A comparison of the McGrath videolaryngoscope with direct laryngoscopy for rapid sequence intubation in the operating theatre: a multicentre randomised controlled trial.

Aspiration of gastric contents is a recognised complication during all phases of anaesthesia. The risk of this event becomes more likely with repeated attempts at tracheal intubation. There is a lack of clinical data on the effectiveness of videolaryngoscopy relative to direct laryngoscopy rapid sequence intubation in the operating theatre. We hypothesised that the use of a videolaryngoscope during rapid sequence intubation would be associated with a higher first pass tracheal intubation success rate than conventional direct laryngoscopy. In this multicentre randomised controlled trial, 1000 adult patients requiring tracheal intubation for elective, urgent or emergency surgery were allocated randomly to airway management using a McGrath™ MAC videolaryngoscope (Medtronic, Minneapolis, MN, USA) or direct laryngoscopy. Both techniques used a Macintosh blade. First-pass tracheal intubation success was higher in patients allocated to the McGrath group (470/500, 94%) compared with those allocated to the direct laryngoscopy group (358/500, 71.6%), odds ratio (95%CI) 1.31 (1.23-1.39); p < 0.001. This advantage was observed in both trainees and consultants. Cormack and Lehane grade ≥ 3 view occurred less frequently in patients allocated to the McGrath group compared with those allocated to the direct laryngoscopy group (5/500, 1% vs. 94/500, 19%, respectively; p < 0.001). Tracheal intubation with a McGrath videolaryngoscope was associated with a lower rate of adverse events compared with direct laryngoscopy (13/500, 2.6% vs. 61/500, 12.2%, respectively; p < 0.001). These findings suggest that the McGrath videolaryngoscope is superior to a conventional direct laryngoscope for rapid sequence intubation in the operating theatre.

A multicentre randomised controlled trial of the McGrath™ Mac videolaryngoscope versus conventional laryngoscopy.

Before completion of this study, there was insufficient evidence demonstrating the superiority of videolaryngoscopy compared with direct laryngoscopy for elective tracheal intubation. We hypothesised that using videolaryngoscopy for routine tracheal intubation would result in higher first-pass tracheal intubation success compared with direct laryngoscopy. In this multicentre randomised trial, 2092 adult patients without predicted difficult airway requiring tracheal intubation for elective surgery were allocated randomly to either videolaryngoscopy with a Macintosh blade (McGrath™) or direct laryngoscopy. First-pass tracheal intubation success was higher with the McGrath (987/1053, 94%), compared with direct laryngoscopy (848/1039, 82%); absolute risk reduction (95%CI) was 12.1% (10.9-13.6%). This resulted in a relative risk (95%CI) of unsuccessful tracheal intubation at first attempt of 0.34 (0.26-0.45; p < 0.001) for McGrath compared with direct laryngoscopy. Cormack and Lehane grade ≥ 3 was observed more frequently with direct laryngoscopy (84/1039, 8%) compared with McGrath (8/1053, 0.7%; p < 0.001) No significant difference in tracheal intubation-associated adverse events was observed between groups. This study demonstrates that using McGrath videolaryngoscopy compared with direct laryngoscopy improves first-pass tracheal intubation success in patients having elective surgery. Practitioners may consider using this device as first choice for tracheal intubation.

Preload and friction in an implant-abutment-screw complex including a carbon-coated titanium alloy abutment screw: an in vitro study.

PURPOSE: An experimental approach was designed to measure the preload force, the coefficient of friction and the component of the tightening torque that is needed to surmount the thread-friction in an implant-abutment-screw complex that includes a carbon-coated screw. With the determined preload values the coefficient of friction was calculated. METHODS: 25 unused complexes, containing an implant, an abutment and a carbon-coated titanium alloy abutment screw, were tested. A custom load frame with two load cells and associated electronics was used. The threads were not lubricated. All abutment screws were torqued ten times to 25 Ncm. The produced preload values and a force that was proportional to the thread-friction component of the tightening torque were recorded. RESULTS: Mean preload values decreased significantly with the number of repetitions (p < 0.0001) from initially 329.9 N ± 33.3 (range 255.7 to 383.9) to 253.7 N ± 36.8 (range 200.1 to 332.5) for the last tightening procedure. The corresponding change in the calculated coefficient of friction was 0.33 ± 0.04 (range 0.28 to 0.43) to 0.44 ± 0.07 (range 0.32 to 0.56). For the thread-friction no corresponding trend for consecutive tightening repetitions could be noticed. CONCLUSIONS: In the investigated implant-abutment units, repeated use of a coated abutment screw appears to increase the friction of the screw head and thereby decrease the preload. These results indicate that a pre-used coated implant-abutment-screw will fail reaching optimal screw preload.

