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BackgroundTreatment with phosphodiesterase type 5 inhibitors (PDE-5is) is effective in treating erectile dysfunction (ED).AimThe objective of this study was to determine the effect of PDE-5is on the incidence of major adverse cardiovascular (CV) events (MACE; composite outcome of CV death, hospitalization for myocardial infarction, coronary revascularization, stroke, heart failure, and unstable angina pectoris) and overall mortality.MethodsA retrospective observational cohort study was conducted in a large US claims database in men with ≥1 diagnosis of ED without prior MACE within 1 year, from January 1, 2006, to October 31, 2020. The exposed group had ≥1 claim for PDE-5i and the unexposed group had no claims for PDE-5i, and the groups were matched up to 1:4 on baseline risk variables.OutcomeThe primary outcome was MACE and the secondary outcomes were overall mortality and individual components of MACE, determined by multivariable Cox proportional hazard modeling.ResultsMatched plus multivariable analyses showed that MACE was lower by 13% in men exposed (n = 23 816) to PDE-5is (hazard ratio [HR] 0.87; 95% CI 0.79-0.95; P = .001) vs nonexposure (n = 48 682) over mean follow-up periods of 37 and 29 months, respectively, with lower incidence of coronary revascularization (HR 0.85; 95% CI 0.73-0.98; P = .029), heart failure (HR 0.83; 95% CI 0.72-0.97; P = .016), unstable angina (HR 0.78; 95% CI 0.64-0.96; P = .021), and CV death (HR 0.61; 95% CI 0.41-0.90; P = .014) with PDE-5i exposure. Phosphodiesterase type 5 inhibitor–exposed men had a 25% lower incidence of overall mortality (HR 0.75; 95% CI 0.65-0.87; P Clinical ImplicationsPDE-5is may have cardioprotective effects.Strengths and LimitationsStrengths are the large numbers of participants and consistency of the data; limitations include the retrospective nature of the study and unknown confounders.ConclusionsIn a large population of US men with ED, PDE-5i exposure was associated with lower incidence of MACE, CV death, and overall mortality risk compared to non-exposure. Risk reduction correlated with PDE-5i exposure level.

Background For the treatment of female sexual dysfunction, the most relevant outcome measures are patient-reported treatment effects and changes in symptoms, underscoring the need for reliable, validated patient-reported outcome (PRO) instruments. The aim of this study was to evaluate the psychometric characteristics (validity and reliability) of the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) PRO measure, which was adapted from the validated FSDS-Revised (FSDS-R) questionnaire and added 2 questions involving arousal and orgasm. Methods Psychometric analyses were based on the data from a multicenter phase 2b dose-finding study that compared the safety and efficacy of bremelanotide versus placebo and were conducted in the evaluable modified intent-to-treat population (N = 325) from that study. Psychometric evaluation of the new items in the FSDS-DAO included confirmatory factor analyses, tests of internal consistency and test–retest reliability, examinations of convergent and discriminant validity, and determination of responsiveness. The validity of the FSDS-DAO was evaluated based on previously developed instruments, including the Female Sexual Function Index (FSFI), General Assessment Questionnaire (GAQ), Women’s Inventory of Treatment Satisfaction (WITS-9), and Female Sexual Encounter Profile-Revised (FSEP-R). Results Confirmatory factor analyses demonstrated that the FSDS-DAO items fit very well (Bentler’s comparative fit index of 0.929). Cronbach’s α for the FSDS-DAO total score was ≥ 0.91 at Visits 1, 2, 5, and 12, demonstrating adequate internal consistency reliability. Test–retest reliability was acceptable with an intra-class coefficient of 0.61 and a Spearman’s correlation coefficient score of 0.62 between Visits 1 and 2 (4 weeks). Acceptable construct validity was demonstrated by significant correlations with related PRO scales in the expected directions and magnitude. For example, participants reporting the worst levels of sexual function on the FSFI also showed the worst FSDS-DAO scores at Visits 5 and 12. The FSDS-DAO total score was responsive to change. Conclusions Evidence supports the validity and reliability of the FSDS-DAO for assessing sexually related distress in women with female sexual arousal disorder and/or hypoactive sexual desire disorder; the addition of the arousal and orgasm items did not impact the validity and reliability of the measure. Clinical Trial Registration ClinicalTrials.gov NCT01382719.

Although numerous longitudinal studies have examined heterogeneity in posttraumatic stress disorder (PTSD) symptom course, the long-term course of the disorder remains poorly understood. This study sought to understand and predict long-term PTSD symptom course among a nationwide sample of Operations Enduring Freedom and Iraqi Freedom veterans enrolled in Veterans Health Administration services. We assessed PTSD symptoms at 4 time points over approximately 4.5 years (M = 55.11 months, SD = 6.89). Participants (N = 1,353) with and without probable PTSD were sampled at a 3:1 ratio, and male and female veterans were sampled at a 1:1 ratio to fully explore the heterogeneity of PTSD symptom course and the effect of sex on symptom course. By coding time as years since index trauma, we estimated the course of PTSD symptoms over 20 years. Results indicate symptom course is most appropriately characterized by substantial heterogeneity. On average, veterans experienced initial PTSD symptom severity above the diagnostic threshold following trauma exposure, which was initially stable over time and later began to gradually improve. Although results indicate symptoms eventually began to decline, this effect was gradual; most participants continued to meet or exceed the PTSD provisional diagnostic threshold long after trauma exposure. We identified several predictors and correlates of symptom course, including Hispanic ethnicity, postdeployment social support, and co-occurring psychopathology. Results highlight the heterogeneous nature of PTSD symptom course following trauma exposure and the urgency of the need to ensure access to evidence-based care and to improve available treatments. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background In recent years, the assessment of erectile dysfunction (ED) has experienced a paradigm shift from objective, quantitative methods to subjective, qualitative patient-reported outcomes. Facilitated by this shift is the ongoing debate on questionnaire selection and need for standardization, particularly among sexual medicine specialists. Aim To review current literature on assessment of erectile function via patient-reported outcomes and discuss the context, advantages, and limitations of currently available questionnaires. Methods A thorough literature search of erectile function questionnaires developed from 1990 through 2019 was carried out using 3 methods: a search of the MedLine databases; hand-search of peer-reviewed urologic, sexual medicine, and health policy journals; and expert review. The following keywords were used: [assessment of], [inventory], [questionnaire], or [validated measure]; in combination with: [sexual function] or [erectile function]. Measures were stratified into one of the following 3 groups: screening, outcome, or disease-specific. 3 screening measures (International Index of Erectile Function, the Male Sexual Health Questionnaire, and Brief Male Sexual Inventory); 5 outcome measures (Sexual Health Inventory for Men, Erection Hardness Score, Erectile Dysfunction Inventory for Treatment and Satisfaction, and Treatment Satisfaction Scale); and 3 categories of disease-specific measures (cancer, Peyronie's disease, and spinal cord injury) were included. Outcomes Strengths, limitations, and valid uses of each erectile function questionnaire. Results There currently exists a wide variety of screening, outcome, and disease-specific measures for ED diagnosis, assessment, and treatment. Rigor of psychometric validation varies greatly across studies. However, depending on purpose of use, all abovementioned questionnaires have merit for use in clinical practice, are nonredundant, and can complement and supplement one another. Clinical Implications Before choosing a specific measure for ED diagnosis, assessment, or treatment, there must be careful consideration of the questionnaire's psychometric properties, context of validation, and its possible limitations. Strengths & Limitations The patient reported outcome measures highlighted in this article complement and supplement one another, as each emphasizes a related yet distinct central theme. During selection for use in clinical practice and research studies, special attention needs to be paid to the context, strengths, and weaknesses of each measure. Conclusion When used conscientiously, patient-reported questionnaires can significantly optimize patient management.

