The statistical significance of randomized controlled trial results is frequently fragile: A case for a Fragility Index
Michael Walsh,Michael Walsh,Sadeesh Srinathan,Daniel F. McAuley,Marko Mrkobrada,Oren Levine,Christine Ribic,Amber O. Molnar,Neil D. Dattani,Andrew Burke,Gordon H. Guyatt,Lehana Thabane,Stephen D. Walter,Janice Pogue,Philip J. Devereaux,Philip J. Devereaux +15 more
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TLDR
The statistically significant results of many RCTs hinge on small numbers of events, and the Fragility Index complements the P-value and helps identify less robust results.About:
This article is published in Journal of Clinical Epidemiology.The article was published on 2014-06-01 and is currently open access. It has received 454 citations till now. The article focuses on the topics: Randomized controlled trial & Fragility.read more
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Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials
Søren Lund Kristensen,Søren Lund Kristensen,Rasmus Rørth,Rasmus Rørth,Pardeep S. Jhund,Kieran F. Docherty,Naveed Sattar,David Preiss,Lars Køber,Mark C. Petrie,John J.V. McMurray +10 more
TL;DR: Overall, GLP-1 receptor agonist treatment reduced MACE by 12% and there was no increase in risk of severe hypoglycaemia, pancreatitis, or pancreatic cancer.
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Homocysteine‐lowering interventions for preventing cardiovascular events
TL;DR: Whether homocysteine-lowering interventions, provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events, as well as reducing all-cause mortality, and to evaluate their safety is evaluated.
Journal ArticleDOI
Strategies to improve retention in randomised trials.
Valerie Catherine Brueton,Jayne F. Tierney,Sally P. Stenning,Seeromanie Harding,Sarah Meredith,Irwin Nazareth,Greta Rait +6 more
TL;DR: The effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting were quantified.
Journal ArticleDOI
The Fragility Index in Multicenter Randomized Controlled Critical Care Trials.
Elliott E. Ridgeon,Paul J Young,Rinaldo Bellomo,Marta Mucchetti,Rosalba Lembo,Giovanni Landoni +5 more
TL;DR: In critical care trials reporting statistically significant effects on mortality, the findings often depend on a small number of events, so critical care clinicians should be wary of basing decisions on trials with a low fragility index.
Journal ArticleDOI
Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial
Flávia Kessler Borges,Mohit Bhandari,Ernesto Guerra-Farfán,Ameen Patel,Alben Sigamani,Masood Umer,Maria Tiboni,Maria del Mar Villar-Casares,Vikas Tandon,Jordi Tomas-Hernandez,Jordi Teixidor-Serra,Victoria Avram,Mitchell Winemaker,Mmampapatla Thomas Ramokgopa,Wojciech Szczeklik,Giovanni Landoni,Chew Yin Wang,Dilshad Begum,John Neary,Anthony Adili,Parag Sancheti,Abdel-Rahman Lawendy,Mariano Balaguer-Castro,Paweł Ślęczka,Richard Jenkinson,Aamer Nabi Nur,Gavin C A Wood,Robert J. Feibel,Stephen John McMahon,Alen Sigamani,Ekaterine Popova,Bruce M Biccard,Iain K. Moppett,Patrice Forget,Paul Landais,Michael