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The article reports on the decision of the management of "The Lancet" to retract medical entry by urologists at the Medical University of Innsbruck in Austria. It states that the write-up claimed positive results for a clinical trial using stem cells to treat urinary incontinence. However, an investigation by the government found serious flaws in the trial such as incomplete patient consent forms and forged insurance documents. As a result, the university suspended principal investigator Hannes Strasser.

Background: Vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (ICU) and associated with worse clinical course. Trials in adult ICU demonstrate rapid restoration of vitamin D status using an enteral loading dose is safe and may improve outcomes. There have been no published trials of rapid normalization of VDD in the pediatric ICU. Methods: We conducted a multicenter placebo-controlled phase II pilot feasibility randomized clinical trial from 2016 to 2017. We randomized 67 critically ill children with VDD from ICUs in Canada, Chile and Austria using a 2:1 randomization ratio to receive a loading dose of enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or placebo. Participants, care givers, and outcomes assessors were blinded. The primary objective was to determine whether the loading dose normalized vitamin D status (25(OH)D > 75 nmol/L). Secondary objectives were to evaluate for adverse events and assess the feasibility of a phase III trial. Results: Of 67 randomized participants, one was withdrawn and seven received more than one dose of cholecalciferol before the protocol was amended to a single loading dose, leaving 59 participants in the primary analyses (40 treatment, 19 placebo). Thirty-one/38 (81.6%) participants in the treatment arm achieved a plasma 25(OH)D concentration > 75 nmol/L versus 1/18 (5.6%) the placebo arm. The mean 25(OH)D concentration in the treatment arm was 125.9 nmol/L (SD 63.4). There was no evidence of vitamin D toxicity and no major drug or safety protocol violations. The accrual rate was 3.4 patients/month, supporting feasibility of a larger trial. A day 7 blood sample was collected for 84% of patients. A survey administered to 40 participating families showed that health-related quality of life (HRQL) was the most important outcome for families for the main trial (30, 75%). Conclusions: A single 10,000 IU/kg dose can rapidly and safely normalize plasma 25(OH)D concentrations in critically ill children with VDD, but with significant variability in 25(OH)D concentrations. We established that a phase III multicentre trial is feasible. Using an outcome collected after hospital discharge (HRQL) will require strategies to minimize loss-to-follow-up. Trial Registration. Clinicaltrials.gov NCT02452762 Registered 25/05/2015. [ABSTRACT FROM AUTHOR]

Background: Sepsis is as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. The mortality of sepsis and particular of septic shock is very high. Treatment mostly focuses on infection control but a specific intervention that targets the underlying pathological host response is lacking to the present time. The investigators hypothesize that early therapeutic plasma exchange (TPE) will dampen the maladaptive host response by removing injurious mediators thereby limiting organ dysfunction and improving survival in patients with septic shock. Although small prospective studies demonstrated rapid hemodynamic stabilization under TPE, no adequately powered randomized clinical trial has investigated hard outcomes. Methods: This is a randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of TPE in patients with early septic shock. Patients with a refractory (defined as norepinephrine (NE) ≥ 0.4 μg/kg/min ≥ 30 min OR NE 0.3 μg/kg/min + vasopressin) and early (shock onset < 24 h) septic shock will be included. The intervention is a standard TPE with donor fresh frozen plasma (1.2 × individual plasma volume) performed within 6 h after randomization and will be compared to a standard of care (SOC) control arm. The primary endpoint is 28 days mortality for which the power analysis revealed a group size of 137 / arm (n = 274) to demonstrate a benefit of 15%. The key secondary objective will be to compare the extent of organ failure indicated by mean SOFA over the first 7 days as well as organ support-free days until day 28 following randomization. Besides numerous biological secondary, safety endpoints such as incidence of bleeding, allergic reactions, transfusion associated lung injury, severe thrombocytopenia, and other severe adverse events will be assessed during the first 7 days. For exploratory scientific analyses, biomaterial will be acquired longitudinally and multiple predefined scientific subprojects are planned. This study is an investigator-initiated trial supported by the German Research Foundation (DFG, DA 1209/7–1), in which 26 different centers in Germany, Switzerland, and Austria will participate over a duration of 33 months. Discussion: This trial has substantial clinical relevance as it evaluates a promising adjunctive treatment option in refractory septic shock patients suffering from an extraordinary high mortality. A positive trial result could change the current standard of care for this septic subgroup. The results of this study will be disseminated through presentations at international congresses, workshops, and peer-reviewed publications. Trial registration: ClinicalTrials.gov NCT05726825, Registered on 14 February 2023. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated a simple environmental intervention called 'Water Schools' in Lower Austria providing free refillable water bottles and educational material.Design: Non-randomised controlled cluster trial with three measurements: at baseline (T0), after the intervention at 9 months (T1) and after 1-year follow-up (T2).Setting: Half-day elementary schools in Lower Austria (Austria).Participants: Third-grade pupils from twenty-two schools in the intervention group (IG) and thirty-two schools in the control group (CG) participated in the study. Data were analysed for 569 to 598 pupils in the IG and for 545 to 613 in the CG, depending on the time of measurement.Results: The consumption of tap water increased in the IG from baseline to T1 and then decreased again at T2, but this was similar in the CG (no statistically significant difference in the time trend between the IG and CG). Similar results were seen for tap water consumption in the mornings. The proportion of children who only drank tap water on school mornings increased significantly from baseline to T1 in the IG compared to the CG (P = 0·020). No difference in the changes over time occurred between the groups for the proportion of pupils drinking approximately one bottle of tap water during school mornings.Conclusions: Not only the children in the IG but also those in the CG drank more tap water after 1 school year than at the beginning. The measurement of drinking habits in the CG may have been intervention enough to bring about changes or to initiate projects. [ABSTRACT FROM AUTHOR]

