Outcomes of liver transplantation for non-alcoholic steatohepatitis: A European Liver Transplant Registry study.

BACKGROUND & AIMS: Little is known about outcomes of liver transplantation for patients with non-alcoholic steatohepatitis (NASH). We aimed to determine the frequency and outcomes of liver transplantation for patients with NASH in Europe and identify prognostic factors. METHODS: We analysed data from patients transplanted for end-stage liver disease between January 2002 and December 2016 using the European Liver Transplant Registry database. We compared data between patients with NASH versus other aetiologies. The principle endpoints were patient and overall allograft survival. RESULTS: Among 68,950 adults undergoing first liver transplantation, 4.0% were transplanted for NASH - an increase from 1.2% in 2002 to 8.4% in 2016. A greater proportion of patients transplanted for NASH (39.1%) had hepatocellular carcinoma (HCC) than non-NASH patients (28.9%, p <0.001). NASH was not significantly associated with survival of patients (hazard ratio [HR] 1.02, p = 0.713) or grafts (HR 0.99; p = 0.815) after accounting for available recipient and donor variables. Infection (24.0%) and cardio/cerebrovascular complications (5.3%) were the commonest causes of death in patients with NASH without HCC. Increasing recipient age (61-65 years: HR 2.07, p <0.001; >65: HR 1.72, p = 0.017), elevated model for end-stage liver disease score (>23: HR 1.48, p = 0.048) and low (<18.5 kg/m2: HR 4.29, p = 0.048) or high (>40 kg/m2: HR 1.96, p = 0.012) recipient body mass index independently predicted death in patients transplanted for NASH without HCC. Data must be interpreted in the context of absent recognised confounders, such as pre-morbid metabolic risk factors. CONCLUSIONS: The number and proportion of liver transplants performed for NASH in Europe has increased from 2002 through 2016. HCC was more common in patients transplanted with NASH. Survival of patients and grafts in patients with NASH is comparable to that of other disease indications. LAY SUMMARY: The prevalence of non-alcoholic fatty liver disease has increased dramatically in parallel with the worldwide increase in obesity and diabetes. Its progressive form, non-alcoholic steatohepatitis, is a growing indication for liver transplantation in Europe, with good overall outcomes reported. However, careful risk factor assessment is required to maintain favourable post-transplant outcomes in patients with non-alcoholic steatohepatitis.

Alprostadil treatment of critical limb ischemia in hemodialysis patients : A retrospective single-center analysis.

BACKGROUND: Peripheral artery disease and critical limb ischemia are common in patients undergoing chronic hemodialysis treatment and are associated with a high rate of amputation and mortality. The effect of treatment with prostanoids in this specific group of patients is unknown. METHODS: A retrospective single-center analysis of hemodialysis patients with critical limb ischemia was performed who were treated with the prostanoid analogue alprostadil as an infusion during hemodialysis in the period from 2000 to 2013. The primary study outcome was a combined end-point including amputation and death 1 year after start of alprostadil. Kaplan-Meier curves were used to describe amputation-free survival and overall survival. A multivariable adjusted Cox proportional hazards model was calculated for the primary outcome. RESULTS: A total of 86 patients (60 males, 69.7%) were studied. The median alprostadil treatment period was 1.8 months. The 1­year amputation-free survival was 41%. In 36% of patients an amputation was necessary and 35% died. Despite alprostadil treatment, 36% of the study patients additionally underwent an endovascular procedure and 16% had bypass surgery. Men had a significantly higher amputation rate (45%) than women (15%) (P = 0.009). Male sex and dialysis vintage were significantly associated with an increased risk for primary outcome CONCLUSIONS: Despite treatment with alprostadil the mortality, amputation rate and the need for revascularization procedures in hemodialysis patients with critical limb ischemia remained high. The outcome, however, was comparable with that of other treatment, such as endovascular procedures and bypass surgery. The effect of any current treatment strategy on amputation rate or mortality in that patient group remains uncertain.

