11 research outputs found
Ponesimod Compared with Teriflunomide in Patients with Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study : A Randomized Clinical Trial
- Author
- Burcklen Michel
- D'Ambrosio Daniele
- Fox Robert J.
- Freedman Mark S.
- Hennessy Brian
- Hohlfeld Reinhard
- Kappos Ludwig
- Kracker Hilke
- Kubala Havrdova Eva
- Linscheid Philippe
- Lublin Fred
- Montalban Xavier
- Pirozek-Lawniczek Magdalena
- Pozzilli Carlo
- Scherz Tatiana
- Sprenger Till
- Universitat Autònoma de Barcelona
- Vaclavkova Andrea
- Publication venue
- Publication date
- 01/01/2021
- Field of study
Importance: To our knowledge, the Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first phase 3 study comparing 2 oral disease-modifying therapies for relapsing multiple sclerosis (RMS). Objective: To compare the efficacy of ponesimod, a selective sphingosine-1-phosphate receptor 1 (S1P) modulator with teriflunomide, a pyrimidine synthesis inhibitor, approved for the treatment of patients with RMS. Design, Setting, and Participants: This multicenter, double-blind, active-comparator, superiority randomized clinical trial enrolled patients from April 27, 2015, to May 16, 2019, who were aged 18 to 55 years and had been diagnosed with multiple sclerosis per 2010 McDonald criteria, with a relapsing course from the onset, Expanded Disability Status Scale (EDSS) scores of 0 to 5.5, and recent clinical or magnetic resonance imaging disease activity. Interventions: Patients were randomized (1:1) to 20 mg of ponesimod or 14 mg of teriflunomide once daily and the placebo for 108 weeks, with a 14-day gradual up-titration of ponesimod starting at 2 mg to mitigate first-dose cardiac effects of S1Pmodulators and a follow-up period of 30 days. Main Outcomes and Measures: The primary end point was the annualized relapse rate. The secondary end points were the changes in symptom domain of Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) at week 108, the number of combined unique active lesions per year on magnetic resonance imaging, and time to 12-week and 24-week confirmed disability accumulation. Safety and tolerability were assessed. Exploratory end points included the percentage change in brain volume and no evidence of disease activity (NEDA-3 and NEDA-4) status. Results: For 1133 patients (567 receiving ponesimod and 566 receiving teriflunomide; median [range], 37.0 [18-55] years; 735 women [64.9%]), the relative rate reduction for ponesimod vs teriflunomide in the annualized relapse rate was 30.5% (0.202 vs 0.290; P <.001); the mean difference in FSIQ-RMS, -3.57 (-0.01 vs 3.56; P <.001); the relative risk reduction in combined unique active lesions per year, 56% (1.405 vs 3.164; P <.001); and the reduction in time to 12-week and 24-week confirmed disability accumulation risk estimates, 17% (10.1% vs 12.4%; P =.29) and 16% (8.1% vs 9.9; P =.37), respectively. Brain volume loss at week 108 was lower by 0.34% (-0.91% vs -1.25%; P <.001); the odds ratio for NEDA-3 achievement was 1.70 (25.0% vs 16.4%; P <.001). Incidence of treatment-emergent adverse events (502 of 565 [88.8%] vs 499 of 566 [88.2%]) and serious treatment-emergent adverse events (49 [8.7%] vs 46 [8.1%]) was similar for both groups. Treatment discontinuations because of adverse events was more common in the ponesimod group (49 of 565 [8.7%] vs 34 of 566 [6.0%]). Conclusions and Relevance: In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation. The safety profile was in line with the previous safety observations with ponesimod and the known profile of other S1P receptor modulators
Temporal changes in fecal microbiota of patients infected with COVID-19: a longitudinal cohort
- Author
- Publication venue
- BMC
- Publication date
- 01/08/2023
- Field of study
Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a multifaceted disease potentially responsible for various clinical manifestations including gastro-intestinal symptoms. Several evidences suggest that the intestine is a critical site of immune cell development, gut microbiota could therefore play a key role in lung immune response. We designed a monocentric longitudinal observational study to describe the gut microbiota profile in COVID-19 patients and compare it to a pre-existing cohort of ventilated non-COVID-19 patients. Methods From March to December 2020, we included patients admitted for COVID-19 in medicine (43 not ventilated) or intensive care unit (ICU) (14 ventilated) with a positive SARS-CoV-2 RT-PCR assay in a respiratory tract sample. 