Assessing Diagnostic Accuracy of Four-dimensional CT for Instable Scapholunate Dissociation: The Prospective ACTION Trial.

Background Timely treatment of scapholunate instability depends on early identification, but current imaging methods are either intricate or fail to demonstrate the dynamic stages. Purpose To calculate the diagnostic accuracy of four-dimensional (4D) CT for diagnosing instable scapholunate ligament (SLL) tears. Materials and Methods This prospective study enrolled consecutive participants with clinically suspected SLL tears who underwent 4D CT from July 2020 to May 2022. A historical study sample diagnosed at cineradiography served as a comparison, and wrist arthroscopy was the reference standard. Scapholunate joints greater than 3 mm were interpreted as instable at index 4D CT and cineradiography. Diagnostic accuracy was expressed as sensitivity and specificity. Areas under the receiver operating characteristic curve and cutoff values for both index tests were calculated. Intraclass correlation coefficients (ICCs) were computed to compare interrater reliability. Effective radiation doses at 4D CT were measured with thermoluminescent dosimeters. Results The study included 40 participants (mean age, 43 years ± 14 [SD]; 24 male) evaluated at 4D CT and 78 patients (mean age, 45 years ± 11; 50 male) historically evaluated at cineradiography. Four-dimensional CT helped detect instable tears in 26 of 35 participants (sensitivity, 74.3% [95% CI: 56.7, 87.5]. Cineradiography revealed instable tears in 52 of 63 patients (sensitivity, 82.5% [95% CI: 70.9, 91]). Four of five participants with stable scapholunate joints were identified at 4D CT (specificity, 80.0% [95% CI: 28.4, 99.5]), and 12 of 15 patients with stable SLLs were identified at cineradiography (specificity, 80.0% [95% CI: 51.9, 95.7]). Interrater agreement of radiologic measurements on 4D CT scans was good to excellent (ICC range, 0.89-0.96). The effective radiation dose ranged from 67 to 72 mSv at the wrist and was less than 1 mSv at the head. Conclusion Four-dimensional CT results are highly reproducible. Instable scapholunate joints greater than 3 mm were detected with a sensitivity of 74.3% and a specificity of 80% in an exploratory trial. Further evidence from larger randomized trials is warranted. German Register for Clinical Trials no. DRKS00021110 (Universal Trial Number U1111-1249-7884) Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Demehri and Ibad in this issue.

The influence of distribution, severity and volume of posttraumatic bone bruise on functional outcome after ACL reconstruction for isolated ACL injuries.

INTRODUCTION: Posttraumatic MRI of ACL tears show a high prevalence of bone bruise (BB) without macroscopic proof of chondral damage. Controversial results are described concerning the association between BB and outcome after ACL tear. Aim of this study is to evaluate the influence of distribution, severity and volume of BB in isolated ACL injuries on function, quality of life and muscle strength following ACL reconstruction (ACLR). MATERIALS AND METHODS: MRI of n = 122 patients treated by ACLR without concomitant pathologies were evaluated. BB was differentiated by four localizations: medial/lateral femoral condyle (MFC/LFC) and medial/lateral tibial plateau (MTP/LTP). Severity was graded according to Costa-Paz. BB volumes of n = 46 patients were quantified (software-assisted volumetry). Outcome was measured by Lysholm Score (LS), Tegner Activity Scale (TAS), IKDC, isokinetics and SF-36. Measurements were conducted preoperatively (t0), 6 weeks (t1), 26 weeks (t2) and 52 weeks (t3) after ACLR. RESULTS: The prevalence of BB was 91.8%. LTP was present in 91.8%, LFC 64.8%, MTP 49.2% and MFC 28.7%. 18.9% were classified Costa-Paz I, 58.2% II and 14.8% III. Total BB volume was 21.84 ± 15.27 cm3, the highest value for LTP (14.31 ± 9.93 cm3). LS/TAS/IKDC/SF-36/isokinetics improved significantly between t0-t3 (p < 0.001). Distribution, severity and volume had no influence on LS/TAS/IKDC/SF-36/isokinetics (n.s.). CONCLUSIONS: No impact of BB after ACLR on function, quality of life and objective muscle strength was shown, unaffected by concomitant pathologies. Previous data regarding prevalence and distribution is confirmed. These results help surgeons counselling patients regarding the interpretation of extensive BB findings. Long-time follow-up studies are mandatory to evaluate an impact of BB on knee function due to secondary arthritis.

