Updated Disclosure Statement for Invited Commentary
Authors: Miguel Martínez-González
Journal: JAMA Internal Medicine (2018)

significantly different among the groups.The corrections following the reanalysis affect the text in the Abstract, Methods, and Results sections; Tables 3 and4; and Figure 2.For the Original Investigation, "Mediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial," 3 published in the November 2015 issue of JAMA Internal Medicine, the overall results of the study are unchanged in the multivariable analysis.This study examined breast cancer incidence as a prespecified secondary outcome of the original trial among women without a prior history of breast cancer among the 3 diet groups and found a lower risk of breast cancer associated with the Mediterranean diet plus extra virgin olive oil diet group compared with the control diet group.The findings from the additional analyses that adjusted for propensity scores, used robust variance estimators, and excluded participants with departures from the individual randomization procedures were consistent with the originally reported findings.These corrections affect the text in the Methods and Results sections, and Tables 2 and3.For the Original Investigation, "Effect of a Mediterranean Diet Supplemented With Nuts on Metabolic Syndrome Status: One-Year Results of the PREDIMED Randomized Trial," 4 published in the December 8/22, 2008, issue of JAMA Internal Medicine (formerly Archives of Internal Medicine), the overall results of the study are unchanged in the multivariable analysis.This study compared the 1-year prevalence of metabolic syndrome (MetS) among participants in the 3 diet groups with baseline MetS who were provided 2 behavioral interventions and showed reduction in the prevalence of MetS associated with the Mediterranean diet plus nuts diet group compared with the low-fat control diet group.The findings from the additional analyses that adjusted for propensity scores and used robust variance estimators were consistent with the originally reported findings.These corrections affect the text in the Abstract, Methods, and Results section, and Figure 3.For the Original Investigation, "Effect of a Traditional Mediterranean Diet on Lipoprotein Oxidation: A Randomized Controlled Trial," 5 published in the June 11, 2017, issue of JAMA Internal Medicine (formerly Archives of Internal Medicine), the overall results of the study are unchanged in the multivariable analysis.This study assessed changes in oxidized lowdensity lipoprotein (oxLDL) levels between the 3 diet groups and found a significant reduction in oxLDL levels associated with the Mediterranean diet plus virgin olive oil group compared with the low-fat control diet group.Most of the findings from the additional analyses that adjusted for propensity scores and used robust variance estimators were consistent with the originally reported findings.However, in the corrected unadjusted model comparing diet groups, the changes in oxLDL levels between the groups were no longer statistically significant.The oxLDL level differences in the adjusted model, however, remained statistically significant.These corrections affect the text in the Abstract, Methods, and Results sections, and Table 4.I have requested that the original articles 2-5 be corrected to explain the irregularities in the randomization in the origi-nal trial and to include the reanalyses.