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Why Mathematics? | Equivalence Testing: TOST, Margins and Evidence of Practical Similarity

Why is mathematics important when the question is whether two methods are close enough for a real purpose? A conventional failure to find a difference does not establish similarity. Equivalence testing reverses the burden: it defines an acceptable difference in advance and asks whether the full uncertainty interval fits inside that range.

Did You Know? Two one-sided tests at the 5% level correspond to checking whether a 90% two-sided confidence interval lies entirely inside the equivalence margins, under the same assumptions.

Full chapter index

Chapters 1–7 · Understand the question
  1. The similarity question
  2. Why nonsignificance is insufficient
  3. Define the estimand
  4. Set equivalence margins
  5. A worked estimate
  6. Calculate the 90% margin of error
  7. Calculate the interval
Chapters 8–14 · Reproduce the example
  1. Make the equivalence decision
  2. The lower one-sided test
  3. The upper one-sided test
  4. Both tests must pass
  5. FDA bioequivalence guidance
  6. Narrower margins require more precision
  7. Sample size planning
Chapters 15–21 · Check assumptions
  1. Paired and crossover designs
  2. Parallel-group designs
  3. Ratio-scale equivalence
  4. Asymmetric margins
  5. Missing data
  6. Multiple endpoints
  7. Assay sensitivity
Chapters 22–28 · Explore applications
  1. Equivalence and superiority
  2. Equivalence versus agreement
  3. Equivalence versus identity
  4. Education example
  5. Diagnostics
  6. Validation plan
  7. Limits
Chapters 29–42 · Study and verify
  1. Communication
  2. A spreadsheet workflow
  3. A coding workflow
  4. Applications and careers
  5. A student investigation
  6. Common misconceptions
  7. Connection to recent mathematics articles
  8. Guidance for students and parents
  9. Practice questions
  10. Frequently asked questions
  11. A reporting checklist
  12. The number-line test
  13. Final equivalence audit
  14. Useful next reading

CHAPTER 1 OF 42 · Understand the question

1. The similarity question

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Suppose a new assessment method is easier to use. The goal may be to show its average score differs from the established method by no more than two marks in either direction.

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CHAPTER 2 OF 42 · Understand the question

2. Why nonsignificance is insufficient

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A large p-value in a difference test can result from true similarity or from imprecise data. Equivalence requires positive evidence that differences outside the acceptable range are incompatible with the data.

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CHAPTER 3 OF 42 · Understand the question

3. Define the estimand

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State exactly what difference is being estimated: new minus reference mean, log ratio, paired change or another population quantity. Direction determines every later inequality.

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CHAPTER 4 OF 42 · Understand the question

4. Set equivalence margins

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Let the acceptable interval be -2 to +2 marks. These margins must come from subject knowledge, measurement quality and decision consequences before results are inspected.

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CHAPTER 5 OF 42 · Understand the question

5. A worked estimate

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Suppose the estimated mean difference is 0.5 marks with standard error 0.6 marks. Use alpha=0.05 for each of the two one-sided tests.

Lower marginEstimateUpper marginSE
-20.520.6
Equivalence inputs.

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CHAPTER 6 OF 42 · Understand the question

6. Calculate the 90% margin of error

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The large-sample 90% critical value is about 1.645. The margin of error is 1.645×0.6=0.987 marks.

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CHAPTER 7 OF 42 · Understand the question

7. Calculate the interval

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The 90% interval is 0.5±0.987, giving approximately -0.487 to 1.487 marks.

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CHAPTER 8 OF 42 · Reproduce the example

8. Make the equivalence decision

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Both endpoints lie inside -2 and +2, so the data support equivalence at these prespecified margins and assumptions.

LowerEstimateUpper
-0.4870.51.487
90% confidence interval for TOST.

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CHAPTER 9 OF 42 · Reproduce the example

9. The lower one-sided test

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The first null says the true difference is at or below -2. Rejecting it supports that the difference is greater than the lower margin.

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CHAPTER 10 OF 42 · Reproduce the example

10. The upper one-sided test

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The second null says the true difference is at or above +2. Rejecting it supports that the difference is less than the upper margin.

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CHAPTER 11 OF 42 · Reproduce the example

11. Both tests must pass

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Equivalence needs rejection of both nonequivalence nulls. Passing only one establishes, at most, that one unacceptable direction has been ruled out.

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CHAPTER 12 OF 42 · Reproduce the example

12. FDA bioequivalence guidance

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Current FDA guidance describes equivalence comparisons using a criterion, a confidence interval and predetermined limits, and notes the two one-sided-tests basis for average bioequivalence. Read the FDA guidance.

