German University Medical Center Research Articles

Optimistic vs Pessimistic Message Framing in Communicating Prognosis to Parents of Very Preterm Infants

In the neonatal intensive care unit, there is a lack of understanding about how best to communicate the prognosis of a serious complication to parents. To examine parental preferences and the effects of optimistic vs pessimistic message framing when providing prognostic information about a serious complication. This crossover randomized clinical trial was conducted at a single German university medical center between June and October 2021. Eligible participants were parents of surviving preterm infants with a birth weight under 1500 g. Data were analyzed between October 2021 and August 2022. Alternating exposure to 2 scripted video vignettes showing a standardized conversation between a neonatologist and parents, portrayed by professional actors, about the prognosis of a hypothetical very preterm infant with severe intraventricular hemorrhage. The video vignettes differed in the framing of identical numerical outcome estimates as either probability of survival and probability of nonimpairment (optimistic framing) or a risk of death and impaired survival (pessimistic framing). The primary outcome was preference odds (ratio of preference for optimistic vs pessimistic framing). Secondary outcomes included state anxiety, perceptions of communication, and recall of numerical estimates. Of 220 enrolled parents (142 [64.5%] mothers; mean [SD] age: mothers, 39.1 [5.6] years; fathers, 42.7 [6.9] years), 196 (89.1%) preferred optimistic and 24 (10.1%) preferred pessimistic framing (preference odds, 11.0; 95% CI, 6.28-19.10; P < .001). Preference for optimistic framing was more pronounced when presented second than when presented first (preference odds, 5.41; 95% CI, 1.77-16.48; P = .003). State anxiety scores were similar in both groups at baseline (mean difference, -0.34; -1.18 to 0.49; P = .42) and increased equally after the first video (mean difference, -0.55; 95% CI, -1.79 to 0.69; P = .39). After the second video, state anxiety scores decreased when optimistic framing followed pessimistic framing but remained unchanged when pessimistic framing followed optimistic framing (mean difference, 2.15; 95% CI, 0.91 to 3.39; P < .001). With optimistic framing, participants recalled numerical estimates more accurately for survival (odds ratio, 4.00; 95% CI, 1.64-9.79; P = .002) but not for impairment (odds ratio, 1.50; 95% CI, 0.85-2.63; P = .16). When given prognostic information about a serious complication, parents of very preterm infants may prefer optimistic framing. Optimistic framing may lead to more realistic expectations for survival, but not for impairment. German Clinical Trials Register (DRKS): DRKS00024466.

Frequency of multiple changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German university medical centers: A meta-research study

Background Clinical trial registries allow assessment of deviations of published trials from their protocol, which may indicate a considerable risk of bias. However, since entries in many registries can be updated at any time, deviations may go unnoticed. We aimed to assess the frequency of changes to primary outcomes in different historical versions of registry entries, and how often they would go unnoticed if only deviations between published trial reports and the most recent registry entry are assessed. Methods and findings We analyzed the complete history of changes of registry entries in all 1746 randomized controlled trials completed at German university medical centers between 2009 and 2017, with published results up to 2022, that were registered in ClinicalTrials.gov or the German WHO primary registry (German Clinical Trials Register; DRKS). Data were retrieved on 24 January 2022. We assessed deviations between registry entries and publications in a random subsample of 292 trials. We determined changes of primary outcomes (1) between different versions of registry entries at key trial milestones, (2) between the latest registry entry version and the results publication, and (3) changes that occurred after trial start with no change between latest registry entry version and publication (so that assessing the full history of changes is required for detection of changes). We categorized changes as major if primary outcomes were added, dropped, changed to secondary outcomes, or secondary outcomes were turned into primary outcomes. We also assessed (4) the proportion of publications transparently reporting changes and (5) characteristics associated with changes. Of all 1746 trials, 23% (n = 393) had a primary outcome change between trial start and latest registry entry version, with 8% (n = 142) being major changes, that is, primary outcomes were added, dropped, changed to secondary outcomes, or secondary outcomes were turned into primary outcomes. Primary outcomes in publications were different from the latest registry entry version in 41% of trials (120 of the 292 sampled trials; 95% confidence interval (CI) [35%, 47%]), with major changes in 18% (54 of 292; 95% CI [14%, 23%]). Overall, 55% of trials (161 of 292; 95% CI [49%, 61%]) had primary outcome changes at any timepoint over the course of a trial, with 23% of trials (67 of 292; 95% CI [18%, 28%]) having major changes. Changes only within registry records, with no apparent discrepancy between latest registry entry version and publication, were observed in 14% of trials (41 of 292; 95% CI [10%, 19%]), with 4% (13 of 292; 95% CI [2%, 7%]) being major changes. One percent of trials with a change reported this in their publication (2 of 161 trials; 95% CI [0%, 4%]). An exploratory logistic regression analysis indicated that trials were less likely to have a discrepant registry entry if they were registered more recently (odds ratio (OR) 0.74; 95% CI [0.69, 0.80]; p&lt;0.001), were not registered on ClinicalTrials.gov (OR 0.41; 95% CI [0.23, 0.70]; p = 0.002), or were not industry-sponsored (OR 0.29; 95% CI [0.21, 0.41]; p&lt;0.001). Key limitations include some degree of subjectivity in the categorization of outcome changes and inclusion of a single geographic region. Conclusions In this study, we observed that changes to primary outcomes occur in 55% of trials, with 23% trials having major changes. They are rarely transparently reported in the results publication and often not visible in the latest registry entry version. More transparency is needed, supported by deeper analysis of registry entries to make these changes more easily recognizable. Protocol registration: Open Science Framework (https://osf.io/t3qva; amendment in https://osf.io/qtd2b).

Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials

ObjectiveProspective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is...

Leveraging Open Tools to Realize the Potential of Self-Archiving: A Cohort Study in Clinical Trials

While open access (OA) is growing, many publications remain behind a paywall. This limits the impact of research and entrenches global inequalities by restricting access to knowledge to those that can afford it. Many journal policies allow researchers to make a version of their publication openly accessible through self-archiving in a repository, sometimes after an embargo period (green OA). Unpaywall and Shareyourpaper are open tools that help users find OA articles and support authors to legally self-archive their papers, respectively. This study leveraged these tools to assess the potential of green OA to increase discoverability in a cohort of clinical trial results publications from German university medical centers. Of the 1897 publications in this cohort, 46% (n = 871/1897, 95% confidence interval (CI) 44% to 48%) were neither openly accessible via a journal or a repository. Of these, 85% (n = 736/871, 95% CI 82% to 87%) had a permission to self-archive the accepted or published version in an institutional repository. Thus, most of the closed-access clinical trial results in this cohort could be made openly accessible in a repository, in line with World Health Organization (WHO) recommendations. In addition to providing further evidence of the unrealized potential of green OA, this study demonstrates the use of open tools to obtain actionable information on self-archiving at scale and empowers efforts to increase science discoverability.

Bariatric surgery in liver cirrhosis.

Obesity is frequently associated with its hepatic manifestation, the nonalcoholic fatty liver disease (NAFLD). The most effective treatment for morbid obesity is bariatric surgery (BS) also improving NAFLD and liver function. In patients where NAFLD has already progressed to liver cirrhosis, BS can be considered a high-risk procedure. Hence, consideration of the procedure and the most appropriate timing is crucial. Obese patients suffering from NAFLD who underwent BS from two German University Medical Centers were retrospectively analyzed. Twenty-seven patients underwent BS. Most common procedures were laparoscopic Roux-en-Y-gastric (RYGB) and laparoscopic sleeve gastrectomy (SG). All patients suffered from liver cirrhosis Child A. A preoperative transjugular portosystemic shunt (TIPS) was established in three patients and failed in another patient. Postoperative complications consisted of wound healing disorders (n = 2), anastomotic bleeding (n = 1), and leak from the staple line (n = 1). This patient suffered from intraoperatively detected macroscopic liver cirrhosis. Excess weight loss was 73% and 85% after 1 and 2 years, respectively. Two patients suffered from postoperative aggravation of their liver function, resulting in a higher Child-Pugh score, while three could be removed from the waiting list for a liver transplantation. BS leads to weight loss, both after SG and RYGB, and potential improvement of liver function in liver cirrhosis. These patients need to be considered with care when evaluated for BS. Preoperative TIPS implantation may reduce the perioperative risk in selected patients.

