Evidence Based Practice Week 5 - Clinical Intervention Studies
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Questions and Answers

In hypothesis testing, what is the primary consequence of increasing the stringency of the significance level (alpha) from 0.05 to 0.01?

  • It has no impact on the probability of committing Type I or Type II errors.
  • It proportionally reduces both Type I and Type II errors.
  • It increases the likelihood of committing a Type II error.
  • It decreases the likelihood of committing a Type I error. (correct)

A researcher is evaluating the inter-rater reliability of a new observational tool. Which statistical measure is most appropriate for quantifying the agreement between multiple raters using this tool?

  • Cohen's Kappa
  • Pearson correlation coefficient
  • Cronbach's alpha
  • Intraclass correlation coefficient (ICC) (correct)

When interpreting Number Needed to Treat (NNT), which of the following scenarios indicates the most effective treatment?

  • NNT = 0
  • NNT = 1 (correct)
  • NNT = 20
  • NNT = 10

In a clinical trial, a new drug reduces the risk of a certain disease from 8% to 6% in the treatment group. What is the Absolute Risk Reduction (ARR)?

<p>2% (A)</p> Signup and view all the answers

Which of the following statements best describes the utility of Cronbach’s alpha in assessing the validity of a measurement instrument?

<p>Cronbach’s alpha assesses the internal consistency of a set of items within a scale. (D)</p> Signup and view all the answers

What is the most accurate interpretation of a statistically significant p-value (e.g., p < 0.05) in clinical research?

<p>If the groups came from the same population, the probability of observing a difference as large as, or larger than, the one reported is less than 5%. (A)</p> Signup and view all the answers

In the context of research, what distinguishes a 'clinically meaningful difference' from a 'statistically significant difference'?

<p>A clinically meaningful difference is large enough to be considered important by patients, whereas a statistically significant difference is determined by a statistical test. (A)</p> Signup and view all the answers

Why is achieving a truly 'representative' sample challenging in clinical research?

<p>Limited time, resources, and practical constraints often compromise the ability to include all segments of the population. (B)</p> Signup and view all the answers

What is the primary advantage of using random or consecutive sampling methods in clinical trials?

<p>They reduce the risk of selection bias by ensuring everyone meeting the criteria has an equal opportunity to be recruited. (C)</p> Signup and view all the answers

How does 'availability' influence the representativeness of a study sample?

<p>It reflects the practical limitations in reaching all segments of the population, potentially skewing the sample. (B)</p> Signup and view all the answers

Why is it important for researchers to consider the method of recruitment and inclusion/exclusion criteria when interpreting study results?

<p>These factors link the characteristics of the sample to the population, affecting the generalizability of the results. (B)</p> Signup and view all the answers

What is the primary challenge researchers face when aiming for a large, perfectly representative sample in clinical research?

<p>The high cost, resource intensity, and logistical difficulties of recruiting a broad and representative sample. (C)</p> Signup and view all the answers

In what way is 'generalizability' best understood concerning the application of study results to patient care?

<p>Generalizability exists on a continuum, with findings being more or less applicable to different patient populations. (D)</p> Signup and view all the answers

What is the most significant implication of selection bias in clinical research?

<p>It compromises the internal validity of a study and limits the generalizability of the findings. (B)</p> Signup and view all the answers

Why might a researcher choose to conduct a study with a small sample size at a single site, despite knowing the limitations this poses to generalizability?

<p>Due to the practical challenges and resource constraints associated with recruiting large samples across multiple sites. (A)</p> Signup and view all the answers

In a study comparing a new drug to a placebo, researchers observe a statistically significant difference in recovery time (p < 0.05). However, the baseline characteristics of the treatment and placebo groups were notably different. What is the most critical concern regarding this study's conclusion?

<p>The observed difference is likely confounded by the pre-existing differences between the groups. (D)</p> Signup and view all the answers

A researcher is analyzing a dataset of income levels in a city. The data is heavily skewed due to a small number of individuals with extremely high incomes. Which combination of descriptive statistics is most appropriate for representing the central tendency and variability of this data?

<p>Median and interquartile range (D)</p> Signup and view all the answers

A physical therapist is evaluating the effectiveness of a new rehabilitation program on improving range of motion in patients after shoulder surgery. They measure each patient's range of motion before and after the program. Which statistical test is most appropriate to determine if there is a significant change in range of motion within the same individuals?

