Real Outcomes Research Articles

Hearts and Minds: Real-Life Cardiotoxicity With Clozapine in Psychosis.

Schizophrenia has a 1% prevalence in the population; 30% of these patients are treatment refractory. Clozapine is the only drug licensed to treat treatment refractory psychosis, but concerns about potential adverse effects result in only a proportion of eligible patients being treated. Although a well-documented neutropenia risk is mitigated by routine blood testing, cardiac toxicity is a commonly cited reason to discontinue clozapine treatment. However, there is little data on the real-life cardiac outcomes in those receiving clozapine treatment. Retrospective review of electrocardiogram, echocardiogram, and clinical outcomes in 39 inpatients with treatment-refractory schizophrenia, treated with clozapine and other antipsychotic medication, referred for cardiology opinion. Commonest reasons for referral were development of left ventricular (LV) impairment or sinus tachycardia with normal LV function. Patients were reviewed by a range of cardiologists, receiving varied interventions.Median LV ejection fraction in the clozapine group was normal (52%). Serial echocardiograms demonstrated that clozapine-treated patients with LV impairment had no change in LV ejection fraction over a 4-month follow-up. Left ventricular ejection fraction did not differ between patients treated with clozapine and other antipsychotics. However, over an 11-year follow-up period, 48% of patients had discontinued clozapine treatment. This naturalistic study demonstrates that clozapine is not associated with significant cardiac mortality or morbidity. There is a real need for multidisciplinary working between specialist cardiologists and psychiatrists caring for these complex patients to facilitate optimal long-term physical and mental health outcomes.

Agency Beliefs Over Time and Across Cultures: Free Will Beliefs Predict Higher Job Satisfaction.

In three studies, we examined the relationship between free will beliefs and job satisfaction over time and across cultures. Study 1 examined 252 Taiwanese real-estate agents over a 3-months period. Study 2 examined job satisfaction for 137 American workers on an online labor market over a 6-months period. Study 3 extended to a large sample of 14,062 employees from 16 countries and examined country-level moderators. We found a consistent positive relationship between the belief in free will and job satisfaction. The relationship was above and beyond other agency constructs (Study 2), mediated by perceived autonomy (Studies 2-3), and stronger in countries with a higher national endorsement of the belief in free will (Study 3). We conclude that free-will beliefs predict outcomes over time and across cultures beyond other agency constructs. We call for more cross-cultural and longitudinal studies examining free-will beliefs as predictors of real-life outcomes.

Real-life management and outcome of thyroid carcinoma-related bone metastases: results from a nationwide multicenter experience.

The M.O.S.CA.TI. (Metastases of the Skeleton from CArcinoma of the ThyroId) is a multicenter, retrospective study investigating the real-life outcome and management of bone metastases (BM) in 143 patients (63 M, 80 F; median age 64 years, range 11-87) with differentiated thyroid carcinoma (DTC). Radio-active iodine (RAI) treatment was performed in 131 patients (91.6%), surgical approach and/or external radiotherapy in 68 patients (47.6%), and anti-resorptive bone-active drugs in 32 patients (22.4%; in 31 zoledronate and in one denosumab). At the start of treatment, 24 patients (75.0%) receiving anti-resorptive bone-active drugs had at least one clinical skeletal-related event (SRE) (p < 0.001). One or more clinical SREs (pathological fractures and/or malignant hypercalcemia and/or spinal cord compression) developed in 53 patients (37.1%). Development of SREs was significantly associated with metachronous BM (hazard ratio (HR) 2.04; p = 0.04), localization of BM to cervical spine (HR 3.89; p = 0.01), and lack of avid RAI uptake (HR 2.66; p = 0.02). Thirty-nine patients (27.3%) died in correlation with development of SREs (HR 6.97; p = 0.006) and localization of BM to the hip (HR 3.86; p = 0.02). Moreover, overall mortality was significantly decreased by RAI therapy (HR 0.10; p = 0.02), whereas no significant effects were induced by bone-active drugs (p = 0.36), external radiotherapy (p = 0.54), and surgery (p = 0.43) of BM. SREs are very frequent in BM from DTC and they impact patient survival. In the real life, the use of bone-active drugs is currently limited to zoledronate in patients with pre-existing SREs. In this clinical setting, RAI therapy, but not zoledronate, decreased mortality.

41 - To dust or to fragment? Real-life ureteroscopic outcomes for the treatment of ureteral and renal stones

41 - To dust or to fragment? Real-life ureteroscopic outcomes for the treatment of ureteral and renal stones

Burden of Arthritic Manifestations on Psoriatic Patients - Sub-Analysis of Pessoa, A Patient Reported Outcomes Study In Portugal

Psoriasis (PsO) and psoriatic arthritis (PsA) is a chronic inflammatory disorder, presenting several types of manifestations with significant impact on quality of life (QoL). This analysis aimed to characterize PsO patients with and without concomitant PsA, and evaluate the disease impact on QoL and resource use. PeSsoA was a cross-sectional study in 564 adult Portuguese patients with PsO. Data was collected through an electronic questionnaire entered directly by patients (Jun-Jul2016). Comparisons were executed between PsA patients (patients with PsO and PsA) and patients with PsO only. 126 patients (22.4%) reported PsA. 63.5% (n=80) were females, mean(SD) age 47.2±12.9 years. Most common type of psoriasis was plaque psoriasis (67.5%). Based on patient reported Body Surface Area, 67.8% had moderate to severe psoriasis. Comparing to other patients, PsA patients presented higher prevalence of depression/ anxiety (37.7% vs 21.9%; p=0.002) and hypertension (30.2% vs 16.6%; p<0.001). The majority of patients were seen by dermatologist in both groups (54.4% in PsA group vs 64.0%) although more patients in PsA group were followed by rheumatologist (23.0% vs 0.8%). Patients with PsA reported higher monthly medication/ heath product cost (56€ vs 36€) and more frequent physician appointments (66% vs 40% with visiting interval < 6 months). EQ-5D-3L results showed that PsA patients had worse scores in anxiety/depression dimension (62.6% were moderately anxious or depressed; 9,3% extremely anxious or depressed) and in pain/discomfort dimension (60,7% had moderate pain or discomfort; 14,9% had extreme pain or discomfort). PsA patients also had a significant worse overall EQ-5D-3L VAS score (59.4 vs 70.6; p<0.001). This sub-analysis reinforces the humanistic burden of PsA in patients with PsO diagnosis. PsA patients had higher prevalence of comorbidities and health resource use. Patients’ perspective should increasingly be integrated in clinical practice to improve disease awareness and obtain more real-life outcomes evaluation.

Aflibercept in macular edema secondary to retinal vein occlusion: A real life study

PurposeTo evaluate the real life outcomes of intravitreal aflibercept (IVAfl) treatment in patients with macular edema (ME) secondary to retinal vein occlusion (RVO) during the first year of treatment. MethodsRetrospective case series. Newly diagnosed or persistent ME patients secondary to RVO who were treated with IVAfl and had a follow-up period of at least 12 months were included. Twenty-two patients (54.8%) received 3 loading month loading doses IVAfl initially, whereas 20 patients (45.2%) did not receive. Then the patients were treated on an as-needed treatment regimen. Primary outcome measures of this study included the change in best corrected visual acuity (BCVA) and central retinal thickness (CRT). Secondary outcome measures were the number of visits and injections. ResultsForty-two eyes of 42 patients were included. Fourteen patients (33.3%) had central RVO, and 28 (66.7%) had branch RVO. Mean BCVA at baseline and month 12 was 0.98±0.58 and 0.82±0.65 LogMAR, respectively (p=0.04). Mean CRT at baseline and month 12 was 511±141 and 304±95 μm, respectively (p<0.0001). Mean number of visits was 5.9±2.1 (range 3–11) and injections was 3.2±1.7 (range 1–8) at month 12. ConclusionIn conclusion, IVAfl treatment seemed to be effective in patients with ME secondary to RVO with respect to visual and anatomical outcomes in real life. In this study the number of visits and injections was lower that randomized controlled trials, but the functional and anatomical outcomes are probably still acceptable.

