To the Editor As reported elsewhere,1 my coinvestigators and coauthors of the PREDIMED trial have identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. Briefly, there were 425 participants who were allocated to the same group as their family member already randomized in the trial and with whom they shared the same household. In addition, 467 participants from 1 of the 11 recruiting sites were not individually randomized but rather were assigned to an intervention group based on clinics (ie, all participants attending a particular clinic, the site where the intervention was delivered for small groups of participants, received the same intervention). The original PREDIMED trial compared cardiovascular outcomes among 3 diet groups: (1) a traditional Mediterranean diet plus virgin olive oil, (2) a traditional Mediterranean diet plus nuts, and (3) a low-fat control diet. Derivative studies assessed other outcomes, including cognitive decline, breast cancer, metabolic syndrome, and lipoprotein oxidation.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Martínez-González MA. Protocol Deviations, Reanalyses, and Corrections to Derivative Studies of the PREDIMED Trial. JAMA Intern Med. 2018;178(12):1730–1731. doi:10.1001/jamainternmed.2018.6456
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: