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"text": "\n138448\nIs there a psychological and physiological difference between DIEP- and free TRAM-flap? A retrospective patient survey].\n\nWurzer, P\n\nSpendel, S\n\nKamolz, LP\n\nParvizi, D\n\nTuca, A\n\nRappl, T\n\nBeiträge in Fachzeitschriften\nISI:000341505900008\n25162244.0\n10.1055/s-0034-1384578\nNone\nThe DIEP- (Deep Inferior Epigastric Perforator) flap and the free TRAM- (Transverser Rectus Abdominis Musculocutaneous) flap are common procedures for breast reconstruction. The aim of the study was to identify a difference in the psychological and physiological patient satisfaction between DIEP- and free TRAM-flap.\n To provide a homogenous group, with a stable result of the reconstruction, the collective for questioning was picked out of the years 2009 and 2010. All patients included underwent a breast reconstruction with a DIEP-flap or free TRAM-flap at our division. For evaluation we formed 2 groups: DIEP-flap group (DLG) and TRAM-flap group (TLG). After preparing the questionnaire a telephone survey was performed. For the null hypothesis we postulated that there is no difference between DLG and TLG in the patient satisfaction.\n We contacted 44 patients, 30 of them took part in our survey (15 from the DLG and 15 from the TLG). The mean BMI in the questionnaire group was 26.9 kg/m² and the mean age was 48.3 years. 2 questions (lifting heavy loads (p=0.005) and performing sit-up's (p=0.001)) show a significant difference between DLG and TLG, a benefit of the DLG could be seen. Both questions had the physiology of the rectus abdominis muscle as background. The complication rate for partial flap loss or partial necrosis was one third lower (p=0.299) in the TLG than compared to the DLG.\n Up to now, physicians think that the DIEP-flap seems to be the best possible procedure for breast reconstruction with belly flaps. However, numerous studies disprove the superiority in the donor site morbidity. In the literature, an advantage of the TRAM-flap is clearly visible by comparing the complication rates. Our oral interviewing also states that there is no -difference in the psychological and physiological satisfaction of the patients. We can recommend a precise patient selection if a DIEP-flap for breast reconstruction should be performed. In case of comorbidities the possibility of the safer free TRAM-flap should be considered. In the future, a comparative analysis between the DIEP-flap, free TRAM-flap and pedicled TRAM-flap should be performed, by keeping the patients satisfaction, the complication rate and the cost effectiveness in mind.\n © Georg Thieme Verlag KG Stuttgart · New York.\n\nKamolz, Lars-Peter\n\nRappl, Thomas\n\nSpendel, Stephan\n\nTuca, Alexandru\n\nWurzer, Paul\n\n\n"
},
{
"text": "\n143696\nAre paediatric operations evidence based? A prospective analysis of general surgery practice in a teaching paediatric hospital.\n\nZani-Ruttenstock, E\n\nZani, A\n\nBullman, E\n\nLapidus-Krol, E\n\nPierro, A\n\nBeiträge in Fachzeitschriften\nISI:000347291400007\n25367096.0\n10.1007/s00383-014-3624-5\nNone\nPaediatric surgical practice should be based upon solid scientific evidence. A study in 1998 (Baraldini et al., Pediatr Surg Int) indicated that only a quarter of paediatric operations were supported by the then gold standard of evidence based medicine (EBM) which was defined by randomized controlled trials (RCTs). The aim of the current study was to re-evaluate paediatric surgical practice 16 years after the previous study in a larger cohort of patients.\n A prospective observational study was performed in a tertiary level teaching hospital for children. The study was approved by the local research ethics board. All diagnostic and therapeutic procedures requiring a general anaesthetic carried out over a 4-week period (24 Feb 2014-22 Mar 2014) under the general surgery service or involving a general paediatric surgeon were included in the study. Pubmed and EMBASE were used to search in the literature for the highest level of evidence supporting the recorded procedures. Evidence was classified according to the Oxford Centre for Evidence Based Medicine (OCEBM) 2009 system as well as according to the classification used by Baraldini et al. Results was compared using Χ (2) test. P < 0.05 was considered statistically significant.\n During the study period, 126 operations (36 different types) were performed on 118 patients. According to the OCEBM classification, 62 procedures (49 %) were supported by systematic reviews of multiple homogeneous RCTs (level 1a), 13 (10 %) by individual RCTs (level 1b), 5 (4 %) by systematic reviews of cohort studies (level 2a), 11 (9 %) by individual cohort studies, 1 (1 %) by systematic review of case-control studies (level 3a), 14 (11 %) by case-control studies (level 3b), 9 (7 %) by case series (type 4) and 11 procedures (9 %) were based on expert opinion or deemed self-evident interventions (type 5). High level of evidence (OCEBM level 1a or 1b or level I according to Baraldini et al. PSI 1998) supported 75 (60 %) operations in the current study compared to 18 (26 %) in the study of 1998 (P < 0.0001).\n The present study shows that nowadays a remarkable number of paediatric surgical procedures are supported by high level of evidence. Despite this improvement in evidence-based paediatric surgical practice, more than a third of the procedures still lack sufficient evidence-based literature support. More RCTs are warranted to support and direct paediatric surgery practice according to the principals of EBM.\n\n\n"
},
{
"text": "\n156037\nExtended pancreas donor program - the EXPAND study rationale and study protocol.\n\nProneth, A\n\nSchnitzbauer, AA\n\nZeman, F\n\nFoerster, JR\n\nHolub, I\n\nArbogast, H\n\nBechstein, WO\n\nBecker, T\n\nDietz, C\n\nGuba, M\n\nHeise, M\n\nJonas, S\n\nKersting, S\n\nKlempnauer, J\n\nManekeller, S\n\nMüller, V\n\nNadalin, S\n\nNashan, B\n\nPascher, A\n\nRauchfuss, F\n\nStröhlein, MA\n\nSchemmer, P\n\nSchenker, P\n\nThorban, S\n\nVogel, T\n\nRahmel, AO\n\nViebahn, R\n\nBanas, B\n\nGeissler, EK\n\nSchlitt, HJ\n\nFarkas, SA\n\nBeiträge in Fachzeitschriften\nNone\n23816330.0\n10.1186/2047-1440-2-12\nPMC3716891\nSimultaneous pancreas kidney transplantation (SPK), pancreas transplantation alone (PTA) or pancreas transplantation after kidney (PAK) are the only curative treatment options for patients with type 1 (juvenile) diabetes mellitus with or without impaired renal function. Unfortunately, transplant waiting lists for this indication are increasing because the current organ acceptability criteria are restrictive; morbidity and mortality significantly increase with time on the waitlist. Currently, only pancreas organs from donors younger than 50 years of age and with a body mass index (BMI) less than 30 are allocated for transplantation in the Eurotransplant (ET) area. To address this issue we designed a study to increase the available donor pool for these patients.