Sample Size in Mental Health Research
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Questions and Answers

What is a primary reason for conducting sample size calculations in research?

  • To reduce the overall cost of the study
  • To ensure outcomes are statistically significant if a treatment effect exists (correct)
  • To speed up the recruitment process
  • To limit the number of participants in a study
  • Which of the following best defines a Type I error?

  • Failing to detect a true treatment effect
  • Finding no difference when one does exist
  • Detecting a treatment effect that does not exist (correct)
  • Incorrectly estimating the size of the treatment effect
  • Which factor does NOT impact the determination of sample size in a study?

  • The duration of the study (correct)
  • The desired level of statistical significance
  • The expected effect size
  • The variability in the outcome measure
  • What is a result of conducting a small study?

    <p>It may create publication bias for statistically significant results. (B)</p> Signup and view all the answers

    What happens when a study is too small in sample size?

    <p>It may lead to inconclusive findings. (C)</p> Signup and view all the answers

    How does trial size impact the credibility of results?

    <p>Very small trials may be regarded as unreliable. (C)</p> Signup and view all the answers

    Why is it important to adjust sample sizes for loss to follow-up?

    <p>To ensure an adequate number of participants remain for analysis. (A)</p> Signup and view all the answers

    In the context of sample size, what does 'risk ratio' indicate?

    <p>The comparison of death rates between treatment and control groups. (C)</p> Signup and view all the answers

    What was the primary outcome measured in the clinical trial investigating CBT for reducing depression in adults with cancer?

    <p>Beck Depression Inventory II (BDI-II) (C)</p> Signup and view all the answers

    What difference in BDI-II score did investigators consider necessary to recommend CBT for clinical practice?

    <p>6 points (A)</p> Signup and view all the answers

    Which factor does NOT contribute to the power of a study?

    <p>Time duration of the study (B)</p> Signup and view all the answers

    What is one way to increase the power of a clinical trial?

    <p>Increase the sample size (A)</p> Signup and view all the answers

    In the context of the CBT study, what represents the expected treatment effect associated with CBT?

    <p>A score reduction of 6 points on the BDI-II (A)</p> Signup and view all the answers

    What is the primary endpoint of the clinical trial investigating the effectiveness of cognitive behavioural therapy?

    <p>Beck Depression Inventory II score (D)</p> Signup and view all the answers

    What is the expected mean BDI-II score in the control group following treatment?

    <p>20 points (B)</p> Signup and view all the answers

    What treatment difference must be detected to implement CBT in clinical practice based on the study's criteria?

    <p>6 points (A)</p> Signup and view all the answers

    What level of statistical significance is set for this trial?

    <p>5% (A)</p> Signup and view all the answers

    What does a sample size calculation help determine in this clinical trial?

    <p>The required sample size per group (C)</p> Signup and view all the answers

    With what degree of power is the trial designed to detect the treatment effect?

    <p>80% (B)</p> Signup and view all the answers

    What variability is indicated by the standard deviation of the BDI-II scores in cancer patients?

    <p>12 points (D)</p> Signup and view all the answers

    How many individual CBT sessions will the intervention group receive in addition to treatment as usual?

    <p>12 sessions (B)</p> Signup and view all the answers

    What is the remaining percentage of participants after a 20% attrition from an initial 120 participants?

    <p>80% (B)</p> Signup and view all the answers

    How is the adjusted sample size calculated when the attrition rate is 25%?

    <p>Sample size ÷ 0.75 (D)</p> Signup and view all the answers

    What does a p-value greater than 0.05 indicate in the context of sample size calculations?

    <p>No difference exists between the groups tested. (C)</p> Signup and view all the answers

    Why should post hoc power calculations be avoided according to the available guidelines?

    <p>They cannot help identify reasons for expected results not being found. (A)</p> Signup and view all the answers

    What does the term 'Q' represent when calculating the adjustment for loss to follow-up?

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

    Which of the following is NOT a reason for obtaining a p-value greater than 0.05?

    <p>Standard deviation is less than specified. (B)</p> Signup and view all the answers

    What is an advisable method to report findings beyond post hoc power calculations?

    <p>95% confidence intervals (B)</p> Signup and view all the answers

    Which statement is true about the relation between sample size and Type I and Type II errors?

    <p>Sample size impacts both Type I and II error rates. (C)</p> Signup and view all the answers

    What is meant by the term 'clinically important effect' in sample size calculations?

    <p>The smallest difference between groups that needs to be detected (A)</p> Signup and view all the answers

    Which factor is typically assumed to be the same between groups when determining sample size?

    <p>Standard deviation of the outcome (C)</p> Signup and view all the answers

    What statistical power is commonly specified in sample size calculations?

    <p>80% or 90% (D)</p> Signup and view all the answers

    In the context of binary outcomes, what does the variable p1 represent?

    <p>The true proportion in the control group (A)</p> Signup and view all the answers

    Which component is NOT part of the required sample size formula for comparing two means?

    <p>Proportion of the control group (A)</p> Signup and view all the answers

    How is the required sample size for means and proportions generally related?

