Literature DB >> 22192231

Comparisons against baseline within randomised groups are often used and can be highly misleading.

J Martin Bland1, Douglas G Altman.   

Abstract

BACKGROUND: In randomised trials, rather than comparing randomised groups directly some researchers carry out a significance test comparing a baseline with a final measurement separately in each group.
METHODS: We give several examples where this has been done. We use simulation to demonstrate that the procedure is invalid and also show this algebraically.
RESULTS: This approach is biased and invalid, producing conclusions which are, potentially, highly misleading. The actual alpha level of this procedure can be as high as 0.50 for two groups and 0.75 for three.
CONCLUSIONS: Randomised groups should be compared directly by two-sample methods and separate tests against baseline are highly misleading.

Entities:  

Mesh:

Year:  2011        PMID: 22192231      PMCID: PMC3286439          DOI: 10.1186/1745-6215-12-264

Source DB:  PubMed          Journal:  Trials        ISSN: 1745-6215            Impact factor:   2.279


  17 in total

1.  A randomized comparative trial of acupuncture versus transcutaneous electrical nerve stimulation for chronic back pain in the elderly.

Authors:  David Jonathan Grant; Jane Bishop-Miller; David Magnus Winchester; Margaret Anderson; Steven Faulkner
Journal:  Pain       Date:  1999-07       Impact factor: 6.961

Review 2.  Statistics notes: Analysing controlled trials with baseline and follow up measurements.

Authors:  A J Vickers; D G Altman
Journal:  BMJ       Date:  2001-11-10

3.  Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes.

Authors:  Isabelle Boutron; Susan Dutton; Philippe Ravaud; Douglas G Altman
Journal:  JAMA       Date:  2010-05-26       Impact factor: 56.272

4.  Evidence for an 'anti-ageing' product may not be so clear as it appears.

Authors:  J M Bland
Journal:  Br J Dermatol       Date:  2009-08-12       Impact factor: 9.302

5.  Randomisation and baseline comparisons in clinical trials.

Authors:  D G Altman; C J Doré
Journal:  Lancet       Date:  1990-01-20       Impact factor: 79.321

6.  Comparisons within randomised groups can be very misleading.

Authors:  J Martin Bland; Douglas G Altman
Journal:  BMJ       Date:  2011-05-06

7.  Confidence intervals rather than P values: estimation rather than hypothesis testing.

Authors:  M J Gardner; D G Altman
Journal:  Br Med J (Clin Res Ed)       Date:  1986-03-15

8.  Who's afraid of informed consent?

Authors:  D D Kerrigan; R S Thevasagayam; T O Woods; I Mc Welch; W E Thomas; A J Shorthouse; A R Dennison
Journal:  BMJ       Date:  1993-01-30

9.  Antithrombin III and heparin cofactor II in patients with chronic renal failure undergoing regular hemodialysis.

Authors:  P Toulon; C Jacquot; L Capron; M O Frydman; D Vignon; M Aiach
Journal:  Thromb Haemost       Date:  1987-06-03       Impact factor: 5.249

10.  High prevalence of potential biases threatens the interpretation of trials in patients with chronic disease.

Authors:  Daniela Vollenweider; Cynthia M Boyd; Milo A Puhan
Journal:  BMC Med       Date:  2011-06-13       Impact factor: 8.775

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  49 in total

Review 1.  Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.

Authors:  Boon How Chew; Rimke C Vos; Maria-Inti Metzendorf; Rob Jpm Scholten; Guy Ehm Rutten
Journal:  Cochrane Database Syst Rev       Date:  2017-09-27

2.  Conclusion of "Nordic walking for geriatric rehabilitation: a randomized pilot trial" is based on faulty statistical analysis and is inaccurate.

Authors:  David B Allison; Michelle S Williams; Gregory A Hand; John M Jakicic; Kevin R Fontaine
Journal:  Disabil Rehabil       Date:  2015-01-19       Impact factor: 3.033

3.  Differences in Nominal Significance (DINS) Error leads to invalid conclusions: Letter regarding, "Diet enriched with fresh coconut decreases blood glucose levels and body weight in normal adults".

Authors:  Cynthia M Kroeger; Andrew W Brown; David B Allison
Journal:  J Complement Integr Med       Date:  2019-06-12

4.  Authors' Reply to Anoop Balachandran et al.: Comment on "Sub-Anesthetic Xenon Increases Erythropoietin Levels in Humans: A Randomized Controlled Trial".

Authors:  Christian Stoppe; Julia Ney; Rolf Rossaint; Mark Coburn; Andreas Goetzenich
Journal:  Sports Med       Date:  2017-02       Impact factor: 11.136

Review 5.  A mapping review of randomized controlled trials in the spinal cord injury research literature.

Authors:  Amanda McIntyre; Brooke Benton; Shannon Janzen; Jerome Iruthayarajah; Joshua Wiener; Janice J Eng; Robert Teasell
Journal:  Spinal Cord       Date:  2018-06-14       Impact factor: 2.772

6.  Statistical testing for baseline differences between randomised groups is not meaningful.

Authors:  L A Harvey
Journal:  Spinal Cord       Date:  2018-10       Impact factor: 2.772

7.  The stated conclusions are contradicted by the data, based on inappropriate statistics, and should be corrected: comment on 'intervention for childhood obesity based on parents only or parents and child compared with follow-up alone'.

Authors:  J A Dawson; A W Brown; D B Allison
Journal:  Pediatr Obes       Date:  2018-08-09       Impact factor: 4.000

8.  Incorrect analyses were used in "Different enteral nutrition formulas have no effect on glucose homeostasis but on diet-induced thermogenesis in critically ill medical patients: a randomized controlled trial" and corrected analyses are requested.

Authors:  Stephanie L Dickinson; Andrew W Brown; Tapan Mehta; Steven B Heymsfield; Cara B Ebbeling; David S Ludwig; David B Allison
Journal:  Eur J Clin Nutr       Date:  2018-06-27       Impact factor: 4.016

9.  Re: Errors in Zhao et al (2015), Impact of enteral nutrition on energy metabolism in patients with Crohn's disease.

Authors:  Kathryn A Kaiser; Brandon J George; David B Allison
Journal:  World J Gastroenterol       Date:  2016-03-07       Impact factor: 5.742

10.  Comment on "Sub-anesthetic Xenon Increases Erythropoietin Levels in Humans: A Randomized Controlled Trial".

Authors:  Anoop Balachandran; David L Streiner; Joseph F Signorile
Journal:  Sports Med       Date:  2017-02       Impact factor: 11.136

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