ud METHODS\ud \ud Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners.\ud \ud RESULTS\ud \ud A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials.\ud \ud CONCLUSION\ud \ud Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials.\ud \ud TRIAL REGISTRATION\ud \ud Clinicaltrials.gov NCT00866619

Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age.

BACKGROUND: Plasmodium falciparum malaria is a pressing global health problem. A previous study of the malaria vaccine RTS,S (which targets the circumsporozoite protein), given with an adjuvant system (AS02A), showed a 30% rate of protection against clinical malaria in children 1 to 4 years of age. We evaluated the efficacy of RTS,S given with a more immunogenic adjuvant system (AS01E) in children 5 to 17 months of age, a target population for vaccine licensure. METHODS: We conducted a double-blind, randomized trial of RTS,S/AS01E vaccine as compared with rabies vaccine in children in Kilifi, Kenya, and Korogwe, Tanzania. The primary end point was fever with a falciparum parasitemia density of more than 2500 parasites per microliter, and the mean duration of follow-up was 7.9 months (range, 4.5 to 10.5). RESULTS: A total of 894 children were randomly assigned to receive the RTS,S/AS01E vaccine or the control (rabies) vaccine. Among the 809 children who completed the study procedures according to the protocol, the cumulative number in whom clinical malaria developed was 32 of 402 assigned to receive RTS,S/AS01E and 66 of 407 assigned to receive the rabies vaccine; the adjusted efficacy rate for RTS,S/AS01E was 53% (95% confidence interval [CI], 28 to 69; P<0.001) on the basis of Cox regression. Overall, there were 38 episodes of clinical malaria among recipients of RTS,S/AS01E, as compared with 86 episodes among recipients of the rabies vaccine, with an adjusted rate of efficacy against all malarial episodes of 56% (95% CI, 31 to 72; P<0.001). All 894 children were included in the intention-to-treat analysis, which showed an unadjusted efficacy rate of 49% (95% CI, 26 to 65; P<0.001). There were fewer serious adverse events among recipients of RTS,S/AS01E, and this reduction was not only due to a difference in the number of admissions directly attributable to malaria. CONCLUSIONS: RTS,S/AS01E shows promise as a candidate malaria vaccine. (ClinicalTrials.gov number, NCT00380393.

Longitudinal estimation of Plasmodium falciparum prevalence in relation to malaria prevention measures in six sub-Saharan African countries.

BACKGROUND: Plasmodium falciparum prevalence (PfPR) is a widely used metric for assessing malaria transmission intensity. This study was carried out concurrently with the RTS,S/AS01 candidate malaria vaccine Phase III trial and estimated PfPR over ≤ 4 standardized cross-sectional surveys. METHODS: This epidemiology study (NCT01190202) was conducted in 8 sites from 6 countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, and Tanzania), between March 2011 and December 2013. Participants were enrolled in a 2:1:1 ratio according to age category: 6 months-4 years, 5-19 years, and ≥ 20 years, respectively, per year and per centre. All sites carried out surveys 1-3 while survey 4 was conducted only in 3 sites. Surveys were usually performed during the peak malaria parasite transmission season, in one home visit, when medical history and malaria risk factors/prevention measures were collected, and a blood sample taken for rapid diagnostic test, microscopy, and haemoglobin measurement. PfPR was estimated by site and age category. RESULTS: Overall, 6401 (survey 1), 6411 (survey 2), 6400 (survey 3), and 2399 (survey 4) individuals were included in the analyses. In the 6 months-4 years age group, the lowest prevalence (assessed using microscopy) was observed in 2 Tanzanian centres (4.6% for Korogwe and 9.95% for Bagamoyo) and Lambaréné, Gabon (6.0%), while the highest PfPR was recorded for Nanoro, Burkina Faso (52.5%). PfPR significantly decreased over the 3 years in Agogo (Ghana), Kombewa (Kenya), Lilongwe (Malawi), and Bagamoyo (Tanzania), and a trend for increased PfPR was observed over the 4 surveys for Kintampo, Ghana. Over the 4 surveys, for all sites, PfPR was predominantly higher in the 5-19 years group than in the other age categories. Occurrence of fever and anaemia was associated with high P. falciparum parasitaemia. Univariate analyses showed a significant association of anti-malarial treatment in 4 surveys (odds ratios [ORs]: 0.52, 0.52, 0.68, 0.41) and bed net use in 2 surveys (ORs: 0.63, 0.68, 1.03, 1.78) with lower risk of malaria infection. CONCLUSION: Local PfPR differed substantially between sites and age groups. In children 6 months-4 years old, a significant decrease in prevalence over the 3 years was observed in 4 out of the 8 study sites. Trial registration Clinical Trials.gov identifier: NCT01190202:NCT. GSK Study ID numbers: 114001

Computerized clinical decision support systems for acute care management: A decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes

<p>Abstract</p> <p>Background</p> <p>Acute medical care often demands timely, accurate decisions in complex situations. Computerized clinical decision support systems (CCDSSs) have many features that could help. However, as for any medical intervention, claims that CCDSSs improve care processes and patient outcomes need to be rigorously assessed. The objective of this review was to systematically review the effects of CCDSSs on process of care and patient outcomes for acute medical care.</p> <p>Methods</p> <p>We conducted a decision-maker-researcher partnership systematic review. MEDLINE, EMBASE, Evidence-Based Medicine Reviews databases (Cochrane Database of Systematic Reviews, DARE, ACP Journal Club, and others), and the Inspec bibliographic database were searched to January 2010, in all languages, for randomized controlled trials (RCTs) of CCDSSs in all clinical areas. We included RCTs that evaluated the effect on process of care or patient outcomes of a CCDSS used for acute medical care compared with care provided without a CCDSS. A study was considered to have a positive effect (<it>i.e.</it>, CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.</p> <p>Results</p> <p>Thirty-six studies met our inclusion criteria for acute medical care. The CCDSS improved process of care in 63% (22/35) of studies, including 64% (9/14) of medication dosing assistants, 82% (9/11) of management assistants using alerts/reminders, 38% (3/8) of management assistants using guidelines/algorithms, and 67% (2/3) of diagnostic assistants. Twenty studies evaluated patient outcomes, of which three (15%) reported improvements, all of which were medication dosing assistants.</p> <p>Conclusion</p> <p>The majority of CCDSSs demonstrated improvements in process of care, but patient outcomes were less likely to be evaluated and far less likely to show positive results.</p