Term
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Definition
| • Study population- what is the population being studied and what are the inclusion and exclusion criteria for the subjects |
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Term
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Definition
| • Study hypothesis- what is the study question? |
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Term
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Definition
• Sample size and statistical power-
• how many subjects?
• Are the number of people enough to show statistical significance?
• Power analysis? ( minimal number of subjects to guarantee usable results) |
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Term
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Definition
| • Assignment process: What method is used to identify and assign subjects to study and control groups? ( is it observed or randomization?) how are you assigning subjects? |
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Term
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Definition
| • Confounding variable: are there differences in control and experimental group that might affect the outcome of the investigation? |
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Term
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Definition
| • Masking ( so that subjects don’t know what grp theyre in): single blind- subjects don’t know what group they are in. Double blind : subjects and experimenter don’t know what group the patients are in |
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Term
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Definition
| • Appropriate measurement: does the measurement answer the study question? |
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Term
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Definition
| • Accurate and precise measurement: is the measurement an accureate and precise measure of the phenomenon that the investigation is measuring? Is the instrument reliable? Complete and unaffected by observation? Is the follow up of subjects nearly 100%? Deals with attrition |
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Term
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Definition
| • is the follow up of subjects complete and is it affects by subjects or investigators knowledge of the study group or control group assignment? |
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Term
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Definition
| • Estimation- how strong are the observations? |
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Term
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Definition
| • Inference- what statistical techniques are used to take into account or control for differences between the study group and control group that may affect the results? |
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Term
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Definition
| • Adjustment- what statistical techniques are used to take into account or control for differences between the study group and control group that may affect the result |
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Term
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Definition
| • Contributory cause of efficacy: does the factor increase the probability that the disease will happen ( contributing cause) or lower the probability of an undesirable outcome (efficacy) |
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Term
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Definition
| • Harms and interactions: are adverse effects or interactions that affect the results indentified? |
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Term
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Definition
| • Subgroups: are the outcomes seen in subgroups different from the outcomes seen in the overall investigation? |
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Term
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Definition
| • Similar individuals, groups, or populations: do the investigators extrapolate the findings from the experiment to that of groups similar to the groups in the experiment? |
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Term
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Definition
| • Beyond the data: do the investigators extrapolate by spreading the conditions beyond the dose, duration, or other characteristics of the investigation? |
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Term
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Definition
| • To other populations: do investigators extrapolate to different groups than groups in the experiment |
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