    <p>They share a similar structure in their formulas. (A)</p> Signup and view all the answers

    What does the significance level typically represent in sample size calculations?

    <p>0.05 (A)</p> Signup and view all the answers

    Which of the following can be affected by the standard deviation in sample size calculations?

    <p>All of the above (D)</p> Signup and view all the answers

    What is the primary effect of larger sample sizes in hypothesis testing?

    <p>They enhance the ability to detect smaller differences between groups. (C)</p> Signup and view all the answers

    How does an increase in variability of outcomes between groups affect sample size requirements?

    <p>It necessitates larger sample sizes. (D)</p> Signup and view all the answers

    What is the significance of 'power' in sample size calculations?

    <p>It represents the likelihood of detecting a true effect. (D)</p> Signup and view all the answers

    What is the impact of a smaller significance level on sample size requirements?

    <p>It increases the required sample size. (D)</p> Signup and view all the answers

    In the context of anticipating loss to follow-up, what should researchers do?

    <p>Recruit additional participants to counteract potential loss. (D)</p> Signup and view all the answers

    What method is typically used to estimate required sample size for continuous outcomes adjusting for baseline?

    <p>Specifying correlations between baseline and follow-up. (D)</p> Signup and view all the answers

    Which factor is likely to increase sample size requirements when conducting a hierarchical study?

    <p>Increased intraclass correlation (ICC). (A)</p> Signup and view all the answers

    What must researchers consider when conducting time to event analysis?

    <p>The timing of events must be carefully recorded. (A)</p> Signup and view all the answers

    What effect does a significant loss to follow up have on a study’s power?

    <p>It reduces the power to detect the specified effect. (D)</p> Signup and view all the answers

    Flashcards

    Sample Size

    The number of participants required to obtain reliable evidence of a treatment effect, while also achieving precise estimates of the effect.

    Type I Error

    Incorrectly rejecting a true null hypothesis. This means concluding there is an effect when there is not.

    Type II Error

    Incorrectly failing to reject a false null hypothesis. This means failing to detect an effect that actually exists.

    Alpha level (α)

    The probability of committing a Type I error. It's the acceptable risk of falsely concluding there's an effect when there isn't.

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    Power (1 - β)

    The power of a study is the probability of correctly rejecting a false null hypothesis. A powerful study can detect an effect that exists.

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    Limitations of small studies

    A small study may lack the power to detect a real treatment effect, resulting in inconclusive findings. This could mislead researchers and clinicians.

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    Publication Bias

    Studies with small sample sizes may be more likely to be published if they show a statistically significant result (p<0.05), regardless of the real effect size.

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    Appropriate Sample Size

    Ensuring that enough participants are enrolled in a study to obtain reliable evidence while balancing ethical, economic, and pragmatic considerations.

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    Power

    The probability of detecting a treatment effect when it is actually present.

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    Effect size

    The specific value of the effect size that the study aims to detect. This is usually based on clinical significance.

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    Standard deviation (SD)

    The variation in the outcome measure within the population. A larger SD means more variability in the data.

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    Clinically Important Effect

    The smallest difference between groups that is considered meaningful and worth detecting.

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    Significance Level (Alpha)

    The probability of incorrectly rejecting a true null hypothesis, typically set at 5%.

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    Sample Size Formula (Two Means)

    The required sample size per group for comparing two means, where μ1 and μ2 are the means of the two groups.

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    Sample Size Formula (Two Proportions)

    The required sample size per group for comparing two proportions, where p1 and p2 are the proportions of the two groups.

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    Sample Size Relationship

    The relationship between sample size, standard deviation, and effect size. A larger effect size or smaller standard deviation requires a smaller sample size.

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    Primary Outcome Measure

    The primary outcome measure used to evaluate the effect of the intervention.

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    What is the primary outcome measure?

    The Beck Depression Inventory II (BDI-II) is a self-report questionnaire used to assess the severity of depressive symptoms in individuals. It is a widely used and reliable instrument.

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    How will the data be analysed?

    Statistical analysis using a t-test is used to compare the average BDI-II scores between the two groups: those receiving standard treatment as usual (TAU) and those receiving TAU plus cognitive behavioral therapy (CBT).

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    What results are expected in the control group?

    It is expected that the control group, receiving only standard treatment as usual (TAU), will have an average BDI-II score of 20 with a standard deviation of 12. This reflects the baseline level of depression in cancer patients receiving typical care.

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    How small a treatment difference needs to be detected?

    The researchers want to detect a difference of at least 6 points on the BDI-II scale between the groups. This means if the CBT group shows a reduction of 6 points or more on the BDI-II compared to the control group, it will be considered a clinically significant improvement.

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    With what degree of certainty?

    The study aims to achieve 80% power. This means there is an 80% chance of finding a statistically significant difference in depression scores between the groups if there is a real difference of at least 6 points.

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    What is the standard deviation of BDI-II scores?

    The standard deviation (SD) of the BDI-II scores in cancer patients is estimated to be 12 points. This indicates the variability or spread of depression scores in the population.

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    What is the statistical significance level?

