Stata 11 help for stpower cox

help stpower cox dialog: stpower cox -------------------------------------------------------------------------------

Title

[ST] stpower cox -- Sample size, power, and effect size for the Cox proportional hazards model

Syntax

Sample-size determination

stpower cox [coef] [, options]

Power determination

stpower cox [coef], n(numlist) [options]

Effect-size determination

stpower cox, n(numlist) {power(numlist) | beta(numlist)} [options]

where coef is the regression coefficient (effect size) of a covariate of interest, in a Cox proportional hazards model, desired to be detected by a test with a prespecified power. coef may be specified either as one number or as a list of values (see numlist) enclosed in parentheses.

options description ------------------------------------------------------------------------- Main * alpha(numlist) significance level; default is alpha(0.05) * power(numlist) power; default is power(0.8) * beta(numlist) probability of type II error; default is beta(0.2) * n(numlist) sample size; required to compute power or effect size * hratio(numlist) hazard ratio (effect size) associated with a one-unit increase in covariate of interest; default is hratio(0.5) onesided one-sided test; default is two sided sd(#) standard deviation of covariate of interest; default is sd(0.5) r2(#) squared coefficient of multiple correlation with other covariates; default is r2(0) failprob(#) overall probability of an event (failure) of interest; default is failprob(1), meaning no censoring wdprob(#) the proportion of subjects anticipated to withdraw from the study; default is wdprob(0) parallel treat number lists in starred options as parallel (do not enumerate all possible combinations of values) when multiple values per option are specified

Reporting hr report hazard ratio, not coefficient table display results in a table with default columns columns(colnames) display results in a table with specified colnames columns notitle suppress table title nolegend suppress table legend colwidth(# [# ...]) column widths; default is colwidth(9) separator(#) draw a horizontal separator line every # lines; default is separator(0) meaning no separator lines saving(filename[, replace]) save the table data to filename; use replace to overwrite existing filename + noheader suppress table header; seldom used + continue draw a continuation border in the table output; seldom used ------------------------------------------------------------------------- * Starred options may be specified either as one number or as a list of values (see numlist). + noheader and continue are not shown in the dialog box.

colnames description ------------------------------------------------------------------------- alpha significance level power power beta type II error probability n total number of subjects e total number of events (failures) hr hazard ratio coef coefficient (log hazard-ratio) sd standard deviation r2 squared multiple-correlation coefficient pr overall probability of an event (failure) w proportion of withdrawals ------------------------------------------------------------------------- By default, the following colnames are displayed: power, n, e, sd, and alpha are always displayed; coef is displayed, unless the hr option is specified, in which case hr is displayed; pr if overall probability of an event (failprob()) is specified; r2 if squared multiple-correlation coefficient (r2()) is specified; and w if withdrawal proportion (wdprob()) is specified.

Menu

Statistics > Survival analysis > Power and sample size > Cox proportional hazards model

Description

stpower cox estimates required sample size, power, and effect size for survival analyses that use Cox proportional hazards (PH) models. It also reports the number of events (failures) required to be observed in a study. The estimates of sample size or power are obtained for the test of the effect of one covariate, x1 (binary or continuous), on time to failure adjusted for other predictors, x2,...,xp, in a PH model. The command provides options to account for possible correlation between a covariate of interest and other predictors and for withdrawal of subjects from the study. Optionally, the minimal effect size (minimal detectable difference in a regression coefficient, beta_1, or hazard ratio) may be obtained for given sample size and power.

You can use stpower cox to

o calculate required number of events and sample size when you know power and effect size expressed as a hazard ratio or a coefficient (log hazard-ratio),

o calculate power when you know sample size (number of events) and effect size expressed as a hazard ratio or a coefficient (log hazard-ratio), and

o calculate effect size and display it as a coefficient (log hazard-ratio) or a hazard ratio when you know sample size (number of events) and power.

stpower cox's input parameter, coef, is the value beta_1a of the regression coefficient, beta_1, of a covariate of interest, x1, from a Cox PH model, which is desired to be detected by a test with prespecified power.

Options

+------+ ----+ Main +-------------------------------------------------------------

alpha(numlist) sets the significance level of the test. The default is alpha(0.05).

power(numlist) sets the power of the test. The default is power(0.8). If beta() is specified, this value is set to be 1-beta(). Only one of power() or beta() may be specified.

beta(numlist) sets the probability of a type II error of the test. The default is beta(0.2). If power() is specified, this value is set to be 1-power(). Only one of beta() or power() may be specified.

n(numlist) specifies the number of subjects in the study to be used to compute the power of the test or the minimal effect size (minimal detectable value of the regression coefficient, beta_1, or hazard ratio) if power() or beta() is also specified.

hratio(numlist) specifies the hazard ratio associated with a one-unit increase in the covariate of interest, x1, when other covariates are held constant. The default is hratio(0.5). This value defines the minimal clinically significant effect of a covariate on the response to be detected by a test with a certain power, specified in power(), in a Cox PH model. If coef is specified, hratio() is not allowed and the hazard ratio is instead computed as exp(coef).

onesided indicates a one-sided test. The default is two sided.

sd(#) specifies the standard deviation of the covariate of interest, x1. The default is sd(0.5).

r2(#) specifies the squared multiple-correlation coefficient between x1 and other predictors x2, ..., xp in a Cox PH model. The default is r2(0), meaning that x1 is independent of other covariates. This option defines the proportion of variance explained by the regression of x1 on x2, ..., xp (see [R] regress).

failprob(#) specifies the overall probability of a subject failing (or experiencing an event of interest, or not being censored) in the study. The default is failprob(1), meaning that all subjects experience an event (or fail) in the study; that is, no censoring of subjects occurs.

wdprob(#) specifies the proportion of subjects anticipated to withdraw from a study. The default is wdprob(0). wdprob() may not be combined with n().

parallel reports results sequentially (in parallel) over the list of numbers supplied to options allowing numlist. By default, results are computed over all combinations of the number lists in the following order of nesting: alpha(), hratio() or list of coefficients coef, power() or beta(), and n(). This option requires that options with multiple values each contain the same number of elements.