Evaluation of Post-Hospital Care of Traumatic Brain Injury in Children, Adolescents and Young Adults-A Survey among General Practitioners and Pediatricians in Germany.

BACKGROUND: The long-term effects of mild Traumatic Brain Injury (TBI) in children and adolescents are increasingly discussed due to their potential impact on psycho-social development and education. This study aims to evaluate post-hospital care of children and adolescents after mild TBI using a physician survey. METHODS: A self-developed, pre-tested questionnaire on diagnostics and treatment of TBI in outpatient care was sent to a representative sample of general practitioners and pediatricians in Germany. RESULTS: Datasets from 699 general practitioners, 334 pediatricians and 24 neuropediatricians were available and included in the analysis. Nearly half of the general practitioners and most pediatricians say they treat at least one acute pediatric TBI per year. However, a substantive proportion of general practitioners are not familiar with scales assessing TBI severity and have difficulties assessing the symptoms correctly. Pediatricians seem to have better knowledge than general practitioners when it comes to treatment and outpatient care of TBI. CONCLUSIONS: To increase knowledge about TBI in outpatient physicians, targeted training courses should be offered, especially for general practitioners. Moreover, handing out written information about long-term effects and reintegration after TBI should be encouraged in outpatient practice.

ACTION trial: a prospective study on diagnostic Accuracy of 4D CT for diagnosing Instable ScaphOlunate DissociatioN.

BACKGROUND: Early detection of scapholunate ligament (SLL) tears is essential after minor and major trauma to the wrist. The differentiation between stable and instable injuries determines therapeutic measures which aim to prevent osteoarthritis. Arthroscopy has since been the diagnostic gold standard in suspected SLL tears because non-invasive methods have failed to exclude instable injuries reliably. This prospective study aims to determine the diagnostic accuracy of dynamic, 4D computed tomography (CT) of the wrist for diagnosing instable SLL tears. METHODS: Single center, prospective trial including 40 patients with suspected SLL tears scheduled for arthroscopy. Diagnostic accuracy of 4D CT will be tested against the reference standard arthroscopy. Radiologists will be blinded to the results of arthroscopy and hand surgeons to radiological reports. A historical cohort of 80 patients which was diagnosed using cineradiography before implementation of 4D CT at the study site will serve as a comparative group. DISCUSSION: Static imaging lacks the ability to detect instable SLL tears after wrist trauma. Dynamic methods such as cineradiography and dynamic magnetic resonance imaging (MRI) are complex and require specific technical infrastructure in specialized centers. Modern super-fast dual source CT scanners are gaining popularity and are being installed gradually in hospitals and ambulances. These scanners enable dynamic imaging in a quick and simple manner. Establishment of dynamic 4D CT of the wrist in patients with suspected SLL tears in in- and outpatient settings could improve early detection rates. Reliable identification of instable injuries through 4D CT scans might reduce the number of unnecessary diagnostic arthroscopies in the future. TRIAL REGISTRATION: This study was registered prospectively at the German Clinical Trials Register (DRKS) DRKS00021110 . Universal Trial Number (WHO-UTN): U1111-1249-7884.

Motor Control Stabilisation Exercise for Patients with Non-Specific Low Back Pain: A Prospective Meta-Analysis with Multilevel Meta-Regressions on Intervention Effects.

Low-to-moderate quality meta-analytic evidence shows that motor control stabilisation exercise (MCE) is an effective treatment of non-specific low back pain. A possible approach to overcome the weaknesses of traditional meta-analyses would be that of a prospective meta-analyses. The aim of the present analysis was to generate high-quality evidence to support the view that motor control stabilisation exercises (MCE) lead to a reduction in pain intensity and disability in non-specific low back pain patients when compared to a control group. In this prospective meta-analysis and sensitivity multilevel meta-regression within the MiSpEx-Network, 18 randomized controlled study arms were included. Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention). From each study site/arm, outcomes at baseline, 3 weeks, 12 weeks, and 6 months were pooled. The outcomes were current pain (NRS or VAS, 11 points scale), characteristic pain intensity, and subjective disability. A random effects meta-analysis model for continuous outcomes to display standardized mean differences between intervention and control was performed, followed by sensitivity multilevel meta-regressions. Overall, 2391 patients were randomized; 1976 (3 weeks, short-term), 1740 (12 weeks, intermediate), and 1560 (6 months, sustainability) participants were included in the meta-analyses. In the short-term, intermediate and sustainability, moderate-to-high quality evidence indicated that MCE has a larger effect on current pain (SMD = -0.15, -0.15, -0.19), pain intensity (SMD = -0.19, -0.26, -0.26) and disability (SMD = -0.15, -0.27, -0.25) compared with no exercise intervention. Low-quality evidence suggested that those patients with comparably intermediate current pain and older patients may profit the most from MCE. Motor control stabilisation exercise is an effective treatment for non-specific low back pain. Sub-clinical intermediate pain and middle-aged patients may profit the most from this intervention.