[Patient-centered perioperative vigilance: perioperative process quality, effectiveness of pain treatment and mobilization progress after implementation of a treatment bundle for total knee endoprosthesis]. / Patient*innenzentrierte perioperative Versorgung: perioperative Prozessqualität, Effektivität von Schmerztherapie und Mobilisationsfortschritt nach Implementation eines Maßnahmenbündels bei Knietotalendoprothese.

BACKGROUND: The perioperative surgical home is a patient-centered, team-based model of care developed in the USA to coordinate diagnosis, treatment and follow-up; however, due to different healthcare systems, scientific findings in the USA cannot be simply transferred to Germany. OBJECTIVE: This preliminary study was carried out to evaluate the effects of a new interdisciplinary treatment bundle (patient-centered perioperative vigilance, PPV) in a German university hospital. MATERIAL AND METHODS: After IRB approval and written informed consent, 34 patients (PPV group) undergoing elective endoprosthetic surgery were enrolled after introduction of the PPV bundle (1. preoperative patient education, 2. specific surgical technique, 3. specific anesthesia technique, 4. start of mobilization on day of operation) and compared to historic matched pairs (HMP) for age cohort, ASA-PS, body mass index, and sex. We hypothesized that PPV shortens induction time (primary outcome). Secondary outcomes were length of hospital stay (LOS), resting pain and pain with movement on postoperative day 1 and mobilization progress on postoperative days 1, 3 and 6. Groups were compared with Wilcoxon-Mann-Whitney test for noninferiority. In the case of noninferiority, a Wilcoxon-Whitney-Mann test for superiority was additionally applied. RESULTS: The median anesthesia induction time was 13.5 min for PPV and 60 min for HMP (p < 0.0001). The LOS was 8 days for PPV and 12 days for HMP (p < 0.0001). Resting pain on postoperative day 1 was 20 for PPV (30 for HMP). Pain with movement was identical (median 40). Mobilization progress was better for PPV on days 1, 3 and 6 (p < 0.0001 for each day). CONCLUSION: The concept of patient-centered perioperative vigilance (PPV) shortens induction time and hospital length of stay. Mobilization improves with PPV on day 1. Higher pain scores in PPV seem to be clinically insignificant, which warrants further study.

Frequency of cataract surgery and its impact on visual function-results from the German Gutenberg Health Study.

PURPOSE: To determine the frequency of cataract surgery in Germany and to evaluate its impact on visual function in an adult population. METHODS: The population-based Gutenberg Health Study was conducted in Germany with its baseline examination between 2007 and 2012 and a 5-year follow-up examiantion. An ophthalmological examination including slit-lamp examination, ocular biometry, and Scheimpflug imaging was carried out. Overall and age-specific frequencies of unilateral and bilateral cataract surgery within 5 years were computed including the 95% confidential intervals [95%-CI]. Association analyses were conducted to determine social and ocular associated factors using multivariable logistic regression analysis. Vision-related quality of life was assessed using NEI VFQ-25. RESULTS: A total of 10,544 people aged 35 to 74 years were bilateral phakic at baseline and had information on lens status at the 5-year examination. Of these, 168 had unilateral cataract surgery (1.6% [1.4-1.9%]), and 448 had bilateral cataract surgery (4.2% [3.9-4.7%]) in the following 5 years. The frequency of cataract surgery increased with age: 45-54-year-old subjects had twice as often cataract surgery (in at least on eye: OR = 2.32) than at age 35-44 years. The frequency further strongly increases with age (55-64 years: OR = 10.5; 65-74 years: OR = 43.8, p < 0.001). Subjects with glaucoma were more likely to have cataract surgery (OR = 2.52, p < 0.001). Visual function increased when undergoing bilateral cataract surgery. CONCLUSIONS: The frequency of cataract surgery is low at younger ages and increases up to 26% at age 70-74 years. Persons with glaucoma are more likely to undergo cataract surgery at population-based level in Germany.

Assessment of haemoglobin measurement by several methods - blood gas analyser, capillary and venous HemoCue® , non-invasive spectrophotometry and laboratory assay - in term and preterm infants.

