Evidence Based Practice Week 6 - Outcomes
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Questions and Answers

In clinical outcome studies, what is the primary purpose of comparing a new clinical outcome to an older, established one?

  • To increase the complexity of clinical trials and ensure more data points.
  • To determine which outcome is inherently superior regardless of context.
  • To demonstrate the novelty of the new outcome for publication purposes.
  • To evaluate if the new outcome is as valid and reliable as the established one while potentially offering improved efficiency. (correct)

How does Cronbach's alpha contribute to quantifying validity in outcome studies?

  • By measuring the test-retest reliability of a single outcome variable over time.
  • By assessing the face validity of the outcome measures based on expert opinions.
  • By calculating the standard error of measurement for individual scores.
  • By measuring the correlation between multiple different outcome variables. (correct)

When comparing two clinical outcomes, what is the MOST critical factor to consider in determining their relationship?

  • The sample size used in each respective study.
  • The statistical software used to analyze the data for each outcome.
  • The geographical location where each study was conducted.
  • How each outcome relates to the underlying construct of interest and whether they provide similar information. (correct)

In the context of clinical outcome studies, which of the following scenarios would MOST necessitate the use of Cronbach's alpha?

<p>When determining if multiple questionnaire items are consistently measuring the same psychological construct. (D)</p> Signup and view all the answers

What is the MOST significant implication of a low Cronbach's alpha value when evaluating multiple outcome variables in a study?

<p>It suggests that the outcome variables are measuring different constructs and may lack internal consistency. (A)</p> Signup and view all the answers

In the context of research methodology, what critical issue arises when variables exhibit a very high degree of correlation with each other?

<p>It introduces multicollinearity, which can lead to redundancy in data collection and inefficient use of resources. (A)</p> Signup and view all the answers

Why is handgrip strength considered a valuable indicator in clinical and research settings?

<p>It serves as a proxy measure for overall strength and is associated with important health outcomes like frailty and mortality. (A)</p> Signup and view all the answers

Why is the validity of a clinical outcome variable not considered a 'black and white' determination?

<p>Because its appropriateness depends heavily on the specific population being studied and the context of its use. (B)</p> Signup and view all the answers

Why is direct dissection regarded as the 'gold standard' for measuring body composition, despite its limitations?

<p>It provides the most direct and accurate assessment of adipose tissue and muscle mass by physical separation. (A)</p> Signup and view all the answers

Underwater weighing, while considered a 'reference standard' is not perfect. What are its limitations?

<p>It relies on estimations and known densities of fat and muscle mass, introducing potential inaccuracies. (B)</p> Signup and view all the answers

What is the fundamental principle behind skinfold testing for estimating body composition?

<p>Assessment of subcutaneous fat thickness at specific body sites using calipers and relating these measurements to underwater weighing results. (A)</p> Signup and view all the answers

Formally, how is reliability defined in the context of measurement, and why is it crucial in research?

<p>Reliability is the extent to which a measure is free from random error, ensuring consistent results across multiple measurements of the same construct. (D)</p> Signup and view all the answers

In the absence of a definitive 'gold standard' for measuring many constructs, what approach is typically used to assess construct validity?

<p>Construct validity is tested against a 'reference standard,' which serves as an imperfect but accepted benchmark for comparison. (C)</p> Signup and view all the answers

When a definitive gold standard is absent, which approach offers the most robust method for assessing a measure's validity?

<p>Hypothesis Testing (C)</p> Signup and view all the answers

In the context of evaluating measurement instruments, what distinguishes 'minimal clinically important change (MCIC)' from 'minimal clinically important difference (MCID)'?

<p>MCIC refers to change within a group or person, while MCID refers to between-group differences. (D)</p> Signup and view all the answers

Why are distribution-based methods primarily interpreted as indicating 'minimum detectable change' rather than 'clinically important change'?

<p>Distribution-based methods are designed to identify the smallest change distinguishable from measurement error, not necessarily a change perceived as meaningful by patients. (B)</p> Signup and view all the answers

How do anchor-based methods determine the minimally important change (MIC) in a patient's condition?