Impact of patient nationality on the severity of early side effects after radiotherapy

BackgroundMajor demographical changes in Germany commenced in the 1960s. Ongoing humanitarian crises in the Ukraine with subsequent immigration will have also long-range effects on national provision of cancer treatment. Ensuring the best possible outcomes for each cancer patient undergoing radiotherapy requires the prediction and prevention of unfavorable side effects. Given that recent research has primarily focused on clinical outcome indicators solely, less is known regarding sociodemographic predictors of therapeutic outcomes, such as patient nationality. Here, we investigated whether the severity of early side effects after radiotherapy are associated with patient nationality and other sociodemographic and clinical characteristics.MethodsOut of 9187 patients treated at a German university medical center between 2017 and 2021, 178 German and 178 non-German patients were selected for matched-pair analysis based on diagnostic and demographic criteria. For all 356 patients, data on side effects from follow-up care after radiotherapy were collected.ResultsNon-German patients were more likely to have severe side effects than German patients. Side effect severity was also associated with tumor entity, concomitant therapy, body mass index, and age.ConclusionForeign cancer patients are at higher risk of experiencing severe side effects of radiotherapy, suggesting a need to develop and implement targeted preventive measures for these patients. Further research investigating factors predicting the occurrence of radiotherapy side effects, including other sociodemographic characteristics, is needed to better personalize therapy regimens for cancer.

Calcification of the visceral aorta and celiac trunk is associated with renal and allograft outcomes after deceased donor liver transplantation

PurposeAtherosclerosis affects clinical outcomes in the setting of major surgery. Here we aimed to investigate the prognostic role of visceral aortic (VAC), extended visceral aortic (VAC+), and celiac artery calcification (CAC) in the assessment of short- and long-term outcomes following deceased donor orthotopic liver transplantation (OLT) in a western European cohort.MethodsWe retrospectively analyzed the data of 281 consecutive recipients who underwent OLT at a German university medical center (05/2010–03/2020). The parameters VAC, VAC+, or CAC were evaluated by preoperative computed tomography-based calcium quantification according to the Agatston score.ResultsSignificant VAC or CAC were associated with impaired postoperative renal function (p = 0.0016; p = 0.0211). Patients with VAC suffered more frequently from early allograft dysfunction (EAD) (38 vs 26%, p = 0.031), while CAC was associated with higher estimated procedural costs (p = 0.049). In the multivariate logistic regression analysis, VAC was identified as an independent predictor of EAD (2.387 OR, 1.290–4.418 CI, p = 0.006). Concerning long-term graft and patient survival, no significant difference was found, even though patients with calcification showed a tendency towards lower 5-year survival compared to those without (VAC: 65 vs 73%, p = 0.217; CAC: 52 vs 72%, p = 0.105). VAC+ failed to provide an additional prognostic value compared to VAC.ConclusionThis is the first clinical report to show the prognostic role of VAC/CAC in the setting of deceased donor OLT with a particular value in the perioperative phase. Further studies are warranted to validate these findings.Graphical abstractCT computed tomography, OLT orthotopic liver transplantation

Effect of personalized perioperative blood pressure management on postoperative complications and mortality in high-risk patients having major abdominal surgery: protocol for a multicenter randomized trial (IMPROVE-multi)

BackgroundIntraoperative hypotension is common in patients having non-cardiac surgery and is associated with serious complications and death. However, optimal intraoperative blood pressures for individual patients remain unknown. We therefore aim to test the hypothesis that personalized perioperative blood pressure management—based on preoperative automated blood pressure monitoring—reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery.MethodsIMPROVE-multi is a multicenter randomized trial in 1272 high-risk patients having elective major abdominal surgery that we plan to conduct at 16 German university medical centers. Preoperative automated blood pressure monitoring using upper arm cuff oscillometry will be performed in all patients for one night to obtain the mean of the nighttime mean arterial pressures. Patients will then be randomized either to personalized blood pressure management or to routine blood pressure management. In patients assigned to personalized management, intraoperative mean arterial pressure will be maintained at least at the mean of the nighttime mean arterial pressures. In patients assigned to routine management, intraoperative blood pressure will be managed per routine. The primary outcome will be a composite of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery.DiscussionOur trial will determine whether personalized perioperative blood pressure management reduces the incidence of major postoperative complications and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery.Trial registrationClinicalTrials.gov NCT05416944. Registered on June 14, 2022.

