Developing a Medical Scribe Program at an Academic Hospital: The Hennepin County Medical Center Experience.

BACKGROUND: Medical scribes are frequently incorporated into the patient care model to improve provider efficiency and enable providers to refocus their attention to the patient rather than the electronic health record (EHR). The medical scribe program was based on four pillars (objectives): (1) provider satisfaction, (2) standardized documentation, (3) documentation components for risk adjustment, and (4) revenue enhancement. METHODS: The medical scribe program was deployed in nine non-resident-supported clinics (internal medicine, ophthalmology, orthopedics, hematology/oncology, urology), with the medical scribes (who have no clinical duties) supporting both physicians and advanced practice providers (nurse practitioners and physician assistants). This paper describes a prospective quasi-experimental study conducted at an academic, inner-city, hospital-based clinic system, RESULTS: A pre-post analysis showed positive results; of the 51 providers, 44 responded to the survey pre and 41 responded post. Respondents in the post-scribe group felt that a scribe was valuable (90.2%), that documentation time at the office improved (75.0% poor or marginal pre-scribe, vs. 24% post; p <0.0001), and that time spent on the EHR at home declined (63.6% with excessive or moderately high home EHR time pre vs. 31.7% post; p = 0.003). More providers felt satisfied with their role in clinic with the use of scribes, and more providers felt that with scribes they could listen sufficiently to patients (p <0.05). CONCLUSION: Scribe support was well received across the institution in multiple clinical settings. Benefits for providers were seen in documentation time and ability to listen to patients. Scribes appear to be an effective intervention for improving clinician work life.

Parting messages from current and former editors of the Journal of Andrology.

The proposal to produce this final commemorative issue for the Journal of Andrology arose during our regular discussions as current editors soon after it was announced that the Journal would complete its own life course and merge into a new publication (to be named Andrology) with the International Journal of Andrology. We considered the momentous occasion to be one that should be celebrated with an enduring tribute in recognition of the Journal's exceptional 33-year existence. Among the various contributions sought for inclusion in this issue, we envisioned an article assembling collected short essays from all living former editors drawing on notable events and highlights, if not less well-known challenges and successes arising during their editorship eras. We thought that any such production of musings, viewpoints, and most of all words of wisdom from those who have had major roles in the direction and accomplishments of the Journal would offer an illuminating read for the society's members and friends and provide all readers another venue to share in and enjoy the Journal's great history. We are enthralled to have gathered these collections, all personal compositions of the former editors-in-chief, and for their effort that has helped us complete this special endeavor we express to them our tremendous gratitude. Serving as the Journal's last editors, we are also grateful to contribute our essay at the very end as part of this joyous chronicle.

Daily vardenafil for 6 months has no detrimental effects on semen characteristics or reproductive hormones in men with normal baseline levels.

PURPOSE: Phosphodiesterase type 5 inhibitors are the first choice therapy in the treatment of erectile dysfunction. Many men in their reproductive years are now using phosphodiesterase type 5 inhibitors. The purpose of this study was to determine the effects of 6 months of treatment with 20 mg vardenafil, compared with 100 mg sildenafil and placebo, on semen characteristics and reproductive hormones in men with and without erectile dysfunction. MATERIALS AND METHODS: This was a randomized, double-blind, placebo controlled, parallel group, multicenter study. A total of 200 men with or without erectile dysfunction, able to produce semen samples without erectile dysfunction therapy, 25 to 64 years old, were randomized to daily treatment with vardenafil, sildenafil or placebo for 6 months. The primary variable was the percentage of vardenafil treated individuals with a 50% or greater decrease in mean sperm concentration from baseline to 6-month last observation carried forward, compared with placebo treated individuals. RESULTS: The between group difference (vardenafil minus placebo) in the percentage of patients with 50% or greater decrease in sperm concentration (baseline to 6 months last observation carried forward) was 0.07% (95% CI, -8.53% to 8.39%). Vardenafil also had no clinically significant effects on any other semen parameters, or on levels of reproductive hormones, when compared with placebo. Similar data were observed with sildenafil. CONCLUSIONS: This study demonstrated that vardenafil had no adverse effects on sperm concentration, compared with sildenafil and placebo, when administered daily at the maximum recommended dose for 6 months. Specifically, use of vardenafil for 6 months does not impair sperm concentration, total sperm count per ejaculate, or sperm morphology and motility. Levels of reproductive hormones were also unaffected.