<p>By calculating the mean change in scores for a group of patients who self-report a meaningful improvement. (D)</p> Signup and view all the answers

In the context of measurement, what statistical methods are most suitable for assessing agreement between two dichotomous measures?

<p>Cohen's kappa and sensitivity/specificity. (A)</p> Signup and view all the answers

What is a key limitation of using a fixed minimally important change (MIC) value to interpret the size of between-group effects in clinical trials?

<p>It overlooks contextual factors such as baseline symptom severity, which can influence a patient's perception of meaningful change. (B)</p> Signup and view all the answers

Within research methodology, under what conditions is it most appropriate to employ the 'benefit-harm trade-off method'?

<p>To compare the costs, time, risks, and benefits associated with different treatment options from a patient's perspective. (A)</p> Signup and view all the answers

What critical assumption is challenged by the statement that measures of reliability and validity exist on a spectrum rather than as absolutes?

<p>The idea that a measure can be definitively classified as either 'reliable' or 'unreliable'. (D)</p> Signup and view all the answers

What crucial element is often overlooked when interpreting the clinical meaningfulness of research outcomes using minimally important change (MIC) thresholds?

<p>The baseline characteristics and individual needs of the patients being treated. (A)</p> Signup and view all the answers

What is the primary caveat associated with employing Cohen's effect size thresholds (0.2, 0.5, 0.8) to gauge the magnitude of an intervention's effect?

<p>They are arbitrary and may not correspond to changes perceived as meaningful by patients. (A)</p> Signup and view all the answers

Flashcards

Clinical Outcome Studies

Comparing existing clinical outcomes to find easier or more efficient ones.

Relating Clinical Outcomes

Comparing two clinical outcomes and how they relate.

Evaluating New Clinical Outcomes

Determining if a new clinical outcome measures what we want to measure, compared to an established one.

Cronbach's Alpha

Measure of internal consistency; correlation among multiple outcome variables.

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Consistency of Outcome Variables

Assessing if multiple outcome variables consistently measure the same thing.

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Overlapping Variables

If variables are too closely related, it leads to redundant information, wasting time and resources during testing.

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Handgrip Strength

Overall strength indicator, linked to frailty risk, disability, and mortality.

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Validity

The degree to which a measurement accurately reflects what it intends to measure.

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Dissection

The most accurate method to assess body fat, involving physical separation and measurement.

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Underwater Weighing

Estimates body fat based on density, using weight on land vs. underwater.

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Skinfold Testing

Estimates body fat by measuring skinfold thickness with calipers, related to underwater weighing results.

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Reliability

The extent to which a measurement is free from error, providing consistent results when repeated.

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Unreliable Measures

Data collected from such measures do not provide useful information.

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Validity Hypothesis Testing

Assessing validity when there's no perfect standard, done by forming hypotheses about how the measure relates to other characteristics.

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Assessing Agreement

Agreement between two scores. can be scores on the same measure collected twice (reliability) or scores on different measures (validity).

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Clinically Meaningful Change

The smallest change in outcome that patients consider important or worthwhile.

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Effect Definition

Difference between groups; avoid using for change within a group or person.

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MCIC/MCID Expression

Expressed in units of a measure or as a proportion of change from baseline; how much does a outcome need to change to meet the 'clinically meaningful' threshold.

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Cohen’s Effect Sizes

Small, medium, and large effects, set at 0.2, 0.5, and 0.8 standard deviations, respectively.

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Minimum Detectable Change

A threshold representing the minimum change detectable beyond measurement error.

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Anchor-Based Methods

Comparing changes on a measures over time to patients’ ratings of their overall change during that period.

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Benefit-Harm Trade-off Method

Presenting patients with costs, time, effort, and risks of an intervention, and asking how much improvement they need to consider it worthwhile.

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MIC/MCID Limitations

Requires considering contextual factors, since patients with more severe symptoms may need larger changes to consider a treatment meaningful.