Evaluation of the time required for overhead tasks performed by physicians, medical physicists, and technicians in radiation oncology institutions: the DEGRO-QUIRO study.

OBJECTIVE: Developments in radiation oncology in recent years have highlighted the increasing deployment of personnel resources for tasks not directly related to patients. These tasks include patient-related activities such as treatment planning, reviewing files, and administrative duties (e.g., invoicing for services, documentation). The aim of the present study, part of the QUIRO project of the German Society of Radiation Oncology (DEGRO), was to describe, on the basis of valid data, the deployment of personnel resources in radiation oncology centers for "overhead" tasks. METHODS: Questionnaires were used to analyze the percentages of time needed for various tasks. The target group comprised physicians, medical physics experts (MPE), and medical technical radiology assistants (MTRA). A total of 760 personnel from 65 radio-oncology centers in the German inpatient and outpatient sector participated (32 % physicians, 23 % MPE, and 45 % MTRA). RESULTS: High percentages of overhead tasks during working time were measured for each of the three personnel groups considered (physicians, MPE, and MTRA). Patient-related efficiency, i.e., the percentage of working time associated directly or indirectly with the patient, was highest among MTRA and lowest among MPE. Particular features could be seen in the activity profiles of personnel in university clinics. Duties in the areas of research and teaching resulted in a greater percentage of overhead tasks for physicians and MPE. Irrespective of function (physician, MPE, or MTRA), a managerial role resulted in lower patient-related efficiency, as well as a narrower time budget for direct patient care compared with non-managerial employees. CONCLUSION: Using the data gathered, it was possible to systematically investigate the time required for overhead tasks in radio-oncological centers. Overall, relatively high time requirements for a variety of overhead tasks were measured. These time requirements, generated for example by administrative duties or research and teaching, are currently not taken into adequate consideration in terms of remuneration or personnel capacity planning.

Evaluating the attendance of medical staff and room occupancy during palliative radiotherapy.

INTRODUCTION: Attendance of staff and use of resources during treatment have an impact on costs. For palliative radiotherapy, no reliable data are available on the subject. Therefore, the measurement of selected variables (staff absorbance and room occupancy) based on daily palliative irradiation was the aim of our prospective study. The analysis is part of a larger study conducted by the German Society of Radiation Oncology (DEGRO). PATIENTS, MATERIAL, AND METHODS: A total of 172 palliative radiation treatments were followed up prospectively between October 2009 and March 2010. The study was performed at two experienced radiotherapy departments (Herne and Bielefeld) and evaluated the attendance of medical personnel and room occupancy related to the selected steps of the treatment procedure: treatment planning and daily application of radiation dose. RESULTS: Computed tomography for treatment planning engaged the unit for 19 min (range: 17-22 min). The localization of target volume required on average 28 min of a technician's working time. The mean attendance of the entire staff (radiation oncologist, physicist, technician) for treatment planning was 159 min, while the total room occupancy was 140 min. Depending on the type of treatment, the overall duration of a radiotherapy session varied on average between 8 and 18 min. The staff was absorbed by the first treatment session (including portal imaging) for 8-27 min. Mean room occupancy was 18 min (range: 6-65 min). The longest medical staff attendance was observed during an initial irradiation session (mean: 11 min). Radiotherapy sessions with weekly performed field verifications occupied the rooms slightly longer (mean: 10 min, range: 4-25 min) than daily radiotherapy sessions (mean: 9 min, range: 3-29 min). We observed that the patients' symptoms, their condition, and their social environment confounded the time schedule. CONCLUSIONS: Target localization, treatment planning, and performance of palliative radiotherapy absorb resources to an extent comparable to nonpalliative treatment. Because of unexpected events, the time schedule before and during radiotherapy may reveal strong interindividual variability.

Evaluation of time, attendance of medical staff and resources for radiotherapy in pediatric and adolescent patients. The DEGRO-QUIRO trial.