+-----------+ ----+ Reporting +--------------------------------------------------------

hr specifies that the hazard ratio be displayed rather than the regression coefficient. This option affects how results are displayed and not how they are estimated.

table displays results in a tabular format and is implied if any number list contains more than one element. This option is useful if you are producing results one case at a time and wish to construct your own custom table by using a forvalues loop.

columns(colnames) specifies results in a table with specified colnames columns. The order of columns in the output table is the same as the order of colnames specified in columns(). Column names in columns() must be space-separated.

notitle prevents the table title from displaying.

nolegend prevents the table legend from displaying and column headers from being marked.

colwidth(# [# ...]) specifies column widths. The default is 9 for all columns. The number of specified values may not exceed the number of columns in the table. A missing value (.) may be specified for any column to indicate the default width (9). If fewer widths are specified than the number of columns in the table, the last width specified is used for the remaining columns.

separator(#) specifies how often separator lines should be drawn between rows of the table. The default is separator(0), meaning that no separator lines should be displayed.

saving(filename[, replace]) creates a Stata data file (.dta file) containing the table values with variable names corresponding to the displayed colnames. replace indicates that filename be overwritten, if it exists. saving() is appropriate only with tabular output.

The following options are available with stpower cox but are not shown in the dialog box:

noheader prevents the table header from displaying. This option is useful when the command is issued repeatedly, such as within a loop. noheader implies notitle.

continue draws a continuation border at the bottom of the table. This option is useful when the command is issued repeatedly within a loop.

Short introduction to stpower cox

The argument coef or option hratio() may be used to specify the effect size desired to be detected by a test. If argument coef is omitted, then the value of the log of the hazard ratio specified in the hratio() option or the log of the default hazard-ratio value of 0.5 is used to compute beta_1a. If argument coef is specified, then hratio() is not allowed and the hazard ratio is computed as exp(coef).

If power determination is desired, then sample size n() must be specified. Otherwise, sample-size determination is assumed with power(0.8) (or, equivalently, beta(0.2)). The default setting for power or, alternatively, the probability of a type II error, a failure to reject the null hypothesis when the alternative hypothesis is true, may be changed by using power() or beta(), respectively. If both n() and power() (or beta()) are specified, the value of the regression coefficient, beta_1a (or hazard ratio if the hr option is specified), which can be detected by a test with requested power() for fixed sample size n(), is computed.

The default probability of a type I error, a rejection of the null hypothesis when the hypothesis is true, of a test is 0.05 but may be changed by using the alpha() option. One-sided tests may be requested by using onesided. By default, no censoring, no correlation between x1 and other predictors, and no withdrawal of subjects from the study are assumed. This may be changed by specifying failprob(), r2(), and wdprob(), respectively.

Optionally, the results may be displayed in a table using table or columns() as demonstrated in Examples below and in [ST] stpower. For examples on how to plot a power curve, see Examples below, [ST] stpower, and example 7 in [ST] stpower logrank.

Remarks on the method used in stpower cox

stpower cox implements the method of Hsieh and Lavori (2000) for the sample-size and power computation, which reduces to the method of Schoenfeld (1983) for a binary covariate. The sample size is related to the power of a test through the number of events observed in the study; that is, for a fixed number of events the power of a test is independent of the sample size. As a result, the sample size is estimated as the number of events divided by the overall probability of a subject failing in a study. See Methods and formulas in [ST] stpower cox for the formulas used in the computation.

Examples

Compute number of failures required to detect a 0.5 reduction in the hazard for a binary covariate of interest with standard deviation 0.5, using a one-sided 5% Wald test with a power of 80% . stpower cox, onesided

Compute required sample size to detect a log hazard-ratio of -1 for a covariate of interest with standard deviation 0.3, assuming only 85% of subjects survive until the end of the study . stpower cox -1, sd(0.3) failprob(0.85)

Compute power of the test just described for a sample size of 150, assuming the covariate of interest is correlated with other covariates with R2 = 0.3 . stpower cox -1, n(150) sd(0.3) failprob(0.8) r2(0.3)

Determine minimal detectable value of the coefficient (log hazard-ratio) for the variable in the previous example with 90% power for a sample size of 150 . stpower cox, n(150) power(0.9) sd(0.3) failprob(0.8) r2(0.3)

Obtain sample sizes for a range of hazard ratios and powers . stpower cox, hratio(0.1(0.2)0.9) power(0.8 0.9) hr

Saved results

stpower cox saves the following in r():

Scalars r(N) total number of subjects r(E) total number of events (failures) r(power) power of test r(alpha) significance level of test r(hratio) hazard ratio r(onesided) 1 if one-sided test, 0 otherwise r(sd) standard deviation r(Pr_E) probability of an event (failure) (if specified) r(r2) squared multiple correlation (if specified) r(w) proportion of withdrawals (if specified)

Macros r(metric) displayed metric (log-hazard or hazard)

References

Hsieh, F. Y., and P. W. Lavori. 2000. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Controlled Clinical Trials 21: 552-560.

Schoenfeld, D. A. 1983. Sample-size formula for the proportional-hazards regression model. Biometrics 39: 499-503.

Also see

Manual: [ST] stpower cox

Help: [ST] stpower, [ST] stpower logrank, [ST] stpower exponential, [R] sampsi, [ST] stcox, [ST] glossary


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