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Article: TI: Aktuelle Herausforderungen bei der Bewertung von Ethikantraegen - Aspekte der Digitalisierung und Personalisierung im Gesundheitswesen

AU: Rauch, Geraldine / Roehmel, Joachim / Gerss, Joachim / Scherag, Andrâ / Hofner, Benjamin / EDR:

JT: Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

(SE:)

PY: 2019 Volume VOLUME / ISSUE: 62, Issue 6, Page(s) PAGINATION: 758–764

Abstract: AB: ...

Title translation	TITLE TRANSLATION: (Current challenges in the assessment of ethical proposals - aspects of digitalization and personalization in the healthcare system)
Institution	CS:
Series title	SE:
Abstract	AB:
Keywords	it: computers ; data banks ; human experimentation ; research design ; research ethics committees ; quality of health care ; evaluation ; keyword identifiers:
Subject code	SC: AN
Language	Latin ; German
Publisher	PU:
Document type	Article
Note	NOTE:
ISSN	ISSN: 0007-5914
Database	Ethics in Medicine (ETHMED)

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Article: Aktuelle Herausforderungen bei der Bewertung von Ethikantraegen - Aspekte der Digitalisierung und Personalisierung im Gesundheitswesen

Rauch, Geraldine / Roehmel, Joachim / Gerss, Joachim / Scherag, Andrâ / Hofner, Benjamin

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

2019 Volume 62, Issue 6, Page(s) 758–764

Title translation	Current challenges in the assessment of ethical proposals - aspects of digitalization and personalization in the healthcare system
Keywords	computers ; data banks ; human experimentation ; research design ; research ethics committees ; quality of health care ; evaluation
Subject code	AN
Language	German
Document type	Article
ZDB-ID	1379-1
ISSN	0007-5914
ISSN	0007-5914
Database	Ethics in Medicine (ETHMED)

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Article ; Online: Influence of Statins on Survival Outcome in Patients with Metastatic Castration Resistant Prostate Cancer Treated with Abiraterone Acetate.

Martin Boegemann / Katrin Schlack / Ann-Kathrin Fischer / Joachim Gerß / Julie Steinestel / Axel Semjonow / Andres Jan Schrader / Laura-Maria Krabbe

PLoS ONE, Vol 11, Iss 9, p e

2016 Volume 0161959

Abstract: Even though the exact mechanism is largely unknown until now, statins are supposed to improve survival outcomes in various malignancies. For prostate cancer however, statins are known to compete with dehydroepiandrosterone (DHEAS) for the transport into ... ...

Abstract	Even though the exact mechanism is largely unknown until now, statins are supposed to improve survival outcomes in various malignancies. For prostate cancer however, statins are known to compete with dehydroepiandrosterone (DHEAS) for the transport into the cytosol both using the cell by the Solute Carrier Transporter and thus diminish the cellular uptake of DHEAS as a precursor of androgens. Abiraterone inhibits CYP17A1 and thus effectively decreases the production of all relevant androgens including DHEAS. In this study we examined whether statins still affect survival outcome in patients with metastatic castration resistant prostate cancer (mCRPC) when treated with Abiraterone.108 men with mCRPC treated with Abiraterone from 02/2010 to 07/2015 with (n = 21) or without (n = 87) concomitant treatment with statins were investigated. Progression free survival (PFS) and overall survival (OS) were analyzed using Kaplan-Meier-estimates and univariate Cox-regression analysis. The influence on best clinical benefit under Abiraterone treatment was analyzed with bivariate and multivariate logistic regression analysis.PSA-decline ≥ 50% was not significantly different in both groups (57 vs. 53%; p = 0.73). The median PFS (9 vs. 10 months; p = 0.97) and OS (14 vs. 18 months; p = 0.77) did not differ significantly between those men treated with and without concomitant statin therapy, respectively. Accordingly, there was no improvement for best clinical benefit in patients using statins (odds ratio: 1.2 (CI: 0.4-4.2); p = 0.76).Use of statins as concomitant medication did not improve survival outcomes or best clinical benefit in men with mCRPC treated with Abiraterone.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2016-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Risk and benefit from clinical trials in minors

Andreas Dirk Henschel / Lillian Geza Rothenberger / Dominik Schrey / Joachim Gerß / Georg Hempel / Joachim Boos

Open Journal of Pediatrics, Vol 03, Iss 02, Pp 151-

Making the case for transparent and consistent publications

2013 Volume 164

Abstract: Rationale, aim and objectives: The European (EU) regulation on medicinal products for pediatric use (EC 1901/2006), which became effective in 2007, aimed to stimulate the clinical testing of medications in minors in order to reduce off-label use. In ... ...

