[Risk Assessment of Acute Exacerbation in COPD Patients in the Context of Pulmonary Follow-Up Rehabilitation Based on the Prevalence and Severity of Comorbidities]. / Risikoabschätzung einer akuten Exazerbation bei COPD-Patienten im Rahmen einer pneumologischen Anschluss-Rehabilitation anhand der Prävalenz und Schwergradausprägung von Komorbiditäten.

INTRODUCTION: Acute COPD exacerbations (AECOPD) in the context of pulmonary rehabilitation (PR) are frequent and dangerous complications and, in addition to impairing quality of life, lead to an interruption of PR and jeopardize PR success. In this study, a correlation between the health status and an increased risk of AECOPD is described. The question arises whether the Charlson Comorbidity Index (CCI) or the Cumulative Illness Rating Scale (CIRS) are suitable for the preventive detection of COPD patients at risk for exacerbation in PR. PATIENTS AND METHODS: In a retrospective study, data of COPD patients who underwent PR in 2018 were analyzed with the CCI as the primary endpoint. All data were taken from the Phoenix Clinical Information System, and COPD exacerbations were recorded. The 44 patients (22 with and 22 without exacerbation during PR) required according to the sample size planning were randomly recruited from this pool of patients (using a random list for each group). CCI and CIRS were determined for all the cases included in the two groups. The primary endpoint (CCI) was evaluated by group comparison of the arithmetic means and Welch test. This was supported by further statistical measures of position and dispersion (median, quartile, standard deviation).In addition, the optimal cut-off point for discrimination in AECOPD and non-AECOPD patients was obtained via Receiver Operating Characteristic (ROC) analysis for both the CCI and the CIRS. RESULTS: Out of 244 COPD patients who underwent PR for an average of 21 days, 59 (24 %) suffered AECOPD that required treatment during PR. The 22 patients with AECOPD had a mean CCI of 6.77 (SD: 1.97) and the 22 patients without AECOPD had a mean CCI of 4.32 (SD: 1.17). This difference of -2.45 was statistically significant at a level of significance of 5 % (p < 0.001; 95 % CI: [-3.45; -1.46]). The ROC analysis led to 6 as the optimal cut-off point for the CCI, with 81.8 % sensitivity for determining an AECOPD and 86.4 % specificity with an area under the curve (AUC) value of 0.87. The optimal cut-off point for CIRS was 19 with a sensitivity of 50 %, a specificity of 77.2 % and an AUC of 0.65. CONCLUSION: COPD patients with acute exacerbation during PR have a higher CCI. The CCI allows the risk of AECOPD to be assessed with high sensitivity and specificity in participants with COPD in an inpatient PR program.

[Indications, procedure and outcome of prehospital emergency resuscitative thoracotomy-a systematic literature search]. / Indikation, Prozedere und Outcome der präklinischen Notfallthorakotomie ­ eine systematische Literaturrecherche.

BACKGROUND: Prehospital resuscitative thoracotomy (PHRT) is a controversially discussed measure for the acute treatment of traumatic cardiac arrest (TCA) recommended by the current guidelines of the European Resuscitation Council (ERC). The aim of this work is the comprehensive presentation and summary of the available literature with the underlying hypothesis that the available publications show the feasibility and survival following PHRT in patients with TCA with a good neurological outcome. METHOD: A systematic literature search was performed in the databases PubMed, EMBASE, Google Scholar, Springer LINK and Cochrane. The study selection, data extraction and evaluation of bias potential were performed independently by two authors. The outcome of patients with TCA after PHRT was selected as the primary endpoint. RESULTS: A total of 4616 publications were found of which 21 publications with a total of 287 patients could be included in the analyses. For a detailed descriptive analysis, 15 publications with a total of 205 patients were suitable. The TCA of these patients was most commonly caused by pericardial tamponade, thoracic vascular injuries and severe extrathoracic multiple injuries. In 24% of the cases TCA occurred in the presence of the emergency physician. Clamshell thoracotomy (53%) was used preclinically more often than anterolateral thoracotomy (47%). Of the PHRT patients after TCA 12% (25/205) left the hospital alive, 9% (n = 19/205) with good neurological outcome and 1% (n = 3/205) with poor neurological outcome (according to the Glasgow outcome scale, GOS). CONCLUSION: The prognosis of TCA seems to be much better than has long been assumed. Decisive for the success of resuscitation efforts in TCA seems to be the immediate, partly invasive treatment of all reversible causes. The measures for TCA recommended by the ERC resuscitation guidelines, seem to be poorly implemented, especially in the preclinical setting. A controversy regarding the recommendations of the guidelines is the question of whether a PHRT can be successfully implemented and if the comprehensive introduction in Germany seems to be meaningful. Despite the recommendation of the guidelines, this systematic review and meta-analysis underlines the lack of high-quality evidence on PHRT, whereby a survival probability to hospital discharge of 12% was reported, of which 75% had a good neurological outcome. The risk of bias of the results in individual publications as well as in this review is high. Further systematic research in the field of preclinical trauma resuscitation is particularly necessary also for acceptance of the guidelines.

[Metaanalysis to estimate the expected drop out-rates reported in clinical trials on cataract surgery]. / Metaanalyse zur Schätzung der in klinischen Studien zur Kataraktchirurgie zu erwartenden drop out-Rate.

