What is the study question being investigated? 2. Study population What population is being investigated and what are the inclusion and exclusion criteria for the participants of the investigation? How many individuals are included in the study and in the control groups? Are the numbers adequate to demonstrate statistical significance if the study hypothesis is true (what is the statistical power)? What method is used to identify and assign individuals or populations to study and control groups? Are there differences between study and control groups, other than the factor being investigated, that may affect the outcome of the investigation? Are the participants and/or the investigators aware of the participants’ assignment to a particular study or control group? 1. Appropriate Does the measurement of outcomes address the study’s question? 2. Accurate and precise Is the measurement of outcomes an accurate and precise measure of the phenomenon that the investigators seek to assess? 3. Complete and unaffected by observation Is the outcome measurement nearly 100% complete and is it affected by the participants’ or the investigators’ knowledge of the study group or control group assignment? 1. Estimation What is the magni
tude or strength of the relationship observed in the investigation? 2. Inference What statistical technique(s) are used to perform statistical significance testing? 3. Adjustment What statistical technique(s) are used to take into account or control for differences between the study group and the control group that may affect the results? 1. Contributory cause or efficacy Does the factor being investigated alter the probability that the disease will occur (contributory cause) or work to reduce the probability of undesirable outcomes (efficacy)? 2. Harms Are adverse events that affect the meaning of the results identified? 3. Subgroups and interactions Do the outcomes in subgroups differ and are there interactions between factors that affect outcomes? Do the investigators extrapolate or extend the conclusions to individuals, groups, or populations that are similar to those who participated in the investigation? Do the investigators extrapolate by extending the conclusions beyond the dose, duration, or other characteristics of the investigation? Do the investigators extrapolate to populations or settings that are quite different from those in the investigation? Rev. 2021 Riegelman, R.K. & Nelson, B.A. (2021). Wolters Kluwer.