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The Princeton Consensus (Expert Panel) Conference is a multispecialty collaborative symposium dedicated to optimizing sexual function and preserving cardiovascular health. The Fourth Princeton Consensus Conference was convened on March 10-11, 2023, at the Huntington Medical Research Institutes in Pasadena, California. Princeton panels I to III addressed the clinical management of men with erectile dysfunction (ED) who also had cardiovascular disease. Thirteen years since Princeton III, Princeton IV builds on previous foundations in several key areas. Mounting evidence supports the need for providers to treat men with ED as being at risk for cardiac events until proven otherwise. Algorithms for the diagnosis and treatment of ED are updated with new recommendations for coronary artery calcium scoring for advanced cardiovascular risk stratification. Optimization of oral phosphodiesterase type 5 inhibitors in the treatment of men with ED and cardiovascular disease is thoroughly explored, including recent evidence of potential cardioprotective effects of these drugs.
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INTRODUCTION: Prior consensus meetings have addressed the relationship between phosphodiesterase type 5 (PDE5) inhibition and cardiac health. Given significant accumulation of new data in the past decade, a fourth consensus conference on this topic was convened in Pasadena, California, on March 10 and 11, 2023. OBJECTIVES: Our meeting aimed to update existing knowledge, assess current guidelines, and make recommendations for future research and practice in this area. METHODS: An expert panel reviewed existing research and clinical practice guidelines. RESULTS: Key findings and clinical recommendations are the following: First, erectile dysfunction (ED) is a risk marker and enhancer for cardiovascular (CV) disease. For men with ED and intermediate levels of CV risk, coronary artery calcium (CAC) computed tomography should be considered in addition to previous management algorithms. Second, sexual activity is generally safe for men with ED, although stress testing should still be considered for men with reduced exercise tolerance or ischemia. Third, the safety of PDE5 inhibitor use with concomitant medications was reviewed in depth, particularly concomitant use with nitrates or alpha-blockers. With rare exceptions, PDE5 inhibitors can be safely used in men being treated for hypertension, lower urinary tract symptoms and other common male disorders. Fourth, for men unresponsive to oral therapy or with absolute contraindications for PDE5 inhibitor administration, multiple treatment options can be selected. These were reviewed in depth with clinical recommendations. Fifth, evidence from retrospective studies points strongly toward cardioprotective effects of chronic PDE5-inhibitor use in men. Decreased rates of adverse cardiac outcomes in men taking PDE-5 inhibitors has been consistently reported from multiple studies. Sixth, recommendations were made regarding over-the-counter access and potential risks of dietary supplement adulteration. Seventh, although limited data exist in women, PDE5 inhibitors are generally safe and are being tested for use in multiple new indications. CONCLUSION: Studies support the overall cardiovascular safety of the PDE5 inhibitors. New indications and applications were reviewed in depth.
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RATIONALE: Psychedelic-assisted psychotherapy (PAP) has emerged as a potential treatment for a variety of mental health conditions, including substance use disorders and depression. Current models of PAP emphasize the importance of psychotherapeutic support before, during, and after ingestion of a psychedelic to maximize safety and clinical benefit. Despite this ubiquitous assumption, there has been surprisingly little empirical investigation of the "psychotherapy" in PAP, leaving critical questions about the necessary and sufficient components of PAP unanswered. OBJECTIVES: As clinical trials for psychedelic compounds continue the transition from safety- and feasibility-testing to evaluating efficacy, the role of the accompanying psychotherapy must be better understood to enhance scientific understanding of the mechanisms underlying therapeutic change, optimize clinical outcomes, and inform cost-effectiveness. RESULTS: The present paper first reviews the current status of psychotherapy in the PAP literature, starting with recent debates regarding "psychotherapy" versus "psychological support" and then overviewing published clinical trial psychotherapy models and putative models informed by theory. We then delineate lessons that PAP researchers can leverage from traditional psychotherapy research regarding standardizing treatments (e.g., publish treatment manuals, establish eligibility criteria for providers), identifying mechanisms of change (e.g., measure established mechanisms in psychotherapy), and optimizing clinical trial designs (e.g., consider dismantling studies, comparative efficacy trials, and cross-lagged panel designs). Throughout this review, the need for increased research into the psychotherapeutic components of treatment in PAP is underscored. CONCLUSIONS: PAP is a distinct, integrative, and transdisciplinary intervention. Future research designs should consider transdisciplinary research methodologies to identify best practices and inform federal guidelines for PAP administration.
