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Audrey Giocanti-Aurégan,1 Alfredo García-Layana,2 Tunde Peto,3 Brittany Gentile,4 Gloria C Chi,4 Mirela Mirt,5 Charlotte E Kosmas,6 Jeremy Lambert,7 Sally Lanar,7 Hannah B Lewis,6 Nancy M Holekamp8 1Ophthalmology Department, Avicenne Hospital, Bobigny, France; 2Clínica Universidad de Navarra, University of Navarra, Pamplona, 31009, Spain; 3Queen’s University Belfast, Belfast, UK; 4Genentech, South San Francisco, CA, USA; 5F. Hoffmann-La Roche, Basel, Switzerland; 6Patient Centred Outcomes, ICON Plc, Reading, UK; 7Patient Centred Outcomes, ICON Plc, Lyon, France; 8Pepose Vision Institute, Chesterfield, MO, USACorrespondence: Audrey Giocanti-Aurégan, Ophthalmology Department, Avicenne hospital, 125 Rue de Stalingrad, Bobigny Cedex, 93009, France, Tel +33 14 895 5815, Fax +33 14 895 5212, Email audrey.giocanti@aphp.frPurpose: 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.Keywords: qualitative interviews, treatment experience, adherence, neovascular age-related macular degeneration, diabetic macular edema

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.

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

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.

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.

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.

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.

To evaluate conflicting theories that perpetration of sexual aggression and perpetration of nonsexual aggression are either manifestations of one another (i.e., derived from the same underlying factors) or completely divergent in origin, we performed a meta-analysis of 68 independent data points that measured perpetration of both forms of aggression. Our findings indicated that research literature only partially supports the view that these aggression forms are similar in origin. While associations of significant magnitude were found between sexual and nonsexual aggression perpetration, they were limited to specific groups of perpetrators (i.e., adult perpetrators, nonincarcerated perpetrators, perpetrators who target adult victims). Important methodological moderators were also identified, including the use of self-report instruments and use of nonaggressive comparison groups, which resulted in stronger associations between sexual and nonsexual aggression. We discuss implications for theory refinement, as well as the identification, treatment, and prevention of sexual aggression.

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.

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.

Objectives: Worsening of symptoms by oncology treatment can adversely affect QoL. The MD Anderson Symptom Inventory (MDASI) is a patient-reported outcome capturing the severity of symptoms and their interference with daily living (activity, working, relations with people, enjoyment of life, mood). The QoL impact of polatuzumab vedotin (pola) plus rituximab (R) was assessed by MDASI in patients (pts) with NHL. Methods: We analyzed pts in the pola + R cohorts of the Phase I/II ROMULUS study (NCT01691898): 40 pts with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with pola (2.4mg/kg) + R, 20 pts with R/R follicular lymphoma (FL) treated with pola (2.4mg/kg) + R, and 20 pts with R/R FL treated with pola (1.8mg/kg) + R. Pts were treated until progressive disease/unacceptable toxicity, up to 17 cycles. MDASI questionnaires were completed at baseline (BL) and Cycles 1-8. Pts rated the worst severity of their symptoms in the last 24 hours from 0 (not present) to 10 (worst imaginable). Interference with daily living was rated from 0 (did not interfere) to 10 (interfered completely). We classed symptom/interference severity as mild ( Results: For DLBCL and FL (pooled doses) cohorts, questionnaire completion rates at BL were 50% (20/40) and 75% (30/40), respectively. Completion rates at Cycle 1-8 ranged from 47-74% (DLBCL) and 67-90% (FL); 10 DLBCL pts and 1 FL pt did not complete a questionnaire after baseline.For DLBCL and FL, symptoms were mild and interference was low at BL. For DLBCL, mean (SD) SS was 1.60 (1.49) and SIS was 2.90 (3.11). Most BL symptoms were rated 'mild' and interference with daily living was low; the most common severe symptoms were distress, constipation, and fatigue (each 20% of pts). The mean BL score for numbness/tingling was 1.25 (1.97; n=19 mild/n=1 severe). For FL (pooled doses), mean SS was 1.28 (1.21) and SIS was 1.95 (2.28) at BL. The most common moderate symptom was fatigue (23% of pts) and the most common severe interference was with work (17%). The mean BL score for numbness/tingling was 1.00 (1.93; n=28, mild/n=2, severe) in pts with FL. Fig 1 shows the SS and SIS change across cycles. For pts with DLBCL treated with pola (2.4mg/kg) + R, estimated mean changes from BL to Cycle (C) 6 and from BL to C8 were: -0.51 (1.26) and +0.67 (1.36), respectively, for total SS; and -1.21 (3.75) and +1.52 (3.35), respectively, for SIS. For pts with FL treated with pola (2.4mg/kg) + R, estimated mean changes from BL to C6 and BL to C8 were: +0.20 (0.75) and +0.47 (1.05) (total SS); and -0.12 (1.89) and -0.09 (1.83; SIS). For FL treated with pola (1.8mg/kg) + R, estimated mean changes from BL to C6 and C8 were: +0.48 (1.05) and +0.42 (1.02; SS); and +1.04 (2.07) and +0.98 (1.97; SIS). Similar results were obtained using a linear mixed effect model accounting for missing data. For DLBCL, there was a slight increase in severity scores for numbness/tingling over time, with mean changes from BL of +0.99 (2.29) at C6 and +2.27 (2.39) from BL to C8. An increase from BL was observed for weakness in arms/legs (changes of +1.08 [2.08] from BL to C6 and +1.74 [2.87] from BL to C8). For FL (pooled), there was a slight increase from BL in numbness/tingling over time, with mean changes of +1.73 (1.92) at C6 and +2.55 (2.37) at C8. An increase was observed from BL in SS for weakness in arms/legs (+1.32 [1.92] from BL to C6 and +1.63 [2.72] from BL to C8, respectively). There was no clear association with numbness/tingling and peripheral neuropathy in DLBCL (Fig 2) or FL (not shown). Conclusions: Symptom burden and interference with daily living remained relatively low for pts with R/R DLBCL or FL while on treatment with pola 1.8 or 2.4mg/kg + R, with few clinically meaningful changes in overall symptom and symptom interference scores. A slight increase was observed in scores for numbness and tingling, and weakness of arms/legs on treatment. Disclosures Thuresson: F. Hoffmann-La Roche Ltd: Employment, Equity Ownership. Gentile:Genentech, Inc.: Employment. Ramies:Genentech, Inc.: Consultancy, Employment. Launonen:F. Hoffmann-La Roche Ltd: Employment. Morschhauser:BMS: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; Epizyme: Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria. OffLabel Disclosure: Polatuzumab vedotin (POLIVY, Genentech, Inc.) is a CD79b-directed antibody-drug conjugate. It was approved by the FDA in June 2019 in combination with bendamustine and rituximab for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma after at least two prior therapies.

