Phase 3 randomized COMMODORE 1 trial: Crovalimab versus eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria.

Crovalimab, a novel C5 inhibitor, allows for low-volume, every-4- week, subcutaneous self-administration. COMMODORE 1 (NCT04432584) is a phase 3, global, randomized trial evaluating crovalimab versus eculizumab in C5 inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria (PNH). Adults with lactate dehydrogenase ≤1.5 × upper limit of normal and receiving approved eculizumab doses for ≥24 weeks were randomized 1:1 to receive crovalimab (weight-based tiered dosing) or continue eculizumab. The original primary study objective was efficacy; however, given the evolving treatment landscape, target recruitment was not met, and all efficacy endpoints became exploratory, with safety as the new primary objective. Exploratory efficacy endpoints included transfusion avoidance, hemolysis control, breakthrough hemolysis, hemoglobin stabilization, FACIT-Fatigue score, and patient preference (crovalimab vs. eculizumab). Eighty-nine patients were randomized (45 to crovalimab; 44 to eculizumab). During the 24-week primary treatment period, adverse events (AEs) occurred in 77% of patients receiving crovalimab and 67% receiving eculizumab. No AEs led to treatment withdrawal or death, and no meningococcal infections occurred. 16% of crovalimab-treated patients had transient immune complex reactions (also known as Type III hypersensitivity events), an expected risk when switching between C5 inhibitors that bind to different C5 epitopes; most were mild/moderate and all resolved without treatment modification. Crovalimab-treated patients had sustained terminal complement activity inhibition, maintained disease control, and 85% preferred crovalimab over eculizumab. Together with phase 3 COMMODORE 2 results in complement inhibitor-naive patients, these data support crovalimab's favorable benefit-risk profile. Crovalimab is a new C5 inhibitor for PNH that is potentially less burdensome than existing therapies for this lifelong disease.

Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition.

Crovalimab is a novel C5 complement inhibitor that enables rapid and sustained C5 inhibition with subcutaneous, low-volume self-administration every 4 weeks. COMMODORE 2 (NCT04434092) is a global, randomized, open-label, multicenter, phase 3 trial evaluating the non-inferiority of crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria not previously treated with C5 inhibition. C5 inhibitor-naive patients with lactate dehydrogenase (LDH) ≥2 × upper limit of normal (ULN) were randomized 2:1 to crovalimab or eculizumab. Co-primary efficacy endpoints were proportion of patients with hemolysis control (centrally assessed LDH ≤1.5 × ULN) and proportion with transfusion avoidance. Secondary efficacy endpoints were proportions of patients with breakthrough hemolysis, stabilized hemoglobin, and change in FACIT-Fatigue score. The primary treatment period was 24 weeks. Two hundred and four patients were randomized (135 crovalimab; 69 eculizumab). Crovalimab was non-inferior to eculizumab in the co-primary endpoints of hemolysis control (79.3% vs. 79.0%; odds ratio, 1.0 [95% CI, 0.6, 1.8]) and transfusion avoidance (65.7% vs. 68.1%; weighted difference, -2.8 [-15.7, 11.1]), and in the secondary efficacy endpoints of breakthrough hemolysis (10.4% vs. 14.5%; weighted difference, -3.9 [-14.8, 5.3]) and hemoglobin stabilization (63.4% vs. 60.9%; weighted difference, 2.2 [-11.4, 16.3]). A clinically meaningful improvement in FACIT-Fatigue score occurred in both arms. Complete terminal complement activity inhibition was generally maintained with crovalimab. The safety profiles of crovalimab and eculizumab were similar with no meningococcal infections. Most patients who switched from eculizumab to crovalimab after the primary treatment period preferred crovalimab. These data demonstrate the positive benefit-risk profile of crovalimab.

