Erratum. Mediterranean Diet, Retinopathy, Nephropathy, and Microvascular Diabetes Complications: A Post Hoc Analysis of a Randomized Trial. Diabetes Care 2015;38:2134–2141
- Andrés Díaz-López,
- Nancy Babio,
- Miguel A. Martínez-González,
- Dolores Corella,
- Antonio J. Amor,
- Montse Fitó,
- Ramon Estruch,
- Fernando Arós,
- Enrique Gómez-Gracia,
- Miquel Fiol,
- José Lapetra,
- Lluís Serra-Majem,
- Josep Basora,
- F. Javier Basterra-Gortari,
- Vicente Zanon-Moreno,
- Miguel Ángel Muñoz,
- Jordi Salas-Salvadó, and
- the PREDIMED Study Investigators
Some imperfections in the randomization procedures affecting a small subset of participants in the Prevención con Dieta Mediterránea (PREDIMED) trial (at most 14%) have been reported in a recent republication of the main PREDIMED article (see Estruch et al. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. N Engl J Med 2018;378:e34). For this reason, the authors wish to make the following corrections to their original PREDIMED substudy on the Mediterranean diet and diabetic retinopathy and nephropathy (Díaz-López et al. Mediterranean diet, retinopathy, nephropathy, and microvascular diabetes complications: a post hoc analysis of a randomized trial. Diabetes Care 2015;38:2134–2141).
In the original substudy, a limited number of participants (n = 184; 5.1% of the total sample) were directly allocated to the same arm of the trial as their relatives because a previous member of their same household (usually the spouse) was already randomized in the trial. Also, center D, one of the eleven recruiting centers, had allocated a subset of its participants (it had 360 participants [9.9% of the total sample]) by clusters (clinics) instead of using individual randomization (23 participants from center D were also second household members).
The authors have reanalyzed the effect of the intervention on the incidence of retinopathy and nephropathy adjusting for propensity scores (built with 30 predictors of allocation) and using a robust estimate of the variance to correct for intra-cluster correlation (see corrected Table 2 below). The authors show in this table the corrected estimates for these outcomes as compared with those reported in their original article. The results are basically unchanged.
Hazard ratios (95% CI) for diabetic retinopathy and diabetic nephropathy incidence according to intervention group in the PREDIMED trial after a median 6.0 years of follow-up
Importantly, the key message from the original article does not change and the final conclusions remain the same.
- © 2018 by the American Diabetes Association.
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