P65: EARLY AUSTRALIAN EXPERIENCE WITH THE USE OF A 12‐SQ HDM IMMUNOTHERAPY TABLET

Sublingual house dust mite immunotherapy tablets have been recently introduced for use in Australia. We report early real-life outcomes of a specialist access program with the 12-SQ HDM tablet. Ninety patients with perennial rhinoconjunctivitis commenced treatment that was provided free of cost for the first six months under this program. Data were collected regarding medications used at commencement and at follow up, as well as sneezing frequency and 10-point VAS scores for nasal symptoms and global allergy. Sixty-five of 90 patients returned for a follow-up visit, at 3–4 months. Twenty-five had ceased the treatment, at least eight as a result of adverse effects. Sneezing did appear reduced in frequency at the follow-up visit. Forty-one of 62 patients (66%) had an improvement by at least one point in the VAS nasal symptom severity score at first follow up visit. Before commencing immunotherapy, 43/86 (50%) of individuals were taking oral antihistamines whereas only 21/86 (24%) were using nasal corticosteroids; 22/86 (26%) were using no medical therapy at all. By the first review, antihistamine use had reduced. This real-life data of the use of the 12-SQ HDM tablet in specialist practice in Australia reveals a high early drop out rate despite free treatment; many of these were attributed to adverse effects. Compliance is a major challenge for patients on long-term immunotherapy. For clinicians, appropriate patient selection and education is paramount for the success of this form of treatment. The limited use of standard medical therapy at baseline in this patient group was an unexpected finding. In those that continued immunotherapy, there appeared to be an early signal of benefit.

High-risk family colorectal cancer screening service in Ireland: Critical review of clinical outcomes

BackgroundWe present the 15-year experience of a family colorectal cancer screening service in Ireland with emphasis on real life experience and outcomes. MethodsQuestionnaires were used to assess family cancer history and assign patients to risk categories; ‘Moderate Risk’, HNPCC, (suspected) genetic syndrome (non-HNPCC), ‘Low Risk’. Screening was by full colonoscopy. We report neoplastic yield, examining effect of risk category, age, gender, and index colonoscopy findings. ResultsBetween 1998 and 2013, 2242 individuals were referred; 57.3% female, 42.7% male, median age 46 years (range9-85yrs). Median follow up time was 7.9yrs (range 0.5-15.3yrs). Follow up data after exclusion (non-compliance, known CRC) was available in 1496 (66.7%): ‘Moderate risk’ 785 (52.5%), HNPCC 256 (17.1%), (suspected) genetic syndrome (non-HNPCC) 85 (5.7%), ‘Low Risk’ 370 (24.7%). Screening was performed in 1025(68.5%) patients; colonoscopy data available for 993 (96.9%); total 1914 colonoscopies. At index colonoscopy, 178 (18.0%) patients had adenomas; 56 (5.5%) advanced adenoma. During the entire study period, 240 (24.2%) had an adenoma; 69 (7.0%) advanced adenoma. Cancers were diagnosed on screening in 2 patients. Older age and male gender were associated with higher adenoma detection rate; p<0.001, p=0.01, respectively. Risk category did not affect adenoma yield. Adenoma and advanced adenoma detection at index colonoscopy were associated with detection of same at follow up screening; p<0.001. ConclusionMale gender and age (>50) were the core identifiable risk factors for neoplasia at screening colonoscopy in this family screening setting. Our results would support less intensive surveillance in younger patients (<50), particularly where index colonoscopy is normal.

Cognitive Performance in Adults’ Daily Lives: Is There a Lab-Life Gap?

This article addresses the “lab-life gap” in cognitive aging research as an important issue of ecological validity in developmental research. Older adults often function competently in complex everyday situations despite age-related deficits on laboratory-based cognitive tasks. Therefore, to what extent do lab-based cognitive tasks predict real-life outcomes in older adults? Our review shows that although they are similar, measures of everyday cognitive competence predict relevant outcomes beyond basic measures. We provide our perspective on critical questions concerning the relevance of everyday cognitive tests in our ever-changing world, new methods of everyday cognitive assessment, and whether everyday cognition can be improved.

