29 Works
Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial
Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Janus Engstrøm, Jane Lindschou, Hartwig Roman Siebner, Frank Verhulst, Pia Jeppesen, Jens Richardt Møllegaard Jepsen, Signe Vangkilde, Per Hove Thomsen, Katja Hybel, Line Katrine Harder Clemmesen, Christian Gluud, Kerstin Jessica Plessen, Anne Katrine Pagsberg & Janus Christian Jakobsen
Abstract Background Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural therapy (CBT), which, in more severely affected patients, can be combined with antidepressant medication. The TECTO trial aims to compare the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation/relaxation training (FPRT) in children and adolescents aged 8 to 17 years. This statistical analysis...
Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial
Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Janus Engstrøm, Jane Lindschou, Hartwig Roman Siebner, Frank Verhulst, Pia Jeppesen, Jens Richardt Møllegaard Jepsen, Signe Vangkilde, Per Hove Thomsen, Katja Hybel, Line Katrine Harder Clemmesen, Christian Gluud, Kerstin Jessica Plessen, Anne Katrine Pagsberg & Janus Christian Jakobsen
Abstract Background Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural therapy (CBT), which, in more severely affected patients, can be combined with antidepressant medication. The TECTO trial aims to compare the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation/relaxation training (FPRT) in children and adolescents aged 8 to 17 years. This statistical analysis...
An algorithm based on the postoperative decrease of albumin (ΔAlb) to anticipate complications after liver surgery
Ismail Labgaa, Luis Cano, Orsalia Mangana, Gaëtan-Romain Joliat, Emmanuel Melloul, Nermin Halkic, Markus Schäfer, Eric Vibert, Nicolas Demartines, Nicolas Golse & Martin Hübner
Abstract Background Perioperative decrease of albumin (ΔAlb) appeared as a promising predictor of complications after digestive surgery, but its role after liver surgery remains unclear. This study aimed to analyze whether and how ΔAlb can be used to predict complications after liver surgery. Methods A bicentric retrospective analysis of patients undergoing liver surgery (2010–2016) was performed, following TRIPOD guidelines. The preoperative and postoperative difference of albumin was calculated on POD 0 and defined as ΔAlb....
An algorithm based on the postoperative decrease of albumin (ΔAlb) to anticipate complications after liver surgery
Ismail Labgaa, Luis Cano, Orsalia Mangana, Gaëtan-Romain Joliat, Emmanuel Melloul, Nermin Halkic, Markus Schäfer, Eric Vibert, Nicolas Demartines, Nicolas Golse & Martin Hübner
Abstract Background Perioperative decrease of albumin (ΔAlb) appeared as a promising predictor of complications after digestive surgery, but its role after liver surgery remains unclear. This study aimed to analyze whether and how ΔAlb can be used to predict complications after liver surgery. Methods A bicentric retrospective analysis of patients undergoing liver surgery (2010–2016) was performed, following TRIPOD guidelines. The preoperative and postoperative difference of albumin was calculated on POD 0 and defined as ΔAlb....
Fluid balance and renal replacement therapy initiation strategy: a secondary analysis of the STARRT-AKI trial
Ron Wald, Brian Kirkham, Bruno R. daCosta, Ehsan Ghamarian, Neill K. J. Adhikari, William Beaubien-Souligny, Rinaldo Bellomo, Martin P. Gallagher, Stuart Goldstein, Eric A. J. Hoste, Kathleen D. Liu, Javier A. Neyra, Marlies Ostermann, Paul M. Palevsky, Antoine Schneider, Suvi T. Vaara & Sean M. Bagshaw
Abstract Background Among critically ill patients with acute kidney injury (AKI), earlier initiation of renal replacement therapy (RRT) may mitigate fluid accumulation and confer better outcomes among individuals with greater fluid overload at randomization. Methods We conducted a pre-planned post hoc analysis of the STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. We evaluated the effect of accelerated RRT initiation on cumulative fluid balance over the course of 14...
