Table 1.

Recommendations for a Core Set of Reporting Standards for Rigorous Study Design

Randomization
 1. Animals should be assigned randomly to experimental groups, and the method of randomization should be reported.
 2. Data should be collected and processed randomly or appropriately blocked.
Blinding
 1. Allocation concealment: Investigators should be unaware of the group to which the next animal taken from a cage will be allocated.
 2. Blinded conduct of the experiment: Animal caretakers and investigators conducting the experiments should be blinded to the allocation sequence.
 3. Blinded assessment of outcome: Investigators assessing, measuring, or quantifying experimental outcomes should be blinded to the intervention.
Sample-size estimation
 1. An appropriate sample size should be computed when the study is being designed and the statistical method of computation reported.
 2. Statistical methods that take into account multiple evaluations of the data should be used when an interim evaluation is performed.
Data handling
 1. Rules for terminating data collection should be defined in advance.
 2. Criteria for inclusion and exclusion of data should be established prospectively.
 3. Outliers should be defined and handled in a manner that should be decided when the experiment is being designed, and any data removed before analysis should be reported.
 4. The primary end point should be prospectively selected. If multiple end points are to be assessed, then appropriate statistical corrections should be applied.
 5. Investigators should report on data missing because of attrition or exclusion.
 6. Pseudo replicate issues need to be considered during study design and analysis.
 7. Investigators should report how often a particular experiment was performed and whether results were substantiated by repetition under a range of conditions.
  • Adapted from Landis et al117 by permission from Macmillan Publishers Ltd. Copyright © 2012, Macmillan Publishers Limited.