Delivery of best-practice care for posttraumatic stress disorder (PTSD) is a priority for clinicians working with active duty military personnel and veterans. The PTSD Clinicians Exchange, an Internet-based intervention, was designed to assist in disseminating clinically relevant information and resources that support delivery of key practices endorsed in the Veterans Administration (VA)-Department of Defense (DoD) Clinical Practice Guidelines (CPG) for the Management of Posttraumatic Stress. We conducted a randomized controlled trial to examine the effectiveness of the Clinicians Exchange intervention in increasing familiarity and perceived benefits of 26 CPG-related and emerging practices. The intervention consisted of ongoing access to an Internet resource featuring best-in-class resources for practices, self-management of burnout, and biweekly e-mail reminders highlighting selected practices. Mental health clinicians (N = 605) were recruited from three service sectors (VA, DoD, community); 32.7% of participants assigned to the Internet intervention accessed the site to view resources. Individuals who were offered the intervention increased their practice familiarity ratings significantly more than those assigned to a newsletter-only control condition, d = 0.27, p = .005. From baseline to 12-months, mean familiarity ratings of clinicians in the intervention group increased from 3.0 to 3.4 on scale of 1 (not at all) to 5 (extremely); mean ratings for the control group were 3.2 at both assessments. Clinicians generally viewed the CPG practices favorably, rating them as likely to benefit their clients. The results suggest that Internet-based resources may aid more comprehensive efforts to disseminate CPGs, but increasing clinician engagement will be important.

Background Clinical trials evaluating new treatments for premature ejaculation (PE) should ideally include both objective end points and patient reported outcomes (PROs), but there is no consensus currently over the optimal measures or combination of outcomes. In addition, many PROs use a 1-month recall period, despite concerns about potential recall bias. Aims Data from a clinical trial of men with lifelong PE were used to examine the consistency of 2 core items of the Premature Ejaculation Profile (PEP), a widely used PRO for assessing subjective aspects of PE. The specific aim was to assess the level of agreement between the original 1-month recall version compared with a new event-based version of the scale in men meeting current definitions of lifelong PE. A further aim was to investigate the convergent validity between an objective end point of intravaginal ejaculatory latency time (IELT), subjective PEP responses, and a patient's Clinical Global Impression of Change (CGIC) measure. Methods For assessment of consistency of PEP responses (short-term [ie, sexual event driven] vs 1-month recall), descriptive statistics, correlation coefficients (Pearson and Spearman), and Bland-Altman plots are presented for each time interval. For assessment of convergent validity, descriptive statistics and correlation coefficients (Pearson and Spearman) are presented for each assessment with geometric mean IELT values. Results are also depicted graphically. Geometric mean IELT over the last 4 weeks of treatment and change from baseline (absolute and fold change) were estimated via a general linear model for each category of change in PEP and CGIC, adjusting for baseline IELT. Outcomes PEP items administered via 1-month recall and short-term event-driven responses gave virtually identical results. There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC. Clinical translation Men with lifelong PE can accurately recall their level of sexual functioning over the previous month. The PEP and CGIC are appropriate instruments to measure the subjective response of men with PE to new treatments. Strengths and limitations Our analyses address gaps in previously published research on PE assessment methodology. Men with acquired PE, men without partners, and men in homosexual relationships were not studied. Conclusions In a clinical trial setting, PEP and CGIC are appropriate end points and are likely the optimal combination of PROs for use with IELT to enable a global assessment of patient response to new PE treatments.

Introduction Web-based interventions hold great promise for the dissemination of best practices to clinicians, and investment in these resources has grown exponentially. Yet, little research exists to understand their impact on intended objectives. Materials & Methods The Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange is a website to support clinicians treating veterans and active duty military personnel with PTSD, evaluated in a randomized controlled trial (N = 605). This manuscript explores how a subset of clinicians, those who utilized the intervention (N = 148), engaged with it by examining detailed individual-level web analytics and qualitative feedback. Stanford University and New England Research Institutes Institutional Review Boards approved this study. Results Only 32.7% of clinicians randomized to the intervention ever accessed the website. The number of pages viewed was positively associated with changes from baseline to 12 months in familiarity (P = 0.03) and perceived benefit of practices (P = 0.02). Thus, engagement with the website did predict an improvement in practice familiarity and benefit outcomes despite low rates of use. Conclusions This study demonstrates the importance of methodologically rigorous evaluations of participant engagement with web-based interventions. These approaches provide insight into who accesses these tools, when, how, and with what results, which can be translated into their strategic design, evaluation, and dissemination.

Introduction Over the past 20 years, the Female Sexual Function Index (FSFI) has been considered the gold standard for the measurement of sexual function in women, with over 1,000 published manuscripts citing the article. Despite the measure’s widespread usage and excellent psychometric properties, there has been some confusion over how to best implement and score the measure and interpret corresponding findings. Aim The aim of the current article is to provide guidance, drawing from 20 years of use, on how to best implement the FSFI in research settings and interpret results based on the validation studies that have been conducted to date. Methods The overview of scoring and interpretation procedures found in this article is drawn from a review of the published literature on the psychometric properties of the FSFI. Main Outcome Measure The measure of interest for the present review is the FSFI. Results This review article provides information about implementing, scoring, and interpreting the full-scale FSFI. Domain-level scoring and interpretation procedures are also discussed across the 5 domains of the FSFI: arousal, satisfaction, desire, pain, and lubrication. Additionally, guidance is provided for evaluating translated versions of the FSFI and using the measure to examine sexual function in culturally diverse populations. Clinical Implications Guidance on appropriately scoring and interpretating the FSFI has the potential to strengthen our empirical understanding of sexual function, and consequently, to guide theory-driven treatment development and clinical practice. Strength & Limitations The present review provides applied guidance for the appropriate use of the FSFI specifically, but does not cover other common measures of sexual function or adaptations of the original measure. Conclusion It is our hope that the guidance found in this review will ultimately lead to more rigorous and appropriate usage of the FSFI in research settings.

