Nonrandom Assignment Research Articles

Safety of Intravenous Iron in Hemodialysis: Longer-term Comparisons of Iron Sucrose Versus Sodium Ferric Gluconate Complex

Controversy exists about any differences in longer-term safety across different intravenous iron formulations routinely used in hemodialysis (HD) patients. We exploited a natural experiment to compare outcomes of patients initiating HD therapy in facilities that predominantly (in≥90% of their patients) used iron sucrose versus sodium ferric gluconate complex. Retrospective cohort study of incident HD patients. Using the US Renal Data System, we hard-matched on geographic region and center characteristics HD facilities predominantly using ferric gluconate with similar ones using iron sucrose. Subsequently, incident HD patients were assigned to their facility iron formulation exposure. Facility-level use of iron sucrose versus ferric gluconate. Patients were followed up for mortality from any, cardiovascular, or infectious causes. Medicare-insured patients were followed up for infectious and cardiovascular (stroke or myocardial infarction) hospitalizations and for composite outcomes with the corresponding cause-specific deaths. HRs. We matched 2,015 iron sucrose facilities with 2,015 ferric gluconate facilities, in which 51,603 patients (iron sucrose, 24,911; ferric gluconate, 26,692) subsequently initiated HD therapy. All recorded patient characteristics were balanced between groups. Over 49,989 person-years, 10,381 deaths (3,908 cardiovascular and 1,209 infectious) occurred. Adjusted all-cause (HR, 0.98; 95% CI, 0.93-1.03), cardiovascular (HR, 0.96; 95% CI, 0.89-1.03), and infectious mortality (HR, 0.98; 95% CI, 0.86-1.13) did not differ between iron sucrose and ferric gluconate facilities. Among Medicare beneficiaries, no differences between ferric gluconate and iron sucrose facilities were observed in fatal or nonfatal cardiovascular events (HR, 1.01; 95% CI, 0.93-1.09). The composite infectious end point occurred less frequently in iron sucrose versus ferric gluconate facilities (HR, 0.92; 95% CI, 0.88-0.96). Unobserved selection bias from nonrandom treatment assignment. Patients initiating HD therapy in facilities almost exclusively using iron sucrose versus ferric gluconate had similar longer-term outcomes. However, there was a small decrease in infectious hospitalizations and deaths in patients dialyzing in facilities predominantly using iron sucrose. This difference may be due to residual confounding, random chance, or a causal effect.

Efficacy of Transcranial Direct Current Stimulation as Support for Neurorehabilitation Therapy: A Meta-analysis of Available Studies

Transcranial direct current stimulation (tDCS) is a non-invasive, well-tolerated, brain stimulation technique, using a weak current applied on the scalp. Rational of tDCS use has been based on the assumption of the post-stroke inter-hemispheric competition model, resulting in a hypo-excitability hemispheric lesion and a hyper-excitability healthy hemisphere, to improve the recovery of motor function. Several small studies have been published but the efficacy of tDCS is not established. We performed a systematic review of published studies to assess efficacy of tDCS on motor function of patients with stroke. A thorough search of main databases has been performed to identify randomized, controlled studies on efficacy of tDCS in patients with stroke. The values derived from the primary outcome measures of these studies have been standardized to make them comparable; eight comparisons were planned: degree of dependence, improvement of upper limb, improvement of global motor function, improvement of lower limb and visual perception; comparison between anode stimulation and sham, anode stimulation and follow-up. 8 studies have been included in the meta-analysis. 3 studies have been excluded because of lack of statistical data, non-randomized assignment and lack of a control group; 178 participants have been included altogether. Most of comparisons did not produce significant results; however a significant improvement of dependence scores (p=0.02), of lower limb index (p=0.02), and of visual perception (p=0.02) have been found. Despite the encouraging results by neurophysiological and instrumental investigations, in some heterogeneous cases, our study shows that there is a need to conduct studies with larger sample sizes.

The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database.

In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials.

Long-term Results of the Expert Patients Program in Patients with Cardiovascular Disease: A Cohort Study

Background: The Expert Patients Program (EPP) has high non-participation and dropout rates and some uncertainty on its effectiveness. Aim: To identify, in patients with a cardiovascular event (CVE), the usefulness of participating in the EPP in relation to the quality of life, morbi-mortality and use of specialized healthcare resources during two years. Methods: The research design is A quasi-experimental study with non-random assignment of EPP with two years of monitoring and the subjects are patients at the first acute myocardial infarction (AMI) or ischemic stroke. The measures taken are Clinical and socio-demographic variables and a quality of life questionnaire were registered at starting. During the monitoring, the new CVE, the number of specialized out-patient or emergency consultations and hospital admittances, life questionnaire and death, were reported. Descriptive and comparative bivariate and multivariate analysis was conducted as statistical analysis. Results: 100 patients with AMI and 69 with stroke were included, 51% refused and 10% dropped out. During monitoring, 21% presented a CVE, 59% went to the emergency, 34% required admittance, and 4% died without any relationship with the participation. There was a significantly higher frequency of scheduled visits in patients who received the intervention. The general health, vitality and mental health worsened significantly regardless of the participation. The physical functioning, social functioning and bodily pain did not undergo significant differences; while the physical and emotional roles changed significantly and in a different way according to the degree of participation. Conclusions: Despite the low participation in the PPE, we find a significant improvement in the quality of life in the intervention group.

A Propensity Score–Matched Analysis of Robotic vs Open Pancreatoduodenectomy on Incidence of Pancreatic Fistula

The adoption of robotic pancreatoduodenectomy (RPD) is gaining momentum; however, its impact on major outcomes, including pancreatic fistula, has yet to be adequately compared with open pancreatoduodenectomy (OPD). To demonstrate that use of RPD does not increase the incidence of clinically relevant pancreatic fistula (CR-POPF) compared with OPD. Data were accrued from 2846 patients who underwent pancreatoduodenectomies (OPDs, n = 2661; RPDs, n = 185), performed by 51 surgeons at 17 institutions worldwide (2003-2015). All RPDs were conducted at a high-volume, academic, pancreatic surgery specialty center-in a standardized fashion-by surgeons who had surpassed the RPD learning curve. Propensity score matching was used to minimize bias from nonrandomized treatment assignment. The RPD and OPD cohorts were matched by propensity scores accounting for factors significantly associated with either undergoing robotic surgery or CR-POPF occurrence on logistic regression analysis. These variables included pancreatic gland texture, pancreatic duct diameter, intraoperative blood loss, pathologic findings of disease, and intraoperative drain placement. Use of RPD or OPD. The major outcome of interest was CR-POPF occurrence, which is the most common and morbid complication following pancreatoduodenectomy. The overall cohort was 51.5% male, with a median age of 64 years (interquartile range, 56-72 years). The propensity score-matched cohort comprised 152 RPDs and 152 OPDs; all covariate imbalances were alleviated. After adjusting for potential confounders, undergoing RPD was associated with a reduced risk for CR-POPF incidence (OR, 0.4 [95% CI, 0.2-0.7]; P = .002) relative to OPD. Other predictors of risk-adjusted CR-POPF occurrence included soft pancreatic parenchyma (OR, 4.7 [95% CI, 3.4-6.6]; P < .001), pathologic findings of high-risk disease (OR, 1.4 [95% CI, 1.1-1.9]; P = .01), small pancreatic duct diameter (vs ≥5 mm: 2 mm, OR, 2.1 [95% CI, 1.4-3.1]; P < .001; ≤1 mm, OR, 1.8 [95% CI, 1.0-3.0]; P = .03), elevated intraoperative blood loss (vs ≤400 mL: 401-700 mL, OR, 1.5 [95% CI, 1.1-2.0]; P = .01; >1000 mL, OR, 2.1 [95% CI, 1.4-2.9]; P < .001), omission of intraoperative drain(s) (OR, 0.5 [95% CI, 0.3-0.8]; P = .005), and octreotide prophylaxis (OR, 3.1 [95% CI, 2.3-4.0]; P < .001). Patients undergoing RPD demonstrated similar CR-POPF rates compared with patients in the OPD cohort (6.6% vs 11.2%; P = .23). This relationship held for both grade B (6.6% vs 9.2%; P = .52) and grade C (0% vs 2.0%; P = .25) POPFs. Robotic pancreatoduodenectomy was also noninferior to OPD in terms of the occurrence of any complication (73.7% vs 66.4%; P = .21), severe complications (Accordion grade ≥3, 23.05% vs 23.7%; P > .99), hospital stay (median: 8 vs 8.5 days; P = .31), 30-day readmission (22.4% vs 21.7%; P > .99), and 90-day mortality (3.3% vs 1.3%; P = .38). To our knowledge, this is the first propensity score-matched analysis of robotic vs open pancreatoduodenectomy to date, and it demonstrates that RPD is noninferior to OPD in terms of pancreatic fistula development and other major postoperative outcomes.