Efficacy and safety of tadalafil in men with erectile dysfunction with a high prevalence of comorbid conditions: results from MOMENTUS: multiple observations in men with erectile dysfunction in National Tadalafil Study in the US.

INTRODUCTION: Limited efficacy and safety data exist from open-label clinical trials of phosphodiesterase 5 inhibitors in men with erectile dysfunction (ED) and multiple comorbid (MCM) conditions, historically a difficult group to treat. AIM: A multicenter study (Multiple Observations in Men with Erectile Dysfunction in National Tadalafil Study in the US) assessed efficacy and safety of tadalafil in men with ED and MCM conditions. MAIN OUTCOME MEASURES: The primary end point was change from baseline in the erectile function (EF) domain of the International Index of Erectile Function. Secondary end points included the Sexual Encounter Profile, Global Assessment Questions, and Sexual Self-Confidence and Spontaneity Domains of the Psychological and Interpersonal Relationship Scales. METHODS: This was an open-label, multicenter study in men with ED. Tadalafil 20 mg was administered as needed prior to sexual activity, up to once/day, for 12 weeks following a 4-week ED-treatment-free period. The MCM group was 155 of 1,911 men enrolled in this study. Men in the MCM group met eligibility criteria but could not be included in other predefined groups: (i) Caucasian; (ii) Black American; (iii) Hispanic (groups 1-3, < or =65 years, no diabetes or depression); (iv) depression, < or =65 years, no diabetes; (v) diabetes, < or =65 years, no depression; (vi) >65 years, no diabetes or depression; and (vii) ED subsequent to traumatic spinal cord injury. RESULTS: Mean baseline EF domain score in MCM (mean age 65 +/- 9 years) was 12.2 +/- 6.5; 52% of subjects had severe ED; 72% diabetes mellitus; 67% cardiovascular disease (including hypertension); 49% hyperlipidemia; 38% depression; 84% had two or more comorbidities. At end point, there was a significant (P < 0.001) mean change of 7.6 from baseline in mean EF domain score. Among men with severe ED, 22% achieved an EF domain score > or =26. Most common adverse events were headache 5.2%; flushing 3.9% and nasal congestion 3.2%; 3% discontinued use because of an adverse event. CONCLUSIONS: In this open-label clinical trial of older men with ED and MCMs, tadalafil 20 mg significantly increased all efficacy end points and was well-tolerated.

Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials.

BACKGROUND: No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation. METHODS: We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094. FINDINGS: 672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0.0001, all doses vs placebo). Mean IELT at baseline was 0.90 (SD 0.47) minute, 0.92 (0.50) minute, and 0.91 (0.48) minute, and at study endpoint (week 12 or final visit) was 1.75 (2.21) minutes for placebo, 2.78 (3.48) minutes for 30 mg dapoxetine, and 3.32 (3.68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8.7%, 20.1%), diarrhoea (3.9%, 6.8%), headache (5.9%, 6.8%), and dizziness (3.0%, 6.2%). INTERPRETATION: On-demand dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation.

Acute effect of vasectomy on the function of the rat epididymal epithelium and vas deferens.

Persistent infertility after apparently successful vasectomy reversal is common. One possible etiology is epididymal epithelial dysfunction resulting in improper sperm maturation after vasectomy reversal. The epididymal epithelium secretes a number of proteins that are thought to be required for the maturation of sperm. Ligation of the vas deferens during vasectomy may affect the synthesis of some of these proteins. In the present study, the function of the epididymal epithelium was assessed at early times after vasectomy (1, 4, and 7 days) by measuring the level of mRNA of 4 secreted proteins: Crisp-1, clusterin, osteopontin, and transferrin. In addition, the site of synthesis of these proteins was determined by immunocytochemistry. The results demonstrated that the expression of Crisp-1 and clusterin, representative epididymal secretory proteins, was largely unaffected by vasectomy. However, osteopontin mRNA increased in the vas deferens in response to vasectomy. Immunocytochemical localization of osteopontin suggested that both infiltrating immune cells and deferential luminal epithelium were responsible for this up-regulation. Transferrin expression was viewed as a marker for immune cells at the site of injury. However, both the caput epididymis and deferential epithelia were found to express transferrin, in addition to immune cells. In conclusion, there appear to be only minor changes in expression of genes encoding epididymal secretory proteins acutely after vasectomy, but, not surprisingly, there was evidence of an inflammatory response after vasectomy.

