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Table 3 Promising and discouraging population rates and decision rules for declaring study feasible

From: Juntas Contra el Virus del Papiloma Humano: protocol for a pilot randomized controlled trial of an HPV self-sampling intervention for underscreened Latinas

 

Promising population rates

Discouraging population rates

Sample decision rule for declaring study feasible under full accruala

% of women who consent (i.e., screen no more than 200 eligible participants to enroll 100 patients)

55%

40%

 ≥ 50% (n ≥ 100)

Probability of declaring enrollment feasible

93%

 < 1%

 

% of intervention arm participants (e.g., ≥ 25/50) who complete study

55%

40%

 ≥ 50% (n ≥ 25)

Probability of declaring completion feasible

80%

9.8%

 
  1. aProbabilities of declaring a future study feasible are defined in terms of hypothetical repeated sampling under promising and discouraging rates and calculated using the binomial distribution. In the event that accrual is less than expected, we will investigate the hypothesis that the feasibility rates are consistent with the 40% discouraging (i.e., null) hypotheses stated using one-sample binomial exact statistics