16S metagenomics was performed on rectal swabs from these 57 COVID-19 patients, 35 with one and 22 with multiple stool collections. Nineteen non-COVID-19 ICU controls were also enrolled, among which 14 developed ventilator-associated pneumonia (pneumonia group) and five remained without infection (control group). SARS-CoV-2 viral loads in fecal samples were measured by qPCR. Results Although similar at inclusion, Shannon alpha diversity appeared significantly lower in COVID-19 and pneumonia groups than in the control group at day 7. Furthermore, the microbiota composition became distinct between COVID-19 and non-COVID-19 groups. The fecal microbiota of COVID-19 patients was characterized by increased Bacteroides and the pneumonia group by Prevotella. In a distance-based redundancy analysis, only COVID-19 presented significant effects on the microbiota composition. Moreover, patients in ICU harbored increased Campylobacter and decreased butyrate-producing bacteria, such as Lachnospiraceae, Roseburia and Faecalibacterium as compared to patients in medicine. Both the stay in ICU and patient were significant factors affecting the microbiota composition. SARS-CoV-2 viral loads were higher in ICU than in non-ICU patients. Conclusions Overall, we identified distinct characteristics of the gut microbiota in COVID-19 patients compared to control groups. COVID-19 patients were primarily characterized by increased Bacteroides and decreased Prevotella. Moreover, disease severity showed a negative correlation with butyrate-producing bacteria. These features could offer valuable insights into potential targets for modulating the host response through the microbiota and contribute to a better understanding of the disease's pathophysiology. Trial registration CER-VD 2020–00755 (05.05.2020) & 2017–01820 (08.06.2018)
Additional file 1 of Temporal changes in fecal microbiota of patients infected with COVID-19: a longitudinal cohort
- Author
- Publication venue
- Publication date
- 18/08/2023
- Field of study
Additional file 1: Figure S1. Flow chart of the study. Figure S2. Alpha diversity changes over time in ventilated and non-ventilated groups. Figure S3. Jaccard beta-diversity of ventilated and non-ventilated patients at day 0 depicted on NMDS
Additional file 2 of Temporal changes in fecal microbiota of patients infected with COVID-19: a longitudinal cohort
- Author
- Publication venue
- Publication date
- 18/08/2023
- Field of study
Additional file 2: Table S1. Demographic characteristics of participants based on the ventilatory status in the COVID-19 cohort. Table S2. COVID-19 symptoms, status and treatment of participants based on the ventilatory status in the COVID-19 cohort. Table S3. Risk factors of COVID-19 infected participants. Table S4. Demographic characteristics of Non-COVID-19 ventilated patients. Table S5. Nutrition characteristics of the patients
Supplementary material 4 from: Korshunova T, Martynov A, Bakken T, Evertsen J, Fletcher K, Mudianta WI, Saito H, Lundin K, Schrödl M, Picton B (2017) Polyphyly of the traditional family Flabellinidae affects a major group of Nudibranchia: aeolidacean taxonomic reassessment with descriptions of several new families, genera, and species (Mollusca, Gastropoda). ZooKeys 717: 1-139. https://doi.org/10.3897/zookeys.717.21885
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- Alder
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
- Alexander Martynov
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- Bernard Picton
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- Calado
- Carus
- Cervera
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- Cockerell
- Cooper
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- Eliot
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- Evertsen
- Folmer
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- Tatiana Korshunova
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- Tatiana Korshunova
- Tatiana Korshunova
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- Tatiana Korshunova
- Tatiana Korshunova
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- Tatiana Korshunova
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- Tatiana Korshunova
- Tatiana Korshunova
- Tatiana Korshunova
- Tatiana Korshunova
- Tatiana Korshunova
- Tatiana Korshunova
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- Tatiana Korshunova
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- Thiele
