Mindfulness, burnout, and effects on performance evaluations in internal medicine residents.

PURPOSE: Burnout has been documented at high levels in medical residents with negative effects on performance. Some dispositional qualities, like mindfulness, may protect against burnout. The purpose of the present study was to assess burnout prevalence among internal medicine residents at a single institution, examine the relationship between mindfulness and burnout, and provide preliminary findings on the relation between burnout and performance evaluations in internal medicine residents. METHODS: Residents (n = 38) completed validated measures of burnout at three time points separated by 2 months and a validated measure of dispositional mindfulness at baseline. Program director end-of-year performance evaluations were also obtained on 22 milestones used to evaluate internal medicine resident performance; notably, these milestones have not yet been validated for research purposes; therefore, the investigation here is exploratory. RESULTS: Overall, 71.1% (n = 27) of the residents met criteria for burnout during the study. Lower scores on the "acting with awareness" facet of dispositional mindfulness significantly predicted meeting burnout criteria χ2(5) = 11.88, p = 0.04. Lastly, meeting burnout criteria significantly predicted performance on three of the performance milestones, with positive effects on milestones from the "system-based practices" and "professionalism" domains and negative effects on a milestone from the "patient care" domain. CONCLUSION: Burnout rates were high in this sample of internal medicine residents and rates were consistent with other reports of burnout during medical residency. Dispositional mindfulness was supported as a protective factor against burnout. Importantly, results from the exploratory investigation of the relationship between burnout and resident evaluations suggested that burnout may improve performance on some domains of resident evaluations while compromising performance on other domains. Implications and directions for future research are discussed.

Initial and Follow-Up Evaluations of Integrated Psychological Services for Anxiety and Depression in a Safety Net Primary Care Clinic.

OBJECTIVE: Despite the recognized importance of integrated behavioral health, particularly in safety net primary care, its effectiveness in real world settings has not been extensively evaluated. This article presents 2 successive studies examining the effectiveness of integrated behavioral care in a safety net setting. METHOD: Study 1 compared the depression and anxiety scores of predominately low-income and minority patients who underwent brief interventions (N = 147) to those of patients from a demographically similar comparison clinic without integrated psychological services, matched on baseline levels of anxiety and depression and length of time between assessments (N = 139). Study 2 did not include a control group but served as a long-term follow-up assessment of anxiety and depression for a subset of 47 patients who finished treatment and could be reached by telephone within 6-18 months of their last session. RESULTS: Study 1 found that patients from the clinic with integrated psychology services experienced greater decreases in depression and anxiety scores than patients in the control clinic. These effects did not differ as a function of age, gender, or race. Study 2 found that patients continued to decline in depression and anxiety over time, with lower scores at the last session and even lower scores after longer-term follow-up ranging from 6 to18 months. These improvements remained significant when controlling for other interim mental health treatments. CONCLUSION: These results support the short- and long-term treatment effects of brief primary care behavioral interventions, further strengthening the case for integrated behavioral healthcare in safety net settings.

The Impact of Integrated Psychological Services in a Safety Net Primary Care Clinic on Medical Utilization.

OBJECTIVE: The integration of psychological and behavioral health services into safety net primary care clinics has been viewed as a step toward reducing disparities in mental health treatment and addressing behavioral factors in chronic diseases. Though it is posited that integrated behavioral health (IBH) reduces preventable medical costs, this premise has yet to be tested in a safety net primary care clinic. METHOD: Retrospective pre- and posttreatment analysis with quasi-experimental control group was constructed using propensity score matching. Participants included 1,440 adult patients at a safety net primary care clinic, 720 of whom received IBH services, and 720 of whom received medical treatment only. RESULTS: Analysis showed that rates of preventable inpatient utilization decreased significantly among IBH-treated patients compared to no change among control patients. CONCLUSION: IBH was associated with decreased rates of preventable inpatient visits. IBH may present opportunities to deliver improved holistic patient care while reducing unnecessary inpatient medical utilization.

The relationship of life stressors, mood disorder, and health care utilization in primary care patients referred for integrated behavioral health services.