Clinical Practice Guidelines on Palliative Sedation Around the World: A Systematic Review
Martyna Tomczyk, Cécile Jaques & Ralf J. Jox
Objective: The principal aim of this study was to identify, systematically and transparently, clinical practice guidelines (CPGs) on palliative sedation from around the world. Methods: A systematic search was performed using 5 databases, grey literature search tools, citation tracking, and contact with palliative care experts across the world. Current CPGs accredited by an international, national, or regional authority, published in English, German, French, or Italian, were subjected to content analysis. Results: In total, 35 CPGs...
Clinical Practice Guidelines on Palliative Sedation Around the World: A Systematic Review
Martyna Tomczyk, Cécile Jaques & Ralf J. Jox
Objective: The principal aim of this study was to identify, systematically and transparently, clinical practice guidelines (CPGs) on palliative sedation from around the world. Methods: A systematic search was performed using 5 databases, grey literature search tools, citation tracking, and contact with palliative care experts across the world. Current CPGs accredited by an international, national, or regional authority, published in English, German, French, or Italian, were subjected to content analysis. Results: In total, 35 CPGs...
Clinical Practice Guidelines on Palliative Sedation Around the World: A Systematic Review
Martyna Tomczyk, Cécile Jaques & Ralf J. Jox
Objective: The principal aim of this study was to identify, systematically and transparently, clinical practice guidelines (CPGs) on palliative sedation from around the world. Methods: A systematic search was performed using 5 databases, grey literature search tools, citation tracking, and contact with palliative care experts across the world. Current CPGs accredited by an international, national, or regional authority, published in English, German, French, or Italian, were subjected to content analysis. Results: In total, 35 CPGs...
Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial
Jean Chastre, Bruno François, Marc Bourgeois, Apostolos Komnos, Ricard Ferrer, Galia Rahav, Nicolas De Schryver, Alain Lepape, Iftihar Koksal, Charles-Edouard Luyt, Miguel Sánchez-García, Antoni Torres, Philippe Eggimann, Despoina Koulenti, Thomas L. Holland, Omar Ali, Kathryn Shoemaker, Pin Ren, Julien Sauser, Alexey Ruzin, David E. Tabor, Ahmad Akhgar, Yuling Wu, Yu Jiang, Antonio DiGiandomenico … & Hasan S. Jafri
Abstract Background Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. Methods EVADE (NCT02696902) was a phase 2, randomised, parallel-group, double-blind, placebo-controlled study in Europe, Turkey, Israel, and the USA. Subjects ≥ 18 years old, mechanically ventilated, tracheally colonised with PA, and without new-onset pneumonia, were randomised (1:1:1)...
A Retrospective Study of the Role of Perioperative Serum Albumin and the Albumin–Bilirubin Grade in Predicting Post-Liver Transplant Length of Stay
Ryan Wang, Daniel Katz, Hung-Mo Lin, Yuxia Ouyang, Jonathan Gal, Sumanth Suresh, Ismail Labgaa, Parissa Tabrizian, Samuel Demaria, Jeron Zerillo & Natalie K. Smith
IntroductionSerum albumin’s association with liver transplant outcomes has been investigated with mixed findings. This study aimed to evaluate perioperative albumin level, independently and as part of the albumin–bilirubin (ALBI) grade, as a predictor of post-liver transplant hospital and intensive care unit (ICU) length of stay (LOS).MethodsAdult liver-only transplant recipients at our institution from September 2011 to May 2019 were included in this retrospective study. Repeat transplants were excluded. Demographic, laboratory, and hospital course data were...