McGillion,Jessica Vincent,Kumar Balasubramanian,Valerie Harvey,Yaiza Garcia-Sanchez,Shirley Pettit,Leslie Gauthier,Gordon H. Guyatt,David Conen,Amit X. Garg,Shrikant I. Bangdiwala,Emilie P. Belley-Côté,Maura Marcucci,Andre Lamy,Richard P. Whitlock,Yannick Le Manach,Dean Fergusson,Salim Yusuf,Philip J. Devereaux,Laurent Veevaete,Bernard le Polain de Waroux,Patricia Lavand'homme,Olivier Cornu,Karim Tribak,Jean Cyr Yombi,Nassim Touil,Maike Reul,Jigme Tshering Bhutia,Carol Clinckaert,Dirk De Clippeleir,Justin de Beer,Diane Simpson,Andrew Worster,Kim Alvarado,Krysten Gregus,Kelly H Lawrence,Darryl P. Leong,Philip Joseph,Patrick Magloire,Benjamin Deheshi,Stuart Bisland,Thomas J Wood,Daniel M. Tushinski,David A. Wilson,Clive Kearon,David Cowan,Vickas Khanna,Amna Zaki,J. Farrell,Anne Marie MacDonald,Steven Cw Wong,Arsha Karbassi,Douglas Wright,Harsha Shanthanna,Ryan Coughlin,Moin Khan,Spencer Wikkerink,Faraaz A Quraishi,Waleed Kishta,Emil H. Schemitsch,Timothy A. Carey,Mark D Macleod,David W. Sanders,Edward M. Vasarhelyi,Debra Bartley,George K. Dresser,Christina Tieszer,Steven Shadowitz,Jacques S. Lee,Stephen Choi,Hans J. Kreder,Markku T Nousiainen,Monica Kunz,Ravianne Tuazon,Mopina Shrikumar,Bheeshma Ravi,David Wasserstein,David Stephen,Diane Nam,Patrick Henry,Stephen M Mann,Melanie T Jaeger,Marco L.A. Sivilotti,Christopher A. Smith,Christopher C Frank,Heather Grant,Leone Ploeg,Jeff Yach,Mark Harrison,Aaron R. Campbell,Ryan T. Bicknell,Davide D. Bardana,Katie McIlquham,Catherine Gallant,Samantha Halman,Venkatesh Thiruganasambandamoorth,Sara Ruggiero,William J Hadden,Brian P-J Chen,Stephanie A Coupal,Lisa M McLean,Hemant R Shirali,Syed Haider,Crystal A Smith,Evan Watts,David J Santone,Kevin Koo,Allan J Yee,Ademilola N Oyenubi,Aaron Nauth,Emil H. Schemitsch,Timothy R. Daniels,S Ward,Jeremy A. Hall,Henry Ahn,Daniel B. Whelan,Amit Atrey,Amir Khoshbin,David Puskas,Kurt P Droll,Claude Cullinan,Jubin Payendeh,Tina Lefrancois,Lise Mozzon,Travis Marion,Michael J. Jacka,James Greene,Matthew Rg Menon,Robert Stiegelmahr,Derek Dillane,Marleen Irwin,Lauren A Beaupre,Chad P. Coles,Kelly Trask,Shelley MacDonald,J Andrew I Trenholm,William M. Oxner,C. Glen Richardson,Niloofar Dehghan,Mehdi Sadoughi,Achal Sharma,Neil J White,Loretta Olivieri,Stephen B Hunt,Thomas R Turgeon,Eric R Bohm,Sarah Tran,Stephen M Giilck,Tom Hupel,Pierre Guy,Peter J O'Brien,Andrew Duncan,Gordon A Crawford,Junlin Zhou,Yanrui Zhao,Yang Liu,Lei Shan,Anshi Wu,Juan Manuel Muñoz,Philippe Chaudier,Marion Douplat,Michel Henri Fessy,Vincent Piriou,Lucie Louboutin,Jean Stephane David,Arnaud Friggeri,Sebastien Beroud,Jean Marie Fayet,Frankie Leung,Christian Fang,Dennis King Hang Yee,Parag Sancheti,Chetan Vijay Pradhan,Atul Patil,Chetan Prabhakar Puram,Madhav Pandurang Borate,Kiran Bhalchandra Kudrimoti,Bharati Anil Adhye,Himanshu Vijaykumar Dongre,Bobby John,Valsamma Abraham,Ritesh Arvind Pandey,Arti Rajkumar,P. 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TL;DR: Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care.
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