Mortality following helicopter versus ground transport of injured children

IntroductionInjured children may be transported to trauma centers by helicopter air ambulance (HAA); however, a benefit in outcomes to this expensive resource has not been consistently shown in the literature and there is concern that HAA is over-utilized. A study that adequately controls for selection biases in transport mode is needed to determine which injured children benefit from HAA. The purpose of this study was to determine if HAA impacts mortality differently in minimally and severely injured children and if there are predictors of over-triage of HAA in children that can be identified. MethodsChildren ≤18 years of age transported by HAA or ground ambulance (GA) from scene to a trauma center were identified from the 2010–2011 National Trauma Data Bank. Analysis was stratified by Injury Severity Score (ISS) into low ISS (≤15) and high ISS (>15) groups. Following propensity score matching of HAA to GA patients, conditional multivariable logistic regression was performed to determine if transport mode independently impacted mortality in each stratum. Rates and predictors of over-triage of HAA were also determined. ResultsTransport by HAA occurred in 8218 children (5574 low ISS, 2644 high ISS) and by GA in 35305 (30506 low ISS, 4799 high ISS). Overall mortality was greater in HAA patients (4.0 vs 1.4%, p<0.001). After propensity score matching, mortality was equivalent between HAA and GA for low ISS patients (0.2 vs 0.2%, p=0.82) but, for high ISS patients, mortality was lower in HAA (9.0 vs 11.1% p=0.014). On multivariable analysis, HAA was associated with decreased mortality in high ISS patients (OR=0.66, p=0.017) but not in low ISS patients (OR=1.13, p=0.73). Discharge within 24h of HAA transport occurred in 36.5% of low ISS patients versus 7.4% high ISS patients (p<0.001). ConclusionsBased on a national cohort adjusted for nonrandom assignment of transport mode, a survival benefit to HAA transport exists only for severely injured children with ISS >15. Many children with minor injuries are transported by helicopter despite frequent dismissal within 24h and no mortality benefit.

Is Outpatient Total Hip Arthroplasty Safe?

BackgroundSafety data for outpatient total hip arthroplasty (THA) remains scarce. MethodsThe present study retrospectively reviews prospectively collected data from the 2005-2014 American College of Surgeons National Surgical Quality Improvement Program Database. Patients who underwent THA were categorized by day of hospital discharge to be outpatient (length of stay [LOS] 0 days) or inpatient (LOS 1-5 days). Those with extended LOS beyond 5 days were excluded. To account for baseline nonrandom assignment between the study groups, propensity score matching was used. The propensity matched populations were then compared with multivariate Poisson regression to compare the relative risks of adverse events during the initial 30 postoperative days including readmission. ResultsA total of 63,844 THA patients were identified. Of these, 420 (0.66%) were performed as outpatients and 63,424 (99.34%) had LOS 1-5 days. Outpatients tended to be younger, male, and to have fewer comorbidities. After propensity score matching, outpatients had no difference in any of 18 adverse events evaluated other than blood transfusion, which was less for outpatients than those with a LOS of 1-5 days (3.69% vs 9.06%, P < .001). ConclusionAfter adjusting for potential confounders using propensity score matching and multivariate logistic regression, patients undergoing outpatient THA were not at greater risk of 30 days adverse events or readmission than those that were performed as inpatient procedures. Based on the general health outcome measures assessed, this data supports the notion that outpatient THA can appropriately be considered in appropriately selected patients.

