The CRECHE study: testing the urban myth that chocolate Santa Clauses are re-wrapped Easter Bunnies.

OBJECTIVE: To test the urban myth that surplus chocolate Easter Bunnies are re-packaged as Santa Clauses for the following Christmas holiday season. DESIGN: Prospective radiographic cohort study of seasonal chocolate figurines, supplemented by anonymous 5-item questionnaire survey of belief in the re-wrapping myth (Generic Risk Items Noted by Chocolate consumers in Health care settings; GRINCH). SETTING: Two tertiary referral trauma centres in Germany (Berlin and Duisburg). PARTICIPANTS: Eighteen chocolate Easter Bunnies and 15 chocolate Santa Clauses from different manufacturers purchased during 2020; 502 randomly selected people passing through the entrance halls of the two hospitals during 16 September - 12 October 2020. MAIN OUTCOME MEASURES: Whole body computed tomography (WBCT) images of chocolate Easter Bunnies and Santa Clauses assessed by four independent, board-certified radiologists using a visual contour resemblance scale (CRS); survey participants' views on statements related to the re-wrapping myth. RESULTS: Expert examiners clearly distinguished the WBCT images of chocolate Easter Bunnies and Santa Clauses; the mean difference in CRS was 84.2 points (95% CI, 78.5-90.0 points), with excellent inter-observer agreement (mean intra-class correlation coefficient, 0.99; 95% CI, 0.99-1.00). A total of 214 survey participants (43%) disagreed and 145 (29%) agreed with the proposition that seasonal chocolate figurines are re-packaged and re-sold the following season. CONCLUSION: Although about one-third of our survey respondents did not rule out the possibility of seasonal sweets being re-used, WBCT imaging found no similarity between chocolate foil-wrapped Easter and Christmas figurines, providing solid evidence against this urban myth. Chocolate Santa Clauses are unlikely to pose a significant threat to hospital food hygiene requirements. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN16847363 (prospective).

What Is the Diagnostic Accuracy of Flat-panel Cone-beam CT Arthrography for Diagnosis of Scapholunate Ligament Tears?

BACKGROUND: Cone beam CT (CBCT) is a widely available technique with possible indications in carpal ligament injuries. The accuracy of CBCT arthrography in diagnosing traumatic tears of the scapholunate ligament has not been reported. QUESTIONS/PURPOSES: (1) What is the diagnostic accuracy of CBCT and how does it relate to the accuracy of multislice CT arthrography and conventional arthrography in diagnosing scapholunate ligament tears? (2) What is the estimated magnitude of skin radiation doses of each method? METHODS: This secondary analysis of a previous prospective study included 71 men and women with suspected scapholunate ligament tears and indications for arthroscopy. Preoperative imaging was conventional arthrography and either MSCT arthrography for the first half of patients to be included (n = 36) or flat-panel CBCT arthrography for the remaining patients (n = 35). Index tests identified therapy-relevant SLL tears with dorsal or complete SLL ruptures, and these tears were compared with relevant SLL tears which were determined through arthroscopy as Geissler Stadium III and IV by probing the instable SL joint with a microhook or arthroscope. These injuries were treated by open ligament repair and Kirschner wire fixation. Accuracy values and 95% confidence intervals were calculated. Additional estimates of the radiation skin doses of each CBCT exam and two MSCT protocols were subsequently calculated using dose area products, dose length products, and CT dose indices. RESULTS: The diagnostic accuracy was high for all imaging methods. 95% CIs were broadly overlapping and therefore did not indicate differences between the diagnostic groups: Sensitivity of CBCT arthrography was 100% (95% CI 77 to 100), specificity was 95% (95% CI 76 to 99.9), positive predictive value was 93% (95% CI 68 to 99.8), and negative predictive value was 100% (95% CI 83 to 100). For MSCT arthrography, the sensitivity was 92% (95% CI 64 to 99.8), specificity was 96% (95% CI 78 to 99.9), positive predictive value was 92% (95% CI 64 to 99.8), and negative predictive value was 96% (95% CI 78 to 99.9). For conventional arthrography, the sensitivity was comparably high: 96% (95% CI 81 to 99.9). Specificity was (81% [95% CI 67 to 92]); the positive predictive value was 77% (95% CI 59 to 89) and negative predictive value was 97% (95% CI 86 to 99.9). Estimated mean (range) radiation skin doses were reported in a descriptive fashion and were 12.9 mSv (4.5 to 24.9) for conventional arthrography, and 3.2 mSv (2.0 to 4.8) for CBCT arthrography. Estimated radiation skin doses were 0.2 mSv and 12 mSv for MSCT arthrography, depending on the protocol. CONCLUSION: Flat-panel CBCT arthrography can be recommended as an accurate technique to diagnose scapholunate ligament injuries after wrist trauma. Estimated skin doses are low for CBCT arthrography and adapted MSCT arthrography protocols. LEVEL OF EVIDENCE: Level III, diagnostic study.

[Clinical studies in trauma surgery and orthopedics: read, interpret and implement]. / Klinische Studien in Unfallchirurgie und Orthopädie: lesen, interpretieren und umsetzen.

Informative, participatory clinical decision-making needs to combine both skills and expertise as well as current scientific evidence. The flood of digital information makes it difficult in everyday clinical practice to keep up to date with the latest publications. This article provides assistance for coping with this problem. A basic understanding of prior and posterior probabilities as well as systematic error (bias) makes it easier to weigh up the benefits and risks, e.g. of a (surgical) intervention compared to a nonsurgical treatment. Randomized controlled trials (RCT, with all modern modifications) deliver undistorted results but in orthopedic and trauma surgery can lead to a heavily selected nonrepresentative sample and the results must be confirmed or refuted by further, independent RCTs. Large-scale observational data (e.g. from registries) can be modelled in a quasi-experimental manner and accompany RCTs in health technology assessment.

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.

Point-of-care ultrasonography for diagnosing thoracoabdominal injuries in patients with blunt trauma.

BACKGROUND: Point-of-care sonography (POCS) has emerged as the screening modality of choice for suspected body trauma in many emergency departments worldwide. Its best known application is FAST (focused abdominal sonography for trauma). The technology is almost ubiquitously available, can be performed during resuscitation, and does not expose patients or staff to radiation. While many authors have stressed the high specificity of POCS, its sensitivity varied markedly across studies. This review aimed to compile the current best evidence about the diagnostic accuracy of POCS imaging protocols in the setting of blunt thoracoabdominal trauma. OBJECTIVES: To determine the diagnostic accuracy of POCS for detecting and excluding free fluid, organ injuries, vascular lesions, and other injuries (e.g. pneumothorax) compared to a diagnostic reference standard (i.e. computed tomography (CT), magnetic resonance imaging (MRI), thoracoscopy or thoracotomy, laparoscopy or laparotomy, autopsy, or any combination of these) in patients with blunt trauma. SEARCH METHODS: We searched Ovid MEDLINE (1946 to July 2017) and Ovid Embase (1974 to July 2017), as well as PubMed (1947 to July 2017), employing a prospectively defined literature and data retrieval strategy. We also screened the Cochrane Library, Google Scholar, and BIOSIS for potentially relevant citations, and scanned the reference lists of full-text papers for articles missed by the electronic search. We performed a top-up search on 6 December 2018, and identified eight new studies which may be incorporated into the first update of this review. SELECTION CRITERIA: We assessed studies for eligibility using predefined inclusion and exclusion criteria. We included either prospective or retrospective diagnostic cohort studies that enrolled patients of any age and gender who sustained any type of blunt injury in a civilian scenario. Eligible studies had to provide sufficient information to construct a 2 x 2 table of diagnostic accuracy to allow for calculating sensitivity, specificity, and other indices of diagnostic test accuracy. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles, abstracts, and full texts of reports using a prespecified data extraction form. Methodological quality of individual studies was rated by the QUADAS-2 instrument (the revised and updated version of the original Quality Assessment of Diagnostic Accuracy Studies list of items). We calculated sensitivity and specificity with 95% confidence intervals (CI), tabulated the pairs of sensitivity and specificity with CI, and depicted these estimates by coupled forest plots using Review Manager 5 (RevMan 5). For pooling summary estimates of sensitivity and specificity, and investigating heterogeneity across studies, we fitted a bivariate model using Stata 14.0. MAIN RESULTS: We included 34 studies with 8635 participants in this review. Summary estimates of sensitivity and specificity were 0.74 (95% CI 0.65 to 0.81) and 0.96 (95% CI 0.94 to 0.98). Pooled positive and negative likelihood ratios were estimated at 18.5 (95% CI 10.8 to 40.5) and 0.27 (95% CI 0.19 to 0.37), respectively. There was substantial heterogeneity across studies, and the reported accuracy of POCS strongly depended on the population and affected body area. In children, pooled sensitivity of POCS was 0.63 (95% CI 0.46 to 0.77), as compared to 0.78 (95% CI 0.69 to 0.84) in an adult or mixed population. Associated specificity in children was 0.91 (95% CI 0.81 to 0.96) and in an adult or mixed population 0.97 (95% CI 0.96 to 0.99). For abdominal trauma, POCS had a sensitivity of 0.68 (95% CI 0.59 to 0.75) and a specificity of 0.95 (95% CI 0.92 to 0.97). For chest injuries, sensitivity and specificity were calculated at 0.96 (95% CI 0.88 to 0.99) and 0.99 (95% CI 0.97 to 1.00). If we consider the results of all 34 included studies in a virtual population of 1000 patients, based on the observed median prevalence (pretest probability) of thoracoabdominal trauma of 28%, POCS would miss 73 patients with injuries and falsely suggest the presence of injuries in another 29 patients. Furthermore, in a virtual population of 1000 children, based on the observed median prevalence (pretest probability) of thoracoabdominal trauma of 31%, POCS would miss 118 children with injuries and falsely suggest the presence of injuries in another 62 children. AUTHORS' CONCLUSIONS: In patients with suspected blunt thoracoabdominal trauma, positive POCS findings are helpful for guiding treatment decisions. However, with regard to abdominal trauma, a negative POCS exam does not rule out injuries and must be verified by a reference test such as CT. This is of particular importance in paediatric trauma, where the sensitivity of POCS is poor. Based on a small number of studies in a mixed population, POCS may have a higher sensitivity in chest injuries. This warrants larger, confirmatory trials to affirm the accuracy of POCS for diagnosing thoracic trauma.

Pediatric out-of-hospital cardiac arrest caused by left coronary-artery agenesis with primary shockable rhythm.

BACKGROUND: To illustrate a rare cause of out-of-hospital cardiac arrest in children, its differential diagnoses, emergency and subsequent treatment at various steps in the rescue chain, and potential outcomes. CASE PRESENTATION: A 4-year-old boy with unknown agenesis of the left coronary ostium sustained out-of-hospital cardiac arrest. Bystander cardio-pulmonary resuscitation was initiated and defibrillation was performed via an automated external defibrillator (AED) shortly after paramedics arrived at the scene, restoring sinus rhythm and spontaneous circulation. After admission to the intensive care unit the child was intubated for airway and seizure control. Further diagnostic work-up by angiography revealed agenesis of the left coronary artery. After initial seizures, the boy's neurological recovery was complete. He subsequently underwent successful internal mammary artery in-situ bypass surgery to the trunk of the left coronary artery. One year after cardiac arrest, the patient had completely recovered with no physical or intellectual sequelae. A catheter examination proved excellent growth of the bypass and good cardiac function. CONCLUSIONS: This case illustrates the long term outcome after agenesis of the LCA while reiterating that prompt access to pediatric defibrillation may be lifesaving-albeit in a minority of pediatric OHCA.

Accuracy of simple plain radiographic signs and measures to diagnose acute scapholunate ligament injuries of the wrist.