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- Thompson
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- Vayssiere
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- Verrill
- Vicente
- Voigt
- Volodchenko
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- Wagele
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- 'Pensoft Publishers'
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THM1 negatively modulates mouse sonic hedgehog signal transduction and affects retrograde intraflagellar transport in cilia
- Author
- A Liu
- Allyson L Chesebro
- Annick Turbe-Doan
- B Wang
- BJ Herron
- Bradley K Yoder
- Bruce J Herron
- C Chiang
- C Chiang
- C Houde
- C Iomini
- C Wang
- CA Perrone
- CJ Haycraft
- CJ Haycraft
- Courtney J Haycraft
- D Huangfu
- D Huangfu
- David R Beier
- EH Villavicencio
- G Piperno
- GJ Pazour
- Haiyan Qiu
- J Vierkotten
- JA Follit
- Jagesh V Shah
- JC Kim
- JC Schafer
- JL Moran
- JP Morgenstern
- JT Eggenschwiler
- KC Corbit
- LA Perkins
- LV Goodrich
- M Persson
- OE Blacque
- P te Welscher
- Pamela V Tran
- Paul J Scherz
- PW Ingham
- Q Ding
- Q Zhou
- R Mo
- R Rohatgi
- RD Sloboda
- Rolf W Stottmann
- S Karlin
- SJ Ansley
- SK Ogden
- SR May
- T Caspary
- Tatiana Y Besschetnova
- TM Jessell
- V Marigo
- WJ Snell
- XM Zhang
- Y Litingtung
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study
- Author
- Achiron Anat
- Achtnichts Lutz
- Agan Kadriye
- Akman-Demir Gulsen
- Allen Alison B
- Antel Jack P
- Antiguedad Alfredo Rodriguez
- Apperson Michelle
- Applebee Angela M
- Arnold Douglas L
- Arnould Sophie
- Ayuso Guillermo Izquierdo
- Baba Masayuki
- Bajenaru Ovidiu
- Balasa Rodica
- Balci Belgin Petek
- Bar-Or Amit
- Barnett Michael
- Bass Ann
- Becker Veit U
- Bejinariu Mihaela
- Bergh Florian Then
- Bergmann Arnfin
- Bernitsas Evanthia
- Berthele Achim
- Bhan Virender
- Bischof Felix
- Bjork Randall John
- Blevins Gregg
- Boehringer Matthias
- Boerner Thomas
- Bonek Robert
- Bowen James D
- Bowling Allen
- Boyko Alexey N
- Boz Cavit
- Bracknies Vera
- Braune Stefan
- Brescia Morra Vincenzo
- Brochet Bruno
- Brola Waldemar
- Brownstone Paul Kenneth
- Brozman Miroslav
- Brunet Donald
- Buraga Ioan
- Burnett Margaret
- Buttmann Mathias
- Butzkueven Helmut
- Cahill Jonathan
- Calkwood Jonathan C
- Camu William
- Cascione Mark
- Castelnovo Giovani
- Centonze Diego
- Cerqueira Joao
- Chan Andrew
- Cimprichova Andrea
- Cohan Stanley
- Comi Giancarlo
- Conway Jill
- Cooper Joanna A
- Corboy John
- Correale Jorge
- Costell Brian
- Cottrell David A
- Coyle Patricia K
- Craner Matthew
- Cree Bruce A C
- Cui Liying
- Cunha Luis
- Czlonkowska Anna
- da Silva Ana Martins
- Dahlke Frank
- de Sa Joao
- de Seze Jérôme
- Debouverie Marc
- Debruyne Jan
- Decoo Danny
- Defer Gilles
- Derfuss Tobias
- Deri Norma H
- Dihenia Bhupesh
- Dioszeghy Peter
- Donath Vladimir
- Dubois Benedicte
- Duddy Martin
- Duquette Pierre
- Edan Gilles
- Efendi Husnu
- Elias Stanton
- Emrich Peter J
- Estruch Bonaventura Casanova
- Evdoshenko Evgeniy P
- Faiss Juergen
- Fedyanin Alexander S
- Feneberg Wolfgang
- Fermont Jiske
- Fernandez Oscar Fernandez
- Ferrer Francisco Coret
- Fink Katharina
- Ford Corey
- Ford Helen
- Fox Robert J
- Francia Ada
- Freedman Mark
- Frishberg Benjamin
- Galgani Simonetta
- Garmany George P
- Gehring Klaus
- Giovannoni Gavin
- Gitt Jeffrey
- Gobbi Claudio
- Gold Ralf
- Goldstick Lawrence P
- Gonzalez Rafael Arroyo
- Grandmaison Francois
- Grigoriadis Nikolaos
- Grigorova Olga
- Grimaldi Luigi Maria Edoardo
- Gross Jeffrey
- Gross-Paju Katrin
- Gudesblatt Mark
- Guillaume Daniel
- Haas Judith
- Hancinova Viera
- Hancu Anca
- Hardiman Orla
- Harmjanz Arndt
- Heidenreich Fedor R
- Hengstman G J D
- Herbert Joseph
- Herring Mark
- Hodgkinson Suzanne
- Hoffmann Olaf M
- Hofmann Werner E
- Honeycutt William D
- Hua Le Hanh
- Huang Dehui
- Huang Deren
- Huang Yining
- Hupperts Raymond
- Imre Piroska
- Jacobs Alan Keith
- Jakab Gabor
- Jasinska Elzbieta
- Kaida Kenichi
- Kalnina Jolanta
- Kappos Ludwig
- Kaprelyan Ara
- Karelis Guntis
- Karussis Dimitrios
- Katz Amos
- Khabirov Farit A
- Khatri Bhupendra
- Kimura Takashi
- Kister Ilya
- Kizlaitiene Rasa
- Klimova Eleonora
- Koehler Juergen
- Komatineni Aparna
- Kornhuber Anselm
- Kovacs Krisztina
- Koves Agnes
- Kozubski Wojciech
- Krastev Georgi
- Krupp Lauren B
- Kurca Egon
- Lassek Christoph
- Laureys Guy
- Lee Liesly
- Lensch Eckart
- Leutmezer Fritz
- Li Hongzeng
- Linker Ralf A
- Linnebank Michael
- Liskova Petra
- Llanera Cristina
- Lu Jiahong
