PASS 2022 Update

Update Release Notes

This page lists the changes that have been made to PASS 2022 since it was released.

Version: 22.0.6

Released: February 1, 2024

1. Corrected a plotting error in the Mann-Whitney U or Wilcoxon Rank-Sum Tests (Noether) procedure. The software was incorrectly labeling a 2-sided test as a 1-sided test in the plot heading.

2. Corrected a “Subscript out of range” error in the One-Sample T-Tests using Effect Size, Paired T-Tests using Effect Size, Two-Sample T-Tests using Effect Size, Tests for One Proportion using Effect Size, and Tests for Two Proportions using Effect Size procedures. The error would occur when entering multiple values for Alpha with the Alternative Hypothesis set to One-Sided.

3. Corrected an error in the Tests for the Difference of Two Hazard Rates Assuming an Exponential Model procedure when solving for "h2 or D". The error occurred when the alternative hypothesis was one-sided (up or down). The procedure now correctly solves for "h2 or D" for all three alternative hypotheses.

4. Corrected an error in the Tests for the Ratio of Two Means in a Higher-Order Cross-Over Design (Log-Normal Data) procedure. The calculations were not correct when Mean Ratio (R1) was less than one.

Version: 22.0.5

Released: May 4, 2023

1. Corrected a non-useful error message in the Logrank Tests and Non-Inferiority Logrank Tests procedures. The user now gets an informative error message if they input Total Time < Accrual Time that indicates that Total Time must be ≥ Accrual Time

2. Corrected the comments regarding the test statistic weights in the help documentation for the Two-Group Survival Comparison Tests (Simulation), Group-Sequential Tests for Two Hazard Rates (Simulation), and Group-Sequential Logrank Tests (Simulation) (Legacy) procedures.

3. Corrected an error in the Tests for Two Ordered Categorical Variables (Proportional Odds) procedure. The software was interpreting the odds ratio (OR) as Odds1/Odds2 instead of Odds2/Odds1 as indicated in the documentation. The procedure now correctly interprets OR as Odds2/Odds1. Some minor typos and the example results in the documentation for this procedure have also been corrected.

4. Corrected an issue with the Simple Linear Regression procedures when solving for sample size. If the effect size is large resulting in a very small required sample size (i.e., 4 or less), the algorithm would not find the right sample size--it would report a required sample size of 2 even though the sample size is required to be 3 or more in the Simple Linear Regression procedures.

Version: 22.0.4

Released: January 23, 2023

1. In the Confidence Intervals for One-Way Repeated Measures Contrasts procedure, there is a Multivariate option and a Univariate option. A bug was causing an error whenever the Univariate option was selected. Now, both options can be run with no error.

2. In the Mann-Whitney U or Wilcoxon Rank-Sum Tests for Non-Inferiority and Mann-Whitney U or Wilcoxon Rank-Sum Tests for Superiority by a Margin procedures, the sample sizes were not reported correctly in the summary statements when solving for effect size. Now, the sample sizes are consistent with those shown in the table.

3. In the Non-Inferiority Tests for the Difference of Two Means in a Higher-Order Cross-Over Design procedure, if "Specify sigma as sigmaw or sigmab and row" was set to "sigmab and row", the sigmab did not read in correctly and the procedure produced incorrect results. This was fixed to read in the sigmab value, and the results are now correct.

4. In the six group-sequential survival (simulation) procedures, the accrual parameter, if different from 0, was not implemented correctly. If the accrual parameter was other than 0 (or the "Percent of T0 Until 50% are Accrued" was other than 50), the starting times for the simulations were generated incorrectly. This was fixed so that the start times are distributed according to the truncated Exponential distribution, as indicated in the option info.

5. Corrected an error in power calculation for the Equivalence Tests for Two Means in a Cluster-Randomized Design and Assurance for Equivalence Tests for Two Means in a Cluster-Randomized Design procedures. When Test Statistic was set to “T-Test Based on Number of Clusters” (not the default) and K1 was not equal to K2, the power was calculated using the wrong degrees of freedom. This resulted in the power being slightly off the correct value.

Version: 22.0.3

Released: August 9, 2022

1. Corrected the formula for the SD of the Uniform Distribution in the documentation for the Data Simulator procedure. The procedure calculations were not affected.

2. Overflow error fixed for all assurance procedures when solving for sample size with a joint prior specification.

3. Corrected an error in the Tests for One-Sample Sensitivity and Specificity procedure. For some language settings (e.g., Hungarian) the N1 and N sample size values would appear mashed together in the Numeric Results table making it appear that only one large sample size was computed.

4. Fixed the Accrual Time (Integers Only) input option in the Two-Group Survival Comparison Tests (Simulation) and Group-Sequential Logrank Tests (Simulation) (Legacy) procedures so that decimal numbers are not included as possible options in the dropdown. The procedures were also updated so that decimal number are correctly rounded to whole numbers before calculation.

5. For newer group sequential procedures, there was a typo for the alternative hypothesis when two-sided asymmetric efficacy-only boundaries were used. This was fixed from stating ‘symmetric’ to correctly being ‘asymmetric.’

6. Corrected an error in the Non-Zero Null Tests for Simple Linear Regression using ρ² procedure. For some combinations of ρ0² and ρ1², solving for N (Sample Size) would return no results.

7. Corrected an issue in the Confidence Intervals for Kappa procedure. When Interval Type was set to something other than Two-Sided, the software was not reading the Distance from κ to Limit option correctly. Instead it was reading and using the hidden Width of Confidence Interval option value in its place.

8. In the Confidence Intervals for an Exponential Lifetime Percentile procedure, the Width of Confidence Interval was limited to values between 0 and 2. It was fixed to correctly allow for all values greater than 0.

9. Corrected an error in the following procedures: Tests for Two Means in a Repeated Measures Design, Tests for Two Proportions, Fisher's Exact Test for Two Proportions, Non-Inferiority (Superiority by a Margin, Equivalence, Non-Zero Null) Tests for the Difference (Ratio, Odds Ratio) Between Two Proportions, Tests for Two Independent Sensitivities, Non-Inferiority (Superiority by a Margin) Tests for Vaccine Efficacy using the Ratio of Two Proportions. When solving for sample size with Group Allocation set to “Enter R” or “Enter percentage in group 1”, the reported sample sizes might have been slightly off (usually by only 1 subject) due to incorrect rounding of the sample sizes.

10. Updated the documentation for the Standard Deviation Estimator tool to include sections about the Covariance Matrix and σm from Range tabs.

11. Corrected various minor typos in the documentation.

Version: 22.0.2

Released: February 14, 2022

1. Modified the allowable ranges for Cluster Size parameters M and m in the three Stepped-Wedge Cluster-Randomized Design procedures. The restriction that both parameters be ≥ 2 was found to be unnecessary. Now both parameters have allowed range of > 0.

2. An error in the “Mann-Whitney or Wilcoxon Rank-Sum Tests (Simulation)” and the “Tests for Two Means (Simulation)” routines has been corrected. The error caused the mean differences to be reported incorrectly in cases where the distribution’s first parameter was not the mean. The power calculations were correct.

Version: 22.0.1

Released: January 28, 2022

1. Initial Release of PASS 2022.