[Skip to Navigation]
Sign In
December 2018

Protocol Deviations and Reanalyses in Derivative Studies of the PREDIMED Trial

JAMA Intern Med. 2018;178(12):1731-1732. doi:10.1001/jamainternmed.2018.6460

Derivative studies of the PREDIMED Trial were published in 4 articles1-4 in JAMA Internal Medicine between 2007 and 2015. After publication of these articles, protocol deviations were discovered that were addressed in reanalyses and that require corrections to these 4 articles. A Letter of Explanation5 describes the reanalyses and corrections. These articles have been corrected online.

Toledo  E, Salas-Salvadó  J, Donat-Vargas  C,  et al.  Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED trial: a randomized clinical trial.  JAMA Intern Med. 2015;175(11):1752-1760. doi:10.1001/jamainternmed.2015.4838PubMedGoogle ScholarCrossref
Valls-Pedret  C, Sala-Vila  A, Serra-Mir  M,  et al.  Mediterranean diet and age-related cognitive decline: a randomized clinical trial.  JAMA Intern Med. 2015;175(7):1094-1103. doi:10.1001/jamainternmed.2015.1668PubMedGoogle ScholarCrossref
Salas-Salvadó  J, Fernández-Ballart  J, Ros  E,  et al; PREDIMED Study Investigators.  Effect of a Mediterranean diet supplemented with nuts on metabolic syndrome status: one-year results of the PREDIMED randomized trial.  Arch Intern Med. 2008;168(22):2449-2458. doi:10.1001/archinte.168.22.2449PubMedGoogle ScholarCrossref
Fitó  M, Guxens  M, Corella  D,  et al; PREDIMED Study Investigators.  Effect of a traditional Mediterranean diet on lipoprotein oxidation: a randomized controlled trial.  Arch Intern Med. 2007;167(11):1195-1203. doi:10.1001/archinte.167.11.1195PubMedGoogle ScholarCrossref
Martínez-González  MA.  Protocol deviations, reanalyses, and corrections to derivative studies of the PREDIMED trial  [published online November 5, 2018].  JAMA Intern Med. doi:10.1001/jamainternmed.2018.6456Google Scholar