- Lutterotti Andreas
- Lycke Jan
- Macdonell Richard
- Maciejowski Maciej
- Maeurer Mathias
- Magzhanov Rim V
- Maida Eva-Maria
- Malciene Lina
- Mao-Draayer Yang
- Marfia Girolama Alessandra
- Markowitz Clyde
- Mastorodimos Vasileios
- Matyas Klotild
- Meca-Lallana Jose
- Merino Juan Antonio Garcia
- Mihetiu Ioan Gheorghe
- Milanov Ivan
- Miller Aaron E
- Millers Andrejs
- Mirabella Massimiliano
- Mizuno Masanori
- Montalban Xavier
- Montoya Lilina
- Mori Masahiro
- Mueller Stefanie
- Nakahara Jin
- Nakatsuji Yuji
- Newsome Scott
- Nicholas Richard
- Nielsen A Scott
- Nikfekr Esmaeil
- Nocentini Ugo
- Nohara Chiyoko
- Nomura Kyoichi
- Odinak Miroslav M
- Olsson Tomas
- Oreja-Guevara Celia
- Oschmann Patrick
- Overell James
- Pachner Andrew
- Panczel Gyula
- Pandolfo Massimo
- Papeix Caroline
- Patrucco Liliana
- Pelletier Jean
- Piedrabuena Raul
- Pless Misha
- Polzer Udo
- Pozsegovits Krisztian
- Rastenyte Daiva
- Rauer Sebastian
- Reifschneider Gerd
- Rey Roberto
- Rizvi Syed A
- Robertson Derrick
- Rodriguez Jose Martinez
- Rog David
- Roshanisefat Homayoun
- Rowe Vernon
- Rozsa Csilla
- Rubin Susan
- Rusek Stanislaw
- Saccà Francesco
- Saida Takahiko
- Salgado Antonio Vasco
- Sanchez Victoria Eugenia Fernandez
- Sanders Kalina
- Satori Maria
- Sazonov Denis V
- Scarpini Elio Angelo
- Scherz Tatiana
- Schlegel Eugen
- Schluep Myriam
- Schmidt Stephan
- Scholz Erich
- Schrijver H M
- Schwab Matthias
- Schwartz Raymond
- Scott James
- Selmaj Krzysztof
- Shafer Stuart
- Sharrack Basil
- Shchukin Ivan A
- Shimizu Yuko
- Shotekov Penko
- Siever Arno
- Sigel Karl-Otto
- Silliman Scott
- Simo Magdolna
- Simu Mihaela
- Sinay Vladimiro
- Siquier Antonio Escartin
- Siva Aksel
- Skoda Ondrej
- Solomon Andrew
- Stangel Martin
- Stefoski Dusan
- Steingo Brian
- Stolyarov Igor D
- Stourac Pavel
- Strassburger-Krogias Katrin
- Strauss Erik
- Stuve Olaf
- Tarnev Ivaylo
- Tavernarakis Antonios
- Tello Cristina Ramo
- Terzi Murat
- Ticha Veronika
- Ticmeanu Marina
- Tiel-Wilck Klaus
- Toomsoo Toomas
- Tubridy Niall
- Tullman Mark J
- Tumani Hayrettin
- Turcani Peter
- Turner Ben
- Uccelli Antonio
- Urtaza Francisco Javier Olascoaga
- Vachova Marta
- Valikovics Attila
- van Oosten B W
- Van Wijmeersch Bart
- Vanopdenbosch Ludo
- Vermersch Patrick
- Vermersch Patrick
- Visser L H
- Vorobeychik Galina
- Wallström Erik
- Walter Silke
- Weber Joerg R
- Weiss Sara
- Weissert Robert
- West Timothy
- Wiendl Heinz
- Wiertlewski Sandrine
- Wildemann Brigitte
- Willekens Barbara
- Wolf Christian
- Xu Xianhao
- Yamamura Takashi
- Yang Yi N
- Yelamos Sergio Martinez
- Yeung Michael
- Zacharias Alan
- Zelkowitz Marvin
- Zettl Uwe
- Zhang Meini
- Zhou Hongyu
- Zieman Ulf
- Ziemssen Tjalf
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2018
- Field of study
International audienc
Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND) : a double-blind, randomised, phase 3 study
- Author
- Achiron Anat
- Achtnichts Lutz
- Agan Kadriye
- Akman-Demir Gulsen
- Allen Alison B
- Antel Jack P
- Antiguedad Alfredo Rodriguez
- Apperson Michelle
- Applebee Angela M
- Arnold Douglas L
- Arnould Sophie
- Ayuso Guillermo Izquierdo
- Baba Masayuki
- Bajenaru Ovidiu
- Balasa Rodica
- Balci Belgin Petek
- Bar-Or Amit
- Barnett Michael
- Bass Ann
- Becker Veit U
- Bejinariu Mihaela
- Bergh Florian Then
- Bergmann Arnfin
- Bernitsas Evanthia
- Berthele Achim
- Bhan Virender
- Bischof Felix
- Bjork Randall John
- Blevins Gregg
- Boehringer Matthias
- Boerner Thomas
- Bonek Robert
- Bowen James D
- Bowling Allen
- Boyko Alexey N
- Boz Cavit
- Bracknies Vera
- Braune Stefan
- Brescia Morra Vincenzo
- Brochet Bruno
- Brola Waldemar
- Brownstone Paul Kenneth
- Brozman Miroslav
- Brunet Donald
- Buraga Ioan
- Burnett Margaret
- Buttmann Mathias
- Butzkueven Helmut
- Cahill Jonathan
- Calkwood Jonathan C
- Camu William
- Cascione Mark
- Castelnovo Giovani
- Centonze Diego
- Cerqueira Joao
- Chan Andrew
- Cimprichova Andrea
- Cohan Stanley
- Comi Giancarlo
- Conway Jill
- Cooper Joanna A
- Corboy John
- Correale Jorge
- Costell Brian
- Cottrell David A
- Coyle Patricia K
- Craner Matthew
- Cree Bruce A C
- Cui Liying
- Cunha Luis
- Czlonkowska Anna
- da Silva Ana Martins
- Dahlke Frank
- de Sa Joao
- de Seze J\ue9r\uf4me
- Debouverie Marc
- Debruyne Jan
- Decoo Danny
- Defer Gilles
- Derfuss Tobias
- Deri Norma H
- Dihenia Bhupesh
- Dioszeghy Peter
- Donath Vladimir
- Dubois Benedicte
- Duddy Martin
- Duquette Pierre
- Edan Gilles
- Efendi Husnu
- Elias Stanton
- Emrich Peter J
