All optical neural interfaces.

Brain/computer interfaces (BCIs) rely on the concurrent recording of many channels of electrical activity from excitable tissue. Traditionally such neural interfacing has been performed using cumbersome, channel-limited multielectrode arrays. We believe that BCIs can greatly benefit from using an optical approach based on simple yet powerful liquid-crystal based transducer technology. This approach potentially offers a technology platform that can sustain the necessary bandwidth, density of channels, responsivity, and conformability that are required for the long-term viability of such interfaces. In this paper we review the overall architecture of this approach, the challenges it faces, and the solutions that are being developed at UNSW Sydney.

Continuous table tennis is associated with processing in frontal brain areas: an EEG approach.

Coordinative challenging exercises in changing environments referred to as open-skill exercises seem to be beneficial on cognitive function. Although electroencephalographic research allows to investigate changes in cortical processing during movement, information about cortical dynamics during open-skill exercise is lacking. Therefore, the present study examines frontal brain activation during table tennis as an open-skill exercise compared to cycling exercise and a cognitive task. 21 healthy young adults conducted three blocks of table tennis, cycling and n-back task. Throughout the experiment, cortical activity was measured using 64-channel EEG system connected to a wireless amplifier. Cortical activity was analyzed calculating theta power (4-7.5 Hz) in frontocentral clusters revealed from independent component analysis. Repeated measures ANOVA was used to identify within subject differences between conditions (table tennis, cycling, n-back; p < .05). ANOVA revealed main-effects of condition on theta power in frontal (p < .01, ηp2 = 0.35) and frontocentral (p < .01, ηp2 = 0.39) brain areas. Post-hoc tests revealed increased theta power in table tennis compared to cycling in frontal brain areas (p < .05, d = 1.42). In frontocentral brain areas, theta power was significant higher in table tennis compared to cycling (p < .01, d = 1.03) and table tennis compared to the cognitive task (p < .01, d = 1.06). Increases in theta power during continuous table tennis may reflect the increased demands in perception and processing of environmental stimuli during open-skill exercise. This study provides important insights that support the beneficial effect of open-skill exercise on brain function and suggest that using open-skill exercise may serve as an intervention to induce activation of the frontal cortex.

Prostatic Artery Embolization: Influence of Cone-Beam Computed Tomography on Radiation Exposure, Procedure Time, and Contrast Media Use.

PURPOSE: To evaluate the effect of cone-beam computed tomography (CBCT) on radiation exposure, procedure time, and contrast media (CM) use in prostatic artery embolization (PAE). MATERIALS AND METHODS: Seventy-eight patients were enrolled in this retrospective, single-center study. All patients received PAE without (group A; n = 39) or with (group B; n = 39) CBCT. Total dose-area product (DAPtotal; Gycm2), total entrance skin dose (ESDtotal; mGy), and total effective dose (EDtotal; mSv) were primary outcomes. Number of digital subtraction angiography (DSA) series, CM use, fluoroscopy time, and procedure time were secondary outcomes. PAE in group A was performed by a single radiologist with 15 years experience, PAE in group B was conducted by four radiologists with 4 to 6 years experience. RESULTS: For groups A vs. B, respectively, median (IQR): DAPtotal 236.94 (186.7) vs. 281.20 (214.47) Gycm2(p = 0.345); EDtotal 25.82 (20.35) vs. 39.84 (23.75) mSv (p = < 0.001); ESDtotal 2833 (2278) vs. 2563 (3040) mGy(p = 0.818); number of DSA series 25 (15) vs. 23 (10)(p = 0.164); CM use 65 (30) vs. 114 (40) mL(p = < 0.001); fluoroscopy time 23 (20) vs. 28 (25) min(p = 0.265), and procedure time 70 (40) vs.120 (40) min(p = < 0.001). Bilateral PAE was achieved in 33/39 (84.6%) group A and 32/39 (82.05%) group B(p = 0.761), all other patients received unilateral PAE. There were no significant differences between clinical parameters and origins of the prostatic arteries (PA) (p = 0.206-1.00). CONCLUSION: Operators with extensive expertise on PAE may not benefit from addition of CBCT to DSA runs, whereas for operators with less expertise, CBCT when used alongside with DSA runs increased the overall radiation exposure.