Osteopenia is associated with inferior survival in patients undergoing partial hepatectomy for hepatocellular carcinoma

Osteopenia is known to be associated with clinical frailty which is linked to inferior outcomes in various clinical scenarios. However, the exact prognostic value of osteopenia in patients undergoing curative intent-surgery for hepatocellular carcinoma (HCC) is not completely understood. This retrospective study was conducted in a cohort of 151 patients who underwent partial hepatectomy for HCC in curative intent at a German university medical center (05/2008–12/2019). Preoperative computed tomography-based segmentation was used to assess osteopenia, and the prognostic impact of pathological changes in bone mineral density (BMD) on perioperative morbidity, mortality, and long-term oncological outcome was analyzed. Five-year overall survival of osteopenic patients was significantly worse compared to those with normal BMD (29% vs. 65%, p = 0.014). In line with this, the probability of disease-free survival at 5 years was significantly worse for patients with osteopenia (21% vs. 64%, p = 0.005). In our multivariable model, osteopenia was confirmed as an independent risk-factor for inferior overall survival (Hazard-ratio 7.743, p = 0.002). Concerning perioperative complications, osteopenic patients performed slightly worse, even though no statistical difference was detected (Clavien-Dindo ≥ 3b; 21% vs. 9%, p = 0.139). The present study confirms osteopenia as an independent risk-factor for inferior survival in patients undergoing partial hepatectomy for HCC in a European cohort. Further studies are warranted to validate these findings.

Attitudes of Patients With Chronic Heart Failure Toward Digital Device Data for Self-documentation and Research in Germany: Cross-sectional Survey Study.

BackgroundIn recent years, the use of digital mobile measurement devices (DMMDs) for self-documentation in cardiovascular care in Western industrialized health care systems has increased. For patients with chronic heart failure (cHF), digital self-documentation plays an increasingly important role in self-management. Data from DMMDs can also be integrated into telemonitoring programs or data-intensive medical research to collect and evaluate patient-reported outcome measures through data sharing. However, the implementation of data-intensive devices and data sharing poses several challenges for doctors and patients as well as for the ethical governance of data-driven medical research.ObjectiveThis study aims to explore the potential and challenges of digital device data in cardiology research from patients’ perspectives. Leading research questions of the study concerned the attitudes of patients with cHF toward health-related data collected in the use of digital devices for self-documentation as well as sharing these data and consenting to data sharing for research purposes.MethodsA cross-sectional survey of patients of a research in cardiology was conducted at a German university medical center (N=159) in 2020 (March to July). Eligible participants were German-speaking adult patients with cHF at that center. A pen-and-pencil questionnaire was sent by mail.ResultsMost participants (77/105, 73.3%) approved digital documentation, as they expected the device data to help them observe their body and its functions more objectively. Digital device data were believed to provide cognitive support, both for patients’ self-assessment and doctors’ evaluation of their patients’ current health condition. Interestingly, positive attitudes toward DMMD data providing cognitive support were, in particular, voiced by older patients aged >65 years. However, approximately half of the participants (56/105, 53.3%) also reported difficulty in dealing with self-documented data that lay outside the optimal medical target range. Furthermore, our findings revealed preferences for the self-management of DMMD data disclosed for data-intensive medical research among German patients with cHF, which are best implemented with a dynamic consent model.ConclusionsOur findings provide potentially valuable insights for introducing DMMD in cardiovascular research in the German context. They have several practical implications, such as a high divergence in attitudes among patients with cHF toward different data-receiving organizations as well as a large variance in preferences for the modes of receiving information included in the consenting procedure for data sharing for research. We suggest addressing patients’ multiple views on consenting and data sharing in institutional normative governance frameworks for data-intensive medical research.

Pulse Wave Analysis Using the Pressure Recording Analytical Method to Measure Cardiac Output in Pediatric Cardiac Surgery Patients: A Method Comparison Study Using Transesophageal Doppler Echocardiography as Reference Method.