\n This study is a prospective, multicenter (20 German centers), single blinded, non-randomized, two armed trial comparing outcome after SPK, PTA or PAK between organs with the currently allowed donor criteria versus selected organs from donors with extended criteria. Extended donor criteria are defined as organs procured from donors with a BMI of 30 to 34 or a donor age between 50 and 60 years. Immunosuppression is generally standardized using induction therapy with Myfortic, tacrolimus and low dose steroids. In principle, all patients on the waitlist for primary SPK, PTA or PAK are eligible for the clinical trial when they consent to possibly receiving an extended donor criteria organ. Patients receiving an organ meeting the current standard criteria for pancreas allocation (control arm) are compared to those receiving extended criteria organ (study arm); patients are blinded for a follow-up period of one year. The combined primary endpoint is survival of the pancreas allograft and pancreas allograft function after three months, as an early relevant outcome parameter for pancreas transplantation.\n The EXPAND Study has been initiated to investigate the hypothesis that locally allocated extended criteria organs can be transplanted with similar results compared to the currently allowed standard ET organ allocation. If our study shows a favorable comparison to standard organ allocation criteria, the morbidity and mortality for patients waiting for transplantation could be reduced in the future.\n Trial registered at: NCT01384006.\n\nSchemmer, Peter\n\n\n"
},
{
"text": "\n163852\nPapillary Thyroid Cancer and Coexisting Autoimmune Thyroiditis.\n\nVeit, F\n\nGraf, D\n\nMomberger, S\n\nHelmich-Kapp, B\n\nRuschenburg, I\n\nPeters, A\n\nKussmann, J\n\nSaeger, W\n\nSchmidt, KW\n\nToetsch, M\n\nNestler, K\n\nMann, K\n\nBeiträge in Fachzeitschriften\nISI:000415273000009\n29136676.0\n10.1055/s-0043-120922\nNone\nHistological findings often display an association between papillary thyroid carcinomas (PTC) and autoimmune thyroiditis (AIT) and so differ significantly from follicular thyroid carcinomas (FTC). The aim of this interdisciplinary, retrospective study was to evaluate the association of AIT in patients with PTC and FTC and a control group of benign nodular goiters. One hundred thyroidectomies with histologically confirmed differentiated thyroid carcinomas, 67 with PTC and 33 with FTC, were submitted for examination. The two control groups consisted of 60 patients with euthyroid nodular goiter, displaying no signs for malignancy (no surgery) and 100 patients (second control group) with surgery of a benign nodular goiter. Controls were collected to obtain data about the incidence of significantly increased TPOAbs in the first group and of lymphocytic infiltrates (LI) in the second group. High TPOAbs were found in 35% (23/67) of patients with PTC. LI were detected by histology in 48% (32/67) of PTC. Ten patients (10/32) of this group showed the clinical and histological manifestation of a classic AIT with diffuse dense LI as well as diffuse hypoechogeneity in ultrasonography. In 7/32 cases, the histological report described focal dense LI (fAIT) and in 15/32 cases scant scattered LI. AIT and fAIT, together 25% of all PTC (17/67), showed germinal centers and can therefore be characterized as chronic autoimmune thyroiditis. In this group, high TPOAb could be detected in 94% (16/17). Scan scattered LI without germinal centers (15/32) do not represent a fAIT, although TPOAb are high in 47% (7/15). The younger age group (<45 years) showed significantly more often high TPOAbs (p<0.023) in comparison with the age-group older than 60 years. In contrast to PTC, only 4/33 (12%) patients with FTC had high TPOAb levels. We conclude that in contrast to benign euthyroid goiters and to FTC, different degrees of LI are often associated with high TPOAb levels and seem to be significantly increased in PTC, particularly prominent in younger age. There is a high coincidence between LI and high TPOAb levels. In the presence of hypoechoic thyroid nodule, signs of thyroid autoimmunity such as the presence of high TPOAbs, lymphocytic infiltration in cytology, and/or characteristic ultrasonic features, are arguments that might favor the decision for surgery if a cytologically indeterminate thyroid nodule is found and focal autonomy is excluded by szintiscan.\n © Georg Thieme Verlag KG Stuttgart · New York.\n\n\n"
},
{
"text": "\n2243\nRelationship between classic risk factors, plasma antioxidants and indicators of oxidant stress in angina pectoris (AP) in Tehran.\n\nMeraji, S\n\nAbuja, PM\n\nHayn, M\n\nKostner, GM\n\nMorris, R\n\nOraii, S\n\nTatzber, F\n\nWonisch, W\n\nZechner, R\n\nGey, KF\n\nBeiträge in Fachzeitschriften\nISI:000087629100019\n10856533.0\n10.1016/S0021-9150(99)00394-9\nNone\nCardiovascular disease (CVD) in general seems to be the leading cause of death in the Eastern Mediterranean Region (EMR) including Iran. This may be due to classic risk factors such as high triglyceride (TG), high total cholesterol (TC), and low levels of high density lipoprotein cholesterol (HDL-C). The impact of antioxidants as potentially protective risk factors against early coronary heart disease (CHD) is unknown in Iran. Therefore, relationships between angina and plasma antioxidants and indicators of lipid peroxidation were investigated in a case-control study. In this study, 82 cases of previously undiagnosed angina pectoris (AP), identified by a modified WHO Rose chest pain questionnaire and verified by electrocardiography during treadmill exercise testing, were compared with 146 controls selected from the same population of over 4000 male civil servants aged 40-60 years. Subjects with AP declared significantly less physical activity and had higher serum TG [means (S.E.M.) 2.32 (0.18) versus 1.61 (0.07) mmol/l] but lower HDL-C [1.01 (0.04) versus 1.18 (0.03) mmol/l] than age-matched controls. Levels of total serum cholesterol, low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) [Lp(a)] were not significantly different between the two groups, while the ratio of LDL-C/HDL-C was significantly higher [4.51 (0.23) versus 3.54 (0. 11)] for subjects with AP than for the controls. There was no significant difference in plasma levels of alpha-tocopherol, vitamin C, alpha- and beta-carotene. However, retinol [1.90 (0.06) versus 2. 09 (0.05)] and beta-cryptoxanthin [0.398 (0.04) versus 0.467 (0.03)] were significantly lower in AP. Furthermore, angina cases exhibited a higher index of lipid peroxidation than controls (e.g. malondialdehyde, MDA; 0.376 (0.010) versus 0.337 (0.009) micromol/l). On multiple logistic regression analysis, retinol with odds ratio (OR) of 0.644 [95% confidence interval (CI; 0.425-0.978)], beta-cryptoxanthin, with an OR of 0.675 (CI; 0.487-0.940), oxidation indices, MDA with OR of 1.612 (95% CI; 1.119-2.322) and LDL-C/HDL-C ratio with OR of 2.006 (95% CI; 1.416-2.849) showed the most significant independent associations with AP in this group of Iranians. In conclusion, the state of lipid peroxidation as well as the status of special antioxidants may be co-determinants of AP in Iran, in parallel with the influence of classical risk factors for cardiovascular disease.\n\nAbuja, Peter Michael\n\nKostner, Gerhard\n\nTatzber, Franz\n\nWonisch, Willibald\n\n\n"
},
{