Patient Experience Survey of Anti-Vascular Endothelial Growth Factor Treatment for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

INTRODUCTION: Understanding patient perspectives of treatment may improve adherence and outcomes. This study explored real-world patient experiences with anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). METHODS: This multinational, non-interventional, quantitative, cross-sectional, observational survey assessed treatment barriers/burden, patient-reported visual functioning, and treatment satisfaction in DME and nAMD patients in the USA, the UK, Canada, France, Italy, and Spain. Treatment patterns and visual outcomes were extracted from medical charts. Regression models evaluated relationships between adherence, total missed visits, number of anti-VEGF injections, and clinical and patient-reported outcomes for visual functioning. Association between treatment satisfaction and aspects of burden were assessed. RESULTS: The survey was completed by 183 DME and 391 nAMD patients. Patients had moderately high vision-related functioning (25-item National Eye Institute Visual Functioning Questionnaire score: mean = 74.8) and were satisfied with their current treatment (mean total score: Macular Disease Treatment Satisfaction Questionnaire = 59.2; Retinopathy Treatment Satisfaction Questionnaire = 61.3). Treatment satisfaction scores were worse with higher time-related impacts of treatment (nAMD/DME), higher impacts on finances and daily life (nAMD), negative impacts on employment and lower expectations for treatment effectiveness (DME). Most patients reported ≥1 barrier (66.1% DME, 49.2% nAMD patients) related to treatment (35.0%), clinic (32.6%), and COVID-19 (21.1%). Moreover, 44.9% of patients reported some impairment in activities of daily living. Work absenteeism was observed among >60% of working patients. Nearly one-quarter (24.2%) of patients needed ≥1 day to recover from intravitreal injections; most reported ≥30 min of travel time (73.7%) and clinic wait time (54.2%). In unadjusted univariable analyses, treatment adherence (vs. nonadherence) was related to higher most recent visual acuity (ß = 8.98 letters; CI, 1.34-16.62) and lower odds of visual acuity below driving vision (≤69 letters) (OR = 0.50; CI, 0.25-1.00). CONCLUSION: More durable treatments with reduced frequency of injections/visits may reduce treatment burden and improve patient satisfaction, which may enhance adherence and visual outcomes.

The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria.

Complement C5 inhibition is the standard of care (SoC) for patients with paroxysmal nocturnal hemoglobinuria (PNH) with significant clinical symptoms. Constant and complete suppression of the terminal complement pathway and the high serum concentration of C5 pose challenges to drug development that result in IV-only treatment options. Crovalimab, a sequential monoclonal antibody recycling technology antibody was engineered for extended self-administered subcutaneous dosing of small volumes in diseases amenable for C5 inhibition. A 3-part open-label adaptive phase 1/2 trial was conducted to assess safety, pharmacokinetics, pharmacodynamics, and exploratory efficacy in healthy volunteers (part 1), as well as in complement blockade-naive (part 2) and C5 inhibitor-treated (part 3) PNH patients. Twenty-nine patients were included in part 2 (n = 10) and part 3 (n = 19). Crovalimab concentrations exceeded the prespecified 100-µg/mL level and resulted in complete and sustained terminal complement pathway inhibition in treatment-naive and C5 inhibitor-pretreated PNH patients. Hemolytic activity and free C5 levels were suppressed below clinically relevant thresholds (liposome assay <10 U/mL and <50 ng/mL, respectively). Safety was consistent with the known profile of C5 inhibition. As expected, formation of drug-target-drug complexes was observed in all 19 patients switching to crovalimab, manifesting as transient mild or moderate vasculitic skin reactions in 2 of 19 participants. Both events resolved under continued treatment with crovalimab. Subcutaneous crovalimab (680 mg; 4 mL), administered once every 4 weeks, provides complete and sustained terminal complement pathway inhibition in patients with PNH, warranting further clinical development (ClinicalTrials.gov identifier, NCT03157635).

Health-related quality of life with fixed-duration venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: Results from the randomized, phase 3 CLL14 trial.

Chronic lymphocytic leukemia (CLL)-related symptoms impair the well-being of patients, making improvement of health-related quality of life (QoL) a goal of treatment. The CLL14 trial demonstrated higher efficacy of fixed-duration venetoclax-obinutuzumab (Ven-Obi) compared to chlorambucil-obinutuzumab (Clb-Obi) in patients with previously untreated CLL. To assess patients' QoL, the following patient-reported outcomes (PRO) measures were assessed: the M.D. Anderson Symptom Inventory (MDASI) core instrument and CLL module and the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). At treatment start, physical functioning (mean 75.9 [standard deviation (SD) ± 20.1] in the Clb-Obi arm and 76.9 [±19.4] in the Ven-Obi arm), role functioning (73.6 [±27.86] and 72.6 [±26.9]) and GHS/QoL (63.6 [±21.0] and 60.3 [±20.5]) were comparable between treatment arms per EORTC QLQ-C30 scale scores. Baseline levels of physical and role functioning were maintained throughout treatment and follow-up, with no relevant improvement or deterioration. On average, patients treated with Ven-Obi showed a meaningful improvement of GHS/QoL during treatment and follow-up by at least eight points at cycle three, whereas improvement was delayed until cycle eight with Clb-Obi. According to MDASI scores, CLL symptoms (1.5 [±1.2] and 1.6 [±1.3]), core cancer symptoms (1.5 [±1.4] and 1.8 [±1.7]) and symptom interference (2.1 [±2.3] and 2.3 [±2.3]) were generally low and comparable between treatment arms at baseline and were maintained throughout treatment and follow-up. This analysis demonstrates that the higher efficacy of Ven-Obi is not associated with QoL impairment and that Ven-Obi achieves early relief of CLL-related symptoms in elderly unfit patients.

Evaluation of the Measurement Properties of Four Performance Outcome Measures in Patients with Elective Hip Replacements, Elective Knee Replacements, or Hip Fractures.

OBJECTIVES: To evaluate the measurement properties of four performance outcome (PerfO) measures (timed up and go, four-step stair climb, long stair climb, and repeated chair stand) in three patient populations(elective total hip replacement [eTHR], elective total knee replacement [eTKR], and hip fracture [HF]). METHODS: A cross-sectional and longitudinal design was used to assess the PerfO measurement properties using the US Food and Drug Administration guidance for industry around patient-reported outcome measures to support labeling claims. Patient-reported outcome measures and patient- and clinician-reported global concept items were completed along with four PerfO measures at visit 1 and two follow-up visits. Measurement properties assessed included reliability, construct validity, ability to detect change, and estimates of meaningful change. RESULTS: A total of 280 patients (100 eTHR, 105 eTKR, and 75 HF) were recruited, with most (n = 276) providing data at visit 1. Most of the patients were female (64%) and retired (64%), and had at least one comorbidity (91%). Inter-rater and test-retest reliability ranged from good to excellent (0.73 ≤ intraclass correlation coefficient ≤ 0.95) for each PerfO measure. Known-groups validity was demonstrated for all PerfO measures, with those reporting less pain better physical functioning and those who did not use an assistive device having quicker mean completion times. Construct validity and ability to detect change were demonstrated and estimates of meaningful change derived. CONCLUSIONS: This study found the measurement properties of four PerfO measures in samples of patients with eTHR, eTKR, and HF to be supported for consideration of future use, and provided estimates for interpretation of change.

A Comparison of the Nomological Networks Associated With Forced-Choice and Likert Formats of the Narcissistic Personality Inventory.

The Narcissistic Personality Inventory (NPI) is one of the most popular measures of narcissism. However, its use of a forced-choice response set might negatively affect some of its psychometric properties. The purpose of this research was to compare a Likert version of the NPI, in which only the narcissistic response of each pair was given, to the original NPI, in 3 samples of participants (N = 1,109). To this end, we compared the nomological networks of the forced-choice and Likert formats of the NPI in relation to alternative measures of narcissism, narcissistic personality disorder, entitlement, self-esteem, general personality traits (reported by self and informants), interpersonal styles, and general pathological traits included in the DSM-5. The Likert format NPI-total and subscales-manifested similar construct validity to the original forced-choice format across all criteria with only minor differences that seem to be due mainly to the increased reliability and variability found in the Likert NPI Entitlement/Exploitativeness subscale. These results provide evidence that a version of the NPI that employs a Likert format can justifiably be used in place of the original.

Gender Role Discrepancy Stress, High-Risk Sexual Behavior, and Sexually Transmitted Disease.

