chapter) to support Se for conducting the study. Also, the ir jormation may be presented using bies the reader to believing the prior ‘h was insignificent in providing evidence applicable to practice. METHODS Following a well-designed plan is | for the clinical trial results to be acceptabie and useful to practitior (i.e., methods) is important far “s:.-"7tts to be valid, just as abiding by the blueprints is vital to building ah unt of information that includes the type of subjects enrolled, the compara ures, and statistics. Flaws within the design of a clinical trial limit the application and significan design leads to reduced study internal validity, thus resulting in limited external study validity (see ).’ The mi thorough in describing to the reader the process in which the study was conducted. In fact, a reader should c used to assess the trial in this section a clinical trial contains 2 large a: outcome mea Table 6-3. Internal vs. External Validity of Clinical Trials Term Meaning Application Internal validity Quality of the study design Strong design should translate into reliable results External validity Ability to apply results into practice Study results meaningful to practitioners and can be us Clinical trials follow @ pattern in presenting the information within the methods section. This standardized fori in an orderly fashion and quickly located. Readers of the biomedical literature should have an understanding appropriately critique clinical trizls and use the study results for patient care-related activities. Study Design Severe! study designs are available for investigators to select from when conducting research. The study que seswer dictate which study design is selected to conduct the research.’ For example, in a case where investic teraction between azithromycin and cyclosporine, serum cyclosporine levels will be compared with patients azithromycin. Although a clinical trial can be used to conduct this research, the consequence of combining the er cyclosporine toxicity or organ transplantation rejection. This study is considered unethical to conduct ir dication for therapeutic purposes. Thus other study techniques must be employed to answer this research ind readers of the literature need to identify the strengths and limitations of the research designs. Although 1 availabie, this chapter only discusses controlled clinical triais. For additional information on other study desig! A simple description of a controtted clinica! trial is that it prospectively measures a difference in effect betwee are similar and treated identically with the exception of the therapies under study. The subjects in the study groups and monitored.” This study type, called parallel design, is the primary study design encountered in tt Controlled clinical trials offer investigators the most rigorous method of establishing a cause-and-effect relatit outcome. Simply explained, the treatment under study is the cause and the consequence of aiving the treatrr The effect of the treatment under study is compared to the effect of the other group(s). Thus, investigators c that 2 treatment hes some effect that may be important in curing or relieving disease symptoms. In addition, the difference in the effect between the groups can be estimated. ‘empl to briefly describe a controllea clinical trial measuring a cause and effect is a study that compare study objective was to compare atorvastatin (cause) to placebo and measure the reduction in average low de (LDL-C) leveis (effect between the two groups. A clinical trial also quantifies the differences in the effect, suc simvastatin in lowering LDL-C. The results of these studies can he used to determine the magnitude of LDL-C make the decision to use, or not use, this medication in practice. The characteristics of a controlled clinical trial were the justification for selecting this study design for the WH unsure of whether CEE/MPE reduced or increased the incidence of CHD. No compelling evidence was availabl effect of this combination product for this Use. The results of the WHI trial demonstrated that CEE/MPE actua