Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments

  1. Isabelle Boutron, MD, PhD;
  2. David Moher, PhD;
  3. Douglas G. Altman, DSc;
  4. Kenneth F. Schulz, PhD, MBA;
  5. Philippe Ravaud, MD, PhD; and
  6. for the CONSORT Group*
  1. 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.
    1. Figure.
      View larger version:
      Figure. Modified CONSORT flow diagram for individual randomized, controlled trials of nonpharmacologic treatment.

      An extra box for each 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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