Winning the Peace Locally: UN Peacekeeping and Local Conflict

AbstractIt remains contested whether peacekeeping works. The impact of peacekeepers’ actions at the local subnational level for overall mission success has lately received critical attention. Local peacekeeping is expected to matter because it reassures local actors, deters resumption of armed hostilities, coerces parties to halt fighting, and makes commitment to agreements credible. Thus peacekeepers affect the relations between central and local elites and avoid the emergence of local power vacuums and areas of lawlessness. This study uses new subnational data on the deployment of United Nations peacekeepers. It uses matching and recursive bivariate probit models with exogenous variables for temporal and spatial variation to deal with possible nonrandom assignment of the treatment. We demonstrate that conflict episodes last for shorter periods when peacekeepers are deployed to conflict-prone locations inside a country, even with comparatively modest deployment. The effect of peacekeeping on the onset of local conflict is, however, less clear cut.

Childhood Arthritis and Rheumatology Research Alliance Consensus Clinical Treatment Plans for Juvenile Dermatomyositis with Persistent Skin Rash.

Juvenile dermatomyositis (JDM) is the most common form of idiopathic inflammatory myopathy in children. While outcomes are generally thought to be good, persistence of skin rash is a common problem. The goal of this study was to describe the development of clinical treatment plans (CTP) for children with JDM characterized by persistent skin rash despite complete resolution of muscle involvement. The Childhood Arthritis and Rheumatology Research Alliance, a North American consortium of pediatric rheumatologists and other healthcare providers, used a combination of Delphi surveys and nominal group consensus meetings to develop CTP that reflected consensus on typical treatments for patients with JDM with persistent skin rash. Consensus was reached on patient characteristics and outcome assessment. Patients should have previously received corticosteroids and methotrexate (MTX). Three consensus treatment plans were developed. Plan A added intravenous immunoglobulin (IVIG) if it was not already being used. Plan B added mycophenolate mofetil, while Plan C added cyclosporine. Continuation of previous treatments, including corticosteroids, MTX, and IVIG, was permitted in plans B and C. Three consensus CTP were developed for use in children with JDM and persistent skin rash despite complete resolution of muscle disease. These CTP reflect typical treatment approaches and are not to be considered treatment recommendations or standard of care. Using prospective data collection and statistical methods to account for nonrandom treatment assignment, it is expected that these CTP will be used to allow treatment comparisons, and ultimately determine the best treatment for these patients.

It is the examinee's IQ.

In response to the question "Whose IQ is it?" raised by McDermott, Watkins, and Rhoad (2014), this study examined the same concern about assessor bias by applying hierarchical linear modeling to a large and representative standardization sample of 2,200 child records in the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV). When differences in child age, gender, ethnicity, parental education level, and some intellectual abilities were cojointly used as covariates to adjust for nonrandom assignment problems, the results revealed that the Level 2 assessor variance was trivial for Full Scale IQ and all WISC-IV scores, ranging from 1%-5%, with the only exception being the Comprehension subtest, which showed a moderate level of between-assessor variance (10%). Evidence shows that WISC-IV scores are valid measures of children's intellectual abilities, with no evidence showing harmful assessor bias. (PsycINFO Database Record

Effects of local land-use planning on development and disturbance in riparian areas

Land-use change can significantly affect the provision of ecosystem services. On a local scale, zoning laws and other land-use regulations are commonly used to influence land-use change, but their effectiveness is often unclear. We evaluate the effectiveness of local land-use planning in concentrating development and minimizing impacts in riparian areas. We use spatially-explicit land cover data from the USGS Land Cover Trends project to measure development and disturbance rates before and after implementation of Oregon’s land-use planning system. We apply a difference-in-difference estimator to address the problem of non-random assignment of regulations on the landscape. We find that land-use laws in Oregon have concentrated development inside of UGBs and lowered development rates in riparian areas. However, disturbance in riparian areas has increased inside of UGBs. Overall, our findings suggest that local land-use planning can be an effective tool for promoting the provision of non-market ecosystem services.

