D. Stengel

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.

Association between a single-pass whole-body computed tomography policy and survival after blunt major trauma: a retrospective cohort study

IntroductionSingle-pass, whole-body computed tomography (pan-scan) remains a controversial intervention in the early assessment of patients with major trauma. We hypothesized that a liberal pan-scan policy is mainly an indicator of enhanced process quality of emergency care that may lead to improved survival regardless of the actual use of the method.MethodsThis retrospective cohort study included consecutive patients with blunt trauma referred to a trauma center prior to (2000 to 2002) and after (2002 to 2007) the introduction of a liberal single-pass pan-scan policy. The overall mortality between the two periods was compared and stratified according to the availability and actual use of the pan-scan. Logistic regression analysis was employed to adjust mortality estimates for demographic and injury-related independent variables.ResultsThe study comprised 313 patients during the pre-pan-scan period, 223 patients after the introduction of the pan-scan policy but not undergoing a pan-scan and 608 patients undergoing a pan-scan. The overall mortality was 23.3, 14.8 and 7.9% (P < 0.001), respectively. By univariable logistic regression analysis, both the availability (odds ratio (OR) 0.57, 95% confidence interval (CI): 0.36 to 0.90) and the actual use of the pan-scan (OR 0.28, 95% CI: 0.19 to 0.42) were associated with a lower mortality. The final model contained the Injury Severity Score, the Glasgow Coma Scale, age, emergency department time and the use of the pan-scan. 2.7% of the explained variance in mortality was attributable to the use of the pan-scan. This contribution increased to 7.1% in the highest injury severity quartile.ConclusionsIn this study, a liberal pan-scan policy was associated with lower trauma mortality. The causal role of the pan-scan itself must be interpreted in the context of improved structural and process quality, is apparently moderate and needs further investigation with regard to the diagnostic yield and changes in management decisions. (The Pan-Scan for Trauma Resuscitation [PATRES] Study Group, ISRCTN35424832 and ISRCTN41462125)

Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial

AbstractBackgroundFractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF) with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation.Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting.Methods/DesignORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius) is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool.The primary objective is to determine differences in the Short Form 36 (SF-36) Physical Component Score (PCS) between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH) instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery), as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture involves a central statistical unit, an independent monitoring institute, and a data safety monitoring board. Following approval by the institutional review boards of all participating centers, conduct and reporting will strictly adhere to national and international rules, regulations, and recommendations (e.g., Good Clinical Practice, data safety laws, and EQUATOR/CONSORT proposals)DiscussionTo our knowledge, ORCHID is the first multicenter RCT designed to assess quality of life and functional outcomes following operative treatment compared to conservative treatment of complex, intra-articular fractures of the distal radius in elderly patients. The results are expected to influence future treatment recommendations and policies on an international level.Trial registrationISRCTN: ISRCTN76120052 Registration date: 31.07.2008; Randomization of first patient: 15.09.2008

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

BackgroundSingle-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/DesignProspective 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.DiscussionAlthough 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 registrationCurrent Controlled Trials ISRCTN74557102.

On the Method of a Randomised Comparison of Programmable Valves with and Without Gravitational Units: The SVASONA Study

OBJECTIVE The supremacy of low-pressure valves (LPV) in the therapy of patients with idiopathic normal pressure hydrocephalus (iNPH) has been proven by the Dutch NPH study. The downside of LPVs is the high rate of overdrainage complications. In the meantime gravitational units have been developed with the objective of minimising overdrainage complications. Do these gravitational units allow the same favourable outcomes as in the Dutch NPH study without overdrainage complications? The goal of this prospective randomised controlled multicentre trial is to compare the rate of overdrainage complications after shunt surgery with programmable valves with or without a gravitational unit. METHOD Patients suspected with iNPH with gait ataxia and one or two other symptoms of Hakims triad and enlarged ventricles on CT or MRI underwent a cerebrospinal fluid (CSF) infusion test, CSF tap test and/or continuous ICP measurement in seven experienced centres. If iNPH was diagnosed the patients were randomised to receive a ventriculoperitoneal shunt with a programmable valve with or without a gravitational unit. The patients were followed up for 3, 6 and 12 months after surgery. The primary hypothesis of the study was that programmable valves with gravitational units will reduce the rate of overdrainage from 25% to 10%. The outcome measured by iNPH-specific outcome scales (Kiefer score, Black grading scale) and the generic quality of life (short form 12, SF12) was defined as the secondary endpoint. To detect the hypothesised difference in the incidence of overdrainage with a type I error of 5% and a type II error of 20%, correcting for multiple testing and an anticipated drop-out rate of 10%, we planned to enrol 250 patients. To ensure safety and efficacy we performed a planned interim analysis halfway. RESULTS The study design has been found to be effective with regard to the primary hypothesis. CONCLUSION The design of the SVASONA study was developed to be able to confirm the primary hypothesis. Thus, the method of the study should solve the dilemma of the Dutch NPH study by the randomised comparison of LPVs with and without gravitational units.