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Alucinógenos , Transtornos Mentais , Psicoterapia , Humanos , Alucinógenos/administração & dosagem , Alucinógenos/farmacologia , Alucinógenos/uso terapêutico , Psicoterapia/métodos , Transtornos Mentais/tratamento farmacológico , Transtornos Mentais/terapia , Transtornos Relacionados ao Uso de Substâncias/terapiaRESUMO
BACKGROUND: Tadalafil is a long-acting phosphodiesterase-5 inhibitor (PDE-5i) indicated for erectile dysfunction (ED). HYPOTHESIS: Our hypothesis was that tadalafil will reduce the risk of major adverse cardiovascular events (MACE: composite of cardiovascular death, myocardial infarction, coronary revascularization, unstable angina, heart failure, stroke) and all-cause death in men with ED. METHODS: A retrospective observational cohort study was conducted in a large US commercial insurance claims database in men with a diagnosis of ED without prior MACE within 1 year. The exposed group (n = 8156) had ≥1 claim for tadalafil; the unexposed group (n = 21 012) had no claims for any PDE-5i. RESULTS: Primary outcome was MACE; secondary outcome was all-cause death. Groups were matched for cardiovascular risk factors, including preventive therapy. Over a mean follow-up of 37 months for the exposed group and 29 months for the unexposed group, adjusted rates of MACE were 19% lower in men exposed to tadalafil versus those unexposed to any PDE-5i (hazard ratio [HR] = 0.81; 95% confidence intervals [CI] = 0.70-0.94; p = .007). Tadalafil exposure was associated with lower adjusted rates of coronary revascularization (HR = 0.69; 95% CI = 0.52-0.90; p = .006); unstable angina (HR = 0.55; 95% CI = 0.37-0.81; p = .003); and cardiovascular-related mortality (HR = 0.45; CI = 0.22-0.93; p = .032). Overall mortality rate was 44% lower in men exposed to tadalafil (HR = 0.56; CI = 0.43-0.74; p < .001). Men in the highest quartile of tadalafil exposure had the lowest rates of MACE (HR: 0.40; 95% CI: 0.28-0.58; p < .001) compared to lowest exposure quartile. CONCLUSION: In men with ED, exposure to tadalafil was associated with significant and clinically meaningful lower rates of MACE and overall mortality.
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Disfunção Erétil , Infarto do Miocárdio , Masculino , Humanos , Tadalafila/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Disfunção Erétil/epidemiologia , Estudos Retrospectivos , Carbolinas/efeitos adversos , Inibidores da Fosfodiesterase 5/efeitos adversos , Infarto do Miocárdio/induzido quimicamente , Angina InstávelRESUMO
BACKGROUND: In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug-drug interactions, but also a potential cardioprotective effect of these drugs. AIM: In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease. METHOD: A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus. OUTCOMES: Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors. RESULTS: An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug-drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non-PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non-PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed. CLINICAL IMPLICATIONS: Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease. STRENGTHS AND LIMITATIONS: Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting. CONCLUSION: The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors.
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Doenças Cardiovasculares , Disfunção Erétil , Masculino , Humanos , Feminino , Inibidores da Fosfodiesterase 5/efeitos adversos , Doenças Cardiovasculares/tratamento farmacológicoRESUMO
BACKGROUND: Treatment with phosphodiesterase type 5 inhibitors (PDE-5is) is effective in treating erectile dysfunction (ED). AIM: The 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. METHODS: A 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. OUTCOME: The primary outcome was MACE and the secondary outcomes were overall mortality and individual components of MACE, determined by multivariable Cox proportional hazard modeling. RESULTS: Matched 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 < .001). Men without coronary artery disease (CAD) but with CV risk factors at baseline showed a similar pattern. In the main study cohort, men in the highest quartile of PDE-5i exposure had the lowest incidence of MACE (HR 0.45; 95% CI 0.37-0.54; P < .001) and overall mortality (HR 0.51; 95% CI 0.37-0.71; P < .001) vs the lowest exposure quartile. In a subgroup with baseline type 2 diabetes (n = 6503), PDE-5i exposure was associated with a lower MACE risk (HR 0.79; 95% CI 0.64-0.97; P = .022). CLINICAL IMPLICATIONS: PDE-5is may have cardioprotective effects. STRENGTHS AND LIMITATIONS: Strengths are the large numbers of participants and consistency of the data; limitations include the retrospective nature of the study and unknown confounders. CONCLUSIONS: In 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.
