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Chapter 9 Quantitative Inquiry Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter Overview • This chapter is presented based upon classical test theory (pretest–posttest) rather than from the perspective of clinical epidemiology (case control, cohort, randomizedcontrolled clinical trial) perspective. • Quantitative inquiry forms the basis for the scientific method. • Through the performance of controlled investigation, researchers can objectively assess clinical and natural phenomena and develop new knowledge. • Differences between the types of measurement data. • Differences between Type I and Type II errors and their relevance to data analysis. • Understand the determinants of reliability. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins The Scientific Method The scientific method is the primary means by which new knowledge is acquired. Phenomena are tested in objective, quantitative, and empirical ways. Basic Steps of the Scientific Method 1. Observation of a natural phenomenon. 2. Ask a research question. 3. Develop a research hypothesis that predicts the answer to the question. 4. Design and conduct an experiment to test your hypothesis. 5. Answer the research question based on whether the experiment confirms or refutes the hypothesis. 6. Confirm your results by replicating the experiment. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins The Scientific Method: Research Question • A good research question cannot be based on clinical observation alone. • It must be developed by framing the observation within the existing knowledge base of a specific discipline. • The hypothesis should be based on both clinical observation and what is known in the existing literature. • The outcomes measures are referred to as dependent variables, whereas the interventions are referred to as independent variables. • The results of the experiment should provide a clear answer to the research question. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins The Scientific Method: Replication • A very important step in the scientific method is the replication of an experiment to confirm the results found in the initial experiment. • The replication study is performed by a different group of researchers than the group that performed the initial study. • Replication ensures that the findings can be generalized to a broader population • Without confirmation, the results of the original study may not be confidently generalized into the routine practice of other clinicians. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Measures of Central Tendency • Hypothesis testing is typically performed to assess: – Whether there is a difference in the scores of a dependent variable between two or more groups. – Whether there is a difference in the scores of a dependent variable over time within the same group of studies. • This requires the comparison of representative scores across groups or testing sessions. • This is most often performed by comparing measures of central tendency. • The most common measure of central tendency used in health care research is the mean. The median and the mode are used less often. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Mean, Median, and Mode • The mean (x̄) represents the arithmetic average of scores across all sampled subjects. • This is expressed mathematically as: xi is the score of each individual subject n is the total number of subjects • The median (Md) represents the individual score that separates the higher half of scores from the lower half of scores. • The median score is determined with the formula: Md = n+1 2 • The mode (Mo) is the score that occurs most frequently out of all included observations. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Estimates of Dispersion • An important characteristic of a data set is the dispersion, or variability, of observed values. • The range of scores represents the arithmetic difference between the highest and lowest scores in a data set. • A limitation of the range is that outliers can skew this estimate of dispersion. • Outliers are individual scores at the low and/or high extremes of the data set. • A more robust estimate of dispersion is the standard deviation. • The standard deviation estimates how much the scores of individual subjects tend to deviate from the mean. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Standard Deviation • The formula to calculate standard deviation is • The numerator of this equation is termed the “sum of squares” and is used in a wide variety of statistical analyses. • Normal distribution: 68% of data points for the entire data set will lie within (+) 1 standard deviation of the mean. Likewise, 95% of data points will lie within (+) 2 standard deviations of the mean, and 99% of data points will lie within (+) 3 standard deviations of the mean. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Tests of Inferential Statistics • Tests of inferential statistics (t-tests, analysis of variance) utilize the concepts of the variability in data sets to compare means. Application: • Variance is defined as the standard deviation squared (s2). • A comparison of two means with these statistical tests is based on the probability of overlap in the normal distribution of the two data sets being compared. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Hypothesis Testing • Statistical analysis is performed to test the hypothesis. • The research hypothesis HA (also called the alternative hypothesis): The investigator has an idea that the independent variable is going to cause a change in the dependent variable. • The null hypothesis HO : The independent variable will not cause a change in the dependent variable. • Inferential statistical analysis is a test of the null hypothesis. • Most statistical analyses are performed to determine if there is not a difference between two measures. • Hypothesis testing will yield a yes or no answer as to whether there is a statistically significant difference between measures in the study sample. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Contingency Table of Hypothesis Testing Results If the results of the tested sample do not match what is true in the population at large, either a Type I or a Type II error has occurred. Population Result Sample Result HA True (difference between measures does exist) HO True (difference between measures does not exist) HA True (difference between measures does exist) HO True (difference between measures does not exist) Correct Incorrect (Type I error) Incorrect (Type II error) Correct Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Sampling • Experiments are performed on a representative sample of subjects rather than on the entire population of individuals. • The sampling frame represents the group of individuals who have a real chance of being selected for the sample. • Investigators need to establish specific inclusion and exclusion criteria for the subjects in studies. • Without such criteria, there are limits to the generalizability of the study results. This concept is referred to as “external validity.” Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Type I and Type II Errors • Type II error: Occurs when a difference exists in the population at large but the study results reveal no difference in the study sample. • The most common reason for a Type II error is inadequate sample size. This is also referred to as having low “statistical power” for the study. • Estimation of an appropriate sample size for a study is done by performing an a priori power analysis. • Type I Error: Occurs when a difference is found in the study sample but there is in fact no difference present in the population at large. • Investigators are willing to accept a 5% risk of incurring a Type I error (α = .05) and a 20% risk of incurring a Type II error (1-β = .80). These values are a bit arbitrary. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Types of Sampling • Probability sampling involves the use of randomization to select individual potential subjects from the sampling frame. • Nonprobability sampling is a method of sampling in which selected subjects are not drawn randomly from the sampling frame. • Random sampling is method of sampling in which every potential individual in the sampling frame has an equal chance of being selected for study participation (uses computerized random number generators). • Systematic random sampling is a method of sampling in which every xth individual out of the entire list of potential subjects is selected for participation. • Stratified random sampling provides a method for dividing the individual members of the sampling frame into groups, or strata, based on specific subject characteristics. • Cluster random sampling is a process of dividing the sampling frame into groups based on some common characteristics and then randomly selecting specific clusters to participate in the study out of all possible clusters. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Convenience vs. Purposive Sampling • Random sampling is considered superior to nonrandom sampling because the results of the study are more likely to be representative of the population at large. • Convenience sampling is a type of sampling in which potential subjects are selected based on the ease of subject recruitment. • Purposive sampling is a type of nonrandom sampling. It entails potential subjects from a predetermined group to be sought out and sampled. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Basic Experimental Research Methods Pre-Experimental Designs One shot posttest design • Consists of a single measurement completed after a group of subjects has already received the treatment of interest (case series). Lacks pretest and a control group. Threats to internal validity. One group pretest–posttest design • Adds a pretest to the previous design. Static group posttest design • Has two groups, one that receives the intervention and one that does not. Both groups are assessed only once. There is no pretest for either group. Nonrandomized pretest–posttest design • Compares two groups before and after intervention. The two groups receive different interventions. The assignment of subjects to groups is based on convenience rather than on randomization. Time series design • Compares a single group at multiple, but regular, time intervals before and after intervention. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Basic Experimental Research Methods True Experimental Designs • Randomized assignment of subjects to groups. This improves the internal validity of the study design. Randomized posttest design • Subjects are randomly assigned to treatment groups. • There is no pretest taken before the administration of treatment. Randomized pretest–posttest design • Subjects are pretested, and then they are randomized to assigned groups. They are posttested after they receive their assigned intervention. • This prevents any potential bias on the part of the research team member. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter Summary and Key Points • Clinician observations can be translated into hypotheses that can be evaluated via experimental study by following the steps of the scientific method. • The concepts of central tendency are the foundation for inferential statistics. • Hypothesis testing allows for the research hypothesis to be confirmed or refuted. • Sampling of potential study volunteers is important to the generalizability of the study results. • Experimental design of a study forms the infrastructure for the project. • Quantitative inquiry is central to advancing the health sciences. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins