References
DeMets DL (1987) Methods for combining randomized clinical trials: strengths and limitations. Stat Med 6(3):341–348
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):364–366
Norton HJ, Divine G. (2015) Simpson’s paradox… and how to avoid it. Significance 12(4):40–43
Altman DG (2018) Avoiding bias in trials in which allocation ratio is varied. J R Soc Med 111(4):143–144
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):105–112
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):669
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):228–235
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This work was funded in part by the National Institute of Health (NIH): R25HL124208, R25DK099080, P30AG050886 and U24AG056053. The opinions expressed are those of the authors and not necessarily of the NIH or any other organization.
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In the last 12 months, Dr. Allison has received personal payments or promises for same from: American Society for Nutrition, American Statistical Association, Biofortis, Columbia University, Fish and Richardson, P.C., Frontiers Publishing, Henry Stewart Talks, IKEA, Indiana University, Laura and John Arnold Foundation, Johns Hopkins University, Law Offices of Ronald Marron, MD Anderson Cancer Center, Medical College of Wisconsin, National Institutes of Health (NIH), Sage Publishing, The Obesity Society, Tomasik, Kotin and Kasserman LLC, University of Alabama at Birmingham, University of Miami, Nestle, WW (formerly Weight Watchers International, LLC). Donations to a foundation have been made on his behalf by the Northarvest Bean Growers Association. Dr. Allison is an Unpaid Member of the International Life Sciences Institute North America Board of Trustees. Dr. Allison’s institution, Indiana University, has received funds to support his research or educational activities from: NIH, Alliance for Potato Research and Education, American Federation for Aging Research, Dairy Management, Inc., Herbalife, Laura and John Arnold Foundation, Oxford University Press. In the last 12 months, Dr. Brown has received personal payments or paid travel from: American Society for Nutrition, Indiana University, Kentuckiana Health Collaborative, Rippe Lifestyle Institute, Inc. Dr. Brown’s institution, Indiana University, has received funds to support his research or educational activities from: American Federation for Aging Research, Dairy Management, Inc., NIH, Oxford University Press, University of Alabama at Birmingham. The other authors declare that they have no disclosures.
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Dickinson, S.L., Golzarri-Arroyo, L., Brown, A.W. et al. 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’. Breast Cancer Res Treat 175, 263–264 (2019). https://doi.org/10.1007/s10549-019-05155-6
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DOI: https://doi.org/10.1007/s10549-019-05155-6