Trauma/original researchRandomized Controlled Clinical Trial of Point-of-Care, Limited Ultrasonography for Trauma in the Emergency Department: The First Sonography Outcomes Assessment Program Trial
Introduction
Annually, more than 38 million people are evaluated in emergency departments (EDs) for trauma, the leading cause of death in persons younger than 45 years.1 The annual incidence of torso trauma is more than 5 million, resulting in more than 500,000 operations and 50,000 deaths.1, 2 Trauma deaths result, on average, in 40 years of life lost and 18 years of productive life lost.3 Total societal costs for trauma are estimated at more than $100 billion annually in the United States alone.4
The term “golden hour” is commonly used to characterize the urgent need for the care of trauma patients.5 The golden hour paradigm states that morbidity and mortality are affected if care is delayed beyond the first hour after injury. That earlier definitive care should be associated with better outcomes is intuitive and is the basis of the modern regional trauma center approach applied in many parts of the country.6, 7, 8, 9 Defining mechanisms to decrease time to provision of definitive care in this population must be a high priority.
Point-of-care, limited ultrasonography (PLUS) examinations are brief and limited studies intended to rapidly answer highly focused clinical questions, ie, is there occult fluid in the peritoneal, pericardial, or pleural cavity? PLUS examinations are distinct from comprehensive ultrasonographic examinations provided by radiology departments in terms of availability, format, and indication.10
Published studies suggest that the accuracy of PLUS for trauma in answering highly focused clinical questions is at least 95%.11, 12, 13, 14, 15 This accuracy is comparable to that obtained by radiologists.16 In addition, the results of 2 international consensus conferences strongly recommend the use of PLUS for trauma.17, 18 Unfortunately, although the questions of accuracy, rapidity, and safety of PLUS may be discussed with great confidence, evidence-based data demonstrating improvement in therapeutic and clinical outcomes for trauma victims are lacking.19 PLUS for trauma, used as a rapid screening tool, has the potential to reduce time to diagnosis and definitive care.15, 20
There are approximately 4,700 EDs in the United States, with approximately 10% having PLUS capability; the number of centers with PLUS availability is increasing.1, 10 The proper introduction of PLUS (equipment and training) to an ED costs approximately $100,000 initially, followed by $20,000 per year to maintain a high-quality resource.21 Therefore, instituting nationwide universal access to PLUS would cost approximately a billion health care dollars during 5 years.
The Sonography Outcomes Assessment Program (SOAP) is a multiphase health services research project designed to assess the effects of PLUS on patient outcomes in the emergency evaluation of common, costly, and potentially lethal clinical conditions. Toward this end, to generate hypotheses and estimate sample size for the prospective phase of this project, a pilot study was conducted using the National Trauma Data Bank of the American College of Surgeons,2 retrospectively assessing patients with torso trauma requiring operative intervention. The analysis compared time to operation, length of stay, and hospital charges in patients evaluated with early ultrasonography and patients not so evaluated.22
At analysis, the National Trauma Data Bank contained 316,975 incident reports on trauma patients, including 45,365 patients with torso trauma. Thirty-five percent of these patients underwent operative care with a mean “door to operative care” time of 55 minutes (48 minutes median, 27.2 minutes SD) in patients evaluated with early ultrasonography (<2 hours from presentation) and 92 minutes (80 minutes median, 72.4 minutes SD) in patients not undergoing early ultrasonographic examination (P<.005), which represented a 40% reduction in median door-to-operative-care time. The analysis yielded a mean reduction in charges of $18,456, with a median difference of $10,875. These differences were maintained in linear regression models controlling for injury severity and specific diagnoses. The length-of-stay analysis revealed a 3.5-day mean, 2.2-day median reduction in hospitalization length, which was not significant in the regression models.
These data facilitated the development of the SOAP-1 study, a randomized, controlled clinical trial to assess the effects of PLUS on the time to definitive care of patients with suspected torso trauma presenting to the EDs of 2 Level I trauma centers. Secondarily, diagnostic test use, length of stay, complication rates, and hospital charges were assessed to draw inferences about clinical and societal effectiveness and lay the groundwork for hypothesis-generating of future research, including a formal cost-effectiveness analysis.
Section snippets
Study Design
The study was a randomized, concealed, and controlled clinical trial. Patients enrolled were randomized to the PLUS (study) or control arms in blocks of 50 and stratified by center. Enrolled patients were randomized using a standard computer randomization program. The data sheets were coded and sealed in opaque envelopes. After screening, consenting, and enrollment, the subjects’ data collection envelopes were opened, revealing group assignment. Neither the treating physicians nor the patients
Characteristics of Study Subjects
Five hundred twenty-five patients were screened on arrival to the 2 EDs during the 6-month trial period in 2002 to 2003 (Figure 1). Four hundred forty-four (85%) patients met eligibility criteria. Eighty-one (18%) patients went directly to the operating suite, mostly (93%) because of penetrating wounds. One hundred eighty-two (41%) patients were not enrolled, because of lack of consent (136) or attending physician’s refusal to randomize (46). Two hundred sixty-two patients were enrolled and
Limitations
There were numerous limitations to our trial. First, the physicians treating the study subjects were not blinded to group assignment; they were required to integrate PLUS findings into the clinical decisionmaking process, which may have introduced a bias toward more rapid provision of care in the intervention group.
Second, 41% of eligible patients were not enrolled in the trial, because of lack of consent or attending refusal. The limited data available from the respective institutional trauma
Discussion
The purpose of this randomized controlled clinical trial was to assess the effect of PLUS for trauma on time from ED arrival to transfer to definitive care for patients suspected of having torso trauma. We found that PLUS resulted in a clinically relevant reduction in time to definitive care for patients with torso trauma.
Additionally, PLUS-evaluated patients underwent less CT, spent fewer days in the hospital, had fewer complications, and had substantially lower total charges for care. These
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Supervising editor: David T. Overton, MD, MBA
Author contributions: LAM, WMB, and CAM conceived the study and designed the trial. LAM and CAM supervised the conduct of the trial and data collection. EL, MGM, and PL undertook recruitment of participating centers and patients and managed the data, including quality control. WMB provided statistical advice on study design and analyzed the data. LAM drafted the manuscript, and all authors contributed substantially to its revision. LAM takes responsibility for the paper as a whole.
Funding and support: All funding was intramural from New York Methodist Hospital Research Committee.
Publication dates: Available online May 2, 2006.