BACKGROUND: A realistic sample size calculation is crucial to achieve significant results in clinical trials. As an expected drop out-rate has to be included in the sample size calculation, current practice consists in the presumption of drop out-rates published in previous similar investigations. This approach may, however, result in severely over- or under-estimated sample sizes. Therefore this meta-analysis sought to aggregate the drop out-rates from published clinical trial reports on cataract surgery to derive a quantitative suggestion for the planning of future clinical trials. METHODS: The data collection was a complete review of all prospective and retrospective studies in five journals of the years 2002-2012; trial-wise recall rates of subjects at follow-up 3, 6, 12, and 24 months after recruitment were documented. The primary endpoint of the meta-analysis was the reported drop out-rates after 6 months. 95 % confidence intervals were calculated for each trial, respectively; a median drop out-rate was estimated including its 95 % confidence interval. The drop-out-rate estimates were furthermore stratified by design characteristics of the reported studies. RESULTS: For randomised clinical trials on cataract surgery, the median drop out-rate increased during the follow-up period of 24 months from 4 % at three months to 17 % at 24 months after recruitment; for the six-month drop out-rate a median drop-out rate of 3 % (95 % CI 0 %; 14 %) was estimated. CONCLUSION: Drop out-rates in sample size calculations for clinical trials on cataract surgery were found to be over-estimated in general, ending up in the calculation of overly large patient numbers and thereby in both ethical and economic consequences. For randomised clinical trials on cataract surgery the median drop out-rate can be expected to be 5 % during a six-month follow-up and may rise up to 15 % during a 12-month trial period.

[Evaluation of methodological quality in published RCTs on cataract surgery : Pilot study on the degree of adherence to CONSORT statement requirements and their qualitative validity]. / Bewertung der methodischen Qualität publizierter RCTs in der Kataraktchirurgie : Pilotstudie zur quantitativen Zielerfüllung bestehender Anforderungen laut CONSORT-Statement und deren qualitative Validierung.

BACKGROUND: The CONSORT statement can be considered as a guideline to ensure transparency in the reporting of randomized clinical trials (RCT), in addition to specific author instructions and requirements of journals. It provides a total of 25 criteria and 12 additional subcriteria on methodological and regulatorical determinants of clinical trials. The availability of the CONSORT recommendations, however, does not necessarily imply adherence to their obligations and correct realisation of the latter from a methodological perspective, so that even in ophthalmology a lack of transparency in trial reporting cannot be excluded. OBJECTIVE: The question was whether a consistent consideration of the CONSORT checklist criteria by authors actually implied transparent reporting of underlying study results. MATERIALS AND METHODS: This pilot study was based on a random sample of six published RCTs on cataract surgery extracted from an existing trial publication register. Compliance with each of the 25 CONSORT criteria and its 12 subcriteria and the content accuracy of the latter were independently assessed by two parallel raters for the six trial publications. RESULTS: The median compliance with the 37 CONSORT criteria and subcriteria was 62% [min-max 48-81%]; the median fraction of their correct implementation was 47% [min-max 34-69%]. CONCLUSIONS: Promotion of transparent reporting by means of the CONSORT statement appears to be problematic in implementation. There is a discrepancy between information as required by CONSORT and the content accuracy of its actual presentation. Thus, in particular, reviewers of clinical trial publications should not only check for the presence of data to be provided according to CONSORT, but also verify the meaningfulness in the respective context, at least on a random basis.

[Value of nerve growth factor levels in overactive bladder syndrome: alterations after botulinum toxin therapy]. / Wertigkeit des "nerve growth factor" beim Syndrom der überaktiven Blase : Veränderungen nach Botulinumtoxin-Therapie.

OBJECTIVES: Several studies discussing the pathology of overactive bladder suggested changes in urinary proteins. The neurotrophin "nerve growth factor" (NGF) seems to be an important marker in overactive bladder syndrome (OAB). In this prospectively designed study we evaluated NGF blood levels (sNGF) initially and after injection of botulinum toxin type A (BTX-A) in the detrusor muscle in patients suffering from idiopathic OAB. MATERIALS AND METHODS: Blood samples were obtained from 26 patients (66.5 years, 28-83) with idiopathic OAB. sNGF levels were measured before and 4 weeks after BTX-A treatment by enzyme-linked immunosorbent assay (ELISA). A group of 32 healthy persons with normal bladder function served as controls (41 years, 19-60). sNGF was evaluated in relation to clinical data and the severity of OAB (wet/dry). RESULTS: Significantly higher sNGF levels were detected in patients with OAB compared to the control group (58.8 vs 2.0 pg/ml, p<0.005). Further, sNGF levels were elevated in patients with wet OAB compared to patients with dry OAB (85.0 vs 0.73 pg/ml, p<0.005). Patients > 60 years showed significantly higher sNGF levels (77.2 vs 8.9 pg/ml, p<0.05) compared to younger OAB patients. After BTX-A therapy sNGF levels decreased significantly compared to baseline (p<0.005). CONCLUSION: NGF appears to play a decisive role in OAB. Its use as a biomarker in both the diagnostics and follow-up after therapy seems promising. To what extent sNGF can be useful as a biomarker or in therapy monitoring needs to be examined prospectively in a larger population.