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Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration
- Isabelle Boutron, MD, PhD;
- David Moher, PhD;
- Douglas G. Altman, DSc;
- Kenneth F. Schulz, PhD, MBA;
- Philippe Ravaud, MD, PhD; and
- for the CONSORT Group*
- From INSERM U738, AP-HP, Hôpital Bichat-Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France; Chalmers Research Group, Children's Hospital of Eastern Ontario Research Unit, University of Ottawa, Ottawa, Ontario, Canada; University of Oxford, Oxford, United Kingdom; and Family Health International, Research Triangle Park, North Carolina.
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View larger version:Figure 1. Modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.An extra box per intervention group relating to care providers has been added. For cluster randomized, controlled trials, authors should refer to the appropriate extension. IQR = interquartile range; max = maximum; min = minimum.
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View larger version:Figure 2. Example of modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.This example was not reported in the article but was developed with the help of the authors (39). IQR = interquartile range; max = maximum; min = minimum.