Belgian experience with direct acting antivirals in people who inject drugs

Background and aimHepatitis C viral infection (HCV) has become a curable disease due to the development of direct acting antivirals (DAA). The WHO has set a target to eliminate HCV completely. Therefore, people who inject drugs (PWID) also need to be treated. In this study, we compared the real-life uptake and outcome of DAA treatment for HCV in PWID and non-PWID. MethodsWe performed a nation-wide, retrospective cohort study in 15 hospitals. All patients who were treated with simeprevir-sofosbuvir, daclatasvir-sofosbuvir, or ombitasvir/paritaprevir ritonavir–dasabuvir between December 2013 and November 2015 were included. ResultsThe study population consisted of 579 patients: 115 PWID (19.9%) and 464 non-PWID (80.1%). Of the PWID 18 were active PWID (15.6%), 35 still received opiate substitution therapy (OST) (30.4%) and 62 were former PWID without OST (53.9%). PWID were more infected with genotype 1a and 3 (p=0.001). There were equal rates of side-effects (44.7% vs. 46.6%; p=0.847), similar rates of treatment completion (95.7% vs 98.1%; p=0.244) and SVR (93.0% vs 94.8%; p=0.430) between PWID and non-PWID, respectively. ConclusionPWID, especially active users, are underserved for DAA treatment in real life in Belgium. Reimbursement criteria based on fibrosis stage make it difficult to treat PWID. Treatment adherence is similar in PWID and the general population, even in patients with active abuse. DAA were safe and effective in PWID despite the higher prevalence of difficult-to-treat genotypes. Based on these data more efforts to treat PWID are needed and policy changes are necessary to reach the WHO targets.

Outcomes of concurrent chemoradiotherapy for anal cancer in Brazil.

e15073 Background: The incidence of anal cancer has increased in the last 30 years and concurrent chemoradiotherapy has been the standard treatment for anal cancer for many decades, since it is a curative treatment in most cases. Although, data from real life outcomes in brazilian patients is lacking. Methods: From October 2001 to November 2016, all the pacientes who were treated with concomitant 5-FU and mitomycin or more recently cisplatin plus radiation at Hospital de Clínicas de Porto Alegre, an academic hospital from South Brazil were identified by electronic database. Medical records were reviewed and demographic data, tumor and treatment characteristics were collected. OS and PFS were estimated by Kaplan-Meier curves. Statistical analysis was performed with SPSS 22. Results: Fifty one patients were analysed for this review. Patient characteristics revealed a mean age of 53 ± 9.03 years, 69% female, with predominantly histology being squamous cell carcinoma (90%). 92% (47) received chemoradiotherapy as a definitive treatment. The chemoterapy regimen used was 5-FU and mitomycin in 69% (35) of the patients and 5-FU plus cisplatin was used in 16 patients (31%). The standard chemoterapy regimen was changed because of lack of supply of mitomycin in our country. Approximately 66% of the patients achieved a complete response while 4 patients (7%) had persistent disease after treatment and 7% had disease progression during treatment. On multivariable analysis, the lymph node status and the size of the tumor were independently associated with worst results. The estimated median PFS was 78 months and the median OS was 92 months. Conclusions: To our knowledge, this is the first report of patients from Brazil treated with concurrent chemoradiation for anal canal cancer. Although we have a delay in the diagnosis and many patients present with locally advanced disease, the CR rate and prognosis are consistent with data from previous studies. We need a longer follow-up to confirm these data and also verify if there will be different outcomes because of the change in the chemoterapy regimen.

Real life outcome of advanced melanoma patients who discontinue pembrolizumab (PEMBRO) in the absence of disease progression.

