Retinal effects of 6 months of daily use of tadalafil or sildenafil.

OBJECTIVE: To assess changes in electroretinography (ERG) and other retinal function parameters during 6 months of daily use of tadalafil, sildenafil citrate, or placebo. METHODS: Subjects were randomized to use of a placebo (n=82), 5 mg of tadalafil (n=85), or 50 mg of sildenafil (n=77) daily for 6 months. Electroretinographs were recorded using the International Society for Clinical Electrophysiology of Vision (ISCEV) protocol and standardized ERG equipment at all 15 study sites. Other tests of ocular anatomy and visual function were performed at each assessment. MAIN OUTCOME MEASURES: The primary outcome was the average mean change for both eyes from baseline to endpoint in ERG b-wave amplitude using dark-adapted combined standard response to a bright ISCEV standard flash. Secondary endpoints were other ERG parameter changes, visual acuity, number of errors in color discrimination testing, mean deviation in automated visual field testing, and intraocular pressure (IOP). RESULTS: No significant differences were found between treatment/placebo groups for the primary outcome, most other ERG variables, visual function, IOP, or anatomic assessments. The medications were well tolerated. CONCLUSIONS: No abnormalities in ERG or visual function and no treatment-related findings suggestive of drug toxicity are associated with daily administration of tadalafil or sildenafil for 6 months. APPLICATION TO CLINICAL PRACTICE: Assessed visual safety of tadalafil/sildenafil administered daily over a prolonged period. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00333281.

Emergency department procedural sedation with propofol: is it safe?

Propofol is a sedative agent gaining popularity for Emergency Department Procedural Sedation (EDPS). However, some institutions across the country continue to restrict the use of propofol secondary to safety concerns. The purpose of our study was to evaluate the complication rate of EDPS with propofol. We conducted a prospective, observational, multi-center study of EDPS patients aged > or = 18 years, consenting to procedural sedation with propofol. Eighty-two patients from two Level I trauma centers were enrolled between August 1, 2002 and January 31, 2003. Transient hypoxemia was the only noted sedation complication. Nine patients (11%) had brief hypoxemia. The combined average hypoxemia time was 1.2 min (SD 0.4), and in all instances responded to simple airway maneuvers or increased oxygen concentration. No patient required advanced airway maneuvers such as intubation or even positive pressure ventilation. EDPS with propofol seems to be safe in our population.

An assessment of the association of bispectral index with 2 clinical sedation scales for monitoring depth of procedural sedation.

OBJECTIVE: We conducted a study to assess the correlation of bispectral index (BIS) to 2 clinical sedation scales. METHODS: This was a prospective, observational study. The BIS number was recorded at baseline and every 30 seconds. One investigator separately monitored the patients for depth of sedation using the Observer's Assessment of Alertness/Sedation and the Continuum of Depth of Sedation scales. RESULTS: During the 6-month period, 75 patients were enrolled. The Spearman correlation between the BIS and the Observer's Assessment of Alertness/Sedation was 0.59 (95% confidence interval [CI], 0.44-0.74). The Spearman correlation between the BIS and the Continuum of Depth of Sedation was 0.53 (95% CI, 0.36-0.70). The mean minimum BIS for patients without a complication was 70 (SD, 15.9) compared with 68 (SD, 12.9) for patients with a complication (difference = 2; 95% CI, -7-11). CONCLUSIONS: Our study demonstrated moderate correlation between BIS and the 2 clinical sedation scales. The correlation is not strong enough to be used reliably in a clinical setting. The mean minimum BIS scores were not significantly different for those with sedation complications vs those without complications.

Semen and sperm reference ranges for men 45 years of age and older.

