Literature DB >> 32939044

Statistical analysis of continuous outcomes from parallel-arm randomized controlled trials in nutrition-a tutorial.

Christian Ritz1.   

Abstract

Randomized controlled trials (RCTs) play a fundamental role in establishing evidence on benefits of diet changes in nutrition. There is, however, little literature on how to analyze data obtained from such trials. This tutorial provides a detailed introduction to the statistical analysis of parallel-arm RCTs in nutrition by means of modern statistical methodology, i.e., analysis of covariance and linear mixed models are informed using specific information about the trial design. Focus will be on understanding how the trial design and possibly other aspects of the trial influence the subsequent statistical analysis. All steps of the statistical analysis will be covered and a practical example is also provided.

Year:  2020        PMID: 32939044     DOI: 10.1038/s41430-020-00750-z

Source DB:  PubMed          Journal:  Eur J Clin Nutr        ISSN: 0954-3007            Impact factor:   4.016


  37 in total

Review 1.  Publishing nutrition research: a review of multivariate techniques--part 2: analysis of variance.

Authors:  Jeffrey E Harris; Patricia M Sheean; Philip M Gleason; Barbara Bruemmer; Carol Boushey
Journal:  J Acad Nutr Diet       Date:  2011-12-22       Impact factor: 4.910

2.  Best (but oft forgotten) practices: testing for treatment effects in randomized trials by separate analyses of changes from baseline in each group is a misleading approach.

Authors:  J Martin Bland; Douglas G Altman
Journal:  Am J Clin Nutr       Date:  2015-09-09       Impact factor: 7.045

3.  ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected].

Authors:  Gerard J P Van Breukelen
Journal:  J Clin Epidemiol       Date:  2006-06-23       Impact factor: 6.437

4.  Publishing nutrition research: a review of sampling, sample size, statistical analysis, and other key elements of manuscript preparation, Part 2.

Authors:  Carol J Boushey; Jeffrey Harris; Barbara Bruemmer; Sujata L Archer
Journal:  J Am Diet Assoc       Date:  2008-04

Review 5.  An overview of statistical methods for handling nonadherence to intervention protocol in randomized control trials: a methodological review.

Authors:  Mohammod Mostazir; Rod S Taylor; William Henley; Ed Watkins
Journal:  J Clin Epidemiol       Date:  2018-12-07       Impact factor: 6.437

6.  Covariate adjustments in randomized controlled trials increased study power and reduced biasedness of effect size estimation.

Authors:  Paul H Lee
Journal:  J Clin Epidemiol       Date:  2016-02-24       Impact factor: 6.437

7.  Intent-to-Treat vs. Non-Intent-to-Treat Analyses under Treatment Non-Adherence in Mental Health Randomized Trials.

Authors:  Thomas R Ten Have; Sharon-Lise T Normand; Sue M Marcus; C Hendricks Brown; Philip Lavori; Naihua Duan
Journal:  Psychiatr Ann       Date:  2008-12

8.  The use of percentage change from baseline as an outcome in a controlled trial is statistically inefficient: a simulation study.

Authors:  A J Vickers
Journal:  BMC Med Res Methodol       Date:  2001-06-28       Impact factor: 4.615

9.  Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study.

Authors:  Bolaji E Egbewale; Martyn Lewis; Julius Sim
Journal:  BMC Med Res Methodol       Date:  2014-04-09       Impact factor: 4.615

10.  Incorrect statistical method in parallel-groups RCT led to unsubstantiated conclusions.

Authors:  David B Allison; Lisa H Antoine; Brandon J George
Journal:  Lipids Health Dis       Date:  2016-04-15       Impact factor: 3.876

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  3 in total

1.  Correction of neonatal vitamin D status using 1000 IU vitamin D/d increased lean body mass by 12 months of age compared with 400 IU/d: a randomized controlled trial.

Authors:  Maryam Razaghi; Nathalie Gharibeh; Catherine A Vanstone; Olusola F Sotunde; Ali Khamessan; Shu Q Wei; Dayre McNally; Frank Rauch; Glenville Jones; Sarah Kimmins; Hope A Weiler
Journal:  Am J Clin Nutr       Date:  2022-06-07       Impact factor: 8.472

2.  Effect of two-weeks of school-based sprint training on physical fitness, risk factors for cardiometabolic diseases and cognitive function in adolescent girls: A randomized controlled pilot trial.

Authors:  Ryan A Williams; Karah J Dring; John G Morris; Caroline Sunderland; Mary E Nevill; Simon B Cooper
Journal:  Front Sports Act Living       Date:  2022-08-05

3.  Promoting work ability with a wearable activity tracker in working age individuals with hip and/or knee osteoarthritis: a randomized controlled trial.

Authors:  Elin Östlind; Frida Eek; Kjerstin Stigmar; Anita Sant'Anna; Eva Ekvall Hansson
Journal:  BMC Musculoskelet Disord       Date:  2022-02-03       Impact factor: 2.362

  3 in total

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