Abstract	Rationale, aim and objectives: The European (EU) regulation on medicinal products for pediatric use (EC 1901/2006), which became effective in 2007, aimed to stimulate the clinical testing of medications in minors in order to reduce off-label use. In consequence, the number of minors taking part in randomized controlled clinical trials (RCTs) is likely to increase. Clinical trials in minors require a complex methodological design, a careful consideration of risks and benefits and a high level of ethical reflection. Unfortunately, as to the quality of clinical trials and their publications in minors little is known. Therefore, we assessed published reports of randomized, controlled clinical trials in minors, focusing on a common disease (asthma) and a defined spectrum of lifethreatening diseases (malignant diseases). Method: In an exploratory design, we scanned the publications for methodological aspects as well as indicators of ethical soundness, e.g., statements that informed consent had been obtained before the start of the trial or that a Data and Safety Monitoring Board ensured the patients’ safety during the trial. We also looked for passages reflecting the debate on equipoise or other forms of weighing risks and benefits. Results: We found that many of these aspects, which according to the scientific literature and generally acknowledged guidelines are essential to ensure good-quality trials and trial reports, were not considered in the publications analyzed. Conclusion: Therefore, we call for a more transparent and consistent presentation of the trials, especially of safety aspects, relying on a more critical and transparent ethical reflection.
Keywords	Clinical Trials ; Minors ; SIGN ; CONSORT ; Ethics ; Pediatrics ; RJ1-570 ; Medicine ; R ; DOAJ:Pediatrics ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Subject code	170
Language	English
Publishing date	2013-06-01T00:00:00Z
Publisher	Scientific Research Publishing
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Decision aid and cost compensation influence uptake of PSA-based early detection without affecting decisional conflict

Dorothee Tiedje / Matthias Borowski / Alexandra Simbrich / Kathrin Schlößler / Klaus Kruse / Christiane Bothe / Katrin Kuss / Charles Christian Adarkwah / Peter Maisel / Ralf Jendyk / Marc-André Kurosinski / Joachim Gerß / Christian Tschuschke / Ralf Becker / Monique J. Roobol / Chris H. Bangma / Hans-Werner Hense / Norbert Donner-Banzhoff / Axel Semjonow

Scientific Reports, Vol 11, Iss 1, Pp 1-

a cluster randomised trial

2021 Volume 10

Abstract: Abstract International guidelines recommend to inform men about the benefits and harms of prostate specific antigen (PSA) based early detection of prostate cancer. This study investigates the influence of a transactional decision aid (DA) or cost ... ...

Abstract	Abstract International guidelines recommend to inform men about the benefits and harms of prostate specific antigen (PSA) based early detection of prostate cancer. This study investigates the influence of a transactional decision aid (DA) or cost compensation (CC) for a PSA test on the decisional behaviour of men. Prospective, cluster-randomised trial to compare two interventions in a 2 × 2 factorial design: DA versus counselling as usual, and CC versus noCC for PSA-testing. 90 cluster-randomised physicians in the administrative district of Muenster, Germany recruited 962 participants aged 55–69 yrs. in 2018. Primary endpoint: the influence of the DA and CC on the decisional conflict. Secondary endpoints: factors which altered the involvement of the men regarding their decision to take a PSA-test. The primary endpoint was analysed by a multivariate regression model. The choice to take the PSA test was increased by CC and reduced by the DA, the latter also reduced PSA uptake in men who were offered CC. The DA led to an increase of the median knowledge about early detection, changed willingness to perform a PSA test without increasing the level of shared decision, giving participants a stronger feeling of having made the decision by themselves. The DA did not alter the decisional conflict, as it was very low in all study groups. DA reduced and CC increased the PSA uptake. The DA seemed to have a greater impact on the participants than CC, as it led to fewer PSA tests even if CC was granted. Trial registration: German Clinical Trial Register (Deutsches Register Klinischer Studien DRKS00007687). Registered: 06/05/2015. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007687 .
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2021-12-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Phase I Dose Escalation Study of the Triple Angiokinase Inhibitor Nintedanib Combined with Low-Dose Cytarabine in Elderly Patients with Acute Myeloid Leukemia.

