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05.02.2019 | 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’

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

Erschienen in: Breast Cancer Research and Treatment | Ausgabe 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]. …

DeMets DL (1987) Methods for combining randomized clinical trials: strengths and limitations. Stat Med 6(3):341–348CrossRefPubMed

Simpson EH (1951) The interpretation of interaction in contingency tables. J R Stat Soc B 1:238–241

Blyth CR (1972) On Simpson’s paradox and the sure-thing principle. J Am Stat Assoc 67(338):364–366CrossRef

Norton HJ, Divine G. (2015) Simpson’s paradox… and how to avoid it. Significance 12(4):40–43CrossRef

Altman DG (2018) Avoiding bias in trials in which allocation ratio is varied. J R Soc Med 111(4):143–144CrossRefPubMed

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

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

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

Titel: 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’
verfasst von: Stephanie L. Dickinson
Lilian Golzarri-Arroyo
Andrew W. Brown
Bryan McComb
Chanaka N. Kahathuduwa
David B. Allison
Publikationsdatum: 05.02.2019
Verlag: Springer US
Erschienen in: Breast Cancer Research and Treatment / Ausgabe 1/2019
Print ISSN: 0167-6806
Elektronische ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-019-05155-6

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Springer Medizin

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’

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Bei Senioren mit Prostatakarzinom auf Anämie achten!

ICI-Therapie in der Schwangerschaft wird gut toleriert

Krebspatienten impfen: Was? Wen? Und wann nicht?

Müde im Alter? Auch an die Nebenniere denken

Update Onkologie

Springer Medizin

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