Risk factors for vertebral fractures and bone loss after denosumab discontinuation: A real-world observational study.

BACKGROUND: Denosumab discontinuation without subsequent bisphosphonates (BPs) is associated with bone loss and multiple vertebral fractures. OBJECTIVE: Identifying risk factors for bone loss and vertebral fractures after denosumab discontinuation. METHODS: This retrospective study measured the outcome of 219 women with osteoporosis who discontinued denosumab treatment and received subsequent treatment with zoledronate, other BPs or a selective estrogen receptor modulator (SERM), or no therapy. Fracture rate, longitudinal bone mineral density (BMD) changes and bone turnover markers (BTMs) within 2 years after denosumab discontinuation were analysed. Linear regression analysis evaluated loss of BMD and age, BMI (kg/m2), denosumab treatment duration, pre-treatment, prior fracture state, baseline T-scores, use of glucocorticoids or aromatase inhibitors and BMD gains under denosumab therapy. RESULTS: 171 women received zoledronate after denosumab discontinuation, 26 had no subsequent treatment and 22 received other therapies (other BPs or a SERM). Zoledronate was associated with the fewest vertebral fractures (hazard ratio 0.16, p = 0.02) and all subsequent therapies retained BMD at all sites to some extent. Higher BMD loss was associated with younger age, lower BMI, longer denosumab treatment, lack of prior antiresorptive treatment and BMD gain under denosumab treatment. BTM levels correlated with denosumab treatment duration and bone loss at the total hip, but not the lumbar spine. CONCLUSIONS: Compared to no subsequent therapy, zoledronate was associated with fewer vertebral fractures after denosumab. Further, BMD loss depended on denosumab treatment duration, age, prior BP therapy and BMD gain under denosumab therapy, whereas BTM levels were associated with bone loss at the total hip and denosumab treatment duration.

Factors influencing GPs' perception of specialised palliative homecare (SPHC) importance - results of a cross-sectional study.

BACKGROUND: General Practitioners (GPs) are the main providers of primary palliative care (PPC). At the same time they are the main initiators of specialised palliative homecare (SPHC). In Germany, little is known about factors which influence GPs in their involvement of SPHC. Aim of our study is to identify factors that drive GPs to give value to and involve SPHC. METHODS: A cross-sectional survey was performed. In 2018, questionnaires were mailed to 6000 randomly selected GPs from eight German federal states, focusing on the extent of GPs' palliative care activities and their involvement of SPHC. RESULTS: With a response rate of 19.4% and exclusion of GPs working in SPHC-teams, n = 1026 questionnaires were appropriate for analysis. GPs valued SPHC support as the most "important/very important" for both "technical/invasive treatment measures" (95%) and availability outside practice opening hours (92%). The most relevant factor influencing perceived SPHC-importance was GPs' self-reported extent of engagement in palliative care (ß = - 0.283; CI 95% = - 0.384;-0.182), followed by the perceived quality of utilised SPHC (ß = 0.119; CI 95% = 0.048;0.190), involvement in treatment of palliative patients after SPHC initiation (ß = 0.088; CI 95% = 0.042;0.134), and conviction that palliative care should be a central part of GPs' work (ß = - 0.062; CI 95% = - 0.116;-0.008). Perceived SPHC-importance is also associated with SPHC-referrals (ß =0.138; p < 0.001). The lower the engagement of GPs in palliative care, the more they involve SPHC and vice versa. CONCLUSIONS: GPs with low reported activity in palliative care are more likely to initialise SPHC for palliative care activities they do not deliver themselves for various reasons, which might mean that the involvement of SPHC is substitutive instead of complementary to primary palliative care. This finding and its interpretation should be given more attention in the future policy framework for (specialised) palliative homecare. TRIAL REGISTRATION: German Clinical Trials Register DRKS00014726 , 14.05.2018.

Changes in incidence of severe hypoglycaemia in people with type 2 diabetes from 2006 to 2016: analysis based on health insurance data in Germany considering the anti-hyperglycaemic medication.

AIM: To investigate the incidence of severe hypoglycaemia over the past 10 years, taking into account changes in anti-hyperglycaemic therapy. METHODS: This retrospective population-based study used German health insurance data. All adults diagnosed with documented type 2 diabetes (extrapolated to the German population: 6.6 million in 2006; 7.9 million in 2011; 8.86 million in 2016) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by Anatomical Therapeutic Chemical (ATC) code. RESULTS: The event rate for severe hypoglycaemia was 460 per 100 000 people in 2006, 490 per 100 000 in 2011 and 360 per 100 000 in 2016. The proportion of people with severe hypoglycaemia receiving sulfonylureas, as well as receiving combination therapy of metformin and sulfonylureas decreased from 2006 to 2016 (23.6% vs. 6.2%) Among those with severe hypoglycaemia in 2006, there were no prescriptions for dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose co-transporter 2 (SGLT2) agonists. The proportions of people with severe hypoglycaemia receiving DPP-4 inhibitors, GLP-1 receptor agonists or SGLT2 agonists in 2011 and 2016 were low. The proportion of people receiving human insulin also decreased (from 11.3% in 2006 to 10.3% in 2011 and 4.3% in 2016); the proportion of people receiving insulin analogues increased from 5.4% in 2006 to 11.5% in 2016. Therapy with mixed insulins was used by 19.7% of people with severe hypoglycaemia in 2006, by 14.0% in 2011 and by 7.3% in 2016. People undergoing therapy with insulin analogues have the highest risk of severe hypoglycaemia adjusted by age, gender, nephropathy diagnosis and year of survey [odds ratio (OR) 14.4, 95% confidence interval (95% CI) 13.5-15.5]. CONCLUSION: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, and decreased in 2016.

Does Pentaerytrithyltetranitrate reduce fetal growth restriction in pregnancies complicated by uterine mal-perfusion? Study protocol of the PETN-study: a randomized controlled multicenter-trial.

BACKGROUND: Affecting approximately 10% of pregnancies, fetal growth restriction (FGR), is the most important cause of perinatal mortality and morbidity. Impaired placental function and consequent mal-perfusion of the placenta is the leading cause of FGR. Although, screening for placental insufficiency based on uterine artery Doppler measurement is well established, there is no treatment option for pregnancies threatened by FGR. The organic nitrate pentaerithrityl tetranitrate (PETN) is widely used for the treatment of cardiovascular disease and has been shown to have protective effects on human endothelial cells. In a randomized placebo controlled pilot-study our group could demonstrate a risk reduction of 39% for the development of FGR, and FGR or death, by administering PETN to patients with impaired uterine artery Doppler at mid gestation. To confirm these results a prospective randomized placebo controlled double-blinded multicentre trial was now initiated. METHOD: The trial has been initiated in 14 centres in Germany. Inclusion criteria are abnormal uterine artery Doppler, defined by mean PI > 1.6, at 190 to 226 weeks of gestation in singleton pregnancies. Included patients will be monitored in 4-week intervals. Primary outcome measures are development of FGR (birth weight < 10th percentile), severe FGR (birth weight < 3rd centile) and perinatal death. Placental abruption, birth weight below the 3rd, 5th and 10th centile, development of FGR requiring delivery before 34 weeks` gestation, neonatal intensive care unit admission, and spontaneous preterm delivery < 34 weeks` and 37 weeks` gestation will be assessed as secondary endpoints. Patient enrolment was started in August 2017. Results are expected in 2020. DISCUSSION: During the past decade therapeutic agents with possible perfusion optimizing potential have been evaluated in clinical trials to treat FGR. Meta-analysis and sub-analysis of trials targeting preeclampsia revealed ASS to have a potential in reducing FGR. Phosphodiesterase-type-5 inhibitors have recently been tested in a worldwide RCT for therapy of established FGR, failing to show an effect on neonatal outcome. The ongoing multicenter trial will, by confirming our previous results, finally provide a therapeutic option in cases at risk for FGR. TRIAL REGISTRATION: DRKS00011374 registered at September 29th, 2017 and NCT03669185 , registered September 13th, 2018.

Metaproteomics of fecal samples of Crohn's disease and Ulcerative Colitis.

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD) of the gastrointestinal tract. This study used non-invasive LC-MS/MS to find disease specific microbial and human proteins which might be used later for an easier diagnosis. Therefore, 17 healthy controls, 11 CD patients and 14 UC patients but also 13 Irritable Bowel Disease (IBS) patients, 8 Colon Adenoma (CA) patients, and 8 Gastric Carcinoma (GCA) patients were investigated. The proteins were extracted from the fecal samples with liquid phenol in a ball mill. Subsequently, the proteins were digested tryptically to peptides and analyzed by an Orbitrap LC-MS/MS. For protein identification and interpretation of taxonomic and functional results, the MetaProteomeAnalyzer software was used. Cluster analysis and non-parametric test (analysis of similarities) separated healthy controls from patients with CD and UC as well as from patients with GCA. Among others, CD and UC correlated with an increase of neutrophil extracellular traps and immune globulins G (IgG). In addition, a decrease of human IgA and the transcriptional regulatory protein RprY from Bacillus fragilis was found for CD and UC. A specific marker in feces for CD was an increased amount of the human enzyme sucrose-isomaltase. SIGNIFICANCE: Crohn's Disease and Ulcerative Colitis are chronic inflammatory diseases of the gastrointestinal tract, whose diagnosis required comprehensive medical examinations including colonoscopy. The impact of the microbial communities in the gut on the pathogenesis of these diseases is poorly understood. Therefore, this study investigated the impact of gut microbiome on these diseases by a metaproteome approach, revealing several disease specific marker proteins. Overall, this indicated that fecal metaproteomics has the potential to be useful as non-invasive tool for a better and easier diagnosis of both diseases.

Impact of perioperative liver dysfunction on in-hospital mortality and long-term survival in infective endocarditis patients.

PURPOSE: Infective endocarditis (IE) is often associated with multiorgan dysfunction and mortality. The impact of perioperative liver dysfunction (LD) on outcome remains unclear and little is known about factors leading to postoperative LD. METHODS: We performed a retrospective, single-center analysis on 285 patients with left-sided IE without pre-existing chronic liver disease referred to our center between 2007 and 2013 for valve surgery. Sequential organ failure assessment (SOFA) score was used to evaluate organ dysfunction. Chi-square, Cox regression, and multivariate analyses were used for evaluation. RESULTS: Preoperative LD (Bilirubin >20 µmol/L) was present in 68 of 285 patients. New, postoperative LD occurred in 54 patients. Hypoxic hepatitis presented the most common origin of LD, accompanied with high short-term mortality. In-hospital mortality was higher in patients with preoperative and postoperative LD compared to patients without LD (51.5, 24.1, and 10.4%, respectively, p < 0.001). 5-year survival was worse in patients with pre- or postoperative LD compared to patients without LD (20.1, 37.1, and 57.0% respectively). A landmark analysis revealed similar 5-year survival between groups after patient discharge. Quality of life was similar between groups when patients survived the perioperative period. Logistic regression analysis identified duration of cardiopulmonary bypass and S. aureus infection as independent predictors of postoperative LD. CONCLUSIONS: Perioperative liver dysfunction in patients with infective endocarditis is an independent predictor of short- and long-term mortalities. After surviving the hospital stay, 5-year prognosis is not different and quality of life is not affected by LD. S. aureus and duration of cardiopulmonary bypass represent risk factors for postoperative LD.

Increase in the incidence of severe hypoglycaemia in people with Type 2 diabetes in spite of new drugs: analysis based on health insurance data from Germany.

AIM: To evaluate the use of new anti-hyperglycaemic agents that offer effective glycaemic control while reducing risk of hypoglycaemia, by analysing the incidence rates of severe hypoglycaemia in 2006 vs 2011 in relation to the medication. METHODS: This cross-sectional, population-based study used German health insurance data. All adults diagnosed with Type 2 diabetes mellitus (extrapolated to the German population: 6.35 million in 2006 and 7.52 million in 2011) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by their Anatomical Therapeutic Chemical code, and defined daily doses of each medication were calculated. RESULTS: The severe hypoglycaemic event rate was 460 per 100,000 people/year in 2006 and 490 per 100,000 people/year in 2011. In 2006 and 2011, 10.9% and 7.3%, respectively, of all people with severe hypoglycaemia were on sulfonylureas, while 12.7% and 9.3%, respectively, were on a combination therapy of metformin and sulfonylureas. Among those with severe hypoglycaemia, there were no prescriptions of dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 receptor agonists in 2006, but in 2011, 1.55% and 0.17%, of those with severe hypoglycaemia were receiving the respective treatments. In 2006 vs 2011, human insulin was prescribed for 11.3% vs 10.3% of people with severe hypoglycaemia, while insulin analogues were prescribed for 5.4% vs 8.1%, and mixed human insulins for 19.7% vs 14.0% of patients with severe hypoglycaemia. People receiving insulin analogue therapy had a higher risk of severe hypoglycaemia than those receiving metformin, after adjusting for age, gender, nephropathy diagnosis and year of survey (odds ratio 14.6; CI 13.3-15.9). CONCLUSION: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, despite increased use of newer anti-hyperglycaemic agents and decreased use of insulins.

Cell-specific cytotoxic effect of pyrazole derivatives on breast cancer cell lines MCF7 and MDA-MB-231.

Pyrazoles and their derivatives belong to a class of compounds that demonstrate a great potential in design of anticancer, antiangiogenic, and antimetastatic drugs. Our earlier studies showed that pyrazole derivatives TOSPYRQUIN and TOSIND diminished viability of colorectal adenocarcinoma cells HT-29. Here we demonstrated for the first time in human mammary gland adenocarcinoma cell lines MCF7 and MDA-MB-231 cells the cytotoxic effects of four pyrazole derivatives: TOSIND, PYRIND, METPYRIND, and DIPYR. Three pyrazoles: PYRIND, METPYRIND, and one novel unpublished derivative DIPYR were tested for the first time in living cells. Viability of MCF7 did not significantly change in the presence of TOSIND but it decreased after 72 hours of treatment with PYRIND (IC-50 39.7 ± 5.8 µM). In the presence of METPYRIND the viability was also diminished, while DIPYR increased MCF7 viability after 24 hours of incubation. The viability of MDA-MB-231 cells was strongly decreased by TOSIND (IC-50 17.7 ± 2.7 µM 72 h), and was not influenced by PYRIND and METPYRIND, while DIPYR increased the viability and stimulated the growth of MDA-MB-231 cells. PYRIND, METPYRIND and DIPYR caused a gradual decrease of caspase-3 and caspase-7 activities in MDA-MB-231 cells and there was no influence of TOSIND on the activity of both caspases. Our results open the way to search for other compounds with pendant pyrazole residues in order to increase their cytotoxic activity; especially with regard to its anti-breast cancer activity. It appears that the pyrazoles synthesized by us diminish cell viability in a cell-specific manner. This observation might be useful in designing 'off-DNA' anticancer drugs, compounds which are not harmful to the healthy cells.

Changes in Quality of Diabetes Care and Morbidity over 20 Years in People with Type 1 Diabetes and Long Diabetes Duration: The JEVIN Trial.

Background: The JEVIN trial started as a cross-sectional study in 1989/90 in Jena, a city of the former German Democratic Republic. At that time, the centralized diabetes care system was broken down and restarted 10 years later; structured treatment and teaching programs were implemented, blood glucose self-monitoring, insulin pump-systems and analogue insulin were introduced. We surveyed people with type-1-diabetes of the baseline JEVIN trial in a 20-year follow-up. Methods: 131 patients with type-1-diabetes were analyzed in 1989/90. Of the living population in 2009/10 (n=104), 83 persons were identified and 75 persons with a mean diabetes duration of 35 years were reexamined regarding HbA1c, self-monitoring, diabetes therapy, severe hypoglycemia, diabetic late complications and compared with the results of the same persons in 1989/90. Results: HbA1c decreased from 57.1 mmol/mol in 1989/90 to 52.7 mmol/mol in 2009/10 (7.4 -7.0%; p=0.049). Self-monitoring of blood glucose increased from 2 to 35 tests/week (p<0.001). 100%-use of animal insulin changed to human and analogue insulin therapy. The incidence of severe hypoglycemia increased from 0.1 to 0.16/patient-year. Retinopathy increased from 29 to 69% (p<0.001), nephropathy from 5 to 27% (p<0.001) and neuropathy from 13 to 43% (p<0.001). 17% had no diabetic late complications. Conclusions: The JEVIN trial shows a significant improve in HbA1c in the past 20 years. Severe hypoglycemia occurred rarely and 17% were still free of any diabetic late complication after 35 years of diabetes. This indicates a good quality of diabetes care in a German setting.

