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. Author manuscript; available in PMC: 2015 Oct 1.
Published in final edited form as: J Bone Miner Res. 2014 Oct;29(10):2131–2140. doi: 10.1002/jbmr.2293

Table 2.

Set of Reporting Standards for Rigorous Study Design

Randomization
  • Animals should be assigned randomly to the various experimental groups, and the method of randomization reported.

  • Data should be collected and processed randomly or appropriately blocked.

Blinding
  • Allocation concealment: the investigator should be unaware of the group to which the next animal taken from a cage will be allocated.

  • Blinded conduct of the experiment: animal caretakers and investigators conducting the experiments should be blinded to the allocation sequence.

  • Blinded assessment of outcome: investigators assessing, measuring, or quantifying experimental outcomes should be blinded to the intervention.

Sample-size estimation
  • An appropriate sample size should be computed when the study is being designed and the statistical method of computation reported.

  • Statistical methods that take into account multiple evaluations of the data should be used when an interim evaluation is carried out.

Data handling
  • Rules for stopping data collection should be defined in advance.

  • Criteria for inclusion and exclusion of data should be established prospectively.

  • How outliers will be defined and handled should be decided when the experiment is being designed, and any data removed before analysis should be reported.

  • The primary end point should be prospectively selected. If multiple end points are to be assessed, then appropriate statistical corrections should be applied.

  • Investigators should report on data missing because of attrition or exclusion.

  • Pseudo replicate issues need to be considered during study design and analysis.

  • Investigators should report how often a particular experiment was performed and whether results were substantiated by repetition under a range of conditions.