Exposure to stressful life events, mood disorder, and health care utilization were evaluated in 102 low-income, primarily minority patients receiving behavioral health and medical services at a safety-net primary care clinic. Exposure to major stressors was far higher in this sample than in the general population, with older patients having lower stress scores. Proportions of patients who met the criteria for clinical depression and anxiety were higher than in normative samples of primary care patients. Stress exposure was higher in the patients who met the criterion for clinical anxiety but was unrelated to clinical depression. Contrary to expectation, anxiety, depression, or stress exposure was not related to service utilization. Latter findings are discussed in terms of the influence of the provision of behavioral health services, the highly skewed distribution of major stressor scores, and the likely greater influence of individual differences in minor stressor exposure on utilization in this population.

The efficacy and tolerability of the ß3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients.

INTRODUCTION: mirabegron is a ß3-adrenoceptor agonist developed for the treatment of symptoms of overactive bladder (OAB). As the prevalence of OAB increases with age, a prospective subanalysis of individual and pooled efficacy and tolerability data from three 12-week, randomised, Phase III trials, and of tolerability data from a 1-year safety trial were conducted in order to evaluate the efficacy and tolerability of mirabegron in subgroups of patients aged ≥65 and ≥75 years. METHODS: primary efficacy outcomes were change from baseline to final visit in the mean number of incontinence episodes/24 h and the mean number of micturitions/24 h. Tolerability was assessed by the incidence of treatment-emergent adverse events (TEAEs). RESULTS: over 12 weeks mirabegron 25 mg and 50 mg once-daily reduced the mean numbers of incontinence episodes and micturitions/24 h from baseline to final visit in patients aged ≥65 and ≥75 years. Mirabegron was well tolerated: in both age groups, hypertension and urinary tract infection were among the most common TEAEs over 12 weeks and 1 year. The incidence of dry mouth, a typical anticholinergic TEAE, was up to sixfold higher among the older patients randomised to tolterodine than any dose of mirabegron. CONCLUSIONS: these analyses have demonstrated the efficacy of mirabegron over 12 weeks and the tolerability of mirabegron over 12 weeks and 1 year in OAB patients aged ≥65 and ≥75 years, supporting mirabegron as a therapeutic option in older patients with OAB.

Evaluation of integrated psychological services in a university-based primary care clinic.

Primary care is increasingly moving toward integration of psychological services; however few studies have been conducted to test the efficacy of such an integrated approach. This paper presents a program evaluation of psychological services provided by doctoral trainees in clinical and counseling psychology within a primary care clinic at an urban academic medical center. It includes: (1) a description of the program, including types of patients served, their presenting problems, and treatments administered and; (2) evidence of the impact of behavioral health services on primary care patients' emotional adjustment and progress on behavioral goals. Intake and follow-up measures of depression, anxiety, smoking, insomnia, chronic pain, and weight loss were collected on 452 adult patients (mean age = 52; 59 % African-American; 35 % uninsured) who were provided brief interventions (mean visits = 2.2) over a 16-month period. Although conclusions are limited by the lack of a control or comparison group, preliminary findings indicate that the integrated behavioral health services provided were effective. Implications and future directions are discussed.

Providers' roles in enhancing patients' adherence to pain self management.

Practice guidelines and empirical research related to pain management encourage clinicians to take active roles in providing education about self management and promoting adoption of a self-management approach. The purpose of the study was to review the relevant literature, summarize aspects of the patient-provider interaction that influence patient engagement in self management for chronic pain, and outline practice recommendations in this area. Review of the literature on aspects of the patient-provider interaction that promote engagement in pain self-management was used. Findings are synthesized into recommendations for providers. Patients benefit from a biopsychosocial and patient-centered approach. Patients are more likely to fully disclose when providers respond empathically, which can improve conceptualization and treatment. Patient education and motivation play important roles in engaging patients in self management. Self management is influenced in part by the patient-provider communication process. Suggestions for communication strategies to facilitate patient engagement in self-management techniques, including empathic discussion of barriers and motivation enhancement, are provided.

Predictors of consent in tissue donation: interpersonal aspects and information provision during requests by phone.