Cardiac output (CO) is a key determinant of oxygen delivery, but choosing the optimal method to obtain CO in pediatric patients remains challenging. The pressure recording analytical method (PRAM), implemented in the MostCareUp system (Vygon), is an invasive uncalibrated pulse wave analysis (PWA) method to measure CO. The objective of this study is to compare CO measured by PRAM (PRAM-CO; test method) with CO simultaneously measured by transesophageal Doppler echocardiography (TEE-CO; reference method) in pediatric patients. In this prospective observational method comparison study, PRAM-CO and TEE-CO were assessed in pediatric elective cardiac surgery patients at 2 time points: after anesthesia induction and after surgery. The study was performed in a German university medical center from March 2019 to March 2020. We included pediatric patients scheduled for elective cardiac surgery with arterial catheter and TEE monitoring. PRAM-CO and TEE-CO were compared using Bland-Altman analysis accounting for repeated measurements per subject, and the percentage error (PE). We included 52 PRAM-CO and TEE-CO measurement pairs of 30 patients in the final analysis. Mean ± SD TEE-CO was 2.15 ± 1.31 L/min (range 0.55-6.07 L/min), and mean PRAM-CO was 2.21 ± 1.38 L/min (range 0.55-5.90 L/min). The mean of the differences between TEE-CO and PRAM-CO was -0.06 ±0.38 L/min with 95% limits of agreement (LOA) of 0.69 (95% confidence interval [CI], 0.53-0.82 L/min) to -0.80 L/min (95% CI, -1.00 to -0.57 L/min). The resulting PE was 34% (95% CI, 27%-41%). With a PE of <45%, PRAM-CO shows clinically acceptable agreement with TEE-CO in hemodynamically stable pediatric patients before and after cardiac surgery.

Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers.

Background/AimsInformed clinical guidance and health policy relies on clinicians, policymakers, and guideline developers finding comprehensive clinical evidence and linking registrations and publications of the same clinical trial. To support the finding and linking of trial evidence, the World Health Organization, the International Committee of Medical Journal Editors, and the Consolidated Standards of Reporting Trials ask researchers to provide the trial registration number in their publication and a reference to the publication in the registration. This practice costs researchers minimal effort and makes evidence synthesis more thorough and efficient. Nevertheless, trial evidence appears inadequately linked, and the extent of trial links in Germany remains unquantified. This cross-sectional study aims to evaluate links between registrations and publications across clinical trials conducted by German university medical centers and registered in ClinicalTrials.gov or the German Clinical Trials Registry. Secondary aims are to develop an automated pipeline that can be applied to other cohorts of trial registrations and publications, and to provide stakeholders, from trialists to registries, with guidance to improve trial links.MethodsWe used automated strategies to download and extract data from trial registries, PubMed, and results publications for a cohort of registered, published trials conducted across German university medical centers and completed between 2009 and 2017. We implemented regular expressions to detect and classify publication identifiers in registrations, and trial registration numbers in publication metadata, abstracts, and full-texts.ResultsIn breach of long-standing guidelines, 75% (1,418) of trials failed to reference trial registration numbers in both the abstract and full-text of the journal article in which the results were published. Furthermore, 50% (946) of trial registrations did not contain links to their results publications. Seventeen percent (327) of trials had no links, so that associating registration and publication required manual searching and screening. Overall, trials in ClinicalTrials.gov were better linked than those in the German Clinical Trials Registry; PubMed and registry infrastructures appear to drive this difference. Trial registration numbers were more likely to be transferred to PubMed metadata from abstracts for ClinicalTrials.gov trials than for German Clinical Trials Registry trials. Most (78%, 662/849) ClinicalTrials.gov registrations with a publication link were automatically indexed from PubMed metadata, which is not possible in the German Clinical Trials Registry.ConclusionsGerman university medical centers have not comprehensively linked trial registrations and publications, despite established recommendations. This shortcoming threatens the quality of evidence synthesis and medical practice, and burdens researchers with manually searching and linking trial data. Researchers could easily improve this by copy-and-pasting references between their trial registrations and publications. Other stakeholders could build on this practice, for example, PubMed could capture additional trial registration numbers using automated strategies (like those developed in this study), and the German Clinical Trials Registry could automatically index publications from PubMed.

The Role of Sarcopenia and Myosteatosis in Short- and Long-Term Outcomes Following Curative-Intent Surgery for Hepatocellular Carcinoma in a European Cohort.

