A prospective multicenter feasibility study of a miniaturized implantable continuous flow ventricular assist device in smaller children with heart failure.

BACKGROUND: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant. METHODS: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure. RESULTS: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient. CONCLUSION: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497).

Risk of Secondary Traumatic Stress in Treating Traumatized Military Populations: Results from the PTSD Clinicians Exchange.

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.

Randomized Controlled Trial of a Web-Based Intervention to Disseminate Clinical Practice Guidelines for Posttraumatic Stress Disorder: The PTSD Clinicians Exchange.

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.

Understanding How Clinicians Use a New Web-based Tool for Disseminating Evidence-Based Practices for the Treatment of PTSD: The PTSD Clinicians Exchange.

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.

Efficacy of a Web-Based Tool in Reducing Burnout Among Behavioral Health Clinicians: Results From the PTSD Clinicians Exchange.

Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

Posttraumatic Stress Disorder Severity and Insomnia-Related Sleep Disturbances: Longitudinal Associations in a Large, Gender-Balanced Cohort of Combat-Exposed Veterans.

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.

Women's experience of vulvovaginal symptoms associated with menopause.

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.