The efficacy and safety of tadalafil: an update.

OBJECTIVE: To provide an update on the efficacy and safety of tadalafil, a phosphodiesterase-5 inhibitor, in the treatment of erectile dysfunction (ED). PATIENTS AND METHODS: In all, 2102 men (mean age 56 years) with mild-to-severe ED of various causes were randomized to placebo or tadalafil, taken as needed with no food restrictions, at fixed 'on-demand' doses of 10 or 20 mg in 11 randomized, double-blind, placebo-controlled trials lasting 12 weeks. The three co-primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF) and the proportion of 'yes' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question (GAQ). RESULTS: Compared with placebo, tadalafil gave significantly better outcomes. Patients receiving either dose of tadalafil had a significant mean improvement of 6.5 and 8.6, respectively, in the IIEF erectile function domain score from baseline (P < 0.001 vs placebo). At both doses the mean success rate for intercourse attempts (SEP-Q3) was 58% and 68%, respectively, compared with 31% in the placebo group (P < 0.001), and 71% and 84% reported improved erections at the endpoint (GAQ), vs 33% on placebo (P < 0.001). Tadalafil was effective up to 36 h after dosing and was effective regardless of disease severity and causes, and in patients of all ages. The most frequent adverse events were headache, dyspepsia, back pain and myalgia. CONCLUSION: Tadalafil was an effective and well-tolerated treatment for ED.

Intravenous administration of prochlorperazine by 15-minute infusion versus 2-minute bolus does not affect the incidence of akathisia: a prospective, randomized, controlled trial.

STUDY OBJECTIVE: We sought to compare the rate of akathisia after administration of intravenous prochlorperazine as a 2-minute bolus or 15-minute infusion. METHODS: We conducted a prospective, randomized, double-blind study in the emergency department of a central-city teaching hospital. Patients aged 18 years or older treated with prochlorperazine for headache, nausea, or vomiting were eligible for inclusion. Study participants were randomized to receive 10 mg of prochlorperazine administered intravenously by means of 2-minute push (bolus group) or 10 mg diluted in 50 mL of normal saline solution administered by means of intravenous infusion during a 15-minute period (infusion group). The main outcome was the number of study participants experiencing akathisia within 60 minutes of administration. Akathisia was defined as either a spontaneous report of restlessness or agitation or a change of 2 or more in the patient-reported akathisia rating scale and a change of at least 1 in the investigator-observed akathisia rating scale. The intensity of headache and nausea was measured with a 100-mm visual analog scale. RESULTS: One hundred patients were enrolled. One study participant was excluded after protocol violation. Seventy-three percent (73/99) of the study participants were treated for headache and 70% (70/99) for nausea. In the bolus group, 26.0% (13/50) had akathisia compared with 32.7% (16/49) in the infusion group (Delta=-6.7%; 95% confidence interval [CI] -24.6% to 11.2%). The difference between the bolus and infusion groups in the percentage of participants who saw a 50% reduction in their headache intensity within 30 minutes was 11.8% (95% CI -9.6% to 33.3%). The difference in the percentage of patients with a 50% reduction in their nausea was 12.6% (95% CI -4.6% to 29.8%). CONCLUSION: A 50% reduction in the incidence of akathisia when prochlorperazine was administered by means of 15-minute intravenous infusion versus a 2-minute intravenous push was not detected. The efficacy of prochlorperazine in the treatment of headache and nausea likewise did not appear to be affected by the rate of administration, although no formal statistical comparisons were made.

Work interrupted: a comparison of workplace interruptions in emergency departments and primary care offices.

STUDY OBJECTIVE: We sought to determine the number of interruptions and to characterize tasks performed in emergency departments compared with those performed in primary care offices. METHODS: We conducted an observational time-motion, task-analysis study in 5 nonteaching community hospitals and 22 primary care offices in 5 central Indiana cities. Twenty-two emergency physicians and 22 office-based primary care physicians (PCPs) were observed at work. The number of interruptions, tasks, simultaneous tasks, and patients concurrently managed were recorded in 1-minute increments during 150- to 210-minute observation periods. RESULTS: Emergency physicians were interrupted an average of 9.7 times per hour compared with 3.9 times per hour for PCPs, for an average difference of 5.8 times per hour (95% confidence interval [CI] 4.2 to 7.4). PCPs spent an average of 11.4 minutes per hour performing simultaneous tasks compared with 6.4 minutes per hour for emergency physicians (average difference, 5.0 minutes; 95% CI 1.2 to 8.8). Emergency physicians spent an average of 37.5 minutes per hour managing 3 or more patients concurrently compared with 0.9 minutes per hour for PCPs. PCPs spent significantly more time performing direct patient care, and emergency physicians spent significantly more time in analyzing data, charting, and taking reports on patients. CONCLUSION: Emergency physicians experienced more interruptions and managed more patients concurrently than PCPs. PCPs spent more time performing simultaneous tasks than emergency physicians. Our study suggests there are important ergonomic differences between emergency medicine and office-based primary care work environments that may require different training approaches, design considerations, and coping strategies.