A laboratory haematology analyser is the gold standard for measuring haemoglobin concentration but has disadvantages, especially in neonates. This study compared alternative blood-sparing and non-invasive methods of haemoglobin concentration measurement with the gold standard. Haemoglobin concentrations were measured using a laboratory haematology analyser (reference method), blood gas analyser, HemoCue® using venous and capillary blood samples and a newly developed non-invasive sensor for neonates < 3 kg. A total of 63 measurements were performed. Body weight (2190 (1820-2520 [967-4450]) g) and haemoglobin concentration (12.3 (10.6-15.2 [8.2-20.5]) g.dl-1 ) varied widely. Bias/limits of agreement between the alternative methods and reference method were -0.1/-1.2 to 1.0 g.dl-1 (blood gas analyser), -0.4/-1.8 to 1.1 g.dl-1 (HemoCue, venous blood), 0.7/-1.9 to 3.2 g.dl-1 (HemoCue, capillary blood) and -1.2/-4.3 to 2 g.dl-1 (non-invasive haemoglobin measurement). Perfusion index, body weight and fetal haemoglobin concentration did not affect the accuracy of the alternative measurement methods, and these were successfully applied in term and preterm infants. However, the accuracies of non-invasive haemoglobin measurement and HemoCue of capillary blood especially lacked sufficient agreement with that of the reference method to recommend these methods for clinical decision making.

Prevalence of depression and anxiety among participants with glaucoma in a population-based cohort study: The Gutenberg Health Study.

BACKGROUND: To investigate the prevalence of depression and anxiety among subjects with self-reported glaucoma and the association between self-reported glaucoma and depression respectively anxiety in a European cohort. METHODS: A study sample of 14,657 participants aged 35 to 74 years was investigated in a population-based cohort study. All participants reported presence or absence of glaucoma. Ophthalmological examinations were carried out in all participants and demographic and disease related information were obtained by interview. Depression was assessed with the Patient Health Questionnaire (PHQ-9), and generalized anxiety with the two screening items (GAD-2) of the short form of the GAD-7 (Generalized Anxiety Disorder-7 Scale). Prevalence of depression and generalized anxiety were investigated for subjects with and without self-reported glaucoma. Logistic regression analyses with depression, respectively anxiety as dependent variable and self-reported glaucoma as independent variable were conducted and adjusted for socio-demographic factors, systemic comorbidities (arterial hypertension, myocardial infarction, stroke, diabetes mellitus, chronic obstructive pulmonary disease, cancer), ocular diseases (cataract, macular degeneration, corneal diseases, diabetic retinopathy), visual acuity, intraocular pressure, antiglaucoma eye drops (sympathomimetics, parasympathomimetics, carbonic anhydrase inhibitors, beta-blockers, prostaglandins) and general health status. RESULTS: 293 participants (49.5% female) reported having glaucoma. Prevalence of depression among participants with and without self-reported glaucoma was 6.6% (95%-CI 4.1-10.3) respectively 7.7% (95%-CI 7.3-8.2), and for anxiety 5.3% (95%-CI 3.1-8.7) respectively 6.6% (95%-CI 6.2-7.1). Glaucoma was not associated with depression (Odds ratio 1.10, 95%-CI 0.50-2.38, p = 0.80) or anxiety (1.48, 95%-CI 0.63-3.30, p = 0.35) after adjustment for socio-demographic factors, ocular/systemic diseases, ocular parameters, antiglaucoma drugs and general health status. A restriction to self-reported glaucoma cases either taking topical antiglaucoma medications or having a history of glaucoma surgery did not alter the result. CONCLUSIONS: This is the first study analyzing both depression and anxiety among glaucoma patients in a European cohort. Subjects with and without self-reported glaucoma had a similar prevalence of depression and anxiety in our population-based sample. Self-reported glaucoma was not associated with depression or anxiety. A lack of a burden of depressive symptoms may result from recruitment from a population-based sample as compared to previous study groups predominantly recruited from tertiary care hospitals.

[Meta-analyses on measurement precision of non-invasive hemodynamic monitoring technologies in adults]. / Metaanalysen zur Messgenauigkeit nichtinvasiver hämodynamischer Überwachungstechnologien bei Erwachsenen.

