Do we need another screw? Sacroiliac screw fixation in open-book pelvic ring injuries (APC type II).

Purpose: To compare anterior plate fixation (SP fixation) both alone and in combination with an additional posterior sacroiliac screw (SP+SIS fixation) as a treatment for pelvic ring injuries with widening of the pubic symphysis and disruption to the anterior sacroiliac ligaments. Methods: To find studies with pelvic ring injuries (APC II; B2.3d) and SP or SP+SIS fixation, a systematic literature review was conducted by searching four databases. A protocol was published a priori at Open Science Framework (https://doi.org/10.17605/OSF.IO/3YHAV). Exclusion criteria included perineal injuries, chronic instability of the symphysis, complete sacroiliac separation, and pediatric patients (age <18 years). Primary outcomes of interest were defined as implant failure, health-related quality of life, and revision rate. Results: Altogether, 1861 studies were screened, and 40 studies qualified for full-text analysis. In total, 14 studies (two surveys, six biomechanical studies, and six retrospective clinical studies) were included. The surveys revealed that surgeons who had more recently begun practicing were more likely to use posterior fixation (SP+ISS). The biomechanical studies were heterogenous and did not yield a uniform pattern. In clinical studies, 117 patients (45%) received SP fixation, and 142 patients (55%) received SP+SIS fixation. Complications occurred in 31 SP patients (30%) and in five SP+SIS patients (3.5%). Conclusion: A high risk of bias was uncovered, and reporting was found to be incomplete. SP+SIS may have the potential to improve outcomes, but the evidence remains too inconclusive to draw reliable recommendations.

Developing a core outcome set for acetabular fractures: a systematic review protocol.

BACKGROUND: Clinical trials investigating acetabular fractures are heterogeneous in their investigated outcomes and their corresponding measurements. Standardization may facilitate comparability and pooling of research results, which would lead to an increase in knowledge about the optimal treatment of acetabular fractures, resulting in long-term evidence-based treatment decisions and improvements in patient care. The aim of this systematic review is to identify the reported outcomes and their measurements from studies on treatments for acetabular fractures to develop a core outcome set which contains the most relevant outcome measures to be included in future studies. METHODS: Studies published in English and German including patients aged 16 years and older, with a surgically treated acetabular fracture, will be included. Studies with nonsurgical treatment, pathologic fractures, polytraumatized patients, and patients younger than 16 years of age will be excluded because other outcomes may be of interest in these cases. Any prospective and retrospective study will be included. Systematic reviews will be excluded, but their included studies will be screened for eligibility. The literature will be searched on MEDLINE, CENTRAL, Web of Science, ClinicalTrials.gov, and WHO ICTRP. Risk of selective reporting of outcomes will be assessed using the Outcome Reporting Bias in Trials classification system. Heterogeneously defined outcomes that measure the same outcome will be grouped and subsequently categorized into outcome domains using the taxonomy of the Core Outcome Measures in Effectiveness Trials Initiative. DISCUSSION: It is expected that a high number of studies will be included, and many outcomes will be identified using different definitions and measurement instruments. A limitation of this systematic review is that only previously investigated outcomes will be detected, thus disregarding potentially relevant outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022357644.

Implementation of health-related quality of life in the German TraumaRegister DGU® - first results of a pilot study.

BACKGROUND: Approximately 30,000 people are affected by severe injuries in Germany each year. Continuous progress in prehospital and hospital care has significantly reduced the mortality of polytrauma patients. With increasing survival rates, the functional outcome, health-related quality (hrQoL) of life and ability to work are now gaining importance. Aim of the study is, the presentation of the response behavior of seriously injured patients on the one hand and the examination of the factors influencing the quality of life and ability to work 12 months after major trauma on the other hand. Building on these initial results, a standard outcome tool shall be integrated in the established TraumaRegister DGU® in the future. METHODS: In 2018, patients [Injury Severity Score (ISS) ≥ 16; age:18-75 years] underwent multicenter one-year posttraumatic follow-up in six study hospitals. In addition to assessing hrQoL by using the Short-Form Health Survey (SF-12), five additional questions (treatment satisfaction; ability to work; trauma-related medical treatment; relevant physical disability, hrQoL as compared with the prior to injury status) were applied. RESULTS: Of the 1,162 patients contacted, 594 responded and were included in the analysis. The post-injury hrQoL does not show statistically significant differences between the sexes. Regarding age, however, the younger the patient at injury, the better the SF-12 physical sum score. Furthermore, the physically perceived quality of life decreases statistically significantly in relation to the severity of the trauma as measured by the ISS, whereas the mentally perceived quality of life shows no differences in terms of injury severity. A large proportion of severely injured patients were very satisfied (42.2%) or satisfied (39.9%) with the treatment outcome. It should be emphasized that patients with a high injury severity (ISS > 50) were on average more often very satisfied with the treatment outcome (46.7%). A total of 429 patients provided information on their ability to work 12 months post-injury. Here, 194 (45.2%) patients had a full employment, and 58 (13.5%) patients were had a restricted employment. CONCLUSION: The present results show the importance of a structured assessment of the postinjury hrQoL and the ability to work after polytrauma. Further studies on the detection of influenceable risk factors on hrQoL and ability to work in the intersectoral course of treatment should follow to enable the best possible outcome of polytrauma survivors.