OBJECTIVE: To examine whether interpersonal behavior and provision of key information by tissue requesters (TRs) during phone requests for tissue donation with initially undecided next-of-kin (NOK) predict consent/refusal to donate. METHODS: The sample consisted of 102 TR-NOK dyads in which NOK reported that they were initially undecided about their intentions to donate their loved ones' tissue. Audiorecordings of requests, gathered from a national sample of tissue banks, were coded to assess for interpersonal behavior of each interactant. The effects of TR and NOK interpersonal behavior as well as information provision by the TR on consent/refusal were examined. RESULTS: Expressions of disapproval by the TR strongly predicted NOK donation decision. Predictors of consent included fewer questions asked and more supportive statements made by the TR, as well as reassurance from the TR that donation would not lead to disfigurement or affect the appearance of the body. CONCLUSION: Aspects of the communication process between TR and NOK during requests for tissue donation significantly predict consent to donate among initially undecided NOK. PRACTICE IMPLICATIONS: TR trainings aimed at improving interpersonal skills and provision of key information could potentially increase tissue donation consent rates.

Results of a randomized phase III trial of mirabegron in patients with overactive bladder.

PURPOSE: Many patients with overactive bladder discontinue pharmacotherapy due to suboptimal efficacy or side effects. Mirabegron, a ß3-adrenoceptor agonist, may offer an effective and well tolerated alternative treatment for overactive bladder. MATERIALS AND METHODS: A randomized, double-blind, placebo controlled trial was conducted in the United States and Canada. After a 2-week placebo run-in period, adults with overactive bladder symptoms for 3 or more months were randomized 1:1:1 to receive placebo, 50 or 100 mg mirabegron once daily for 12 weeks. Efficacy data were collected via patient completed diaries and quality of life assessments. Co-primary efficacy end points were changes from baseline to final visit in mean number of incontinence episodes per 24 hours and micturitions per 24 hours. Key secondary micturition and incontinence end points were also evaluated. Safety assessments included treatment emergent adverse events, laboratory assessments, vital signs, electrocardiograms and post-void residual volume. RESULTS: Compared to placebo, 50 and 100 mg mirabegron groups demonstrated statistically significantly greater mean decreases (95% CI) from baseline for incontinence episodes (-1.13 [-1.35, -0.91], -1.47 [-1.69, -1.25] and -1.63 [-1.86, -1.40]) and micturitions (-1.05 [-1.31, -0.79], -1.66 [-1.92, -1.40] and -1.75 [-2.01, -1.48]) per 24 hours (p <0.05). Significant improvements in all key secondary end points were observed for both mirabegron doses vs placebo. The incidence of frequently reported treatment emergent adverse events (hypertension, urinary tract infection, headache, nasopharyngitis) was similar in the mirabegron and placebo groups. Dry mouth was reported for 1.5%, 0.5% and 2.1% of patients in the placebo, 50 and 100 mg mirabegron groups, respectively. CONCLUSIONS: Once daily mirabegron in a 50 or 100 mg dose is an effective treatment for overactive bladder symptoms with a low occurrence of side effects.

The interpersonal process in tissue donation requests with "undecided" next of kin.

CONTEXT: Although recent studies have demonstrated that tissue requesters' behavior during conversations about tissue donation affects consent rates, the link between requesters' behavior and consent rates remains unclear. OBJECTIVE: To examine whether positive/collaborative requester behaviors elicit complementary behaviors from next of kin who were initially undecided about their willingness to donate their deceased family member's tissues. DESIGN: -Audio recordings of requests were coded to assess for interpersonal behavior of each interactant. SETTING: Audio recordings were gathered from a national sample of tissue banks. PARTICIPANTS: One hundred and two requester-next-of-kin dyads, consisting of 102 relatives and 53 requesters. MAIN OUTCOME MEASURES: Tissue requester and next-of-kin affiliation and interpersonal control were assessed. Tissue requesters' persuasion, confirmation (eg, approval, empathy, reassurance) and disapproval, as well as next-of-kin approval and disapproval, were examined. RESULTS: Tissue requesters and next of kin tended to match one another on affiliation and complement one another on interpersonal control. "Key topics," which may affect the next of kin's decision, are discussed in only about one-third of requests. Next of kin were less affiliative and more disapproving when requesters were also more disapproving. Interpersonal behavior of the tissue requester, such as affiliation, statements of disapproval, and persuasion, as well as discussion of key topics, was a significant predictor of the interpersonal behavior of the next of kin. CONCLUSIONS: Positive requester behaviors elicited a positive response from undecided next of kin. Because many next of kin have limited knowledge about tissue donation before the request, the communication process may affect the next of kin's perceptions of donation and thus affect the likelihood of consent. Findings could potentially inform communication skills training for tissue requesters; future research could examine effects of such training on consent rates.

OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial.

BACKGROUND: Patients with urgency urinary incontinence (UUI) due to overactive bladder (OAB) refractory to oral antimuscarinics have limited therapeutic options. OnabotulinumtoxinA appears to be an effective new treatment. OBJECTIVE: Assess disease-specific quality-of-life outcomes and general health-related quality-of-life (HRQOL) outcomes following treatment with onabotulinumtoxinA in patients with idiopathic OAB and UUI inadequately managed with antimuscarinics. DESIGN, SETTING, AND PARTICIPANTS: A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study conducted at 40 sites from July 2005 to June 2008 with 313 patients (288 females) with idiopathic OAB experiencing eight or more UUI episodes per week and eight or more micturitions per day at baseline, with follow-up of 36 wk. INTERVENTION: Intradetrusor onabotulinumtoxinA (50 U, 100 U, 150 U, 200 U, or 300 U) or placebo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQOL was assessed using the urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), the King's Health Questionnaire (KHQ) symptom component, and the Medical Outcomes Study 36-Item Short-Form Health Survey. Descriptive statistics were used for absolute scores/changes from baseline. Within-group changes from baseline were assessed using paired t tests. Change from baseline for each onabotulinumtoxinA group compared with placebo was analyzed using an analysis of covariance model. RESULTS AND LIMITATIONS: OnabotulinumtoxinA treatment at doses≥100 U produced significantly greater improvements than placebo in the I-QOL total and subscale scores at all follow-up visits from week 2 through week 24 (p<0.05). OnabotulinumtoxinA doses≥100 U produced significantly greater improvements than placebo in the KHQ symptom score at a majority of follow-up visits. HRQOL instruments demonstrated low to moderate correlations (Spearman correlation range: 0.01-0.51) with the symptoms of UUI recorded using daily diary data, with I-QOL demonstrating the highest correlations. A study limitation was that certain quality-of-life measures were exploratory and not validated. CONCLUSIONS: A single onabotulinumtoxinA treatment with doses≥100 U resulted in statistically significant and clinically meaningful improvement in HRQOL by week 2 compared with placebo, and this improvement was sustained for ≤36 wk in patients with idiopathic OAB and UUI who were inadequately managed by oral antimuscarinics. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00168454.

Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.

INTRODUCTION: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS. AIMS: This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy. METHODS: Men were ≥ 45 years old, sexually active, and experiencing ED for ≥ 3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation). MAIN OUTCOME MEASURES: The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed. RESULTS: Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo -3.8 ± 0.5, tadalafil 2.5 mg -4.6 ± 0.4, and 5 mg -6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters. CONCLUSIONS: Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.

Roles of sex and ethnicity in procurement coordinator--family communication during the organ donation discussion.

CONTEXT: Interpersonal relations with health care providers influence families' decisions to consent to solid-organ donation. However, previous research has been based on retrospective interviews with donation-eligible families and has not directly examined the interpersonal interactions between families and organ procurement coordinators. OBJECTIVE: To increase understanding of the interpersonal interaction between procurement coordinators and families during the organ donation discussion, with special attention to the influence of the sex and race of the procurement coordinator and the race of the potential donor's family. DESIGN: A descriptive study in which standardized patients portrayed family members interacting with actual procurement coordinators in simulated donation request scenarios. SETTING AND PARTICIPANTS: Thirty-three videotaped interactions between standardized patients and 17 procurement coordinators involving 2 different scenarios depicting deceased donation were evaluated. MAIN OUTCOME MEASURES: Video recordings were rated by independent coders. Coders completed the Impact Message Inventory-Form C, the Participatory Style of Physician Scale, and the Siminoff Communication and Content and Affect Program-Global Observer Ratings scale. RESULTS AND CONCLUSIONS: African American procurement coordinators, particularly African American women, were rated as more controlling and work-oriented than white procurement coordinators. Male procurement coordinators were more affiliative with the white family than the African American family, whereas female procurement coordinators were slightly less affiliative with the white family. African American procurement coordinators expressed more positive affect when interacting with the African American family than the white family, whereas the opposite was true for white procurement coordinators. Research is needed to cross-validate these exploratory findings and further examine cultural mistrust between procurement coordinators and families of ethnic minorities, especially given the negative attitudes of many minorities toward donation.