A Retrospective Study of the Role of Perioperative Serum Albumin and the Albumin–Bilirubin Grade in Predicting Post-Liver Transplant Length of Stay
Ryan Wang, Daniel Katz, Hung-Mo Lin, Yuxia Ouyang, Jonathan Gal, Sumanth Suresh, Ismail Labgaa, Parissa Tabrizian, Samuel Demaria, Jeron Zerillo & Natalie K. Smith
IntroductionSerum albumin’s association with liver transplant outcomes has been investigated with mixed findings. This study aimed to evaluate perioperative albumin level, independently and as part of the albumin–bilirubin (ALBI) grade, as a predictor of post-liver transplant hospital and intensive care unit (ICU) length of stay (LOS).MethodsAdult liver-only transplant recipients at our institution from September 2011 to May 2019 were included in this retrospective study. Repeat transplants were excluded. Demographic, laboratory, and hospital course data were...
Reproducibility of lung cancer radiomics features extracted from data-driven respiratory gating and free-breathing flow imaging in [18F]-FDG PET/CT
Daphné Faist, Mario Jreige, Valentin Oreiller, Marie Nicod Lalonde, Niklaus Schaefer, Adrien Depeursinge & John O. Prior
Abstract Background Quality and reproducibility of radiomics studies are essential requirements for the standardisation of radiomics models. As recent data-driven respiratory gating (DDG) [18F]-FDG has shown superior diagnostic performance in lung cancer, we evaluated the impact of DDG on the reproducibility of radiomics features derived from [18F]-FDG PET/CT in comparison to free-breathing flow (FB) imaging. Methods Twenty four lung nodules from 20 patients were delineated. Radiomics features were derived on FB flow PET/CT and on...
The combined impact of persistent infections and human genetic variation on C-reactive protein levels
Flavia Hodel, Olivier Naret, Clara Bonnet, Nicole Brenner, Noemi Bender, Tim Waterboer, Pedro Marques-Vidal, Peter Vollenweider & Jacques Fellay
Abstract Multiple human pathogens establish chronic, sometimes life-long infections. Even if they are often latent, these infections can trigger some degree of local or systemic immune response, resulting in chronic low-grade inflammation. There remains an incomplete understanding of the potential contribution of both persistent infections and human genetic variation on chronic low-grade inflammation. We searched for potential associations between seropositivity for 13 persistent pathogens and the plasma levels of the inflammatory biomarker C-reactive protein (CRP),...
Physiological response to prone positioning in intubated adults with COVID-19 acute respiratory distress syndrome: a retrospective study
Andrea Boffi, Maximilien Ravenel, Ermes Lupieri, Antoine Schneider, Lucas Liaudet, Michel Gonzalez, Jean-Daniel Chiche & Lise Piquilloud
Abstract Background COVID-19 related acute respiratory distress syndrome (ARDS) has specific characteristics compared to ARDS in other populations. Proning is recommended by analogy with other forms of ARDS, but few data are available regarding its physiological effects in this population. This study aimed to assess the effects of proning on oxygenation parameters (PaO2/FiO2 and alveolo-arterial gradient (Aa-gradient)), blood gas analysis, ventilatory ratio (VR), respiratory system compliance (CRS) and estimated dead space fraction (VD/VT HB). We...
Identifying complex patients in family medicine for potential benefit from a case manager: a short questionnaire derived from the INTERMED Self-Assessment (IMSA) questionnaire
Christine Cohidon, Emilie Gallay, Pascal Wild, Friedrich Stiefel, Céline Bourquin & Nicolas Senn
Abstract Purpose To investigate how useful the Intermed-Self Assessment (IMSA) questionnaire and its components were for identifying which patient candidates would benefit most from case management (CM) in general practice. Methods The study was carried out in a group family medicine practice in Lausanne comprising seven GPs and four medical assistants, from February to April 2019. All the patients attending the practice between February and April 2019 were invited to complete the IMSA questionnaire. Additionally,...
