Research Methodology: Bias and Validity
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Questions and Answers

What does bias refer to in the context of a study?

  • An error due to random sampling.
  • A systematic error that influences study results. (correct)
  • Errors related only to the outcome measurement.
  • Random fluctuations in data interpretation.

What is confounding bias primarily associated with?

  • Only random errors in a study.
  • Estimates derived solely from the outcome measurement.
  • Influences that are completely independent of the exposure.
  • Confounding factors that affect both the exposure and outcome. (correct)

Which condition must be met for a variable to be classified as a confounder?

  • It cannot be the outcome of the exposure. (correct)
  • It must solely explain the outcome without any relation to the exposure.
  • It has to be a direct cause of the exposure.
  • It must be a proxy for the exposure being studied.

Which of these options correctly describes the outcome of bias in a study?

<p>It can either underestimate or overestimate true associations. (D)</p> Signup and view all the answers

Which statement about confounders is NOT true?

<p>A confounder does not necessarily relate to the occurrence of the outcome. (A)</p> Signup and view all the answers

What is the main expectation regarding concurrent validity?

<p>Both measures should be highly correlated when obtained at the same time. (B)</p> Signup and view all the answers

Which type of validity involves expecting a measurement instrument to accurately forecast a criterion measure obtained later?

<p>Predictive validity (A)</p> Signup and view all the answers

What is expected if a measure has convergent validity?

<p>Correlation with measures of the same construct will be high. (B)</p> Signup and view all the answers

With which type of validity do we expect low correlation with measures of a distinctly different construct?

<p>Divergent validity (A)</p> Signup and view all the answers

Which of the following constructs is an example where gold-standard measurement may not exist?

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

What is the main purpose of the FDA review process after phase 3 of clinical trials?

<p>To evaluate the treatment's safety and effectiveness (C)</p> Signup and view all the answers

In factorial design, what is the primary focus of the trial?

<p>To analyze multiple intervention components simultaneously (D)</p> Signup and view all the answers

What is a key characteristic of crossover design in clinical trials?

<p>Each participant experiences all treatments over time (A)</p> Signup and view all the answers

What is the main purpose of blinding/masking in a randomized controlled trial (RCT)?

<p>To reduce bias and ensure the integrity of the trial results. (B)</p> Signup and view all the answers

What is the purpose of a washout period in a crossover design?

<p>To assess the prior treatment's lasting effects on participants (B)</p> Signup and view all the answers

Which statement accurately describes the difference between statistical significance and clinical significance?

<p>Statistical significance indicates if results are due to chance, while clinical significance addresses whether the effect is meaningful for patients. (D)</p> Signup and view all the answers

In a cluster randomized trial, what is randomized instead of the individuals?

<p>The study sites where the treatment is applied (A)</p> Signup and view all the answers

According to Hill's criteria, which of the following is NOT one of the criteria used to assess causality?

<p>Cost-effectiveness (D)</p> Signup and view all the answers

Which of the following best describes the role of the EQUATOR network?

<p>To promote clear reporting guidelines for health research to improve its reliability. (C)</p> Signup and view all the answers

What does a risk ratio of 1.2 with a 95% confidence interval of 1.1 to 1.3 imply?

<p>There is a 20% increased risk, and the confidence interval indicates strong statistical significance. (B)</p> Signup and view all the answers

Which guideline is specifically designed for randomized controlled trials?

<p>CONSORT guidelines (A)</p> Signup and view all the answers

Which of the following aspects is NOT typically considered when assessing clinical significance?

<p>Statistical p-value (A)</p> Signup and view all the answers

Which of the following accurately describes causal inference in research?

<p>Causality must always be inferred from a set of subjective evidence and criteria. (C)</p> Signup and view all the answers

What precedes the research question in a study?

<p>Problem statement (B)</p> Signup and view all the answers

Which type of question focuses on predicting future outcomes?

<p>Prognosis questions (A)</p> Signup and view all the answers

Which of the following correctly describes a null hypothesis?