Changes in peak urinary flow and voiding efficiency in men with signs and symptoms of benign prostatic hyperplasia during once daily tadalafil treatment.

OBJECTIVE: To determine, by post hoc analysis, the effects of tadalafil (a long-acting phosphodiesterase 5 inhibitor) on peak urinary flow (Q(max)), bladder capacity, voiding efficiency and the obstructive symptoms of benign prostatic hyperplasia (BPH) in men with lower urinary tract symptoms secondary to BPH (BPH-LUTS), compared with placebo. PATIENTS AND METHODS: After a 4-week placebo run-in period, 1058 men with BPH-LUTS were randomly allocated to receive once daily treatment with placebo or tadalafil (2.5, 5, 10, or 20 mg) for 12 weeks. Uroflowmetry, postvoid residual volume (PVR), and BPH symptom score measurements were assessed throughout the trial. RESULTS: Increases in Q(max) were numerically greater for tadalafil (2.5, 5, 10, and 20 mg with percentage changes of 15%, 16%, 17%, 22%, respectively) vs placebo (12%), but did not reach statistical significance. Age, baseline Q(max), erectile dysfunction history, sexual activity, and previous alpha-blocker therapy significantly influenced the Q(max) response. Tadalafil was not associated with significant changes in PVR. Tadalafil had its greatest effects on bladder capacity and voiding efficiency in men with a Q(max) of <10 mL/s at baseline, but these changes were not significantly different from placebo responses. Tadalafil treatment significantly improved the IPSS obstructive subscores (tadalafil 2.5, 5, 10, 20 mg with percentage changes of 24%, 31%, 33%, 33%, respectively) vs placebo (13%). CONCLUSIONS: Once daily tadalafil did not significantly change Q(max) or voiding efficiency compared with placebo in men with BPH-LUTS, although there were dose-dependent improvements. No subgroups were identified where tadalafil or placebo treatment had a deleterious effect on Q(max). Despite these minimal changes in uroflowmetric measures, tadalafil was associated with clinically meaningful and statistically significant improvements in the obstructive symptoms of BPH.

Emotional distress, coping and adjustment in family members of neuroscience intensive care unit patients.

OBJECTIVE: We evaluated emotional distress, coping strategy use, caregiver adjustment, and the relationship among these variables in family members (FMs) of patients hospitalized in a neuroscience intensive care unit (NSICU). METHODS: Fifty-one primary relatives of NSICU patients were administered the Brief Symptom Inventory (BSI) and an abbreviated version of the COPE within 2 days of admission to the NSICU, just prior to patient discharge from the unit, and approximately 30 days after patient discharge (follow-up). FMs' adjustment to the role of caregiver was also evaluated at follow-up with the Caregiver Appraisal Scale (CAS). RESULTS: BSI emotional distress levels were higher than those of the nonpatient normative sample at patient admission, but, except for anxiety, were within a standard deviation of the mean of the said group; with the exception of anxiety they declined to below nonpatient normative levels at follow-up. Females' distress levels were higher than those of males'. FMs' use of both problem-focused and emotion-focused coping strategies increased from admission through follow-up. Emotional distress was unrelated to problem-focused coping but was associated with emotion-focused coping at admission and discharge, with use of denial as a coping strategy primarily accounting for this relationship. Extent of use of both problem-focused and emotion-focused coping at admission was associated with better caregiver adjustment at follow-up, but over time only increases in problem-focused coping were associated with better subsequent caregiver adjustment. CONCLUSIONS: Findings suggest that interventions fostering increased use of problem-focused coping and sense of control will be effective in lowering FM distress level and enhancing subsequent adjustment in the role of caregiver.

