Long-term benefits and harms of early colorectal cancer screening in German individuals with familial cancer risk.

Individuals with a family history of colorectal cancer (CRC) may benefit from early screening with colonoscopy or immunologic fecal occult blood testing (iFOBT). We systematically evaluated the benefit-harm trade-offs of various screening strategies differing by screening test (colonoscopy or iFOBT), interval (iFOBT: annual/biennial; colonoscopy: 10-yearly) and age at start (30, 35, 40, 45, 50 and 55 years) and end of screening (65, 70 and 75 years) offered to individuals identified with familial CRC risk in Germany. A Markov-state-transition model was developed and used to estimate health benefits (CRC-related deaths avoided, life-years gained [LYG]), potential harms (eg, associated with additional colonoscopies) and incremental harm-benefit ratios (IHBR) for each strategy. Both benefits and harms increased with earlier start and shorter intervals of screening. When screening started before age 50, 32-36 CRC-related deaths per 1000 persons were avoided with colonoscopy and 29-34 with iFOBT screening, compared to 29-31 (colonoscopy) and 28-30 (iFOBT) CRC-related deaths per 1000 persons when starting age 50 or older, respectively. For iFOBT screening, the IHBRs expressed as additional colonoscopies per LYG were one (biennial, age 45-65 vs no screening), four (biennial, age 35-65), six (biennial, age 30-70) and 34 (annual, age 30-54; biennial, age 55-75). Corresponding IHBRs for 10-yearly colonoscopy were four (age 55-65), 10 (age 45-65), 15 (age 35-65) and 29 (age 30-70). Offering screening with colonoscopy or iFOBT to individuals with familial CRC risk before age 50 is expected to be beneficial. Depending on the accepted IHBR threshold, 10-yearly colonoscopy or alternatively biennial iFOBT from age 30 to 70 should be recommended for this target group.

Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial.

BACKGROUND: Transcranial direct current stimulation (tDCS) has been proposed as a feasible treatment for major depressive disorder (MDD). However, meta-analytic evidence is heterogenous and data from multicentre trials are scarce. We aimed to assess the efficacy of tDCS versus sham stimulation as an additional treatment to a stable dose of selective serotonin reuptake inhibitors (SSRIs) in adults with MDD. METHODS: The DepressionDC trial was triple-blind, randomised, and sham-controlled and conducted at eight hospitals in Germany. Patients being treated at a participating hospital aged 18-65 years were eligible if they had a diagnosis of MDD, a score of at least 15 on the Hamilton Depression Rating Scale (21-item version), no response to at least one antidepressant trial in their current depressive episode, and treatment with an SSRI at a stable dose for at least 4 weeks before inclusion; the SSRI was continued at the same dose during stimulation. Patients were allocated (1:1) by fixed-blocked randomisation to receive either 30 min of 2 mA bifrontal tDCS every weekday for 4 weeks, then two tDCS sessions per week for 2 weeks, or sham stimulation at the same intervals. Randomisation was stratified by site and baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score (ie, <31 or ≥31). Participants, raters, and operators were masked to treatment assignment. The primary outcome was change on the MADRS at week 6, analysed in the intention-to-treat population. Safety was assessed in all patients who received at least one treatment session. The trial was registered with ClinicalTrials.gov (NCT02530164). FINDINGS: Between Jan 19, 2016, and June 15, 2020, 3601 individuals were assessed for eligibility. 160 patients were included and randomly assigned to receive either active tDCS (n=83) or sham tDCS (n=77). Six patients withdrew consent and four patients were found to have been wrongly included, so data from 150 patients were analysed (89 [59%] were female and 61 [41%] were male). No intergroup difference was found in mean improvement on the MADRS at week 6 between the active tDCS group (n=77; -8·2, SD 7·2) and the sham tDCS group (n=73; -8·0, 9·3; difference 0·3 [95% CI -2·4 to 2·9]). Significantly more participants had one or more mild adverse events in the active tDCS group (50 [60%] of 83) than in the sham tDCS group (33 [43%] of 77; p=0·028). INTERPRETATION: Active tDCS was not superior to sham stimulation during a 6-week period. Our trial does not support the efficacy of tDCS as an additional treatment to SSRIs in adults with MDD. FUNDING: German Federal Ministry of Education and Research.

[Results of PCR Pool Testing In Primary and Special Needs Schools In Bavaria For The School Year 2021/2022: Sentinel Surveillance In Face-To-Face Teaching During The Sars-CoV-2 Pandemic]. / Ergebnisse von PCR-Pooltestungen an bayerischen Grund- und Förderschulen im Schuljahr 2021/2022 zur Surveillance im Präsenzunterricht während der SARS-CoV-2-Pandemie.