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Study Notes

  • Clinical outcome studies compare existing clinical outcomes to find easier or more efficient alternatives.
  • These studies aim to determine if a new clinical outcome is as effective as an established one.

Quantifying Validity with Cronbach’s Alpha

  • Cronbach’s Alpha measures the correlation among multiple outcome variables.
  • It assesses whether variables consistently measure the same thing.
  • Closely related variables can lead to redundant information and wasted resources.
  • Handgrip strength reflects overall strength.
  • It is associated with risks of frailty, disability, and mortality.
  • It indicates engagement in other strength training activities.

Validity

  • Validity assesses whether a measurement accurately reflects what is intended to be measured.
  • Validity depends on the population.

Accuracy of Body Composition Measurements

  • Dissection is the most accurate method for measuring body fat, serving as the gold standard being the dissection of cadavers to determine the density of adipose tissue and density of the muscle mass.
  • Densitometry is the application of an equation of a person's land and water weight to estimate body fat.
  • Underwater weighing (reference standard) is rooted in densitometry and relates results to known densities.
  • Skinfold testing uses calipers to measure skinfold thickness, relating measurements to underwater weighing to predict underwater weight statistically.

Reliability

  • Reliability indicates the extent to which a measurement is free from error.
  • A reliable measure yields consistent results when measuring the same construct repeatedly.
  • Unreliable measures provide less useful data.
  • A measure must be reliable to be valid.

Validity

  • Validity indicates how well a measure reflects the construct it aims to measure.
  • Many constructs lack gold standards.
  • Construct validity is tested against a reference standard.
  • Hypothesis testing is used to test validity when there is no gold standard.
  • This involves the creation of relationships between measure scores and other characteristics.

Statistics

  • Testing reliability and validity involves assessing agreement between two scores.
  • Scores can be from repeated measurements or different measures.
  • Statistics for agreement vary based on whether measures are dichotomous or continuous.

Conclusion

  • Measures exist on a spectrum of reliability and validity.
  • No measure is perfectly reliable or valid.
  • Practical concerns in measure selection include administration time, patient comprehension, and data storage/use.

Interpreting Outcomes

  • Clinical meaningfulness is "the smallest change that is important to patients."

Change and Difference

  • The term "effect" should only be used for between-group differences.
  • Minimally important change (MIC) and minimal clinically important change (MCIC) differ from minimal clinically important difference (MCID).

Defining MCIC and MCID

  • Researchers express MCIC or CMID in units of a measure or as a proportion of change from baseline.

Proposal

  • Cohen’s effect sizes (0.2, 0.5, 0.8) are thresholds for small, medium, and large effects, measured in standard deviations.
  • These thresholds are arbitrary and may not reflect patient perceptions.

Distribution-Based Methods

  • Provides a threshold, better interpreted as "minimum detectable change" rather than clinically important change.
  • Changes smaller than the minimum detectable change may be noise due to poor measure reliability.

Anchor-Based Methods

  • They compare changes in a measure over time to patient ratings of overall change.
  • Patients rate their condition before and after a treatment.
  • Patients are divided into groups based on whether they consider themselves improved.
  • MIC reflects the mean change in scores for those who consider themselves improved.

Benefit-Harm Trade-off Method

  • Interviews present patients with the costs, time, effort, and risks of an intervention.
  • Patients indicate the improvement needed to make the intervention worthwhile.

Interpreting Meaningful Change and Difference

  • MICs are commonly used to interpret the size of between-group effects.
  • The benefit-harm trade-off method helps compare costs, time, and risks across treatments.
  • A MIC is attached to a measurement instrument (e.g. a pain scale), which will then be used to interpret between-group differences in trials.
  • This interpretation overlooks contextual factors.
  • Patients with more severe symptoms may need larger changes to consider the change meaningful.
  • MIC or MCID should not be considered solely as a feature of a measurement instrument.

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Clinical outcome studies compare outcomes to find efficient alternatives and assess new outcome effectiveness. Cronbach’s Alpha measures correlations among outcome variables, indicating measurement consistency. Validity assesses if a measurement accurately reflects what it intends to measure, varying by population.

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