Background Chronic lymphocytic leukemia (CLL) primarily affects elderly patients, who regularly present with clinically relevant coexisting conditions. Improvement and maintenance of health-related quality of life (QoL) is an important objective of effective therapies. In the phase 3 CLL14 trial, elderly patients with CLL and comorbidities were randomized to receive either chlorambucil-obinutuzumab (ClbG) or venetoclax-obinutuzumab (VenG) over 12 cycles. In the primary analysis, treatment with VenG achieved significantly longer progression-free survival compared with ClbG (Fischer et al, 2019). Here, we report data from a longitudinal observation of patient-reported outcomes (PRO) focusing on functioning, symptoms, and QoL in patients treated in CLL14. Methods Paper PRO questionnaires were completed at each treatment cycle and every 3 months during follow-up. Disease- and treatment-related symptoms were assessed using the M.D. Anderson Symptom Inventory (MDASI) with the CLL module. Lower MDASI scores (range 0-10) indicate lower symptom severity or interference. Changes in physical functioning, role functioning, and global health status (GHS)/QoL were assessed using the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Higher scores (range 0-100) for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). All scores are given as mean values for all patients per study arm. Results At baseline, compliance was 100% for both the EORTC and MDASI questionnaires, and completion rates remained above 90% throughout treatment and 85% throughout follow-up until month 18 after completion of study treatment. Median observation time was 28.1 months. At the start of treatment, physical function (mean 75.9 [standard deviation (SD) ±20.1] in the ClbG arm and 76.9 (±19.4) in the VenG arm), role function (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. Overall, patients reported moderate-to-high functioning and GHS/QoL, and low symptom severity, with dyspnea (21.3 [± 25.6] and 24.8 [±27.76]), fatigue (35.8 [±23.3] and 39.2 [±24.7]) and insomnia (26.9 [±29.0] and 30.8 [±30.5]) being the most severe symptoms at baseline, followed by pain (16.8 [±22.1] and 18.4 [±25.6]), appetite loss (14.7 [±23.6] and 15.6 [±26.7]), and constipation (10.9 [±20.9] and 12.8 [±23.7]). 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 VenG showed a meaningful improvement of GHS/QoL during treatment and follow-up by at least 8 points at cycle 3, whereas less pronounced and consistent improvement was observed with ClbG at cycle 8 (Figure 1). Insomnia and fatigue scales likewise demonstrated improvement starting at cycle 3 in the VenG arm, whereas this was observed later at cycle 4 and 6, respectively, in the ClbG arm (Figures 2 and 3). According to MDASI scoring, 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. No clinically meaningful improvements or deterioration were observed for either arm during treatment and follow-up (Figure 4). Conclusion Overall, patients treated in CLL14 with either ClbG or VenG experienced no impairment to baseline physical functioning, role functioning, and global health status/QoL during treatment and follow-up, nor increase in symptom burden and interference. This status was maintained after treatment completion and into follow-up. This analysis also shows that patients treated with VenG showed earlier improvement on the GHS/QoL scale by approximately 5 months on average compared with patients treated with ClbG. Earlier relief from insomnia and fatigue was observed with VenG, as well. As elderly patients with CLL typically experience impairment of QoL, particularly when suffering from various other conditions, such improvement should be considered a main therapeutic goal. Our data confirm that rapid and sustained improvement of QoL as measured by PRO can be achieved with a tolerable, fixed-duration treatment with VenG. Disclosures Al-Sawaf: Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support; Janssen: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel support. Gentile:Genentech, Inc.: Employment. Devine:Genentech: Employment, Other: stock options; AbbVie: Other: Alliance Partner. Sail:AbbVie: Employment, Other: and may hold stock or stock options. Tandon:Roche: Equity Ownership; Roche Products Ltd: Employment. Fink:Celgene: Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees; Roche: Other: travel grants. Kutsch:Gilead Sciences, Inc.: Research Funding; Mundipharma, AbbVie, Janssen: Other: Travel, accomodation, expenses. Eichhorst:Gilead Sciences, Inc.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; ArQule: Membership on an entity's Board of Directors or advisory committees; BeiGene: Research Funding. Fischer:AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Other: travel grants. Hallek:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Boehringer Ingelheim: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