9539 Background: PEMBRO improves survival of patients (pts) with advanced melanoma. Optimal duration of treatment in responding pts hasn’t been established. Methods: 12 European hospitals collected data from 509 pts treated with PEMBRO outside an interventional clinical trial. Outcome was evaluated for pts who discontinued PEMBRO in the absence of progressive disease [PD]. Results: After a median follow up of 56 wks [range 1-135], median PFS was 22 wks [95% CI 18-26] and median OS was 70 wks [95% CI 59-81] for the total population. PEMBRO is ongoing in 66 [13%] pts, 344 [68%] pts stopped PEMBRO because of PD, and 99 [19%] pts discontinued PEMBRO without evidence of PD (of which 65 [13%] pts upon pt/MD decision, 26 [5%] pts due to a PEMBRO-related AE of grade &lt; 4 and 8 [2%] pts due to a grade 5 PEMBRO-unrelated AE). Pts discontinuing PEMBRO without PD had a significant [ P &lt;.005] better ECOG PS, less advanced tumor stage, less frequent brain metastases and more often a normal LDH at baseline. There was no significant difference between pts stopping due to AE or upon pt/MD decision. The median time on treatment for the 65 pts who stopped PEMBRO upon pt/MD decision was 55 wks [range 9-112].Their best objective response rate [BORR] was 80% [31 [48%] CR, 21 [32%] PR, 12 [18%]SD, 1[2%]NE]. After a median follow-up of 26 wks [range 1-75] after the last PEMBRO dose, 3 [5%] pts progressed (after 9, 14 and 15 wks). PEMBRO was reintroduced in 1 patient resulting in a CR. The median time on treatment of the 26 pts who stopped PEMBRO due to an AE in the absence of PD was 27 wks [range 1-103]. Their BORR was 77% [9 [35%] CR, 11 [42%] PR, 5 [19%] SD, 1 [4 %] NE]. After a median follow-up of 50 wks [range 12-109] following the last PEMBRO dose, 9 [35 %] pts progressed. Median time to PD was 26 wks [range 7-108]. PD was not correlated with BOR. PEMBRO was reintroduced in 4 pts resulting in 1 CR, 1 PD, 1 SD and 1 NE. Conclusions: In this real life experience, advanced melanoma pts who discontinue PEMBRO treatment upon pt/MD decision, in the absence of PD or AE, were at low risk for short-term recurrence. Pts stopping PEMBRO due to an AE in the absence of PD (having a shorter exposure to PEMBRO and longer FU after discontinuing treatment) seem to have a higher risk for subsequent PD.

Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population’s health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system’s needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes.

Treatment and pattern of bone metastases in 1094 patients with advanced breast cancer – Results from the prospective German Tumour Registry Breast Cancer cohort study

A high proportion of patients with breast cancer develop bone metastases, yet data on routine treatment with bone-targeted agents (BTA) are rare. We report real-life outcome data of patients with breast cancer metastasised to the bone treated by office-based oncologists in Germany.The ongoing, prospective, multicentre, population-based cohort study Tumour Registry Breast Cancer (TMK) was started in 2007 in 140 centres across Germany.This interim analysis of 1094 patients with bone metastases revealed differences among the tumour subtypes: at start of first-line therapy, 36% of the patients with hormone receptor (HR)-positive and only 20% of the patients with HR-negative tumours presented with bone-only metastasis. The majority of patients with bone metastases (89%, n = 976) received BTA therapy. In 2014–2015, 37% of the patients received the bisphosphonate zoledronic acid and 36% the antibody denosumab. Median duration of BTA therapy was 20 months (interquartile range 31.5 months), starting a median of 3 weeks after diagnosis of bone metastases, and ending a median of 7 weeks before death. The median overall survival (OS) also varied among the types of metastasis at start of first-line therapy ranging from 54 months (95% confidence interval [CI] 37.6–70.8), 38 months (95% CI 29.4–44.2) to 28 months (95% CI 24.2–31.0) for patients with bone-only metastases, non-visceral with or without bone metastases and visceral with or without bone metastases respectively.We show that choice and duration of BTA therapies are in conformity with guidelines applicable in Germany. To our knowledge, this is the first presentation of data on incidence, metastatic pattern, treatment and survival of patients with bone metastases in routine practice.

Self-reported executive functioning competencies and lifetime aggression

ABSTRACTNeuropsychological research can be advanced through a better understanding of relationships between executive functioning (EF) behavioral competencies and the expression of aggressive behavior. While performance-based EF measures have been widely examined, links between self-report indices and practical real-life outcomes have not yet been established. Executive Functioning Index subscale scores in this sample (N = 579) were linked to trait hostility (Buss-Perry Aggression Questionnaire), aggression in the natural environment (Lifetime Acts of Violence Assessment), and conduct disorder symptoms prior to age 15. Significant associations were found between all of the EFI subscales (Motivational Drive, Organization, Strategic Planning, Impulse Control, and Empathy), trait aggression, and conduct disturbance. Lifetime acts of aggression were predicted by all but Organization scores. Physical injuries inflicted on other(s) were 2 to 4 times more likely to occur among respondents generating low (z < −1) EFI subscale scores. While these EFI relationships were modest in size, they are pervasive in scope. These findings provide support for the potential role of perceived EF deficits in moderating lifetime aggression.

Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry).