Association of Low-Dose Whole-Body Computed Tomography With Missed Injury Diagnoses and Radiation Exposure in Patients With Blunt Multiple Trauma.

Importance: Initial whole-body computed tomography (WBCT) for screening patients with suspected blunt multiple trauma remains controversial and a source of excess radiation exposure. Objective: To determine whether low-dose WBCT scanning using an iterative reconstruction algorithm does not increase the rate of missed injury diagnoses at the point of care compared with standard-dose WBCT with the benefit of less radiation exposure. Design, Setting, and Participants: This quasi-experimental, prospective time-series cohort study recruited 1074 consecutive patients admitted for suspected blunt multiple trauma to an academic metropolitan trauma center in Germany from September 3, 2014, through July 26, 2015, for the standard-dose protocol, and from August 7, 2015, through August 20, 2016, for the low-dose protocol. Five hundred sixty-five patients with suspected blunt multiple trauma prospectively received standard-dose WBCT, followed by 509 patients who underwent low-dose WBCT. Confounding was controlled by segmented regression analysis and a secondary multivariate logistic regression model. Data were analyzed from January 16, 2017, through October 14, 2019. Interventions: Standard- or low-dose WBCT. Main Outcomes and Measures: The primary outcome was the incidence of missed injury diagnoses at the point of care, using a synopsis of clinical, surgical, and radiological findings as an independent reference test. The secondary outcome was radiation exposure with either imaging strategy. Results: Of 1074 eligible patients, 971 (mean [SD] age, 52.7 [19.5] years; 649 men [66.8%]) completed the study. A total of 114 patients (11.7%) had multiple trauma, as defined by an Injury Severity Score of 16 or greater. The proportion of patients with any missed injury diagnosis at the point of care was 109 of 468 (23.3%) in the standard-dose and 107 of 503 (21.3%) in the low-dose WBCT groups (risk difference, -2.0% [95% CI, -7.3% to 3.2%]; unadjusted odds ratio, 0.89 [95% CI, 0.66-1.20]; P = .45). Adjustments for autocorrelation and multiple confounding variables did not alter the results. Radiation exposure, measured by the volume computed tomography dose index, was lowered from a median of 11.7 (interquartile range, 11.7-17.6) mGy in the standard-dose WBCT group to 5.9 (interquartile range, 5.9-8.8) mGy in the low-dose WBCT group (P < .001). Conclusions and Relevance: Low-dose WBCT using iterative image reconstruction does not appear to increase the risk of missed injury diagnoses at the point of care compared with standard-dose protocols while almost halving the exposure to diagnostic radiation.

Single versus dual Kirschner wires for closed reduction and intramedullary nailing of displaced fractures of the fifth metacarpal neck (1-2 KiWi): a randomized controlled trial.

AIMS: The aim of this study was to investigate whether clinical and radiological outcomes after intramedullary nailing of displaced fractures of the fifth metacarpal neck using a single thick Kirschner wire (K-wire) are noninferior to those of technically more demanding fixation with two thinner dual wires. PATIENTS AND METHODS: This was a multicentre, parallel group, randomized controlled noninferiority trial conducted at 12 tertiary trauma centres in Germany. A total of 290 patients with acute displaced fractures of the fifth metacarpal neck were randomized to either intramedullary single-wire (n = 146) or dual-wire fixation (n = 144). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire six months after surgery, with a third of the minimal clinically important difference (MCID) used as the noninferiority threshold. Secondary outcomes were pain, health-related quality of life (EuroQol five-dimensional questionnaire (EQ-5D)), radiological measures, functional deficits, and complications. RESULTS: Overall, 151/290 of patients (52%) completed the six months of follow-up, leaving 83 patients in the single-wire group and 68 patients in the dual-wire group. In the modified intention-to-treat analysis set, mean DASH scores six months after surgery were 3.8 (sd 7.0) and 4.4 (sd 9.4), respectively. With multiple imputation (n = 288), mean DASH scores were estimated at 6.3 (sd 8.7) and 7.0 (sd 10.0). Upper (1 - 2α)) confidence limits consistently remained below the noninferiority margin of 3.0 points in the DASH instrument. While there was a statistically nonsignificant trend towards a higher rate of shortening and rotational malalignment in the single wire group, no statistically significant differences were observed across groups in any secondary outcome measure. CONCLUSION: A single thick K-wire is sufficient for intramedullary fixation of acute displaced subcapital fractures of the fifth metacarpal neck. The less technically demanding single-wire technique produces noninferior clinical and radiological outcomes compared with the dual-wire approach. Cite this article: Bone Joint J 2019;101-B:1263-1271.