- Estruch Bonaventura Casanova
- Evdoshenko Evgeniy P
- Faiss Juergen
- Fedyanin Alexander S
- Feneberg Wolfgang
- Fermont Jiske
- Fernandez Oscar Fernandez
- Ferrer Francisco Coret
- Fink Katharina
- Ford Corey
- Ford Helen
- Fox Robert J
- Francia Ada
- Freedman Mark
- Frishberg Benjamin
- Galgani Simonetta
- Garmany George P
- Gehring Klaus
- Giovannoni Gavin
- Gitt Jeffrey
- Gobbi Claudio
- Gold Ralf
- Goldstick Lawrence P
- Gonzalez Rafael Arroyo
- Grandmaison Francois
- Grigoriadis Nikolaos
- Grigorova Olga
- Grimaldi Luigi Maria Edoardo
- Gross Jeffrey
- Gross-Paju Katrin
- Gudesblatt Mark
- Guillaume Daniel
- Haas Judith
- Hancinova Viera
- Hancu Anca
- Hardiman Orla
- Harmjanz Arndt
- Heidenreich Fedor R
- Hengstman G J D
- Herbert Joseph
- Herring Mark
- Hodgkinson Suzanne
- Hoffmann Olaf M
- Hofmann Werner E
- Honeycutt William D
- Hua Le Hanh
- Huang Dehui
- Huang DeRen
- Huang Yining
- Hupperts Raymond
- Imre Piroska
- Jacobs Alan Keith
- Jakab Gabor
- Jasinska Elzbieta
- Kaida Kenichi
- Kalnina Jolanta
- Kappos Ludwig
- Kaprelyan Ara
- Karelis Guntis
- Karussis Dimitrios
- Katz Amos
- Khabirov Farit A
- Khatri Bhupendra
- Kimura Takashi
- Kister Ilya
- Kizlaitiene Rasa
- Klimova Eleonora
- Koehler Juergen
- Komatineni Aparna
- Kornhuber Anselm
- Kovacs Krisztina
- Koves Agnes
- Kozubski Wojciech
- Krastev Georgi
- Krupp Lauren B
- Kurca Egon
- Lassek Christoph
- Laureys Guy
- Lee Liesly
- Lensch Eckart
- Leutmezer Fritz
- Li Hongzeng
- Linker Ralf A
- Linnebank Michael
- Liskova Petra
- Llanera Cristina
- Lu Jiahong
- Lutterotti Andreas
- Lycke Jan
- Macdonell Richard
- Maciejowski Maciej
- Maeurer Mathias
- Magzhanov Rim V
- Maida Eva-Maria
- Malciene Lina
- Mao-Draayer Yang
- Marfia Girolama Alessandra
- Markowitz Clyde
- Mastorodimos Vasileios
- Matyas Klotild
- Meca-Lallana Jose
- Merino Juan Antonio Garcia
- Mihetiu Ioan Gheorghe
- Milanov Ivan
- Miller Aaron E
- Millers Andrejs
- Mirabella Massimiliano
- Mizuno Masanori
- Montalban Xavier
- Montoya Lilina
- Mori Masahiro
- Mueller Stefanie
- Nakahara Jin
- Nakatsuji Yuji
- Newsome Scott
- Nicholas Richard
- Nielsen A Scott
- Nikfekr Esmaeil
- Nocentini Ugo
- Nohara Chiyoko
- Nomura Kyoichi
- Odinak Miroslav M
- Olsson Tomas
- Oreja-Guevara Celia
- Oschmann Patrick
- Overell James
- Pachner Andrew
- Panczel Gyula
- Pandolfo Massimo
- Papeix Caroline
- Patrucco Liliana
- Pelletier Jean
- Piedrabuena Raul
- Pless Misha
- Polzer Udo
- Pozsegovits Krisztian
- Rastenyte Daiva
- Rauer Sebastian
- Reifschneider Gerd
- Rey Roberto
- Rizvi Syed A
- Robertson Derrick
- Rodriguez Jose Martinez
- Rog David
- Roshanisefat Homayoun
- Rowe Vernon
- Rozsa Csilla
- Rubin Susan
- Rusek Stanislaw
- Sacc\ue0 Francesco
- Saida Takahiko
- Salgado Antonio Vasco
- Sanchez Victoria Eugenia Fernandez
- Sanders Kalina
- Satori Maria
- Sazonov Denis V
- Scarpini Elio Angelo
- Scherz Tatiana
- Schlegel Eugen
- Schluep Myriam
- Schmidt Stephan
- Scholz Erich
- Schrijver H M
- Schwab Matthias
- Schwartz Raymond
- Scott James
- Selmaj Krzysztof
- Shafer Stuart
- Sharrack Basil
- Shchukin Ivan A
- Shimizu Yuko
- Shotekov Penko
- Siever Arno
- Sigel Karl-Otto
- Silliman Scott
- Simo Magdolna
- Simu Mihaela
- Sinay Vladimiro
- Siquier Antonio Escartin
- Siva Aksel
- Skoda Ondrej
- Solomon Andrew
- Stangel Martin
- Stefoski Dusan
- Steingo Brian
- Stolyarov Igor D
- Stourac Pavel
- Strassburger-Krogias Katrin
- Strauss Erik
- Stuve Olaf
- Tarnev Ivaylo
- Tavernarakis Antonios
- Tello Cristina Ramo
- Terzi Murat
- Ticha Veronika
- Ticmeanu Marina
- Tiel-Wilck Klaus
- Toomsoo Toomas
- Tubridy Niall
- Tullman Mark J
- Tumani Hayrettin
- Turcani Peter
- Turner Ben
- Uccelli Antonio
- Urtaza Francisco Javier Olascoaga
- Vachova Marta
- Valikovics Attila
- van Oosten B W
- Van Wijmeersch Bart
- Vanopdenbosch Ludo
- Vermersch Patrick
- Vermersch Patrick
- Visser L H
- Vorobeychik Galina
- Wallstr\uf6m Erik
- Walter Silke
- Weber Joerg R
- Weiss Sara
- Weissert Robert
- West Timothy
- Wiendl Heinz
- Wiertlewski Sandrine
- Wildemann Brigitte
- Willekens Barbara
- Wolf Christian
- Xu Xianhao
- Yamamura Takashi
- Yang Yi N
- Yelamos Sergio Martinez
- Yeung Michael
- Zacharias Alan
- Zelkowitz Marvin
- Zettl Uwe
- Zhang Meini
- Zhou Hongyu
- Zieman Ulf
- Ziemssen Tjalf
- Publication venue
- Publication date
- 01/01/2018
- Field of study
Prospective observational cohort study on grading the severity of postoperative complications in global surgery research
- Author
- Abayasinghe Chamika
- Abbas Muntadhar
- Abbott T. E. F.