Christoph Schliemann / Joachim Gerss / Stefanie Wiebe / Jan-Henrik Mikesch / Nicola Knoblauch / Tim Sauer / Linus Angenendt / Tobias Kewitz / Marc Urban / Trude Butterfass-Bahloul / Sabine Edemir / Kerstin Vehring / Carsten Müller-Tidow / Wolfgang E Berdel / Utz Krug

PLoS ONE, Vol 11, Iss 10, p e

2016 Volume 0164499

Abstract: Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-α/-β, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic cells, especially when used in combination with cytarabine. This phase I study ... ...

Abstract	Nintedanib (BIBF 1120), a potent multikinase inhibitor of VEGFR-1/-2/-3, FGFR-1/-2/-3 and PDGFR-α/-β, exerts growth inhibitory and pro-apoptotic effects in myeloid leukemic cells, especially when used in combination with cytarabine. This phase I study evaluated nintedanib in combination with low-dose cytarabine (LDAC) in elderly patients with untreated or relapsed/refractory acute myeloid leukemia (AML) ineligible for intensive chemotherapy in a 3+3 design. Nintedanib (dose levels 100, 150, and 200 mg orally twice daily) and LDAC (20 mg subcutaneous injection twice daily for 10 days) were administered in 28-day cycles. Dose-limiting toxicity (DLT) was defined as non-hematological severe adverse reaction CTC grade ≥ 4 with possible or definite relationship to nintedanib. Between April 2012 and October 2013, 13 patients (median age 73 [range: 62-86] years) were enrolled. One patient did not receive study medication and was replaced. Nine (69%) patients had relapsed or refractory disease and 6 (46%) patients had unfavorable cytogenetics. The most frequently reported treatment-related adverse events (AE) were gastrointestinal events. Twelve SAEs irrespective of relatedness were reported. Two SUSARs were observed, one fatal hypercalcemia and one fatal gastrointestinal infection. Two patients (17%) with relapsed AML achieved a complete remission (one CR, one CRi) and bone marrow blast reductions without fulfilling PR criteria were observed in 3 patients (25%). One-year overall survival was 33%. Nintedanib combined with LDAC shows an adequate safety profile and survival data are promising in a difficult-to-treat patient population. Continuation of this trial with a phase II recommended dose of 2 x 200 mg nintedanib in a randomized, placebo-controlled phase II study is planned. The trial is registered to EudraCT as 2011-001086-41.ClinicalTrials.gov NCT01488344.
Keywords	Medicine ; R ; Science ; Q
Subject code	610 ; 616
Language	English
Publishing date	2016-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Feasibility of azacitidine added to standard chemotherapy in older patients with acute myeloid leukemia--a randomised SAL pilot study.

PLoS ONE, Vol 7, Iss 12, p e

2012 Volume 52695

Abstract: Older patients with acute myeloid leukemia (AML) experience short survival despite intensive chemotherapy. Azacitidine has promising activity in patients with low proliferating AML. The aim of this dose-finding part of this trial was to evaluate ... ...