Simple SummaryRecent studies have shown that pathological changes of body composition, in particular reduced muscle mass (sarcopenia) and impaired muscle quality (myosteatosis), are linked to poor outcomes in a variety of clinical conditions. Hepatocellular carcinoma (HCC) is the most frequent primary malignant tumor of the liver in the Western hemisphere and remains a prominent cause of cancer-associated mortality. The present study investigates the prognostic value of alterations in body composition in predicting perioperative morbidity, mortality and long-term oncological outcome in HCC using preoperative computed-tomography-based segmentation. Our study found supporting evidence for the relevance of muscle quality over quantity in a European population and verifies the predictive role of myosteatosis in patients suffering from HCC, with a particularly significant value in the earlier perioperative phase.Alterations of body composition, especially decreased muscle mass (sarcopenia) and impaired muscle quality (myosteatosis), are associated with inferior outcomes in various clinical conditions. The data of 100 consecutive patients who underwent partial hepatectomy for hepatocellular carcinoma (HCC) at a German university medical centre were retrospectively analysed (May 2008–December 2019). Myosteatosis and sarcopenia were evaluated using preoperative computed-tomography-based segmentation. We investigated the predictive role of alterations in body composition on perioperative morbidity, mortality and long-term oncological outcome. Myosteatotic patients were significantly inferior in terms of major postoperative complications (Clavien–Dindo ≥ 3b; 25% vs. 5%, p = 0.007), and myosteatosis could be confirmed as an independent risk factor for perioperative morbidity in multivariate analysis (odds ratio: 6.184, confidence interval: 1.184–32.305, p = 0.031). Both sarcopenic and myosteatotic patients received more intraoperative blood transfusions (1.6 ± 22 vs. 0.3 ± 1 units, p = 0.000; 1.4 ± 2.1 vs. 0.3 ± 0.8 units, respectively, p = 0.002). In terms of long-term overall and recurrence-free survival, no statistically significant differences could be found between the groups, although survival was tendentially worse in patients with reduced muscle density (median survival: 41 vs. 60 months, p = 0.223). This study confirms the prognostic role of myosteatosis in patients suffering from HCC with a particularly strong value in the perioperative phase and supports the role of muscle quality over quantity in this setting. Further studies are warranted to validate these findings.

Declining Numbers of Neurosurgical Emergencies at a German University Medical Center during the Coronavirus Lockdown.

The coronavirus pandemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is posing unprecedented challenges to health care systems around the globe. Consequently, various lockdown scenarios have been politically imposed to get control over the spread of this disease. We examined the impact of the lockdown situation on the number of neurosurgical emergency patients admitted to our tertiary care center with a catchment area of ∼2.2 million inhabitants in the south of Germany to ensure adequate neurosurgical emergency care during a pandemic lockdown. All emergency admissions (with consecutive inpatient treatment) to the Department of Neurosurgery at the University Medical Center Regensburg, Germany, between March 1 and May 8 (69 days) of the years 2018, 2019, and 2020 were retrospectively identified and reviewed for this study. Demographic data, diagnoses, urgency of surgery, and duration of the journey to the emergency room were examined. Between March 1 and May 8, 2020, 59 emergency patients were neurosurgically treated at our department. Compared with 2018 and 2019, emergency admissions in 2020 had thus declined by 37.2 and 27.1%, respectively. Regarding the year 2020, we found a significant drop from 1.71 and 1.52 emergency patients per day in January and February 2020, respectively, to 0.86 during lockdown (p < 0.001). The decline especially concerned nontraumatic spinal cases and also patients with other neurosurgical diagnoses such as intracranial hemorrhage. Evaluation of the overall disease severity of admitted patients by means of the urgency of surgery showed no difference between the baseline years and the lockdown period. Our findings are in line with other observational studies of neurosurgical, neurologic, and cardiologic centers in Europe that have described a drop in emergency cases. The reasons for this drop that seems to affect various medical fields and countries across Europe are still unidentified. Morbidity and mortality rates are still unknown, and efforts should be made to facilitate neurosurgical emergency care during a pandemic lockdown.