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.

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.

The aim of the present study was to assess the psychometric properties of the Narcissistic Personality Inventory (NPI) and two of its short forms (NPI-16 and NPI-13) among a Portuguese sample of male incarcerated juvenile offenders (N=221). Of these, only the NPI-13 short version demonstrated a good fit in terms of its factor structure. The NPI-13 also showed promising psychometric properties in terms of its internal consistency, convergent validity, discriminant validity, and criterion-related validity. Statistically significant associations were found with age of crime onset, crime seriousness, conduct disorder symptoms, alcohol abuse, and cannabis use. These findings justify the use of the NPI-13, especially its Entitlement/Exploitativeness dimension, among incarcerated male youths., Portuguese Foundation for Science and Technology (FCT) [Grant SFRH/BPD/86666/2012] with co-financing of the European Social Fund (POPH/FSE), the Portuguese Ministry of Education and Science (MEC), the FEDER under the PT2020 Partnership Agreement (UID/PSI/01662/2013), and national funds provided by FCT- Foundation for Science and Technology [UID/SOC/04020/2013]

Compared to previous generations, more American college students now rate themselves as above average on attributes such as academic ability, drive to achieve, leadership ability, public speaking ability, self-confidence, and writing ability (based on a nationally representative sample collected 1966–2009; N = 6.5 million). These birth cohort differences are similar with controls for race and gender and occurred despite the college population becoming less selective. Trends in positive self-views are correlated with grade inflation (which increased d = 0.81), but are not explained by changes in objective performance (e.g., SAT scores have declined, d = −0.22) or effort (time spent studying is down, d = − 0.31). Broad cultural shifts emphasizing positive self-views have apparently resulted in enhanced self-evaluations on agentic domains. Self-evaluations on communal attributes, such as understanding others, cooperativeness, and spirituality, either decreased or were unchanged.

Millions of people use social networking sites (SNSs), but it is unclear how these sites shape personality traits and identity. In Experiment 1, college students were randomly assigned to either edit their MySpace page or complete a control task online (interacting with Google Maps). Those who focused on their MySpace page scored significantly higher on the Narcissistic Personality Inventory (NPI) than a control group. In Experiment 2, those who focused on their Facebook page scored significantly higher in general self-esteem, but not narcissism, than a control group. Thus, spending time on SNSs profiles causes young people to endorse more positive self-views, although the specific form this takes depends on the site. Consistent with previous research, narcissism was associated with a larger number of SNSs ''friends'' in both experiments.