"text": "\n182362\nPost-Laser Twin Anemia Polycythemia Sequence: Diagnosis, Management, and Outcome in an International Cohort of 164 Cases.\n\nTollenaar, LSA\n\nLopriore, E\n\nFaiola, S\n\nLanna, M\n\nStirnemann, J\n\nVille, Y\n\nLewi, L\n\nDevlieger, R\n\nWeingertner, AS\n\nFavre, R\n\nHobson, SR\n\nRyan, G\n\nRodo, C\n\nArévalo, S\n\nKlaritsch, P\n\nGreimel, P\n\nHecher, K\n\nde Sousa, MT\n\nKhalil, A\n\nThilaganathan, B\n\nBergh, EP\n\nPapanna, R\n\nGardener, GJ\n\nCarlin, A\n\nBevilacqua, E\n\nSakalo, VA\n\nKostyukov, KV\n\nBahtiyar, MO\n\nWilpers, A\n\nKilby, MD\n\nTiblad, E\n\nOepkes, D\n\nMiddeldorp, JM\n\nHaak, MC\n\nKlumper, FJCM\n\nAkkermans, J\n\nSlaghekke, F\n\nBeiträge in Fachzeitschriften\nISI:000549303800001\n32517071.0\n10.3390/jcm9061759\nPMC7355738\nThe aim of this study was to investigate the management and outcome in the post-laser twin anemia polycythemia sequence (TAPS). Data of the international TAPS Registry, collected between 2014 and 2019, were used for this study. The primary outcomes were perinatal mortality and severe neonatal morbidity. Secondary outcomes included a risk factor analysis for perinatal mortality and severe neonatal morbidity. A total of 164 post-laser TAPS pregnancies were included, of which 92% (151/164) were diagnosed antenatally and 8% (13/164) postnatally. The median number of days between laser for TTTS and detection of TAPS was 14 (IQR: 7-28, range: 1-119). Antenatal management included expectant management in 43% (62/151), intrauterine transfusion with or without partial exchange transfusion in 29% (44/151), repeated laser surgery in 15% (24/151), selective feticide in 7% (11/151), delivery in 6% (9/151), and termination of pregnancy in 1% (1/151). The median gestational age (GA) at birth was 31.7 weeks (IQR: 28.6-33.7; range: 19.0-41.3). The perinatal mortality rate was 25% (83/327) for the total group, 37% (61/164) for donors, and 14% (22/163) for recipients (p < 0.001). Severe neonatal morbidity was detected in 40% (105/263) of the cohort and was similar for donors (43%; 51/118) and recipients (37%; 54/145), p = 0.568. Independent risk factors for spontaneous perinatal mortality were antenatal TAPS Stage 4 (OR = 3.4, 95%CI 1.4-26.0, p = 0.015), TAPS donor status (OR = 4.2, 95%CI 2.1-8.3, p < 0.001), and GA at birth (OR = 0.8, 95%CI 0.7-0.9, p = 0.001). Severe neonatal morbidity was significantly associated with GA at birth (OR = 1.5, 95%CI 1.3-1.7, p < 0.001). In conclusion, post-laser TAPS most often occurs within one month after laser for TTTS, but may develop up to 17 weeks after initial surgery. Management is mostly expectant, but varies greatly, highlighting the lack of consensus on the optimal treatment and heterogeneity of the condition. Perinatal outcome is poor, particularly due to the high rate of perinatal mortality in donor twins.\n\nGreimel, Patrick\n\nKlaritsch, Philipp\n\n\n"
},
{
"text": "\n185238\nPrimary cutaneous peripheral T-cell lymphoma, not otherwise specified: results of a multicentre European Organization for Research and Treatment of Cancer (EORTC) cutaneous lymphoma taskforce study on the clinico-pathological and prognostic features.\n\nKempf, W\n\nMitteldorf, C\n\nBattistella, M\n\nWillemze, R\n\nCerroni, L\n\nSantucci, M\n\nGeissinger, E\n\nJansen, P\n\nVermeer, MH\n\nMarschalko, M\n\nPapadavid, E\n\nPiris, MA\n\nOrtiz-Romero, PL\n\nNovelli, M\n\nPaulli, M\n\nQuaglino, P\n\nRanki, A\n\nRodríguez Peralto, JL\n\nWobser, M\n\nAuschra, B\n\nRobson, A\n\nBeiträge in Fachzeitschriften\nISI:000600663900001\n32997839.0\n10.1111/jdv.16969\nNone\nCutaneous peripheral T-cell lymphoma, not otherwise specified (PTL NOS) is an aggressive, but poorly characterized neoplasm.\n The European Organization for Research and Treatment of Cancer cutaneous lymphoma taskforce (EORTC CLTF) investigated 33 biopsies of 30 patients with primary cutaneous PTL NOS to analyse their clinical, histological, immunophenotypic features and outcome.\n Retrospective analysis of clinical data and histopathological features by an expert panel.\n Cutaneous PTL NOS manifested clinically either with solitary or disseminated rapidly grown ulcerated tumours or disseminated papulo-nodular lesions. Histologically, a mostly diffuse or nodular infiltrate in the dermis and often extending into the subcutis was found. Epidermotropism was rarely present and only mild and focal. Unusual phenotypes were frequent, e.g. CD3+ /CD4- /CD8- and CD3+ /CD4+ /CD8+ . Moreover, 18% of the cases exhibited an aberrant expression of the B-cell marker CD20 by the tumour cells. All solitary tumours were located on the limbs and presented a high expression of GATA-3 but this did not correlate with outcome and therefore could not serve as a prognostic factor. The prognosis was shown to be generally poor with 10 of 30 patients (33%) dying of lymphoma within the follow-up of 36 months (mean value; range 3-144). The survival rates were 61% after 3 years (CI, 43-85%) and 54% after 5 years (CI, 36-81%). Small to medium-sized morphology of tumour cells was associated with a better outcome than medium to large or large tumour cells. Age, gender, clinical stage, CD4/CD8 phenotype and GATA-3 expression were not associated with prognosis. Chemotherapy was the most common treatment modality, but surgical excision and/or radiotherapy may represent an appropriate first-line treatment for solitary lesions.\n Cutaneous PTL NOS shows an aggressive course in most patients independent of initial presentation, age and phenotype. Cytomorphology was identified as a prognostic factor. The data indicate a need for more effective treatment modalities in PTL NOS.\n © 2020 European Academy of Dermatology and Venereology.\n\nCerroni, Lorenzo\n\n\n"
},
{
"text": "\n2018\nPostoperative radiotherapy in radically resected non-small cell lung cancer.\n\nMayer, R\n\nSmolle-Juettner, FM\n\nSzolar, D\n\nStuecklschweiger, GF\n\nQuehenberger, F\n\nFriehs, G\n\nHackl, A\n\nBeiträge in Fachzeitschriften\nISI:A1997YA35100017\n9377958.0\n10.1378/chest.112.4.954\nNone\nPURPOSE: To evaluate the value of adjuvant postoperative external-beam radiation (EBR) in patients with radically resected non-small cell lung cancer (NSCLC) pT1-3 pN0-2 compared to patients with resected NSCLC without adjuvant EBR. MATERIALS AND METHODS: In 155 patients (121 male, 34 female; mean age, 59 years) 105 lobectomies, 12 bilobectomies, and 38 pneumonectomies with radical lymph node dissection of the contralateral [corrected] side were performed. Postoperative staging was done according to the TNM system and was as follows: pT1 (n=38), pT2 (n=89), pT3 (n=28); pN0 (n=39), pN1 (n=67) and pN2 (n=49). Histopathologic study revealed 68 squamous cell carcinomas, 53 adenocarcinomas, 21 large cell carcinomas, 6 adenosquamous cell carcinomas, and 7 bronchioloalveolar cell carcinomas. All patients were randomly assigned into two treatment groups: 72 patients with no further treatment (control group), and 83 patients (EBR group) with adjuvant postoperative EBR of the bronchial stump and mediastinum (50 to 56 Gy, 8 or 23 MV photons, 2 Gy/d, 5 d/wk) beginning 4 to 6 weeks after surgery. RESULTS: The overall 5-year survival rate (median observation time, 43 months) of all patients was 24.1% (EBR group, 29.7%; control