BACKGROUND: The German Society of Radiation Oncology (DEGRO) initiated a multicenter trial to develop and evaluate adequate modules to assert core procedures in radiotherapy. The aim of this prospective evaluation was to methodical assess the required resources for radiotherapy in pediatric and adolescent patients. MATERIAL AND METHODS: At three radiotherapy centers of excellence (University Hospitals of Heidelberg and Münster, the Medical School of Hannover), the manpower and time required for radiotherapy in pediatric and adolescent patients was prospectively documented consistently over a 2-year period. The data were collected using specifically developed standard forms and were evaluated using specific process analysis tools. RESULTS: A total number of 1914 data sets were documented and carefully analyzed. The personnel time requirements for all occupational groups were calculated as total time needed for a specific procedure and mean time per person. Regarding radiotherapy in general anesthesia, the required manpower was higher. The personnel time requirements in these cases were also longer, mainly due to longer room occupancy. Overall, the required resources were remarkably similar between the three different departments and may, therefore, be considered as representative. CONCLUSION: For the first time, the personnel time requirements of a radiotherapy department for the maintenance, protection, and optimization of operational readiness for radiotherapy in pediatric and adolescent patients with and without general anesthesia were determined methodically.

Evaluation of time, attendance of medical staff, and resources during radiotherapy for head and neck cancer patients: the DEGRO-QUIRO trial.

INTRODUCTION: A number of national and international societies have published recommendations regarding the required equipment and manpower that is assumed to be necessary to treat a specific number of patients with radiotherapy. None of these recommendations were based on actual time measurements needed for specific radiotherapy procedures. The German Society of Radiation Oncology (DEGRO) was interested in substantiating their recommendations by prospective evaluations of all important core procedures of radiotherapy in the most frequent cancer treated by radiotherapy. The results of the examinations of radiotherapy in head and neck cancer (HNC) patients are presented in this manuscript. PATIENTS AND METHODS: Four radiation therapy centers (University of Jena, University of Erlangen, University of Düsseldorf and the community hospital of Neuruppin) participated in this prospective study. Working time of the different occupational groups and room occupancies for the core procedures of radiotherapy in HNC were prospectively documented during a 4-month period and subsequently statistically analyzed. RESULTS: The time needed per patient varied considerably between individual patients and between centers for all evaluated procedures. Room occupancy, presence of technicians, and overall medical staff times were 21 min, 26 min, and 42 min, respectively, for planning CT with i.v. contrast medium (n = 79), and 23 min, 44 min, and 51 min respectively, for planning CT without contrast medium (n = 45). Definition of the target volume (n = 91) was the most time consuming procedure for the physicians taking 1 h 45 min on average. Medical physicists spent a mean time of 3 h 8 min on physical treatment planning (n = 97) and 1 h 8 min on authorization of the treatment plan (n = 71). Treatment simulations (n = 185) required an average room occupancy of 23 min, and a mean technicians presence of 47 min. The mean room occupancy (n = 84) was 24 min for the first radiotherapy including portal imaging associated with a mean presence of the technicians of 53 min. For routine radiotherapy sessions (n = 2,012) and routine radiotherapy sessions including portal imaging (n = 407), mean room occupancies were 13 min and 16 min, respectively. The presence of increasing number of technicians was significantly associated with shorter room occupancy. IMRT including portal imaging (n = 213) required an average room occupancy of 24 min and a mean technician time of 48 min. CONCLUSION: The data presented here allow an estimate of the required machine time and manpower needed for the core procedures of radiotherapy in an average head and neck cancer patient treated with a specific number of fractions. However, one has to be aware that a number of necessary and time consuming activities were not evaluated in the present study.

Efficacy and safety of high-dose budesonide/formoterol (Symbicort) compared with budesonide administered either concomitantly with formoterol or alone in patients with persistent symptomatic asthma.

