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After completing this chapter, the reader will be able to

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  • List and explain the skills pharmacists need to locate and evaluate current information for pharmacy practice activities.
  • Describe special characteristics of a controlled clinical trial that distinguish this research design as the prototype for clinical research.
  • Differentiate between the types of data and measures of central tendency.
  • Prepare a null hypothesis (H0) based upon the clinical trial objective and endpoints.
  • Differentiate between Type I and Type II errors; discuss methods to reduce the possibility of either of these errors occurring.
  • Interpret p-values and 95% confidence interval (CI); discuss whether to reject or fail-to-reject the H0 by using clinical trial results.
  • Calculate and interpret relative risk (RR), relative risk reduction (RRR), absolute risk reduction (ARR), and number-needed-to-treat (NNT).
  • State whether a statistical significance and clinical difference are present, using the clinical trial results.
  • Explain the purpose and usage of editorials, letters to the editor, and secondary journals in critiquing clinical trials and in the decision-making process of applying the results into practice.

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  • Image not available. Pharmacists need to efficiently locate, critically analyze, and effectively communicate data from the primary literature in daily activities of patient care and the medication use process.
  • Image not available. A controlled clinical trial is the premier study design to measure and quantify differences in effect between the intervention versus control.
  • Image not available. Decision making should not rely solely on reading abstracts; the entire manuscript is to be read and thoroughly evaluated.
  • Image not available. The results of a controlled clinical trial should be extrapolated to the type of patient enrolled in the study, and readers should be aware of the limitations of surrogate endpoints and subgroup analysis results.
  • Image not available. Randomization is an essential component of controlled clinical trials and a significant differentiator from other study designs.
  • Image not available. The controlled clinical trial primary endpoint should be appropriate for the study purpose and measured using valid techniques and methods.
  • Image not available. An appropriate sample size in a controlled clinical trial is vital for the study results to have any significant meaning; conducting a power analysis is important to determine a suitable sample size.
  • Image not available. Correctly interpreting the p-values is crucial in evaluating a controlled clinical trial; not all statistically significant p-values are clinically important. The magnitude of difference in effect between the intervention and control cannot be determined solely with the p-value.
  • Image not available. The use of 95% confidence intervals can assist the reader in assessing the magnitude of difference in effect between the intervention and control.
  • Image not available. Calculating measures of association (RR, ARR, RRR, NNT) for nominal data provides further information to evaluate the meaning of controlled clinical trial results.
  • Image not available. Non-statistically significant results do not equate to the intervention and control being the same or equal.
  • Image not available. All controlled clinical trial results need to be assessed to determine the clinical relevance (i.e., meaningfulness) of the intervention versus control.
  • Image not available. Controlled clinical trial investigators and authors should disclose any funding sources and potential conflicts of interest.
  • Image not available. Editorials, letters to the editor, and commentary publications can assist in ...

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