In the school years 2019/20 and 2020/21, children were physically, psychologically, and socially stressed by school closures caused by the SARS-CoV-2 pandemic. To ensure attendance with optimal infection protection, PCR pool testing was conducted during the 2021/22 school year at Bavarian elementary schools and schools for pupils with special needs for timely detection of SARS-CoV-2 infection. This study analyzes the results of PCR pool testing over time stratified by region, school type, and age of children. The data were obtained from classes in elementary and special needs schools, involving pupils aged 6 to 11 years, who participated in the Bavaria-wide PCR pool testing from 09/20/21 to 04/08/22. Samples were collected twice weekly, consisting of PCR pool samples and individual PCR samples, which were only evaluated in case of a positive pool test. A class was considered positive if at least one individual sample from that class was positive within a calendar week (CW). A school (class) was considered to be infection-prone if three or more classes in that school (students in that class) were positive within a CW. The data included 2,430 elementary schools (339 special needs schools) with 23,021 (2,711) classes and 456,478 (29,200) children. A total of 1,157,617 pools (of which 3.37% were positive) and 724,438 individual samples (6.76% positive) were analyzed. Larger schools exhibited higher PR compared to smaller schools. From January 2022, the Omicron variant led to a massive increase in PR across Bavaria. The incidence rates per 100,000 person-weeks within the individual school samples were significantly lower than the concurrently reported age-specific and general infection incidences in the overall Bavarian population. PCR pool testing revealed relatively few positive pools, with an average of four children per one hundred pools testing positive. Schools and classes were rarely considered infection-prone, even during periods of high incidences outside of schools. The combination of PCR pool testing and hygiene measures allowed for a largely safe in-person education for pupils in primary and special needs schools in the school year 2021/22.

Retrospective clinical study on the performance and aesthetic outcome of pressed lithium disilicate restorations in posterior teeth up to 8.3 years.

OBJECTIVES: Evaluation of cumulative survival and complication rate of monolithic lithium disilicate inlays and partial crowns performed by supervised undergraduate students up to 8.3 years of clinical service. MATERIALS AND METHODS: In this retrospective clinical study 143 lithium disilicate posterior restorations (IPS e.max Press) were examined according to the FDI criteria. A standardised questionnaire was used to determine patient satisfaction. The aesthetic outcome was evaluated by dentists and dental technicians using intraoral photographs. Data were descriptively analysed. Cumulative survival and success rates were calculated using Kaplan-Meier estimation. RESULTS: The cumulative survival rate of lithium disilicate restorations was 97.5% after a mean service time of 5.9 years and 95.0% after 8.3 years. The cumulative success rate decreased from 94.4% after 5.9 years to 30.7% after 8.3 years. Repairs were required for 7 restorations (4.9%), and 5 (3.5%) were classified as failures. The results of the questionnaire indicate a high level of patient satisfaction. The subjective aesthetics were assessed more critically by dental technicians compared to dentists. CONCLUSION: Lithium disilicate posterior restorations survived successfully up to 8.3 years when carried out by undergraduate students. CLINICAL RELEVANCE: Pressed lithium disilicate glass ceramic inlays and partial crowns are reliable treatment options in posterior teeth.

Evaluation of direct restorations using the revised FDI criteria: results from a reliability study.

OBJECTIVES: The purpose of this in vitro reliability study was to determine the intra- and inter-examiner agreement of the revised FDI criteria including the categories "fracture of material and retention" (F1) and "caries at restoration margin" (B1). MATERIALS AND METHODS: Forty-nine photographs of direct tooth-coloured posterior (n = 25) and anterior (n = 24) restorations with common deficiencies were included. Ten dental experts repeated the assessment in three blinded rounds. Later, the experts re-evaluated together all photographs and agreed on a reference standard. Statistical analysis included the calculation of Cohen's (Cκ), Fleiss' (Fκ), and weighted Kappa (wκ), the development of a logistic regression with a backward elimination model and Bland/Altman plots. RESULTS: Intra- and inter-examiner reliability exhibited mostly moderate to substantial Cκ, Fκ, and wκ values for posterior restorations (e.g. Intra: F1 Cκ = 0.57, wκ = 0.74; B1 Cκ = 0.57, wκ = 0.73/Inter F1 Fκ = 0.32, wκ = 0.53; B1 Fκ = 0.41, wκ = 0.64) and anterior restorations (e.g. Intra F1 Cκ = 0.63, wκ = 0.76; B1 Cκ = 0.48, wκ = 0.68/Inter F1 Fκ = 0.42, wκ = 0.57; B1 Fκ = 0.40, wκ = 0.51). Logistic regression analyses revealed significant differences between the evaluation rounds, examiners, categories, and tooth type. Both the intra- and inter-examiner reliability increased along with the evaluation rounds. The overall agreement was higher for anterior restorations compared to posterior restorations. CONCLUSIONS: The overall reliability of the revised FDI criteria set was found to be moderate to substantial. CLINICAL RELEVANCE: If properly trained, the revised FDI criteria set are a valid tool to evaluate direct and indirect restorations in a standardized way. However, training and calibration are needed to ensure reliable application.