[A retrospective identification of severely injured patients using ICD 10 diagnoses codes : Part of the project "Quality of life and ability to work after severe trauma" (LeAf Trauma)]. / Eine retrospektive Identifikation von Schwerverletzten mittels ICD-10-Diagnosen : Teil des Projekts "Lebensqualität und Arbeitsfähigkeit nach schwerem Trauma" (LeAf Trauma).

BACKGROUND: Due to continuous improvements in treatment, more and more severely and seriously injured patients are surviving. The complexity of the injury patterns of these patients means that they are difficult to map in routine data. AIM OF THE WORK: The aim of the data exploration was to identify ICD 10 diagnoses that show an association with an injury severity score (ISS) ≥ 16 and could therefore be used to operationalize severely injured patients in routine data. MATERIAL AND METHODS: The coded four-digit ICD 10 S diagnoses and the calculated ISS of trauma patients from the Armed Forces Central Hospital Koblenz (BwZKrhs) and the University Hospital Düsseldorf (UKD) were analyzed using statistical association measures (phi and Cramer's V), linear regressions and machine learning methods (e.g., random forest). RESULTS: The S diagnoses of facial, head, thoracic and pelvic injuries, associated with an ISS ≥ 16 were identified. Some S diagnoses showed an association with an ISS ≥ 16 in only 1 of the 2 datasets. Likewise, facial, head, thoracic and pelvic injuries were found in the subgroup of 18-55-year-old patients. DISCUSSION: The current evaluations show that it is possible to identify ICD 10 S diagnoses that have a significant association with an ISS ≥ 16. According to the annual report of the trauma register of the German Society for Trauma Surgery (TR-DGU®), injuries with an abbreviated injury scale (AIS) ≥ 3 are particularly common in the head and thoracic regions.

The potential of point-of-care diagnostics to optimise prehospital trauma triage: a systematic review of literature.

PURPOSE: In the prehospital care of potentially seriously injured patients resource allocation adapted to injury severity (triage) is a challenging. Insufficiently specified triage algorithms lead to the unnecessary activation of a trauma team (over-triage), resulting in ineffective consumption of economic and human resources. A prehospital trauma triage algorithm must reliably identify a patient bleeding or suffering from significant brain injuries. By supplementing the prehospital triage algorithm with in-hospital established point-of-care (POC) tools the sensitivity of the prehospital triage is potentially increased. Possible POC tools are lactate measurement and sonography of the thorax, the abdomen and the vena cava, the sonographic intracranial pressure measurement and the capnometry in the spontaneously breathing patient. The aim of this review was to assess the potential and to determine diagnostic cut-off values of selected instrument-based POC tools and the integration of these findings into a modified ABCDE based triage algorithm. METHODS: A systemic search on MEDLINE via PubMed, LIVIVO and Embase was performed for patients in an acute setting on the topic of preclinical use of the selected POC tools to identify critical cranial and peripheral bleeding and the recognition of cerebral trauma sequelae. For the determination of the final cut-off values the selected papers were assessed with the Newcastle-Ottawa scale for determining the risk of bias and according to various quality criteria to subsequently be classified as suitable or unsuitable. PROSPERO Registration: CRD 42022339193. RESULTS: 267 papers were identified as potentially relevant and processed in full text form. 61 papers were selected for the final evaluation, of which 13 papers were decisive for determining the cut-off values. Findings illustrate that a preclinical use of point-of-care diagnostic is possible. These adjuncts can provide additional information about the expected long-term clinical course of patients. Clinical outcomes like mortality, need of emergency surgery, intensive care unit stay etc. were taken into account and a hypothetic cut-off value for trauma team activation could be determined for each adjunct. The cut-off values are as follows: end-expiratory CO2: < 30 mm/hg; sonography thorax + abdomen: abnormality detected; lactate measurement: > 2 mmol/L; optic nerve diameter in sonography: > 4.7 mm. DISCUSSION: A preliminary version of a modified triage algorithm with hypothetic cut-off values for a trauma team activation was created. However, further studies should be conducted to optimize the final cut-off values in the future. Furthermore, studies need to evaluate the practical application of the modified algorithm in terms of feasibility (e.g. duration of application, technique, etc.) and the effects of the new algorithm on over-triage. Limiting factors are the restriction with the search and the heterogeneity between the studies (e.g. varying measurement devices, techniques etc.).

Screw fixation in the treatment of displaced intra-articular calcaneus fractures: a systematic review protocol.

BACKGROUND: The Calcaneus is the largest bone of the foot and the most frequent tarsal bone to be fractured. Overall, it causes round about 10 cases per 100,000 residents per year mainly in men. Especially displaced intra-articular calcaneus fractures often have early and late complications and its associated disability. There are various strategies for the treatment of displaced intra-articular calcaneus fractures, but the gold standard is still subject of a long-standing controversy. Minimally invasive procedures became more common in an attempt to reduce the high rate of complications associated with open reduction and internal fixation. With the increase in minimally invasive techniques, screw fixation also gained in significance. The current literature does not sufficiently elucidate whether the screw fixation is superior to other treatment options especially in relation to adverse events, health-related quality of life and postoperative pain. This study aims to investigate benefits and harms of treating displaced intra-articular calcaneus fractures (types II, III and IV according to Sanders) with screw fixation in adults. METHODS: A systematic review will be conducted based on the principles described in the Cochrane Handbook. We will include adults with displaced intra-articular calcaneus fractures of Sanders type II, III and IV. The surgical method of screw fixation shall be compared to other surgical interventions to stabilise calcaneus fractures. Primary outcomes are serious adverse events, health-related quality of life and postoperative pain level. MEDLINE, CENTRAL, CINAHL, Web of Science and bibnet.org, ClinicalTrial.gov and the World Health Organization International Clinical Trials Registry Platform (ICTR) will be searched. Screening and data extraction will be performed by two authors independently. A third author will arbitrate disputes. Risk of Bias will be assessed with the Cochrane tool. Meta-analysis will be performed if participants, interventions, comparisons and outcomes are sufficiently similar to ensure a result that is clinically meaningful. DISCUSSION: Due to the increasing use of minimally invasive techniques and the increasing use of screw fixation instead of open reduction and plate fixation, it is important to analyse the benefits and harms of screw fixation for calcaneus fractures. Screw fixation could, in the future, help to operate in a less invasive and tissue preserving manner while still achieving an adequate functional result for the patient SYSTEMATIC REVIEW REGISTRATION: CRD42021244695.

Understanding the use of patient-reported data by health care insurers: A scoping review.

BACKGROUND: Patient-reported data are widely used for many purposes by different actors within a health system. However, little is known about the use of such data by health insurers. Our study aims to map the evidence on the use of patient-reported data by health insurers; to explore how collected patient-reported data are utilized; and to elucidate the motives of why patient-reported data are collected by health insurers. METHODS: The study design is that of a scoping review. In total, 11 databases were searched on. Relevant grey literature was identified through online searches, reference mining and recommendations from experts. Forty-two documents were included. We synthesized the evidence on the uses of patient-reported data by insurers following a structure-process-outcome approach; we also mapped the use and function of those data by a health insurer. RESULTS: Health insurers use patient-reported data for assurance and improvement of quality of care and value-based health care. The patient-reported data most often collected are those of outcomes, experiences and satisfaction measures; structure indicators are used to a lesser extent and often combined with process indicators. These data are mainly used for the purposes of procurement and purchasing of services, quality assurance, improvement and reporting, and strengthening the involvement of insured people. CONCLUSIONS: The breadth to which insurers use patient-reported data in their business models varies greatly. Some hindering factors to the uptake of such data are the varying and overlapping terminology in use in the field and the limited involvement of insured people in a health insurer's business. Health insurers are advised to be more explicit in regard to the role they want to play within the health system and society at large, and accommodate implications for the use of patient-reported data accordingly.

