Baseline Data

You will need to specify what baseline data should be gathered prior to the start of intervention and how it will be gathered—by interview, questionnaire, physical examination, specialized examinations (angiograms, ultrasound, MRI), and/or laboratory tests. Baseline data will be used both to determine eligibility and, as discussed in the next chapter, to stratify the patients into more homogeneous subgroups.

Be comprehensive. Unexpected differences in outcome (or lack thereof) may be the result of differences in baseline variables. What isn't measured can't be accounted for.

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