Experimental research in biostatistics

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Questions and Answers

In a factorial experimental design assessing the impact of exercise and diet on weight loss, which analysis would best determine if the effect of exercise on weight loss differs depending on the type of diet?

  • Assess the main effects of exercise and diet separately using two-way ANOVA.
  • Conduct separate regression analyses for exercise and diet, then compare R-squared values.
  • Perform independent t-tests comparing weight loss between the exercise and no-exercise groups for each diet type.
  • Examine the interaction effect between exercise and diet using a two-way ANOVA. (correct)

A researcher aims to study the effect of a new drug on blood pressure but notices that participants in the treatment group are, on average, significantly younger than those in the control group. What is the most appropriate statistical method to account for this difference when analyzing the results?

  • Chi-square test, since age is a potential confounding variable.
  • Regression analysis, including age as a covariate. (correct)
  • Stratified analysis, adjusting for age categories.
  • A simple t-test, because age is a continuous variable.

In a clinical trial for a new asthma medication, some participants in the treatment group begin using an over-the-counter remedy without informing the researchers. What type of bias is most likely to be introduced by this behavior?

  • Attrition bias
  • Selection bias
  • Detection bias
  • Performance bias (correct)

A researcher is conducting a crossover study to compare two different pain medications. After the first treatment period, it's discovered that the first medication has a prolonged effect that carries over into the second treatment period. What is the most appropriate action for the researchers to take?

<p>Extend the washout period to allow the effects of the first medication to dissipate. (A)</p> Signup and view all the answers

A public health researcher is planning a community-based intervention to promote physical activity. Due to logistical constraints, they cannot randomize individuals but instead randomize entire neighborhoods to either the intervention or control condition. What type of experimental design is this?

<p>A cluster randomized trial (C)</p> Signup and view all the answers

Suppose a clinical trial investigating a new drug for hypertension experiences a significant dropout rate, with more participants dropping out of the treatment group due to reported side effects. How should this be addressed in the statistical analysis to avoid bias?

<p>Use intention-to-treat analysis, including all participants based on their original group assignment. (C)</p> Signup and view all the answers

In a study examining the effect of a new educational program on student test scores, the researchers discover that students in the intervention group also have access to better resources at home. What threat to internal validity does this situation primarily represent?

<p>Selection-maturation interaction (C)</p> Signup and view all the answers

A researcher is analyzing data from a randomized controlled trial and observes a statistically significant difference between the treatment and control groups. However, the 95% confidence interval for the effect size includes zero. What is the most appropriate interpretation of this result?

<p>The result may not be practically meaningful, despite the statistical significance. (B)</p> Signup and view all the answers

In an experimental study assessing the impact of a new teaching method on student performance, the teachers involved are aware of which students are receiving the new method and which are not. What type of bias is most likely to be introduced?

<p>Performance bias (B)</p> Signup and view all the answers

A researcher conducts an experimental study on the effectiveness of a new therapy for depression. Participants are recruited through advertisements, and those who volunteer are randomly assigned to either the treatment or control group. What is the primary concern regarding the generalizability (external validity) of the study's findings?

<p>The potential for selection bias due to voluntary participation. (C)</p> Signup and view all the answers

Flashcards

Experimental Research

Planned intervention to observe the effect on an outcome, used to establish cause-and-effect.

Randomized Controlled Trial (RCT)

Participants are randomly assigned to different groups to receive treatment or placebo.

Crossover Study

Participants receive treatments in a sequence, acting as their own controls.

Factorial Design

Examines multiple interventions simultaneously, allowing you to see interaction effects.

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Blinding

Participants (single) or both participants and researchers (double) are unaware of treatment assignments.

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Confounding Variables

Variables related to both the intervention and the outcome, potentially distorting the results.

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Bias in Experimental Research

Systematic differences between groups due to non-random assignment, care differences, assessment differences or dropouts.

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Independent Variable

The variable that is manipulated by the researcher.

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Dependent Variable

The variable that is measured to see if it is affected by the manipulation.

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Validity in Experimental Research

The extent to which the intervention caused the outcome (internal) and results can be generalized (external).

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Study Notes

  • Experimental research involves the planned intervention in a study to observe the effect on an outcome
  • Experimental research establishes cause-and-effect relationships

Key Characteristics

  • Manipulation involves researchers actively changing a variable
  • Control refers to efforts to minimize extraneous factors
  • Randomization is when participants are assigned randomly to groups

Study Designs

  • Randomized Controlled Trial (RCT) features participants randomly assigned to different groups
  • Crossover Study involves participants receiving a sequence of different treatments
  • Factorial Design examines multiple interventions simultaneously

Randomized Controlled Trial

  • Participants are randomly allocated into groups
  • One group receives the intervention (treatment group)
  • The other receives a placebo or standard care (control group)
  • Outcomes are compared to determine the intervention's effect

Crossover Study

  • Participants receive a sequence of different treatments.
  • Each participant serves as their own control
  • Washout periods are included between treatments to minimize carryover effects

Factorial Design

  • Examines multiple interventions simultaneously
  • Allows investigation of interactions between interventions
  • Efficient for studying multiple research questions in a single experiment

Blinding

  • Single-blinding means participants are unaware of their treatment assignment
  • Double-blinding means both participants and researchers are unaware of treatment assignments
  • Blinding reduces bias in outcome assessment

Confounding Variables

  • Confounding variables can influence the outcome and are related to the intervention
  • Randomization helps to balance confounding variables between groups

Bias in Experimental Research

  • Selection Bias: Systematic differences between groups due to non-random assignment
  • Performance Bias: Differences in care or attention provided to different groups
  • Detection Bias: Systematic differences in how outcomes are assessed
  • Attrition Bias: Systematic differences between groups due to participant dropout

Data Collection

  • Standardized protocols are used for data collection
  • Data quality is monitored to ensure accuracy and completeness

Sample Size

  • Adequate sample size is needed to detect meaningful effects
  • Power analysis is conducted to determine the required sample size

Statistical Analysis

  • Outcome data is analyzed using appropriate statistical tests
  • T-tests, ANOVA, chi-square tests, and regression models are commonly used
  • Intention-to-treat analysis: Data is analyzed based on the original group assignment

Reporting Results

  • Results are reported clearly and transparently
  • Include descriptive statistics, statistical tests, and confidence intervals
  • Discuss limitations and potential sources of bias

Strengths of Experimental Research

  • Establishes cause-and-effect relationships
  • High degree of control over variables
  • Can be replicated by other researchers

Limitations of Experimental Research

  • Can be expensive and time-consuming
  • May not be feasible or ethical for all research questions
  • Results may not be generalizable to real-world settings

Ethical Considerations

  • Informed consent is obtained from participants
  • Risks and benefits are carefully considered
  • Studies are reviewed by an institutional review board (IRB)

Validity in Experimental Research

  • Internal validity refers to the degree to which the intervention caused the outcome
  • External validity refers to the degree to which the results can be generalized

Types of Variables

  • Independent Variable: The variable that is manipulated
  • Dependent Variable: The variable that is measured
  • Control Variables: Variables kept constant to prevent confounding

Data Analysis Techniques

  • Descriptive statistics summarize the data
  • Inferential statistics draw conclusions and make generalizations

Interpretation of Results

  • Consider the magnitude of the effect
  • Take into account the clinical significance
  • Interpret findings in the context of previous research

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