Seroprevalence of hepatitis E virus (HEV) in humans living in high pig density areas of Germany.

An increase in acute autochthonous hepatitis E virus (HEV) infections has been recorded in Germany. These are suspected to be zoonotically transmitted from wild boar, deer and domestic pig. The latter may represent a major reservoir for HEV. In this study, 537 sera from humans living in Westphalia and Lower Saxony, representing areas of high pig density in Germany, were tested for the presence of HEV-specific antibodies. Among them were 302 individuals with occupational, direct contact to pigs and 235 individuals without direct contact to pigs. Two commercial tests and one in-house assay were applied for the detection of HEV-specific immunoglobulin G (IgG) antibodies. Sera were also tested in an assay that detects all classes of HEV-specific antibodies. Depending on the test used, the seroprevalence ranged from 4.1 to 27.9 %. Exposition to pigs was found to be associated with a significantly higher seroprevalence in subjects with contact to pigs (13.2-32.8 %) compared with that in non-exposed humans (7.7-21.7 %). In particular, individuals younger than 40 years with occupational exposure exhibited a markedly higher HEV seroprevalence compared with non-exposed individuals of that age group. In general, HEV seroprevalence increased with age resulting in a similar prevalence level in the age group of ≥ 50 years for exposed and non-exposed individuals. Analysis of all sera by a commercial anti-HEV IgM ELISA revealed 35 positive and 25 borderline samples. However, only one positive serum could be confirmed by an IgM line assay. Selected samples from IgM and/or IgG as well as total HEV antibody-positive individuals were also tested for the presence of HEV RNA. In one of the 78 samples, the only IgM ELISA positive and IgM line assay confirmed sample, RNA of HEV genotype 3 was detected. This sequence has high similarity to HEV sequences obtained from wild boars and domestic pigs from Germany and The Netherlands. This study demonstrates that in addition to the consumption of raw or undercooked meat, direct contact to pigs has to be considered as an additional risk factor for HEV infection.

Prevalence of hepatitis E virus antibodies in children in Germany.

BACKGROUND: Since asymptomatic hepatitis E virus (HEV) infections particularly affect children, there is a need for studies to determine the HEV seroprevalence among infants, children and adolescents. METHODS: The prevalence of anti-HEV IgG antibodies was determined in sera taken in 2008-2010 from 1646 children aged 0-17 years living in Germany. Antibody testing was carried out using the enzyme-linked immunosorbent assay recomWell HEV IgG as well as the recomLine HEV IgG/IgM distributed by Mikrogen. Furthermore, the performance of MP Biomedicals enzyme-linked immunosorbent assay HEV and the HEV-Ab enzyme-linked immunosorbent assay from Axiom was analyzed in comparison with the recomWell/recomLine test system using a defined subset of sera. RESULTS: In children, the overall prevalence of antibodies was 1.0%. Starting with the 5- to 6-year olds, there was a significant increase of HEV seroprevalence to 1.5% in the group of the 15- to 17-year olds. There was no statistically significant difference between seroprevalences of boys (1.2%) and girls (0.7%). Passively transmitted maternal antibodies persisted for about 3 months. The strength of agreement between the recomWell/recomLine system and the ELISAs from MP Biomedicals or Axiom varied between 0.229 and 0.542 and was calculated at 0.111 when the assays from MP Biomedicals and Axiom were compared. CONCLUSIONS: In Germany, only a very small number of HEV infections occur in children. Many infections occur in adults with increasing age. Because of considerable variations in assay accordance, there is an urgent need for standardization of HEV serology.

Age-related and regional differences in the prevalence of hepatitis E virus-specific antibodies in pigs in Germany.