Duration of antibiotic treatment and risk of recurrence after surgical management of orthopaedic device infections: a multicenter case-control study.

BACKGROUND: Device-related infections in orthopaedic and trauma surgery are a devastating complication with substantial impact on morbidity and mortality. Systemic suppressive antibiotic treatment is regarded an integral part of any surgical protocol intended to eradicate the infection. The optimal duration of antimicrobial treatment, however, remains unclear. In a multicenter case-control study, we aimed at analyzing the influence of the duration of antibiotic exposure on reinfection rates 1 year after curative surgery. METHODS: This investigation was part of a federally funded multidisciplinary network project aiming at reducing the spread of multi-resistant bacteria in the German Baltic region of Pomerania. We herein used hospital chart data from patients treated for infections of total joint arthroplasties or internal fracture fixation devices at three academic referral institutions. Subjects with recurrence of an implant-related infection within 1 year after the last surgical procedure were defined as case group, and patients without recurrence of an implant-related infection as control group. We placed a distinct focus on infection of open reduction and internal fixation (ORIF) constructs. Uni- and multivariate logistic regression analyses were employed for data modelling. RESULTS: Of 1279 potentially eligible patients, 269 were included in the overall analysis group, and 84 contributed to an extramedullary fracture-fixation-device sample. By multivariate analysis, male sex (odds ratio [OR] 2.06, 95% confidence interval [CI] 1.08 to 3.94, p = 0.029) and facture fixation device infections (OR 2.05, 95% CI 1.05 to 4.02, p = 0.036) remained independent predictors of reinfection. In the subgroup of infected ORIF constructs, univariate point estimates suggested a nearly 60% reduced odds of reinfection with systemic fluoroquinolones (OR 0.42, 95% CI 0.04 to 2.46) or rifampicin treatment (OR 0.41, 95% CI 0.08 to 2.12) for up to 31 days, although the width of confidence intervals prohibited robust statistical and clinical inferences. CONCLUSION: The optimal duration of systemic antibiotic treatment with surgical concepts of curing wound and device-related orthopaedic infections is still unclear. The risk of reinfection in case of infected extramedullary fracture-fxation devices may be reduced with up to 31 days of systemic fluoroquinolones and rifampicin, although scientific proof needs a randomized trial with about 1400 subjects per group. Concerted efforts are needed to determine which antibiotics must be applied for how long after radical surgical sanitation to guarantee sustainable treatment success.

Biomechanical comparison of the proximal interphalangeal joint arthrodesis using a compression wire.

INTRODUCTION/AIM: Arthrodesis of the proximal interphalangeal joint of the finger is a common procedure for the treatment of osteoarthritis. The aim of this biomechanical study was to compare the primary stability of one, respectively, two compression wires to intraosseous wiring and tension band wiring for the arthrodesis. MATERIALS AND METHODS: The stability of the arthrodesis was tested by applying flexion (n = 11) and extension (n = 10) force with 10° bending. Arthrodesis was achieved by one, respectively, two crossed compression wires and intraosseous wiring. In a control group (n = 11) tension band wiring was tested to 10° flexion and extension as well. RESULTS: Mean values for flexion bending for intraosseous wiring were 10.94 N, for one compression wire 12.82 N, for tension band wiring 17.95 N, and for two crossed compression wires 20.42 N. Mean values for extension bending were 9.71 N for intraosseous wiring, 13.63 N for one compression wire, 21.43 N for tension band wiring and 22.56 N for two crossed compression wires. CONCLUSION: The primary stability of the compression wires was statistically significant superior to intraosseous wiring. In comparison to tension band wiring which showed an intermediate stability. The application of a compression wire could be considered for further clinical testing in the arthrodesis of interphalangeal joints.

