Chapter 1: Studying a Study: M.A.A.R.I.E. Framework—Method, Assignment, Assessment

Introduction Four basic types of investigations which compare groups of people are found in the health research literature ([1],[2]): population comparisons or ecological studies case-control studies or retrospective studies cohort studies or prospective studies randomized controlled trials or randomized clinical trials Each type of investigation attempts to address a defined question or hypothesis by comparing […]

Chapter 2: Studying a Study: M.A.A.R.I.E. Framework—Results

Introduction The fourth component of the M.A.A.R.I.E. framework is the results or analysis section. Like the previous components, results require us to address three key questions [(1)]: Estimation: What is the magnitude or strength of the association or relationship observed in the investigation? Inference: What statistical technique(s) are used to perform statistical significance testing? Adjustment: […]

Chapter 3: Studying a Study: M.A.A.R.I.E. Framework—Interpretation, Extrapolation

Interpretation Interpretation asks us to address questions about the meaning of the investigation’s results for those who have participated in the investigation. There are three types of questions that can be addressed by interpretation. Contributory cause or efficacy: Does the factor being investigated alter the probability that the disease will occur (contributory cause) or work […]

Chapter 4: Randomized Controlled Trials

Introduction Randomized controlled trials (RCTs) or randomized clinical trials are now widely considered the gold standard by which we judge efficacy. The U.S. Food and Drug Administration (FDA) requires them for drug approval4.1; the National Institutes of Health rewards them with funding; the journals encourage them by publication; and increasingly, practitioners read them and apply […]

Chapter 5: Observational Studies

Introduction Randomized controlled trials are the gold standard for efficacy, but they are not the gold standard for effectiveness or safety. In addition, randomized controlled trials may not be feasible or ethical. They are nearly always very expensive and time consuming. Therefore, there is a great need for other types of analytic studies to complement […]

Chapter 6: Safety

Introduction Randomized controlled trials are the gold standard for efficacy so we might ask the question: What is the gold standard for safety? Unfortunately, the answer is not so easy since there is no one type of study that can provide us with all the evidence we need. We might think of the gold standard […]

Chapter 7: Meta-analysis

Introduction Thus far, we have examined the basic types of investigations in the health research literature that are designed to compare study and control groups. These investigations often provide consistent results. At times, however, studies published in the health research literature seem to conflict with one another, making it difficult to provide definitive answers to […]

Chapter 8: Testing a Test—M.A.A.R.I.E. Framework: Method, Assignment, and Assessment

Introduction Testing a Test is about how we use evidence to make decisions. We will begin by using the M.A.A.R.I.E. framework to better understand research articles on tests. That is, we will look at the methods, assignment, assessment, results, interpretation, and extrapolation issues, and see how they apply to evaluation of a test. We will […]

Chapter 9: Testing a Test—M.A.A.R.I.E. Framework: Results, Interpretation, and Extrapolation

Results ([1],[2]) The results component of the M.A.A.R.I.E. framework for Testing a Test asks about the performance of the index test compared with the reference standard, that is, gold standard test, or definitive test. The results component presents quantitative estimates of the information provided by the index test compared with the perfectly performing reference standard. […]

Chapter 10: Screening—Prediction and Decision Rules

Introduction Screening for asymptomatic disease as well as prediction and decision rules are two increasingly important applications of the principle of testing that we examined in Chapters 8 and 9. In this chapter, we will take a look at each of these applications of testing principles. Screening ([1]–[3]) Criteria for Successful Screening Screening is a […]