„damage control surgery“ bei schweren abdominellen Verletzungen

ZusammenfassungDas Konzept der Versorgung schwerster abdomineller Verletzungen nach Prinzipien des „damage control“ findet auch im deutschen Sprachraum zunehmend Verbreitung. Die Indikation zur „damage control“-Versorgung stellt sich bei Vorliegen der Trias Azidose, Hypothermie und Koagulopathie (AHK-Syndrom). Als Zugang wird eine Medianlaparotomie gewählt. Bei Hohlorganverletzungen wird keine primäre Anastomose erzwungen, im Vordergrund steht die Kontaminationskontrolle. Methoden der Wahl sind die Anlage eines Anus praeter oder der temporäre Blindverschluss. Bei Milzrupturen steht die Splenektomie im Vordergrund. Massiv blutende Leberverletzungen werden durch Packing ggf. mit temporärer Gefäßokklusion kontrolliert. Abschließend erfolgt ein temporärer Bauchdeckenverschluss. Nach intensivmedizinischer Stabilisierung wird eine definitive Versorgung im Intervall vorgenommen.AbstractThe concept of treating severe abdominal trauma according to the principles of damage control surgery is becoming more widespread in Germany. Damage control surgery is indicated when evidence of AHC syndrome, meaning the combination of acidosis, hypothermia and coagulopathy, is found. The preferred surgical approach is the median laparotomy. In hollow organ injury a primary anastomosis should not be forced; contamination control is far more important. Methods of choice are construction of an anus preter or temporary blind closure. In the case of splenic injury total splenectomy is commonly performed. Liver injuries with massive bleeding should be controlled by packing or interim vascular occlusion, with subsequent temporary closure of the abdominal wall. Definitive organ repair should follow stabilization in the intensive care unit.

[Assessment of injury severity at the accident scene by the emergency physician: utility of technical crash parameters: results of a pilot study].

