Increased efficiency and cost-effectiveness in the evaluation of the blunt abdominal trauma patient with the use of ultrasound. Prospective evidence of the superiority of a sonography-based algorithm in the assessment of blunt abdominal injury. Randomized controlled study of ultrasound therapy in the management of acute lateral ligament sprains of the ankle joint. Randomized controlled clinical trial of point-of-care, limited ultrasonography for trauma in the emergency department: the first sonography outcomes assessment program trial. A randomized controlled clinical trial of 2295 ultrasound-guided embryo transfers. Intracranial haemodynamics in patients with spontaneous carotid dissection. Transcranial Doppler ultrasound follow-up studies. Prospective, randomized evaluation of early removal of nasogastric tubes in postceliotomy trauma patients. Ultrasound and pulsed electromagnetic energy treatment for perineal trauma. A randomized placebo-controlled trial. Randomized controlled trials in pediatric surgery: could we do better?
The efficacy and effectiveness of ultrasound (US) in evaluating patients suspected of having blunt abdominal trauma are near that of computed tomography (CT) and diagnostic peritoneal lavage (DPL). Because no cost-effectiveness study has been reported, the purpose of this study was to demonstrate that US is more efficient and cost-effective than CT/DPL in evaluating blunt abdominal trauma. Over a 9-month period, 331 patients suspected of sustaining blunt abdominal trauma were evaluated at a Level I trauma center by US, CT, and/or DPL. Cost data and time to disposition were determined for analysis. The sensitivity, specificity, and accuracy of US were similar to those reported in previous studies. There was a significant difference in time to disposition with the US group being significantly lower (P = 0.001). The total procedural cost was 2.8 times greater for the CT/DPL group than for the US group. US is not only effective in diagnosing blunt abdominal trauma, but it is also more efficient and cost-effective than is CT/DPL. Although the routine use of FAST (focused assessment with sonography for trauma) in the evaluation of trauma victims is increasing, to our knowledge, a prospective comparison of contemporary adult trauma victims managed with and without FAST has not been reported in North America.
                Adult victims of blunt trauma for whom there was a suspicion of abdominal injury were managed with one of two diagnostic algorithms, FAST or no-FAST. The two algorithms were compared for diagnostic accuracy, cost, time, and delayed diagnoses.
                Among 706 patients (mean Injury Severity Score, 23), 460 were managed with FAST and 246 with no-FAST. The two groups were similar with respect to age, Injury Severity Score, prehospital time, and mortality (p = not significant). There were 3 of 460 (0.7%) delayed diagnoses in the FAST group and 4 of 246 (1.6%) in the no-FAST group (p = not significant). The diagnostic accuracy for the FAST and no-FAST algorithms was 99% and 98%, respectfully. The FAST and no-FAST algorithms led to similar rates of laparotomy, 13% and 14%, respectfully, but nonoperative management was more common in the no-FAST group (p < 0.01). The mean diagnostic cost for the FAST algorithm was $156, compared with $540 with the no-FAST algorithm (p < 0.0001) and the mean time required for diagnostic work-up was 53 minutes with the FAST algorithm, compared with 151 minutes with the no-FAST algorithm (p < 0.0001).
                This study has provided prospective evidence that a FAST-based algorithm for blunt abdominal injury was more rapid, less expensive, and as accurate as an algorithm that used computed tomography or diagnostic peritoneal lavage only. Trauma centers are encouraged to incorporate a FAST-based algorithm into their initial management of blunt trauma victims. To determine the efficacy of a fixed dose of ultrasound energy to treat acute lateral ligament sprains of the ankle joint.
                Double-blind randomised controlled trial.
                Accident and Emergency department of University Teaching Hospital.
                Patients presenting at Accident and Emergency with ankle injuries.
                Ultrasound or placebo, and Tubigrip.
                Pain measured with visual analogue scales, swelling using a tape measure, range of movement using a fluid-filled goniometer, and weight bearing using two scales simultaneously.
                Patients in both groups improved symptomatically. There were no statistically significant differences between groups in any outcome measure. Within groups, statistically significant differences were detected in pain perceived, and range of movement (dorsiflexion).
                At the dose and duration used, ultrasound therapy is no better than placebo in the management of lateral ligament injuries. Annually, 38 million people are evaluated for trauma, the leading cause of death in persons younger than 45 years. The primary objective is to assess whether using a protocol inclusive of point-of-care, limited ultrasonography (PLUS), compared to usual care (control), among patients presenting to the emergency department (ED) with suspected torso trauma decreased time to operative care.
                The study was a randomized controlled clinical trial conducted during a 6-month period at 2 Level I trauma centers. The intervention was PLUS conducted by verified clinician sonographers. The primary outcome measure was time from ED arrival to transfer to operative care; secondary outcomes included computed tomography (CT) use, length of stay, complications, and charges. Regression models controlled for confounders and analyzed physician-to-physician variability. All analyses were conducted on an intention-to-treat basis. Results are presented as mean, first-quartile, median, and third-quartile, with multiplicative change and 95% confidence intervals (CIs), or percentage with odds ratio and 95% CIs.
                Four hundred forty-four patients with suspected torso trauma were eligible; 136 patients lacked consent, and attending physicians refused enrollment of 46 patients. Two hundred sixty-two patients were enrolled: 135 PLUS patients and 127 controls. There were no important differences between groups. Time to operative care was 64% (48, 76) less for PLUS compared to control patients. PLUS patients underwent fewer CTs (odds ratio 0.16) (0.07, 0.32), spent 27% (1, 46) fewer days in hospital, and had fewer complications (odds ratio 0.16) (0.07, 0.32), and charges were 35% (19, 48) less compared to control.