The most widely used reference values for human semen and sperm variables were developed by the World Health Organization (WHO) to help assess the fertility status of men interested in reproduction (typically a younger population). In this retrospective analysis, data from a large population of men aged 45 years or older were analyzed to derive semen and sperm reference ranges for an older population. Baseline semen samples were obtained from 1174 men with no or mild erectile dysfunction (ED) during the screening phase of two clinical trials evaluating the effects of a drug on human spermatogenesis. The median values and 95% reference ranges for 4 measured semen and sperm parameters (semen volume, sperm concentration, sperm motility, and sperm morphology) and 1 derived parameter (total sperm count) were calculated for the population and by age quartile. These references ranges were compared to established WHO reference values. Associations between the semen and sperm parameters and smoking status, alcohol use, and serum hormone concentrations were also analyzed. The mean age was 52.9 years (range: 45-80). Median semen volume, sperm motility, and sperm morphology parameters declined significantly with age. Only 46% of study subjects had baseline values for semen and sperm parameters that met or surpassed all the WHO reference values. This is the first study to statistically derive semen reference ranges from a large population of men aged 45 years or older. The observation that less than half the men in this study met all 4 WHO reference values for measured semen and sperm parameters underscores the need for age-specific reference ranges.

An evaluation of an alternative dosing regimen with tadalafil, 3 times/week, for men with erectile dysfunction: SURE study in 14 European countries.

OBJECTIVE: To examine the preference for 2 dosing regimens (on demand or 3 times/week) for tadalafil, a phosphodiesterase 5 inhibitor with a duration of effectiveness up to 36 hours in men with erectile dysfunction (ED). DESIGN AND METHODS: SURE is a 14 European country, multicenter, crossover, and open-label study. Men with ED (N=4262) were randomized to tadalafil 20mg treatment on demand (maximum one dose per day and before sexual activity) or 3 times/week for 5-6 weeks. After a 1-week washout period, patients were crossed over to the alternate regimen for 5-6 weeks. The patient's response to a treatment preference question (TPQ) was used to determine the preferred treatment regimen. RESULTS: The mean age of the randomized patients was 55 years and 85.2% reported a history of ED for one year or greater. Overall, the responses of 3861 men to the TPQ assessment showed that 57.8% preferred the on-demand regimen and 42.2% preferred the 3 times/week dosing. Both regimens were efficacious and well tolerated. CONCLUSIONS: In this study, while 57.8% of men preferred the on-demand regimen of tadalafil 20mg, a substantial number (42.2%) preferred the 3 times/week treatment. The two regimens provide additional treatment options by giving men with erectile dysfunction unique flexibility in dosing with tadalafil.

A survey to determine the prevalence and characteristics of training in Evidence-Based Medicine in emergency medicine residency programs.

We conducted a survey to determine the prevalence, training methods, and allotment of time for teaching evidence-based medicine (EBM) skills within accredited Emergency Medicine (EM) residency programs in the United States. A survey was mailed to program directors of all 122 accredited Emergency Medicine residency programs. The survey was also sent to program directors using an e-mail listserv. Responses were obtained from 53% of programs; 80% (95% CI: 68-89) of EM programs reported teaching some EBM. Although respondents believed a median of 10 hours were required to adequately cover this topic, only 22% provided more than 5 hours per year. Sixtey-three percent (95% CI: 50-75) of respondents reported using the JAMA Users' Guides series in journal club and 83% reported efforts to link journal clubs to patient care. Perceived barriers to integrating EBM into teaching and patient care included lack of trained faculty, lack of time, lack of familiarity with EBM resources, insufficient funding, and lack of interested faculty. In summary, academic EM programs are attempting to train residents in EBM, but perceive a lack of trained faculty, time, and funding as barriers. Desired resources include a defined curriculum, on-line training for faculty, and defined strategies for integration of EBM into training and patient care.

An extended care facility-to-emergency department transfer form improves communication.

OBJECTIVES: Previous studies have established that essential information is inconsistently provided during the transfer of extended care facility (ECF) patients to the emergency department (ED). The authors tested the hypothesis that a one-page, standard ECF-to-ED transfer form would change the rate of successful documentation of ECF patient information. METHODS: The design was a pre- and postintervention investigation. The setting was the Methodist Hospital ED, an urban teaching facility in Indianapolis, Indiana. The population included consecutive patients transferred from ECFs to the ED. The intervention consisted of the introduction of a one-page, standard ECF-to-ED transfer form that listed 11 data elements that are critical for patient care. The completed form was to be sent with patients transferred to the ED. Successful documentation was defined as the recording of at least nine of 11 data elements. RESULTS: In the preintervention period, the ED received 130 transfers from 41 ECFs. Sixty-five of 130 transfers were from ten ECFs, which were the targets of the intervention. In the postintervention period, 72 consecutive transfers from ten ECFs were studied. Postintervention, the proportion of transfers with successful documentation was 77.8% (56 of 72), an increase of 19.3% (95% CI = 4.0% to 34.7%) over the preintervention period. In 31.9% (23 of 72) of postintervention ED transfers, the transfer form was transported with the patient. Successful documentation was achieved in 22 (95.6%) of these 23 transfers. CONCLUSIONS: Use of a one-page, standard ECF-to-ED transfer form increased the amount of essential data provided to the ED.