Survival Outcomes and Clinicopathological Features in Inflammatory Bowel Disease-associated Colorectal Cancer: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of our study was to conduct a systematic review and meta-analysis comparing the survival outcomes of IBD-associated and non-IBD-associated CRC. SUMMARY OF BACKGROUND DATA: Investigations comparing the prognosis in CRC patients with and without IBD have yielded conflicting results. METHODS: PubMed/MEDLINE, Embase, Web of Science, Cochrane Library were searched for studies evaluating the prognostic outcomes between CRC patients with IBD and those without IBD. Estimates of survival-related outcomes and clinicopathological features in IBD-CRC and non-IBD CRC were pooled through random-effects or fix-effects models. The study is registered with PROSPERO, CRD42021261513. RESULTS: Of 12,768 records identified, twenty-five studies with 8034 IBD-CRC and 810,526 non-IBD CRC patients were included in the analysis. IBD-CRC patients have a significant worse overall survival (OS) with the hazard ratio (HR) of 1.33 [95% confidence interval (CI): 1.20-1.47] than those without IBD. Pooled estimates of cancer-specific survival demonstrated that IBD-CRC patients had a poorer cancer-specific survival than those without IBD with fixed-effect model (HR, 2.17; 95% CI: 1.68-2.78; P < 0.0001). Moreover, ulcerative colitis-associated CRC patients have favorable OS than Crohn's disease-associated CRC (HR 0.79,95% CI: 0.72-0.87). Compared to non-IBD-CRC, patients with IBD-associated CRC are characterized by an increased rate of poor differentiation (OR 2.02, 95% CI: 1.57-2.61), mucinous or signet ring cell carcinoma (OR 2.43, 95% CI: 1.34-4.42), synchronous tumors (OR 3.18, 95% CI: 2.26-4.47), right-sided CRC (OR 1.62, 95%CI: 1.05-2.05), male patients (OR 1.10, 95% CI: 1.05-1.16), and a reduced rate of R0 resections (OR 0.60, 95% CI: 0.44-0.82). CONCLUSIONS: IBD-CRC patients have a significant worse OS than patients with non-IBD CRC, which may be attributed to more aggressive histological characteristics and a lower rate of R0 resections at the primary tumor site. Optimized therapeutic standards and tailored follow-up strategies might improve the prognosis of IBD-CRC patients.

Endoscopic vacuum therapy for the treatment of colorectal leaks - a systematic review and meta-analysis.

BACKGROUND: During the last two decades, vacuum-assisted wound therapy has been successfully transferred to an endoscopic treatment approach of various upper and lower gastrointestinal leaks called endoscopic vacuum therapy (EVT). As mostly small case series are published in this field, the aim of our systematic review and meta-analysis was to evaluate the efficacy and safety of EVT in the treatment of colorectal leaks. METHODS: A systematic search of MEDLINE/PubMed and Cochrane databases was performed using search terms related to EVT and colorectal defects (anastomotic leakage, rectal stump insufficiency) according to the PRISMA guidelines. Randomized controlled trials (RCTs), observational studies, and case series published by December 2020 were eligible for inclusion. A meta-analysis was conducted on the success of EVT, stoma reversal rate after EVT as well as procedure-related complications. Statistical interferences were based on pooled estimates from random effects models using DerSimonian-Laird estimator. RESULTS: Only data from observational studies and case series were available. Twenty-four studies reporting on 690 patients with colorectal defects undergoing EVT were included. The mean rate of success was 81.4% (95% CI: 74.0%-87.1%). The proportion of diverted patients was 76.4% (95% CI: 64.9%-85.0%). The mean rate of ostomy reversal across the studies was 66.7% (95% CI: 58.0%-74.4%). Sixty-four patients were reported with EVT-associated complications, the weighted mean complication rate across the studies was 12.1% (95% CI: 9.7%-15.2%). CONCLUSIONS: Current medical evidence on EVT in patients with colorectal leaks lacks high quality data from RCTs. Based on the data available, EVT can be seen as a feasible treatment option with manageable risks for selected patients with colorectal leaks.