Nearly 20 million new sexually transmitted infections occur every year in the United States. Traditionally, men have demonstrated much greater risk for contraction of and mortality from STDs perhaps because they tend to engage in a number of risky sexual activities. Research on masculinity suggests that gender roles influence males' sexual health by encouraging risk-taking behavior, discouraging access to health services, and narrowly defining their roles as partners. However, despite the propensity of highly masculine men to engage in high-risk sexual behavior, there is reason to suspect that men at the other end of the continuum may still be driven to engage in similar high-risk behaviors as a consequence of gender socialization. Discrepancy stress is a form of gender role stress that occurs when men fail to live up to the ideal manhood derived from societal prescriptions (i.e., Gender Role Discrepancy). In the present study, we surveyed a national sample of 600 men via Amazon Mechanical Turk to assess perceived gender role discrepancy, experience of discrepancy stress, and the associations with risky sexual behavior and potential contraction of STDs. Results indicated that men who believe they are less masculine than the typical man (i.e., gender role discrepancy) and experience distress stemming from this discrepancy (i.e., discrepancy stress) engage in high-risk sexual behavior and are subsequently diagnosed with more STDs. Findings are discussed in relation to implications for primary prevention strategies.

Masculine discrepancy stress, substance use, assault and injury in a survey of US men.

To understand and ultimately prevent injury and behavioural health outcomes associated with masculinity, we assessed the influence of masculine discrepancy stress (stress that occurs when men perceive themselves as falling short of the traditional gender norms) on the propensity to engage in stereotypically masculine behaviours (eg, substance use, risk taking and violence) as a means of demonstrating masculinity. Six-hundred men from the USA were recruited via Amazon's Mechanical Turk (MTurk) online data collection site to complete surveys assessing self-perceptions of gender role discrepancy and consequent discrepancy stress, substance use/abuse, driving while intoxicated (DWI) and violent assaults. Negative binomial regression analyses indicated significant interactive effects wherein men high on gender role discrepancy and attendant discrepancy stress reported significantly more assaults with a weapon (B=1.01; SE=0.63; IRR=2.74; p=0.05) and assaults causing injury (B=1.01; SE=0.51; IRR=2.74; p<0.05). There was no association of discrepancy stress to substance abuse, but there was a protective effect of gender role discrepancy for DWI among men low on discrepancy stress (B=-1.19, SE=0.48; IRR=0.30; p=0.01). These findings suggest that gender role discrepancy and associated discrepancy stress, in particular, represent important injury risk factors and that prevention of discrepancy stress may prevent acts of violence with the greatest consequences and costs to the victim, offender and society.

Man enough? Masculine discrepancy stress and intimate partner violence.

Research on gender roles suggests that men who strongly adhere to traditional masculine gender norms are at increased risk for the perpetration of violent and abusive acts toward their female intimate partners. Yet, gender norms alone fail to provide a comprehensive explanation of the multifaceted construct of intimate partner violence (IPV) and there is theoretical reason to suspect that men who fail to conform to masculine roles may equally be at risk for IPV. In the present study, we assessed effect of masculine discrepancy stress, a form of distress arising from perceived failure to conform to socially-prescribed masculine gender role norms, on IPV. Six-hundred men completed online surveys assessing their experience of discrepancy stress, masculine gender role norms, and history of IPV. Results indicated that masculine discrepancy stress significantly predicted men's historical perpetration of IPV independent of other masculinity related variables. Findings are discussed in terms of potential distress engendered by masculine socialization as well as putative implications of gender role discrepancy stress for understanding and intervening in partner violence perpetrated by men.

A test of the construct validity of the Five-Factor Narcissism Inventory.