An evaluation of emergency medicine resident interaction time with faculty in different teaching venues.

OBJECTIVES: To measure actual emergency medicine (EM) resident interaction time with faculty and to investigate the potential to use direct observation as an assessment tool for the core competencies. By 2006 all EM residencies must implement resident assessment techniques of the six Accreditation Council for Graduate Medical Education core competencies. Emergency medicine educators recommend direct observation as the optimal evaluation tool for patient care, systems-based practice, interpersonal and communication skills, and professionalism. Continuous faculty presence in the emergency department (ED) is widely believed to facilitate direct observation as an assessment technique. METHODS: Observational study of EM resident-faculty interaction time during two-hour periods. Study venues included two EDs, two trauma services, inpatient medicine, adult and pediatric intensive care units (ICUs), and a pediatric outpatient clinic. Using a priori definitions, the authors categorized faculty-EM resident interaction time as direct observation of patient care, indirect patient care, or non-patient care activities, and calculated total faculty interaction time. Subjects were blinded to the nature of the study, and data gathering was encrypted. RESULTS: Two hundred seventy observation periods of two hours each were conducted, sampling 32 EMR1, 33 EMR2-3, 41 EM, and 38 non-EM faculty. The mean total faculty interaction time ranged from a high of 30% (95% CI = 20% to 41%) in the pediatric ICU to a low of 10% (95% CI = 3% to 16%) on internal medicine wards. Overall, EM faculty interaction time was 20% (95% CI = 18% to 22%). Direct observation by faculty ranged from a high of 6% for EMR2-3s in the critical care areas of the ED (95% CI = 3% to 9%) to a low of 1% (95% CI = 0% to 2%) on internal medicine wards. Overall ED direct observation time was 3.6% (95% CI = 2.6% to 4.7%). Emergency department direct observation did not vary within EM resident training level or by ED site. Direct observation varied by treatment area within the EDs, with the critical care areas being substantially higher (6%) than the noncritical care areas (1%). CONCLUSIONS: Faculty direct observation time of EM residents was low in all training venues studied. Direct observation was the highest in ED critical care areas and lowest on medicine ward rotations. Emergency medicine faculty involved simultaneously in routine ED teaching, supervision, and patient care rarely performed direct observation, despite their continuous physical presence. This finding suggests that alternative strategies may be required to assess core competencies through direct observation in the ED.

Droperidol vs prochlorperazine for the treatment of acute headache.

To determine if droperidol i.v. is as effective as prochlorperazine i.v. in the emergency department (ED) treatment of uncomplicated headache, a randomized, controlled, blinded study was conducted in the Emergency Departments of two urban teaching hospitals. Patients >or= 18 years old with crescendo-onset headache were eligible for inclusion. Ninety-six patients (48 in each group) were randomized to receive droperidol 2.5 mg i.v. or prochlorperazine 10 mg i.v. Baseline characteristics were similar between the two study groups. For the main study outcome, 83.3% in the droperidol group and 72.3% in the prochlorperazine group reported 50% pain reduction at 30 min (p <.01; one-sided test of equivalence). The mean decrease in headache intensity was 79.1% (SD 28.5%) in the droperidol group and 72.1% (SD 28.0%) in the prochlorperazine group (p =.23). It is concluded that droperidol i.v. provided a similar reduction of headache as achieved with prochlorperazine i.v. with a similar incidence of akathisia.

Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study.

