Back to Course

FoSSA Français

0% Complete
0/0 Steps
  1. Information sur le cours

    Rencontrez l'équipe enseignante
  2. Jeu de données du cours 1
  3. Jeu de données du cours 2
  4. MODULE A1: INTRODUCTION AUX STATISTIQUES AVEC R ET STATA
    A1.1 Qu'est-ce que les Statistiques?
  5. A1.2.1a Introduction à Stata
  6. A1.2.2b: Introduction à R
  7. A1.2.2c: Introduction to SPSS
  8. A1.3: Statistiques Descriptives
  9. A1.4: Estimations et Intervalles de Confiance
  10. A1.5: Tests d'Hypothèses
  11. A1.6: Transformation de Variables
  12. Fin du Module A1
    1 Quiz
  13. MODULE A2: CALCULS DE PUISSANCE STATISTIQUE & DE TAILLE D’ÉCHANTILLON
    A2.1 Concepts Clés
  14. A2.2 Calculs de puissance pour une différence de moyennes
  15. A2.3 Calculs de puissance pour une différence de proportions
  16. A2.4 Calcul de taille d’échantillon pour les essais randomisés (RCTs)
  17. A2.5 Calculs de taille d’échantillon pour les études transversales (ou sondages)
  18. A2.6 Calcul de taille d'échantillon pour un devis cas-contrôle
  19. Fin du Module A2
    1 Quiz
  20. MODULE B1: RÉGRESSION LINÉAIRE
    B1.1 Corrélation et Nuages de Points (scatterplots)
  21. B1.2 Différences Entre Moyennes (ANOVA à un facteur)
  22. B1.3 Régression Linéaire Univariée
  23. B1.4 Régression Linéaire Multivariée
  24. B1.5 Sélection de Modèles et Tests F
  25. B1.6 Diagnostics de Régression
  26. Fin du Module B1
    1 Quiz
  27. MODULE B2: COMPARAISONS MULTIPLES & MESURES RÉPÉTÉES
    B2.1 ANOVA Approfondie— Tests Post-Hoc
  28. B2.2 Correction pour Comparaisons Multiples
  29. B2.3 ANOVA à deux facteurs (Two-way ANOVA)
  30. B2.4 Mesures Répétées et Test T Apparié
  31. B2.5 ANOVA pour Mesures Répétées
  32. Fin du Module B2
    1 Quiz
  33. MODULE B3: MÉTHODES NON-PARAMETRIC
    B3.1 Hypothèses des Tests Paramétriques
  34. B3.2 Test U de Mann-Whitney
  35. B3.3 Test de Kruskal-Wallis
  36. B3.4 Test des rangs signés de Wilcoxon
  37. B3.5 Test de Friedman
  38. B3.6 Corrélation des Rangs de Spearman
  39. Fin du Module B3
    1 Quiz
  40. MODULE C1: DONNÉES BINAIRES & RÉGRESSION LOGISTIQUE
    C1.1 Introduction à la prévalence, au Risque, aux Cotes (Odds) et aux Taux
  41. C1.2 Le Test du Chi Carré & le Test de Tendance
  42. C1.3 Régression Logistique Univariée
  43. C1.4 Régression Logistique Multivariée
  44. Fin du Module C1
    1 Quiz
  45. MODULE C2: DONNÉES DE SURVIE
    C2.1 Introduction aux Données de Survie
  46. C2.2 Fonction de Survie de Kaplan-Meier & Test du Log-Rank
  47. C2.3 Régression de Cox à Risque Proportionnel
  48. C2.4 Régression de Poisson
  49. Fin du Module C2
    1 Quiz
Lesson 16 of 49
In Progress

A2.4 Calcul de taille d’échantillon pour les essais randomisés (RCTs)

Learning Outcomes

By the end of this section, students will be able to:

  • Explain the key concept of power and what impacts it
  • Estimate the power of a given study
  • Estimate the sample size needed to test hypotheses in different study designs

You can download a copy of the slides here: A2.4: Sample Size Calculations for RCTs

Video A2.4 Sample Size Calculation for RCTs (11 minutes)

A2.4 PRACTICAL: R

Sample size calculation for testing a hypothesis (Clinical trials or clinical interventional studies)

Here is an example:

In a parallel RCT, 25% of the subjects on the standard therapy had a successful outcome. It is only of clinical relevance if a 40% absolute improvement is observed in the new therapy. How many subjects are required in order to detect this difference with 80% power at the 5% level of significance?