    The statistical significance level (alpha) for the study is set at 5%. This means there is a 5% chance of incorrectly concluding that CBT has an effect when it actually doesn't.

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    What formula is used for sample size calculation?

    The formula for sample size calculation considers the difference to be detected, the standard deviation, the alpha level, and the desired power. This formula helps determine how many participants are needed per group to obtain statistically reliable results.

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    Attrition Adjustment

    An adjustment applied to the calculated sample size to account for potential participant dropouts or loss to follow-up during a study, ensuring enough participants remain to achieve the desired statistical power.

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    Post Hoc Power Calculation

    A statistical method used to estimate the probability of finding a significant result based on the observed data after the study has been completed. However, it is generally not considered to be informative and should be avoided.

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    Standard Deviation

    The standard deviation of the outcome variable in the population, representing the variability or spread of data.

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    Statistical Power

    The probability of correctly rejecting a false null hypothesis, meaning the study's ability to detect a true difference between groups.

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    Alpha (α)

    The probability of incorrectly rejecting a true null hypothesis. It's the risk of concluding there's a difference when there isn't one.

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    Statistical Power (1- β)

    The probability of correctly rejecting a false null hypothesis, meaning you detect an effect that is actually there.

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    Detectable Difference

    The difference between two groups that is considered to be clinically meaningful or practically important. It's what you aim to detect.

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    Sample Size Per Group

    The number of participants needed in each group to have enough statistical power to detect a meaningful difference between groups.

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    Variability in the Outcome

    The range of values for the outcome variable in your study. Higher variability means more spread out data.

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    Loss to Follow-Up

    The extent to which participant drop-out affects the results. It can reduce the statistical power of the study.

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    Hierarchical Data Structures

    A group of nested observations, like a patient within a clinic, or a child within a family. This can affect sample size calculations.

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    Correlation Between Baseline and Follow-Up

    The correlation between measurements taken at different time points. This can influence sample size calculations.

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    Intraclass Correlation (ICC)

    A measure of how similar observations are within the same cluster, for example, how similar patients treated by the same therapist might be.

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    Study Notes

    Power and Sample Size in Mental Health Research

    • Sample size calculations are crucial for mental health research.
    • Understanding Type I and Type II errors is vital.
    • Key factors determining sample size include:
      • The magnitude of the expected effect.
      • The variability in the data.
      • The desired level of statistical power.
      • The significance level (alpha).
    • Calculating sample size for continuous and binary outcomes is important in the study design.
    • Loss to follow-up must be considered in adjusting sample size.
    • Sample sizes should be large enough to detect clinically important effects, but not so large that resources are wasted.

    Approaches to Sample Size Determination

    • Statistical/Scientific Approach: Determine the number of patients needed to reliably detect a treatment effect (if one exists).
    • Economic/Pragmatic Approach: Assess the availability of patients, recruitment time, and cost. Consider how many patients are available, how long recruitment will take and what the cost of the trial will be.
    • Ethical Considerations: Establish how soon a trial should be stopped given an inferior treatment.
    • Credibility Considerations: Ensure the size of the trial is sufficient to create reliable results.
    • Important to consider ethical implications and limitations of the available resources, such as patient numbers.

    Small Studies

    • Small studies often fail to detect clinically important and realistically sized treatment effects.
    • They may show a clinically significant but not statistically significant effect.
    • Small studies frequently yield imprecise estimates.
    • Wide confidence intervals for effect estimates are common in small studies.
    • Findings from small studies are less likely to be representative of the population as a whole.
    • Publication bias favours small studies with statistically significant (p<0.05) results over those that are not. This can lead to misleading conclusions. Therefore, small studies with statistically significant results are more often published compared to small studies with non-significant results.
    • Unethical when participants' time is spent in a study with a low chance of producing useful outcomes.

    Results from Trials of Different Sizes

    • Examples of trials (1st Australian and ISIS-2) illustrate how different sample sizes can lead to varying results.
    • Analysis of trials of the drug streptokinase showed varying results depending on sample size, with the larger trial yielding a more reliable result.

    Sample Size: Too Small vs. Too Large

    • Too Small:
      • Lack of precision in results.
      • Difficulty distinguishing real improvements from chance variation.
      • Ethical issues may arise if the study is too small to detect a true effect, wasting resources and participants' time.
    • Too Large:
      • Waste of resources (patients, funding, time).
      • Ethical issues, especially for trials that involve treatments that may be inferior, wasting resources and participants' time.

    Drawing the Wrong Conclusions

    • Type I Error: False positive; concluding an effect exists when none exists in reality. This is a false positive result.
    • Type II Error: False negative; concluding no effect exists when one does. This is a false negative result.
    • Alpha (α)—Probability of a Type I error.
    • Beta (β)—Probability of a Type II error.
    • Power (1-β)—Probability of detecting an effect when one exists.
    • Important to consider Type I and Type II errors in the context of sample size decisions.

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    Description

    This quiz explores the critical aspects of sample size calculations in mental health research. It covers essential topics such as Type I and Type II errors, statistical power, and factors influencing sample size determination. Gain insight into both statistical and pragmatic approaches to ensure effective study designs.

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