ZusammenfassungHintergrundTechnische Unfallparameter werden häufig im Rahmen der ersten notärztlichen Behandlung Schwerverletzter erfasst. Ihre Vorhersagekraft zur Diskriminierung zwischen moderat und lebensgefährlich verletzten Patienten wurde bisher nur unzureichend untersucht.Material und MethodeIn einem mehrstufigen Experiment wurden 3 erfahrene Notärzte aufgefordert, auf der Basis technischer Datenfragmente von 100 realen Pkw-Verkehrsunfällen aus einem regionalen Unfallforschungsprojekt die Verletzungsschwere des Pkw-Fahrers (mittlerer ISS=23,6±26,9) zu bestimmen. Die Verletzungskategorien wurden anhand der ISS-Werte zwischen leicht bis schwer (ISS≤ 8–15) und lebensgefährlich bis tödlich (ISS ≥16) dichotomisiert. Vorgelegt wurden in zufälliger Reihenfolge einfache Routineparameter, erweiterte Parameter sowie eine Fotodokumentation des Unfallortes. Berechnet wurden die Übereinstimmung der Teilnehmer im Hinblick auf die eingeschätzte Verletzungsschwere jenseits des Zufalls (Kappa-Statistik) sowie die diagnostische Testgüte (Sensitivität, Spezifität, Fläche unter der ROC-Kurve, Likelihood-Ratios).ErgebnisseDie Beobachterübereinstimmung der Verletzungsschwere unter Kenntnis einfacher, erweiterter und Bildparameter lag bei Kappa-Werten von 0,42, 0,65 und 0,61. Die Sensitivität schwankte zwischen den Beobachtern und unterschiedlicher Informationsmenge zwischen 18 und 80%, die Spezifität zwischen 41 und 89%. Durch die Präsentation von Fotos vom Unfallort ließ sich eine Steigerung der Sensitivität erzielen. Die Verschiebung der Vortestwahrscheinlichkeit von 50% für eine lebensbedrohliche Verletzung betrug im Falle negativer technischer Befunde maximal 40%, im positiven Fall 67%.SchlussfolgerungWeder anhand von isolierten technischen Parametern, die in der Regel am Unfallort leicht ersichtlich sind, noch durch zusätzliche technische Informationen oder eine Fotodokumentation gelingt es dem Notarzt, robuste Rückschlüsse auf die Verletzungsschwere eines verunfallten Pkw-Fahrers zu ziehen. Die Ergebnisse dieser Studie sollten durch eine Folgeuntersuchung mit einer größeren Stichprobe untermauert werden.AbstractBackgroundTechnical parameters of road traffic crashes are routinely documented by emergency physicians on scene. It is, however, unclear whether this information contributes to the estimation of injury severity of vehicle drivers.Materials and methodsIn this study, three experienced emergency physicians were asked to predict the injury severity of vehicle drivers [categorized according to Injury Severity Score (ISS) values of <16 and ≥16 as moderate to severe or life-threatening] based on increasingly complex technical crash information, ranging from routine variables to photo documentation of the crash scene. A sample of 100 cases (mean ISS 23.6±26.9) was obtained from the prospective database of an in-depth technical and medical car crash research project conducted in the northeastern part of Germany. Statistical analysis comprised inter-rater agreement beyond chance (kappa values) and indicators of diagnostic test accuracy (i.e. sensitivity, specificity and so on).ResultsThe inter-rater agreement of injury severity based on technical crash information was moderate to substantial (kappa 0.42–0.66). Amongst the three observers and various amounts of technical data, sensitivity ranged between 18 and 80%, and specificity ranged between 41 and 89% in predicting the presence of major trauma. Presentation of photographs from the crash scene increased diagnostic accuracy. Still, the presented information led to a shift from a 50% prior probability of life-threatening injuries to a maximum of 40% in the negative and 67% in the positive case.ConclusionNeither basic technical parameters that are easy to obtain after a car crash nor additional technical information markedly contribute to the emergency physician’s estimation of a vehicle driver’s injury severity. The presented results should be supported by a subsequent study including a larger sample.BACKGROUND Technical parameters of road traffic crashes are routinely documented by emergency physicians on scene. It is, however, unclear whether this information contributes to the estimation of injury severity of vehicle drivers. MATERIALS AND METHODS In this study, three experienced emergency physicians were asked to predict the injury severity of vehicle drivers [categorized according to Injury Severity Score (ISS) values of <16 and ≥16 as moderate to severe or life-threatening] based on increasingly complex technical crash information, ranging from routine variables to photo documentation of the crash scene. A sample of 100 cases (mean ISS 23.6±26.9) was obtained from the prospective database of an in-depth technical and medical car crash research project conducted in the northeastern part of Germany. Statistical analysis comprised inter-rater agreement beyond chance (kappa values) and indicators of diagnostic test accuracy (i.e. sensitivity, specificity and so on). RESULTS The inter-rater agreement of injury severity based on technical crash information was moderate to substantial (kappa 0.42-0.66). Amongst the three observers and various amounts of technical data, sensitivity ranged between 18 and 80%, and specificity ranged between 41 and 89% in predicting the presence of major trauma. Presentation of photographs from the crash scene increased diagnostic accuracy. Still, the presented information led to a shift from a 50% prior probability of life-threatening injuries to a maximum of 40% in the negative and 67% in the positive case. CONCLUSION Neither basic technical parameters that are easy to obtain after a car crash nor additional technical information markedly contribute to the emergency physicians estimation of a vehicle drivers injury severity. The presented results should be supported by a subsequent study including a larger sample.

Semistationäre Prothesenrehabilitation@@@Partial hospitalization treatment for prosthetic rehabilitation: Innovatives Konzept zur Rehabilitation amputierter Versicherter@@@Innovative concept for the rehabilitation of insured amputees

ZusammenfassungDie berufliche und soziale Integration amputierter Verletzter ist problematisch. Trotz wesentlicher Verbesserungen der medizinischen Versorgung und orthopädietechnischer Standards gestaltet sich die Behandlung oft langwierig. Anhand einer neu konzipierten Prothesenrehabilitation im semistationären Rahmen unter Einbindung ärztlicher, physiotherapeutischer sowie orthopädietechnischer Spezialisten soll eine gezielte und individuell angepasste Reintegration des amputierten Versicherten erreicht werden. Dieses Rehabilitationsprogramm wird vorgestellt, und seine möglichen Effekte werden diskutiert.AbstractBoth the social and occupational reintegration of patients suffering a traumatic amputation remains difficult. In spite of major improvements of initial medical treatment as well as in prosthetics, the duration of treatment and rehabilitation is frequently long. Very often the outcome is poor. A new rehabilitation program including medical, physiotherapeutic, and technical specialists sets out to improve the process of individual rehabilitation. This prosthesis rehabilitation program is introduced. The aims and objectives are discussed.

Evidenzbasierte Medizin (EBM) in der Unfallchirurgie

ZusammenfassungDie Umsetzung der evidenzbasierten Medizin (EBM) in ihrem eigentlichen Sinn – als innovativer Weg der Verbesserung individueller Krankenversorgung durch die Synthese der besten verfügbaren externen Evidenz (d. h. der Ergebnisse klinischer Forschung) und der ärztlichen Erfahrung – ist in der Unfallchirurgie bislang nur unzureichend gelungen. Neben fachfremden Gründen wie zu theoretische und zu formale Ausgestaltung wurden die Besonderheiten chirurgischer Fächer von den Begründern der EBM nur unzureichend berücksichtigt. Die Bedeutung klinischer Studien wird zunehmend anhand hierarchisch aufgebauter Evidenzstufen bewertet; die Metaanalyse randomisierter Studien und nachfolgend diese selbst stellen den Referenzstandard für therapeutische Interventionsstudien dar. Der Nachweis einer ursächlichen Beziehung zwischen Intervention und Ergebnis hängt nicht nur vom Studiendesign, sondern auch von anerkannten Kausalitätskriterien, der A-priori-Wahrscheinlichkeit und der Größe des beobachteten Therapieeffekts ab. Die Unfallchirurgie weist gegenüber nichtoperativen Fächern spezifische Unterschiede auf, die für die Wahl des Studiendesigns und bei der Evidenzgraduierung berücksichtigt werden müssen. Die Ergebnisqualität ist untrennbar mit der operativen Expertise verbunden.AbstractImplementation of evidence-based medicine (EBM) in its actual sense – as an innovative way to improve individual patient care by synthesizing the best available external evidence (i.e., results of clinical research) and medical experience – into trauma surgery has not yet been adequately achieved. Besides reasons not pertaining to the field such as an overly theoretical and formal definition, the special features of surgical disciplines were not sufficiently taken into consideration by the originators of EBM. The significance of clinical trials is increasingly assessed based on hierarchically structured evidence levels. Meta-analysis of randomized studies and subsequently those analyses themselves represent the reference standard for therapeutic intervention trials. Verification of a causative relationship between intervention and results not only depends on the study design but also on recognized criteria for causality, the a priori probability, and the extent of the treatment effect observed. Trauma surgery exhibits specific differences from nonsurgical disciplines which need to be considered when choosing the study design and grading the evidence. The quality of the results is inseparably linked to surgical expertise.

Wissenschaftliche Aspekte der Zusammenhangsbegutachtung

ZusammenfassungDie Zusammenhangsbegutachtung gehört zu den verantwortungsvollsten Aufgaben der am berufsgenossenschaftlichen Heilverfahren beteiligten Ärzte. Praktisch jede Problemstellung lässt sich klar und einfach lösen, wenn man die Fragen „1. War der angeschuldigte Unfall geeignet, den Körperschaden hervorzurufen?“ und „2. War der Unfall rechtlich wesentlich?“ chronologisch bearbeitet. Die kritische Würdigung der wissenschaftlichen Literatur ist Voraussetzung für eine fundierte Abwägung konkurrierender Kausalitäten. Am Beispiel des so genannten posttraumatischen Zervikalsyndroms nach „HWS-Distorsion“ lässt sich gut belegen, dass der aktuelle klinisch-epidemiologische Kenntnisstand nur im Einzelfall die Einschätzung einer Eignung erlaubt, da die Effektstärke demografischer und sonstiger Variablen als überwiegend einzuschätzen ist und die geforderte rechtliche Wesentlichkeit des Ereignisses im Regelfall für die Betrachtung der langanhaltenden und häufig erst später auftretenden Symptome, nicht erfüllt wird.AbstractRendering an expert opinion on the causal relationship between an accident and late consequences for the victim’s health is one of the most responsible tasks undertaken by physicians engaged in treatments approved by the employers’ liability insurance associations. Practically any problem can be solved, providing two questions are dealt with in order: (1) Was the documented event sufficient (in terms of time, force, and direction) to cause the alleged physical harm? and (2) Was the event (in a legal sense) of such a relevance that its importance for the health deficit exceeds a specific threshold? Physicians need a good knowledge of the current medical literature to be able to address these questions properly. In the case of whiplash-associated disorders, recent clinical and epidemiological data rarely allow confirmation of adequacy that the accident was sufficiently serious to cause neck pain, and almost never, to justify any assumption of causality.