Single-blind, multicenter, placebo controlled, parallel study to assess the safety and efficacy of intralesional interferon alpha-2B for minimally invasive treatment for Peyronie's disease.

PURPOSE: We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie's disease. MATERIALS AND METHODS: A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie's disease were enrolled in a single-blind, multicenter, placebo controlled, parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy (Schering, Kenilworth, New Jersey), including 62 who received placebo and 55 who received interferon alpha-2b. Saline (10 ml) in controls and interferon alpha-2b (5 x 10(6) U) were administered biweekly for 12 weeks. Each patient was evaluated for penile curvature, plaque size and density, penile pain, erectile function and penile hemodynamics before and after study completion. Improvement in these parameters was statistically compared between the groups. RESULTS: A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study. Improvement in penile curvature, plaque size and density, and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo. The increase in mean International Index of Erectile Function scores was not significantly different between the groups. Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo. The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases. Side effects, mostly flu-like symptoms, which were frequently noted in patients on interferon alpha-2b, were mild to moderate in degree and of short duration. CONCLUSIONS: This single-blind, multicenter, placebo controlled, parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie's disease.

Carnitine for the treatment of idiopathic asthenospermia: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine the effect of oral carnitine supplementation on the semen parameters of men with idiopathic asthenospermia. DESIGN: Prospective, randomized, double-blind placebo-controlled study. SETTING: Academic tertiary referral centers. PATIENT(S): Male patients presenting with infertility and with sperm motility of 10%-50% were selected. INTERVENTION(S): Patients were randomized to 24-week treatment arms of oral carnitine (2,000 mg L-carnitine and 1,000 mg L-acetyl-carnitine per day) or placebo. MAIN OUTCOME MEASURE(S): Sperm motility and total motile sperm counts at baseline, 12 weeks, and 24 weeks. Seminal plasma and sperm free, acetyl, and total L-carnitine levels at baseline and at week 24. RESULT(S): Twenty-one patients entered the study, with 12 patients in the carnitine arm and 9 in the placebo arm. There were no significant differences in baseline semen parameters between the carnitine and placebo arms. There was no statistically significant or clinically significant increase in motility or total motile sperm counts between baseline, 12 week, or 24 weeks in the carnitine or placebo arms. CONCLUSION(S): Carnitine supplementation demonstrated no clinically or statistically significant effect on sperm motility or total motile sperm counts in men with idiopathic asthenospermia.

Prevalence and effect of varicoceles in an elderly population.

OBJECTIVES: The prevalence of a varicocele in the adolescent and young adult populations is approximately 15%. Because other varicose veins increase in prevalence with advanced age, we hypothesized that the incidence of varicoceles in the elderly population would be greater and might affect testicular size, consistency, and function. METHODS: As part of a prostate cancer screening program, we prospectively evaluated 354 men (mean age 60.7 years) by physical examination for the presence of a varicocele, testicular size, and consistency, and measured the serum testosterone level. RESULTS: A varicocele was present bilaterally in 19.8% (70 of 354), left sided only in 22.0% (78 of 354), and right sided only in 1.1% (4 of 354) of patients. Decreased testosterone levels correlated with older age (P = 0.001) and the presence of bilaterally soft testes (P = 0.02) but not the presence of a varicocele. Testes in men with bilateral varicoceles were significantly smaller (P = 0.001) and softer (P = 0.001) than in men without varicoceles. Higher grade varicoceles were more likely to be associated with soft testes (P = 0.001) than were lower grade varicoceles. CONCLUSIONS: The 42% prevalence of varicoceles in our elderly population was greater than that for historic control younger populations, suggesting either an increase with age or examiner sensitivity bias. Varicoceles in the elderly, especially when bilateral, significantly affect testicular consistency (softer) and testicular size (smaller), but do not directly decrease serum testosterone levels. The presence of bilaterally soft testes in elderly men indicates bilateral gonadal dysfunction and may be a physical examination finding associated with decreased serum testosterone.

Postradiotherapy intratesticular leiomyosarcoma.