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Doença da Artéria Coronariana , Diabetes Mellitus Tipo 2 , Disfunção Erétil , Insuficiência Cardíaca , Masculino , Humanos , Inibidores da Fosfodiesterase 5/uso terapêutico , Diabetes Mellitus Tipo 2/complicações , Estudos Retrospectivos , Fatores de Risco , Insuficiência Cardíaca/complicações , Atenção à SaúdeRESUMO
OBJECTIVE: Psychiatric disorders increase risk for contracting coronavirus disease 2019 (COVID-19), but we know little about relationships between psychiatric symptoms and COVID-19 risky and protective behaviors. Posttraumatic stress disorder (PTSD) has been associated with increased propensity to engage in risky behaviors, but may also be associated with increased COVID-19 protective behaviors due to increased threat sensitivity and social isolation. METHOD: We examined associations of PTSD symptoms with COVID-19-related protective and risky behaviors using data from a cross-sectional online United States study among 845 US adults in August through September 2020. PTSD symptoms (PTSD Checklist-5), sociodemographics, COVID-19-related experiences and vulnerabilities, and past 30-day engagement in 10 protective and eight risky behaviors for COVID-19 were assessed via self-report. We examined associations between PTSD symptoms and COVID-19 protective and risky behaviors with linear regressions, adjusting for covariates. RESULTS: Probable PTSD and higher PTSD symptom severity were associated with greater engagement in protective behaviors, but also greater engagement in risky behaviors. Associations were only slightly attenuated by adjustment for COVID-19 exposures and perceived likelihood and severity of COVID-19. Associations varied by PTSD clusters: intrusions and arousal were associated with both more protective and more risky behaviors, whereas negative cognitions or mood was associated only with more risky, and avoidance only with more protective, behaviors. CONCLUSION: Higher PTSD symptoms were associated with engagement in more protective but also more risky behaviors for COVID-19. Mental health should be considered in the design of public health campaigns dedicated to limiting infectious disease spread. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
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COVID-19 , Transtornos de Estresse Pós-Traumáticos , Adulto , COVID-19/prevenção & controle , Estudos Transversais , Humanos , Assunção de Riscos , SARS-CoV-2 , Transtornos de Estresse Pós-Traumáticos/psicologia , Estados Unidos/epidemiologiaRESUMO
Individual behaviors are critical for preventing the spread of coronavirus disease 2019 (COVID-19) infection. Given that both protective and risky behaviors influence risk of infection, it is critical that we understand how such behaviors cluster together and in whom. Using a data-driven approach, we identified clusters of COVID-19-related protective and risky behaviors and examined associations with socio-demographic, pandemic, and mental health factors. Data came from a cross-sectional online U.S. nationwide study of 832 adults with high levels of pre-pandemic trauma. Latent class analysis was performed with ten protective (e.g., washing hands, wearing masks) and eight risky (e.g., attending indoor restaurants, taking a flight) behaviors for COVID-19. Then, we examined distributions of socio-demographic and pandemic factors across behavior classes using ANOVA or Chi-square tests, and associations between mental health factors (depressive, anxiety, posttraumatic stress symptoms) and behavior classes using multinomial logistic regression. We identified four classes, including three classes with relatively low risky but high (28.8%), moderate (33.5%) and minimal (25.5%) protective behaviors and one high risky behaviors class with associated moderate protective behaviors (12.1%). Age, sexual orientation, political preference, and most pandemic factors differed significantly across behavior classes. Anxiety and posttraumatic stress symptoms, but not depression, were higher in the High Risk, but also Highly and Moderately Protective classes, relative to Minimally Protective. Prevention and intervention efforts should examine constellations of protective and risky behaviors to comprehensively understand risk, and consider current anxiety and posttraumatic stress symptoms as potential risk indicators.
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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.
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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.
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Militares , Transtornos de Estresse Pós-Traumáticos , Esgotamento Profissional/epidemiologia , Fadiga de Compaixão , Prática Clínica Baseada em Evidências , Humanos , Fatores de Risco , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/terapiaRESUMO
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).
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Apoio Social , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Veteranos/psicologia , Adulto , Campanha Afegã de 2001- , Feminino , Humanos , Guerra do Iraque 2003-2011 , Estudos Longitudinais , Masculino , Avaliação de SintomasRESUMO
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).
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Consumo de Bebidas Alcoólicas/psicologia , Alcoolismo/complicações , Transtornos de Estresse Pós-Traumáticos/complicações , Veteranos/psicologia , Adulto , Alcoolismo/diagnóstico , Alcoolismo/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Transtornos de Estresse Pós-Traumáticos/psicologiaRESUMO
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.