Efficacy and pharmacokinetics of betaine in CBS and cblC deficiencies: a cross-over randomized controlled trial
Apolline Imbard, Artemis Toumazi, Sophie Magréault, Nuria Garcia-Segarra, Dimitri Schlemmer, Florentia Kaguelidou, Isabelle Perronneau, Jérémie Haignere, Hélène Ogier de Baulny, Alice Kuster, François Feillet, Corinne Alberti, Sophie Guilmin-Crépon, Jean-François Benoist & Manuel Schiff
Abstract Background Betaine is an “alternate” methyl donor for homocysteine remethylation catalyzed by betaine homocysteine methyltransferase (BHMT), an enzyme mainly expressed in the liver and kidney. Betaine has been used for more than 30 years in pyridoxine non-responsive cystathionine beta-synthase (pnrCBS) and cobalamin C (cblC) deficiencies to lower the hyperhomocysteinemia, although little is known about the optimal therapeutic dosage and its pharmacokinetic in these patients. Aims We compared 2 betaine doses (100 mg/kg/day vs. 250...
Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
Andreas R. Gantenbein, Reto Agosti, Christian P. Kamm, Gunther Landmann, Niklaus Meier, Gabriele Susanne Merki-Feld, Jens A. Petersen, Heiko Pohl, Philippe Ryvlin, Christoph J. Schankin, Dragana Viceic, Chiara Zecca, Elisabeth Schäfer, Ina Meyer & Michael E. Arzt
Abstract Background The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. Methods An interim analysis was conducted...
Fluid balance and renal replacement therapy initiation strategy: a secondary analysis of the STARRT-AKI trial
Ron Wald, Brian Kirkham, Bruno R. daCosta, Ehsan Ghamarian, Neill K. J. Adhikari, William Beaubien-Souligny, Rinaldo Bellomo, Martin P. Gallagher, Stuart Goldstein, Eric A. J. Hoste, Kathleen D. Liu, Javier A. Neyra, Marlies Ostermann, Paul M. Palevsky, Antoine Schneider, Suvi T. Vaara & Sean M. Bagshaw
Abstract Background Among critically ill patients with acute kidney injury (AKI), earlier initiation of renal replacement therapy (RRT) may mitigate fluid accumulation and confer better outcomes among individuals with greater fluid overload at randomization. Methods We conducted a pre-planned post hoc analysis of the STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. We evaluated the effect of accelerated RRT initiation on cumulative fluid balance over the course of 14...
VoiceS: voice quality after transoral CO2 laser surgery versus single vocal cord irradiation for unilateral stage 0 and I glottic larynx cancer—a randomized phase III trial
Philipp Reinhardt, Roland Giger, Eberhard Seifert, Mohamed Shelan, Elena Riggenbach, Dario Terribilini, Andreas Joosten, Daniel H. Schanne, Daniel M. Aebersold, Peter Manser, Matthias S. Dettmer, Christian Simon, Esat M. Ozsahin, Raphaël Moeckli, Andreas Limacher, Francesca Caparrotti, Deepa Nair, Jean Bourhis, Martina A. Broglie, Abrahim Al-Mamgani & Olgun Elicin
Abstract Background Surgery and radiotherapy are well-established standards of care for unilateral stage 0 and I early-stage glottic cancer (ESGC). Based on comparative studies and meta-analyses, functional and oncological outcomes after both treatment modalities are similar. Historically, radiotherapy (RT) has been performed by irradiation of the whole larynx. However, only the involved vocal cord is being treated with recently introduced hypofractionated concepts that result in 8 to 10-fold smaller target volumes. Retrospective data argues for...
The combined impact of persistent infections and human genetic variation on C-reactive protein levels
Flavia Hodel, Olivier Naret, Clara Bonnet, Nicole Brenner, Noemi Bender, Tim Waterboer, Pedro Marques-Vidal, Peter Vollenweider & Jacques Fellay
Abstract Multiple human pathogens establish chronic, sometimes life-long infections. Even if they are often latent, these infections can trigger some degree of local or systemic immune response, resulting in chronic low-grade inflammation. There remains an incomplete understanding of the potential contribution of both persistent infections and human genetic variation on chronic low-grade inflammation. We searched for potential associations between seropositivity for 13 persistent pathogens and the plasma levels of the inflammatory biomarker C-reactive protein (CRP),...