Chronic low back pain: a prospective study with 4 to 15 years follow-up after a multidisciplinary biopsychosocial rehabilitation program.

BACKGROUND: Multidisciplinary biopsychosocial rehabilitation (MBR) in patients with chronic low back pain (CLBP) is superior to less intensive treatments for at least one year, but the long-term course of the disease is largely unknown. The primary aim of this study was to describe the long-term course of an MBR in relation to pain, disability, and quality of life from the beginning of an MBR to between 4 to 15 years after participation. The secondary aim was to explore the long-term course of an MBR in relation to physiological outcomes of functioning. METHODS: This was a observational study conducted at a university hospital. The cohort consisted of participants of a 3-week, CLBP-specific MBR program between August 2001 and January 2013. The North American Spine Society questionnaire (NASS) pain and disability scale was the primary patient -reported outcome measure (PROM). The NASS neurogenic symptoms scale and the Short-Form 36 (SF-36) health survey were secondary PROMs. Patients were assessed before entry to the MBR (T0), at entry (T1), at discharge (T2) and 4 to 15 years after discharge (T3). Effects were quantified by effect size (ES). Score differences were tested for significance using parametric or non-parametric tests and linear mixed models. RESULTS: Of 299 consecutive patients from the MBR program, 229 could be contacted. Of these, 84 declined participation, five did not meet the inclusion criteria, and 26 had incomplete data. Thus, 114 patients were included. The mean follow-up time was 9.2 years. At T3, patients exhibited beneficial effects for NASS pain and disability with a moderate ES (ES = 0.63; p < 0.001). The NASS neurogenic symptoms scale was stable. The SF-36 scales showed an improvement in the bodily pain domain (ES = 1.02; p < 0.001), but no significant changes for physical functioning, physical role, general health, vitality, social functioning, emotional role, or mental health. The physical health component summary was improved (ES = 0.40, p = 0.002), and the mental health summary was unchanged. The linear mixed model analysis confirmed improvements in pain and disability between T1 and T3 (p = 0.010). CONCLUSIONS: The results of this study suggest that there is a long-term benefit of MBR participation in patients with CLBP.

Systematic review and meta-analysis of diagnostic methods for occlusal surface caries.

AIM: This systematic review and meta-analysis aimed to assess the diagnostic performance of commonly used methods for occlusal caries diagnostics, such as visual examination (VE), bitewing radiography (BW) and laser fluorescence (LF), in relation to their ability to detect (dentin) caries under clinical and laboratory conditions. MATERIALS AND METHODS: A systematic search of the literature was performed to identify studies meeting the inclusion criteria using the PIRDS concept (N = 1090). A risk of bias (RoB) assessment tool was used for quality evaluation. Reports with low/moderate RoB, well-matching thresholds for index and reference tests and appropriate reporting were included in the meta-analysis (N = 37; 29 in vivo/8 in vitro). The pooled sensitivity (SE), specificity (SP), diagnostic odds ratio (DOR) and areas under ROC curves (AUCs) were computed. RESULTS: SP ranged from 0.50 (fibre-optic transillumination/caries detection level) to 0.97 (conventional BW/dentine detection level) in vitro. AUCs were typically higher for BW or LF than for VE. The highest AUC of 0.89 was observed for VE at the 1/3 dentin caries detection level; SE (0.70) was registered to be higher than SP (0.47) for VE at the caries detection level in vivo. CONCLUSION: The number of included studies was found to be low. This underlines the need for high-quality caries diagnostic studies that further provide data in relation to multiple caries thresholds. CLINICAL RELEVANCE: VE, BW and LF provide acceptable measures for their diagnostic performance on occlusal surfaces, but the results should be interpreted with caution due to the limited data in many categories.

Systematic review and meta-analysis of diagnostic studies of proximal surface caries.

AIM: This systematic review and meta-analysis aimed to assess the diagnostic accuracy and reliability of commonly used caries detection methods for proximal caries diagnostics. Visual examination (VE), bitewing radiography (BWR), laser fluorescence (LF), and fibre-optic transillumination (FOTI) were considered in detail. MATERIAL AND METHODS: PRISMA guidelines for the reporting of systematic reviews and meta-analyses were applied. The mnemonic PIRDS (problem, index test, reference test, diagnostic and study type) concept was used to guide the literature search. Next, studies that met the inclusion criteria were stepwise selected and evaluated for their quality with a risk of bias (RoB) assessment tool. Studies with low/moderate bias and sufficient reporting were considered for meta-analysis. The pooled sensitivity (SE), specificity (SP), diagnostic odds ratio (DOR), and area under the ROC curve (AUC) were calculated. RESULTS: From 129 studies meeting the selection criteria, 31 in vitro studies and five clinical studies were finally included in the meta-analysis. The AUC values for in vitro VE amounted to 0.84 (caries detection) and 0.85 (dentin caries detection). BWR ranged in vitro from 0.55 to 0.82 (caries detection) and 0.81-0.92 (dentin caries detection). LF showed higher AUC values for overall caries detection (0.91) and dentin caries detection (0.83) than did other methods. Clinical data are limited. CONCLUSION: The number of diagnostic studies with low/moderate RoB was found to be low and indicates a need for high-quality, well-designed caries diagnostic studies. CLINICAL RELEVANCE: BWR and LF showed good diagnostic performance on proximal surfaces. However, because of the low number of includable clinical studies, these data should be interpreted with caution.

Variability of forced vital capacity in progressive interstitial lung disease: a prospective observational study.

BACKGROUND: Fibrotic interstitial lung disease (ILD) is often associated with poor outcomes, but has few predictors of progression. Daily home spirometry has been proposed to provide important information about the clinical course of idiopathic pulmonary disease (IPF). However, experience is limited, and home spirometry is not a routine component of patient care in ILD. Using home spirometry, we aimed to investigate the predictive potential of daily measurements of forced vital capacity (FVC) in fibrotic ILD. METHODS: In this prospective observational study, patients with fibrotic ILD and clinical progression were provided with home spirometers for daily measurements over 6 months. Hospital based spirometry was performed after three and 6 months. Disease progression, defined as death, lung transplantation, acute exacerbation or FVC decline > 10% relative was assessed in the cohort. RESULTS: From May 2017 until August 2018, we included 47 patients (IPF n = 20; non-IPF n = 27). Sufficient daily measurements were performed by 85.1% of the study cohort. Among these 40 patients (IPF n = 17; non-IPF n = 23), who had a mean ± SD age of 60.7 ± 11.3 years and FVC 64.7 ± 21.7% predicted (2.4 ± 0.8 L), 12 patients experienced disease progression (death: n = 2; lung transplantation: n = 3; acute exacerbation: n = 1; FVC decline > 10%: n = 6). Within the first 28 days, a group of patients had high daily variability in FVC, with 60.0% having a variation ≥5%. Patients with disease progression had significantly higher FVC variability than those in the stable group (median variability 8.6% vs. 4.8%; p = 0.002). Cox regression identified FVC variability as independently associated with disease progression when controlling for multiple confounding variables (hazard ratio: 1.203; 95% CI:1.050-1.378; p = 0.0076). CONCLUSIONS: Daily home spirometry is feasible in IPF and non-IPF ILD and facilitates the identification of FVC variability, which was associated with disease progression.

Evaluating the effects of a risk-adapted screening program for familial colorectal cancer in individuals between 25 and 50 years of age: study protocol for the prospective population-based intervention study FARKOR.

BACKGROUND: Colorectal cancer (CRC) is the second most common malignant disease and the second most common cause of cancer death in Germany. Official CRC screening starts at age 50. As there is evidence that individuals with a family history of CRC have an increased risk of developing CRC before age 50, there are recommendations to start screening for this group earlier. This study aims to evaluate the clinical and economic effects of a risk-adapted screening program for CRC in individuals between 25 and 50 years of age with potentially increased familial CRC risk. METHODS: FARKOR (Familiäres Risiko für das Kolorektale Karzinom) is a population-based prospective intervention study. All members of cooperating statutory health insurance companies between 25 and 50 years of age living in a model region in Germany (federal state of Bavaria, 3.5 million inhabitants in this age group) can participate in the program between October 2018 and March 2020. Recruitment takes place through physicians and through a public campaign. Additionally, insurances contact recently diagnosed CRC patients in order to encourage their relatives to participate in the program. Physicians assess a participant's familial history of CRC using a short questionnaire. All participants with a family history of CRC are invited to a shared decision making process to decide on further screening options consisting of either undergoing an immunological test for fecal occult blood or colonoscopy. Comprehensive data collection based on self-reported lifestyle information, medical documentation and health administrative databases accompanies the screening program. Longterm benefits, harms and the cost-effectiveness of the risk-adapted CRC screening program will be assessed by decision analytic modeling. DISCUSSION: The data collected in this study will add important pieces of information that are still missing in the evaluation of the effects and the cost-effectiveness of a risk-adapted CRC screening strategy for individuals under 50 years of age. TRIAL REGISTRATION: German Clinical Trials Register, DRKS-IDDRKS00015097.