The impact on patient health outcomes of interventions targeting the patient-physician relationship.

Over the past 3-4 decades, numerous studies have been published evaluating interventions targeted at healthcare providers, at patients, or at both patients and healthcare providers, which are designed to, in some fashion, improve the provider-patient relationship and thereby enhance patient health outcomes. This article synthesizes findings from 14 literature reviews of relevant studies published between 1991 and 2007. Findings indicate that interventions aimed at physicians and other providers have consistently produced positive effects on provider communication behaviors and interpersonal skills. However, only moderately positive effects on patient satisfaction, and limited impact on patient healthcare behaviors such as compliance, appointment adherence, and resource use were found. Effects on primary medical outcomes were minimal although some positive effects on secondary medical outcomes such as quality of life were obtained. Patient-targeted interventions also showed consistently positive effects on patient-physician communication in addition to enhanced patient participation in decision making. Effects on patient primary medical outcomes were limited, and weak effects on patient satisfaction were obtained. Characteristics of studies and training programs that may have influenced outcomes are discussed, as are practical impediments to promoting better physician-patient communication in clinical practice.

Vardenafil demonstrates first-dose success and reliability of penetration and maintenance of erection in men with erectile dysfunction - RELY-II.

OBJECTIVE: Vardenafil has been shown to be efficacious in patients with erectile dysfunction (ED). We evaluated first-dose and repeat-dose response to vardenafil 20 mg. METHODS: This randomized, placebo-controlled study consisted of a 4-week, treatment-free run-in phase; a 1-week, open-label challenge phase; and a 12-week, double-blind treatment phase. Primary efficacy was assessed in terms of reliability of insertion based on dose as measured by the Sexual Encounter Profile question 2 (SEP2). We assessed safety by evaluating adverse events (AEs). RESULTS: Baseline patient characteristics in the 2 treatment groups were similar. The most common comorbidities were hypertension (41%), dyslipidemia (28%) and diabetes mellitus (24%). Of the 573 patients receiving the 20-mg vardenafil challenge dose, 464 (81%) achieved first-time successful penetration (SEP2), and 401 (70%) reported successful erection maintenance (SEP3). Patients receiving vardenafil 20 mg had statistically (p < 0.001) and clinically superior SEP2 rates (85%) through weeks 0-12, compared with patients receiving placebo (45%). The increase in reliability of insertion was seen within the first 4 weeks of treatment. Vardenafil therapy was statistically (p < 0.001) and clinically superior to placebo for all secondary efficacy end points as well. Most AEs associated with vardenafil were mild to moderate, with headache, flushing and nasal congestion most frequently reported. CONCLUSION: Vardenafil 20 mg had a high first-dose success rate for both SEP2 (81%) and SEP3 (70%); this was maintained through to the study end point (85% for SEP2 and 78% for SEP3). These findings were achieved in men with frequently associated comorbidities including hypertension, dyslipidemia and diabetes.

Psychological factors associated with response to maxillofacial injury and its treatment.

PURPOSE: This study evaluated symptoms of acute stress disorder (ASD), satisfaction with appearance postsurgery, and satisfaction with care in patients with maxillofacial injury at their first postsurgical physician visit. To determine the best predictors of patients' ASD symptoms and satisfaction, data also were obtained on the patients' strategies for coping with the stress of the injury, on the patients' and doctors' interpersonal appraisals of each other, and on the doctors' participatory behavior during the visits. PATIENTS AND METHODS: A total of 47 patients who had sustained traumatic maxillofacial injury requiring emergency medical/surgical treatment were administered self-report measures immediately before and after their first postsurgical visit 10 to 12 days after trauma exposure. Doctors completed self-report measures after the visit and evaluated the patients' severity of injury. RESULTS: Patients experienced high levels of ASD in the short-term period after surgery. Use of emotion-focused strategies by patients to cope with stress was associated with more ASD symptoms but better satisfaction with facial appearance. The more severely injured patients were less satisfied with their appearance and were viewed by their doctors as being more interpersonally controlling during the postsurgical visit. CONCLUSIONS: Closer attention by doctors to patients' interpersonal behavior may aid in early identification of those patients with maxillofacial injury who may experience longer-term social problems related to their altered facial appearance.