The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial.

BACKGROUND: The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency. METHODS/DESIGN: This is a multicenter randomized controlled trial to evaluate the Luminor® paclitaxel-coated DEB catheter for stenotic or occlusive lesions (length ≤15 cm) in the superficial femoral artery (SFA) and the popliteal artery (PA) up to the P1 segment compared to the noncoated, plain old balloon angioplasty (POBA) catheter. In total 172 subjects will be treated with either the DEB catheter or the POBA catheter in 11 German study centers in a 1:1 randomization study design. The primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with the Walking Impairment Questionnaire (WIQ) and the EQ-5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at the index limb, number of dropouts and all-cause mortality. DISCUSSION: EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of the Luminor® paclitaxel-coated DEB catheter for the reduction of restenosis compared to the POBA catheter for the SFA and the PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying paclitaxel-coated DEBs from different manufacturers with different coating technologies in the same target vessel. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02540018 , registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.

Knowledge and Implementation of the S3 Guideline on Gestational Diabetes among Gynecologists and Diabetologists Four Years after Publication: Results of a Survey of 773 Gynecologists and 76 Diabetologists on their Knowledge of the Guideline on Gestational Diabetes (AWMF 057-008, 2011).

BACKGROUND: An S3 guideline on the diagnosis and differentiated management of gestational diabetes (GDM) was published in Germany in 2011. This guideline replaced the previously applicable recommendations for the diagnosis and treatment of GDM and, for the first time, compiled evidence-based recommendations for the care of patients with GDM. The new guideline has focused particularly on the counselling offered to all patients with GDM about the associated long-term health risks. In this study we investigated the state of knowledge about the guideline among gynecologists and diabetologists in Thuringia and Lower Saxony. METHOD: A questionnaire with 23 questions was sent out to 773 gynecologists and 76 diabetologists providing outpatient care in Lower Saxony and Thuringia. The statistical analysis was descriptive and inferential for comparisons between groups. RESULTS: The response rate was 54 %; an average of 47.6 % of the individual questions were answered correctly in the completed questionnaires. The questions were answered correctly significantly more frequently by persons in the group with a good knowledge of the guidelines (75 vs. 61 %, p < 0.001). There were no significant differences between groups when differences between federal states or medical specialties were compared. CONCLUSIONS: The results of our study show a good general state of knowledge of the guideline and point to a high level of willingness to implement the recommendations of the S3 guideline on GDM. With regard to the follow-up care provided to patients with GDM and depression, this study found a significant need for further training.

Gynaecological Prolapse Surgery in Very Old Female Patients: A Case-Control Study on Co-Morbidity and Surgical Complications.

BACKGROUND: The aim of this study is to compare very elderly female patients with a younger control group after prolapse surgery with regard to co-morbidity and complications. METHOD: In a case-control design, the consecutive data of patients after prolapse surgery at the age of over 80 years and those of a control group were analysed by means of the Clavien-Dindo (CD) classification of surgical complications, the Charlson Comorbidity Index and the Cumulative Illness Rating Scale Geriatrics (CIRS-G). Statistics: Student's t, Fisher's exact and Mann-Whitney U tests. RESULTS: The analysis comprised n = 57 vs. n = 60 operations. In the very elderly patients there was often a grade IV prolapse (p < 0.001), apical fixations were more frequent (p < 0.001), but the operating times were not different. In the very elderly patients 21 % CD II+III complications were observed, in the control group 6.6 % (p = 0.031). No CD IV and V complications occurred in either group, the duration of inpatient stay amounted to 5 (± 1) vs. 4.1 (± 0.8; p < 0.001) days, the very elderly patients needed an inpatient follow-up more frequently (p < 0.001). The co-morbidities of the very elderly patients differed from those of the control group in number (median 2.0 vs. 1.5; p < 0.001), in CIRS-G (4.1 ± 2.2 vs. 2.4 ± 1.7; p < 0.01) and in Charlson Index (1.6 ± 1.6 vs. 0.5 ± 0.7; p < 0.001). CONCLUSIONS: A prolapse in very elderly women can be safely managed by surgery. In no case did the complications require intensive care treatment nor were they life-threatening, but they did lead to a longer duration of hospital stay and more frequently to further treatment geriatric or inpatient internal medicine facilities.