Pirfenidone exerts beneficial effects in patients with IPF undergoing single lung transplantation.

Pirfenidone demonstrated pleiotropic antiinflammatory effects in various experimental and clinical settings. The aim of this study was to assess the impact of previous treatment with pirfenidone on short-term outcomes after single lung transplantation (SLTx). Therefore, patients with idiopathic pulmonary fibrosis (IPF) who were undergoing SLTx were screened retrospectively for previous use of pirfenidone and compared to respective controls. Baseline parameters and short-term outcomes were recorded and analyzed. In total, 17 patients with pirfenidone were compared with 26 patients without antifibrotic treatment. Baseline characteristics and severity of disease did not differ between groups. Use of pirfenidone did not increase blood loss, wound-healing, or anastomotic complications. Severity of primary graft dysfunction at 72 hours was less (0.3 ± 0.6 vs 1.4 ± 1.3, P = .002), and length of mechanical ventilation (37.5 ± 34.8 vs 118.5 ± 151.0 hours, P = .016) and intensive care unit (ICU) stay (6.6 ± 7.1 vs 15.6 ± 20.3, P = .089) were shorter in patients with pirfenidone treatment. An independent beneficial effect of pirfenidone was confirmed by regression analysis while controlling for confounding variables (P = .016). Finally, incidence of acute cellular rejections within the first 30 days after SLTx was lower in patients with previous pirfenidone treatment (0.0% vs 19.2%; P = .040). Our data suggest a beneficial role of previous use of pirfenidone in patients with IPF who were undergoing SLTx.

No Differences in Renal Function between Balanced 6% Hydroxyethyl Starch (130/0.4) and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy: A Randomized Controlled Trial.

BACKGROUND: The use of artificial colloids has declined in critical care, whereas they are still used in perioperative medicine. Little is known about the nephrotoxic potential in noncritically ill patients during routine surgery. The objective of this trial was to evaluate the influences of albumin 5% and balanced hydroxyethyl starch 6% (130/0.4) on renal function and kidney injury. METHODS: One hundred urologic patients undergoing elective cystectomy were randomly assigned for this prospective, single-blinded, controlled study with two parallel groups to receive either albumin 5% or balanced hydroxyethyl starch 6% (130/0.4) as the only perioperative colloid. The primary endpoint was the ratio of serum cystatin C between the last visit at day 90 and the first preoperative visit. Secondary endpoints were estimated glomerular filtration rate and serum neutrophil gelatinase-associated lipocalin until the third postoperative day and risk, injury, failure, loss, and end-stage renal disease criteria at postoperative days 3 and 90. RESULTS: The median cystatin C ratio was 1.11 (interquartile range, 1.01 to 1.23) in the albumin and 1.08 (interquartile range, 1.00 to 1.20) in the hydroxyethyl starch group (median difference = 0.03; 95% CI, -0.09 to 0.08; P = 0.165). Also, there were no significant differences concerning serum cystatin C concentrations; estimated glomerular filtration rate; risk, injury, failure, loss, and end-stage renal disease criteria; and neutrophil gelatinase-associated lipocalin. Infusion requirements, transfusion rates, and perioperative hemodynamics were similar in both groups. CONCLUSIONS: With respect to renal function and kidney injury, this study indicates that albumin 5% and balanced hydroxyethyl starch 6% have comparable safety profiles in noncritically ill patients undergoing major surgery.

Renal volume assessed by magnetic resonance imaging volumetry correlates with renal function in living kidney donors pre- and postdonation: a retrospective cohort study.