Topical application of morphine for wound healing and analgesia in patients with oral lichen planus: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: The objective of this study was to investigate the effect of topical morphine on erosive/ulcerative lesions in patients with oral lichen planus (OLP). Previous studies reported on an enhanced remission of skin wounds when morphine was applied topically. MATERIALS AND METHODS: This was single-center, prospective, double-blind, placebo-controlled, randomized, multi-arm (3), phase II study (RCT). Patients diagnosed with erosive and/or ulcerative OLP applied 0.2 or 0.4 mg morphine dissolved in glycerine, three times a day for 5 days. The primary outcome was the extent of healing. Secondary outcomes were as follows: (1) effect on pain, (2) presence and severity of opioid-related central and local side effects, (3) whether patients required 'rescue medication' for treatment of pain, and (4) total intake of test substance. RESULTS: A total of 123 patients were screened for eligibility, 45 patients were recruited into the study, and 43 completed it. Patients applied a solution of either placebo or 0.2 or 0.4% morphine in groups of n = 12, n = 15, and n = 16, respectively. Extent of healing was similar in the three groups. Severity of pain was minor pre-treatment and throughout the course of the study. Only minor adverse events were reported (dry mouth, burning sensation). CONCLUSION: Morphine did not enhance wound healing compared to placebo-treated patients. Healing was observed in all groups, which may be attributed to an effect of glycerine or to the natural course of the disease. Patients experienced only mild levels of pain, rendering the model insensitive for assessing pain. CLINICAL RELEVANCE: OLP is a chronic disease and current treatment options are limited. Healing occurred in all three study groups, an effect we attribute to the carrier.

Nationwide Incidence of Normal Pressure Hydrocephalus (NPH) Assessed by Insurance Claim Data in Germany.

BACKGROUND: The purpose of this study is to investigate the epidemiology of the idiopathic normal pressure hydrocephalus (iNPH) in Germany. METHODS: The database of the nationwide Barmer Health Insurance was queried for specific combinations of corresponding International Classification of Diseases, Ninth Revision (ICD-9) codes and OPS codes (German modification of the ICPM and official classification of surgical procedures) in order to assess the number of patients treated for iNPH and the number surgical procedures associated with the disease in a 10 years period between 2003 and 2012. RESULTS: Between 2003 and 2012, the incidence of iNPH increased from zero to 1.36/100.000/year. CONCLUSION: This is the first population-based epidemiologic study on iNPH in Germany covering a ten year period.

Emergency ultrasound-based algorithms for diagnosing blunt abdominal trauma.