In this case we need to assess a difference in proportions again, this time with an effect size that has a 0.40 difference between the groups:

> power6<-pwr.2p.test(h=ES.h(p1=0.25, p2=0.65), power=0.8, sig.level=0.05)
>
power6

Difference of proportion power calculation for binomial distribution (arcsine transformation)

          h = 0.8282914
n = 22.88076
sig.level = 0.05
power = 0.8
alternative = two.sided

NOTE: same sample sizes

23 subjects per group and 46 subjects are required in total.

Question A2.4: In the same parallel trial as described in the example above, we still observe that 25% of the subjects on the standard therapy had a successful outcome, but this time it is only of clinical relevance if a 40% relative improvement is observed in the new therapy. How many subjects are required in order to detect this difference with 80% power at the 5% level of significance?

Answer

First you need to work out what a 40% relative increase on 25% is: 0.25*1.40=35% of subjects would need to have a successful outcome for there to be clinical relevance.

> power7<-pwr.2p.test(h=ES.h(p1=0.25, p2=0.35), power=0.8, sig.level=0.05)
> power7

Difference of proportion power calculation for binomial distribution (arcsine transformation)

          h = 0.2189061
n = 327.5826
sig.level = 0.05
power = 0.8
alternative = two.sided

NOTE: same sample sizes

We need many more patients than in the example above due to the small effect size that we now wish to detect.

A2.4 PRACTICAL: Stata

Sample size calculation for testing a hypothesis (Clinical trials or clinical interventional studies)

Here is an example:

In a parallel RCT, 25% of the subjects on the standard therapy had a successful outcome. It is only of clinical relevance if a 40% absolute improvement is observed in the new therapy. How many subjects are required in order to detect this difference with 80% power at the 5% level of significance?

power twoproportions 0.25 0.65, alpha(0.05) power(0.80)

*– Estimated sample sizes:

            N =        48

  N per group =        24

24 subjects per group and 48 subjects are required in total.

Question A2.4: In the same parallel trial as described in the example above, we still observe that 25% of the subjects on the standard therapy had a successful outcome, but this time it is only of clinical relevance if a 40% relative improvement is observed in the new therapy. How many subjects are required in order to detect this difference with 80% power at the 5% level of significance?

Answer

First you need to work out what a 40% relative increase on 25% is: 0.25*1.40=35% of subjects would need to have a successful outcome for there to be clinical relevance.

power twoproportions 0.25 0.35, alpha(0.05) power(0.80)

Estimated sample sizes for a two-sample proportions test
Pearson’s chi-squared test 
Ho: p2 = p1  versus  Ha: p2 != p1
Study parameters:

  alpha =    0.0500
        power =    0.8000
        delta =    0.1000  (difference)
           p1 =    0.2500

p2 =    0.3500

Estimated sample sizes:

            N =       658
  N per group =       329

We need many more patients than in the example above due to the small effect size that we now wish to detect.

A2.4 PRACTICAL: SPSS

Sample size calculation for testing a hypothesis (Clinical trials or clinical interventional studies)

In a parallel RCT, 25% of the subjects on the standard therapy had a successful outcome. It is only of clinical relevance if a 40% absolute improvement is observed in the new therapy. How many subjects are required in order to detect this difference with 80% power at the 5% level of significance? Use the same test as in the previous practical (Independent Samples Binomial Test) but adapt the input values for this scenario. 

In the same parallel trial as described in the example above, we still observe that 25% of the subjects on the standard therapy had a successful outcome, but this time it is only of clinical relevance if a 40% relative improvement is observed in the new therapy. How many subjects are required in order to detect this difference with 80% power at the 5% level of significance?

Answer

In the first part we calculate that 24 subjects per group and 48 subjects are required in total when we are looking for 40% absolute difference.

In the second part, we first need to work out what a 40% relative increase on 25% is (0.25*1.40=35%). Therefore 35% of subjects would need to have a successful outcome for there to be clinical relevance.

When we conduct the test we calculate that we need 329 subjects per group and 658 overall.

We need many more patients than in the example above due to the small effect size that we now wish to detect.

👋 Before you go, leave an anonymous rating & feedback

Average rating 4.5 / 5. Vote count: 16

No votes so far! Be the first to rate this post.

Please share any positive or negative feedback you may have.

Feedback is completely anonymous

0 Comments
Newest
Oldest Most Voted
Inline Feedbacks
View all comments
0
Questions or comments?x