OBJECTIVE AND BACKGROUND: Budesonide/formoterol 160/4.5 microg, two inhalations bd, is an effective and well-tolerated maintenance therapy for patients not controlled on inhaled corticosteroids alone. The authors assessed the efficacy and safety of a higher dose of budesonide/formoterol in patients with persistent symptomatic asthma. METHODS: This was a 24-week, double-blind, double-dummy randomized study. Budesonide/formoterol 320/9 microg, two inhalations bd (1280/36 microg/day), was compared with corresponding doses of budesonide during weeks 1-12 and budesonide plus formoterol via separate inhalers during weeks 1-24. Efficacy was assessed during weeks 1-12; the primary variable was morning PEF. Safety was assessed over weeks 1-24. RESULTS: Patients (n=456; aged 12-79 years) had a mean reversibility in FEV1 of 28% and mean pre-study inhaled corticosteroid dose of 1038 microg/day. Mean morning PEF increased by 37 L/min and 36 L/min with budesonide/formoterol and budesonide plus formoterol, respectively, versus an increase of 5 L/min with budesonide (P<0.001 for both vs. budesonide). Budesonide/formoterol increased time to first mild exacerbation (P<0.005) versus budesonide. Budesonide/formoterol and budesonide plus formoterol had similar efficacy. All treatments were well tolerated and the incidence of class-related adverse events was similarly low in all groups. Changes in serum potassium and plasma cortisol were comparable across treatments. CONCLUSIONS: High-dose budesonide/formoterol (320/9 microg, two inhalations bd) is effective and well tolerated in patients with persistent symptomatic asthma. The findings also support the safety of regular high-dose formoterol (36 microg/day).

[Immunization in the elderly--necessary, helpful, superfluous?]. / Influenza, Pneumokokken, Pertussis, Zoster: Welche Schutzimpfungen sind im Alter sinnvoll?

For all adults, vaccinations against tetanus, diphtheria, poliomyelitis, pertussis, TBE (in endemic regions) and specific vaccinations for travelers are recommended. In addition to this standard protection, the Robert-Koch Institute also recommends--in particular for over-60-year-olds--an annual vaccination against influenza, as well as against pneumococci that must be repeated every six years.

Impact of pneumococcal vaccination on morbidity and mortality of geriatric patients: a case-controlled study.

BACKGROUND: Infections due to Streptococcus pneumoniae are the major cause of adult community-acquired pneumonia, especially in elderly persons with chronic medical conditions. Despite their well-documented efficacy against bacteraemic disease and deaths in the elderly population, pneumococcal polysaccharide vaccines are still very much underused. OBJECTIVE: A retrospective, case-controlled study was performed to investigate the impact of vaccination with a polysaccharide pneumococcal vaccine, together with other risk factors, on the incidence of pneumonia and deaths in patients in a long-stay geriatric hospital. METHODS: Subjects were 1,077 residents in a long-stay geriatric hospital in Vienna, Austria, including 359 patients diagnosed as having pneumonia during the period from July 1996 to October 1998 and 718 control subjects. Two controls resident in the hospital during the same time period were matched for each case according to demographic characteristics, chronic illness, and duration of stay in the geriatric ward. The vaccination status was established for all subjects. A logistic regression analysis was performed to assess the efficacy of vaccination and the impact of other cofactors on disease and death. RESULTS: In cases and controls, 514 (47.7%) had received a pneumococcal vaccine within 2 years prior to the study. There were no differences in demographic characteristics, underlying medical conditions, or duration of stay in the hospital between vaccinated and non-vaccinated patients. In patients diagnosed with pneumonia, 66% were unvaccinated. Logistic regression analysis showed that vaccination significantly decreased the risk of pneumonia (odds ratio 0.279; p < 0.0001). Of the cofactors tested, only gender (lower risk in males) and diabetes mellitus (higher risk) had any impact on disease risk and vaccine efficacy. There appeared to be a highly significant effect of vaccination, reducing the risk of all deaths (odds ratio 0.269; p < 0.0001) and deaths due to pneumonia (odds ratio 0.331; p < 0.0001). CONCLUSION: This study showed that vaccination with a polysaccharide pneumococcal vaccine is effective in all groups of geriatric subjects and has a consequential value for health and well-being of elderly institutionalized patients.