BACKGROUND AND PURPOSE: Hyperbaric oxygen therapy (HBO) has promise as a treatment for acute stroke. This study was conducted to evaluate the efficacy, safety, and feasibility of using HBO in acute ischemic stroke. METHODS: We conducted a randomized, prospective, double-blind, sham-controlled pilot study of 33 patients presenting with acute ischemic stroke who did not receive thrombolytics over a 24-month period. Patients were randomized to treatment for 60 minutes in a monoplace hyperbaric chamber pressurized with 100% O2 to 2.5-atm absolute (ATA) in the HBO group or 1.14 ATA in the sham group. Primary outcomes measured included percentage of patients with improvement at 24 hours (National Institutes of Health Stroke Scale [NIHSS]) and 90 days (NIHSS, Barthel Index, modified Rankin Scale, Glasgow Outcome Scale). Secondary measurements included complications of treatment and mortality at 90 days. RESULTS: Baseline demographics were similar in both groups. There were no differences between the groups at 24 hours (P=0.44). At 3 months, however, a larger percentage of the sham patients had a good outcome defined by their stroke scores compared with the HBO group (NIHSS, 80% versus 31.3%; P=0.04; Barthel Index, 81.8% versus 50%; P=0.12; modified Rankin Scale, 81.8% versus 31.3%; P=0.02; Glasgow Outcome Scale, 90.9% versus 37.5%; P=0.01) with loss of statistical significance in a intent-to-treat analysis. CONCLUSIONS: Although our HBO protocol appears feasible and safe, it does not appear to be beneficial and may be harmful in patients with acute ischemic stroke.

The high prevalence of pain in emergency medical care.

Although there is a widely held belief that pain is the number 1 complaint in emergency medical care, few studies have actually assessed the prevalence of pain in the emergency department (ED). We conducted an analysis of secondary data by using explicit data abstraction rules to determine the prevalence of pain in the ED and to classify the location, origin, and duration of the pain. This retrospective cross-sectional study was conducted at an urban teaching hospital in Indianapolis, IN. Charts from 1,665 consecutive ED visits during a 7-day period were reviewed. Pain was defined as the word pain or a pain equivalent word (including aching, burning, and discomfort) recorded on the chart. Of the 1,665 visits, 61.2% had pain documented anywhere on the chart, 34.1% did not have pain, and 4.7% were procedures. Pain was a chief complaint for 52.2% of the visits. This high prevalence of pain has important implications for the allocation of resources as well as educational and research efforts in emergency medical care.

The Frontlines of Medicine Project: a proposal for the standardized communication of emergency department data for public health uses including syndromic surveillance for biological and chemical terrorism.

The Frontlines of Medicine Project is a collaborative effort of emergency medicine (including emergency medical services and clinical toxicology), public health, emergency government, law enforcement, and informatics. This collaboration proposes to develop a nonproprietary, "open systems" approach for reporting emergency department patient data. The common element is a standard approach to sending messages from individual EDs to regional oversight entities that could then analyze the data received. ED encounter data could be used for various public health initiatives, including syndromic surveillance for chemical and biological terrorism. The interlinking of these regional systems could also permit public health surveillance at a national level based on ED patient encounter data. Advancements in the Internet and Web-based technologies could allow the deployment of these standardized tools in a rapid time frame.

Should parents be present during emergency department procedures on children, and who should make that decision? A survey of emergency physician and nurse attitudes.

OBJECTIVE: To survey physician and nurse attitudes regarding parental presence during painful procedures on children performed in the emergency department (ED) and who should make that decision. METHODS: The design was an anonymous written survey consisting of six clinical scenarios distributed to all staff and resident physicians and nurses in ten EDs at institutions in the United States routinely caring for children. Participants were asked whether parents should remain with children undergoing intravenous (IV) placement, laceration repair, lumbar puncture, conscious sedation, major resuscitation, and major resuscitation with death. They also were asked who should make the decision. RESULTS: The percentage of physicians who responded that parents should be present was 91.3% for peripheral IV start, 93.3% for laceration repair, 65.7% for lumbar puncture, 83.1% for conscious sedation, 31.9% for major resuscitation, and 35.6% for major resuscitation where death was likely. The percentage of nurses who responded that parents should be present was 86.8% for peripheral IV start, 89.6% for laceration repair, 55.0% for lumbar puncture, 74.9% for conscious sedation, 41.4% for major resuscitation, and 54.3% for major resuscitation where death was likely. In 64.8% of the completed surveys, the physicians indicated that they alone or in conjunction with a parent should make the decision. In 61.5% of the completed surveys, the nurses indicated that they should be involved in the decision. CONCLUSIONS: A majority of emergency physicians and nurses indicated parents should be present for some invasive pediatric procedures. However, as the invasiveness of the pediatric procedures increased, fewer physicians and nurses believed that parents should be present.