Results dissemination from completed clinical trials conducted at German university medical centers remained delayed and incomplete. The 2014 –2017 cohort

ObjectiveTimely publication of clinical trial results is central for evidence-based medicine. In this follow-up study we benchmark the performance of German university medical centers (UMCs) regarding timely dissemination of clinical trial results in recent years. MethodsFollowing the same search and tracking methods used in our previous study for the years 2009 – 2013, we identified trials led by German UMCs completed between 2014 and 2017 and tracked results dissemination for the identified trials. ResultsWe identified 1,658 trials in the 2014 –2017 cohort. Of these trials, 43% published results as either journal publication or summary results within 24 months after completion date, which is an improvement of 3.8% percentage points compared to the previous study. At the UMC level, the proportion published after 24 months ranged from 14% to 71%. Five years after completion, 30% of the trials still remained unpublished. ConclusionDespite minor improvements compared to the previously investigated cohort, the proportion of timely reported trials led by German UMCs remains low. German UMCs should take further steps to improve the proportion of timely reported trials.

End-of-Life Decision-Making in Intensive Care Ten Years after a Law on Advance Directives in Germany.

Background and Objectives: Mortality on Intensive Care Units (ICUs) is high and death frequently occurs after decisions to limit life-sustaining therapies. An advance directive is a tool meant to preserve patient autonomy by guiding anticipated future treatment decisions once decision-making capacity is lost. Since September 2009, advance directives are legally binding for the caregiver team and the patients’ surrogate decision-maker in Germany. The change in frequencies of end-of-life decisions (EOLDs) and completed advance directives among deceased ICU patients ten years after the enactment of a law on advance directives in Germany is unknown. Materials and Methods: Retrospective analysis on all deceased patients of surgical ICUs of a German university medical center from 08/2008 to 09/2009 and from 01/2019 to 09/2019. Frequency of EOLDs and advance directives and the process of EOLDs were compared between patients admitted before and after the change in legislation. (No. of ethical approval EA2/308/20) Results: Significantly more EOLDs occurred in the 2019 cohort compared to the 2009 cohort (85.8% vs. 70.7% of deceased patients, p = 0.006). The number of patients possessing an advance directive to express a living or therapeutic will was higher in the 2019 cohort compared to the 2009 cohort (26.4% vs. 8.9%; difference: 17.5%, p < 0.001). Participation of the patients’ family in the EOLD process (74.7% vs. 60.9%; difference: 13.8%, p = 0.048) and the frequency of documentation of EOLD-relevant information (50.0% vs. 18.7%; difference: 31.3%, p < 0.001) increased from 2009 to 2019. Discussion: During a ten-year period from 2009 to 2019, the frequency of EOLDs and the completion rate of advance directives have increased considerably. In addition, EOLD-associated communication and documentation have further improved.

Various myosteatosis selection criteria and their value in the assessment of short- and long-term outcomes following liver transplantation

Body composition and myosteatosis affect clinical outcomes in orthotopic liver transplantation (OLT). Here we aimed to compare the value and limitations of various selection criteria to define pre-transplant myosteatosis in the assessment of short- and long-term outcomes following OLT. We retrospectively analyzed the data of 264 consecutive recipients who underwent deceased donor OLT at a German university medical centre. Myosteatosis was evaluated by preoperative computed-tomography-based segmentation. Patients were stratified using muscle radiation attenuation of the whole muscle area (L3Muslce-RA), psoas RA (L3Psoas-RA) and intramuscular adipose tissue content (IMAC) values. L3Muslce-RA, L3Psoas-RA and IMAC performed well without major differences and identified patients at risk for inferior outcomes in the group analysis. Quartile-based analyses, receiver operating characteristic curve and correlation analyses showed a superior association of L3Muslce-RA with perioperative outcomes when compared to L3Psoas-RA and L3IMAC. Long-term outcome did not show any major differences between the used selection criteria. This study confirms the prognostic role of myosteatosis in OLT with a particularly strong value in the perioperative phase. Although, based on our data, L3Muscle-RA might be the most suitable and recommended selection criterion to assess CT-based myosteatosis when compared to L3Psoas-RA and L3IMAC, further studies are warranted to validate these findings.