The Five-Factor Narcissism Inventory (FFNI) is a new self-report measure that was developed to assess traits associated with grandiose and vulnerable narcissism from a Five-factor model (FFM) perspective. In a sample of undergraduates (N = 283), the relations among the FFNI scales, grandiose and vulnerable dimensions, and an array of relevant criteria were examined including self- and informant reports of the Big Five domains, measures of the Dark Triad, ratings of the interpersonal circumplex, externalizing and internalizing behaviors and symptoms, and romantic and attachment styles. The FFNI grandiose and vulnerable dimensions demonstrated good convergent and criterion validity. The FFNI grandiose and vulnerable dimensions manifested converging (e.g., disagreeableness, low love/communion, psychopathy, Machiavellianism, Ludus/Manic love styles) and diverging (e.g., neuroticism, extraversion, dominance, externalizing, internalizing, attachment anxiety) relations in a manner largely consistent with predictions. The FFNI joins the Pathological Narcissism Inventory as a measure that can simultaneously assess both grandiose and vulnerable dimensions of narcissism.

Grandiose and vulnerable narcissism and the DSM-5 pathological personality trait model.

The Diagnostic and Statistical Manual of Personality Disorders (4th ed., American Psychiatric Association, 2000) personality disorders (PDs) that will be included in the DSM-5 will be diagnosed in an entirely different manner; the explicit criterion sets will be replaced with impairments in self and interpersonal functioning and personality traits from a 25-trait dimensional model of personality pathology. From a trait perspective, narcissistic personality disorder (NPD), the focus of this study, is assessed using 2 specific traits: grandiosity and attention seeking. Using a sample collected online from Amazon's Mechanical Turk (MTurk; N=306), we examined the relations among traits from a new measure of DSM-5's trait model--the Personality Inventory for DSM-5 (PID5; Krueger, Derringer, Markon, Watson, & Skodol, in press)--and grandiose and vulnerable narcissism. The 25 traits from PID5 captured a significant portion of the variance in grandiose and vulnerable factors, although the 2 specific facets designated for the assessment of NPD fared substantially better in the assessment of grandiose rather than vulnerable narcissism. These results are discussed in the context of improving the DSM-5's ability to capture both narcissism dimensions.

Drivers of and Barriers to Adherence to Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema Treatment Management Plans: A Multi-National Qualitative Study.

Purpose: Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) patients treated with intravitreally injected anti-vascular endothelial growth factor (anti-VEGF) monotherapies achieve lower vision improvements compared with patients in clinical trials. This qualitative research study aimed to better understand the real-world anti-VEGF treatment experience from nAMD and DME patients', caregivers', and retina specialists' perspectives. Methods: One-time, semi-structured, individual interviews were conducted with adult patients with nAMD or DME treated with anti-VEGF injections for ≥12 months, their caregivers, and experienced retina specialists. Interview transcripts were analyzed qualitatively using a thematic analysis approach. Results: A total of 49 nAMD and 46 DME patients, 47 nAMD and 33 DME caregivers, and 62 retina specialists were interviewed in the USA, Canada, France, Germany, Italy and Spain. Most (79%) patients and caregivers reported disruptions to their routine on the day before, the day of, or the day after anti-VEGF injection. Seven nAMD patients (14%) and 14 DME patients (30%) reported having missed an injection visit. The most frequently reported driver for adherence for patients was the doctor-patient relationship (n=66, 70%), whereas for caregivers, it was the ease of booking an appointment (n=25, 32%). Retina specialists reported patient education on the treatment (n=28, 45%) as the most important driver. Treatment barriers could be grouped into four categories: tolerability, clinical factors, logistical parameters and human factors. The most frequently reported barrier to adherence for patients and caregivers was related to side effects (pain/discomfort/irritation: n=63, 67% of patients; n=52, 66% of caregivers), whereas for retina specialists it was logistical parameters (travel logistics: n=44, 71%). Conclusion: This study highlights the importance of the doctor-patient relationship and patient education as key drivers, and treatment tolerability and logistics as key barriers to treatment adherence. Improved doctor-patient relationship/communication and patient education together with new therapies offering convenience, long-acting effectiveness, and better tolerability may improve treatment adherence.

Grandiose and vulnerable narcissism: a nomological network analysis.

