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Breast Cancer Research and Treatment
Published in: Breast Cancer Research and Treatment 1/2019

01-05-2019 | Letter to the Editor

Change in study randomization allocation needs to be included in statistical analysis: comment on ‘Randomized controlled trial of weight loss versus usual care on telomere length in women with breast cancer: the lifestyle, exercise, and nutrition (LEAN) study’

Authors: Stephanie L. Dickinson, Lilian Golzarri-Arroyo, Andrew W. Brown, Bryan McComb, Chanaka N. Kahathuduwa, David B. Allison

Published in: Breast Cancer Research and Treatment | Issue 1/2019

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Excerpt

Data are often combined across multiple studies, sites, strata or phases of data collection, for a variety of reasons. In a randomized controlled trial (RCT), employing proper methods when combining data collected in separate contexts ensures unbiased estimates of the combined treatment effect. Collapsing (or ‘lumping’) data across studies or strata without statistical adjustment can provide misleading results [1], such as occurs in Simpson’s paradox where treatment effects that are consistent across each strata separately are reversed when data are collapsed [2‐4]. This paradox occurs specifically when there are differences between the two or more strata (or studies) in the ratio of people in each treatment group [3]. Altman wrote recently of dangers of bias in combining data across studies with varied randomization allocation ratios [5]. …
Literature
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DeMets DL (1987) Methods for combining randomized clinical trials: strengths and limitations. Stat Med 6(3):341–348CrossRefPubMed
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Simpson EH (1951) The interpretation of interaction in contingency tables. J R Stat Soc B 1:238–241
3.
Blyth CR (1972) On Simpson’s paradox and the sure-thing principle. J Am Stat Assoc 67(338):364–366CrossRef
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Norton HJ, Divine G. (2015) Simpson’s paradox… and how to avoid it. Significance 12(4):40–43CrossRef
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Altman DG (2018) Avoiding bias in trials in which allocation ratio is varied. J R Soc Med 111(4):143–144CrossRefPubMed
6.
Sanft T, Usiskin I, Harrigan M, Cartmel B, Lu L, Li FY, Zhou Y, Chagpar A, Ferrucci LM, Pusztai L, Irwin ML (2018) Randomized controlled trial of weight loss versus usual care on telomere length in women with breast cancer: the lifestyle, exercise, and nutrition (LEAN) study. Breast Cancer Res Treat 172(1):105–112CrossRefPubMed
7.
Harrigan M, Cartmel B, Loftfield E, Sanft T, Chagpar AB, Zhou Y, Playdon M, Li F, Irwin ML (2016) Randomized trial comparing telephone versus in-person weight loss counseling on body composition and circulating biomarkers in women treated for breast cancer: the lifestyle, exercise, and nutrition (LEAN) study. J Clin Oncol 34(7):669CrossRefPubMed
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Bangdiwala SI, Bhargava A, O’Connor DP, Robinson TN, Michie S, Murray DM, Stevens J, Belle SH, Templin TN, Pratt CA (2016) Statistical methodologies to pool across multiple intervention studies. Transl Behav Med 6(2):228–235CrossRefPubMedPubMedCentral
Metadata
Title
Change in study randomization allocation needs to be included in statistical analysis: comment on ‘Randomized controlled trial of weight loss versus usual care on telomere length in women with breast cancer: the lifestyle, exercise, and nutrition (LEAN) study’
Authors
Stephanie L. Dickinson
Lilian Golzarri-Arroyo
Andrew W. Brown
Bryan McComb
Chanaka N. Kahathuduwa
David B. Allison
Publication date
01-05-2019
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 1/2019
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-019-05155-6

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