A pilot study to assess the safety of dobutamine stress echocardiography in the emergency department evaluation of cocaine-associated chest pain.

STUDY OBJECTIVE: Chest pain in the setting of cocaine use poses a diagnostic dilemma. Dobutamine stress echocardiography (DSE) is a widely available and sensitive test for evaluating cardiac ischemia. Because of the theoretical concern regarding administration of dobutamine in the setting of cocaine use, we conducted a pilot study to assess the safety of DSE in emergency department patients with cocaine-associated chest pain. METHODS: A prospective case series was conducted in the intensive diagnostic and treatment unit in the ED of an urban tertiary-care teaching hospital. Patients were eligible for DSE if they had used cocaine within 24 hours preceding the onset of chest pain and had a normal ECG and tropinin I level. Patients exhibiting signs of continuing cocaine toxicity were excluded from the study. All patients were admitted to the hospital for serial testing after the DSE testing in the intensive diagnostic and treatment unit. RESULTS: Twenty-four patients were enrolled. Two patients had inadequate resting images, one DSE was terminated because of inferior hypokinesis, another DSE was terminated because of a rate-related atrial conduction deficit, and 1 patient did not reach the target heart rate. Thus, 19 patients completed a DSE and reached their target heart rates. None of the patients experienced signs of exaggerated adrenergic response, which was defined as a systolic blood pressure of greater than 200 mm Hg or the occurrence of tachydysrhythmias (excluding sinus tachycardia). Further suggesting lack of exaggerated adrenergic response, 13 (65%) of 20 patients required supplemental atropine to reach their target heart rates. CONCLUSION: No exaggerated adrenergic response was detected when dobutamine was administered to patients with cocaine-related chest pain.

Sublingual hyoscyamine sulfate in combination with ketorolac tromethamine for ureteral colic: a randomized, double-blind, controlled trial.

STUDY OBJECTIVE: We evaluate the safety and efficacy of a single dose of hyoscyamine sulfate in combination with ketorolac tromethamine for the reduction of pain in emergency department patients with ureteral colic. METHODS: We conducted a prospective, randomized, double-blind study at 2 EDs with residency programs in emergency medicine. Patients were at least 18 years old and presented to the ED with an initial history and physical examination consistent with ureteral colic. Patients received a single intravenous dose of 30 mg of ketorolac tromethamine given over a 1-minute period with either a single sublingual dose of 0.125 mg of hyoscyamine sulfate or a placebo. If inadequate analgesia was noted after 30 minutes, a standard dose of meperidine could be administered for rescue. All other treatments including intravenous fluids and antiemetics were standardized. The main study outcome was change in visual analog scale pain score from baseline to 30 minutes. RESULTS: Seventy-two patients were evaluated for inclusion. Thirteen patients who had self-administered pain medications within 4 hours of presentation were excluded before randomization. Sixteen patients who did not have a renal calculus confirmed by either intravenous urogram or helical computed tomography were also excluded from efficacy analysis. There did not appear to be any clinically important differences in the baseline characteristics between the 2 groups. The repeated-measures analysis of the remaining 43 patients showed no clinically important difference in pain score using the visual analog scale at any time point. There were no clinically important differences between the 2 study groups for amount of rescue meperidine administered or end-of-study global satisfaction scores. CONCLUSION: Hyoscyamine sulfate did not provide any additional pain relief from ureteral colic when administered with ketorolac tromethamine. There was no clinically important difference in change of pain scores at 30 minutes in patients with ureteral colic receiving supplemental hyoscyamine sulfate.

Emergency department workplace interruptions: are emergency physicians "interrupt-driven" and "multitasking"?

OBJECTIVE: Although interruptions have been shown in aviation and other work settings to result in error with serious and sometimes fatal consequences, little is known about interruptions in the emergency department (ED). The authors conducted an observational, time-motion task-analysis study to determine the number and types of interruptions in the ED. METHODS: Emergency physicians were observed in three EDs located in an urban teaching hospital, a suburban private teaching hospital, and a rural community hospital. A single investigator followed emergency staff physicians for 180-minute periods and recorded tasks, interruptions, and breaks-intask. An "interruption" was defined as any event that briefly required the attention of the subject but did not result in switching to a new task. A "break-intask" was defined as an event that required the attention of the physician for more than 10 seconds and subsequently resulted in changing tasks. RESULTS: The mean (+/-SD) total number of patients seen at all three sites during the 180-minute study period was 12.1 +/- 3.7 patients (range 5-20). Physicians performed a mean of 67.6 +/- 15.7 tasks per study period. The mean number of interruptions per 180-minute study period was 30.9 +/- 9.7 and the mean number of breaks-in-task was 20.7 +/- 6.3. Both the number of interruptions (r = 0.63; p < 0.001) and the number of breaks-in-task (r = 0.56; p < 0.001) per observation period were positively correlated with the average number of patients simultaneously managed. CONCLUSIONS: Emergency physicians are "interruptdriven." Emergency physicians are frequently interrupted and many interruptions result in breaks-in-task.

