Title: Research Pearl - Needed for Sample Size Calculation<br/>
Author: Michael Witting<br/>
<a href='mailto:mwitting@som.umaryland.edu'>[Click to email author]</a><hr/>
Link: <a href='https://umem.org/educational_pearls/4533/'>https://umem.org/educational_pearls/4533/</a><hr/><p>Needed for sample size determination</p>
<p><strong>Power</strong> – (1-beta), where beta is the risk of a type 2 error – rejecting the accepting the null hypothesis when it is true – this is usually selected to be 0.8 or 0.9.</p>
<p><strong>Significance</strong> (alpha), the chance of making a type 1 error – accepting the alternate hypothesis when the null hypothesis is true. This is usually selected to be 0.05.</p>
<p><strong>One-tailed or two-tailed</strong> – is the null hypothesis one of no difference (experimental arm not better or worse) or one-sided (experimental arm not better)?</p>
<p><strong>Effect Size.</strong> This is the challenging part. This is the size of the difference in outcomes you’re looking for. </p>
<p> For continuous outcomes (example – difference in pain scores). You’ll need an estimate for the variation in the scores between presentations, or the standard deviation. You can get this from a literature estimate or a from small local measurement, say of 10 patients or so.</p>
<p> For a dichotomous outcome (example – percentage of successes), you can usually estimate the percentage in one group and choose the difference you are looking for.</p>
<p>The effect size has a big effect on the sample size. Generally, cutting the effect size in half increases the sample size by fourfold.</p>
<p><strong>Statistical software</strong> - next pearl.</p>