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Methodology Each of the 6 components in the M.A.A.R.I.E. framework can be divided into three specific issues. This

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has been the focus for the majority of our text book readings, class discussions, project work and your research proposal. The methodology of any research paper (randomized control trial, cohort study, prospective study, etc.) is normally the first thing you encounter, and typically the issues and key questions are: • • • Study hypothesis Study population Sample size and statistical power 1- In your own words, what does METHOD, the first component of the framework, define? 2- Explain to me how the 3 above key questions complement one another and your interpretation of what each of them means (do not just give me the text book definition of study hypothesis, etc.). Assignment The second component of the framework is assignment, or the selection of study participants for the study and control group(s). The three basic issues and key questions are as follows: • • • Process of assignment Confounding variables Masking 3- Explain to me how you dealt with these three issues in your research proposal for this class. What was your process of assignment, and how did you identify it? How did you control for confounding variables? Was masking possible? Answer these questions, and then discuss how despite the simplicity of this component of the framework, how it can effect interpretation of results of a study. Assessment This is the measurement of outcomes or end points in the study group and in the control group. In order to assess the results of an investigation, researchers must define the outcome or end points they intend to measure. The assessment portion of research is considered valid when it fulfills these 3 criteria: • • • Measurement is Appropriate Measurement is Accurate Measurement is Precise Additionally, implementation of measurement or assessment should be: • • Complete Unaffected by the process 4- What does it mean to pick a measurement that is not appropriate versus one that is appropriate? 5- In your own words, relating to assessment of end points in a research trial, what is the difference between accuracy and precision? 6- Why is it so devastating for a study when follow-up of patients is incomplete? 7- Define the placebo affect and tell me how that might have outcomes on affecting the “process” Results The fourth component of the framework is where we perform statistical calculations on the raw data collected during the assessment phase. In this component, we address 3 key questions: • • • Estimation Inference Adjustment 8- Please put in your own words what each of these 3 questions mean as it relates to Results of a study. What does Estimation mean in research results? 9- What does inference mean in research results? 10- What does Adjustment mean in research results? Interpretation The fifth component asks us to address questions about the meaning of the investigations results for those who participated in the investigation. The 3 questions/issues that can be addressed by interpretation are: • • • Contributory cause of efficacy Harms Subgroups 11-What is the difference between contributory cause and efficacy, in your own words? 12- Did you discuss Harms in your research proposal? If so, what are they? If not, what could they be? Extrapolation The final component asks what the results of the investigation tell us about individuals not included in the study and for situations not directly addressed by the study. 13- Why is the process of extrapolation so important to consider when looking at a Randomized Controlled Trial? When conducting extrapolation, we ask how the investigation applied the results to: • • • People similar to the average participant in the investigation Situations that go beyond the range of the study’s data Populations or settings that differ from those in the investigation 14- In your own words, what is the biggest difference between interpretation of results and extrapolation of results?
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