Evidence has accrued to suggest that there are 2 distinct dimensions of narcissism, which are often labeled grandiose and vulnerable narcissism. Although individuals high on either of these dimensions interact with others in an antagonistic manner, they differ on other central constructs (e.g., Neuroticism, Extraversion). In the current study, we conducted an exploratory factor analysis of 3 prominent self-report measures of narcissism (N=858) to examine the convergent and discriminant validity of the resultant factors. A 2-factor structure was found, which supported the notion that these scales include content consistent with 2 relatively distinct constructs: grandiose and vulnerable narcissism. We then compared the similarity of the nomological networks of these dimensions in relation to indices of personality, interpersonal behavior, and psychopathology in a sample of undergraduates (n=238). Overall, the nomological networks of vulnerable and grandiose narcissism were unrelated. The current results support the need for a more explicit parsing of the narcissism construct at the level of conceptualization and assessment.

Searching for a vulnerable dark triad: comparing Factor 2 psychopathy, vulnerable narcissism, and borderline personality disorder.

Paulhus and Williams (2002) identified a "Dark Triad" comprising the following related personality styles: narcissism, psychopathy, and Machiavellianism. The heterogeneity found in narcissism and psychopathy raises the possibility of a second triad made up of emotional vulnerability and dark traits (i.e., the vulnerable dark triad; VDT). Along with vulnerable narcissism and Factor 2 psychopathy, the third member of the hypothesized VDT is borderline personality disorder (BPD). Using a sample of 361 undergraduates, we examine the relations between these constructs and their relations with criterion variables, including personality, environmental etiological factors (e.g., abuse), and current functioning (e.g., psychopathology, affect). The results suggest that the VDT constructs are significantly related to one another and manifest similar nomological networks, particularly vulnerable narcissism and BPD. Although the VDT members are related to negative emotionality and antagonistic interpersonal styles, they are also related to introversion and disinhibition. Ultimately, it seems there is a "dark continuum" of pathological personality traits that differ primarily in relation to negative and positive emotionality and disinhibition.

Validity and reliability of the Colorado Adult Joint Assessment Scale in adults with moderate-severe hemophilia A.

BACKGROUND: The Colorado Adult Joint Assessment Scale (CAJAS) is designed to assess joint health in adults with hemophilia. The CAJAS comprises nine items (swelling, muscle atrophy, axial deformity, crepitus, range of motion, contracture, instability, strength, gait) and assesses six joints. OBJECTIVE: To assess CAJAS content validity and psychometric properties. PATIENTS/METHODS: Data were obtained from the Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment (SPINART) study and a separate CAJAS validation study. CAJAS assessments in SPINART were performed by physical therapists (PTs) from the United States, Romania, Bulgaria, and Argentina. In the validation study, content validity was assessed from interviews with six PTs at three US hemophilia centers; cultural equivalence was assessed with seven non-US PTs from SPINART. Reliability data were collected from 30 subjects at four US centers. Test-retest reliability was evaluated by having the same PT perform CAJAS examinations at two visits, 7-10 days apart. Inter-rater reliability was assessed by comparing CAJAS scores of two different PTs performing separate examinations of the same patient several hours apart at the same visit. Psychometric properties were assessed using SPINART and validation study data. RESULTS: The CAJAS demonstrated good content validity. Test-retest reliability was high (intraclass correlation coefficient, 0.98), as was inter-rater reliability (intraclass correlation coefficient, 0.88). Internal consistency reliability was strong (α = .90). The CAJAS demonstrated good convergent/divergent validity, known-groups validity, and ability to detect change. CONCLUSIONS: The CAJAS is a valid and reliable measure of joint health in adults with moderate-severe hemophilia and is appropriate for use in clinical practice.

How Oncologists Perceive the Availability and Quality of Information Generated From Patient-Reported Outcomes (PROs).

BACKGROUND: Despite increased incorporation of patient-reported outcome (PRO) measures into clinical trials, information generated from PROs remains largely absent from drug labeling and electronic health records, giving rise to concerns that such information is not adequately informing clinical practice. OBJECTIVE: To evaluate oncologists' perceptions concerning the availability and quality of information generated from PRO measures. Additionally, to identify whether an association exists between perceptions of availability and attitudes concerning quality. METHOD: An online, 11-item questionnaire was developed to capture clinician perspectives on the availability and use of PRO data to inform practice. The survey also asked respondents to rate information on the basis of 4 quality metrics: "usefulness," "interpretability," "accessibility," and "scientific rigor." RESULTS: Responses were received from 298 of 1301 invitations sent (22.9% response rate). Perceptions regarding the availability of PRO information differed widely among respondents and did not appear to be linked to practice setting. Ratings of PRO quality were generally consistent, with average ratings for the 4 quality metrics between "satisfactory" and "good." A relationship was observed between ratings of PRO data quality and perceptions of the availability. CONCLUSION: Oncologists' attitudes toward the quality of information generated from PRO measures are favorable but not enthusiastic. These attitudes may improve as the availability of PRO data increases, given the association we observed between oncologists' ratings of the quality of PRO information and their perceptions of its availability.