The Effectiveness of Functional Family Therapy for Adolescent Behavioral and Substance Misuse Problems: A Meta-Analysis.

A systematic review of published and unpublished English language articles identified 14 studies containing 18 comparisons between functional family therapy (FFT) and another condition in the treatment of adolescent disruptive behavior and substance use disorders. In 11 of these comparisons, assignment to conditions was random, while nonrandom assignment occurred in seven studies. For both random and nonrandom comparisons, separate meta-analyses were conducted for subgroups of studies depending on the type of comparison group used. Data from studies of untreated control groups (CTL), treatment as usual (TAU), and well-defined alternative treatments (ALTs) were analyzed separately. Effect sizes from these six meta-analyses were as follows: random assignment FFT versus CTL (k=3, d=0.48, p<.01); random assignment FFT versus TAU (k=3, d=.20, ns); random assignment FFT versus ALT (k=5, d=.35, p<.05); nonrandom assignment FFT versus CTL (k=2, d=.90, ns); nonrandom assignment FFT versus TAU (k=2, d=.08, ns); and nonrandom assignment FFT versus ALT (k=3, d=.75, p<.001). These results provide support for the effectiveness of FFT compared with untreated controls and well-defined ALTs, such as cognitive behavior therapy, other models of family therapy, and individual and group therapy for adolescents.

Eliminating composite bias in treatment effects estimates: Applications to quality of life assessment

Researchers are often interested in composite measures such as overall ratings, indices of physical or mental health, or health-related quality-of-life (HRQoL) outcomes. Such measures are typically composed of two or more underlying discrete variables. In this paper, I investigate conditions where the estimated treatment effect based solely on the composite outcome is biased under non-random treatment assignment, which I refer to as composite bias. I then compare the magnitude of this bias across a variety of estimators, including ordinary least squares, propensity score estimators, and an alternative two-stage approach that first estimates treatment effects on the underlying outcomes and then combines these effects into an overall effect on the composite outcome of interest. The results highlight the presence of composite bias, identify general conditions under which such bias exists, and offer guidance as to how best to minimize this bias in practice.

Oncological outcomes of minimally invasive partial versus minimally invasive radical nephrectomy for cT1-2/N0/M0 clear cell renal cell carcinoma: a propensity score-matched analysis.

To compare the oncologic outcomes of partial nephrectomy (PN) and radical nephrectomy (RN) for cT1-2/N0 renal tumors and pathologically confirmed pT1-pT3a-pNx clear cell (cc)-renal cell carcinoma (RCC). Few studies compared the oncologic outcomes of PN and RN for renal tumors >7cm. A prospective "renal cancer" database was queried for cT<3-cN0-cM0 and pT1a-pT3a-pNx cc-RCC. Out of 1650 cases treated between 2001 and 2013, 921 were cc-RCC and 666 met inclusion criteria, 232 of which treated with minimally invasive RN and 434 with MIPN. A 1:1 propensity score-matched (PSM) analysis was employed to minimize the selection bias of non-random assignment of patients to PN as opposed to RN. Kaplan-Meier method was used to compare the oncologic outcomes of the PSM cohorts. Survival rates were computed at 2, 5, and 10years after surgery, and the log-rank test was applied to assess statistical significance between the two PSM groups. RN tumors were significantly larger (p<0.001), with higher pT stages (p<0.001), higher Fuhrman grades (p=0.002) and a more frequent sarcomatoid differentiation (p=0.04). After applying the PSM analysis, the two cohorts of 155 RN and 155 PN cases did not differ for all clinical and pathologic covariates (all p≥0.32). PN and RN cohorts displayed comparable 5-year metastasis-free survival (88.9 vs 89.9%, p=0.811), local recurrence-free survival (94.2 vs 95.9%, p=0.283), overall survival (94.5 vs 96.8%, p=0.419) and cancer-specific survival (96 vs 98.6%, p=0.907) rates. PN and RN for patients with cc-RCC larger than 7cm provided equivalent oncologic outcomes. Safety and reproducibility of our findings should be further investigated in larger multicentric cohorts.

Proposal for an Enhanced Physical Education Program in the Primary School: Evaluation of Feasibility and Effectiveness in Improving Physical Skills and Fitness.