The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) introduced numerous revisions to the fourth edition's (DSM-IV) criteria for posttraumatic stress disorder (PTSD), posing a challenge to clinicians and researchers who wish to assess PTSD symptoms continuously over time. The aim of this study was to develop a crosswalk between the DSM-IV and DSM-5 versions of the PTSD Checklist (PCL), a widely used self-rated measure of PTSD symptom severity. Participants were 1,003 U.S. veterans (58.7% with PTSD) who completed the PCL for DSM-IV (the PCL-C) and DSM-5 (the PCL-5) during their participation in an ongoing longitudinal registry study. In a randomly selected training sample (n = 800), we used equipercentile equating with loglinear smoothing to compute a "crosswalk" between PCL-C and PCL-5 scores. We evaluated the correspondence between the crosswalk-determined predicted scores and observed PCL-5 scores in the remaining validation sample (n = 203). The results showed strong correspondence between crosswalk-predicted PCL-5 scores and observed PCL-5 scores in the validation sample, ICC = .96. Predicted PCL-5 scores performed comparably to observed PCL-5 scores when examining their agreement with PTSD diagnosis ascertained by clinical interview: predicted PCL-5, κ = 0.57; observed PCL-5, κ = 0.59. Subsample comparisons indicated that the crosswalk's accuracy did not differ across characteristics including gender, age, racial minority status, and PTSD status. The results support the validity of this newly developed PCL-C to PCL-5 crosswalk in a veteran sample, providing a tool with which to interpret and translate scores across the two measures.Spanish Abstracts by Asociación Chilena de Estrés Traumático (ACET) Un cruce empírico para la lista de verificación de TEPT: traducción de DSM-IV a DSM-5 utilizando una muestra de veteranos CRUCE PARA LA LISTA DE VERIFICACIÓN DEL TEPT La quinta edición del Manual Diagnóstico y Estadístico de los Trastornos Mentales (DSM-5) introdujo numerosas revisiones a los criterios de la cuarta edición (DSM-IV) para el trastorno de estrés postraumático (TEPT), lo que representa un desafío para los médicos e investigadores que desean evaluar los síntomas de TEPT de manera continua a través del tiempo. El objetivo de este estudio fue desarrollar un cruce entre las versiones DSM-IV y DSM-5 de la Lista de verificación de TEPT (PCL en su sigla en inglés), una medida autoevaluada ampliamente utilizada de la gravedad de los síntomas de TEPT. Los participantes fueron 1.003 veteranos estadounidenses (58.7% con TEPT) que completaron el PCL para DSM-IV (PCL-C) y DSM-5 (PCL-5) durante su participación en un estudio de registro longitudinal en curso. En una muestra de entrenamiento seleccionada al azar (n = 800), utilizamos equipercentil equiparado con suavizado loglineal para calcular un “cruce” entre las puntuaciones PCL-C y PCL-5. Evaluamos la correspondencia entre las puntuaciones pronosticadas determinadas por el cruce y las puntuaciones PCL-5 observadas en la muestra de validación restante (n = 203). Los resultados mostraron una fuerte correspondencia entre los puntajes PCL-5 pronosticados para el cruce y los puntajes PCL-5 observados en la muestra de validación, ICC = .96. Los puntajes de PCL-5 pronosticados se compararon con los puntajes de PCL-5 observados al examinar su acuerdo con el diagnóstico de TEPT determinado por entrevista clínica: PCL-5 predicho, κ = 0.57; PCL-5 observado, κ = 0,59. Las comparaciones de submuestras indicaron que la precisión del cruce no difirió entre las características, incluidos el género, la edad, el estado de minoría racial y el estado de TEPT. Los resultados respaldan la validez de este paso de cruce recién desarrollado de PCL-C a PCL-5 en una muestra de veteranos, proporcionando una herramienta con la que interpretar y traducir las puntuaciones en las dos medidas.Traditional and Simplified Chinese Abstracts by the Asian Society for Traumatic Stress Studies (AsianSTSS) 簡體及繁體中文撮要由亞洲創傷心理研究學會翻譯 An Empirical Crosswalk for the PTSD Checklist: Translating DSM-IV to DSM-5 Using a Veteran Sample Traditional Chinese 標題: PTSD檢查表的實證橋樑:透過退役軍人樣本, 把基於DSM-IV的理解轉換至DSM-5 撮要: 《精神疾病診斷與統計手冊第五版》(DSM-5), 對第四版(DSM-IV)的創傷後壓力症(PTSD)準則作出多處修訂, 使希望持續評估PTSD症狀的臨床治療師與研究員面臨考驗。本研究旨在為PTSD檢查表(PCL)的DSM-IV與DSM-5版本之間建立理解的橋樑。此檢查表廣泛用於PTSD症狀嚴重度的自評測量。樣本為1,003名美國退役軍人(58.7%患PTSD);他們參與一個持續進行的縱貫註冊研究時, 完成了DSM-IV及DSM-5版本的PCL(分別為PCL-C與PCL-5)。我們在一份隨機選出的訓練樣本中(n = 800), 採用相等百分位數, 與對數線性平滑化(loglinear smoothing)相等, 計算出PCL-C與PCL-5分數之間的「橋樑」。我們在餘下的驗證樣本中(n = 203), 評估橋樑找出的PCL-5預測分數與觀察得出的PCL-5分數之間的對應值。結果顯示, 兩者之間有強勁的對應值(ICC = .96)。我們亦將兩者跟臨床面談所得的PTSD診斷作比較, 發現兩者的吻合程度相若 (預測的PCL-5, κ = 0.57; 觀察的PCL-5, κ = 0.59) 。子樣本的比較反映, 橋樑的精確度並沒有因以下特徵而生異:性別、年齡、少數族群身分、PTSD狀態。研究以退役軍人樣本驗證了這個新建立的PCL-C與PCL-5橋樑, 提供了一個工具去轉換對兩種測量法的詮釋和理解。 Simplified Chinese 标题: PTSD检查表的实证桥梁:透过退役军人样本, 把基于DSM-IV的理解转换至DSM-5 撮要: 《精神疾病诊断与统计手册第五版》(DSM-5), 对第四版(DSM-IV)的创伤后压力症(PTSD)准则作出多处修订, 使希望持续评估PTSD症状的临床治疗师与研究员面临考验。本研究旨在为PTSD检查表(PCL)的DSM-IV与DSM-5版本之间建立理解的桥梁。此检查表广泛用于PTSD症状严重度的自评测量。样本为1,003名美国退役军人(58.7%患PTSD);他们参与一个持续进行的纵贯注册研究时, 完成了DSM-IV及DSM-5版本的PCL(分别为PCL-C与PCL-5)。我们在一份随机选出的训练样本中(n = 800), 采用相等百分位数, 与对数线性平滑化(loglinear smoothing)相等, 计算出PCL-C与PCL-5分数之间的「桥梁」。我们在余下的验证样本中(n = 203), 评估桥梁找出的PCL-5预测分数与观察得出的PCL-5分数之间的对应值。结果显示, 两者之间有强劲的对应值(ICC = .96)。我们亦将两者跟临床面谈所得的PTSD诊断作比较, 发现两者的吻合程度相若 (预测的PCL-5, κ = 0.57; 观察的PCL-5, κ = 0.59) 。子样本的比较反映, 桥梁的精确度并没有因以下特征而生异:性别、年龄、少数族群身分、PTSD状态。研究以退役军人样本验证了这个新建立的PCL-C与PCL-5桥梁, 提供了一个工具去转换对两种测量法的诠释和理解。.

Objective This study describes women's experiences of the genitourinary syndrome of menopause (GSM) elicited through focus groups and cognitive debriefing sessions during development of a novel patient-reported outcome measure (PROM) designed for use in both clinical care and research. Methods A draft questionnaire to identify and assess bothersome genitourinary symptoms associated with estrogen deficiency in menopausal women was developed in five discrete phases from multiple sources of information in accordance with standards for PROM development. GSM was confirmed by report of symptoms in conjunction with a confirmatory pelvic examination and laboratory assessments. Results Qualitative content interviews were completed in 36 menopausal women with GSM. Cognitive testing of draft PROM items was performed in nine focus groups, including 26 menopausal women with and 15 without GSM. Participants reported a range of symptoms and described associated impacts on more than 15 quality-of-life domains. The majority of women reported that their symptoms impacted their sexual functioning and had a negative effect on their overall quality of life. GSM affected many aspects of menopausal women's lives beyond sexual function, with descriptions of pain when walking, urinating, wearing tight clothes, and with other activities of daily living. Conclusions Women's own words methodically recorded and analyzed during qualitative interviews and cognitive debriefing focus groups illuminate the subjective experience of women with GSM. It is hoped that the PROM currently in development will provide an effective tool for increasing our understanding of the prevalence, predictors, and impact of GSM in menopausal women's lives.