The prevalence of peripheral artery disease (PAD) is increasing worldwide. Revascularization procedures constitute a cornerstone of the therapy in PAD, not only in critical limb ischaemia but increasingly also in patients with intermittent claudication. The German Society of Angiology - Society for Vascular Medicine is establishing a nationwide, prospective, multicentre registry to address the lack of contemporary real life data regarding current practice of medical and interventional care in vascular patients and its subsequent long-term outcome. The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform. In the initial phase, patients referred for endovascular revascularization of PAD of the lower limbs will be prospectively included and followed up for at least one year. At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed. Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits. The therapeutic management will be exclusively left to the discretion of the vascular specialists. The RECCORD registry will provide a comprehensive dataset depicting the current real life practice and outcome of vascular care. The seven predefined quality indicators will be used for benchmarking the participating centres. Moreover, identifying factors promoting a favourable outcome might pave the way for an evidence-based therapeutic strategy and a dedicated therapeutic pathway for patients with PAD including patient-oriented best interventional approaches. In the future, the RECCORD registry may provide a general platform to study the courses of various defined vascular diseases in order to get detailed insights into the real life current practice of health care provided to vascular patients.

Resilience in the United States Air Force: Psychometric properties of the Connor-Davidson Resilience Scale (CD-RISC).

Results are presented for the largest study (N = 53,692) ever conducted on the 25-item Connor-Davidson Resilience Scale (CD-RISC), a popular measure of resilience. We examined the internal consistency of the CD-RISC items and associated mean resilience levels within a sample of enlisted basic trainees in the United States Air Force. In addition, the predictive validity of the CD-RISC Total Score was examined for real-life military outcomes, including attrition from service and mental health diagnosis. The CD-RISC items demonstrated strong internal consistency. Item-level examinations of scores revealed that most trainees reported relatively high resilience. Results indicated that resilience measured at the beginning of military service is a significant predictor of (a) attrition from service and (b) obtaining a mental health diagnosis within 6 months of entry. Implications and future directions are discussed. (PsycINFO Database Record

Roles beyond Lawyers: Summary, Recommendations and Research Report of an Evaluation of the New York City Court Navigators Program and Its Three Pilot Projects

Roles Beyond Lawyers (RBLs) encompass a range of service models for civil legal assistance that draw upon personnel who have not received full formal legal training. These programs attempt to achieve the goals of increasing access to justice and ensuring consumer protection. The Roles Beyond Lawyers research project explores these models, both as currently implemented and as opportunities to be realized. This report presents the findings of an independent evaluation of the New York City Court Navigators program and its three pilot projects. The three Navigator pilot projects differ in important respects, but all involve the same core capacities: providing to unrepresented litigants the services of information, moral support, and accompaniment to negotiations with the other side’s attorneys and into courtrooms. Navigators are authorized to respond to questions from court attorneys and judges and to prompt litigants to provide additional information. The evaluation uncovered evidence that assistance from appropriately trained and supervised individuals without formal legal training is associated with changes in a range of outcomes, including both legal and real-life outcomes.

Drugs and Driving Research in Medicinal Drug Development

Medicinal drugs that cause drowsiness and inattentiveness may impair driving. The FDA recently emphasized that standardized procedures for measuring drug effects on driving are needed as part of drug registration. Here, I provide an overview of a standardized on-the-road driving test that offers maximal drug sensitivity and uses a real-life outcome measure of driver impairment that is strongly associated with crash risk.

Gaze-contingent reinforcement learning reveals incentive value of social signals in young children and adults.

While numerous studies have demonstrated that infants and adults preferentially orient to social stimuli, it remains unclear as to what drives such preferential orienting. It has been suggested that the learned association between social cues and subsequent reward delivery might shape such social orienting. Using a novel, spontaneous indication of reinforcement learning (with the use of a gaze contingent reward-learning task), we investigated whether children and adults' orienting towards social and non-social visual cues can be elicited by the association between participants' visual attention and a rewarding outcome. Critically, we assessed whether the engaging nature of the social cues influences the process of reinforcement learning. Both children and adults learned to orient more often to the visual cues associated with reward delivery, demonstrating that cue–reward association reinforced visual orienting. More importantly, when the reward-predictive cue was social and engaging, both children and adults learned the cue–reward association faster and more efficiently than when the reward-predictive cue was social but non-engaging. These new findings indicate that social engaging cues have a positive incentive value. This could possibly be because they usually coincide with positive outcomes in real life, which could partly drive the development of social orienting.