Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: the diaspirin cross-linked hemoglobin traumatic hemorrhagic shock efficacy trial.

In 1996, the US Food and Drug Administration (FDA) enacted Rule 21 CFR section 50.24, which allows a narrow exception to the requirement for prospective informed consent from human research subjects in clinical trials investigating potentially beneficial therapies for acute, life-threatening conditions. The first clinical trial to be conducted under this rule was sponsored by Baxter Healthcare Corporation and approved by the FDA on November 21, 1996. This large, multicenter, randomized clinical trial was designed to compare the addition of diaspirin cross-linked hemoglobin (DCLHb) with standard care in the initial resuscitation of adults experiencing severe, uncompensated, traumatic hemorrhagic shock. Before the first planned interim analysis of the data, review of fatal adverse events revealed an imbalance in mortality between the 2 treatment groups. The Data Monitoring Committee (DMC) recommended suspension of patient enrollment 24 days later. Additional data collection and analyses confirmed the excess number of deaths in patients treated with DCLHb but failed to reveal the cause of these deaths. The trial was formally terminated after only 112 of the planned 850 patients had been enrolled. We review the events leading up to and the rationale behind the DMC recommendations for suspension of patient enrollment and trial termination. Although the DCLHb trial was unsuccessful in achieving its goals, the monitoring process worked well. Emergency research was facilitated by DMC oversight, and the interests of research subjects were protected by the actions of the DMC.

Career planning and development for emergency medicine faculty.

In this article, we propose a methodology to be used by emergency medicine faculty members who are interested in career planning and faculty development on an individual basis. The basic competencies needed by faculty and methods of setting goals are described. Educational courses, workshops, seminars, and self-study strategies that can be used to provide the basic competencies and meet defined goals are described, including the advantages and disadvantages of each method, the time commitment, and needed resources. The advantage of this methodology is the ability to customize a program to meet individual needs and fit into the constraints of available time and monetary resources.

A prospective study to identify high-yield criteria associated with acute intracranial computed tomography findings in head-injured patients.

We conducted a multicenter, prospective study of head-injured patients to identify high-yield clinical criteria for acute intracranial injuries. Emergency patients with a history of blunt head trauma occurring within 2 weeks and who underwent nonenhanced cranial computed tomography (CT) were entered onto the study during a 12-month period. Of the 264 patients, 32 (12%) had abnormal CT findings. Nine high-yield variables were associated with abnormal CT findings: alcohol use before injury, antegrade amnesia, prolonged loss of consciousness, anisocoria and/or fixed and dilated pupils, abnormal Babinski reflex, focal motor paralysis, cranial nerve deficit, Glasgow coma scale score of less than 15, and clinical signs of basilar skull fracture. Patients 2 years old or younger or older than 60 years of age showed a significantly greater prevalence of abnormal CT findings than patients of other ages.

Contrasting acute care and long-term care information systems needs.

Information systems in nursing facilities have their own set of requirements. While these may appear to be less complex than those required of acute care systems, they offer their own series of traps and pitfalls and the information systems manager should be wary of vendors who suggest that acute care systems can be readily modified for long-term care usage. Well-designed and implemented long-term care applications demand the same challenges to integration as do acute care products. Information provided by these systems must be designed to support not only the routine transactions of the facility, but also the strategic planning necessary for intelligent management decision making. It is not sufficient in this era to record and replay data. Data must be synthesized into meaningful summaries in order to be effectively used by executives. [7] This is also true for clinicians. Assessment data are increasingly used to position a patient in a case-mix or reimbursement group. Whereas acute care revolves around DRGs and ICD-9 codes (soon to be ICD-10), long-term care uses a patient review instrument (PRI), resident assessment protocols (RAPs), and resource utilization groups (RUGS). The successful information systems manager will have all of these measures at his or her disposal by financial class, insurance class, and days receivable if eyes are kept on the goal of planning all of the systems with equal care and an eye to the future.

The incidence of post minor traumatic brain injury syndrome: a retrospective survey of treating physicians.

There is a relative lack of information in the literature regarding the epidemiology, functional significance, and clinical resolution of the consequences of minor traumatic brain injury (MTBI). Most retrospective studies to date have been elicited by direct patient interview. Because it was supposed that a minor, but significant, traumatic brain injury would require continuing medical intervention beyond the emergency room contact, a survey was conducted of primary care physicians who were believed to be providing continuing medical care. Had their patients required reevaluations for symptoms of the post-MTBI syndrome? Two hundred fifty-six patients with traumatic brain injury initially seen in the emergency room of two community hospitals were reviewed. One hundred ninety-two (75%) had MTBIs (Glasgow coma scale more than 12 and a negative head CAT scan). One hundred twenty-two physicians were surveyed by mail; 67 (55%) responded. Twenty-one percent of their patients were experiencing symptoms of the post-MTBI syndrome from two to six months after their injuries. Studies relying on patient interviews have also estimated the post-MTBI syndrome at 20%. This correlation implies that "suggestion" does not bias patient interview style research in evaluating the post-MTBI syndrome.

Microscopic hematuria and calculus-related ureteral obstruction.

The evaluation of patients with ureteral calculi in the emergency department has historically included urinalysis (UA) and intravenous pyelograms (IVP). This retrospective study was done to determine if a statistically significant relationship existed between the degree of calculus-related ureteral obstruction, proven by IVP, and the presence or absence of microscopic hematuria. Urine red blood cells were recorded as less than 3 rbc/hpf (negative) or greater than or equal to 3 rbc/hpf (positive). IVPs were recorded as nonsevere or severe. IVP criteria were based on the presence or absence of extravasation, greater than 2-hour ureteral filling times, and a numerical scoring system of 1 to 4 for ureteral or calyceal dilatation and nephrogenic effect. Eighty-nine men (72%) had non-severe obstructions and 34 (28%) had severe obstructions. Twenty-five women (68%) had nonsevere obstructions and 12 (32%) had severe obstructions. Of the 28 patients with normal UAs, 11 had severe ureteral obstructions and 17 had nonsevere ureteral obstructions. There were no statistically significant differences between the presence or absence of significant microscopic hematuria and the presence or absence of severe ureteral obstruction. Microscopic hematuria is neither sensitive nor specific in determining the degree of calculus-related ureteral obstruction.

Emergency department revisits.

We reviewed the charts of patients returning within 72 hours to our emergency department to determine whether monitoring revisits is a useful quality assurance indicator. Patient visits for June and December 1987 were selected to eliminate a potential seasonal difference. Of the 13,261 visits during these two months, 455 (3.4%) were revisits within 72 hours. Charts were available on 444 patients, of whom 407 (91.7%) represented cases in which the return and the initial visits were clearly related. Charts were reviewed for deficiencies in medical management, appropriate prescribed follow-up, patient education, and patient compliance. Suspected medical management problems were discussed by the three senior authors, and a consensus decision was made. Return visits were considered avoidable if a deficiency was noted in at least one of the areas listed above. There were 297 unscheduled related return visits, 96 (32.3%) of which were avoidable. Of these avoidable visits, 38 (39.6%) had medical management deficiencies, 14 (14.6%) had inappropriate prescribed follow-up, 20 (20.8%) had not been given proper education, and 35 (36.5%) were due to patient noncompliance. Of the 110 scheduled return visits, there was one (0.9%) deficiency in medical management and none in the other categories. Of the unscheduled return visits, 146 (49.2%) returned within 24 hours; 89 (30.0%) between 24 and 48 hours; and 62 (20.8%) between 48 and 72 hours. Of the avoidable visits, 85% returned within 48 hours, as did 92% of those with medical management deficiencies.(ABSTRACT TRUNCATED AT 250 WORDS)

Emergency thoracotomy.

Emergency thoracotomy is a valuable therapeutic modality for the moribund patient when trauma is the cause of the shock state. It is a procedure that requires an understanding of the technique and indications and should be instituted based on the indications listed above. There is probably no reason to do this procedure in the patient who is in extremis as a result of blunt trauma, because results have been universally dismal in these patients. In the patient with a rapidly expanding abdomen resulting from trauma and who is moribund, opening the chest and cross-clamping the aorta may be beneficial. Emergency thoracotomy does not take the place of volume replacement and definitive surgical care for the trauma patient.

Thoracostomy.

Tube thoracostomy in the Emergency Department is an integral part of trauma and care and treatment of nontraumatic intrapleural collections. An understanding of pleuropulmonary anatomy, physiology, and pathophysiology forms the basis for appropriate and safe application of this procedure. Rapid diagnosis and treatment of intrapleural collections in the trauma patient is essential when one considers the grave prognosis of untreated tension pneumothorax or massive hemothorax. Prior knowledge of possible procedural complications with particular attention to thoracostomy site, sterile technique, and careful blunt dissection makes chest tube placement straightforward and safe. Most post-procedural complications can be avoided through a thorough understanding of the collection system and careful monitoring of the patient.