Introduction: Medical gloves are routinely used to prevent the spread of microorganisms between patients, health care workers and their environment. However, when used incorrectly, they can also increase the dissemination of pathogens. Antibacterial medical gloves coated in polyhexamethylene-biguanide hydrochloride (PHMB) show reduced bacterial contamination after clinical use, but whether they can also reduce cross- contamination of surrounding surfaces is not known. Objective: The primary objective of this study was to investigate the effect of antibacterial medical gloves on bacterial transmission to commonly touched surface areas. Methods: This study was performed in an outpatient wound care room in the Hospital Neunkirchen, Austria. A chicken breast was inoculated with a Staphylococcus aureus reference strain (ATCC 6538). After 30-minute incubation time, the skin was touched wearing a non-antibacterial glove, which then touched surrounding surface areas (another, non-contaminated, chicken breast; a computer keyboard and a window curtain). After 10 repetitions, the entire procedure was repeated using an antibacterial glove. Contact time was 40 seconds for each touch. Results: Antibacterial gloves significantly reduced the number of bacterial colonies forming units (cfu) on every surface area tested (p<0.05, two-sided Mann--Whitney U test) from a mean of 5.6 log10 bacteria to a mean of 4.2 log10 bacteria. Conclusion: Antimicrobial gloves reduce bacterial cross-contaminations of surface areas in a real hospital surroundings and could prove valuable in the reduction of microbial transmission in patient care. However, they do not prevent bacterial transfer completely and, thus, cannot replace proper glove technique and hand hygiene. [ABSTRACT FROM AUTHOR]

Objective: Clinical trials demonstrate improving survival in patients with multiple myeloma (MM) after treatment. However, it is unclear whether increased survival translates to a similar benefit in a real world setting. Methods: We analyzed the overall survival of 347 multiple myeloma patients in Austria by means of a national registry (AMR), focused on results from 3rd and later lines of therapy. This benchmark was chosen to define a baseline prior to the broad application of upcoming 2nd generation drugs (carfilzomib, pomalidomide). Results: Projected 10 years survival for patients with MM in Austria is estimated to be 56% in patients diagnosed in between the years 2011–2014, 21% in patients with a diagnosis made between 2000–2005, and 39% in those with a diagnosis made between 2006–2010). For the same intervals a significant increase in the use of both bortezomib, lenalidomide and thalidomide—so called IMiDs (from 2005 onwards) and their simultaneous use in combination therapies (from 2010 onwards) could be shown. The use of autologous transplantation (ASCT) remained more or less constant at ~ 35% of patients in the 1st line setting over the whole period, comparing well to international practice patterns, while the use of 2nd line ASCT increased from 5.5% to 18.7% of patients. Patients in 3rd or later line treatment (n = 105), showed that even in relapsed and refractory disease median survival was 27 months with a considerable proportion of long-term survivors (~20%). Conclusion & Perspective: With the expected emergence of additional active anti-myeloma compounds, we aim to assess survival in patients with relapsed and refractory MM. [ABSTRACT FROM AUTHOR]

The article features the lawsuit filed by Dieter Bollman, 70-year old patient, against Hannes Strasser in Austria. He consented to the surgery procedure because Strasser, a urologists at the University Hospital Innsbruck, told him that the treatment had a very high success rate and implied that stem cell clinical trials had been completed. It reveals that the consent form that he signed did not include the word "experimental" and after the operation, his symptoms did not improve. Because of such incident, he sued TILAK, the administrative body that runs the university hospital, for damages. When the country's ministry of health investigated the issue, it found that the patients undergoing such procedures are not insured for experimental procedures. Discussed are the details of the lawsuit.