A growing empirical literature documents the existence of two distinct dimensions of narcissism, grandiose and vulnerable. In order to better understand the nature of these dimensions, we examined them in the context of the interpersonal circumplex (IPC). Using a sample collected on-line ( N = 277), we examined the relations between these two narcissism dimensions – generated as a result of an exploratory factor analysis of 15 narcissism and narcissism-related scales – and two measures of the IPC. GN was most strongly linked with high agency and low communion. Conversely, vulnerable narcissism was most strongly linked with low communion. The data also suggest that the assessment of IPC can substantially influence the pattern of findings for vulnerable narcissism.

Change over time in culture can appear among individuals and in cultural products such as song lyrics, television, and books. This analysis examines changes in pronoun use in the Google Books ngram database of 766,513 American books published 1960-2008. We hypothesize that pronoun use will reflect increasing individualism and decreasing collectivism in American culture. Consistent with this hypothesis, the use of first person plural pronouns (e.g., we, us) decreased 10% first person singular pronouns (I, me) increased 42%, and second person pronouns (you, your) quadrupled. These results complement previous research finding increases in individualistic traits among Americans.

The status of women in the United States varied considerably during the 20th century, with increases 1900–1945, decreases 1946–1967, and considerable increases after 1968. We examined whether changes in written language, especially the ratio of male to female pronouns, reflected these trends in status in the full text of nearly 1.2 million U.S. books 1900–2008 from the Google Books database. Male pronouns included he, him, his, himself and female pronouns included she, her, hers, and herself. Between 1900 and 1945, 3.5 male pronouns appeared for every female pronoun, increasing to 4.5 male pronouns during the postwar era of the 1950s and early 1960s. After 1968, the ratio dropped precipitously, reaching 2 male pronouns per female pronoun by the 2000s. From 1968 to 2008, the use of male pronouns decreased as female pronouns increased. The gender pronoun ratio was significantly correlated with indicators of U.S. women’s status such as educational attainment, labor force participation, and age at first marriage as well as women’s assertiveness, a personality trait linked to status. Books used relatively more female pronouns when women’s status was high and fewer when it was low. The results suggest that cultural products such as books mirror U.S. women’s status and changing trends in gender equality over the generations.

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.

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.

Three meta-analyses find increases over the generations in Rosenberg Self-Esteem scale (RSE) scores between 1988 and 2008 among American middle school ( d = 0.78, n = 10,119), high school ( d = 0.39, n = 16,669), and college students ( d = 0.30, n = 28,918). The changes are consistent with an increasing emphasis on self-worth in American culture and, for high school students, with small increases in academic competence over time. College students’ scores change only when the RSE is administered with a 4-point Likert scale with no midpoint. By 2008, a score of 40 (perfect self-esteem) was the modal response of college students, chosen by 18% of participants; 51% scored 35 or over. Given these shifts in responses, the possibility of revising the RSE is discussed.

Two cross-temporal meta-analyses find large generational increases in psychopathology among American college students (N=63,706) between 1938 and 2007 on the MMPI and MMPI-2 and high school students (N=13,870) between 1951 and 2002 on the MMPI-A. The current generation of young people scores about a standard deviation higher (average d=1.05) on the clinical scales, including Pd (Psychopathic Deviation), Pa (Paranoia), Ma (Hypomania), and D (Depression). Five times as many now score above common cutoffs for psychopathology, including up to 40% on Ma. The birth cohort effects are still large and significant after controlling for the L and K validity scales, suggesting that the changes are not caused by response bias. The results best fit a model citing cultural shifts toward extrinsic goals, such as materialism and status and away from intrinsic goals, such as community, meaning in life, and affiliation.

This meta-analysis examines gender differences in 10 specific domains of self-esteem across 115 studies, including 428 effect sizes and 32,486 individuals. In a mixed-effects analysis, men scored significantly higher than women on physical appearance ( d = 0.35), athletic ( d = 0.41), personal self ( d = 0.28), and self-satisfaction self-esteem ( d = 0.33). Women scored higher than men on behavioral conduct ( d = −0.17) and moral–ethical self-esteem ( d = −0.38). The gender difference in physical appearance self-esteem was significant only after 1980 and was largest among adults. No significant gender differences appeared in academic, social acceptance, family, and affect self-esteem. The results demonstrate the influence of reflected appraisals on self-esteem.

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.