Renal function of potential living kidney donors is routinely assessed with scintigraphy. Kidney anatomy is evaluated by imaging techniques such as magnetic resonance imaging (MRI). We evaluated if a MRI-based renal volumetry is a good predictor of kidney function pre- and postdonation. We retrospectively analyzed the renal volume (RV) in a MRI of 100 living kidney donors. RV was correlated with the tubular excretion rate (TER) of MAG3-scintigraphy, a measured creatinine clearance (CrCl), and the estimated glomerular filtration rate (eGFR) by Cockcroft-Gault (CG), CKD-EPI, and modification of diet in renal disease (MDRD) formula pre- and postdonation during a follow-up of 3 years. RV correlated significantly with the TER (total: r = 0.6735, P < 0.0001). Correlation between RV and renal function was the highest for eGFR by CG (r = 0.5595, P < 0.0001), in comparison with CrCl, MDRD-GFR, and CKD-EPI-GFR predonation. RV significantly correlated with CG-GFR postdonation and predicted CG-GFR until 3 years after donation. MRI renal volumetry might be an alternative technique for the evaluation of split renal function and prediction of renal function postdonation in living kidney donors.

Burden of oral mucositis in stem cell transplant patients-the patients' perspective.

PURPOSE: Purpose of this study was to determine the impact of Oral Mucositis (OM) on health-related quality of life (HRQoL) and quality of life associated symptoms and functions in patients undergoing hematopoietic stem cell transplantation (HSCT). METHODS: Prospective, non-interventional single-center observational study at a German tertiary teaching hospital. Inpatient allogenic and autologous stem cell transplant patients ≥18-year-old with high-dose chemotherapy. OM was assessed with the WHO Oral Toxicity Scale, pain according to the Numeric Rating Scale (NRS) and the performance status using the ECOG Score. QOL was captured with the EORTC QLQ-C30 and the QLQ-OH15 questionnaires. RESULTS: Forty-five stem cell transplant patients (20 autologous, 25 allogenic) were enrolled between August 2016 and February 2017. Twenty-six (58%, 95% CI: 42% - 72%) patients developed OM (10 grade I, 4 grade II, 8 grade III, 4 grade IV). OM affected patients suffered more from pain, sore mouth and sensitive mouth. A lower physical functioning (34.5 vs 7.5, p = 0.003) and a lower oral health-related quality of life (24.3 vs 7.7, p = 0.006) was found in patients with OM development. There was found a positive correlation between the grade of OM and the NRS-value (r = 0.93, 95% CI: 0.89-0.96, p < 0.001). CONCLUSION: OM is associated with health-related quality of life and quality of life associated functions and symptoms. More research should be performed to find ways to prevent OM and to stabilize patients' quality of life during HSCT.

Barriers for the implementation of guidelines in palliative care-results from a national survey of professionals.

BACKGROUND: In 2015, an evidence- and consensus-based palliative care guideline in adults with incurable cancer was published by the German Guideline Program. Barriers and enablers for the guideline implementation of members of the German Association for Palliative Medicine (DGP) were unknown. Therefore, the aims of this study were (1) to evaluate professionals' knowledge, motivation, and outcome expectancy towards already existing recommendations for palliative care and (2) to evaluate the self-experienced competence in five medical key topics presented in the new guideline. METHODS: A web-based online survey with all DGP members in 2014 using a specifically designed questionnaire including 62 questions was used. Independent predictors for identified barriers were analysed using multivariable logistic regression analyses. RESULTS: All 4786 members with known email address were invited, 1181 followed the link, 1138 began to answer, and 1031 completed the questionnaire. Fifty-four percent know already existing recommendations concerning palliative care, 8.4% know and use these recommendations; of the latter group, 44.2% do not notice any improvement of their treatment when applying them. Of key symptoms addressed in the guideline, depression was the symptom with lowest perceived competence (63.7 vs. > 90% for other symptoms). Non-physicians and those working in settings with little contact to seriously ill or dying patients feel less competent in almost all symptoms. CONCLUSION: Emphasis on the high-quality and evidence- and consensus-based character of the guideline should be underlined in future implementation processes. Implementation strategies should focus on depression and non-physicians and those professionals working in settings with little contact to seriously ill patients.

Hydroxyethyl Starch 130/0.4 and Its Impact on Perioperative Outcome: A Propensity Score Matched Controlled Observation Study.