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CHAPTER 13 OF 42 · Reproduce the example

13. Narrower margins require more precision

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If the acceptable range were -1 to +1, the same interval would not fit. A more demanding practical claim needs more information or less variability.

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CHAPTER 14 OF 42 · Reproduce the example

14. Sample size planning

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Equivalence power depends strongly on the margins, expected true difference, variability, design and dropout. Planning at an unrealistically perfect true difference can be fragile.

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CHAPTER 15 OF 42 · Check assumptions

15. Paired and crossover designs

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When the same participant receives both methods, within-person correlation can reduce variance. Period, sequence and carryover effects must still be addressed.

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CHAPTER 16 OF 42 · Check assumptions

16. Parallel-group designs

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Independent groups avoid some carryover concerns but often need more participants for the same precision. The analysis must match allocation and variance structure.

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CHAPTER 17 OF 42 · Check assumptions

17. Ratio-scale equivalence

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Pharmacokinetic outcomes are often analysed on a log scale, where additive log differences correspond to ratios after exponentiation. Symmetry on the log scale is multiplicative on the original scale.

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CHAPTER 18 OF 42 · Check assumptions

18. Asymmetric margins

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Some settings tolerate more difference in one direction than the other. Asymmetric margins are valid when scientifically justified and prespecified.

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CHAPTER 19 OF 42 · Check assumptions

19. Missing data

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Missing outcomes can widen intervals and bias the estimated difference. Sensitivity analyses should examine departures from the missing-data assumptions.

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CHAPTER 20 OF 42 · Check assumptions

20. Multiple endpoints

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Claiming equivalence on several primary outcomes creates multiplicity questions. The required family rule depends on whether all endpoints or any endpoint must pass.

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CHAPTER 21 OF 42 · Check assumptions

21. Assay sensitivity

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A comparison can appear equivalent because both methods are ineffective or the study cannot distinguish meaningful differences. Design quality and a responsive outcome are essential.

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CHAPTER 22 OF 42 · Explore applications

22. Equivalence and superiority

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An interval can support equivalence and also exclude zero if it is narrow and shifted. These are different claims and should be reported separately.

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CHAPTER 23 OF 42 · Explore applications

23. Equivalence versus agreement

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Equivalent group means do not guarantee that individual measurements agree. Method-comparison work may need paired differences and limits of agreement.

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CHAPTER 24 OF 42 · Explore applications

24. Equivalence versus identity

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The conclusion is not that the methods are exactly equal. It is that differences outside a chosen practical range were ruled out with stated uncertainty.

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CHAPTER 25 OF 42 · Explore applications

25. Education example

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A digital and paper test might be considered equivalent for average scores within two marks, yet still differ for particular subgroups or individual students.

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CHAPTER 26 OF 42 · Explore applications

26. Diagnostics

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Check the estimand, subtraction direction, margin source, confidence level, design, standard error, missingness, multiplicity and individual-agreement needs.

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CHAPTER 27 OF 42 · Explore applications

27. Validation plan

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Reproduce -0.487 to 1.487, tighten the margins, increase the standard error, shift the estimate and compare TOST with a difference test.

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CHAPTER 28 OF 42 · Explore applications

28. Limits

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Equivalence testing does not prove identical mechanisms, equal safety, equal individual responses or transfer to populations outside the study.

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CHAPTER 29 OF 42 · Study and verify

29. Communication

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Say “equivalent within prespecified margins of ±2 marks” rather than “the methods are the same.” The margin is part of the conclusion.

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CHAPTER 30 OF 42 · Study and verify

30. A spreadsheet workflow

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Keep estimate, SE, critical value, lower and upper margins, interval endpoints and both one-sided decisions in labelled cells.

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CHAPTER 31 OF 42 · Study and verify

31. A coding workflow

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Implement TOST with explicit direction and unit tests, then verify the confidence-interval decision against a trusted statistical package.

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CHAPTER 32 OF 42 · Study and verify

32. Applications and careers

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Quality engineers, clinicians, psychologists, educators and product teams use equivalence tests when practical similarity is the real decision.

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CHAPTER 33 OF 42 · Study and verify

33. A student investigation

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Simulate paired scores under true differences of 0, 1 and 2.5 marks, then compare difference-test and equivalence-test conclusions.

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CHAPTER 34 OF 42 · Study and verify

34. Common misconceptions

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Nonsignificance is not equivalence, a 90% interval is not chosen to hide uncertainty, and equivalence margins are not data-driven error bars.

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CHAPTER 35 OF 42 · Study and verify

35. Connection to recent mathematics articles

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The effect-size guide helps define meaningful magnitude. The confidence-interval guide explains interval coverage.