Background The primary purpose of this study was to examine the place of posttraumatic stress disorder (PTSD) vis-a-vis the external dimensions of general distress and physiological arousal. Methods Using data collected from veterans of the wars in Iraq and Afghanistan (N = 1350), latent variable covariance structure modeling was employed to compare correlations of PTSD symptom clusters and individual PTSD symptoms with general distress and physiological arousal. Results Each PTSD symptom cluster, and 17 of 20 individual PTSD symptoms were more strongly associated with general distress than with physiological arousal. However, moderate to strong associations were also found between physiological arousal and both PTSD clusters and symptoms. Limitations Findings are based on self-reported data elicited from a single sample of veterans with substantial PTSD symptoms. Replication, particularly by clinician interview, is necessary. Generalizability to other traumatized populations is unknown. Conclusions Results offer support, with caveats, for viewing PTSD as a distress disorder. Findings are not consistent with the position that PTSD is a hybrid disorder with some features reflecting hyperarousal and others indicative of general distress. Results have implications for the conceptualization and measurement of PTSD.

Summary Aim To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia. Methods This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT‐TAM FDC), or placebo. End‐points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs. Results The intent‐to‐treat population comprised 489 patients (DUT‐TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT‐TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT‐TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT‐TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6‐10 points in the total MSHQ score were more likely to report SexAEs. Conclusion Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT‐TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.

Introduction This study examined risk factors for secondary traumatic stress (STS) in behavioral health clinicians and whether access to the Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange website mitigated STS risk. Methods A diverse sample of clinicians (N = 605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings were randomized to a newsletter-only control group or the exchange group. The exchange website included resources for treating PTSD and promoting clinician well-being. Online surveys were administered at 0-, 6-, and 12-months postrandomization. Regression analyses were used to examine the link among risk factors, exchange access, and STS. Results Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs if required were not linked with STS at the 12-month assessment period. Providing care at the VA, more burnout, less compassion satisfaction, greater trauma caseload, less openness to new EBPs, and greater divergence from EBP procedures were linked with greater STS. Only burnout and divergence were associated with STS after accounting for other significant STS risk factors. Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence. Conclusions Given that burnout was linked with STS, future intervention may use techniques targeting burnout and STS (eg, emotion regulation strategies). Research exploring the link between divergence from EBPs and STS may inform EBP dissemination efforts and STS interventions. Finally, results highlight the need for research optimizing STS intervention efficacy among clinicians treating military populations.

Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes . Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test–retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire that loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p

Posttraumatic stress disorder (PTSD) is associated with higher levels of alcohol use among returning veterans. Persistent PTSD symptoms can predict alcohol use over the span of hours, days, weeks, and months; however, knowledge of the strength of these associations beyond 1 year remains limited. In this study, we examined the 6-year course of co-occurring PTSD and alcohol use to explicate the directional and possible enduring effects of PTSD on alcohol use severity over time. Our study included 1,649 returning veterans (M age = 37.49; SD = 9.88) who completed 4 waves of data collection between 2010 and 2016. We used parallel process modeling to evaluate temporal associations between PTSD symptoms and alcohol use severity across 4 (T1-T4) waves of data collection. PTSD and alcohol use both decreased significantly between T1 and T4 and in tandem with one another. That is, decreases in one were associated with decreases in the other. Further, individuals with higher levels of PTSD symptom severity at T1 reported accelerated rates of change regarding PTSD symptoms and alcohol use over time. Conversely, baseline alcohol use severity did not predict the rate of change in PTSD symptom severity. Our findings provide evidence of a prospective association between PTSD symptoms and alcohol use and highlight the potential for reciprocal associations between them over the span of years. Importantly, our demonstration of the natural course of co-occurring PTSD symptoms and alcohol use suggests further trauma-focused and combined intervention strategies are needed to disrupt this enduring and reciprocal pattern among returning veterans. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

AIMS Five-α reductase inhibitor (5ARI) therapy has been associated with sexual dysfunction in some patients. This study assessed the impact of a fixed-dose combination of the 5ARI dutasteride 0.5 mg and the α1 -adrenoceptor antagonist tamsulosin 0.4 mg (DUT-TAM FDC) on Men's Sexual Health Questionnaire (MSHQ) domain scores in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). METHODS This was a post hoc analysis of a double-blind, randomised, placebo-controlled, parallel-group, multicentre study in sexually active patients, aged ≥50 years, with a confirmed clinical diagnosis of BPH. Sexual activity, sexual desire, and bother domain scores of the MSHQ were assessed at baseline and at Months 1, 3, 6, 9, and 12. Correlation between MSHQ sexual activity/desire scores and ejaculation, erection, and satisfaction domains at baseline was also evaluated. RESULTS In the intent-to-treat population (N = 489), 243 and 246 patients were randomised to DUT-TAM FDC and placebo groups, respectively. Compared with placebo, DUT-TAM FDC therapy resulted in statistically significant reductions (worsening) from baseline in adjusted mean MSHQ sexual activity and bother domain scores at Months 1, 3, 6, 9, and 12 (all P

In response to high suicide rates among veterans, the Department of Veterans Affairs (VA) has mandated that veterans at risk for suicide be given Safety Plans (SP). Research on the efficacy of SPs, however, is unclear and no prior study has examined the degree to which more personally relevant (i.e., higher quality) SPs may be associated with better outcomes or evaluate which components of SPs may be most effective at reducing suicidal behavior. The goal of the present study was to examine whether more personally relevant (i.e., higher quality) SPs reduce future suicide-related outcomes (psychiatric hospitalization, self-harm, and suicide attempts), and to determine which components of a SP may be most effective at reducing these outcomes. Participants were 68 individuals enrolled in a longitudinal national registry of returning military veterans receiving care from the VA, and who had at least one suicide-related event in the VA Suicide Prevention Applications Network. Data were collected between December 2009 and September 2016 and were analyzed between March 2016 and February 2017. Scores of SP quality were used to predict suicide-related outcomes. SP quality was low. Higher SP quality scores predicted a decreased likelihood of future suicide behavior reports (note entered into veteran's chart after a report of any self-harm behavior, including a suicide attempt). Higher scores on Step 3 (people and places that serve as distractions) predicted a decreased likelihood of future suicide behavior reports. More personally relevant SPs may reduce future suicide-related outcomes among veterans. Low SP quality scores highlight the need for training around SP implementation in the VA.

BACKGROUND: Initial weight loss after bariatric surgery has been associated with improvements in reproductive hormones and sexual functioning in women. Few studies have investigated the durability of these changes. OBJECTIVES: Investigate changes in sex hormones, sexual functioning, and relevant psychosocial constructs over 4 years in women who underwent bariatric surgery. SETTING: Prospective cohort of 106 women from the Longitudinal Assessment of Bariatric Surgery Consortium. METHODS: Changes in sex hormones were assessed by blood assay. Sexual functioning, quality of life (QOL), body image, depressive symptoms, and marital adjustment were assessed by psychometric measures. RESULTS: Women lost on average (95% confidence interval) 32.3% (30.4%, 34.3%) at postoperative year 3 and 30.6% (28.5%, 32.8%) at postoperative year 4. Compared to baseline, women experienced significant changes at 4 years in all hormones assessed, except estradiol. Women reported significant improvements in sexual functioning (i.e., arousal, desire, and satisfaction) through year 3, but these changes were not maintained through year 4. Changes in relationship quality followed a similar pattern. Improvements in physical aspects of QOL, body image, and depressive symptoms were maintained through 4 years. CONCLUSIONS: Improvements in reproductive hormones, and physical aspects of QOL, body image and depressive symptoms were maintained 4 years after bariatric surgery. Improvements in sexual functioning, relationship satisfaction, and mental components of QOL eroded over time.