Short- and long-term agreement and reproducibility of 48-hours intraocular pressure measurements in glaucoma patients

BackgroundGlaucomatous eyes often show strong intraocular pressure (IOP) fluctuations and individual measurements at different time points are necessary for personalized therapy. To survey IOP variations 48-hours diurnal and nocturnal IOP measurements were performed on two consecutive days. Aims of this study were to investigate the short-term repeatability of 48-hours measurements within one patient’s IOP profile and long-term repeatability between two separate IOP profiles of the same patient.MethodsA retrospective cohort study was performed evaluating data of 90 glaucoma patients in a German university medical center between 2006 and 2013. All patients underwent two separate diurnal IOP profiles of 48 h. IOP was measured at 8 am, 2 pm, 6 pm, 9 pm using Goldmann applanation tonometry and at 12 midnight using Perkins tonometry in supine position on two consecutive days. Intraclass correlation coefficients (ICC) were calculated to evaluate agreement for the same time points (each time point agreement) and for consecutive measurements within the IOP profiles (between time point agreement). ICC ≤ 0.4 was defined as poor agreement, 0.4–0.75 as moderate and ≥ 0.75 as excellent. Differences between time points were investigated by Bland Altman plots.ResultsEach time point measurements of profile 1 showed moderate to excellent agreement (ICCs 0.62–0.93). There was a moderate to excellent agreement for measurements between time points of profile 1 (ICCs day one 0.57–0.86, day two 0.71–0.90). Profile 2 was performed at a median interval of 12.0 months (quartiles 11.0 to 21.0). Each time point agreements within profile 2 showed ICCs from 0.23 to 0.81. It showed moderate to excellent agreement for changes between time points (ICCs 0.53–0.94). Day two demonstrated ICCs from 0.74 to 0.88. Long term IOP repeatability (over both pressure profiles) showed moderate to good agreement (ICCs 0.39–0.67).ConclusionsShort and long-term agreement of IOP measurements evaluated by diurnal IOP profiles is moderate to good. Due to mostly moderate agreements, which we believe represent IOP fluctuations, we conclude that it is necessary to perform 48-hours IOP profiles to gain a better overview of the individual IOP fluctuations.

Intraoperative transfusion practice in burned children in a university hospital over four years: a retrospective analysis

BackgroundPatient blood management programs should be applied to the pediatric population, but little is known about the current transfusion practice of pediatric burn injury patients. This retrospective study was performed to evaluate the practice of red blood cell (RBC) transfusion in children with burn injury, their predictive factors, and adherence to the German transfusion guideline.MethodsWe reviewed the RBC transfusion practice of all children younger than 8 years with burn injury who were operated during a four-year period in a German university medical center. We analyzed the data associated with transfusion and guideline conformity of transfusion triggers for RBCs from the beginning to the end of hospital stay using logistic regression.ResultsDuring the four-year period, 138 children (median age 21 months, minimum-maximum 9–101 months) with burn injury needed surgery, 31 children were transfused with RBCs. During their hospital stay, the median hemoglobin concentrations (Hb) of transfused and non-transfused children were 8 g/dL (6.3–11.3 g/dL) and 10.7 (7–13.8 g/dL), respectively. Total body surface area burned (TBSA) (OR = 1.17 per % TBSA, 95% CI = [1.05; 1.30], p = 0.0056), length of surgery (OR = 1.016 per minute, 95% CI = [1.003; 1.028], p = 0.0150), and Hb (OR = 0.48 per 1 g/dl in Hb, 95% CI = [0.24; 0.95], p = 0.0343) were associated with transfusion while other factors (age, gender, ASA, and catecholamines) did not show notable association. Length of stay was mainly influenced by TSBA (+ 1.38 days per %, p < 0.0001), age (+ 0.21 days per month, p = 0.0206), and administering of catecholamines (+ 14.3 days, p = 0.0118), but not by RBC transfusion. The decision to transfuse was in 23% too restrictive and in 74% too liberal according to the German guidelines.ConclusionsAmount of TBSA, length of surgery, and Hb influenced the RBC transfusion rate in burned children. However, age and length of stay were not affected by transfusion of RBCs. In clinical practice of burned children, physicians follow a more liberal transfusion strategy than the proposed in guidelines.

Declining numbers of neurosurgical emergencies at a German University Medical Center during the coronavirus lockdown

Declining numbers of neurosurgical emergencies at a German University Medical Center during the coronavirus lockdown