An ideal non-invasive monitoring system should provide accurate and reproducible measurements of clinically relevant variables that enables clinicians to guide therapy accordingly. The monitor should be rapid, easy to use, readily available at the bedside, operator-independent, cost-effective and should have a minimal risk and side effect profile for patients. An example is the introduction of pulse oximetry, which has become established for non-invasive monitoring of oxygenation worldwide. A corresponding non-invasive monitoring of hemodynamics and perfusion could optimize the anesthesiological treatment to the needs in individual cases. In recent years several non-invasive technologies to monitor hemodynamics in the perioperative setting have been introduced: suprasternal Doppler ultrasound, modified windkessel function, pulse wave transit time, radial artery tonometry, thoracic bioimpedance, endotracheal bioimpedance, bioreactance, and partial CO2 rebreathing have been tested for monitoring cardiac output or stroke volume. The photoelectric finger blood volume clamp technique and respiratory variation of the plethysmography curve have been assessed for monitoring fluid responsiveness. In this manuscript meta-analyses of non-invasive monitoring technologies were performed when non-invasive monitoring technology and reference technology were comparable. The primary evaluation criterion for all studies screened was a Bland-Altman analysis. Experimental and pediatric studies were excluded, as were all studies without a non-invasive monitoring technique or studies without evaluation of cardiac output/stroke volume or fluid responsiveness. Most studies found an acceptable bias with wide limits of agreement. Thus, most non-invasive hemodynamic monitoring technologies cannot be considered to be equivalent to the respective reference method. Studies testing the impact of non-invasive hemodynamic monitoring technologies as a trend evaluation on outcome, as well as studies evaluating alternatives to the finger for capturing the raw signals for hemodynamic assessment, and, finally, studies evaluating technologies based on a flow time measurement are current topics of clinical research.

Effectiveness of a miswak extract-containing toothpaste on gingival inflammation: a randomized clinical trial.

OBJECTIVES: In this study, the efficacy of a miswak extract-containing toothpaste (Salvadora persica) on gingival inflammation was compared with that of a herbal and a conventional toothpaste. METHODS: Non-smoking outpatients with sulcus bleeding index (SBI) ≥25% and with periodontal pocket depths ≤3 mm were randomly selected and divided into three groups: M-group, miswak extract-containing toothpaste; P-group, herbal toothpaste; and C-group, conventional toothpaste. After instructing the patients to brush their teeth twice a day for 3 weeks with the assigned toothpaste using a flat-trimmed manual toothbrush, a thorough oral examination was performed by a calibrated examiner (EH). The primary outcome was the SBI after 21 days. Furthermore, the amount of plaque was measured by approximal plaque index (API). RESULTS: Sixty-six patients with a mean age of 57.8 ± 10.2 years were recruited and enrolled. After 3 weeks of brushing, all three patient groups showed a significant reduction in SBI. The P-group (SBI reduction: 17.1% ± 9.1) and the M-group (14.5% ± 8.1) showed the strongest effect followed by the C-group (9.4% ± 7.8). All three groups showed a significant reduction in API without significant differences between the groups. CONCLUSIONS: The use of each of the three tested toothpastes caused a significant reduction in gingival inflammation and amount of plaque. The miswak extract-containing toothpaste showed a similar effect as the herbal toothpaste and can be safely used for domestic oral hygiene in patients with gingivitis.

[Simulation-based training and OR apprenticeship for medical students : A prospective, randomized, single-blind study of clinical skills]. / Simulationsbasiertes Training und Lehre im OP für Studierende : Eine prospektive randomisierte, einfach verblindete Studie klinischer Fertigkeiten.