Recent proposals for revisions to the 11th edition of the International Classification of Diseases (ICD-11) posttraumatic stress disorder (PTSD) diagnostic criteria have argued that the current symptom constellation under the Diagnostic and Statistical Manual of Mental Disorders-5 is unwieldy and includes many symptoms that overlap with other disorders. The newly proposed criteria for the ICD-11 include only 6 symptoms. However, restricting the symptoms to those included in the ICD-11 has implications for PTSD diagnosis prevalence estimates, and it remains unclear whether these 6 symptoms are most strongly associated with a diagnosis of PTSD. Network analytic methods, which assume that psychiatric disorders are networks of interrelated symptoms, provide information regarding which symptoms are most central to a network. We estimated network models of PTSD in a national sample of veterans of the Iraq and Afghanistan wars. In the full sample, the most central symptoms were persistent negative emotional state, efforts to avoid external reminders, efforts to avoid thoughts or memories, inability to experience positive emotions, distressing dreams, and intrusive distressing thoughts or memories; that is, 3 of the 6 most central items to the network would be eliminated from the diagnosis under the current proposal for ICD-11. An empirically defined index summarizing the most central symptoms in the network performed comparably to an index reflecting the proposed ICD-11 PTSD criteria at identifying individuals with an independently assessed DSM-5 defined PTSD diagnosis. Our results highlight the symptoms most central to PTSD in this sample, which may inform future diagnostic systems and treatment. (PsycINFO Database Record

Background Cognitive impairment associated with schizophrenia (CIAS) can be a distressing feature that contributes to the burden of the disorder, as well as being a strong predictor of functional impairment. To fully assess the burden to patients living with this illness, there is a need to develop a specific measure of patient-reported outcomes (PROs). Methods Following initial development of the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) instrument, the domain structure, reliability (inter-item consistency and test-retest reliability), and validity (discriminant validity, divergent, and convergent validity) of the tool were assessed in patients (aged 18–55 years) with CIAS participating in a 12-week, Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BI 409306. Healthy control subjects were recruited separately. The PRECIS instrument was completed at baseline, Week 6, Week 9, and Week 12. Results The questionnaire responses of 410 patients with schizophrenia and 88 control subjects were compared. Of the original 35 items included in the draft PRECIS instrument, 11 were eliminated due to poor performance against pre-defined criteria, resulting in a 24-item questionnaire. In confirmatory factor analysis, the 24 items loaded well onto 5 domains (Attention, Memory, Executive Function, Communication, and Bother). The revised 24-item PRECIS instrument demonstrated adequate discriminant validity between patient and control groups in each of the 5 domains (p

Burnout is widespread among behavioral health clinicians treating posttraumatic stress disorder (PTSD) among military populations. Intervention-based strategies have shown some benefit in addressing clinician burnout. One Web-based tool, the PTSD Clinicians Exchange, was designed to disseminate clinical best practices for the treatment of PTSD and facilitate self-care to mitigate burnout. This study sought to determine whether this tool could reduce burnout among clinicians treating military populations.A total of 605 behavioral health clinicians from the U.S. Department of Veterans Affairs, the Department of Defense, and the community were enrolled in a randomized controlled trial to test the effectiveness of the PTSD Clinicians Exchange. Clinicians were assessed on demographic characteristics, practice patterns, and organizational support with an online survey at baseline and at 6 and 12 months. Burnout, secondary traumatic stress (STS), and compassion satisfaction were measured with the Professional Quality of Life Scale.At baseline, no differences were observed in mean±SD burnout scores for the intervention (19.9±5.1) and control groups (20.2±5.4). Participation in the Exchange had no effect on burnout score at 12 months; burnout scores remained stable across the study period. In a multivariable stepwise regression model, older age, lower burnout at baseline, and lower STS scores and higher compassion satisfaction scores at 12 months were significantly associated with lower burnout scores.The PTSD Clinicians Exchange did not mitigate burnout among clinicians, possibly because of the content provided, the dissemination mechanism, or participants' limited use of the Web site. These results can be used to inform and enhance future interventions.

OBJECTIVE Research suggests that the nature of combat may affect later development of posttraumatic stress disorder (PTSD) in combat veterans. Studies comparing rates of PTSD across different conflicts indicate that the use of asymmetric or guerilla-style tactics by enemy fighters may result in higher rates of PTSD among U.S. military personnel than the use of symmetric tactics, which mirror tactics used by U.S. forces. Investigations of the association between enemy combat tactics and PTSD across conflicts were limited because of cohort effects and a focus on male veterans. The current study examined rates of PTSD diagnosis in a sample of male and female veterans deployed to Operation Iraqi Freedom (OIF), a conflict with 3 distinct phases marked by varying enemy tactics. METHOD Participants were 738 veterans enrolled in Project VALOR (Veterans' After-Discharge Longitudinal Registry) who deployed once to OIF. Participants completed a clinician interview as well as self-report measures. RESULTS Male veterans deployed during the OIF phase marked by asymmetric tactics were more than twice as likely to be diagnosed with PTSD as those deployed during the other 2 phases, even after controlling for extent of combat exposure, demographic characteristics, and other deployment-related risk factors for PTSD. Differing rates of PTSD across the 3 OIF phases were not observed among female participants. CONCLUSION The nature of combat (specifically, asymmetric enemy tactics) may be a risk factor for the development of PTSD among males. Factors other than enemy tactics may be more important to the development of PTSD among females. (PsycINFO Database Record

This study examined the unique and combined relationship between mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) with psychosocial functioning in a cohort of 1,312 U.S. male and female veterans of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF) enrolled in the Veterans After-Discharge Longitudinal Registry (Project VALOR). We assessed mTBI with structured screening questions reflective of current TBI classification standards and PTSD via the SCID-IV PTSD module; all other variables were assessed by self-report questionnaires. We identified significant diagnostic group differences in psychosocial functioning for both sexes. Individuals with PTSD, with or without a history of mTBI, reported significantly worse psychosocial functioning than individuals with mTBI alone or neither mTBI nor PTSD (males, η(2) p = .11, p < .001; females, η(2) p = .14, p < .001), even after adjusting for demographics and severity of chronic pain. The results suggested that veterans experiencing PTSD, regardless of whether they had a history of mTBI, were at increased risk for long-term psychosocial impairment. Further research examining possible benefits from improved access to resources and treatment to address these needs would be valuable.

