Literature DB >> 26670066

Statistical Controversies in Reporting of Clinical Trials: Part 2 of a 4-Part Series on Statistics for Clinical Trials.

Stuart J Pocock1, John J V McMurray2, Tim J Collier3.   

Abstract

This paper tackles several statistical controversies that are commonly faced when reporting a major clinical trial. Topics covered include: multiplicity of data, interpreting secondary endpoints and composite endpoints, the value of covariate adjustment, the traumas of subgroup analysis, assessing individual benefits and risks, alternatives to analysis by intention to treat, interpreting surprise findings (good and bad), and the overall quality of clinical trial reports. All is put in the context of topical cardiology trial examples and is geared to help trialists steer a wise course in their statistical reporting, thereby giving readers a balanced account of trial findings.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  intention-to-treat analysis; logistic models; proportional hazards models; randomized controlled trials as topic; risk assessment; statistics

Mesh：

Year:  2015        PMID： 26670066     DOI： 10.1016/j.jacc.2015.10.023

Source DB:  PubMed          Journal:  J Am Coll Cardiol        ISSN： 0735-1097            Impact factor:   24.094


  22 in total

1.  Statistical considerations in reporting cardiovascular research.

Authors:  Merry L Lindsey; Gillian A Gray; Susan K Wood; Douglas Curran-Everett
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2.  Effect of a Strategy of Comprehensive Vasodilation vs Usual Care on Mortality and Heart Failure Rehospitalization Among Patients With Acute Heart Failure: The GALACTIC Randomized Clinical Trial.

Authors:  Nikola Kozhuharov; Assen Goudev; Dayana Flores; Micha T Maeder; Joan Walter; Samyut Shrestha; Danielle Menosi Gualandro; Mucio Tavares de Oliveira Junior; Zaid Sabti; Beat Müller; Markus Noveanu; Thenral Socrates; Ronny Ziller; Antoni Bayés-Genís; Alessandro Sionis; Patrick Simon; Eleni Michou; Samuel Gujer; Tommaso Gori; Philip Wenzel; Otmar Pfister; David Conen; Ioannis Kapos; Richard Kobza; Hans Rickli; Tobias Breidthardt; Thomas Münzel; Paul Erne; Christian Mueller; Nisha Arenja
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Review 3.  Evidence-based statistical analysis and methods in biomedical research (SAMBR) checklists according to design features.

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Review 5.  Challenges of Cardio-Kidney Composite Outcomes in Large-Scale Clinical Trials.

Authors:  Ravi B Patel; Jozine M Ter Maaten; João Pedro Ferreira; Finnian R McCausland; Sanjiv J Shah; Patrick Rossignol; Scott D Solomon; Muthiah Vaduganathan; Milton Packer; Aliza Thompson; Norman Stockbridge; Faiez Zannad
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Journal:  Clin Res Cardiol       Date:  2021-03-12       Impact factor: 5.460

7.  Upright versus lying down position in second stage of labour in nulliparous women with low dose epidural: BUMPES randomised controlled trial.

Authors: 
Journal:  BMJ       Date:  2017-10-18

8.  Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.

Authors:  M A Oyama; S S Ellenberg; P A Shaw
Journal:  J Vet Intern Med       Date:  2017-05-30       Impact factor: 3.333

Review 9.  Critical appraisal of cardiology guidelines on revascularisation: clinical practice.

Authors:  David R Dobies; Kimberly R Barber
Journal:  Open Heart       Date:  2018-02-24

10.  Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity.

Authors:  Maureen Markle-Reid; Jenny Ploeg; Kimberly D Fraser; Kathryn A Fisher; Amy Bartholomew; Lauren E Griffith; John Miklavcic; Amiram Gafni; Lehana Thabane; Ross Upshur
Journal:  J Am Geriatr Soc       Date:  2017-11-27       Impact factor: 5.562
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