OBJECTIVE: To determine the accuracy of common radiological indices for diagnosing ruptures of the scapholunate (SL) ligament, the most relevant soft tissue injury of the wrist. METHODS: This was a prospective diagnostic accuracy study with independent verification of index test findings by a reference standard (wrist arthroscopy). Bilateral digital radiographs in posteroanterior (pa), lateral and Stecher's projection were evaluated by two independent expert readers. Diagnostic accuracy of radiological signs was expressed as sensitivity, specificity, positive (PPV) and negative (NPV) predictive values with 95 % confidence intervals (CI). RESULTS: The prevalence of significant acute SL tears (grade ≥ III according to Geissler's classification) was 27/72 (38 %, 95 % CI 26-50 %). The SL distance on Stecher's projection proved the most accurate index to rule the presence of an SL rupture in and out. SL distance on plain pa radiographs, Stecher's projection and the radiolunate angle contributed independently to the final diagnostic model. These three simple indices explained 97 % of the diagnostic variance. CONCLUSIONS: In the era of computed tomography and magnetic resonance imaging, plain radiographs remain a highly sensitive and specific primary tool to triage patients with a suspected SL tear to further diagnostic work-up and surgical care. KEY POINTS: • Scapholunate ligament (SL) lesions are the most relevant soft tissue wrist injuries. • Missed and untreated SL ruptures can cause painful and disabling post-traumatic wrist osteoarthritis. • Reliable threshold values of radiographic indices should prompt further imaging or surgical care. • Plain radiographs deliver conclusive clinical information if certain hand positions are used.

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%.

[Perceived utility of the inclusion of physician assistants in the surgical process quality and continuing education in Germany : Results of an interprofessional online survey]. / Empfundener Nutzen der Einbindung von Physician Assistants in die chirurgische Prozessqualität und Weiterbildung in Deutschland : Ergebnisse einer interprofessionellen Online-Umfrage.

BACKGROUND: Compared to Anglo-American countries, physician assistants (PA) remain an underrepresented professional group within the German healthcare system. In the surgical disciplines, PAs may relieve the administrative burden of doctors by taking on delegable routine tasks, thus creating time and resources for advanced surgical training. OBJECTIVE: According to interprofessional experts, can the use of PA lead to an optimization of surgical training and a gain in time for surgical qualification in Germany? MATERIAL AND METHODS: After searching for systematic reviews of the current state of knowledge, an online survey was initiated among surgeons and PAs via social networks to determine current and desired clinical areas of activity for PAs in surgery and their future influence on specialist training in Germany. RESULTS: A total of nine systematic reviews were identified, suggesting a beneficial impact of PAs on length of stay, direct costs, and treatment outcomes in surgical scenarios. The online survey included 234 surgeons and 114 PAs. Hospitals with ≥ 90 surgical beds employed PAs far more frequently (65%) than smaller institutions (40%). Although both professional groups are generally highly satisfied with the integration of PAs into clinical workflows, there are gradually different opinions about the preferred spectrum of tasks and duties. DISCUSSION: PAs would like to have greater responsibility in ordering and interpreting diagnostic tests, communicating with patients, and working in the operating theater. Surgeons are concerned that PAs could replace surgical interns and residents. PAs may enrich healthcare in Germany on various levels and can also improve surgical training. The voice and needs of all professional groups must be considered and respected during the upcoming health system reform.

May the 4th be with you: mixed-methods best-evidence synthesis on 4th-generation alumina-zirconia ceramic bearings in total hip arthroplasty.

Purpose: To assess utility, benefits, and risks of 4th-generation alumina-zirconia ceramic pairings in elective total hip arthroplasty (THA). Methods: A comprehensive mixed-methods best-evidence synthesis using data from systematic reviews, randomized controlled trials (RCTs), prospective and retrospective cohort studies, as well as joint replacement registries, was conducted to estimate overall revision and survival rates, periprosthetic infection, bearing fractures, and noise phenomena with 4th-generation alumina-zirconia ceramic versus other tribological couplings in elective THA. The systematic review part across multiple databases was registered with PROSPERO (CRD42023418076), and individual study data were extracted for statistical re-analysis. Results: Twenty overlapping systematic reviews, 7, 17, and 8 references from RCTs, cohort studies, and joint replacement registries form the basis of this work. According to current best evidence, it is (i) 15-33 times more likely that 4th-generation alumina-zirconia pairings avoid a revision for infection than causing a revision for audible noise, (ii) 38-85 times more likely that 4th-generation alumina-zirconia pairings avoid a revision for infection than causing a revision for ceramic head fractures, and (iii) three to six times more likely that 4th-generation alumina-zirconia pairings avoid a revision for infection than cause a revision for ceramic liner fractures. Conclusion: Fourth-generation alumina-zirconia pairings in THA show a favorable benefit-risk ratio, with rare compound-specific adverse events and complications significantly outbalanced by long-term advantages, such as a markedly lower incidence of revision for infection.

In-hospital mortality after prehospital endotracheal intubation versus alternative methods of airway management in trauma patients. A cohort study from the TraumaRegister DGU®.

PURPOSE: Prehospital airway management in trauma is a key component of care and is associated with particular risks. Endotracheal intubation (ETI) is the gold standard, while extraglottic airway devices (EGAs) are recommended alternatives. There is limited evidence comparing their effectiveness. In this retrospective analysis from the TraumaRegister DGU®, we compared ETI with EGA in prehospital airway management regarding in-hospital mortality in patients with trauma. METHODS: We included cases only from German hospitals with a minimum Abbreviated Injury Scale score ≥ 2 and age ≥ 16 years. All patients without prehospital airway protection were excluded. We performed a multivariate logistic regression to adjust with the outcome measure of hospital mortality. RESULTS: We included n = 10,408 cases of whom 92.5% received ETI and 7.5% EGA. The mean injury severity score was higher in the ETI group (28.8 ± 14.2) than in the EGA group (26.3 ± 14.2), and in-hospital mortality was comparable: ETI 33.0%; EGA 30.7% (27.5 to 33.9). After conducting logistic regression, the odds ratio for mortality in the ETI group was 1.091 (0.87 to 1.37). The standardized mortality ratio was 1.04 (1.01 to 1.07) in the ETI group and 1.1 (1.02 to 1.26) in the EGA group. CONCLUSIONS: There was no significant difference in mortality rates between the use of ETI or EGA, or the ratio of expected versus observed mortality when using ETI.

Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA).

OBJECTIVES: To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). BACKGROUND: Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear. METHODS: We conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire. RESULTS: We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference -36%, 95% CI -49% to -23%; p<0.001). This difference exceeded predetermined stopping rules and resulted in premature discontinuation of patient recruitment. Disease specific outcome scales did not differ between the groups although there was a significant advantage of the gravitational device in the SF-12 Mental Component Scores at the 6 and 12 month visits. CONCLUSIONS: Implanting a gravitational rather than another type of valve will avoid one additional overdrainage complication in about every third patient undergoing VP shunting for iNPH.

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.

Primary ligament sutures as a treatment option of knee dislocations: a meta-analysis.