<p>There is no difference between the groups being studied (D)</p> Signup and view all the answers

What must research hypotheses indicate?

<p>A predicted relationship between independent and dependent variables (D)</p> Signup and view all the answers

What type of hypothesis predicts the direction of a relationship?

<p>Directional hypothesis (C)</p> Signup and view all the answers

In what way can hypotheses be classified?

<p>As simple or complex (B)</p> Signup and view all the answers

What is the role of the problem statement in research?

<p>To articulate the research problem and its significance (C)</p> Signup and view all the answers

How does a non-directional hypothesis differ from a directional one?

<p>It predicts the existence of a relationship without indicating its direction (C)</p> Signup and view all the answers

What is the purpose of allocation concealment in a study?

<p>To ensure research staff do not know upcoming assignments (B)</p> Signup and view all the answers

Which of the following best describes blinding in a randomized controlled trial?

<p>Concealing the intervention arm from participants and staff (C)</p> Signup and view all the answers

What distinguishes randomization from random sampling in research?

<p>Randomization assigns participants to groups while random sampling selects individuals for possible inclusion in a study. (A)</p> Signup and view all the answers

What type of control might be used in an RCT?

<p>Standard care, placebo, or alternative interventions (A)</p> Signup and view all the answers

Which statement is true regarding intervention conditions in research?

<p>They must adhere to a theoretical rationale and be replicable. (A)</p> Signup and view all the answers

What does a double-blind study ensure?

<p>Neither participants nor researchers know the treatment assignments. (A)</p> Signup and view all the answers

What could be an ethical consideration when designing a control condition?

<p>Ensuring all participants receive a standard of care (D)</p> Signup and view all the answers

In which scenario might blinding be more challenging to implement?

<p>In studies where side effects are easily observable (C)</p> Signup and view all the answers

Flashcards

Bias in research studies

Systematic errors in research design, conduct, or analysis, leading to incorrect estimates of an exposure's effect on an outcome.

Confounding Bias

Bias in the estimated effect of an exposure (IV) on an outcome (DV) due to an association with other factors that influence the outcome.

Confounding Variable

A variable associated with both the exposure and the outcome, but not a part of the direct exposure-outcome pathway.

Conditions for Confounding

A variable must be associated with the exposure, predictive of the outcome, and not an intermediate.

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Risk ratio

A statistical measure of the risk of an outcome in one group compared to another group, often used in epidemiological studies.

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Research Question

Specific questions a researcher wants to answer to address a research problem.

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Problem Statement

Indicates the research problem and why a study is needed, generally preceding the research question.

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Research Hypothesis

Predicted relationship between independent and dependent variables.

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Simple Hypothesis

Predicts a relationship between one independent and one dependent variable.

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Complex Hypothesis

Predicts a relationship between multiple independent and/or dependent variables.

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Directional Hypothesis

Predicts the direction of a relationship (e.g., positive or negative correlation).

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Null Hypothesis (H₀)

States there's no difference or relationship between groups.

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Alternative Hypothesis (H₁)

States there is a difference or relationship between groups.

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Blinding/masking in RCT

A method used in randomized controlled trials (RCTs) to reduce bias by keeping participants and researchers unaware of treatment assignments.

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Statistical significance

Measures whether an effect is likely due to chance; it doesn't indicate 'importance'.

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Clinical significance

In healthcare research, measures whether an effect is meaningful and substantial enough to make a difference for patients or populations.

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Causality

The relationship where one factor directly leads to another.

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Hill's criteria

A set of guidelines used to assess whether an association between factors is likely a causal relationship.

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Temporality (Causality)

The requirement in assessing causality that the exposure must precede the outcome.

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Reporting guidelines

Standardized sets of guidelines to improve the quality and comparability of published health research.

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CONSORT guidelines

Specific reporting guidelines for randomized controlled trials (RCTs).

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Factorial Design

A type of Randomized Controlled Trial (RCT) used when there are multiple intervention components to be tested. Participants are randomly assigned to groups receiving different combinations of these components.

