Observation Versus Embolization in Patients with Blunt Splenic Injury after Trauma: A Propensity Score Analysis

Background: Non-operative management (NOM) is the standard of care in hemodynamically stable patients with blunt splenic injury after trauma. Splenic artery embolization (SAE) is reported to increase observation success rate. Studies demonstrating improved splenic salvage rates with SAE primarily compared SAE with historical controls. The aim of this study was to investigate whether SAE improves success rate compared to observation alone in contemporaneous patients with blunt splenic injury. Methods: We included adult patients with blunt splenic injury admitted to five Level 1 Trauma Centers between January 2009 and December 2012 and selected for NOM. Successful treatment was defined as splenic salvage and no splenic re-intervention. We calculated propensity scores, expressing the probability of undergoing SAE, using multivariable logistic regression and created five strata based on the quintiles of the propensity score distribution. A weighted relative risk (RR) was calculated across strata to express the chances of success with SAE. Results: Two hundred and six patients were included in the study. Treatment was successful in 180 patients: 134/146 (92 %) patients treated with observation and 48/57 (84 %) patients treated with SAE. The weighted RR for success with SAE was 1.17 (0.94-1.45); for complications, the weighted RR was 0.71 (0.41-1.22). The mean number of transfused blood products was 4.4 (SD 9.9) in the observation group versus 9.1 (SD 17.2) in the SAE group. Conclusions: After correction for confounders with propensity score stratification technique, there was no significant difference between embolization and observation alone with regard to successful treatment in patients with blunt splenic injury after trauma

The value of nonoperative versus operative treatment of frail institutionalized elderly patients with a proximal femoral fracture in the shade of life (FRAIL-HIP); protocol for a multicenter observational cohort study

BACKGROUND: Proximal femoral fractures are strongly associated with morbidity and mortality in elderly patients. Mortality is highest among frail institutionalized elderly with both physical and cognitive comorbidities who consequently have a limited life expectancy. Evidence based guidelines on whether or not to operate on these patients in the case of a proximal femoral fracture are lacking. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life as operative treatment. This study aims to determine the effect of nonoperative management versus operative management of proximal femoral fractures in a selected group of frail institutionalized elderly on the quality of life, level of pain, rate of complications, time to death, satisfaction of the patient (or proxy) and the caregiver with the management strategy, and health care consumption. METHODS: This is a multicenter, observational cohort study. Frail institutionalized elderly (70 years or older with a body mass index < 18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an American Society of Anesthesiologists score of 4 or 5), who sustained a proximal femoral fracture are eligible to participate. Patients with a pathological or periprosthetic fractures and known metastatic oncological disease will be excluded. Treatment decision will be reached following a structured shared decision process. The primary outcome is quality of life (Euro-QoL; EQ-5D-5 L). Secondary outcome measures are quality of life measured with the QUALIDEM, pain level (PACSLAC), pain medication use, treatment satisfaction of patient (or proxy) and caregivers, quality of dying (QODD), time to death, and direct medical costs. A cost-utility and cost-effectiveness analysis will be done, using the EQ-5D utility score and QUALIDEM score, respectively. Non-inferiority of nonoperative treatment is assumed with a limit of 0.15 on the EQ-5D score. Data will be acquired at 7, 14, and 30 days and at 3 and 6 months after trauma. DISCUSSION: The results of this study will provide insight into the true value of nonoperative treatment of proximal femoral fractures in frail elderly with a limited life expectancy. The results may be used for updating (inter)national treatment guidelines. TRIAL REGISTRATION: The study is re

Routine versus on demand removal of the syndesmotic screw; A protocol for an international randomised controlled trial (RODEO-trial)

Background: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. Design: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. Discussion: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. Trial registration: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov (NCT02896998) on July 15th 2016

Dutch Prospective Observational Study on Prehospital Treatment of Severe Traumatic Brain Injury: The BRAIN-PROTECT Study Protocol

Background: Severe traumatic brain injury (TBI) is associated with a high mortality rate and those that survive commonly have permanent disability. While there is a broad consensus that appropriate prehospital treatment is crucial for a favorable neurological outcome, evidence to support currently applied treatment strategies is scarce. In particular, the relationship between prehospital treatments and patient outcomes is unclear. The BRAIN-PROTECT study therefore aims to identify prehospital treatment strategies associated with beneficial or detrimental outcomes. Here, we present the study protocol. Study Protocol: BRAIN-PROTECT is the acronym for BRAin INjury: Prehospital Registry of Outcome, Treatments and Epidemiology of Cerebral Trauma. It is a prospective observational study on the prehospital treatment of patients with suspected severe TBI in the Netherlands. Prehospital epidemiology, interventions, medication strategies, and nonmedical factors that may affect outcome are studied. Multivariable regression based modeling will be used to identify confounder-adjusted relationships between these factors and patient outcomes, including mortality at 30 days (primary outcome) or mortality and functional neurological outcome at 1 year (secondary outcomes). Patients in whom severe TBI is suspected during prehospital treatment (Glasgow Coma Scale score 8 in combination with a trauma mechanism or clinical findings suggestive of head injury) are identified by all four helicopter emergency medical services (HEMS) in the Netherlands. Patients are prospectively followed up in 9 participating trauma centers for up to one year. The manuscript reports in detail the objectives, setting, study design, patient inclusion, and data collection process. Ethical and juridical aspects, statistical considerations, as well as limitations of the study design are discussed. Discussion: Current prehospital treatment of patients with suspected severe TBI is based on marginal evidence, and optimal treatment is basically unknown. The BRAINPROTECT study provides an opportunity to evaluate and compare different treatment strategies with respect to patient outcomes. To our knowledge, this study project is the first large-scale prospective prehospital registry of patients with severe TBI that also collects long-term follow-up data and ma

Prognosis of nonoperative treatment in elderly patients with a hip fracture: A systematic review and meta-analysis

Objective: Hip fractures in frail elderly patients are associated with significant mortality and morbidity. Surgery remains the predominant treatment of choice, despite the poor prognosis. Limited research has been done with regards to nonoperative management of frail elderly patients with a hip fracture and therefore the natural course is relatively unknown. This systematic review aimed to provide an overview of the prognosis of nonoperative management in frail elderly patients with a hip fracture in terms of mortality, complications, mobility, and quality of life (QoL). Design: A systematic review of the literature was conducted in PubMed, EMBASE, and Cochrane Central. In addition, a meta-analysis was performed. The primary outcome measurement was 30-days mortality. Results: A total of 4,318 studies were screened. In total eighteen studies matched the eligibility criteria; with low to moderate quality. Approximately two-thirds of the patients were managed nonoperatively due to medical reasons and one-third due to non-medical reasons. Pooled mortality rates after 30 days, six months and one year were 36%, 46%, and 60%, respectively. 33% of the patients developed in-hospital complications. At six months post trauma, 9.6% of the patients were able to mobilize. Data on quality of life (QoL), functional outcome, pain, comfort during nursing care, and costs were not reported. Conclusion

The effect of the introduction of the Amsterdam Trauma Workflow Concept on mortality and functional outcome of patients with severe traumatic brain injury

The purpose of this study was to analyze the effect of the introduction of an all-in workflow concept that included direct computed tomography (CT) scanning in the trauma room on mortality and functional outcome of trauma patients with severe traumatic brain injury (TBI) admitted to a level-1 trauma center. To this end, a retrospective comparison was made of a 1-year cohort prior to the implementation of the all-in workflow concept (Pre-CT in trauma room cohort [Pre-TRCT]) and a 1-year cohort after the implementation (Post-TRCT). All severely injured TBI patients aged 16 years or older that were presented in our level-1 trauma center and that underwent a CT of the head were initially included. Severe TBI was defined as an Abbreviated Injury Scale (AIS) score of >2 of the head region following trauma. Primary outcome parameter was TBI-related mortality during primary hospital admission. Secondary outcome parameter was the functional outcome based on GOS-Extended. A total of 59 patients were included in the Pre-TRCT and 49 in the Post-TRCT. Median age was 49 years in the Post-TRCT and 44 years in the Pre-TRCT (not significant [NS]). Median ISS was similar (ISS = 25). Median Head-AIS was higher in the Post-TRCT (5 vs. 4, NS). Initial CT scanning was completed faster in the Post-TRCT. There was a significant difference of 23% mortality in favor of the Post-TRCT for TBI-related mortality during primary hospital admission (p < 0.05). For acute neurosurgical interventions, time until intervention tended to be faster in the Post-TRCT (NS). Functional outcomes for survivors were higher in the Post-TRCT (6 vs. 5, NS

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial

Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. clinicaltrials.gov Identifier: NCT0222582

Impact of secondary transfer on patients with severe traumatic brain injury

BACKGROUND: Within a trauma network in the Netherlands, neurosurgical facilities are usually limited to Level I hospitals. Initial transport to a district hospital of patients who are later found to require neurosurgical intervention may cause delay. The purpose of this study was to assess the influence on outcome and time intervals of secondary transfer in trauma patients requiring emergency neurosurgical intervention. METHODS: In a 3-year period, all patients who sustained a severe traumatic brain injury and underwent a neurosurgical intervention within 6 hours after admission to a Level I trauma center were included. Patients were classified into two groups: direct presentation to the Level I trauma center (TC) group or requiring secondary transport after having been diagnosed for neurosurgical intervention in other hospitals (transfer group). RESULTS: Eighty patients were included for analyses. Twenty-four patients in the transfer group had a better Glasgow Coma Scale on-scene but a higher 30-day mortality compared with patients who were primarily presented to the Level I trauma center (33% vs. 27%; p = 0.553). In the transfer group, time to operation was 304 minutes compared with 151 minutes in the TC group (p <0.001). Most delay occurred during the initial trauma evaluation and the interval between the first computed tomography and the transfer ambulance departure at the referring hospital. CONCLUSION: Patients requiring an emergency neurosurgical intervention appear to have a clinically relevant worse outcome after secondary transfer to a neurosurgical service. Therefore, patient care can probably be improved by better triage on-scene and standardized procedures in case of a secondary transfer. (J Trauma. 2012; 72: 487-490. Copyright (C) 2012 by Lippincott Williams & Wilkins