Number needed to treat (NNT).

Because decisions regarding therapy are so common in clinical practice, the application of number needed to treat (NNT) is one of the most important evidence-based medicine skills to be acquired. NNT provides a clinically useful "yardstick" of the effort required to have a beneficial outcome or prevent a bad outcome with a therapy. A brief overview of the concept, derivation, and application of NNT is presented.

Academic emergency medicine's future. The SAEM Task Force on Emergency Medicine's Future. Society for Academic Emergency Medicine.

Emergency medicine (EM) will change over the next 20 years more than any other specialty. Its proximity to and interrelationships with the community, nearly all other clinicians (physicians and nonphysicians), and scientific/technologic developments guarantee this. While emergency physicians (EPs) will continue to treat both emergent and nonemergent patients, over the next decades our interventions, methods, and place in the medical care system will probably become unrecognizable from the EM we now practice and deliver. This paper, developed by the Society for Academic Emergency Medicine (SAEM) Task Force on Academic Emergency Medicine's Future, was designed to promote discussions about and actions to optimize our specialty's future. After briefly discussing the importance of futures planning, it suggests "best-case," "worst-case," and most probable future courses for academic EM over the next decades. The authors predict that EPs will practice a much more technologic and accurate form of medicine, with diagnostic, patient, reference, and consultant information rapidly available to them. They will be at the center of an extensive consultation network stemming from major medical centers and the purveyors of a sophisticated home health system, very similar to or even more advanced than what is now delivered on hospital wards. The key to planning for our specialty is for EM organizations, academic centers, and individuals to act now to optimize our possible future.

Prehospital oral endotracheal intubation by rural basic emergency medical technicians.

STUDY OBJECTIVE: To determine whether basic emergency medical technicians (EMT-B) can perform prehospital oral endotracheal intubation with success rates comparable to those of paramedics. METHODS: This was a nonrandomized, controlled trial using historical controls. Seven basic life support emergency medical services systems in six counties and their corresponding emergency departments in rural Indiana participated. Eighty-seven full-time EMTs with no prior or concurrent paramedic training volunteered for intubation training. Apneic prehospital patients aged 16 years or older without an active gag reflex or massive facial trauma were eligible for intubation and study enrollment. The EMTs completed a 9-hour didactic and airway manikin training course in direct laryngoscopic endotracheal intubation. The course was adapted from the national paramedic curriculum. RESULTS: Thirty-four (39%) of the EMT-Bs attempted to intubate 57 eligible patients. In 49.1% of these patients, successful endotracheal tube placement was confirmed by the receiving physician (95% confidence interval, 36.4% to 61.9%); in contrast, the prehospital intubation success rates from three previous studies of manikin-trained paramedics ranged from 76.9% to 90.6% (P < .001). Complications included five (9%) inadvertent extubations, two endotracheal tube cuff ruptures, two prolonged intubation attempts, and one mainstem bronchus intubation. There were no unrecognized esophageal intubations. Two of the seven EMS agencies did not report any intubation data. CONCLUSION: Rural EMTs with didactic and airway manikin training failed to achieve prehospital intubation success rates comparable to those of paramedic controls. Possible explanations include training deficiencies, poor skill transference from manikin to human intubation, infrequent intubation experiences, and inconsistent supervision.

Strategies for improving information management in emergency medicine to meet clinical, research, and administrative needs. Information Management Work Group.

The ED of the future will require the effective integration of information technologies into clinical care. This article proposes strategies for improving information management in emergency medicine to facilitate patient care, public health surveillance, clinical research, medical education, and health care management.

Strategies for improving information management in emergency medicine to meet clinical, research, and administrative needs. The Information Management Work Group.

The emergency department of the future will require the effective integration of information technologies into clinical care. This article proposes strategies for improving information management in emergency medicine to facilitate patient care, public health surveillance, clinical research, medical education, and health care management. Cordell WH, Overhage JM, Waeckerle JF, for the Information Management Work Group: Strategies for improving information management in emergency medicine to meet clinical, research, and administrative needs.

How do physicians and nurses spend their time in the emergency department?