- Abbott Tom
- Abdullah Noor Hairiza
- Abdur-Rahman Lukman
- Abeloos Jacques
- Abernethy Caroline
- Abidin Ucu Nurhadiat
- Abrunhosa Alexandra
- Absar Mohammed
- Adam Suwayba
- Adams George
- Adamson Michael
- Adekola Oyebola
- Adelaja Yemi
- Ademola Adeyinka
- Adenekan Anthony
- Adenike Odewabi
- Adeolu Augustine A
- Adetoye Adedapo
- Adewale Badru
- Adigun Tinuola
- Adolfsson Anne
- Aflori Laura
- Africander Cucu
- Afshari Arash
- Agarwal Vandana
- Agodirin Olayide
- Aguzzoli Crisitiano
- Ahmad Abdurrahman
- Ahmad Norfaizan
- Ahmad T.
- Ahmad Tahania
- Ahmad Yousra
- Ahmed Ahmed
- Ahmed Jamil
- Ahmed Tahania
- Ai Yanqiu
- Aignatoaie Mariana
- Aimoniotou-Georgiou Eleni
- Akanmu Olanrewaju
- Akerman Nik
- Akinwale Mukaila
- Al Amri Khalid
- Al Hussaini Sabah
- Al-Soudaine Yassr
- Aladin Hafiz
- Alagbe-Briggs Olubusola
- Albaj Safauldeensalem
- Alcock David
- Alcock Liam
- Aldecoa Cesar
- Aldecoa Cesar
- Aleixo Fábia Berganton
- Alexander Hazel
- Alexander Maini
- Alexander-Sefre Farhad
- Alherz Fadhel
- Ali Hani
- Ali Marlynn
- Ali Sarah
- Alias Abdul Hafiz
- Alias Anita
- Alias Raja Liza Raja
- Allen Samantha
- Allen Sara Jane
- Allison Joanna
- Alloj Chiara
- Allorto Nikki Leigh
- Allsop Joanne
- Almeida William
- Alonso Eduardo
- Alonso José Ignacio
- Alphonsus Christella
- Alvares Danielle
- Alves Maria Joao
- Amador Juan Carlos Bravo
- Ameer Yusuf
- Amendola Cristina Prata
- Ami Noam
- Amstrup-Hansen Louise
- Anagnou Athina
- Andersen Cheme
- Anderson Charlotte
- Anderson Colette
- Anderson Frank
- Anderson Philip
- Andreadaki Evangelia
- Andreou Alexandros
- Andreou Prematie
- Andrew Alyson
- Andrews Emma
- Angel Miguel Paludi
- Angermair Stefan
- Angus Kirsty
- Anillo Victor
- Anizi Mashel Al
- Antal Oana
- Antill Philip
- Antoniadou Eleni
- Apagaki Eymorfia
- Apostolou Konstantinos
- Applewhaite Christopher
- Applewhaite Christopher
- Aquino Laura Patricia González
- Ar Praburaj
- Araujo Daniela Marques
- Arawwawala Dilshan
- Ardern Diane
- Argue Ruth
- Aribawa Mahaalit Alit
- Arkalaki Eleni
- Armaganidis Apostolos
- Armstrong John
- Armstrong Richard
- Arnaoutoglou Christina
- Arnaoutoglou Elena
- Arnold Glenn
- Arrandale Lindsay
- Arrich James
- Arrigo Mario
- Arshad Homa
- Arshad Mohammed Asif
- Artiles Tania Socorro
- Arumugam Swarna
- Arustei Mirela
- Arvaniti Kostoula
- Arvaniti Kostoula
- Arya Aryabiantara
- Arya Shobhit
- Asimakos Andreas
- Aslam M
- Asudo Felicia
- Athanasakis Elias
- Atiku Mamuda
- Attrill Elizabeth
- Attwood Clare
- Auer Patrick
- Avidan Michael
- Avila Erendira Jocelin Dominguez
- Avis Joanne
- Awad Hadi
- Axioti Elena
- Azam Ummi Azmira Ahmad
- Azambuja Pedro
- Azevedo Caroline
- Aziz Faizal Zuhri
- Baas Peter
- Baghirzada Leyla
- Bai Hui-Ping
- Baillie Shelley
- Baines Duncan
- Baio Thalissa Hermínia
- Bairaktari Aggeliki
- Baker Gerard
- Baker Katie-Anne
- Baker Paul
- Balain Birender
- Balajonda Naraida
- Balanescu Andreea
- Balasubramaniam Madhu
- Baldisserotto Sérgio
- Baldwin Jacqueline
- Baldwin Matthew
- Balfoussia Danai
- Bali Christina
- Bandeira Maria Expedito
- Banerjee Robin
- Bankewitz Carla
- Banner-Goodspeed Valerie
- Bao Qi
- Barcraft-Barnes Helena
- Barneto Lisa
- Barnett Andrew
- Barraclough James
- Barras Jean-Pierre
- Barrett Stephen
- Barrett Wendy Joan
- Basanth Sujith
- Batchelor Nick
- Bateman Brian
- Bates Alexander
- Bates Sarah
- Batista Hugo Dias
- Bauchmuller Kris
- Bauer Marlene
- Baumgarten Georg
- Baxter Linden
- Beaton Ceri
- Beattie Scott
- Beattie Scott
- Beattie Scott
- Beavis Vanessa
- Beavis Vanessa
- Bechan Sudha
- Beer Johan
- Bejia Tarek
- Belciu Ioana
- Belda Margarita Tormo
- Bell Gillian
- Bell Rachel
- Bell Rachel
- Bell Stephanie
- Bellandi Mattia
- Bello Jibril
- Beloeil Helene
- Belskiy Vladislav
- Beltran Anna Valle
- Ben-Menachem Erez
- Benavent Pau
- Benevento Angelo
- Bengeri Sheshagiri
- Bennett Cambell
- Bennett Michael
- Bennett Rachael
- Bennett Victoria
- Bentley Conor
- Beretta Luigi
- Berg Andrew
- Berg Bianca
- Bergin Colin
- Bernard Andre
- Bernard Andre
- Bernard Andre
- Bernat Maria Jose
- Berntsen Emer
- Berntsen Emer
- Bertram Wendy
- Bester Delia
- Bester Marlet
- Bettega Fernanda
- Bettinelli Alessandra
- Bhardwaj Neeraj
- Bhatia Kailash
- Bhula Chettan
- Bi Yanbing
- Biais M.
