Literature DB >> 30948454

Assessing assumptions for statistical analyses in randomised clinical trials.

Emil Eik Nielsen1,2, Anders Kehlet Nørskov1, Theis Lange3,4, Lehana Thabane5, Jørn Wetterslev1,6, Jan Beyersmann7, Jacobo de Uña-Álvarez8, Valter Torri9, Laurent Billot10, Hein Putter11, Per Winkel1, Christian Gluud1, Janus Christian Jakobsen1,12.   

Abstract

In order to ensure the validity of results of randomised clinical trials and under some circumstances to optimise statistical power, most statistical methods require validation of underlying statistical assumptions. The present paper describes how trialists in major medical journals report tests of underlying statistical assumptions when analysing results of randomised clinical trials. We also consider possible solutions how to improve current practice by adequate reporting of tests of underlying statistical assumptions. We conclude that there is a need to reach consensus on which underlying assumptions should be assessed, how these underlying assumptions should be assessed and what should be done if the underlying assumptions are violated. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Mesh:

Year:  2019        PMID: 30948454     DOI: 10.1136/bmjebm-2019-111174

Source DB:  PubMed          Journal:  BMJ Evid Based Med        ISSN: 2515-446X


  6 in total

1.  Short-term outcomes of phosphodiesterase type 5 inhibitors for fetal growth restriction: a study protocol for a systematic review with individual participant data meta-analysis, aggregate meta-analysis, and trial sequential analysis.

Authors:  Jessica Liauw; Katie Groom; Wessel Ganzevoort; Christian Gluud; Christopher J D McKinlay; Andrew Sharp; Laura Mackay; Chirag Kariya; Ken Lim; Peter von Dadelszen; Jacqueline Limpens; Janus C Jakobsen
Journal:  Syst Rev       Date:  2021-12-03

2.  Protocol for an individual patient data meta-analysis on blood pressure targets after cardiac arrest.

Authors:  Markus B Skrifvars; Koen Ameloot; Johannes Grand; Matti Reinikainen; Johanna Hästbacka; Ville Niemelä; Christian Hassager; Jesper Kjaergaard; Anders Åneman; Marjaana Tiainen; Niklas Nielsen; Susann Ullen; Josef Dankiewicz; Markus Harboe Olsen; Caroline Kamp Jørgensen; Manoj Saxena; Janus C Jakobsen
Journal:  Acta Anaesthesiol Scand       Date:  2022-06-09       Impact factor: 2.274

3.  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.

Authors:  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
Journal:  Trials       Date:  2022-10-06       Impact factor: 2.728

4.  An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial.

Authors:  Markus Harboe Olsen; Britt Morthorst; Anne Katrine Pagsberg; Michella Heinrichsen; Bo Møhl; Lotte Rubæk; Johan Bjureberg; Olivia Simonsson; Jane Lindschou; Christian Gluud; Janus Christian Jakobsen
Journal:  Trials       Date:  2021-07-16       Impact factor: 2.279

5.  Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project).

Authors:  Steven Kwasi Korang; Sophie Juul; Emil Eik Nielsen; Joshua Feinberg; Faiza Siddiqui; Giok Ong; Sarah Klingenberg; Areti Angeliki Veroniki; Fanlong Bu; Lehana Thabane; Allan Randrup Thomsen; Janus C Jakobsen; Christian Gluud
Journal:  Syst Rev       Date:  2020-11-20

6.  Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan.

Authors:  Janus Christian Jakobsen; Josef Dankiewicz; Theis Lange; Tobias Cronberg; Gisela Lilja; Helena Levin; Jan Bělohlávek; Clifton Callaway; Alain Cariou; David Erlinge; Jan Hovdenes; Michael Joannidis; Per Nordberg; Mauro Oddo; Paolo Pelosi; Hans Kirkegaard; Glenn Eastwood; Christian Rylander; Manoj Saxena; Christian Storm; Fabio Silvio Taccone; Matthew P Wise; Matt P G Morgan; Paul Young; Alistair Nichol; Hans Friberg; Susann Ullén; Niklas Nielsen
Journal:  Trials       Date:  2020-10-07       Impact factor: 2.279

  6 in total

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