An increasing number of acute autochthonous human hepatitis E virus (HEV)-infections was noticed in Germany and other developed countries, most likely the result of a zoonotic virus transmission from pig, wild boar and deer. Currently there is still a lack of profound data concerning the actual prevalence of HEV-specific antibodies in domestic pig herds in Germany, in particular for regions with high pig density, and its age-dependency. 2273 domestic pig sera were collected in 2011 mainly from Bavaria, North Rhine-Westphalia and Lower Saxony from areas having a high pig density. Initially, 420 randomly selected pig sera were tested in three commercially available and in two in-house HEV-antibody ELISAs. 43.6% (183/420) to 65.5% (275/420) of the sera were demonstrated to be reactive against human pathogenic HEV genotypes 1 and/or 3. The majority of sera reacted only weakly or not at all with the rat HEV antigen with very few sera showing a stronger reactivity to this antigen compared to the genotype 3 antigen. The results of all three HEV-IgG tests, i.e. the PrioCHECK(®) HEV Ab porcine ELISA kit, the ID Screen(®) Hepatitis E Indirect Multi-species ELISA kit and the genotype 3 in-house ELISA were in good accordance. Therefore, the remaining sera were tested using the PrioCHECK(®) HEV Ab porcine ELISA kit. Samples with a borderline result were finally determined by application of the conjugate-modified recomLine HEV IgG assay. A total of 1065 of the 2273 sera (46.9%) were found to be anti-HEV IgG-positive. While 38.4% (306/796) of fatteners (age between 3 and 9 months) exhibited HEV-specific antibodies, 51.4% (759/1477) of sows (age older than 9 months) exhibited anti-HEV antibodies (P<0.001). Fatteners kept in Southern Germany had a significantly higher HEV IgG prevalence compared to fatteners kept in the high pig density federal states North Rhine-Westphalia and Lower Saxony but also in German federal states with a low pig density. In conclusion, the present study clearly demonstrates that a high percentage of domestic pigs in Germany have had contact with HEV. Seroprevalence depends on the pig's age and herd origin with the most significant regional variations for fatteners. The presence of anti-HEV-free herds may indicate that it is feasible to establish and sustain HEV-free pig herds. HEV seroprevalence still depends on the assay used for testing. This demonstrates an urgent need for test validation.

Spinal antinociceptive effects of cyclooxygenase inhibition during inflammation: Involvement of prostaglandins and endocannabinoids.

Both cyclooxygenase-1 and -2 are expressed in the spinal cord, and the spinal COX product prostaglandin E(2) (PGE(2)) contributes to the generation of central sensitization upon peripheral inflammation. Vice versa spinal COX inhibition is considered an important mechanism of antihyperalgesic pain treatment. Recently, however, COX-2 was shown to be also involved in the metabolism of endocannabinoids. Because endocannabinoids can have analgesic actions it is conceivable that inhibition of spinal COX produces analgesia not only by inhibition of PG synthesis but also by inhibition of endocannabinoid breakdown. In the present study, we recorded from spinal cord neurons with input from the inflamed knee joint and we measured the spinal release of PGE(2) and the endocannabinoid 2-arachidonoyl glycerol (2-AG) in vivo, using the same stimulation procedures. COX inhibitors were applied spinally. Selective COX-1, selective COX-2 and non-selective COX inhibitors attenuated the generation of spinal hyperexcitability when applied before and during development of inflammation but, when inflammation and spinal hyperexcitability were established, only selective COX-2 inhibitors reversed spinal hyperexcitability. During established inflammation all COX inhibitors reduced release of spinal PGE(2) almost equally but only the COX-2 inhibitor prevented breakdown of 2-AG. The reversal of spinal hyperexcitability by COX-2 inhibitors was prevented or partially reversed by AM-251, an antagonist at the cannabinoid-1 receptor. We conclude that inhibition of spinal COX-2 not only reduces PG production but also endocannabinoid breakdown and provide evidence that reversal of inflammation-evoked spinal hyperexcitability by COX-2 inhibitors is more related to endocannabinoidergic mechanisms than to inhibition of spinal PG synthesis.

Development of a vessel-simulating flow-through cell method for the in vitro evaluation of release and distribution from drug-eluting stents.

A novel in vitro dissolution test for drug-eluting stents (DES) based on the compendial flow-through cell was developed. The model contains an additional compartment simulating the vessel wall enabling the examination of drug release and distribution. The compartment consists of alginate hydrogel containing a central aperture forming the lumen for stent placement and media flow. The method was tested utilizing stents coated with hydrophilic (fluorescein sodium) and hydrophobic (triamterene) fluorescent model substances as well as the cytostatic drug doxorubicin hydrochloride and compared to standard dissolution methods. The results show the suitability of the developed method to observe drug release and distribution. The determination of model substance content in the compartments media, hydrogel and stent yielded differing distribution patterns for the model compounds and enabled the observation of redistribution processes. The dissolution profiles differed from the results of compendial dissolution testing. Besides lower endpoints and slower rises of media concentrations due to distribution into the hydrogel, the release rates from the stent coatings were altered. These findings emphasize the necessity to adapt dissolution testing for DES to the unique conditions influencing delivery to the vessel wall to learn more about local distribution and to anticipate the in vivo performance of DES.