- Biais Matthieu
- Biais Matthieu
- Biccard Bruce
- Biccard Bruce M
- Bidd Heena
- Bidd Heena
- Bidgoli Jawad
- Biffen Andrew
- Bignami Elena
- Bilolikar Anjali
- Birch Julie
- Bishop David Gray
- Biyase Thuli
- Bizios Christol
- Blackwell Clare
- Blackwood Douglas
- Blaj Mihaela
- Blakemore Stephen P
- Bland Martin
- Blunt Mark
- Blyth Katharine
- Bocchino Speranza
- Bodansky Daniella
- Bodger Phoebe
- Boer Christa
- Boer Hans Donald
- Boereboom Catherine
- Boggiano Victoria
- Bokkel-Andela Janneke
- Bolaji Benjamin
- Bolton David
- Boone Myles
- Boschi Luca
- Boshier Piers
- Botes Marisa
- Botis Ioannis
- Bottini Corrado
- Bottrill Fiona
- Bouchez Stefaan
- Boulton Kerenza
- Bouris Vasilios
- Bourner Lynsey
- Boutsikos Georgios
- Bouwman Arthur
- Bouwman Arthur
- Bowrey Sarah
- Boxall Leigh
- Boyd Christine
- Bradburn Mike
- Bradburn Mike
- Bradley Jacqueline
- Branagan Graham
- Branco Teresa
- Brand Bastiaan
- Brandsborg Birgitte
- Breitenstein Stefan
- Brennan Andrew
- Brennan Emma
- Brenner Laura
- Brincat Maximilian
- Briscoe Richard
- Bristogiannis Sotirios
- Brooke Jenny
- Brookes Jamie
- Brookes Morag
- Brooks Carolyn
- Broomby Rupert
- Brotto Ana Flavia
- Brown Andrew
- Brown Caroline Wrey
- Brown Gemma
- Brown Jamie
- Brown Janette
- Brown Lynne
- Brown Richard
- Brown Robyn
- Browning Julie
- Bruma Dana
- Brunete Tamara
- Brunswicker Annemarie
- Bryant Helen
- Bua Emmanuel
- Buccimazza Ines
- Buckley Sarah
- Buerkle Christian
- Buhre Wolfgang
- Buhre Wolfgang
- Builu Pierre Monji
- Buise Marc
- Bullock Clare
- Bunwarie Bimalshakth
- Burns Karen
- Burrows Lorna
- Burrows Tom
- Burston Ben
- Burtenshaw Andrew
- Burton Megan
- Busuioc Mihai
- Butryn Izabella
- Butt Georgina
- Byrne Kelly
- Bührer Thomas
- Cabezuelo Estefania
- Cabral Raquel
- Cabrini Luca
- Cacala Sharon
- Cai Fang
- Cai Yunfei
- Cain Helen
- Cairns Carel
- Cakova Veronika
- Calderwood Claire
- Callaghan Mark
- Campbell Debbie
- Campbell Doug
- Campbell Doug
- Campbell Douglas
- Campbell Gill
- Campbell Graham
- Campbell Kathleen
- Campbell Marta
- Campbell Tara
- Campey Lorraine
- Campos Ferreira Mariana Fosch
- Camsooksai Julie
- Cancho David
- Candido Keulle
- Cang Jing
- Cannavo Maurizio
- Cao Jianqiao
- Cao Ying
- Cao Zhongming
- Cardellino Silvano
- Cardosa Jorge
- Cardoso Gutemberg
- Cardy Jon
- Carmino Livio
- Carp Cristina Paula
- Carr Adrienne
- Carrera Ronald
- Carroll Christine
- Carroll Jo
- Caser Eliana
- Castaño Beatriz
- Castle Gail
- Castro Gabriel Isaac Pereira
- Cavanagh Sarah
- Cawthorn Louise
- Cernea Daniela Denisa
- Chaddock Mark
- Chaloulis Panagiotis
- Chan Alexander
- Chan Hey Man Heymans
- Chan Mathew
- Chan Matthew
- Chan Matthew
- Chan Peter
- Chan Vincent
- Chan Wai Kit Jacky
- Chan Weng Ken
- Chan Yik Lam
- Chande Shiv
- Chandler Ben
- Chandra Susilo
- Chandra Susilo
- Chandrasekharan Shardha
- Chang Yuan Hsuan
- Chaniotaki Fotini
- Charitos Efthimios
- Charlalampidoy Alexandra
- Charles Rob
- Chatterjee Devnandan
- Chatterjee Jayanta
- Chatzimichali Aikaterini
- Chau Simon
- Chazova Elena
- Cheah Clarissa
- Cheah Seleen
- Cheeseman Michelle
- Cheing Yushio
- Chen Chao
- Chen Chen
- Chen Feifei
- Chen Fumei
- Chen Hong
- Chen James
- Chen Junping
- Chen Lee-lynn
- Chen Lee-lynn
- Chen Linbi
- Chen Liyong
- Chen Pushan
- Chen Qiang
- Chen Rong
- Chen Shasha
- Chen Shiyu
- Chen Sijia
- Chen Yaqiu
- Chen Yijiao
- Chen Yijun
- Chen Yongjie
- Chen Zhang
- Cheng Baoli
- Cheng Ka Ho
- Cherian Ritchie
- Cherrett Veronica
- Chetty Rubendraj R
- Chew Michelle
- Chew Michelle
- Chhabra Ashok
- Chicken Dennis-Wayne
- Chilinciuc Ion
- Chin Im Im
- Chirkut Subash
- Chlorou Dimitra
- Choi Hyun-min David
- Choi Stephen
- Chow Lorraine
- Christian Rachel
- Christiansen Ida Cecilie
- Christmas Natasha
- Christodoulidis Gregory
- Christodoulopoulou Theodora
- Christofaki Maria
- Christoforidis Dimitri
- Chronis Christos
- Chu Hiu Man
- Chu Susanna
- Chua Pandora
- Chukkambotla Srikanth
- Chung Chun Kwong Eric
- Cifra Elna
- Ciobanu Cristina
- Ciobotaru Oana Roxana
- Cirstea Emanuel