The issue of Americans' levels of narcissism is subject to lively debate. The focus of the present research is on the perception of national character (PNC) of Americans as a group. In Study 1, American adults (N = 100) rated Americans as significantly more narcissistic than they perceived themselves and acquaintances. In Study 2, this finding was replicated with American college students (N = 322). PNC ratings of personality traits and externalizing behaviors revealed that Americans were perceived as disagreeable and antisocial as well. In Study 3, we examined the broader characteristics associated with PNC ratings (N = 183). Americans rated the typical American as average on a variety of characteristics (e.g., wealth, education, health, likability) and PNC ratings of narcissism were largely unrelated to these ratings. In Study 4 (N = 1,202) Americans rated PNCs for different prespecified groups of Americans; as expected, PNC ratings of narcissism differed by gender, age, and occupational status such that American males, younger Americans, and Americans working in high-visibility and status occupations were seen as more narcissistic. In Study 5 (N = 733), citizens of 4 other world regions (Basque Country, China, England, Turkey) rated members of their own region as more narcissistic than they perceived themselves, but the effect sizes were smaller than those found in the case of Americans' perceptions of Americans. Additionally, members of these other regions rated Americans as more narcissistic than members of their own region. Finally, in Study 6, participants from around the world (N = 377) rated Americans as more narcissistic, extraverted, and antagonistic than members of their own countries. We discuss the role that America's position as a global economic and military power, paired with a culture that creates and reifies celebrity figures, may play in leading to perceptions of Americans as considerably narcissistic.

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

The most widely used measure of trait narcissism is the Narcissistic Personality Inventory (NPI), which can provide both total and subscale scores. However, with a length of 40 items, this measure may not be ideal in settings in which time or participant attention may limit the types of measures that can be administered. In response, Ames, Rose, and Anderson (2006) created the NPI-16, which provides a shorter, unidimensional measure of the construct. In the present research, we examine the reliability and validity of the NPI-16 in conjunction with a new short measure of narcissism, the NPI-13, which provides both a total score and 3 subscale scores (Leadership/Authority; Grandiose Exhibitionism; Entitlement/Exploitativeness). Across 2 studies, we demonstrate that both short measures manifest good convergent and discriminant validity and adequate overall reliability. The NPI-13 may be favored over the NPI-16 because it allows for the extraction of 3 subscales, consistent with the use of its parent measure.

The five-factor narcissism inventory (FFNI) is a new self-report measure that was developed to assess traits associated with narcissistic personality disorder (NPD), as well as grandiose and vulnerable narcissism from a five-factor model (FFM) perspective. In the current study, the FFNI was examined in relation to Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; DSM-IV; American Psychiatric Association, 2000) NPD, DSM-5 (http://www.dsm5.org) NPD traits, grandiose narcissism, and vulnerable narcissism in both community (N = 287) and clinical samples (N = 98). Across the samples, the FFNI scales manifested good convergent and discriminant validity such that FFNI scales derived from FFM neuroticism were primarily related to vulnerable narcissism scores, scales derived from FFM extraversion were primarily related to grandiose scores, and FFNI scales derived from FFM agreeableness were related to both narcissism dimensions, as well as the DSM-IV and DSM-5 NPD scores. The FFNI grandiose and vulnerable narcissism composites also demonstrated incremental validity in the statistical prediction of these scores, above and beyond existing measures of DSM NPD, grandiose narcissism, and vulnerable narcissism, respectively. The FFNI is a promising measure that provides a comprehensive assessment of narcissistic pathology while maintaining ties to the significant general personality literature on the FFM.

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.

Cultural products such as song lyrics, television shows, and books reveal cultural differences, including cultural change over time. Two studies examine changes in the use of individualistic words (Study 1) and phrases (Study 2) in the Google Books Ngram corpus of millions of books in American English. Current samples from the general population generated and rated lists of individualistic words and phrases (e.g., "unique," "personalize," "self," "all about me," "I am special," "I'm the best"). Individualistic words and phrases increased in use between 1960 and 2008, even when controlling for changes in communal words and phrases. Language in American books has become increasingly focused on the self and uniqueness in the decades since 1960.

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.

Lynam and colleagues recently developed a new self-report inventory for the assessment of psychopathy, the Elemental Psychopathy Assessment (EPA). Using a sample of undergraduates ( N = 227), the authors examined the construct validity of the EPA by examining its correlations with self and stranger ratings on the Five-Factor Model, as well as self-reported ratings of personality disorders, social cognition, and love styles. The EPA psychopathy scores manifested expected correlations with both self and stranger ratings of the Five-Factor Model, particularly with the domains of Agreeableness and Conscientiousness, and were significantly related to various forms of personality pathology such as narcissism and antisocial personality disorders. The EPA also manifested expected relations with aggressive social cognitions. Finally, the EPA psychopathy scores were correlated with romantic love styles indicative of game playing and infidelity. The current results provide further evidence of the construct validity of the EPA as it manifests relations consistent with the nomological network of psychopathy.

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.