BACKGROUND: Simulation-based training (SBT) has developed into an established method of medical training. Studies focusing on the education of medical students have used simulation as an evaluation tool for defined skills. A small number of studies provide evidence that SBT improves medical students' skills in the clinical setting. Moreover, they were strictly limited to a few areas, such as the diagnosis of heart murmurs or the correct application of cricoid pressure. Other studies could not prove adequate transferability from the skills gained in SBT to the patient site. Whether SBT has an effect on medical students' skills in anesthesiology in the clinical setting is controversial. To explore this issue, we designed a prospective, randomized, single-blind trial that was integrated into the undergraduate anesthesiology curriculum of our department during the second year of the clinical phase of medical school. OBJECTIVES: This study intended to explore the effect of SBT on medical students within the mandatory undergraduate anesthesiology curriculum of our department in the operating room with respect to basic skills in anesthesiology. MATERIALS AND METHODS: After obtaining ethical approval, the participating students of the third clinical semester were randomized into two groups: the SIM-OR group was trained by a 225 min long SBT in basic skills in anesthesiology before attending the operating room (OR) apprenticeship. The OR-SIM group was trained after the operating room apprenticeship by SBT. During SBT the students were trained in five clinical skills detailed below. Further, two clinical scenarios were simulated using a full-scale simulator. The students had to prepare the patient and perform induction of anesthesia, including bag-mask ventilation after induction in scenario 1 and rapid sequence induction in scenario 2. Using the five-point Likert scale, five defined skills were evaluated at defined time points during the study period. 1) application of the safety checklist, 2) application of basic patient monitoring, 3) establishment of intravenous access, 4) bag-and-mask ventilation, and 5) adjustment of ventilatory parameters after the patients' airways were secured. A cumulative score of 5 points was defined as the best and a cumulative score of 25 as the worst rating for a defined time point. The primary endpoint was the cumulative score after day 1 in the operating room apprenticeship and the difference in cumulative scores from days 1 to 4. Our hypothesis was that the SIM-OR group would achieve a better score after day 1 in the operating room apprenticeship and would gain a larger increase in score from day 1 to day 4 than the OR-SIM group. RESULTS: 73 students were allocated to the OR-SIM group and 70 students to the SIM-OR group. There was no significant difference between the two groups after day 1 of the operating room apprenticeship and no difference in increase of the cumulative score from day 1 to day 4 (median of cumulative score on day 1: 'SIM-OR' 11.2 points vs. 'OR-SIM' 14.6 points; p = 0.067; median of difference from day 1 to day 4: 'SIM-OR' -3.7 vs. 'OR-SIM' -6.4; p = 0.110). CONCLUSION: With the methods applied, this study could not prove that 225 min of SBT before the operating room apprenticeship increased the medical students' clinical skills as evaluated in the operating room. Secondary endpoints indicate that medical students have better clinical skills at the end of the entire curriculum when they have been trained through SBT before the operating room apprenticeship. However, the authors believe that simulator training has a positive impact on students' acquisition of procedural and patient safety skills, even if the methods applied in this study may not mirror this aspect sufficiently.

A comparison of the Enk Fiberoptic Atomizer Set(™) with boluses of topical anaesthesia for awake fibreoptic intubation.

We compared the Enk Fiberoptic Atomizer Set(™) with boluses of topical anaesthesia administered via the working channel during awake fibreoptic tracheal intubation in 96 patients undergoing elective surgery. Patients who received topical anaesthesia via the atomiser, compared with boluses via the fibreoptic scope, reported a better median (IQR [range]) level of comfort: 1 (1-3 [1-10]) vs. 4 (2-6 [1-10]), p < 0.0001; experienced a reduced total number of coughs: 6 (3-10 [0-34]) vs. 11 (6-13 [0-25]), p = 0.0055; and fewer distinct coughing episodes: 7% vs. 27% respectively, p = 0.0133. The atomiser technique was quicker: 5 (3-6 [2-12]) min vs. 6 (5-7 [2-15]) min, p = 0.0009; and required less topical lidocaine: 100 mg (100-100 [80-160]) vs. 200 mg (200-200 [200-200]), p < 0.0001. Four weeks after nasal intubation, the incidence of nasal pain was less in the atomiser group compared with the control group (8% vs. 50%, p = 0.0015). We conclude that the atomiser was superior to bolus application for awake fibreoptic tracheal intubation.

Influence of CAD/CAM zirconia for implant-abutment manufacturing on gingival fibroblasts and oral keratinocytes.

OBJECTIVES: This study investigated the influence of three CAD/CAM zirconia ceramics for implant-abutment manufacturing on cell viability, migration ability, and cytotoxicity of human gingival fibroblasts (HGF) and oral keratinocytes (HOK) in vitro. MATERIALS AND METHODS: HGF and HOK were cultured on zirconia ceramic disks (VITA In-Ceram YZ, Ivoclar IPS e.max ZirCAD, Sirona inCoris ZI) and on control disks made of tissue culture polystyrene. Cell viability was analyzed by a MTT assay. Migration ability was detected by a scratch assay. A ToxiLight assay was used to analyze the influence of the tested zirconia ceramics on adenylate kinase (ADK) release and cytotoxicity. RESULTS: At MTT assay, HGF showed an increased cell viability compared to the control after 9 and 12 days for all ceramics (p each ≤0.0002) while HOK demonstrated a decreased cell viability after 9 and 12 days for all ceramics (p each ≤0.0003). At scratch assay, HGF exhibited for all ceramics decreased relative distances of the scratch wound compared to the control from 24 to 48 h (p each <0.0001) with exception of VITA In-Ceram YZ after 48 h. HOK showed increased distances compared to the control for all ceramics after 48 h (p each <0.0001). At ToxiLight assay, a minimal cytotoxicity of the tested materials could be detected. CONCLUSIONS: Overall, significant influences of the investigated CAD/CAM zirconia ceramics on HGF and HOK could be shown. CLINICAL RELEVANCE: The analyzed zirconia ceramics could influence oral soft-tissue cells that might affect the esthetic outcome after implant placement using CAD/CAM zirconia abutments.