                A PLUS-inclusive protocol significantly decreased time to operative care in patients with suspected torso trauma, with improved resource use and lower charges. We wanted to test the hypothesis that using abdominal ultrasound at the time of embryo transfer to guide replacement, improved pregnancy rates by at least 5%.
                An RCT in a large assisted conception unit. A pilot study and power calculation suggested that at least 2000 embryo transfers were required to demonstrate a difference of 5%, for a test with 80% power and Type 1 error 0.05. Randomization, data entry and analysis were arranged independently. Randomization was stratified for age and fresh/frozen embryo transfer. Analysis was by intention to treat.
                There was no difference in clinical pregnancy or live birth rates between the two groups. The clinical pregnancy rate for ultrasound-guided embryo transfer was 22% and for non-ultrasound-guided embryo transfer was 23% (odds ratio: 0.96; 95% confidence interval: 0.79-1.18).
                We set out to determine whether ultrasound-guided embryo transfer improved clinical pregnancy rates and live birth rates in assisted conception. We used an appropriately powered RCT design. We did not demonstrate a difference. This outcome is at odds with the UKs National Institute of Clinical Excellence recommendations for fertility treatment (Fertility Assessment and Treatment for People with Fertility Problems. London, UK: RCOG Press, 2004, 112.) which used a meta-analysis of four smaller trials (range 362-800 patients, totalling 2051 embryo transfers) to conclude that ultrasound should be offered. We suggest that the current Cochrane review should be updated with data from our trial and recommend that consideration is given to accounting for heterogeneity between the included trials. In this study 11 patients aged between 34 and 57 years with clinical and angiographic findings typical of carotid dissection were thoroughly examined with transcranial Doppler ultrasound (TCD) repeatedly during a follow-up period of 1-6 months. Stagnating blood flow velocities in the downstream middle cerebral artery (MCA) were recorded initially as well as enhanced velocities due to postischaemic hyperperfusion syndrome. MCA embolism originating from the extracranial carotid artery with or without resolution could be detected by TCD in 5 cases. TCD findings in another 2 cases pointed to haemodynamic upset. In 3 cases, clinical as well as TCD data did not allow strict differentiation between embolic and haemodynamic complications, suggesting more complex pathophysiological mechanisms as the cause of infarction. Carotid recanalization was seen in 9 cases. The follow-up investigations moreover demonstrated that intracranial haemodynamics may change from day to day in patients suffering from internal carotid artery dissection. TCD data may thus improve the understanding of pathogenetics as well as rationales for individual therapeutic intervention in this particular disease. The objective of this study is to compare early (24-hour) removal of nasogastric tubes (NGTs) in trauma patients who have undergone emergency celiotomy to removal based on clinical signs of return of bowel function. All trauma patients who underwent an emergency celiotomy between November 1994 and August 1997 were randomized to 24-hour NGT removal, or removal when flatus and decreased NG output indicated. Exclusion criteria included patients with duodenal or esophageal injuries, those with airway intubations that were >24 hours, or those who had undergone same-hospitalization repeat celiotomy. Gastric or severity of intestinal injury were not exclusion criteria. Failure of NGT removal was defined as pain, abdominal distention, and vomiting. Mechanisms of injury, Injury Severity Score, operative findings, NGT removal times, morbidity, laboratory data, and reasons for failure were evaluated. A total of 177 patients qualified for the study. Two patients were inappropriately randomized and subsequently excluded. Of the remaining 175 patients, 151 sustained penetrating injuries and 24 sustained blunt injuries. Of the 151 patients in the penetrating injury group, 68 were randomized to the 24-hour pull (study) group and 83 were randomized to the clinical pull (control) group. There were three failures in the study group [3 of 68 patients (4.4%)] and three failures in the control group [3 of 83 patients (3.6%)]. Of the 24 blunt injury patients, 10 were randomized to the study group and 14 were randomized to the control group. There was one failure in the study group [1 of 10 patients (10.0%)] and one failure in the control group [1 of 14 patients (7.1%)]. Overall failure rate for the study group was 5.1 per cent [(3+1)/(68+10) = 5.1%] versus 4.1 per cent for the control group. Overall failure for all patients in the study was 4.6 per cent. Injury severity score, morbidity, and lab values were not significantly different. It is safe to remove NGTs at 24 hours in most trauma patients regardless of the severity of injury (failure rate, 5.1%). The surgical dogma of the need to have an NGT in longer for blunt trauma was not revealed in this study, however, a larger study would be needed to determine this with significance. Ultrasound and pulsed electromagnetic energy therapies are increasingly used for perineal trauma sustained during childbirth. The study included 414 women with moderate or severe perineal trauma randomly allocated to receive active ultrasound, or active pulsed electromagnetic energy, or corresponding placebo therapies; the allocation was double-blind for each machine. Overall, more than 90% thought that treatment made their problem better. There were no clear differences between the groups in outcome either immediately after treatment, or 10 days or 3 months postpartum, other than more pain associated with pulsed electromagnetic energy treatment at 10 days. Bruising looked more extensive after ultrasound therapy but then seemed to resolve more quickly. Neither therapy had an effect on perineal oedema or haemorrhoids. The place of these new therapies in postnatal care should be clarified by further controlled trials before they become part of routine care. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved.
There is currently insufficient evidence from RCTs to justify promotion of ultrasound-based clinical pathways in diagnosing patients with suspected blunt abdominal trauma.