group, 20.4%; p>0.05, not significant). The relative risk of the EBR group was 0.85 with a two-sided confidence interval of 0.66 to 1.09. The overall 5-year recurrence-free survival was 20.6% (EBR, 27.1%; control group, 15.6%; p=0.07). The relative risk of the EBR group was 0.80 with a confidence interval of 0.63 to 1.01. The rate of local recurrences at the bronchial stump and/or mediastinum was significantly smaller in the EBR group (n=5) than in the control group (n=17) (p<0.01). Multivariate analysis (chi2 test) demonstrated an independent influence of postoperative EBR on the incidence of local recurrences. The incidence of distant metastases was slightly but not significantly higher in patients without EBR (38 patients) compared to those who had EBR (32 patients). CONCLUSION: High-dose postoperative EBR to the mediastinum significantly reduces the risk of local recurrence at the bronchial stump and/or mediastinum. Age, sex, histologic subtype, tumor size, surgical approach, or extent of lymph node involvement had no prognostic value--only postoperative EBR had an independent influence on the risk of local recurrence. The effect of postoperative EBR was on the verge of significance with respect to recurrence-free survival and showed the same tendency in overall survival, however with an attenuated relative risk.\n\nQuehenberger, Franz\n\nSmolle-Juettner, Freyja-Maria\n\n\n"
},
{
"text": "\n5209\nRituximab for treatment of advanced extranodal marginal zone B cell lymphoma of the mucosa-associated lymphoid tissue lymphoma.\n\nRaderer, M\n\nJäger, G\n\nBrugger, S\n\nPüspök, A\n\nFiebiger, W\n\nDrach, J\n\nWotherspoon, A\n\nChott, A\n\nBeiträge in Fachzeitschriften\nISI:000187794200003\n14707449.0\n10.1159/000074641\nNone\nBACKGROUND: Extranodal marginal zone B cell lymphoma of the mucosa-associated lymphoid tissue (MALT) is a relatively common type of lymphoma. Owing to its B cell lineage, it appears to be a potential target for treatment with the CD20 antibody rituximab. We present an analysis of our experience with rituximab for treatment of patients with advanced MALT lymphoma. PATIENTS AND METHODS: A retrospective analysis of patients with histologically verified MALT lymphoma undergoing treatment with rituximab was done. After reassessment of histological samples for the presence of MALT lymphoma, patients were evaluated as regards date of diagnosis, prior therapy for MALT lymphoma, sites of involvement upon treatment with rituximab, clinical response in terms of complete remission (CR), partial response (PR), stable disease (SD) and progressive disease as well as symptomatic response, duration of response and survival. RESULTS: A total of 9 patients with advanced MALT lymphoma undergoing therapy with single-agent rituximab were identified. All patients received treatment at a dose of 375 mg/m(2) once weekly x4. One patient each had relapsed after chemotherapy and radiation, respectively, while none of the other 7 patients had received prior cytotoxic treatment or radiation. Three patients achieved a CR, 2 patients had PR for 6 and 14 months, while the remaining patients had SD between 8 and 18+ months. One patient died of progressive disease in spite of the initiation of chemotherapy and 1 patient succumbed to a cardiovascular event while having been in ongoing PR for 11 months. The other 7 patients are currently alive with disease 10-27 months after initiation of therapy. Follow-up biopsies for histological assessment were available in 5 patients with gastric lymphoma. In 1 patient with SD, however, persistence of CD20-positive cells within lymphoepithelial lesions was noted in spite of almost complete depletion of B lymphocytes from the normal gastric mucosa, suggesting either recirculation of MALT lymphoma cells to these lesions or defining lymphoepithelial lesions as a sanctuary site from rituximab penetration. CONCLUSION: Rituximab had only moderate activity in terms of inducing objective responses in our unselected and heterogeneous cohort of patients with disseminated MALT lymphoma. Long-term disease stabilization, however, along with a symptomatic benefit was seen in all patients. Our data nevertheless indicate that rituximab might not optimally penetrate into the gastric mucosa in all patients.\n\n\n"
},
{
"text": "\n62514\nKetamine has stereospecific effects in the isolated perfused guinea pig heart.\n\nGraf, BM\n\nVicenzi, MN\n\nMartin, E\n\nBosnjak, ZJ\n\nStowe, DF\n\nBeiträge in Fachzeitschriften\nISI:A1995RC51300015\n7793656.0\n10.1097/00000542-199506000-00014\nNone\nBACKGROUND: S(+)-Ketamine is judged to produce more potent anesthesia than either the racemate or the R(-) ketamine isomer because of differential activation of specific cerebral receptors. Other than central nervous system effects, the most important side effects of ketamine occur in the cardiovascular system. We examined the direct cardiac effects of the isomers and the racemate of ketamine in the isolated perfused guinea pig heart. METHODS: Twenty-three guinea pig hearts were perfused by the Langendorff technique with modified 37 degrees C Krebs-Ringer's solution (97% oxygen and 3% carbon dioxide) at a constant perfusion pressure. Eight animals were pretreated with reserpine to deplete hearts of catecholamines. These pretreated hearts were also perfused with Krebs-Ringer's solution containing propranolol, phenoxybenzamine, and atropine to block any remaining effects of catecholamines and of acetylcholine. Five additional hearts were perfused with naloxone to block cardiac opioid receptors. Ten hearts were not treated. All 23 hearts were then exposed to four increasing equimolar concentrations of each isomer and the racemate of ketamine for 10 min. Heart rate, atrioventricular conduction time (AVCT), left ventricular pressure, coronary flow, and inflow and outflow oxygen tensions were measured. Percentage oxygen extraction, oxygen delivery, and oxygen consumption were calculated. RESULTS: Both isomers and the racemate caused a concentration-dependent depression of systolic left ventricular pressure and an increase in AVCT. In the untreated hearts, S(+)-ketamine decreased heart rate and left ventricular pressure and, at higher concentrations, oxygen consumption and percentage oxygen extraction significantly less than R(-)-ketamine independent of blocked or unblocked opioid receptors. Racemic ketamine depressed cardiac function to a degree intermediate to that produced by the isomers. Coronary flow and AVCT were equally affected by the isomers and by the racemic mixture. In the catecholamine-depleted hearts both isomers and the racemate caused equipotent depression of all variables. In these hearts cardiac depression was greater, and AVCT, coronary flow, and oxygen delivery were significantly greater than in untreated and opioid receptor-blocked hearts. CONCLUSIONS: Lesser cardiac depression by the S(+) isomer is attributable to an increased availability of catecholamines, because previous depletion of catecholamine stores and autonomic blockade completely inhibited these differences. The inability of cardiac tissue to reuptake released catecholamines into neuronal or extraneuronal sites during exposure to ketamine is stereoselective and caused predominantly by the S(+) isomer. Cardiac opioid receptors are apparently not involved in this phenomenon.\n\nVicenzi, Martin\n\n\n"
},
{
"text": "\n65966\nPharmacoeconomic evaluation of pravastatin in the secondary prevention of coronary heart disease in patients with average cholesterol levels. An analysis for Germany based on the CARE study\n\nSzucs, TD\n\nGuggenberger, G\n\nBerger, K\n\nMärz, W\n\nSchäfer, JR\n\nBeiträge in Fachzeitschriften\nISI:000075583900007\n9757381.0\n10.1007/BF03044365\nNone\nThose people who are to decide about health care systems are increasingly forced to identify unnecessary costs and achieve savings in health care. Especially for diseases with high prevalence like illnesses of the heart and the circulatory system preventive measures are very important. This economic analysis tries to clarify whether the secondary-preventive application of the HMG-CoA reductase-inhibitor pravastatin is, apart from the clinical benefit, economically justified in patients suffering from coronary heart disease with average cholesterol levels. In the case of this study, the underlying type of economic evaluation was an incremental cost-effectiveness analysis. The outcome was defined as costs per life-year saved. This retrospective study is based on the results of the CARE (Cholesterol And Recurrent Events) study which has been published elsewhere [21]. When calculating costs we took into account the perspective of 3rd party payers (public health insurance) in Germany. The calculation of cost-effectiveness was carried out for the whole study population in CARE as well as for all patients aged 60 or more years in the CARE study. This was done because the different groups vary by the numbers of avoided myocardial infarctions, strokes and loss of life years. Netcosts for pravastatin therapy, i.e. drug costs for pravastatin minus costs for avoided events, were about 9.54 Mio DM (referring to 1, 00 patients treated for a period of 5 years). Net-costs for patients aged 60 or more years were 8.18 Mio DM. The effectiveness was defined as the number of life years saved and amounted to 216 years of life saved (YOLS) in the overall study group. For patients aged 60 or more years we found that 358 years were saved. The costs per life years saved (i.e. the net-costs of pravastatin therapy divided through the number of life years saved) turned out to be 44, 00 DM per person in the study group. For patients over 60 the costs were 23, 00 DM. Lipid-lowering with pravastatin in the secondary prevention of coronary heart disease in Germany is cost-effective. In those patients aged 60 or more yeas the use of pravastatin is even more cost-effective than in all patients included in the CARE study.\n\nMärz, Winfried\n\n\n"
},
{
"text": "\n74684\nF-18 positron emission tomography and computed tomography image-fusion for image-guided detection of local recurrence in patients with head and neck cancer using a 3-dimensional navigation system: a preliminary report.\n\nFeichtinger, M\n\nAigner, RM\n\nKärcher, H\n\nBeiträge in Fachzeitschriften\nISI:000251966300034\n18083440.0\n10.1016/j.joms.2006.10.057\nNone\n[18F]-2-fluorodeoxyglucose positron emission tomography (F-18 FDG-PET) has played an important role recently in the staging process for squamous cell carcinoma of the head and neck (SCCHN).(1) Various studies show a high sensitivity and specificity in detection of nodal metastases with this imaging modality.(2-5) Moreover, FDG-PET also has played a significant role in differentiating residual/recurrent disease from treatment-induced normal tissue changes.(6) Some authors show a sensitivity and specificity up to 100%, in contrast to the 75% sensitivity and 80% specificity of computed tomography (Cl)/magnetic resonance imaging (MRI).(7-9) A major disadvantage, however, is the fact that this method yields only limited information on the exact anatomic location of the lesion detected.(10) For this reason combined PET and CT systems (PET/CT) have emerged as promising imaging modalities.(11, 2) The almost synchronous image acquisition and exact co-registration of anatomic and metabolic data improves the anatomic localization of PET abnormalities and reduces the number of equivocal PET interpretations.(13, 4) Rodel et al(15) showed that PET/CT significantly improved sensitivity, specificity, and accuracy of both PET and CT alone and allowed accurate diagnosis of 93% of lesions in 90% of patients with head and neck oncology. After radical surgery or radiation therapy for head and neck malignancies, however, normal tissue planes are altered substantially. The surgical treatment entails excision and complex reconstructive surgery involving distant soft and bony tissue transfer, which distorts anatomy significantly and renders postoperative imaging challenging. Additional radiotherapy further distorts local structures.(16) Thus even with this combined imaging modality the evaluation of the postradiotherapy patient remains difficult. Reassessment of the suspect region therefore is often done with extensive biopsies under anesthesia. With postradiotherapy patients, however, the risk of significant morbidity is increased.(17-19) Improved methods of detecting local recurrence in patients with SCCHN are needed. The aim of this study is to show a new method of matching FDG-PET and CT data sets on a commercially available navigation system for image-guided biopsy targeting in cases of suspected local recurrence of squamous cell carcinoma of the oral cavity. This preliminary report describes our early experience with this combined technique.\n\nAigner, Reingard\n\nKärcher, Hans\n\n\n"
},
{
"text": "\n169202\nDiagnostic guidelines for the histological particle algorithm in the periprosthetic neo-synovial tissue.\n\nPerino, G\n\nSunitsch, S\n\nHuber, M\n\nRamirez, D\n\nGallo, J\n\nVaculova, J\n\nNatu, S\n\nKretzer, JP\n\nMüller, S\n\nThomas, P\n\nThomsen, M\n\nKrukemeyer, MG\n\nResch, H\n\nHügle, T\n\nWaldstein, W\n\nBöettner, F\n\nGehrke, T\n\nSesselmann, S\n\nRüther, W\n\nXia, Z\n\nPurdue, E\n\nKrenn, V\n\nBeiträge in Fachzeitschriften\nISI:000442796800001\n30158837.0\n10.1186/s12907-018-0074-3\nPMC6109269\nThe identification of implant wear particles and non-implant related particles and the characterization of the inflammatory responses in the periprosthetic neo-synovial membrane, bone, and the synovial-like interface membrane (SLIM) play an important role for the evaluation of clinical outcome, correlation with radiological and implant retrieval studies, and understanding of the biological pathways contributing to implant failures in joint arthroplasty. The purpose of this study is to present a comprehensive histological particle algorithm (HPA) as a practical guide to particle identification at routine light microscopy examination.\n The cases used for particle analysis were selected retrospectively from the archives of two institutions and were representative of the implant wear and non-implant related particle spectrum. All particle categories were described according to their size, shape, colour and properties observed at light microscopy, under polarized light, and after histochemical stains when necessary. A unified range of particle size, defined as a measure of length only, is proposed for the wear particles with five classes for polyethylene (PE) particles and four classes for conventional and corrosion metallic particles and ceramic particles.