Few studies have investigated the range and severity of insomnia-related sleep complaints among veterans with posttraumatic stress disorder (PTSD), and the temporal association between insomnia and PTSD severity has yet to be examined. To examine these associations, a large, gender-balanced cohort of veterans (N = 1,649) of the Iraq and Afghanistan conflicts participated in longitudinal assessments of PTSD and insomnia-related symptoms over a period of 2.5 years following enrollment (range: 2-4 years). Data were obtained from multiple sources, including interviews, self-report assessments, and electronic medical record data. Three-fourths (74.0%) of veterans with PTSD diagnoses at Time 1 (T1) reported insomnia-related sleep difficulties on at least half the nights during the past 30 days, and one-third of participants had received a prescription for a sedative-hypnotic drug in the past year. Veterans without PTSD had fewer sleep problems overall, although the prevalence of sleep problems was high among all study participants. In longitudinal, cross-lagged panel models, the frequency of sleep problems at T1 independently predicted increases in PTSD severity at Time 2 (T2), B = 0.27, p.001, after controlling for gender and relevant comorbidities. Conversely, T1 PTSD severity was associated with increasing sleep complaints at T2 but to a lesser degree, B = 0.04, p.001. Moderately high rates of sedative-hypnotic use were seen in veterans with PTSD, with more frequent use in women compared to men (40.4% vs. 35.0%). Sleep complaints were highly prevalent overall and highlight the need for increased clinical focus on this area.Spanish Abstracts by Asociación Chilena de Estrés Traumático (ACET) Gravedad del TEPT y Trastornos del Sueño Relacionados con el Insomnio: Asociaciones Longitudinales en una gran Cohorte, Balanceados por Género. de Veteranos Expuestos al Combate SUEÑO, INSOMNIO Y SEVERIDAD DE TEPT Pocos estudios han investigado el rango y la gravedad de las quejas del sueño relacionadas con el insomnio entre veteranos con trastorno de estrés postraumático (TEPT) y la asociación temporal entre el insomnio y la severidad del TEPT aún no se han examinado. Para examinar estas asociaciones, una gran cohorte de veteranos (N = 1,649) de los conflictos de Irak y Afganistán, balanceados por género, participaron en evaluaciones longitudinales de TEPT y síntomas relacionados con el insomnio durante un período de 2.5 años posteriores a la inscripción (rango: 2-4 años). Los datos se obtuvieron de múltiples fuentes, incluyendo entrevistas, autoevaluaciones y datos de registros médicos electrónicos. Tres cuartos (74.0%) de los veteranos con diagnóstico de TEPT en el tiempo 1 (T1) informaron dificultades de sueño relacionadas con el insomnio en al menos la mitad de las noches durante los últimos 30 días, y un tercio de los participantes habían recibido una prescripción de un fármaco sedante-hipnótico en el último año. Los veteranos sin TEPT tenían menos problemas de sueño en general, aunque la prevalencia de problemas de sueño fue alta entre todos los participantes del estudio. En los modelos longitudinales de panel con retardo cruzado, la frecuencia de los problemas de sueño en T1 predijeron independientemente aumentos en la severidad del TEPT en el Tiempo 2 (T2), B = 0.27, p.001, después controlar por género y comorbilidades relevantes. Por el contrario, la gravedad del TEPT en T1 se asoció con un aumento de las quejas de sueño en T2 pero en menor grado, B = 0.04, p.001. Se observaron tasas moderadamente altas de uso de hipnóticos-sedativos en veteranos con TEPT, con un uso más frecuente en mujeres comparadas con hombres (40.4% vs. 35.0%). En general las quejas de sueño fueron altamente prevalentes y destacan la necesidad de una mayor focalización clínica en esta área.Traditional and Simplified Chinese Abstracts by the Asian Society for Traumatic Stress Studies (AsianSTSS) 簡體及繁體中文撮要由亞洲創傷心理研究學會翻譯 PTSD Severity and Insomnia-Related Sleep Disturbances: Longitudinal Associations in a Large, Gender-Balanced Cohort of Combat-Exposed Veterans Traditional Chinese 標題: PTSD嚴重度與失眠相關的睡眠問題:針對有戰鬥經歷的退役軍人的大型、性別平均世代研究中的縱貫關連 撮要: 少有研究檢視患創傷後壓力症(PTSD)的退役軍人其失眠相關的睡眠問題的幅度和嚴重度, 而失眠與PTSD嚴重度的時間性關連亦未受檢視。為檢視以上關連, 我們進行了一個大型、性別平均的世代研究(N = 1,649), 樣本為曾參與伊拉克和阿富汗戰爭的退役軍人, 他們自參與研究後, 接受為期2.5年 (值域:2-4年) 的PTSD與失眠相關症狀的縱貫評估。我們從多個來源取得數據, 包括面談、自評測量、電子醫療記錄數據。在時點1(T1)患PTSD的退役軍人當中, 四分之三(74.0%)在過去30天內, 至少一半日子有失眠相關的睡眠問題, 而三分一的樣本在過去一年取得鎮靜催眠藥處方。雖然樣本的睡眠問題普遍率高, 但無患PTSD的退役軍人整體來說有較少睡眠問題。在縱貫的交叉延宕模型裡, 以性別和相關共病作對照後, T1的睡眠問題頻率獨立地預測到時點2(T2)的PTSD嚴重度提升(B = 0.27, p.001)。相反, T1的PTSD嚴重度跟T2的睡眠問題上升有關, 但關連較小(B = 0.04, p.001)。患PTSD的退役軍人使用鎮靜催眠藥比率偏高, 女性使用的頻率較男性高(40.4% 比對 35.0%)。整體來說, 睡眠問題非常普遍, 凸顯臨床治療應多加注意這個領域。 Simplified Chinese 标题: PTSD严重度与失眠相关的睡眠问题:针对有战斗经历的退役军人的大型、性别平均世代研究中的纵贯关连 撮要: 少有研究检视患创伤后压力症(PTSD)的退役军人其失眠相关的睡眠问题的幅度和严重度, 而失眠与PTSD严重度的时间性关连亦未受检视。为检视以上关连, 我们进行了一个大型、性别平均的世代研究(N = 1,649), 样本为曾参与伊拉克和阿富汗战争的退役军人, 他们自参与研究后, 接受为期2.5年 (值域:2-4年) 的PTSD与失眠相关症状的纵贯评估。我们从多个来源取得数据, 包括面谈、自评测量、电子医疗记录数据。在时点1(T1)患PTSD的退役军人当中, 四分之三(74.0%)在过去30天内, 至少一半日子有失眠相关的睡眠问题, 而三分一的样本在过去一年取得镇静催眠药处方。虽然样本的睡眠问题普遍率高, 但无患PTSD的退役军人整体来说有较少睡眠问题。在纵贯的交叉延宕模型里, 以性别和相关共病作对照后, T1的睡眠问题频率独立地预测到时点2(T2)的PTSD严重度提升(B = 0.27, p.001)。相反, T1的PTSD严重度跟T2的睡眠问题上升有关, 但关连较小(B = 0.04, p.001)。患PTSD的退役军人使用镇静催眠药比率偏高, 女性使用的频率较男性高(40.4% 比对 35.0%)。整体来说, 睡眠问题非常普遍, 凸显临床治疗应多加注意这个领域。.

OBJECTIVE This study examined the extent to which veterans' posttraumatic stress disorder (PTSD) service connection (SC) status corresponded to their PTSD diagnostic status, as determined by a semistructured diagnostic interview. METHOD Participants were 834 veterans in the Veterans After-Discharge Longitudinal Registry (Project VALOR), an observational registry of veterans with and without PTSD who are enrolled in the Veterans Affairs (VA) health care system. PTSD diagnostic status was confirmed using the Structured Clinical Interview for DSM-IV (SCID). RESULTS Concordance between PTSD SC status and current and lifetime PTSD diagnosis was 70.2% and 77.2%, respectively. Individuals with PTSD SC were twice as likely as those without PTSD SC to have a current SCID PTSD diagnosis (OR = 2.11 [95% CI, 1.47-3.04]; P < .001) and almost 3 times as likely to have a lifetime SCID PTSD diagnosis (OR = 2.72 [95% CI, 1.67-4.41]; P < .001). For current PTSD, results showed a slightly higher proportion of false positives-individuals who did not meet SCID criteria but who did have SC for PTSD-than false negatives-individuals who met SCID criteria but did not have SC for PTSD. For lifetime PTSD, the proportion of false negatives was approximately twice the proportion of false positives. CONCLUSIONS PTSD diagnostic and SC status are discordant for a significant minority of veterans. Findings revealed that both the number of veterans who are service connected without meeting criteria for PTSD and the number of veterans who meet PTSD criteria but have not been granted SC status are concerning.