Collaborative medication management for older adults after hospital discharge: a qualitative descriptive study
Filipa Pereira, Marion Bieri, Maria del Rio Carral, Maria Manuela Martins & Henk Verloo
Abstract Background Safe medication management for older adults after hospital discharge requires a well-coordinated, interprofessional, patient-centered approach. This study aimed to describe the perceived needs for collaborative medication management for older adults taking several different medications at home after hospital discharge. Methods A qualitative descriptive study was conducted using semi-structured interviews with older adults (n = 28), informal (n = 17), and professional caregivers (n = 13). Results Findings revealed four main needs: older adults...
Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial
Jean Chastre, Bruno François, Marc Bourgeois, Apostolos Komnos, Ricard Ferrer, Galia Rahav, Nicolas De Schryver, Alain Lepape, Iftihar Koksal, Charles-Edouard Luyt, Miguel Sánchez-García, Antoni Torres, Philippe Eggimann, Despoina Koulenti, Thomas L. Holland, Omar Ali, Kathryn Shoemaker, Pin Ren, Julien Sauser, Alexey Ruzin, David E. Tabor, Ahmad Akhgar, Yuling Wu, Yu Jiang, Antonio DiGiandomenico … & Hasan S. Jafri
Abstract Background Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. Methods EVADE (NCT02696902) was a phase 2, randomised, parallel-group, double-blind, placebo-controlled study in Europe, Turkey, Israel, and the USA. Subjects ≥ 18 years old, mechanically ventilated, tracheally colonised with PA, and without new-onset pneumonia, were randomised (1:1:1)...
Efficacy and pharmacokinetics of betaine in CBS and cblC deficiencies: a cross-over randomized controlled trial
Apolline Imbard, Artemis Toumazi, Sophie Magréault, Nuria Garcia-Segarra, Dimitri Schlemmer, Florentia Kaguelidou, Isabelle Perronneau, Jérémie Haignere, Hélène Ogier de Baulny, Alice Kuster, François Feillet, Corinne Alberti, Sophie Guilmin-Crépon, Jean-François Benoist & Manuel Schiff
Abstract Background Betaine is an “alternate” methyl donor for homocysteine remethylation catalyzed by betaine homocysteine methyltransferase (BHMT), an enzyme mainly expressed in the liver and kidney. Betaine has been used for more than 30 years in pyridoxine non-responsive cystathionine beta-synthase (pnrCBS) and cobalamin C (cblC) deficiencies to lower the hyperhomocysteinemia, although little is known about the optimal therapeutic dosage and its pharmacokinetic in these patients. Aims We compared 2 betaine doses (100 mg/kg/day vs. 250...
Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results
Andreas R. Gantenbein, Reto Agosti, Christian P. Kamm, Gunther Landmann, Niklaus Meier, Gabriele Susanne Merki-Feld, Jens A. Petersen, Heiko Pohl, Philippe Ryvlin, Christoph J. Schankin, Dragana Viceic, Chiara Zecca, Elisabeth Schäfer, Ina Meyer & Michael E. Arzt
Abstract Background The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. Methods An interim analysis was conducted...
Reproducibility of lung cancer radiomics features extracted from data-driven respiratory gating and free-breathing flow imaging in [18F]-FDG PET/CT
Daphné Faist, Mario Jreige, Valentin Oreiller, Marie Nicod Lalonde, Niklaus Schaefer, Adrien Depeursinge & John O. Prior
Abstract Background Quality and reproducibility of radiomics studies are essential requirements for the standardisation of radiomics models. As recent data-driven respiratory gating (DDG) [18F]-FDG has shown superior diagnostic performance in lung cancer, we evaluated the impact of DDG on the reproducibility of radiomics features derived from [18F]-FDG PET/CT in comparison to free-breathing flow (FB) imaging. Methods Twenty four lung nodules from 20 patients were delineated. Radiomics features were derived on FB flow PET/CT and on...