\n All implant wear and non-implant related particles were described and illustrated in detail by category. A particle scoring system for the periprosthetic tissue/SLIM is proposed as follows: 1) Wear particle identification at light microscopy with a two-step analysis at low (× 25, × 40, and × 100) and high magnification (× 200 and × 400); 2) Identification of the predominant wear particle type with size determination; 3) The presence of non-implant related endogenous and/or foreign particles. A guide for a comprehensive pathology report is also provided with sections for macroscopic and microscopic description, and diagnosis.\n The HPA should be considered a standard for the histological analysis of periprosthetic neo-synovial membrane, bone, and SLIM. It provides a basic, standardized tool for the identification of implant wear and non-implant related particles at routine light microscopy examination and aims at reducing intra-observer and inter-observer variability to provide a common platform for multicentric implant retrieval/radiological/histological studies and valuable data for the risk assessment of implant performance for regional and national implant registries and government agencies.\n\nSunitsch, Sandra\n\n\n"
},
{
"text": "\n170118\nThe Department of Ophthalmology, Medical University Graz, achieved the EFQM Recognised fur Excellence (R4E&*) Award\n\nLangmann, G\n\nGranitz, E\n\nKohlhofer, A\n\nKreilinger, A\n\nGliebe, W\n\nLangmann, A\n\nWedrich, A\n\nBeiträge in Fachzeitschriften\nISI:000446519400002\nNone\n10.1007/s00717-018-0407-8\nNone\nBackground Based on two Committed to Excellence (C2E) awards in 2008 and 2010, the Department of Ophthalmology, Medical University Graz was awarded with the R4E&* prize in February 2017. Methods For the R4E assessment, an in-depth brochure of the department had to be prepared referring to the criteria matrix with nine main criterions and 32 subcriterions of the EFQM model based on the RADAR logic (Results-Approach-Deployment-Assessment-Refinement). These criterions include, for example, the leadership and the strategy development, processes, employee orientation and key results (such as number of publications, number of cataract operations). After a SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) of the department, interdisciplinary teams were formed with members of the management, as well as quality officers and risk managers dealing with the 9 criterions and 32 subcriterions. Editorial teams summarized and incorporated the results of the analysis into the EFQM brochure criterion by criterion. Results In February 2017, the department was evaluated by three assessors of the Quality Austria and achieved 400-450 points, thus exceeding the score of 300 points which is needed for Recognised for Excellence (R4E). The strengths of the department were a high patient satisfaction (the department ranks at the top within the University Hospital Graz) as well as a people (criterion 7) focused leadership approach. Additional strengths identified were the introduction and further development of a challenging QM system, an excellent corporate atmosphere, which reflects a particular people focus as well as the fact that the organisation is agile and flexible to manage in an effective manner an external induced change. Potentials that need to be worked on for further development towards a higher score, include but are not limited to the development of a strategy focusing on the key performance indicators, an alignment of this strategy to the mission and vision of the Medical University Graz (MUG) and the "Krankenanstalten Gesellschaft" (KAGes) (healthcare company of Styria), which is a special challenge for a department with two employers. Conclusion The EFQM can also be successfully implemented in operational health units - even in competition with private companies. Decisive is the continuous development of the structure, process and results quality, whereby this continuous development through consistent use of closed RADAR circles in all relevant areas represents the strength of the EFQM model.\n\nLangmann, Andrea\n\nLangmann, Gerald\n\nWedrich, Andreas\n\n\n"
},
{
"text": "\n185382\nOperative treatment of intraarticular calcaneal fractures: Anatomical and functional outcome of three different operative techniques.\n\nGusic, N\n\nFedel, I\n\nDarabos, N\n\nLovric, Z\n\nBukvic, N\n\nBakota, B\n\nLemac, D\n\nBeiträge in Fachzeitschriften\nNone\n26606987.0\n10.1016/j.injury.2015.10.061\nNone\nManagement of the intraarticular calcaneal fracture is a challenge. The optimal method of treatment remains controversial. This study evaluates the anatomical and functional postoperative outcomes of displaced intraarticular calcaneal fractures that have been treated using three different techniques of ORIF.\n Between 2004 and 2011 we treated 143 patients with calcaneal fractures, 40 of these patients (28%) were treated conservatively. This is a retrospective study of the remaining 103 patients (72%) who were operated on consecutively, mainly by one surgeon (NG). Calcaneal fractures were classified according to the Sanders classification. Three types of osteosynthesis were used: standard anatomical plate (SP), locking anatomical plate (LCP) and standard anatomical plate with autologous bone graft (SP+ABG). Clinical outcome was assessed one year after the operation: anatomical reduction was evaluated according to the analysis of Bohler's angle at final follow-up, and functional assessment was conducted using the Maryland Foot Score (MFS).\n The fractures were classified as follows: 35 (34%) Sanders type II, 47 (45.6%) Sanders type III and 21 (20.4%) Sanders type IV. The SP was used in 67 (65%) fractures, LCP in 16 (15.5%) and SP+ABH in 20 (19.4%). The correlation test showed a weak association between the Sanders fracture type and the operation technique (Pearson correlation coefficient r=0.26). The non-parametric tests showed that the fracture type did not significantly influence the postoperative Bohler's angle outcome (p=0.132), or the type of operation (p=0.664). Excellent or good reduction of the posterior calcaneal facet was achieved in all operated fractures. One year after the operation, the distribution of Bohler's angle was normal with a mean 31.9° (SD 4.84) in all three groups. There was no significant difference in the functional postoperative outcome in terms of MFS in the three groups (p=0.601), but the Sanders fracture type had significant influence on the functional postoperative outcome in terms of MFS (p=0.001).\n In the representative sample of 103 operatively treated intraarticular calcaneal fractures, anatomical and functional postoperative efficacy outcomes appeared to be similar in all three treatment groups. High-grade displaced intraarticular calcaneal fractures (Sanders IV) had worse functional results irrespective of the type of operation. The optimal method for management of intraarticular calcaneal fracture is operative, using the standard anatomic calcaneal plate. Autologous bone grafting is not required. Large sample comparative studies are still needed.\n Copyright © 2015 Elsevier Ltd. All rights reserved.\n\n\n"