© 2015, Springer International Publishing Switzerland.Purpose: Patient-reported outcome (PRO) measures are essential for assessing subjective patient experiences. Interactive voice response (IVR) data collection provides advantages for clinical trial design by standardizing and centralizing the assessment. Prior to adoption of IVR as a mode of PRO administration in the Testosterone Trials (TTrials), we compared IVR to paper versions of the instruments to be used. Methods: IVR versions of the FACIT-Fatigue scale and Psychosexual Daily Questionnaire, Question 4, were developed. In one pilot study, IVR versions of these scales were compared to paper versions in 25 men ≥ 65 years at each of two clinical sites. In another study, IVR versions of the SF-36 Vitality Scale (SF-36), Positive and Negative Affect Scale, and Patient Health Questionnaire were evaluated in comparison with previously validated paper versions in 25 men at two clinical sites. Both paper and IVR versions of each instrument were administered in counterbalanced order, and test–retest reliability was evaluated by repeated administration of the test. Bland–Altman plots were used to assess the degree of agreement. Test–retest correlations for each measure were also determined. Results: Satisfactory agreement was observed between IVR and paper versions of each study measure. Specifically, linear and highly positive associations were observed consistently across the study for IVR and paper versions of all study measures. These ranged from r = 0.91–0.99. Test–retest reliability for all measures was acceptable or better (r = 0.70–0.90). Conclusions: The IVR versions of TTrials endpoints in these two studies performed consistently well in comparison with paper versions.

Objective To establish a descriptive profile of men with coexistent erectile dysfunction (ED) and/or benign prostatic hyperplasia (BPH), ED only or BPH only compared to those with neither condition and to identify the determinants of coexisting disease. Materials and Methods Self-report and/or medication use measures defining ED and BPH were assessed in men aged ≥40 years (N = 2142) between 2001 and 2004 using the National Health and Nutrition Examination Surveys. Descriptive analyses examined the ED and/or BPH covariate distribution. Logistic regressions calculated odds ratios (ORs, 95% confidence interval) comparing men with ED and/or BPH, BPH only, or ED only to men with neither condition. Results Of 393 men with BPH, 57.8% had coexistent ED, confirming the moderately strong co-occurrence of the conditions (P

Epidemiologic studies of sexual function problems in men have focused on the individual male and related sociodemographic characteristics, individual risk factors and lifestyle concomitants, or medical comorbidities. Insufficient attention has been given to the role of sexual and relationship satisfaction and, more particularly, to the perspective of the couple as causes or correlates of sexual problems in men or women. Previously, we reported results of the first large, multi-national study of sexual satisfaction and relationship happiness in 1,009 midlife and older couples in five countries (Brazil, Germany, Japan, Spain, U.S.). For the present study, we examined, within each problem, the association of four major sexual problems in men (loss of sexual desire, erectile problems, premature ejaculation, delayed/absent orgasm) and multiple problems, with male and female partners' assessments of physical intimacy, sexual satisfaction, and relationship happiness, as well as associations with well-known health and psychosocial correlates of sexual problems in men. Sexual problem rates of men in our survey were generally similar to rates observed in past surveys in the general population, and similar risk factors (age, relationship duration, overall health) were associated with lack of desire, anorgasmia, or erection difficulties in our sample. As in previous surveys, there were few correlates of premature ejaculation. As predicted, men with one or more sexual problems reported decreased relationship happiness as well as decreased sexual satisfaction compared to men without sexual problems. Moreover, female partners of men with sexual problems had reduced relationship happiness and sexual satisfaction, although these latter outcomes were less affected in the women than the men. The association of men's sexual problems with men's and women's satisfaction and relationship happiness were modest, as these couples in long-term, committed relationships were notable for their relatively high levels of physical affection and relationship happiness.

Introduction Treatment satisfaction of men receiving phosphodiesterase 5 inhibitors (PDE5) for erectile dysfunction (ED) and their partners is essential to successful long-term therapy. Aim This study aims to assess treatment satisfaction, in men with a partial response to on-demand (PRN) PDE5 and their female partners, following tadalafil 5 mg once daily or placebo. Methods The study was randomized, double-blind, parallel, and placebo-controlled in men primarily with mild to moderate ED. Treatment satisfaction was assessed following a 4-week maximum dose PRN lead-in, 4-week nondrug washout, and treatment through 12 weeks. Men were ≥18 years old with ED for ≥3 months and International Index of Erectile Function Erectile Function score of ≥17 and Main Outcome Measures Treatment satisfaction was assessed using the Treatment Satisfaction Scale (TSS) for patients and partners. TSS domain scores range from 0 to 100, with higher values indicating greater satisfaction. Statistical comparisons were made using analysis of covariance. Results Treatment satisfaction was significantly greater with tadalafil once daily vs. placebo across all TSS domains for both patients and their partners (all P Conclusions Treatment satisfaction was comparable for tadalafil 5 mg once daily and PRN PDE5 for both patients and female partners, suggesting that tadalafil once daily is a viable therapy option for men with ED who had a partial response to PRN PDE5 therapy.

Increasing evidence of a link between erectile dysfunction and cardiovascular disease suggests a shared vascular etiology with endothelial dysfunction as a plausible underlying biological mechanism. To our knowledge whether this association is different for large arterial endothelium compared to microvascular endothelium has not yet been established. We investigated the association of erectile dysfunction with macrovascular and microvascular endothelial function.A sample of 390 men with a mean age of 55.5 years was recruited from the BACH survey, a population based survey of urological symptoms. Erectile dysfunction was assessed using IIEF-5. The percent of brachial artery flow mediated dilatation, a measure of macrovascular function, and hyperemic flow velocity in cm per second, a measure of microvascular function, were assessed by ultrasound. Linear regression was used to assess the association of erectile dysfunction and endothelial function, and adjust for potential confounders.Reactive hyperemia was lower in men with vs without erectile dysfunction (mean ± SE 97.1 ± 2.5 vs 106.0 ± 1.6 cm per second, p = 0.003). However, the difference in flow mediated dilatation between men with vs without erectile dysfunction was statistically nonsignificant (mean 6.6% ± 0.33% vs 7.2% ± 0.24%, p = 0.147). The association of erectile dysfunction with reactive hyperemia was attenuated but it remained statistically significant in men with moderate to severe erectile dysfunction (IIEF-5 less than 12) after adjusting for traditional cardiovascular risk factors (p = 0.038).These results provide evidence of greater microvascular than macrovascular endothelial dysfunction as a potential contributor to erectile dysfunction and an underlying mechanism linking erectile dysfunction and cardiovascular disease.

The Testosterone Trials (TTrials) were a coordinated set of seven placebo-controlled, double-blind trials in 788 men with a mean age of 72 years to determine the efficacy of increasing the testosterone levels of older men with low testosterone. Testosterone treatment increased the median testosterone level from unequivocally low at baseline to midnormal for young men after 3 months and maintained that level until month 12. In the Sexual Function Trial, testosterone increased sexual activity, sexual desire, and erectile function. In the Physical Function Trial, testosterone did not increase the distance walked in 6 minutes in men whose walk speed was slow; however, in all TTrial participants, testosterone did increase the distance walked. In the Vitality Trial, testosterone did not increase energy but slightly improved mood and depressive symptoms. In the Cognitive Function Trial, testosterone did not improve cognitive function. In the Anemia Trial, testosterone increased hemoglobin in both men who had anemia of a known cause and in men with unexplained anemia. In the Bone Trial, testosterone increased volumetric bone mineral density and the estimated strength of the spine and hip. In the Cardiovascular Trial, testosterone increased the coronary artery noncalcified plaque volume as assessed using computed tomographic angiography. Although testosterone was not associated with more cardiovascular or prostate adverse events than placebo, a trial of a much larger number of men for a much longer period would be necessary to determine whether testosterone increases cardiovascular or prostate risk.