A large proportion of children do not reach the recommended levels of physical activity for health. A quasiexperimental study with nonrandom assignment was performed to evaluate the effectiveness and feasibility of a school-based physical education intervention aimed at increasing the levels of moderate-to-vigorous physical activity (MVPA). Ten classes from 4 primary schools, including 241 children aged 8 to 10 years, were recruited. The experimental group (n = 97) received 4 additional sessions/week of 60 minutes of MVPA for 8 months. The control group (n = 135) continued their standard program (2 sessions of 50 minutes/week). Motor abilities (standing long jump, handgrip strength, Harre circuit, sit and reach), physical fitness (Yo-Yo Intermittent Recovery Level-1), anthropometric measures (body mass index, waist to height ratio), and self-efficacy (Perceived Physical Ability Scale for Children) were evaluated at baseline and after the intervention. The experimental group significantly improved in the Harre circuit both in males (P < .001) and females (P < .01), whereas physical fitness test improved only in males (P < .001). Males in the experimental group improved the perception of self-efficacy in coordinative abilities (P = .017). The proposed school-based MVPA program showed effectiveness and feasibility. The differences observed by gender highlight the need to use different strategies to increase the involvement of all the participants.

Teacher Characteristics and Productivity: Quasi-Experimental Evidence from Teacher Mobility

Many studies have attempted to estimate the relationship between teacher characteristics and teacher productivity. Much of this work is potentially confounded by nonrandom assignment of students to teachers. To the extent that students with higher unobserved ability are assigned to teachers with attractive characteristics, many prior estimates will tend to overstate the true relationship between these characteristics and teacher productivity. This work reexamines this question using a quasi-experimental design that exploits teacher mobility across school-grade-year-subject cells. Assuming teacher mobility across cells within a given school is not related to changes in aggregate student characteristics in those cells, this approach is robust to nonrandom teacher-student sorting. Using this quasi-experimental approach, this work finds that teacher productivity is positively related to experience and certification exam scores. Whether a teacher holds an advanced degree is not indicative of productivity. Unlike many related studies, this work finds that teacher experience matters well beyond the first few years.

Aiding Victims, Abetting Violence: The Influence of Humanitarian Aid on Violence Patterns During Civil Conflict

Annual allocations of bilateral and multilateral humanitarian assistance to conflict-affected states total billions of dollars each year. Humanitarian assistance plays a vital role in sustaining vulnerable populations. However, inflows of such aid may also exacerbate violence by both threatening insurgents and creating incentives for these groups to extend or deepen control over the areas in which aid is concentrated. Insurgent efforts to ameliorate threats and co-opt resources ultimately raise the risk of conflict between insurgent and counterinsurgent forces. We use recently constructed geo-located data on both aid commitments and conflict events in a sample of twenty sub-Saharan African countries during the post–Cold War era to evaluate the impact of aid on violence. Even after accounting for the non-random assignment of aid within conflict zones, we find that humanitarian aid increases the frequency of subsequent violent engagements between rebel and government forces in the areas in which aid is concentrated. Importantly, however, we find no evidence that other forms of foreign development aid exacerbate or prolong violence in the areas in which they are allocated.

Acute Rejection Rates and Graft Outcomes According to Induction Regimen among Recipients of Kidneys from Deceased Donors Treated with Tacrolimus and Mycophenolate.

IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent for induction therapy in renal transplantation. However, this remains controversial in deceased donor renal transplantation (DDRT) maintained on tacrolimus (TAC)/mycophenolic acid (MPA) with or without steroids. We studied the United Network for Organ Sharing Registry for patients receiving DDRT from 2000 to 2012 maintained on TAC/MPA at transplantation hospital discharge (n=74,627) to compare outcomes of IL2-RA and other induction agents. We initially divided the cohort into two groups on the basis of steroid use at the time of discharge: steroid (n=59,010) versus no steroid (n=15,617). Each group was stratified into induction categories: IL2-RA, rabbit antithymocyte globulin (r-ATG), alemtuzumab, and no induction. The main outcomes were incidence of acute rejection within the first year and overall graft failure (defined as graft failure and/or death) post-transplantation. Propensity score (PS), specifically inverse probability of treatment weight, analysis was used to minimize selection bias caused by nonrandom assignment of induction therapies. Median (25th, 75th percentiles) follow-up times were 3.9 (1.1, 5.9) and 3.2 (1.1, 4.9) years for steroid and no steroid groups, respectively. Acute rejection within the first year and overall graft failure within 5 years of transplantation were more common in the no induction category (13.3%; P<0.001 and 28%; P=0.01, respectively) in the steroid group and the IL2-RA category (11.1%; P=0.16 and 27.4%; P<0.001, respectively) in the no steroid group. Compared with IL2-RA, PS-weighted and covariate-adjusted multivariable logistic and Cox analyses showed that outcomes in the steroid group were similar among induction categories, except that acute rejection was significantly lower with r-ATG (odds ratio [OR], 0.68; 95% confidence interval [95% CI], 0.62 to 0.74). In the no steroid group, compared with IL2-RA, odds of acute rejection with r-ATG (OR, 0.80; 95% CI, 0.60 to 1.00) and alemtuzumab (OR, 0.68; 95% CI, 0.53 to 0.88) were lower, and r-ATG was associated with better graft survival (hazard ratio, 0.86; 95% CI, 0.75 to 0.99). In DDRT, compared with IL2-RA induction, no induction was associated with similar outcomes when TAC/MPA/steroids were used. r-ATG seems to offer better graft survival over IL2-RA in steroid avoidance protocols.

The bank lending channel of unconventional monetary policy: The impact of the VLTROs on credit supply in Spain

We assess the impact on the credit supply to non-financial corporations of the two very long term refinancing operations (VLTROs) conducted by the Eurosystem in December 2011 and February 2012 for the case of Spain. To do so we use bank–firm level information from a sample of more than one million lending relationships during two years. Our methodology tackles three main identification challenges: (i) how to disentangle credit supply from demand; (ii) the non-random assignment of firms to banks; (iii) the endogeneity of the VLTRO bids, as banks with more deteriorated funding conditions were more likely both to ask for a large amount of funds and to restrain credit supply. Our findings suggest that the VLTROs had a positive moderate-sized effect on the supply of bank credit to firms. We also find that the effect was greater for illiquid banks and that it was driven by credit to SMEs, as there was no impact on loans to large firms. By contrast, strong firm–bank relationships were less sensitive to the positive liquidity shock caused by the VLTROs, which is consistent with the studies that find that relationship lending is a more stable source of credit than transaction lending. Finally, the VLTROs had no impact on either the degree of loan collateralisation or the probability of making loans to new borrowers, while they decreased the probability of renewing old ones, which suggests that those funds were not used for loan “evergreening”.

Are Advocates General Political? Policy Preferences of EU Member State Governments and the Voting Behavior of Members of the European Court of Justice

This paper investigates whether members of the European Court of Justice (ECJ), as is often assumed, behave in accordance with legalistic models of judge behavior. So far, different from courts in the U.S. And elsewhere, there is no conclusive evidence that the background of individual judges influence the decision-making of the Court. There are two possible explanations for this. First, it seems possible that the unique institutional culture at the Court has created an environment which minimizes the influence of such factors. Second, it seems possible that these effects exist, but that they have so far gone largely unnoticed, because the non-disclosure of individual votes and non-random case assignment pose great challenges to any attempt to identify them. This paper focuses on the impact of the political preferences of Member State governments on the decision-making of the Advocates General, who are judge-like members of the ECJ. I develop a formal test to answer whether a relationship exists between the policy preferences of EU Member State governments with regard to European integration, and the decision behavior of Advocates General appointed by these governments. This test formalizes the intuition that, if one Advocate General shows a high probability of deviating from a certain chamber in an integration-friendly direction, while another Advocate General shows a high probability of deviating in an integration-critical direction from decisions by the same chamber, one can infer that the decision standard applied by the first Advocate General is more integration-friendly than that of the second Advocate General. I find that Advocates General appointed by governments with prointegration preferences are on average more likely to deviate from the Court in a pro-integration direction.