Public Comments - Methodology Standards

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12: Standards on Research Designs Using Clusters

RC-1: Specify whether the study objectives, the interventions, and the primary outcomes pertain to the cluster level or individual level

  1. Describe the target population of clusters and individuals to which the study findings will be generalizable.
  2. Describe the clusters to be randomized and the subjects to be enrolled in the trial.

Public comments

As a whole Standard 12, and in particular RC-1 and RC-2, is restrictive in its binary classification of the cluster and individual level of study objectives, interventions, and primary outcomes. This hierarchical manner of thinking is restrictive for research designs.
Lisa Simpson, AcademyHealth, Stakeholder - Other, 04/11/2016 - 4:50pm