Background Limited information is available on the performance characteristics of 2 questionnaires commonly used in clinical research, the Psychosexual Daily Questionnaire (PDQ) and the Derogatis Interview for Sexual Function (DISF)-II Assessment, especially in older men with low testosterone (T) and impaired sexual function. Aim To determine reliability of PDQ and DISF-II by assessing the correlation within and between domains in the questionnaires and to define clinically meaningful changes in sexual activity (PDQ question 4 [Q4]) and desire (DISF-II sexual desire domain [SDD]) domains. Methods Data from 470 men participating in the T Trials were used to calculate Spearman correlation coefficients of individual items and total score among questionnaires to determine convergent and construct validity. Clinically meaningful changes for sexual desire and activity were determined by randomly dividing the sample into training and validation sets. Anchor- and distribution-based clinically meaningful change criteria were defined in the training set, and selected changes were evaluated in the validation set. Outcomes Validity of the PDQ and DISF-II and clinically meaningful changes in sexual desire and activity were determined in older men in T Trials. Results Moderate to strong correlations were shown within and between domains from different questionnaires. Using Patient Global Impression of Change as an anchor, clinically meaningful change in PDQ sexual activity was ≥0.6, and in DISF-SDD was ≥5.0. Applying these change cut-points to the validation set, a greater proportion of T-treated men achieved clinically meaningful improvement in their sexual desire and activity compared to placebo-treated men. Clinical Implications The PDQ-Q4 and DISF-II-SDD can be used to reliably assess clinically meaningful changes in sexual activity and sexual desire in hypogonadal men treated with T. Strengths & Limitations Strengths of this study include a large sample size, long trial duration, and inclusion of men with low libido and unequivocally low T levels. Limitations include using data from a single study that enrolled only older hypogonadal men, and only 1 anchor for both sexual desire and activity. Conclusion Moderate to strong correlations were demonstrated within and between different sexual domains of the PDQ and DISF-II confirming construct and convergent validity. Clinically meaningful improvement in elderly hypogonadal men was change of ≥0.6 score in the PDQ-Q4 and ≥5.0 in the DISF-SDD. Improvements in sexual activity and desire in the T Trials were modest but clinically meaningful.

Objective To prospectively assess the impact of the fixed-dose combination (FDC) of the 5α-reductase inhibitor (5ARI), dutasteride 0.5 mg and the α1-adrenoceptor antagonist, tamsulosin 0.4 mg (DUT-TAM FDC) therapy on sexual function domain scores in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), using the Men's Sexual Health Questionnaire (MSHQ). Patients and Methods This European and Australian double-blind, placebo-controlled, parallel-group study was conducted at 51 centres. Inclusion criteria: age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen 1.5–10 ng/mL. Patients were randomised 1:1 to DUT-TAM FDC therapy or placebo for 12 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains (secondary outcome) was assessed, using a mixed model repeated measures analysis. Safety was evaluated. Results The intention-to-treat population included 489 patients (243 DUT-TAM FDC therapy; 246 placebo). A significant decrease (worsening) was observed with DUT-TAM FDC therapy versus placebo on the total MSHQ score (−8.7 vs −0.7; standard error [se]: 0.81, 0.78; P < 0.001), and the ejaculation (−7.5 vs −0.6; se: 0.56, 0.55; P < 0.001) and satisfaction (−0.6 vs +0.3; se: 0.3, 0.29, P = 0.047) domains, but not the erection domain (−1.0 vs −0.5; se: 0.19, 0.19, P = 0.091). Conclusion This is the first domain-specific quantitative evaluation of DUT-TAM FDC therapy on sexual function in men with LUTS secondary to BPH. The observed changes in the MSHQ with DUT-TAM FDC therapy were mainly driven by changes in the ejaculation domain. These findings will help give context to erectile and ejaculatory dysfunction AEs reported spontaneously in earlier 5ARI studies.

Background Suicide rates among veterans have increased markedly since the onset of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF; LeardMann et al., 2013). Identification of factors with the greatest contribution to suicide risk among veterans is needed to inform risk assessment and to identify intervention targets. Methods This study examined predictors of suicide attempts among participants in the Veterans After-Discharge Longitudinal Registry; a nationwide cohort of OEF/OIF veterans enrolled in Department of Veterans Affairs (VA) services. Veterans with and without probable posttraumatic stress disorder (PTSD) were sampled at a 3:1 ratio, and male and female veterans were sampled at a 1:1 ratio. Participants (N = 1,649) were assessed at two time points, roughly 2 years apart (M = 28.74 months, SD = 8.72). Results Seventy-four participants (4.49%) attempted suicide during the follow-up period. The strongest predictors of suicide attempts among the full sample were suicidal intent, attempt history, suicide ideation, PTSD symptoms, alcohol use disorder (AUD) symptoms, and depression. Veterans with multiple risk factors were particularly vulnerable; of veterans with 0, ≥1, ≥2, ≥3, or ≥ 4 of these risk factors, 0%, 7.81%, 10.31%, 18.45%, and 20.51% made a suicide attempt, respectively. Conclusions This prospective study identified several strong predictors of suicide attempts among OEF/OIF veterans which may be important targets for suicide prevention efforts. Further, co-occurrence of multiple risk factors was associated with markedly greater risk for suicide attempts; veterans with multiple risk factors appear to be at the highest risk among OEF/OIF veterans enrolled in VA care.

Cognitive impairment is a serious, often distressing aspect of schizophrenia that affects patients’ day-to-day lives. Although several interview-based instruments exist to assess cognitive functioning, a reliable measure developed based on the experiences of patients facing cognitive difficulties is needed to complement the objective performance-based assessments. The present article describes the initial development of a patient-reported outcome (PRO) measure to assess the subjective experience of cognitive impairment among patients with schizophrenia, the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS). The phases of development included the construction of a conceptual model based on the existing knowledge and two sets of qualitative interviews with patients: 1) concept elicitation interviews to ensure face and content validity from the perspective of people with schizophrenia and 2) cognitive debriefing of the initial item pool. Input from experts was elicited throughout the process. The initial conceptual model included seven domains. The results from concept elicitation interviews (n=80) supported these domains but yielded substantive changes to concepts within domains and to terminology. Based on these results, an initial pool of 53 items was developed to reflect the most common descriptions and languages used by the study participants. Cognitive debriefing interviews (n=22) resulted in the removal of 18 items and modification of 22 other items. The remaining 35 items represented 23 concepts within six domains plus two items assessing bother. The draft PRO measure is currently undergoing psychometric testing as a precursor to broad-based clinical and research use., Video abstract

Objective To examine the safety and efficacy of using a clitoral vacuum suction device (CVSD) versus vibratory stimulation (V) to treat orgasmic dysfunction in women with multiple sclerosis (MS) or spinal cord injury (SCI). Design Randomized clinical trial. Setting Two academic medical centers. Participants Women (N=31) including 20 with MS and 11 with SCI. Intervention A 12-week trial of the use of a CVSD versus V. Main Outcome Measures Female Sexual Function Inventory (FSFI) and Female Sexual Distress Scale (FSDS). Results Twenty-three women (18 MS, 5 SCI) completed the study including 13 of 16 randomized to CVSD and 10 of 15 randomized to V. There was a statistically significant increase in total FSFI score ( P =.011), desire ( P =.009), arousal ( P =.009), lubrication ( P =.008), orgasm ( P =.012), and satisfaction ( P =.049), and a significant decrease in distress as measured by FSDS ( P =.020) in subjects using the CVSD. In subjects who used V, there was a statistically significant increase in the orgasm subscale of the FSFI ( P =.028). Subjects using the CVSD maintained improvements 4 weeks after treatment. Conclusions CVSD is safe and overall efficacious to treat female neurogenic sexual dysfunction related to MS and SCI. V is also safe and efficacious for female neurogenic orgasmic dysfunction; however, results were limited to the active treatment period. Because of ease of access and cost, clinicians can consider use of V for women with MS or SCI with orgasmic dysfunction. CVSD is recommended for women with multiple sexual dysfunctions or for whom V is ineffective.