Principles of self-adjustment of insulin dose in people with diabetes type 2 and flexible insulin therapy.

AIMS: Structured treatment and education programmes for people with type 2 diabetes mellitus (T2DM) and flexible insulin therapy provide rules for self-adjustment of insulin dose, that are extensively trained. The aim of this cohort study was to register current principles and the frequency of self-adjustment of insulin dose and their association with metabolic control in people with T2DM. METHODS: Details of insulin dose adjustment were assessed by a structured interview in 149 people with T2DM on flexible insulin therapy (mean HbA1c 7.1%/53.8mmol/mol, age 65y, diabetes duration 19.0y, BMI 33.8kg/m(2)) in a tertiary care centre. The frequency of insulin dose adjustments was obtained from the last 28days of the patients' diaries. RESULTS: Insulin dose adjustment by adjustment rules was used by 33 people (22.1%) and by personal experience/feeling in 111 participants (74.5%). People adjusting by rules were younger (60.9±9.8 vs. 65.7±9.2, p=0.011) and did more insulin dose adjustments per 28days (50.0±31.0 vs. 33.4±23.5, p=0.016). HbA1c and incidence of hypoglycaemia were comparable. There were no differences in satisfaction of treatment, quality of life as well as current well-being between the groups. CONCLUSIONS: Only a fifth of the participants used the rule trained within the education programme to adjust their insulin dose. The majority adjusted their insulin dose by personal experience/feeling. However, people in both groups were able to adjust their insulin dose. Although people using adjustment rules adjust their insulin dose more frequently, HbA1c and the incidence of hypoglycaemia was similar compared to those using personal experience/feeling.

Diabetes-Related Burden and Distress is Low in People with Diabetes at Outpatient Tertiary Care Level.

OBJECTIVE: The importance of diabetes-related distress (DRD) for the treatment of diabetes is emphasized in national and international guidelines recommending routinely screening for psychosocial problems. To detect DRD, the PAID (Problem Area In Diabetes) questionnaire provides a valid and reliable instrument. RESEARCH DESIGN AND METHODS: 783 patients with diabetes mellitus type 1 (DM1, n=191, age 54.5 y, diabetes duration 22.5 y, HbA1c 7.2% (55 mmol/mol)) and type 2 (DM2, n=592, age 66.6 y, diabetes duration 15.6 y, HbA1c 7.0% (60.1 mmol/mol)) were interviewed with the PAID and WHO-5 questionnaire in a University outpatient department for endocrinology and metabolic diseases in 2012. A PAID score≥40 (range 0-100) was considered as high DRD. RESULTS: The mean PAID score was 17.1±15.1 in all participants. Only 8.9% of all responders showed high DRD (score≥40). The PAID score neither differed in people with DM1 and DM2, nor between participants with DM2 with or without insulin therapy. Females achieved significantly higher scores than men (19.0±16.6 vs. 15.6±13.7, p=0.003). A strong negative correlation existed between the PAID score and the WHO-5 Well-being Index (r=- 0.482, p<0.001). A 10 points higher WHO-5 Well-being Index was associated with 15.9 points lower PAID score in people with DM1 (p<0.001), and 9.2 points lower PAID score in DM2 (p<0.001), respectively. One percent higher HbA1c was associated with an increase of diabetes-related distress by 2.5 points in people with DM1 and by 2.0 points in people with DM2. CONCLUSIONS: Less than 10% of our outpatients with diabetes showed high diabetes-related distress.