How relevant are the systematic reviews in the cochrane library to emergency medical practice?

STUDY OBJECTIVES: The Cochrane Database of Systematic Reviews (CDSR), one of the databases in the Cochrane Library, is a compilation of regularly updated systematic reviews with meta-analytic summary statistics. We conducted a study of the CDSR to evaluate the relevance of this database to emergency medical practice. METHODS: Using criteria that were determined a priori, 2 reviewers independently screened the titles of 795 completed reviews from the April 2000 CDSR for possible relevance to emergency medicine practice. Five reviewers independently ranked summaries of these reviews for degree of relevance. Agreement was measured using kappa statistics. Disagreements were resolved by consensus or adjudication. RESULTS: Screening of 795 completed reviews identified 136 (17%) as "possibly" and 151 (19%) as "likely" relevant (simple agreement, 74%; kappa=0.82). Further independent assessment indicated 95 (12%) of the 151 "likely" systematic reviews were directly relevant to emergency medicine practice, whereas 44 (6%) were indirectly relevant (simple agreement, 77%; kappa=0.45). Cochrane Review Groups producing the most emergency medicine-relevant systematic reviews included acute respiratory infections (14 [10%]), injuries (14 [10%]), pregnancy and childbirth (13 [10%]), stroke (12 [10%]), and airways (11 [8%]). In contrast, only 1 (0.1%) of the reviews produced by the Heart Review Group was considered directly relevant to emergency medicine practice. CONCLUSION: More than one third of CDSR reviews have some relevance, and 12% are directly relevant, to emergency medical practice or discharge planning. Although certain conditions are well covered, other key emergency medicine areas are not. Emergency physicians should consider the Cochrane Library an important evidence-based resource for emergency medicine therapeutic interventions and should examine ways of increasing the number of reviews relevant to emergency medicine.

A randomized, controlled trial of clinical information shared from another institution.

STUDY OBJECTIVE: Emergency physicians often must deliver medical care with minimal access to historical clinical information. We demonstrate the feasibility and potential value of increased access to patients' clinical information from another hospital while they are receiving care in the emergency department. METHODS: We conducted a pilot randomized, controlled trial of providing information from a large, longitudinal, computer-based patient record system of clinical data from an urban hospital to emergency physicians at either of 2 urban EDs. We randomized patients seen at either ED to have the information from the computer-based patient record system provided to their physician or to not have the information provided. We delivered information to the emergency physician both as a printed abstract and by means of online access to the computer-based patient record. We assessed charges, hospital admissions, repeat visits to EDs, and the emergency physicians' satisfaction with the information. RESULTS: Under certain assumptions, the intervention was estimated to decrease charges for ED care by approximately $26 per encounter (P =.03) at 1 hospital, but there was no effect on charges at the other hospital. This result was likely because of marked differences in the workflows and information access at these 2 EDs. We demonstrated no differences in admission rates or repeat visits to the ED. Emergency physicians identified that remembering their passwords and the time required to search for the information were significant barriers to accessing clinical information online. CONCLUSION: Our pilot study is the first to demonstrate the feasibility of sharing clinical information between different health care systems. We observed a trend toward cost savings at 1 of 2 hospitals and no differences in the quality measures we studied. Our experience underscores the difficulties inherent in studying the effects of community-wide health care interventions on cost and quality of ED care.

The clinician and the medical literature: When can we take a shortcut?

[Wyer PC, Rowe BH, Guyatt GH, Cordell WH. The clinician and the medical literature: when can we take a shortcut? Ann Emerg Med. August 2000;36:149-155.].

Echocardiography in the Emergency Department: From the Perspective of the Emergency Physician and the Cardiologist.

Echocardiography performed in the emergency department must adapt to this new setting for noninvasive diagnostic testing. Emergency physicians require echocardiography to provide rapid diagnosis in life-threatening emergencies. New initiatives are being proposed by emergency physicians in the delivery of this test. Cardiologists now use echocardiography in the emergency department to make the diagnosis of heart disease earlier and with greater accuracy.