},
{
"text": "\n14642\nTransjugular intrahepatic portosystemic shunt creation with the Viatorr expanded polytetrafluoroethylene-covered stent-graft.\n\nHausegger, KA\n\nKarnel, F\n\nGeorgieva, B\n\nTauss, J\n\nPortugaller, H\n\nDeutschmann, H\n\nBerghold, A\n\nBeiträge in Fachzeitschriften\nISI:000227677700004\n15028808.0\n10.1097/01.RVI.0000116194.44877.C1\nNone\nPURPOSE: To evaluate the midterm clinical results and patency of transjugular portosystemic shunts (TIPS) created with a commercially available expanded polytetrafluoroethylene (ePTFE)-covered stent-graft based on angiographic and ultrasonographic (US) criteria in a series of 71 patients. MATERIALS AND METHODS: Seventy-one patients (61 men, 10 women; mean age, 58.6 years, range, 25-78 years) were included in this series, which was performed in two centers. Indications for TIPS creation were refractory ascites (n = 44) and recurrent esophageal bleeding (n = 27). Ten patients had Child-Pugh class A liver cirrhosis, 43 had class B disease, and 18 had class C disease. Underlying liver diseases were alcoholic cirrhosis (n = 58), cirrhosis resulting from hepatitis (n = 9), cryptogenic cirrhosis (n = 3), and Budd-Chiari syndrome (n = 1). TIPS were created with commercially available ePTFE-covered stent-grafts in all patients. The diameters of the stent-grafts were 10 mm in 58 patients and 8 mm in the remaining 13 patients. Follow-up included clinical examination and color-coded US after 5 days, 1, 3, and 6 months, and every 6 months thereafter. Shunt angiograms were obtained every 6 months. Median follow-up was 16.3 months (range, 3.8-26.6 months). RESULTS: TIPS creation was successful in all patients without complications, and effective portal decompression was observed with a reduction of the mean portal gradient from 19 mm Hg to 6 mm Hg before and after TIPS creation. Four shunt occlusions were observed after 5 days, 2 months, 3 months, and 6 months. Shunt stenosis was observed in three patients at the hepatic vein, which was not fully covered by the stent-graft, after 6 months (n = 2) and 12 months, and at the portal side after 1 month in a patient who initially had portal vein thrombosis. The repeat intervention rate was 11.3%. The primary patency rates were 87.4% (95% CI, 77.7%-97.1%) after 6 months and 80.8% (95% CI, 68.2%-93.4%) after 12 months. The rate of de novo or deteriorated hepatic encephalopathy was 31%. The recurrent bleeding rate was 3.7% (one of 27), and ascites improved or resolved in 64% of patients after 1 month. CONCLUSION: TIPS patency can be significantly increased if the ePTFE-covered stent-graft is used for shunt creation. The increased shunt patency contributes to low repeat intervention and recurrent bleeding rates. The rate of hepatic encephalopathy is within the range of previously reported rates.\n\nBerghold, Andrea\n\nDeutschmann, Hannes\n\nHausegger, Klaus\n\nPortugaller, Rupert\n\n\n"
},
{
"text": "\n82647\nPredicting the long-term effects of cardiac resynchronization therapy on mortality from baseline variables and the early response a report from the CARE-HF (Cardiac Resynchronization in Heart Failure) Trial.\n\nCleland, J\n\nFreemantle, N\n\nGhio, S\n\nFruhwald, F\n\nShankar, A\n\nMarijanowski, M\n\nVerboven, Y\n\nTavazzi, L\n\nBeiträge in Fachzeitschriften\nISI:000258031300006\n18672164.0\n10.1016/j.jacc.2008.04.036\nNone\nOBJECTIVES: This study was designed to investigate whether selected baseline variables and early response markers predict the effects of cardiac resynchronization therapy (CRT) on long-term mortality. BACKGROUND: Cardiac resynchronization therapy reduces long-term morbidity and mortality in patients with moderate or severe heart failure and markers of cardiac dyssynchrony, but not all patients respond to a similar extent. METHODS: In the CARE-HF (Cardiac Resynchronization in Heart Failure) study, 813 patients with heart failure and markers of cardiac dyssynchrony were randomly assigned to receive or not receive CRT in addition to pharmacological treatment and were followed for a median of 37.6 months. A model including assigned treatment, 15 pre-specified baseline variables, and 8 markers of response at 3 months was constructed to predict all-cause mortality. RESULTS: On multivariable analysis, plasma concentration of amino terminal pro-brain natriuretic peptide (univariate and multivariable model chi-square test: 105.0 and 48.4; both p < 0.0001) and severity of mitral regurgitation (chi-square test: 44.0 and 17.9; both p < 0.0001) at 3 months, regardless of assigned treatment, were the strongest predictors of mortality. Ischemic heart disease as the cause of ventricular dysfunction (chi-square test: 34.9 and 7.4; p < 0.0001 and p = 0.0066), being in New York Heart Association functional class IV (chi-square test: 18.8 and 9.6; p < 0.0001 and p = 0.0020), or having less interventricular mechanical delay (chi-square test: 29.8 and 8.8; p < 0.0001 and p = 0.0029) at baseline all predicted a worse outcome. However, the reduction in mortality in patients assigned to CRT was similar before (hazard ratio: 0.602; 95% confidence interval: 0.468 to 0.774) and after (hazard ratio: 0.679; 95% confidence interval: 0.494 to 0.914) adjustment for variables measured at baseline and at 3 months. CONCLUSIONS: Patients who have more severe mitral regurgitation or persistently elevated amino terminal pro-brain natriuretic peptide despite treatment for heart failure, including CRT, have a higher mortality. However, patients assigned to CRT had a lower mortality even after adjusting for variables measured before and 3 months after intervention. The effect of CRT on mortality cannot be usefully predicted using such information. (CARE-HF CArdiac Resynchronization in Heart Failure; NCT00170300).\n\nFruhwald, Friedrich\n\n\n"
},
{
"text": "\n119701\nGender Differences During Mechanical Circulatory Support.