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Crossover Design

A type of RCT where participants are randomly assigned to different treatment orderings. Participants act as their own controls.

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Washout Period

A time period between treatments in a crossover design where participants are not exposed to any intervention. Used to minimize the carry-over effects of previous treatments.

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Cluster Randomized Trial

An RCT where entire groups (e.g., clinics, schools) are randomized to receive different interventions, rather than individual participants.

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Within Subject Design

A research design where the same participants are observed under different conditions or treatments. This means participants serve as their own controls.

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Concealing Allocation

Ensuring research staff don't know the next participant's group assignment.

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Sequentially Numbered Envelopes

A common technique to conceal allocation, where each envelope contains the group assignment for the next participant.

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Blinding or Masking

Hiding information about treatment assignment from participants, staff, or data analysts.

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Single-Blind Study

Participants are unaware of their group assignment.

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Double-Blind Study

Neither participants nor researchers know the treatment assignment.

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Intervention Condition/Arm

The treatment group in a study, receiving the intervention being tested.

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Control Condition/Arm

The comparison group in a study, receiving either standard care, a placebo, or an alternative treatment.

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Wait-list Control Group

A control group that receives the intervention after a delay, allowing researchers to study the effect of delayed treatment.

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Concurrent validity

A type of validity where two measures are taken at the same time to see if they correlate. This is used to assess the validity of a new measurement tool.

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Predictive validity

A type of validity that assesses how well a measurement predicts future outcomes. This is used to see if a measurement tool can accurately forecast a future event.

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Convergent validity

A type of construct validity that measures how well a measurement tool correlates with other measures of the same concept.

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Divergent validity

A type of construct validity that measures how poorly a tool correlates with measures of a different concept.

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Construct validity

This assesses how well a measurement tool truly reflects the underlying concept or construct it's supposed to measure. It's crucial because it checks if the tool actually measures what it claims to measure.

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Study Notes

Evidence-Based Practice (EBP) in Nursing

  • A problem-solving approach using research evidence, patient/family preferences, and clinical expertise to make clinical decisions.
  • Translates research knowledge into practice to improve quality of care, patient outcomes and reduce costs, and geographic variations.
  • Utilizes the best research evidence, clinical expertise, patient preferences, and values.
  • Improves quality of care, patient outcomes, costs, and delivery variations.

EBP Models

  • 5-step model (Medicine)
    • Ask a clinical question
    • Acquire evidence
    • Appraise the evidence
    • Apply the evidence
    • Assess the performance
  • 7-step model (Nursing)
    • Cultivate a spirit of inquiry
    • Ask question (PICOT format)
    • Search/find best evidence
    • Critically appraise the evidence
    • Integrate all evidence with clinical expertise & patient values
    • Evaluate the outcomes of practices, using evidence
    • Share results of EBP changes with other professionals

Learning Outcomes

  • Explain the role of research in establishing EBP in nursing.
  • Describe the different approaches (paradigms) to research methodologies.
  • Put into practice effective literature search skills.
  • Describe the various levels of evidence in the evidence pyramid. (systematic reviews, synthesizes, etc)

Research Pyramid

  • Research at higher levels is more valuable but less voluminous.
  • Studies, at the bottom of the pyramid, are voluminous but have lesser value than those at higher levels.

Levels of Evidence, Criteria & Examples

  • Different levels of evidence in the pyramid with varying degrees of value & complexity.
  • Systems: Clinical information system; computerized decision support systems; point-of-care tools
  • Summaries: Abstracts, reviews, systematic reviews, meta-analyses
  • Synopses of syntheses and Syntheses: Summaries, systematic reviews, meta-analyses, synopses of synopses
  • Synopses of studies: Reviews of high-quality studies, methodologies
  • Studies: Original primary studies, expert opinions, narrative reviews, background resources
  • Explanations/examples for each level relating to research methods, and data collection

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Description

Explore the intricate concepts of bias and validity in research methodology through this quiz. Test your understanding of confounding bias, concurrent validity, and the intricacies of measurement instruments. Perfect for students delving into statistical methods in research.

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