We report what we believe to be the first case of high-grade, radiation-induced, intratesticular leiomyosarcoma in a 30-year-old man who had had testicular relapse of acute lymphoblastic leukemia at age 12 years that was treated with standard testicular field radiation (2400 cGy) and chemotherapy. Radiation-induced tumors of this type are rare, have a median latency of 10 years, and are usually dose dependent (around 5000 cGy). Testicular leiomyosarcoma, especially high grade, remains to be fully characterized. After radical orchiectomy, patients should be followed up with serial germ cell tumor markers and imaging to monitor for metastatic spread. The use of retroperitoneal lymph node dissection and chemotherapy remains controversial but is probably not indicated.

Premature ejaculation: an observational study of men and their partners.

INTRODUCTION: Premature ejaculation (PE) is the most common male sexual dysfunction affecting men and their partners. Lack of community-based data describing this condition limits understanding of PE and its outcomes. AIM: To characterize PE in a large population of men with and without PE using patient-reported outcome (PRO) measures elicited from men and their partners. METHODS: 4-week, multicenter, observational study of males (> or =18 years) and their female partners in monogamous relationships (> or =6 months). Screening, baseline, and follow-up visits scheduled at 2-week intervals. Clinicians diagnosed PE utilizing DSM-IV-TR criteria. Intravaginal ejaculatory latency time (IELT), measured by a stopwatch held by the partner, was recorded for each sexual intercourse experience. Subject and partner independently assessed PROs: control over ejaculation and satisfaction with sexual intercourse (0 = very poor to 4 = very good), personal distress and interpersonal difficulty (0 = not at all to 4 = extremely), and severity of PE (0 = none to 3 = severe). Results. Of the total study population (N = 1,587), 207 subjects were diagnosed with PE and 1,380 were assigned to the non-PE group. Median IELT (min) was 1.8 (range, 0-41) for PE and 7.3 (range, 0-53) for non-PE subjects (P < 0.0001). More PE vs. non-PE subjects gave ratings of "very poor" or "poor" for control over ejaculation (72% vs. 5%; P < 0.0001) and satisfaction with sexual intercourse (31% vs. 1%; P < 0.0001). More subjects in the PE vs. non-PE group gave ratings of "quite a bit" or "extremely" for personal distress (64% vs. 4%; P < 0.0001) and interpersonal difficulty (31% vs. 1%; P < 0.0001). Subject and partner assessments showed similar patterns and correlated moderately (0.36-0.57). CONCLUSIONS: PE subjects reported significantly shorter IELT. Overlap in IELT distributions was observed between the PE and non-PE groups, indicating the need for additional PRO measures to characterize PE. Shorter IELT was significantly associated with reduced ejaculatory control and sexual satisfaction and increased distress and interpersonal difficulty.

Use of botulinum toxin type B for the treatment of detrusor hyperreflexia in a patient with multiple sclerosis: a case report.

We describe a patient with multiple sclerosis (MS) who had detrusor hyperreflexia that was not responsive to oral medications or clean intermittent catheterization. This patient was successfully treated with 2 separate injections of botulinum toxin type B into the bladder. The results of the treatment lasted 4 months and there were no side effects. A cystometrogram (CMG) done before the botulinum toxin type B injections showed significant detrusor instability. A repeat CMG months later showed no detrusor instability. To our knowledge, this is the first reported successful use of botulinum toxin type B in a patient with detrusor hyperreflexia from MS.

Varicocele--the most common cause of male factor infertility?

Varicocele is often cited as the most common cause of male factor infertility. Arguments in support of this statement include reports of increased prevalence of varicocele in populations of infertile men compared with fertile or otherwise unselected men, association of varicocele with abnormal semen parameters, and improvements in semen parameters and/or pregnancy rates after varicocele repair. Logically, there would appear to be three possibilities regarding the relationship between varicocele and fertility: (i) varicocele has no association with or effect on male fertility; (ii) varicocele may be associated with, but is not the cause of, male subfertility; and (iii) varicocele is a direct cause of male subfertility. In the following, we review evidence from the literature for and against these three possibilities: at the current time, available evidence appears inadequate to confirm or deny any of these three possibilities. Since the ultimate goal of infertile couples is to conceive, it seem logical that future varicocele research should focus primarily on adequately powered, controlled clinical trials in well-characterized infertile couples, randomized to intervention or appropriate controlled observation, with pregnancy as the primary outcome.