\n\nPotapov, E\n\nSchweiger, M\n\nLehmkuhl, E\n\nVierecke, J\n\nStepanenko, A\n\nWeng, G\n\nPasic, M\n\nHuebler, M\n\nRegitz-Zagrosek, V\n\nHetzer, R\n\nKrabatsch, T\n\nBeiträge in Fachzeitschriften\nISI:000305998800005\n22635009.0\n10.1097/MAT.0b013e318251cdf9\nNone\nLong-term mechanical circulatory support (MCS) with ventricular assist devices (VADs) is now an acceptable option for patients with end-stage heart failure (HF). There are growing numbers of reports identifying sex-related differences in the development and prognosis of HF and cardiac surgery. With the experience of 1, 07 VAD implantations in our institution we are the first to analyze our data to determine gender distribution in our patient populations and the effect of gender on outcomes. Of the total 1, 56 patients with MCS, 1, 25 were male and 231 female. The patients were divided into three age groups-below 13 years (group 1, n = 100), between 13 and 50 years (group 2, n = 540) and older than 50 years (group 3, n = 824). Five-year survival, HF etiology, and procedural success, defined as 30-day and 5-year survival were analyzed retrospectively. In group 1 the gender distribution was equal; the leading HF etiology was dilated cardiomyopathy (DCMP) with 17% in male (n = 17) and 19% in female (n = 19) patients, followed by congenital diseases (13% in male versus 9% in female) and postcardiotomy failure (13% in male versus 8% in female). No differences were seen in 5-year survival and procedural success. In group 2, significantly more men (n = 451, p < 0.0001) were supported by VADs. DCMP was the major cause for VAD implantation (54%) and was significantly more frequent in men (57.6%, p = <0.0001). Male patients were older (mean age = 37.1 years, p < 0.0001), with a longer median support time (151.6 days, p < 0.0001) and a higher median weight (78.2 kg, p < 0.0001). No difference was seen in procedural success whereas 5-year survival was better in men than in women (53% vs. 42%, p = 0.02).Group 3 consisted of 723 male patients and 101 female patients (p < 0.0001). Ischemic cardiomyopathy was the main HF etiology (37.9 %) and it was significantly more often the reason for left ventricular assist device support in men (p = 0.009). No differences were seen in procedural success; 5-year survival showed a better outcome in men (49% vs. 25%, p = 0.026). In patients supported by a VAD, gender has a significant impact on the distribution of diagnoses in the adult population. Women were underrepresented in the age group 13-50 years, and 50 years and older, and women had a higher risk for mortality on VAD support in the adult age groups (groups 2 and 3).\n\n\n"
},
{
"text": "\n140046\nSystematic implementation of clinical risk management in a large university hospital: the impact of risk managers.\n\nSendlhofer, G\n\nBrunner, G\n\nTax, C\n\nFalzberger, G\n\nSmolle, J\n\nLeitgeb, K\n\nKober, B\n\nKamolz, LP\n\nBeiträge in Fachzeitschriften\nISI:000348787900001\n25392253.0\n10.1007/s00508-014-0620-7\nNone\nFor health care systems in recent years, patient safety has increasingly become a priority issue. National and international strategies have been considered to attempt to overcome the most prominent hazards while patients are receiving health care. Thereby, clinical risk management (CRM) plays a dominant role in enabling the identification, analysis, and management of potential risks. CRM implementation into routine procedures within complex hospital organizations is challenging, as in the past, organizational change strategies using a top-down approach have often failed. Therefore, one of our main objectives was to educate a certain number of risk managers in facilitating CRM using a bottom-up approach.\n To achieve our primary purpose, five project strands were developed, and consequently followed, introducing CRM: corporate governance, risk management (RM) training, CRM process, information, and involvement. The core part of the CRM process involved the education of risk managers within each organizational unit. To account for the size of the existing organization, we assumed that a minimum of 1 % of the workforce had to be trained in RM to disseminate the continuous improvement of quality and safety. Following a roll-out plan, CRM was introduced in each unit and potential risks were identified.\n Alongside the changes in the corporate governance, a hospital-wide CRM process was introduced resulting in 158 trained risk managers correlating to 2.0 % of the total workforce. Currently, risk managers are present in every unit and have identified 360 operational risks. Among those, 176 risks were scored as strategic and clustered together into top risks. Effective meeting structures and opportunities to share information and knowledge were introduced. Thus far, 31 units have been externally audited in CRM.\n The CRM approach is unique with respect to its dimension; members of all health care professions were trained to be able to identify potential risks. A network of risk managers supported the centrally coordinated CRM process. There is a strong commitment among management, academia, clinicians, and administration to foster cooperation. The introduction of CRM led to a visible shift with regard to patient safety culture throughout the entire organization. Still, there is a long way to go to keep people engaged in CRM and work on national and international patient safety initiatives to continuously decrease potential hazards.\n\nBrunner, Gernot\n\nKamolz, Lars-Peter\n\nSendlhofer, Gerald\n\nSmolle, Josef\n\n\n"
},
{
"text": "\n142976\nZoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozol plus ovarian function suppression in premenopausal early breast cancer: final analysis of the Austrian Breast and Colorectal Cancer Study Group Trial 12.\n\nGnant, M\n\nMlineritsch, B\n\nStoeger, H\n\nLuschin-Ebengreuth, G\n\nKnauer, M\n\nMoik, M\n\nJakesz, R\n\nSeifert, M\n\nTaucher, S\n\nBjelic-Radisic, V\n\nBalic, M\n\nEidtmann, H\n\nEiermann, W\n\nSteger, G\n\nKwasny, W\n\nDubsky, P\n\nSelim, U\n\nFitzal, F\n\nHochreiner, G\n\nWette, V\n\nSevelda, P\n\nPloner, F\n\nBartsch, R\n\nFesl, C\n\nGreil, R\n\nAustrian Breast and Colorectal Cancer Study Group, Vienna, Austria\n\nBeiträge in Fachzeitschriften\nISI:000349609600009\n25403582.0\n10.1093/annonc/mdu544\nNone\nZoledronic acid (ZOL) plus adjuvant endocrine therapy significantly improved disease-free survival (DFS) at 48- and 62-month follow-up in the ABCSG-12 trial. We present efficacy results of a final additional analysis after 94.4 months.\n Patients were premenopausal women who had undergone primary surgery for stage I/II estrogen-receptor-positive and/or progesterone-receptor-positive breast cancer with <10 positive lymph nodes, and were scheduled for standard goserelin therapy. All 1803 patients received goserelin (3.6 mg every 28 days) and were randomized to tamoxifen (20 mg/days) or anastrozole (1 mg/days), both with or without ZOL (4 mg every 6 months) for 3 years. The primary end point was DFS; recurrence-free survival and overall survival (OS) were secondary end points.\n After 94.4-month median follow-up (range, 0-114 months), relative risks of disease progression [hazard ratio (HR) = 0.77; 95% confidence interval (CI) 0.60-0.99; P = 0.042] and of death (HR = 0.66; 95% CI 0.43-1.02; P = 0.064) are still reduced by ZOL although no longer significant at the predefined significance level. Overall, 251 DFS events and 86 deaths were reported. Absolute risk reductions with ZOL were 3.4% for DFS and 2.2% for OS. There was no DFS difference between tamoxifen alone versus anastrozole alone, but there was a pronounced higher risk of death for anastrozole-treated patients (HR = 1.63; 95% CI 1.05-1.45; P = 0.030). Treatments were generally well tolerated, with no reports of renal failure or osteonecrosis of the jaw.\n These final results from ABCSG 12 suggest that twice-yearly ZOL enhances the efficacy of adjuvant endocrine treatment, and this benefit is maintained long-term.\n NCT00295646 (http://www.clinicaltrials.gov/ct2/results?term=00295646).\n © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.\n\nBalic, Marija\n\nBjelic-Radisic, Vesna\n\nHofmann, Guenter\n\nLuschin-Ebengreuth, Gero\n\nStoeger, Herbert\n\n\n"
}
]
}