Gentamicin alters Akt-expression and its activation in the guinea pig cochlea.

Gentamicin treatment induces hair cell death or survival in the inner ear. Besides the well-known toxic effects, the phosphatidylinositol-3 kinase/Akt (PI3K/Akt) pathway was found to be involved in cell protection. After gentamicin application, the spatiotemporal expression patterns of Akt and its activated form (p-Akt) were determined in male guinea pigs. A single dose of 0.1 mL gentamicin (4 mg/ear/animal) was intratympanically injected. The auditory brainstem responses (ABRs) were recorded prior to application and 1, 2 and 7 days afterward. At these three time points the cochleae (n=10 in each case) were removed, transferred to fixative and embedded in paraffin. Seven ears were used as untreated controls. Gentamicin, Akt and p-Akt were identified immunohistochemically in various regions of the cochlea and their staining intensities were quantified on sections using digital image analysis. The application of gentamicin resulted in hearing loss with a concomitant up-regulation of Akt-expression in the organ of Corti and spiral ganglion cells and an additional activation in spiral ganglion cells. At the level of individual ears, clear intracellular correlations were found between Akt- and p-Akt-expression in the stria vascularis and interdental cells and, to a minor extent, in the spiral ligament and the organ of Corti. Furthermore, statistical evidence for the connection between gentamicin up-take and hearing loss was detected. The increase in Akt- and p-Akt-expression in the organ of Corti and spiral ganglion cells indicates a selected response of the cochlea against gentamicin toxicity.

German Survey on EUS-Guided Diagnosis and Management of Gastrointestinal Stromal Tumors (GISTs) - Evidence or "Gut-Feeling"?

PURPOSE: To examine practice patterns of endosonographers in diagnosing and managing gastrointestinal stromal tumors (GISTs) in Germany. MATERIALS AND METHODS: A modified published survey (Ha et al., Gastrointest Endosc 2009) was sent to endosonographic ultrasound (EUS) customers in Germany. The survey was also publicized on the homepage of an EUS interest group. To avoid duplicate opinions, participants were asked to return one survey per institution. RESULTS: 142 centers of roughly 850 German EUS centers responded. 25 % were from University hospitals and 74 % from community hospitals. 61 % performed > 2 EUS scans for suspected subepithelial lesions/week. Although 97 % of respondents believed that tissue acquisition with CD117 immunohistochemistry best predicts a GIST, 11 % do not perform EUS-FNA when suspecting a GIST, 68 % perform it occasionally and 18 % perform it regularly. The main EUS criteria used for a suspected GIST are the typical layer (85 %), hypoechoic appearance (80 %) and gastric location (51 %). 69 % would diagnose a GIST with negative CD117 if the EUS criteria and spindle cells are present. FNA was rated helpful in < 50 % by 55 % of participants. Size was the primary criterion for suspecting malignancy. 95 % of respondents would perform surveillance ≥ 1x/year of GISTs that are not resected. CONCLUSION: There is significant variability in the diagnosis and management of GISTs in Germany. Diagnostic certainty of EUS-FNA is suboptimal in many centers and EUS is frequently used for guidance. The diagnosis of a GIST is often guided by a "gut feeling" rather than evidence. Efforts should be made to unify existing guidelines.

Survey of root canal irrigating solutions used in dental practices within Germany.

AIM: Irrigant usage information in relation to years of professional experience was collected from general dentists in different German federal states by means of a questionnaire. METHODOLOGY: A short survey concerning endodontic treatment and use of irrigants was mailed to 4240 dentists or delivered to 3720 dental offices as an extra page in a journal in eight German states. Detailed information concerning the most frequently used irrigants, their concentrations, the spectrum of disinfectants used in root canal treatment concepts for vital and nonvital pulps, main topics of continuing education as well as years of professional experience was collected. The statistical analysis of differences found amongst the dentists in relation to professional experience or federal state was performed using the chi-square test. RESULTS: Of a total of 7960 invitations, 1630 replies were evaluated (response rate 20.5%). The majority of the dentists (57.3%) had >20 years of professional experience, 23% had >30 years. Dentists with long-standing professional experience (20-30 years) used H2 O2 significantly more often than dentists with less experience (P < 0.001), and of the older colleagues (>30 years of professional experience), 14.6% never used NaOCl, whilst the younger colleagues almost always used it (P < 0.001). Differences were also found for the usage of irrigants amongst dentists from the various German states. CONCLUSIONS: Whilst NaOCl was used in almost all states, regional differences were found regarding the choice of additional irrigants, which were mainly determined by the irrigation protocols taught at different universities.

Completeness and timeliness: Cancer registries could/should improve their performance.

UNLABELLED: Cancer registries must provide complete and reliable incidence information with the shortest possible delay for use in studies such as comparability, clustering, cancer in the elderly and adequacy of cancer surveillance. Methods of varying complexity are available to registries for monitoring completeness and timeliness. We wished to know which methods are currently in use among cancer registries, and to compare the results of our findings to those of a survey carried out in 2006. METHODS: In the framework of the EUROCOURSE project, and to prepare cancer registries for participation in the ERA-net scheme, we launched a survey on the methods used to assess completeness, and also on the timeliness and methods of dissemination of results by registries. We sent the questionnaire to all general registries (GCRs) and specialised registries (SCRs) active in Europe and within the European Network of Cancer Registries (ENCR). RESULTS: With a response rate of 66% among GCRs and 59% among SCRs, we obtained data for analysis from 116 registries with a population coverage of ∼280 million. The most common methods used were comparison of trends (79%) and mortality/incidence ratios (more than 60%). More complex methods were used less commonly: capture-recapture by 30%, flow method by 18% and death certificate notification (DCN) methods with the Ajiki formula by 9%. The median latency for completion of ascertainment of incidence was 18 months. Additional time required for dissemination was of the order of 3-6 months, depending on the method: print or electronic. One fifth (21%) did not publish results for their own registry but only as a contribution to larger national or international data repositories and publications; this introduced a further delay in the availability of data. CONCLUSIONS: Cancer registries should improve the practice of measuring their completeness regularly and should move from traditional to more quantitative methods. This could also have implications in the timeliness of data publication.

Coupled variable selection for regression modeling of complex treatment patterns in a clinical cancer registry.

For determining a manageable set of covariates potentially influential with respect to a time-to-event endpoint, Cox proportional hazards models can be combined with variable selection techniques, such as stepwise forward selection or backward elimination based on p-values, or regularized regression techniques such as component-wise boosting. Cox regression models have also been adapted for dealing with more complex event patterns, for example, for competing risks settings with separate, cause-specific hazard models for each event type, or for determining the prognostic effect pattern of a variable over different landmark times, with one conditional survival model for each landmark. Motivated by a clinical cancer registry application, where complex event patterns have to be dealt with and variable selection is needed at the same time, we propose a general approach for linking variable selection between several Cox models. Specifically, we combine score statistics for each covariate across models by Fisher's method as a basis for variable selection. This principle is implemented for a stepwise forward selection approach as well as for a regularized regression technique. In an application to data from hepatocellular carcinoma patients, the coupled stepwise approach is seen to facilitate joint interpretation of the different cause-specific Cox models. In conditional survival models at landmark times, which address updates of prediction as time progresses and both treatment and other potential explanatory variables may change, the coupled regularized regression approach identifies potentially important, stably selected covariates together with their effect time pattern, despite having only a small number of events. These results highlight the promise of the proposed approach for coupling variable selection between Cox models, which is particularly relevant for modeling for clinical cancer registries with their complex event patterns.

Risk factors for heterotopic ossification and spur formation after total knee arthroplasty.