BACKGROUND: Ultrasonography (performed by means of a four-quadrant, focused assessment of sonography for trauma (FAST)) is regarded as a key instrument for the initial assessment of patients with suspected blunt abdominal and thoraco-abdominal trauma in the emergency department setting. FAST has a high specificity but low sensitivity in detecting and excluding visceral injuries. Proponents of FAST argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of unnecessary multi-detector computed tomography (MDCT) scans, and enable quicker triage to surgical and non-surgical care. Given the proven accuracy, increasing availability of, and indication for, MDCT among patients with blunt abdominal and multiple injuries, we aimed to compile the best available evidence of the use of FAST-based assessment compared with other primary trauma assessment protocols. OBJECTIVES: To assess the effects of diagnostic algorithms using ultrasonography including in FAST examinations in the emergency department in relation to the early, late, and overall mortality of patients with suspected blunt abdominal trauma. SEARCH METHODS: The most recent search was run on 30th June 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, MEDLINE (OvidSP), EMBASE (OvidSP), ISI Web of Science (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), clinical trials registers, and screened reference lists. Trial authors were contacted for further information and individual patient data. SELECTION CRITERIA: We included randomised controlled trials (RCTs). Participants were patients with blunt torso, abdominal, or multiple trauma undergoing diagnostic investigations for abdominal organ injury. The intervention was diagnostic algorithms comprising emergency ultrasonography (US). The control was diagnostic algorithms without US examinations (for example, primary computed tomography (CT) or diagnostic peritoneal lavage (DPL)). Outcomes were mortality, use of CT or invasive procedures (DPL, laparoscopy, laparotomy), and cost-effectiveness. DATA COLLECTION AND ANALYSIS: Two authors (DS and CG) independently selected trials for inclusion, assessed methodological quality, and extracted data. Methodological quality was assessed using the Cochrane Collaboration risk of bias tool. Where possible, data were pooled and relative risks (RRs), risk differences (RDs), and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed-effect or random-effects models as appropriate. MAIN RESULTS: We identified four studies meeting our inclusion criteria. Overall, trials were of poor to moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. Strong heterogeneity amongst the trials prompted discussion between the review authors as to whether the data should or should not be pooled; we decided in favour of a quantitative synthesis to provide a rough impression about the effect sizes achievable with US-based triage algorithms. We pooled mortality data from three trials involving 1254 patients; the RR in favour of the FAST arm was 1.00 (95% CI 0.50 to 2.00). FAST-based pathways reduced the number of CT scans (random-effects model RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result was unclear. AUTHORS' CONCLUSIONS: The experimental evidence justifying FAST-based clinical pathways in diagnosing patients with suspected abdominal or multiple blunt trauma remains poor. Because of strong heterogeneity between the trial results, the quantitative information provided by this review may only be used in an exploratory fashion. It is unlikely that FAST will ever be investigated by means of a confirmatory, large-scale RCT in the future. Thus, this Cochrane Review may be regarded as a review which provides the best available evidence for clinical practice guidelines and management recommendations. It can only be concluded from the few head-to-head studies that negative US scans are likely to reduce the incidence of MDCT scans which, given the low sensitivity of FAST (or reliability of negative results), may adversely affect the diagnostic yield of the trauma survey. At best, US has no negative impact on mortality or morbidity. Assuming that major blunt abdominal or multiple trauma is associated with 15% mortality and a CT-based diagnostic work-up is considered the current standard of care, 874, 3495, or 21,838 patients are needed per intervention group to demonstrate non-inferiority of FAST to CT-based algorithms with non-inferiority margins of 5%, 2.5%, and 1%, power of 90%, and a type-I error alpha of 5%.

Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study.

BACKGROUND: Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. METHODS/DESIGN: Prospective observational study with two consecutive cohorts of patients. SETTING: A high-volume, academic, supra-regional trauma centre in Germany. STUDY POPULATION: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call.Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. DATA: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. MAIN OUTCOMES: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients' safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). ANALYSIS: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. DISCUSSION: Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74557102.

Emergency ultrasound-based algorithms for diagnosing blunt abdominal trauma.

BACKGROUND: Ultrasonography is regarded as the tool of choice for early diagnostic investigations in patients with suspected blunt abdominal trauma. Although its sensitivity is too low for definite exclusion of abdominal organ injury, proponents of ultrasound argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of computed tomography scans and cut costs. OBJECTIVES: To assess the effects of trauma algorithms that include ultrasound examinations in patients with suspected blunt abdominal trauma. SEARCH METHODS: We searched the Cochrane Injuries Group's Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EBSCO), publishers' databases, controlled trials registers and the Internet. Bibliographies of identified articles and conference abstracts were searched for further elligible studies. Trial authors were contacted for further information and individual patient data. The searches were updated in February 2013. STUDIES: randomised controlled trials (RCTs) and quasi-randomised trials (qRCTs). PARTICIPANTS: patients with blunt torso, abdominal or multiple trauma undergoing diagnostic investigations for abdominal organ injury. INTERVENTIONS: diagnostic algorithms comprising emergency ultrasonography (US). CONTROLS: diagnostic algorithms without ultrasound examinations (for example, primary computed tomography [CT] or diagnostic peritoneal lavage [DPL]). OUTCOME MEASURES: mortality, use of CT and DPL, cost-effectiveness, laparotomy and negative laparotomy rates, delayed diagnoses, and quality of life. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials for inclusion, assessed methodological quality and extracted data. Where possible, data were pooled and relative risks (RRs), risk differences (RDs) and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed- or random-effects modelling, as appropriate. MAIN RESULTS: We identified four studies meeting our inclusion criteria. Overall, trials were of moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. We pooled mortality data from three trials involving 1254 patients; relative risk in favour of the US arm was 1.00 (95% CI 0.50 to 2.00). US-based pathways significantly reduced the number of CT scans (random-effects RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result is unclear. Given the low sensitivity of ultrasound, the reduction in CT scans may either translate to a number needed to treat or number needed to harm of two. AUTHORS' CONCLUSIONS: There is currently insufficient evidence from RCTs to justify promotion of ultrasound-based clinical pathways in diagnosing patients with suspected blunt abdominal trauma.