- Clark Richard
- Clarkson Aisling
- Clavien Pierre-Alain
- Claxton Andrew
- Clemmons Karen
- Cloro Luigi Maria
- Clyde Antony
- Cobzaru Isabelle
- Codita Anisoara
- Colangelo Antonio
- Colangelo Chiara
- Colling Kerry
- Collins Michelle
- Collins Nwokoro
- Colvin Carolyn
- Commey Thelma
- Comptaer Nicolas
- Conceição Soares Maria
- Conde Carlos
- Conradie Alae
- Constantin Kathryn
- Cook Tim
- Cooper Lauren
- Cooper Lucy
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- Delgado García David R
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- Zundert Tom
- Zyl Rebekka
- åkring Irene
- Ögren Katrin
- Publication venue
- 'Wiley'
- Publication date
- 22/10/2018
- Field of study
Background
The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high- (HICs) and low- and middle-income countries (LMICs).
Methods
This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7-day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs.
Results
A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59).
Conclusion
Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally
The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis
- Author
- Ab Majid Mohd Azuan
- Ab Rahman Ahmad Sufian
- Ab Rahman Rusnah
- Abayasinghe Chamika
- Abbas Muntadhar
- Abbott T. E. F.
- Abbott Tom
- Abd Ghafar Fara Nur Idayu
- Abd Hadi Husni Zaeem
- Abdel Goad Ehab Helmy
- Abdullah Noor Hairiza
- Abdur-Rahman Lukman
- Abeloos Jacques
- Abernethy Caroline
- Abidin Ucu Nurhadiat
- Abrunhosa Alexandra
- Absar Mohammed
- Adam Suwayba
- Adams David
- Adams George
- Adamson Michael
- Adekola Oyebola
- Adelaja Yemi
- Ademola Adeyinka
- Adenekan Anthony
- Adenike Odewabi
- Adeolu Augustine A.
- Adetoye Adedapo
- Adewale Badru
- Adigun Tinuola
- Adolfsson Anne
- Africander Cucu
- Afshari Arash
- Agarwal Vandana
- Agodirin Olayide
- Aguzzoli Crisitiano
- Ahamed khader null
- Ahmad Azam Ummi Azmira
- Ahmad Abdurrahman
- Ahmad Norfaizan
- Ahmad T.
- Ahmad Tahania
- Ahmad Yousra
- Ahmed Ahmed
- Ahmed Jamil
- Ahmed Tahania
- Ai Yanqiu
- Aignatoaie Mariana
- Aimoniotou-Georgiou Eleni
- Akanmu Olanrewaju
- Akerman Nik
- Akinwale Mukaila
- Al Anizi Mashel
- Al hussaini Sabah
- Al'Amri Khalid
- Al-Soudaine Yassr
- Aladin Hafiz
- Alagbe-Briggs Olubusola
- Albaj Safauldeensalem
- Alberto Lisi Zaheer Moolla
- AlbertoVolta Carlo
- Alcock David
- Alcock Liam
- Aldecoa Cesar
- Aleixo Fábia Berganton
- Alexander Hazel
- Alexander Maini
- Alexander-Sefre Farhad
- Alherz Fadhel
- Ali Hani
- Ali Marlynn
- Ali Sarah
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- Allsop Joanne
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- Zapata Darcy Danitza Mari
- Zbitnew Geoff
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- Zerman Luiza
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- Zhang Yuan
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- Zhao Jinning
- Zhao Lei
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- Zhao Ting
- Zhao Weihong
- Zhao Weilu
- Zhao Xiaoying
- Zhen Jungang
- Zheng Kang
- Zheng Lina
- Zheng Tianzhao
- Zhong Yi
- Zhou Ce
- Zhou Dachun
- Zhou Haidong
- Zhou Haiyan
- Zhou Jiali
- Zhou Jialong
- Zhou Jing
- Zhou Xian-jin
- Zhu Xiaomao
- Zhu Xiaoping
- Zhu Yi
- Zhu Zhipeng
- Zhuang Xiuxiu
- Zilis Georgios
- Zingerle Nicolette
- Zingg Urs
- Zoerner Frank
- Zonneveldt Harry
- Zou Xiaohua
- Zoulamoglou Menelaos
- Zsisku Lajos
- Åkring Irene
- Ögren Katrin
- Publication venue
- Health Sciences Research Commons
- Publication date
- 30/10/2017
- Field of study
© 2017 British Journal of Anaesthesia Background: The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Methods: Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. Results: We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32–0.77); P\u3c0.01], but no difference in complication rates [OR 1.02 (0.88–1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62–0.92); P\u3c0.01; I2=87%] and reduced complication rates [OR 0.73 (0.61–0.88); P\u3c0.01; I2=89%). Conclusions: Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine