Skip to main content
JAMA Network logoLink to JAMA Network
. 2018 Nov 5;178(12):1731–1732. doi: 10.1001/jamainternmed.2018.6460

Protocol Deviations and Reanalyses in Derivative Studies of the PREDIMED Trial

PMCID: PMC12520701  PMID: 30398520

Derivative studies of the PREDIMED Trial were published in 4 articles1,2,3,4 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.

References

  • 1.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.2015.4838 [DOI] [PubMed] [Google Scholar]
  • 2.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.2015.1668 [DOI] [PubMed] [Google Scholar]
  • 3.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.168.22.2449 [DOI] [PubMed] [Google Scholar]
  • 4.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.167.11.1195 [DOI] [PubMed] [Google Scholar]
  • 5.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.2018.6456 [DOI] [PubMed] [Google Scholar]

Articles from JAMA Internal Medicine are provided here courtesy of American Medical Association

RESOURCES