PURPOSE: Treatment of knee dislocation is still controversial. There is no evidence to favour ligament suture or reconstruction. Until now, no meta-analyses have examined suture versus reconstruction of cruciate ligaments in knee dislocations with respect to injury pattern and rupture classification. METHODS: We searched Medline, the Cochrane Controlled Trial Database, and EMBASE for studies on surgical treatment for 'knee dislocation' and 'multiple ligament injured knee'. A meta-analysis was performed using individual patient data. RESULTS: Nine studies including 195 patients (200 knees) with a mean age of 31.4 (±13) years fulfilled the study requirements. Thirteen cases of type II dislocations, 63 cases of type III medial, 84 cases of type III lateral, and 40 cases of type IV dislocations, according to Schenck's classification, were found. Poor or moderate results were found in 70 % of patients without surgical treatment of ACL or PCL (n = 27). Patients (n = 40) treated by sutures of the ACL and PCL demonstrated a significantly greater proportion of excellent or good results (40 and 37.5 %, respectively) (p < 0.001). Patients who underwent reconstruction of the ACL and PCL (n = 75) showed excellent or good results (28 and 45 %, respectively). No significant difference was found when comparing suture versus reconstruction of the ACL and PCL (n.s.). The outcome depends considerably on Schenck's injury pattern classification. CONCLUSION: Conservative treatment after knee dislocation yields poor clinical results. Suture repair of cruciate ligaments can still serve as an alternative option for multiligament injuries of the knee and achieve good clinical results, which are comparable to those of ligament reconstruction. The data provided by this meta-analysis should be reinforced by a prospective study, in which suture repair and ligament reconstruction are compared. LEVEL OF EVIDENCE: IV.

Large-scale, pragmatic randomized trials in the era of big data, precision medicine and machine learning. Valid and necessary, or outdated and a waste of resources?

During the past decade, more and more large-scale pragmatic clinical trials have been carried out in orthopedic trauma surgery. This trend is fueled by the common belief that the larger the numbers in a trial, the broader the eligibility criteria, and the less strict the regimentation of local treatment standards by protocol, the more trustworthy the findings would be. However, it must also be taken into account that the precision of an outcome measurement does not depend on the sample size alone, but the homogeneity of the studied population. Consequently, a small trial with stringent entry and assessment criteria may offer similarly precise answers as a large trial with less strict entry and assessment criteria because of the basic mathematical correlation between standard deviation and standard error of the mean. There is now a lively and controversial debate about the role of randomized controlled trials (RCT) in an era of stratified medicine driven by the ever increasing understanding and clinical measurability of molecular pathways, making a certain intervention more effective in patients who show a distinct genetic variant. Cluster and pattern recognition by artificial intelligence (AI) and its methodological variety applied to huge datasets and population-based cohorts further propel the spiral of knowledge. Advanced adaptive RCT concepts like enrichment designs, basket and bucket trials, master protocols etc. were developed to combine classic principles of the scientific method with big data, the latter of which have not arrived yet in trauma care. In spite of all biomedical and methodological achievements made, surprisingly such key questions remain unanswered as a) is a certain treatment causally responsible for making a difference in patient-centered outcomes compared to placebo, a control treatment, or the standard of care, b) do the results of a controlled experiment are relevant enough to change clinical practice, and c) under which conditions and assumptions shall we conduct large-scale pragmatic RCTs, focused confirmatory RCTs, or personalized analyses with or without AI support.

[Evidence-based versus expertise-based medicine in orthopedic and trauma surgery : There is nothing more practical than a good theory]. / Evidenzbasierte Medizin versus Erfahrungsmedizin in Orthopädie und Unfallchirurgie : Es gibt nichts Praktischeres als eine gute Theorie.

About a quarter of a century after the introduction of the concept and principles of evidence-based medicine (EbM), some healthcare providers are still adamant that these are incompatible with knowledge gained through experience. Across the surgical disciplines, it is often argued EbM underestimates or neglects the importance of intuition and surgical skills. To put it bluntly, these assumptions are wrong and often characterized by a misunderstanding of the methodology of EbM. Even the best controlled trial cannot be properly interpreted or implemented without clinical reasoning; furthermore, clinicians of all disciplines are obligated to provide care according to the current state of scientific knowledge. In an era of revolutionary biomedical developments, exponential increase of research but incremental innovations, they must become familiar with pragmatic tools to appraise the validity and relevance of clinical study results, and to decide whether there is a need to adapt current beliefs and practices based on the new information. We herein use the recent example of a new medical device for the surgical treatment of rotator cuff tears and subacromial impingement syndrome to illustrate how important it is to interpret data in the context of a precise, answerable question and to combine clinical expertise with methodological principles offered by EbM.