STUDY OBJECTIVES: To determine how emergency physicians and nurses spend their time on emergency department activities. METHODS: An observational time-and-motion study was performed at a 36-bed ED with annual census of 84,000 in a central city teaching hospital sponsoring an emergency medicine residency program. Participants were emergency medicine faculty physicians, second- and third-year emergency medicine resident physicians, and emergency nurses. A single investigator followed individual health care providers for 180-minute periods and recorded time spent on various activities, type and number of activities, and distance walked. Activities were categorized as direct patient care (eg. history and physical examination), indirect patient care (eg. charting), or non-patient care (eg. break time). RESULTS: On average, subjects spent 32% of their time on direct patient care, 47% on indirect patient care, and 21% on non-patient care Faculty physicians, residents, and emergency nurses differed in the time spent on these three categories of activities. Although the overall time spent on direct patient care activities was not significantly different, emergency nurses spent more of their time (2.2%) providing comfort measures (a subcategory of direct patient care) than did faculty physicians (.05%) or resident physicians (.03%). Emergency nurses spent 38.9% of their time performing indirect care, whereas faculty physicians spent 51.3% and resident physicians 53.7%. Resident physicians spent more time charting than did faculty physicians or emergency nurses (21.4%, 11.9%, and 6.9%, respectively). Emergency nurses spent more time on personal activities than did physicians, and faculty physicians walked less than either emergency nurses or resident physicians. CONCLUSION: Emergency physicians and nurses spent almost half of their time on indirect patient care. Physicians spent significantly more time on indirect patient care activities and significantly less time on personal activities than did nurses.

Comparison of routes of flumazenil administration to reverse midazolam-induced respiratory depression in a canine model.

OBJECTIVE: To determine whether flumazenil, a drug used to reverse benzodiazepine-induced respiratory depression and approved only for i.v. use, is effective by alternative routes. METHODS: A randomized, controlled, nonblinded, crossover canine trial was performed to evaluate reversal of midazolam-induced respiratory depression by flumazenil when administered by alternative routes. Mongrel dogs were sedated with thiopental 19 mg/kg i.v., then tracheally intubated. With the dogs spontaneously breathing, tidal volume, end-tidal CO2, and O2 saturation were observed until a stable baseline was achieved. Incremental doses of midazolam were administered until respiratory depression (30% decline in tidal volume, 10% decrease in O2 saturation, and 15% increase in end-tidal CO2) occurred. Flumazenil was administered by a randomly selected route [0.2 mg followed 1 minute later by 0.3 mg i.v., sublingual (s.l.) or intramuscular (i.m.); or 1 mg followed 1 minute later by 1.5 mg per rectum (PR)]. Time to return to baseline respiratory functions was recorded ("time to reversal"). Each of 10 dogs was studied using all 4 routes of flumazenil administration with a washout period of at least 7 days. An additional dog served as a control (no flumazenil). RESULTS: The control time to reversal was 1,620 seconds. The i.v. route was significantly faster (mean 120 +/- 24.5 sec) than the other 3 routes (p < 0.005). The SL route was the second fastest (mean 262 +/- 94.5 sec), the IM route was the third fastest (mean 310 +/- 133.7 sec) and the PR route was the s;owest (mean 342 +/- 84.4 sec). The SL, IM, and PR routes did not differ significantly from one another. CONCLUSIONS: Flumazenil administered by all 4 routes reversed midazolam-induced respiratory depression in a dog model. For the selected dosages used, the i.v. route was significantly faster than all 3 other routes, and SL was the second fastest.

Dobutamine stress tele-echocardiography for evaluation of emergency department patients with chest pain.

OBJECTIVES: The practically and accuracy of dobutamine stress tele-echocardiography (DSTE) were assessed in patients presenting to the emergency department with chest pain. BACKGROUND: Many patients evaluated for chest pain in the emergency department (ED) are admitted to the hospital needlessly because of the difficulty in differentiating noncardiac chest pain from myocardial ischemia. METHODS: One hundred sixty-three patients with no evidence of myocardial infarction on initial blood studies or the electrocardiogram who were recommended for hospital admission to rule out myocardial infarction or myocardial ischemia were enrolled in this four-phase study. Rest echocardiography was performed in the ED, and the images were transmitted to a cardiologist for interpretation. If the results were normal, DSTE was then administered by a trained nurse. In the first three phases, all patients were admitted for observation regardless of the results of DSTE. In the fourth phase, those having normal DSTE results were able to be released. RESULTS: The test was completed within an average of 5.4 h of presentation to the ED. The sensitivity and specificity of DSTE versus clinical and cardiac catheterization findings were 89.5% and 88.9%, respectively, with a negative predictive value for DSTE of 98.5%. Patients experienced frequent mild side effects (54.7%), but few (6.3%) caused the test to be discontinued prematurely. In phase 4 of the study, 72% of those slated for hospital admission because of cardiac risk factors and chest pain suggesting myocardial ischemia were discharged after normal DSTE results. CONCLUSIONS: The use of DSTE in the evaluation of patients presenting with chest pain may improve screening for those who can be safely released from the ED.