BACKGROUND: Adverse effects of hydroxyethyl starches (HESs) have been verified in patients suffering from sepsis or kidney disease, but not in surgical patients at large. The investigation aimed to determine whether the use of HES 130/0.4 was associated with the incidence of acute postinterventional adverse events compared to Ringer's acetate alone in a perioperative setting. METHODS: This propensity score matched, controlled observational study was performed in a single-centre university hospital. The perioperative data of 9085 patients were analyzed. Group matching was based on 13 categories including demographic data, type of procedure, and 5 preexisting comorbidities. Duration of procedure and intraoperative transfusion requirements were integrated in the matching process to reduce selection and indication bias. The primary outcome was incidence of postoperative kidney failure. Secondary outcomes were in-hospital mortality, fluid requirements, blood loss, hemodynamic stability, and the need for postoperative intensive care unit (ICU) treatment. RESULTS: The administration of HES 130/0.4 was not associated with an increased frequency of postoperative kidney failure. In-hospital mortality (Ringer's acetate: 2.58%; HES 130/0.4: 2.68%) and the need for ICU care (Ringer's acetate: 30.5%; HES 130/0.4: 34.3%) did not differ significantly between groups. Significant intergroup differences were observed for mean blood loss (Ringer's acetate: 406 ± 821 mL; HES 130/0.4: 867 ± 1275 mL; P < .001) and median length of hospital stay (Ringer's acetate: 10.5 (5/17) days; HES 130/0.4: 12.0 (8/19) days; P < .001). CONCLUSIONS: An association between intraoperative HES therapy and postoperative kidney failure was not observed in a mixed cohort of elective surgical patients. In addition, HES 130/0.4 was not associated with an increased morbidity or the need for ICU therapy in this propensity score matched study.

Idiopathic Pulmonary Fibrosis Among Young Patients: Challenges in Diagnosis and Management.

INTRODUCTION: Idiopathic pulmonary fibrosis (IPF) is considered a disease of older patients, being rare in patients ≤ 50 years. Still, IPF can occur in younger patients, but this particular patient group is not well characterised so far. The aim of this study was to compare the diagnostic certainty, clinical features, comorbidities and survival in young versus older IPF patients. METHODS: We reviewed our medical records from February 2011 until February 2015, to identify IPF patients, who were then classified as young (≤ 50 years) or older IPF (> 50 years). Radiographic and histological findings, lung function parameters, comorbidities, disease progression and survival were analysed and compared between the two groups. RESULTS: Of 440 patients with interstitial lung disease, 129 patients with IPF were identified, including 30 (23.3%) ≤50 years and 99 (76.7%) > 50 years. There were no differences between age groups in baseline demographics; younger patients were less likely to have a confirmed diagnosis by high-resolution computed tomography (p = 0.014), more likely to require a biopsy (p = 0.08) and less likely to have received antifibrotic therapy (p = 0.006). Despite an overall limited prognosis, younger patients had a significantly better median survival after diagnosis (p = 0.0375), with a significantly higher proportion of older patients dying due to respiratory failure (p = 0.0383). CONCLUSION: IPF patients under the age of 50 years have similar features and clinical course compared to older IPF patients. These patients should be diagnosed by adopting a multidisciplinary team approach, potentially benefitting from earlier intervention with effective antifibrotic therapy.

Preemptive volume therapy to prevent hemodynamic changes caused by the beach chair position: hydroxyethyl starch 130/0.4 versus Ringer's acetate-a controlled randomized trial.

BACKGROUND: Hemodynamic instability frequently occurs in beach chair positioning for surgery, putting patients at risk for cerebral adverse events. This study examined whether preoperative volume loading with crystalloids alone or with a crystalloid-colloid combination can prevent hemodynamic changes that may be causative for unfavorable neurologic outcomes. METHODS: The study randomly assigned 43 adult patients undergoing shoulder surgery to 3 study groups. Each group received an infusion of 500 mL of Ringer's acetate between induction of anesthesia and being placed in the beach chair position. The crystalloid group received an additional bolus of 1000 mL Ringer's acetate. The hydroxyethyl starch group was administered an additional bolus of 500 mL of 6% hydroxyethyl starch 130/0.4. Hemodynamic monitoring was accomplished via an esophageal Doppler probe. Cerebral oxygen saturation was examined with near-infrared spectroscopy. Changes in stroke volume variation between the prone and beach chair positions were defined as the primary outcome parameter. Secondary outcomes were changes in cardiac output and cerebral oxygen saturation. RESULTS: The control group was prematurely stopped after enrollment of 4 patients because of adverse events. In the hydroxyethyl starch group, stroke volume variation remained constant during positioning maneuvers (P = .35), whereas a significant increase was observed in the Ringer's acetate group (P < .01; P = .014 for intergroup comparison). This was also valid for changes in cardiac output. Cerebral oxygen saturation significantly decreased in both groups. CONCLUSIONS: Preprocedural boluses of 500 mL of 6% hydroxyethyl starch 130/0.4 as well as 1000 mL of Ringer's acetate were efficient in preserving hemodynamic conditions during beach chair position.