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CHAPTER 36 OF 42 · Study and verify

36. Guidance for students and parents

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Students should draw the margins and interval on one number line. Parents can ask who decided what difference in marks would be educationally acceptable.

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CHAPTER 37 OF 42 · Study and verify

37. Practice questions

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  • Reproduce the 90% interval.
  • Test ±1 margins.
  • Increase SE to 1.0.
  • Reverse the subtraction order.
  • Distinguish equivalence from agreement.

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CHAPTER 38 OF 42 · Study and verify

38. Frequently asked questions

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### Does p>0.05 prove equivalence? No.

### Why a 90% interval? It matches two one-sided tests at alpha=0.05.

### Are margins universal? No.

### Does equivalence mean identical? No.

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CHAPTER 39 OF 42 · Study and verify

39. A reporting checklist

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Report the estimand and direction, margins and justification, design, estimate, SE, 90% interval, both one-sided tests, missing-data analysis, multiplicity and practical interpretation.

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CHAPTER 40 OF 42 · Study and verify

40. The number-line test

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Place the lower and upper equivalence margins on a number line, then place the full confidence interval. The claim succeeds only when the whole interval is inside.

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CHAPTER 41 OF 42 · Study and verify

41. Final equivalence audit

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Confirm the margin source, direction, matching confidence level, design-aware SE, complete sensitivity analyses and wording that preserves the chosen practical range.

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CHAPTER 42 OF 42 · Study and verify

42. Useful next reading

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Continue through the Mathematics Learning Hub. Recalculate one decision boundary, state its assumptions and explain which conclusion it can and cannot support.

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Extended practice laboratory

Practice case 1: Define estimand

Setup: Start from the article’s equivalence-TOST mechanism for case 1. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 2: Set lower margin

Setup: Start from the article’s equivalence-TOST mechanism for case 2. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 3: Set upper margin

Setup: Start from the article’s equivalence-TOST mechanism for case 3. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 4: Set alpha

Setup: Start from the article’s equivalence-TOST mechanism for case 4. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 5: Set estimate

Setup: Start from the article’s equivalence-TOST mechanism for case 5. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 6: Set standard error

Setup: Start from the article’s equivalence-TOST mechanism for case 6. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 7: Calculate 90% margin

Setup: Start from the article’s equivalence-TOST mechanism for case 7. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 8: Calculate lower bound

Setup: Start from the article’s equivalence-TOST mechanism for case 8. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 9: Calculate upper bound

Setup: Start from the article’s equivalence-TOST mechanism for case 9. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 10: Run lower one-sided test

Setup: Start from the article’s equivalence-TOST mechanism for case 10. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 11: Run upper one-sided test

Setup: Start from the article’s equivalence-TOST mechanism for case 11. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 12: Compare interval with margins

Setup: Start from the article’s equivalence-TOST mechanism for case 12. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 13: Narrow margins

Setup: Start from the article’s equivalence-TOST mechanism for case 13. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 14: Increase standard error

Setup: Start from the article’s equivalence-TOST mechanism for case 14. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 15: Increase sample size

Setup: Start from the article’s equivalence-TOST mechanism for case 15. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 16: Add paired design

Setup: Start from the article’s equivalence-TOST mechanism for case 16. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 17: Add multiplicity

Setup: Start from the article’s equivalence-TOST mechanism for case 17. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 18: Add missingness

Setup: Start from the article’s equivalence-TOST mechanism for case 18. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 19: Add transformation

Setup: Start from the article’s equivalence-TOST mechanism for case 19. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 20: Check direction

Setup: Start from the article’s equivalence-TOST mechanism for case 20. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 21: Audit margin source

Setup: Start from the article’s equivalence-TOST mechanism for case 21. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 22: Audit power

Setup: Start from the article’s equivalence-TOST mechanism for case 22. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 23: Audit assumptions

Setup: Start from the article’s equivalence-TOST mechanism for case 23. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 24: Name limits

Setup: Start from the article’s equivalence-TOST mechanism for case 24. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.

Practice case 25: Write conclusion

Setup: Start from the article’s equivalence-TOST mechanism for case 25. Task: Change the named quantity, recompute the dependent result and compare with the original.

Check: Preserve the estimand and design, verify the statistical identity, state one diagnostic, record units and compare one defensible alternative with clear reasoning. Show the arithmetic, name the response and predictor units, and separate the numerical result from the claim it supports. Then vary one defensible assumption, calculate again and explain whether the conclusion changed because of the data, the fitted model or the validation purpose. Finish with one compact table or graph that could reveal a failure hidden by the summary.