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Pessoal de Saúde/estatística & dados numéricos , Intervenção Baseada em Internet , Transtornos de Estresse Pós-Traumáticos/terapia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Militares/psicologia , Guias de Prática Clínica como Assunto , Estados Unidos , Veteranos/psicologiaRESUMO
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.
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Prática Clínica Baseada em Evidências/métodos , Padrões de Prática Médica/normas , Transtornos de Estresse Pós-Traumáticos/terapia , Navegador/tendências , Adulto , Prática Clínica Baseada em Evidências/tendências , Feminino , Humanos , Internet , Entrevistas como Assunto/métodos , Masculino , Pessoa de Meia-Idade , New England , Padrões de Prática Médica/tendências , Pesquisa Qualitativa , Transtornos de Estresse Pós-Traumáticos/psicologiaRESUMO
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.
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Dutasterida/efeitos adversos , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Hiperplasia Prostática/tratamento farmacológico , Saúde Sexual , Tansulosina/efeitos adversos , Idoso , Método Duplo-Cego , Dutasterida/uso terapêutico , Ejaculação/efeitos dos fármacos , Humanos , Libido/efeitos dos fármacos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Saúde do Homem , Pessoa de Meia-Idade , Ereção Peniana , Estudos Prospectivos , Hiperplasia Prostática/complicações , Comportamento Sexual , Inquéritos e Questionários , Tansulosina/uso terapêuticoRESUMO
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.
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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. Meston CM, Freihart BK, Handy AB, et al. Scoring and Interpretation of the FSFI: What can be Learned From 20 Years of use? J Sex Med 2020;17:17-25.
Assuntos
Disfunções Sexuais Psicogênicas/diagnóstico , Inquéritos e Questionários , Feminino , Humanos , Satisfação Pessoal , PsicometriaRESUMO
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.
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Distúrbios de Guerra/psicologia , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Veteranos/estatística & dados numéricos , Adulto , Campanha Afegã de 2001- , Fatores Etários , Alcoolismo/epidemiologia , Estudos de Coortes , Distúrbios de Guerra/epidemiologia , Depressão/epidemiologia , Feminino , Humanos , Hipnóticos e Sedativos/uso terapêutico , Guerra do Iraque 2003-2011 , Masculino , Estado Civil/estatística & dados numéricos , Transtorno de Pânico/epidemiologia , Índice de Gravidade de Doença , Fatores Sexuais , Distúrbios do Início e da Manutenção do Sono/psicologia , Apoio Social , Transtornos de Estresse Pós-Traumáticos/psicologia , Desemprego/estatística & dados numéricos , Estados Unidos/epidemiologiaRESUMO
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.
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Lista de Checagem , Manual Diagnóstico e Estatístico de Transtornos Mentais , Transtornos de Estresse Pós-Traumáticos/psicologia , Avaliação de Sintomas , Adulto , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Transtornos de Estresse Pós-Traumáticos/diagnóstico , Estados Unidos , Veteranos/psicologiaRESUMO
OBJECTIVES: Military sexual trauma (MST) is a pervasive problem among veterans, and is associated with a host of deleterious outcomes. It is, therefore, imperative to identify individuals who have experienced MST so that they can be offered appropriate treatment. To determine how to best identify MST survivors, the current study examined how different assessment modalities might affect MST endorsement, and whether endorsement varied as a product of demographic group membership. METHODS: Data from 697 male and female veterans participating in the Veterans' After-Discharge Longitudinal Registry (Project VALOR) were used to examine how three different MST assessment modalities-the Veterans Health Administration screen, a study interview, and a study questionnaire measure-might affect MST endorsement across five different demographic variables (gender, ethnicity, sexual orientation, race, and age). Each participant was evaluated for MST exposure using each of the three assessment modalities. RESULTS: Both assessment modality and demographic membership influenced MST endorsement. MST endorsement on the study measures was consistently twice as large as on the Veterans Health Administration screen, across demographic groups. For men, MST endorsement varied by a factor of 11 across measures, with endorsement being lowest on the Veterans Health Administration screen and highest on the study questionnaire. Although differences were also detected for sexual minority and Black participants, these findings may have been better explained by gender differences. CONCLUSIONS: Both assessment modality and demographic membership substantially influenced MST endorsement. Providing a clear rationale for screening and increasing privacy around screening results, particularly for male veterans, may help to facilitate MST disclosure.