Abstract	Older patients with acute myeloid leukemia (AML) experience short survival despite intensive chemotherapy. Azacitidine has promising activity in patients with low proliferating AML. The aim of this dose-finding part of this trial was to evaluate feasibility and safety of azacitidine combined with a cytarabine- and daunorubicin-based chemotherapy in older patients with AML.Prospective, randomised, open, phase II trial with parallel group design and fixed sample size.Patients aged 61 years or older, with untreated acute myeloid leukemia with a leukocyte count of <20,000/µl at the time of study entry and adequate organ function were eligible. Patients were randomised to receive azacitidine either 37.5 (dose level 1) or 75 mg/sqm (dose level 2) for five days before each cycle of induction (7+3 cytarabine plus daunorubicine) and consolidation (intermediate-dose cytarabine) therapy. Dose-limiting toxicity was the primary endpoint.Six patients each were randomised into each dose level and evaluable for analysis. No dose-limiting toxicity occurred in either dose level. Nine serious adverse events occurred in five patients (three in the 37.5 mg, two in the 75 mg arm) with two fatal outcomes. Two patients at the 37.5 mg/sqm dose level and four patients at the 75 mg/sqm level achieved a complete remission after induction therapy. Median overall survival was 266 days and median event-free survival 215 days after a median follow up of 616 days.The combination of azacitidine 75 mg/sqm with standard induction therapy is feasible in older patients with AML and was selected as an investigational arm in the randomised controlled part of this phase-II study, which is currently halted due to an increased cardiac toxicity observed in the experimental arm.This trial is registered at clinical trials.gov (identifier: NCT00915252).
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2012-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial)

Joachim Gerss / Javier Ripollés-Melchor / Emmanuel Futier / Melanie Meersch / Carola Wempe / Detlef Kindgen-Milles / Alexander Zarbock / Markus W Hollmann / Sigismond Lasocki / Thomas Rimmele / Tim Rahmel / Michael Adamzik / Hartmuth Nowak / Ingeborg Welters / Brian Johnston / Ane Abad-motos / Alfredo Abad-gurumeta / Marc Moritz Berger / Davide Ricci /