Masculine Discrepancy Stress, Emotion-Regulation Difficulties, and Intimate Partner Violence.

Research suggests that masculine socialization processes contribute to the perpetration of intimate partner violence (IPV) by men. Although this research has traditionally focused on men who strongly adhere to traditional gender norms, men who negatively evaluate themselves as falling short of these norms (a construct termed masculine discrepancy stress) have proven to be at increased risk of IPV perpetration. Likewise, men experiencing problems with emotion regulation, a multidimensional construct reflecting difficulties in effectively experiencing and responding to emotional states, are also at risk of IPV perpetration. In the present research, we tested the hypothesis that the link between discrepancy stress and IPV perpetration is mediated via difficulties in emotion regulation. Three hundred fifty-seven men completed online surveys assessing their experience of discrepancy stress, emotion-regulation difficulties, and history of IPV perpetration. Results indicated that discrepancy-stressed men's use of physical IPV was fully mediated by emotion-regulation difficulties. In addition, emotion-regulation difficulties partially mediated the association between discrepancy stress and sexual IPV. Findings are discussed in terms of the potential utility of emotion-focused interventions for modifying men's experience and expression of discrepancy stress and reducing perpetration of IPV.

Psychopathy Traits and Violent Assault Among Men With and Without History of Arrest.

Although research suggests that the antisocial behavior (ASB) facet of psychopathy generally carries the greatest predictive power for future violence, these findings are drawn primarily from forensic samples and may reflect criterion contamination between historical violence and future violence perpetration. Likewise, these findings do not negate the association of other psychopathy facets to violence or their role in the development of violence, nor do they offer practical utility in the primary prevention of violence. There are a number of empirical and theoretical reasons to suspect that the callous affect (CA) facet of psychopathy may demonstrate stronger statistical association to violence in nonforensic populations. We tested the association of CA to severe acts of violence (e.g., assault with intent to harm, injure, rape, or kill) among men with and without history of arrest ( N = 600) using both the three- and four-facet models of psychopathy. CA was robustly associated with violence outcomes across the two groups in the three-facet model. When testing the four-facet model, CA was strongly associated with violence outcomes among men with no history of arrest, but only moderately associated with assaults causing injury among men with history of arrest. These results are consistent with data from youth populations that implicate early emotional deficits in later aggressive behavior and suggest CA may help to identify individuals at risk for violence before they become violent. Implications for the public health system and the primary prevention of violence are discussed.

A Psychological Exploration of Engagement in Geek Culture.

Geek culture is a subculture of enthusiasts that is traditionally associated with obscure media (Japanese animation, science fiction, video games, etc.). However, geek culture is becoming increasingly mainstream; for example, in the past year alone, Dragon*Con, a major Geek convention in Atlanta, Georgia, attracted an attendance of over 57,000 members. The present article uses an individual differences approach to examine three theoretical accounts of geek culture. Seven studies (N = 2354) develop the Geek Culture Engagement Scale (GCES) to quantify geek engagement and assess its relationships to theoretically relevant personality and individual differences variables. These studies present evidence that individuals may engage in geek culture in order to maintain narcissistic self-views (the great fantasy migration hypothesis), to fulfill belongingness needs (the belongingness hypothesis), and to satisfy needs for creative expression (the need for engagement hypothesis). Geek engagement is found to be associated with elevated grandiose narcissism, extraversion, openness to experience, depression, and subjective well-being across multiple samples. These data lay the groundwork for further exploration of geek culture as well as provide a foundation for examining other forms of subculture participation.