INTRODUCTION: The present study investigated the incidence and risk factors of heterotopic ossification (HO) after implantation of knee prosthesis. MATERIALS AND METHODS: We undertook a retrospective cohort study in 434 cases (363 patients) treated with a total knee replant using a Press-Fit-Condylar (P.F.C.(®)Sigma(®)) prosthesis. The occurrence of HO in radiograph after a follow-up period of 11.2 ± 2.4 months was correlated in a regression model with a variety of influencing factors. RESULTS: 21 patients (4.8 %) developed heterotopic ossifications, all located in the area of the distal femur. The only risk factor found concerning the development of HO was osteoarthritis when compared to rheumatoid arthritis (OR = 4.07, 95 % CI 1.18-14.05; p = 0.0201) and postoperative wound healing problems (OR = 11.32, 95 % CI 3.26-39.33; p = 0.0001). Notching (OR = 2.22, 95 % CI 0.92-5.36; p = 0.0765) and osteophyte forming (hypertrophic) arthrosis (OR = 2.40, 95 % CI 0.97-5.95; p = 0.0596), however, were associated with the development of a bony spur in the contact area of the femoral component of the prosthesis. CONCLUSIONS: Our study has revealed that patients with rheumatoid arthritis are at lower risk of HO than patients with osteoarthritis. An impairment of wound healing would appear to promote the development of a HO. Notching and hypertrophic arthrosis are highly likely to be associated with the development of a bony spur in the ventral contact area of the prosthesis.

Characterizing psychosocial distress in melanoma patients using the expert rating instrument PO-Bado SF.

BACKGROUND: Although psychosocial distress has been evaluated well in cancer entities like breast or prostate cancer, its impact on melanoma patients still needs to be characterized. The objectives of this study were to (i) evaluate psychosocial distress in melanoma patients using an expert rating instrument [basic documentation for psycho-oncology short version (PO-Bado SF)]; (ii) determine associated demographic and clinical variables; and (iii) assess the acceptance of using PO-Bado SF as a routine procedure in a skin cancer unit. METHODS: A cross-sectional group of 696 melanoma patients was recruited. During the routine contact, doctors assessed the patients subjective distress using PO-Bado SF. Sociodemographic data, tumour data, treatment and the course of the disease were extracted from the patients' charts. RESULTS: PO-Bado SF was completed in 688 of 696 (99%) participating patients, revealing a high acceptance. In 51 (7%) patients, the PO-Bado SF cut-off score indicated the potential need of psychosocial support. Patients with previous or ongoing radiotherapy, a history of major surgery due to organ metastases, younger age and shorter time since diagnosis were considered significantly more distressed than patients without these criteria. Patients were most distressed by suffering from anxiety/worries and/or tensions. In younger patients emotional variables and other problems like social or family problems were deemed more relevant while functional limitations in daily living were reasons for higher distress in older patients. CONCLUSION: PO-Bado SF is a useful, well-accepted, practical and economic screening tool to identify distressed melanoma patients. Although most melanoma patients seem to cope well with their disease, special attention should be given to young patients in the first years after initial diagnosis and to patients with advanced disease, radiotherapy and major surgery due to their disease. Combination of expert rating tools with self-report screening instruments could further characterize the specific sources of distress to optimize psychosocial support.

17ß-Estradiol reduces nitric oxide production in the Guinea pig cochlea.

Intense noise exposure and the application of ototoxic substances result in increased levels of reactive oxygen species (ROS) and reactive nitrogen species (RNS), such as nitric oxide (NO). In order to reduce the free NO concentration in the inner ear under pathological conditions, the use of natural cytoprotective substances such as 17ß-estradiol is a promising therapeutic concept. In male guinea pigs the organ of Corti and the lateral wall were isolated from the cochlea and afterwards incubated for 6 h in cell-culture medium. 17ß-Estradiol was adjusted in 2 concentrations to organ cultures of the right ears (12 animals per concentration). The left ears were used as controls. The NO production was quantified in the supernatant by chemiluminescence after incubation. Depending on the concentration, 17ß-estradiol reduced NO in the organ of Corti by 43% (p=0.015) and 46% (p=0.026), respectively. In the lateral wall, the NO concentration was reduced by 24%, but without statistical significance (p=0.86). However, when analyzing the association between the 2 cochlear regions for each animal separately, the NO concentrations were lower in nearly all 17ß-estradiol-treated ears compared to controls. In order to demonstrate the flexibility of the organ culture system, the NO donor DETA NONOate and the nitric oxide synthase inhibitors L-NAME and L-NMMA were applied. The electron microscopic analysis revealed a well-preserved cochlear cell morphology after incubation. The ability of 17ß-estradiol to influence the NO production preferentially in the organ of Corti might offer new therapeutic perspectives for inner ear protection.