Maurizio Cecconi / Gudrun Kunst / Christian Stoppe / Christian Putensen / Marlies Ostermann / Sascha Ott / Brijesh Patel / Gabriele Baldini / Antoine Lamblin / Karen Williams / Elena Mancini / Christian Arndt / Hinnerk Wulf / Marc Irqsusi / Wim Vandenberghe / John Kellum / Raphael Weiss / Jackie Donovan / Lui G Forni / Giacomo Monti / Céline Monard / Markus A Weigand / Thorsten Brenner / Ulrich Jaschinski / Carlos Lopez / Maxime Leger / Emmanuel Rineau / Philipp Simon / María Gómez-Rojo / Lars Bergmann / Alicia Waite / Savino Spadaro / Alexander Wolf / Andrew Spence / Simon Dubler / Alexander PJ Vlaar / Patrick Schober / Ben C Creagh-Brown / Nandor Marczin / Emilio Maseda / Christian Strauss / Stefano Romagnoli / Christian Nusshag / Ulrich Gobel / Ángel Candela-Toha / Jon Silversides / Nuttha Lumlertgul / Khaschayar Saadat-Gilani / Vincent Legros / Timo Brandenburger / Thomas Dimski / Laura Huthmann / Claude Pelletier / Manon Schleß / Peter Rosenberger / Helene Häberle / Jan Gerrit Haaker / Matthias Gründel / Lucia Cattin / Laura Villarino Villa / Juan Victor Lorente / Christine Martin / Jan Larmann / Wolfgang Bauer / Giovanni Borghi / Benjamin O’Brien / Thilo von Groote / Antoine Guillaume Schneider / Silvia De Rosa / Diego Parise / Alice Bernard / Paula Fernández-Valdes-Bango / Irene Romero Bhathal / A Suarez-de-la-Rica / Gianluca Villa / Raquel García-Álvarez / Antonio Siniscalchi / Richard Ellerkmann / Florian Espeter / Christian Porschen / Mahan Sadjadi / Michael Storck / Tobias Brix / Dana Meschede / Wida Amini / Carina Stenger / Julius Freytag / Jens Brands / Matthias Unterberg / Britta Marko / Fabian Dusse / Wolfgang A Wetsch / Sandra E Stoll / Hendrik Drinhaus / Bernd W Böttiger / Onnen Mörer / Lars-Olav Harnisch / Roswitha Lubjuhn / Daniel Heise / Christian Bode / Andrea Sauer / Konrad Peukert / Lennart Wild / Philippe Kruse / Jan Menzenbach / Valbona Mirakaj / Sabine Hermann / Stefanie Decker / Mona Jung-König / Tobias Hölle / Sarah Dehne / Jörg Reutershan / Thomas Prüfer / Stefan Pielmeier / Indra Wimmelmeier / Michaela Scholz / Andrea Paris / Isabel Christina Gallego Zapata / Holger Pohl / Nirmeen Fayed / Kai Dielmann / Evelyn Martin / Tilo Koch / Alexander Mück / Philipp Deetjen / Ngoc Bich Mehlmann / Peter M Spieth / Andreas Güldner / Axel Rand / Maximillian Ragaller / Martin Mirus / Rebecca Bockholt / Marc Herzog / Maren Kleine-Brüggeney / Ant Isabelle Cristiani / Marion Ohl / Monica Vieira Da Silva / Gilda Filipe de Castro Reblo / Matthias Hilty / Katharina Spanaus / Benedetta Mura / Eleonora Terreni / Francesco Magiotti / Lorenzo Turi / Cristiana Laici / Chiara Capozzi / Andrea Castelli / Massimiliano Greco / Antonio Messina / Gianluca Castellani / Romina Aceto / Vinicio Danzi / Alessandro Rigobello / Massimo De Cal / Monica Zanella / Gaetano Scaramuzzo / Riccardo La Rosa / Paolo Priani / Alberto Volta Carlo / Stefano Turi / Martina Baiardo Redaelli / Marilena Marmiere / Kittisak Weerapolchai / Shelley Lorah / Fabiola D’Amato / Aneta Bociek / Rosario Lim / Benjie Cendreda / Reynaldo Dela Cuesta / Eirini Kosifidou / Zoka Milan / Juliana Fernanda / Emma Clarey / Daveena Meeks / Nicholas J Lees / Marco Scaramuzzi / Orinta Kviatkovske / Adam Glass / Christine Turley / Charlotte Quinn / Syeda Haider / Adam Rossiter / Syed Nasser / Ned Gilbert-Kawai / Tatjana Besse-Hammer / Eric Hoste / Hannah Schaubroeck / Jan De Waele / Jenni Breel / Eline de Klerk / Harm-Jan de Grooth / Lothar Schwarte / Alexander Loer / Alicia Ruiz-Escobar / Diana Fernández-García / Nerea Gómez-Pérez / Pascual Crespo-Aliseda / Cristina Cerro-Zaballos / Cristina Fernández-Martín / Eduardo Martín-Montero / Alejandro Suarez de la Rica / Héctor Berges Gutiérrez / Maria del Pino Heredia Pérez / Maria de los Reyes Bellido Fernández / Liena Izquierdo López / Javier Valiente Lourtau / Ma Angeles Ferre Colomer / Ma Azucena Pajares Moncho / Maria Jesús Montero Hernández / Esther Pérez Sancho / Silvia Polo Matínez / Pedro Rivera Soria / Maider Puyada Jáuregui / Hugo Rivera Ramos / Marta Antelo Adrán / Ramón Adalia Bartolomé / Patricia Galán Menéndez / Laura Llinares Espin / Yuri Santiago Loaiza Aldean / Víctor MoralesAriza / Rosalía Navarro-Perez / Luis Santé-Serna / Pedro de la Calle-Elguezabal / Rubén Sánchez-Martín / Inés De Soto / Pau Vallhonrat Alcántara / Laura Perelló Cerdà / Gal·la Rouras Hurtado / Paula Rodriguez Nieto / John Narros Sicluna / Angel Molero Molinero / Juan Pablo Nocete / Elena Murcia Sánchez / Stanislas Abrard / Marie-Luce Parrouffe / Frank Bidar / Lucie Aupetitgendre / Ugo Schiff / Bertille Paquette / Gaëlle Sellier / Nathalie Borgnetta / Benjamin Brochet / Thierry Floch / Julien Coffinet / Marion Leclercq-Rouget

BMJ Open, Vol 13, Iss

study protocol for an international, prospective, randomised controlled multicentre trial

2023 Volume 3

Abstract: Introduction Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might ... ...

Abstract	Introduction Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation.Methods and analysis The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2insulin like growth factor binding protein 7 (TIMP-2)IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)*(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage.Ethics and dissemination The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will ...
Keywords	Medicine ; R
Subject code	616 ; 610
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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