<p>Paired samples t-test (D)</p> Signup and view all the answers

A researcher is investigating the relationship between several independent variables (age, BMI, physical activity level) and a dependent variable (VO2 max). All variables are continuous. Which statistical test is most appropriate for determining the combined predictive power of the independent variables on VO2 max?

<p>Multiple linear regression (D)</p> Signup and view all the answers

A study aims to identify factors that predict which patients with lower back pain will respond positively to physical therapy and which will not. The outcome is binary: 'responder' or 'non-responder.' Which statistical method is best suited to predict group membership based on several independent predictor variables?

<p>Binary Logistic Regression (A)</p> Signup and view all the answers

A researcher conducts an ANOVA to compare the means of four treatment groups. The ANOVA yields a significant p-value (p < 0.05). What does this p-value indicate?

<p>At least one group mean is significantly different from the others. (A)</p> Signup and view all the answers

A research study reports a 95% confidence interval for the mean systolic blood pressure of a population to be 120-130 mmHg. Which of the following is the most accurate interpretation of this confidence interval?

<p>If the study were repeated many times, 95% of the calculated confidence intervals would contain the true population mean systolic blood pressure. (B)</p> Signup and view all the answers

In a correlation analysis, a researcher finds a correlation coefficient of r = -0.85 between two variables. What is the most accurate interpretation of this result?

<p>As one variable increases, the other variable decreases strongly. (D)</p> Signup and view all the answers

A researcher is analyzing the effectiveness of a new treatment for a rare disease. The data is not normally distributed, and the sample size is small. Which type of statistical test is most appropriate?

<p>Non-parametric test (C)</p> Signup and view all the answers

A study compares the effectiveness of three different exercise programs on weight loss. Participants are randomly assigned to one of the three programs. After 12 weeks, the mean weight loss is calculated for each group. Which statistical test is most appropriate to compare the mean weight loss across the three groups?

<p>ANOVA (D)</p> Signup and view all the answers

A researcher is investigating the relationship between hours of exercise per week and body fat percentage. Both variables are continuous. Which statistical test is most appropriate to determine the strength and direction of the linear relationship between these two variables?

<p>Pearson correlation (C)</p> Signup and view all the answers

A study examines the impact of a new educational program on student test scores. The researchers find a statistically significant improvement in test scores after the program. However, they also discover that students who participated in the program had significantly higher baseline test scores compared to those who did not. Which statistical approach would best adjust for these pre-existing differences?

<p>Employing an Analysis of Covariance (ANCOVA) with baseline scores as a covariate. (B)</p> Signup and view all the answers

A researcher wants to determine the independent effects of age, gender, and education level on annual income. Which statistical method is most suitable for this analysis?

<p>Multiple linear regression (B)</p> Signup and view all the answers

A rehabilitation researcher aims to determine the simultaneous impact of age, BMI, and disease duration on predicting the likelihood of successful return to work (yes/no) following a work-related injury. What statistical test aligns best with this research question?

<p>Binary Logistic Regression (D)</p> Signup and view all the answers

A study is designed to assess the effectiveness of a new drug in reducing blood pressure. Patients are randomly assigned to either the treatment group or the placebo group. What is the primary purpose of ensuring similar baseline characteristics between the two groups?

<p>To ensure that any observed differences in blood pressure are due to the drug and not pre-existing differences. (D)</p> Signup and view all the answers

A research team is investigating the impact of a novel therapeutic exercise on shoulder abduction range of motion (measured in degrees) among individuals with adhesive capsulitis. Recognizing pre-intervention variability, they employ a repeated-measures design. Which statistical test is most appropriate?

<p>Paired t-test (B)</p> Signup and view all the answers

A researcher is comparing the effectiveness of two different rehabilitation protocols on improving functional outcomes after stroke. The distribution of functional outcome scores is non-normal. Which statistical test is most appropriate for comparing the two groups?

<p>Mann-Whitney U test (B)</p> Signup and view all the answers

In a study examining the correlation between grip strength (in kilograms) and functional independence (as measured by the Functional Independence Measure (FIM) score) among elderly individuals, the research team discovers a non-linear relationship. Which statistical method is now most appropriate for assessing the relationship between these two variables?

<p>Spearman correlation (C)</p> Signup and view all the answers

Researchers are evaluating the effectiveness of a fall-prevention program among older adults with a history of falls. Participants are divided into a fall-prevention group and a control group. What statistical approach should be used to determine if participation in the fall-prevention program is associated with a reduction in the number of falls over a 12-month period?

<p>Regression Analysis (D)</p> Signup and view all the answers

A research team investigates the impact of a novel rehabilitation program on functional mobility (measured using the Timed Up and Go test) in stroke survivors. Data is gathered before and after the intervention. What statistical approach should be used to determine if there is a statistically significant change in functional mobility following the rehabilitation program?

<p>Paired t-test (D)</p> Signup and view all the answers

Consider a cohort study design comparing the effectiveness of a novel rehabilitation approach (Group A) to a traditional approach (Group B) on improving a patient reported outcome measure. If the purpose is to determine the comparative effectiveness of the novel approach in relation to the traditional approach, what type of analysis should be considered?

<p>Between-group difference analysis comparing Group A and Group B (B)</p> Signup and view all the answers

In the context of outcome evaluation, what critical consideration must be accounted for when interpreting within-group mean change following an intervention?

<p>Within-group change may encompass natural recovery, regression to the mean, and nonspecific effects, alongside the treatment effect. (D)</p> Signup and view all the answers

When evaluating the clinical meaningfulness of an outcome score change, which of the following considerations is MOST important for physical therapists?

<p>Determining the true real-world impact of a change or difference of that size. (A)</p> Signup and view all the answers

In a randomized controlled trial (RCT) evaluating a new intervention, the authors report conclusions solely based on within-group changes, despite the presence of a control group. Under what circumstance might this occur?

<p>When there is no statistically significant difference observed between the intervention and control groups. (A)</p> Signup and view all the answers

Which study design most effectively isolates the treatment effect from confounding factors such as natural history and nonspecific effects?

<p>Randomized controlled trial (RCT) with a comparison group. (C)</p> Signup and view all the answers

A physical therapist is examining the correlation between lower extremity strength (measured in Nm) and balance confidence (measured by the Activities-Specific Balance Confidence Scale) in a group of patients with multiple sclerosis (MS). After plotting the data, the therapist observes a curvilinear relationship. Which statistical method is MOST appropriate for quantifying the association between these variables?

<p>Quadratic regression analysis (D)</p> Signup and view all the answers

A research team is studying the effectiveness of a new rehabilitation protocol on improving functional outcomes in patients following total knee arthroplasty (TKA). They measure several outcome variables, including pain, range of motion, and functional mobility. Which of the following statistical methods would be most appropriate for determining the overall effect of the rehabilitation protocol on this set of intercorrelated outcome variables?

<p>Multivariate Analysis of Variance (MANOVA) (B)</p> Signup and view all the answers

A researcher aims to investigate the comparative effectiveness of three different exercise interventions (A, B, and C) on improving shoulder range of motion in patients with adhesive capsulitis. Recognizing the potential influence of baseline range of motion on treatment response, which statistical approach should incorporate baseline values?

<p>ANCOVA with baseline range of motion as a covariate (B)</p> Signup and view all the answers

A physical therapist wants to assess the reliability of a new goniometer for measuring knee joint range of motion. Two therapists independently measure the knee range of motion of the same group of patients, and the therapist wants to determine the degree of agreement between the two sets of measurements. Which statistical test is most appropriate for this analysis?

<p>Intraclass Correlation Coefficient (ICC) (C)</p> Signup and view all the answers

Which of the following statements BEST describes the difference between statistical significance and clinical meaningfulness?

<p>Statistical significance refers to the likelihood that the results are due to chance, while clinical meaningfulness indicates the practical importance and impact of an intervention on patients' lives. (B)</p> Signup and view all the answers

Flashcards

Descriptive Statistics

Describes data without making comparisons. Summarizes characteristics of a dataset (e.g., mean, median).

Inferential Statistics

Estimates population characteristics and makes inferences based on sample data. Used to draw conclusions beyond the immediate data.

Type I Error

The probability of rejecting the null hypothesis when it is actually true (false positive).

Type II Error

The probability of failing to reject the null hypothesis when it is actually false (false negative).

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Cronbach's Alpha

Measures the correlation between multiple outcome variables to assess internal consistency. High alpha indicates items are related, but not overly redundant.

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Clinical Meaningfulness

Determines if a change or difference in a study is relevant and important to patients or clinical practice.

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P-value

The probability that the observed difference occurred by chance, assuming no real difference exists.

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Statistical Significance

A difference unlikely to have occurred by chance, based on a pre-defined p-value threshold.

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Clinically Meaningful Difference

A mean difference between groups considered important by patients.

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Representative Sample

Aims to ensure the study group resembles the broader group you want to learn about.

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Random Sampling

Every person has an equal chance of being selected.

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Consecutive Sampling

Recruiting all eligible people over a specific period.

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Selection Bias

When certain people are more likely to be chosen.

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Voluntary Participation

People can choose whether to be in a study.

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Generalizability

Applying study results from a group to a larger population.

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Average Values

Describes how common values are in a dataset.

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Data Variability

Describes how spread out or clustered the data is.

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Normal Distribution

A symmetrical, bell-shaped distribution where most data points cluster around the mean.

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Normally Distributed Data

Use mean to find the central tendency, and standard deviation to find the variability

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Skewed Data

Data skewed to the left or right, without a central tendency.

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Median

The middle value that separates the higher half from the lower half of the data set.

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Confidence Interval

A range within which we are 95% confident the true population mean lies.

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Baseline Characteristics

Ensuring that the data from the participants looks the same at the beginning of the study

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T-Test

Compares the means of two groups to see if they are statistically different.

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T-Test Data Type

Data must be continuous

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Paired Samples T-Test

Compares changes within the same individual or paired subjects.

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ANOVA

Compares the means of three or more groups.

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Correlation

Measures the strength and direction of a linear relationship between two continuous variables.

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Logistic Regression

Tries to predict group membership

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Independent t-test

Compares means between two independent groups.

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Paired t-test

Compares means of paired or matched groups (pre/post intervention).

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Multinomial Logistic Regression

Predicts a binary outcome using multiple predictor variables.

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Binary Logistic Regression

Predicts a binary outcome based on predictor variables.

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Change (within-group)

The score at a later time minus the score at an earlier time.

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Difference (between-group)

The score difference on an outcome measure between two groups.

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Treatment Effect (comparative)

Effect of a treatment compared to another treatment, not natural recovery.

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Outcome

Level of interest for clinicians (e.g., pain, function, quality of life).

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Constructs of Interest

Clinically relevant constructs

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Outcome Score

Assessment of construct level.

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Interpreting an Outcome Score

Judgment of what a change or difference really means.

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Change in Outcome Scores

A change in outcome scores from pretreatment to posttreatment.

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Interpreting Meaningfulness

Does the change justify the cost/effort of the treatment?

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Study Notes

  • Study notes on clinical intervention studies, covering data distribution, types of data, reliability, hypothesis testing, inferential statistics, and validity.

Distribution of Data

  • Data can follow normal or skewed distributions.
  • Normal distributions allow the use of parametric statistics, while skewed distributions require non-parametric statistics.

Descriptive Statistics

  • Used to describe data without making comparisons.
  • Includes measures like average values (mean or median), commonality of values, data variability (standard deviation), and the range of values.
  • For normally distributed data, use the mean and standard deviation.
  • For skewed data, use the median.
  • In normally distributed data, the median and mean are close; in skewed data, they can differ significantly.

Confidence Intervals

  • Usually reported as a 95% confidence interval.
  • It estimates the range within which the true population mean lies, based on the sample mean.

Baseline Characteristics

  • Ensures that participants and data are similar at the beginning of a study.

Inferential Statistics

  • Drawing conclusions about a population based on sample data.
  • Includes null hypothesis significance testing.

T-test

  • Compares two groups to determine if there is a statistically significant difference between them.
  • Requires continuous data.
  • Statistical significance is determined when the p-value is less than 0.05.

Paired Samples T-Test

  • Compares changes within the same individual over time.
  • Example: Measuring bench press max at the start and end of a training season.

ANOVA (Analysis of Variance)

  • Compares multiple groups (more than two).
  • Example: Comparing treatment A vs. treatment B vs. treatment C.

Correlation

  • Examines the relationship between two continuous variables within the same individuals, without dividing them into groups.
  • Example: Relationship between body fat level and systolic blood pressure.

Linear Regression

  • Explores the relationship between multiple variables, identifying independent predictors.
  • Independent predictors have a significant relationship with the outcome of interest, even when controlling for other factors.
  • Dependent variables are the outcomes being predicted or measured, influenced by independent variables.

Binary Logistic Regression

  • Groups data based on multiple independent predictors.
  • Used when the outcome is binary (two groups).
  • Example: Grouping patients into those who respond well or poorly to a treatment based on various independent variables.
  • Multinomial logistic regression is used for placing data into more than two groups.

Cronbach’s Alpha

  • Measures the correlation between multiple outcome variables, ensuring they are related but not overly redundant.
  • Aims to confirm that measured data are closely related but not too repetitive.

Research Scenario Examples and Statistical Tests

  • Effectiveness of a 12-week resistance training program on quadriceps strength: Use a paired sample T-test.
  • Predicting FIM scores at hospital discharge based on age, physical activity level, and BMI: Use multiple linear regression.
  • Comparing three physical therapy interventions for knee range of motion after ACL reconstruction: Use ANOVA.
  • Comparing physical therapy to no intervention for chronic low back pain: Use an independent t-test.
  • Effectiveness of a six-week balance training program for patients with Parkinson’s disease: Use a paired t-test.
  • Relationship between quadriceps strength and gait speed in stroke survivors: Use correlation.
  • Predicting fall risk in older adults based on age, muscle strength and the use of assistive devices: Use multi nominal logistic regression.
  • Association between adherence to a home exercise program and pain reduction: Use binary logistic regression.
  • Determine if quadriceps strength differs among basketball players, volleyball players, and runners: Use ANOVA.

Change vs. Difference

  • Change refers to the score on an outcome measure at follow-up minus the score at baseline, indicating within-person or within-group change over time.
  • Difference involves data from two groups, where the between-group difference is the score on an outcome measure in treatment group A minus the mean score in group B.

Treatment Effect

  • Within-group change over time is not the same as the treatment effect.
  • Between-group difference can reasonably be called the treatment effect, as it accounts for natural history, regression to the mean, and nonspecific effects.
  • The "effectiveness" of treatment A is interpreted in light of what treatment B involved.

Statistical Significance vs. Clinical Meaningfulness

  • Interpreting outcomes involves judging the meaning of a change or difference in scores.
  • Requires determining if the change or difference is clinically meaningful, statistically significant, or both.

P-value

  • P-value represents the probability that the true difference between the means of two groups is as big as, or bigger than, the difference reported in the study, assuming the groups came from the same population.
  • A P-value itself is not a good measure of evidence regarding hypotheses about treatment effectiveness.
  • Statistical significance refers to the probability under a specified statistical model that a statistical summary of the data would be equal to more extreme than its observed value.
  • Clinically meaningful difference refers to a mean difference between groups that is large enough for patients to consider the difference important.

Sampling

  • The goal of any sampling method is to recruit a “representative” sample which mirrors the population.
  • Obtaining a representative sample is difficult due to limited time and resources.

Random Sampling

  • Requires that contact details of everyone in the population are available
  • Each individual in the population therefore has an equal chance of being selected for the sample.
  • Then a random process is used to select who is contacted and invited to be in the study.

Consecutive Sampling

  • Common in clinical research.
  • Everyone who meets the study's inclusion criteria at a certain place during a defined period is invited into the study until the necessary sample size is reached.

Recruitment Bias

  • Recruiting cannot choose who is recruited.
  • Ensuring that everyone who meets the criteria is recruited, the risk of selection bias is reduced.
  • Selection bias occurs when certain members of the population are preferentially recruited into the study (e.g. younger or fitter people).

Practical Challenges to Sample Recruitment

  • Researchers have to distribute information about the study, contact interested people, screen potential participants for eligibility, provide required information for informed consent, and collect all necessary measurements and data.
  • Challenges are magnified with large samples and when participants are recruited from numerous and geographically dispersed locations.

Choosing to participate

  • Individuals usually have a choice as to whether or not they wish to participate in a study, and can drop out of a study at any time.
  • Participants in a randomized controlled trial must agree to accept one treatment or another based on random allocation
  • Participants must also agree to the data-collection protocol, which typically involves more time and inconvenience than usual clinical care.

Conclusion

  • The results of a study are only useful to the extent that they can be applied to the patient being treated
  • Generalizability is a continuum; study findings are not a dichotomy of “generalizable” or “not,” but, rather, more or less generalizable.

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Study notes on clinical intervention studies, covering data distribution, types of data, reliability, hypothesis testing, inferential statistics, and validity. Includes descriptive statistics, confidence intervals and hypothesis testing.

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