IEA

International Journal of Epidemiology, 2022, 2000–2013

https://doi.org/10.1093/ije/dyac123
Advance Access Publication Date: 9 June 2022
International Epidemiological Association
Education Corner

Education Corner

Sample size calculators for planning

stepped-wedge cluster randomized
trials: a review and comparison

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Yongdong Ouyang ,1,2* Fan Li ,3,4 John S Preisser5 and
Monica Taljaard1,2
1
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada, 2School of
Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada, 3Department of Biostatistics,
Yale School of Public Health, New Haven, CT, USA, 4Center for Methods in Implementation and
Prevention Science, Yale School of Public Health, New Haven, CT, USA and 5Department of
Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
*Corresponding author. Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1053 Carling Ave, Ottawa,
ON K1Y 4E9, Canada. E-mail: youyang@ohri.ca
Received 31 December 2021; Editorial decision 5 May 2022; Accepted 17 May 2022

Abstract
Recent years have seen a surge of interest in stepped-wedge cluster randomized trials
(SW-CRTs). SW-CRTs include several design variations and methodology is rapidly
developing. Accordingly, a variety of power and sample size calculation software for
SW-CRTs has been developed. However, each calculator may support only a selected set
of design features and may not be appropriate for all scenarios. Currently, there is no
resource to assist researchers in selecting the most appropriate calculator for planning
their trials. In this paper, we review and classify 18 existing calculators that can be imple-
mented in major platforms, such as R, SAS, Stata, Microsoft Excel, PASS and nQuery.
After reviewing the main sample size considerations for SW-CRTs, we summarize the
features supported by the available calculators, including the types of designs, out-
comes, correlation structures and treatment effects; whether incomplete designs,
cluster-size variation or secular trends are accommodated; and the analytical approach
used. We then discuss in more detail four main calculators and identify their strengths
and limitations. We illustrate how to use these four calculators to compute power for two
real SW-CRTs with a continuous and binary outcome and compare the results. We show
that the choice of calculator can make a substantial difference in the calculated power
and explain these differences. Finally, we make recommendations for implementing
sample size or power calculations using the available calculators. An R Shiny app is avail-
able for users to select the calculator that meets their requirements (https://douyang.shi
nyapps.io/swcrtcalculator/).

Key words: Stepped-wedge design, power, sample size, software, correlation structures

C The Author(s) 2022; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association
V 2000
International Journal of Epidemiology, 2022, Vol. 51, No. 6 2001

Key Messages

• Stepped-wedge cluster randomized trials (SW-CRTs) are an attractive alternative to parallel-arm cluster randomized

trials in some scenarios and have been increasing in popularity. A variety of calculators that can help researchers
calculate power and sample size for SW-CRTs have been developed.
• Available calculators differ in the features they can support, including the types of designs, outcomes, correlation

structures and treatment effects that can be specified; ability to accommodate incomplete designs, cluster-size
variation or secular trends; and the type of analytical approach used; available calculators can also differ substantially
in the calculated power in some scenarios.
• We summarize and compare the features of 18 available calculators to calculate power and sample size for

SW-CRTs and describe a Shiny app to help researchers identify the calculators that support the desired features for a
particular planned trial.

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• We advise users on how to choose the most appropriate calculator based on their requirements and what to

prioritize when no calculator can accommodate all their needs.

Introduction then illustrate how to use these calculators to obtain power

In recent years, the stepped-wedge cluster randomized trial
(SW-CRT) design has been increasing in popularity.1–4 In
SW-CRTs (Figure 1a), each cluster begins in the control
condition. At different time points, clusters are randomized
to cross over to the intervention condition until by the end
of the trial, all clusters have received the intervention. In a
complete SW-CRT design, measurements are taken from
each cluster in each period. The SW-CRT can help facili-
tate recruitment when stakeholders perceive there are ben-
efits to being exposed to the intervention at some point
during the trial.5,6 The design is also attractive when the
goal is to implement the intervention in all clusters but
there are inadequate resources to do so in all clusters simul-
taneously.5,6 Despite their potential advantages, the use of
stepped-wedge (SW) designs must be appropriately justi-
fied and researchers must be aware of the potential risks of
bias.7,8
Methods for planning SW-CRTs are rapidly evolving
and a variety of sample size calculation methods and tools
are now available. Applied statisticians are faced with a be-
wildering array of choices and there is no centralized dis-
cussion of the functionalities of different calculators. We
aim to provide a comprehensive overview of the trial de-
sign features that can be accommodated by available
power and sample size calculators for SW-CRTs, illustrate
how to use the main calculators and provide a guide to al-
low users to select the most appropriate calculators for
their studies.
The rest of the article is organized as follows. We start
with an overview of SW-CRTs, including major features to
consider in sample size calculation. We then provide a de-
tailed review of four main calculators including their
strengths and limitations. Using two example trials, we
for each of the trials and compare the results across the
four calculators. We conclude by summarizing our findings
and making recommendations for selecting the most ap-
propriate calculator in practice.
Main factors to consider when planning a
SW-CRT
Types of SW designs based on sampling
structure
There are three main types of SW-CRTs, depending on the
sampling structure.9 In a cross-sectional design, outcomes
are measured on different participants over time so each
participant contributes outcomes to either the control or
intervention condition but not both. In the closed cohort
design, the same participants are measured repeatedly over
time so each participant contributes outcomes under both
the control and intervention conditions. The open cohort is
a variation on the closed cohort in which participants may
join or leave the cohort during the trial and thus at least
some participants contribute outcomes under both control
and intervention conditions.10 The majority of work on
sample size calculation for SW-CRTs has focused on cross-
sectional or closed cohort designs; open cohort designs
have received relatively little development except for the
work by Kasza et al.10 Recent work has started to consider
cross-sectional designs arising from the common scenario
in which participants are recruited continuously in
time (but exposed for only a short period) as a special class
of design requiring different correlation structures,
called ‘continuous-time decay’, and different analytical
approaches.9,11 Further work is required but some
methodology for continuous-time decay has already been
2002
developed by Grantham et al.12 that includes an R Shiny
web app to determine power for some scenarios, assuming
individual measurement times are evenly spaced within
each interval. In practice, cross-sectional designs are often
considered to be approximations of continuous recruit-
ment short exposure designs and, depending on the as-
sumed correlation structure, sample size calculators based
on discrete sampling may yield identical calculations.
Incomplete designs
Standard SW-CRTs collect data in each cluster period.
Incomplete SW-CRTs are designs that do not collect data
in all cluster periods.13,14 Figure 1b illustrates a design in
which no data are collected during the period immediately
prior to the intervention. These ‘transition periods’ allow
extra time to implement the intervention or for the inter-
vention to start exerting its effect. Each sequence can have
Figure 1 (a) Stepped-wedge design with five sequences and six periods (steps). (b) Stepped-wedge design with transition periods. (c) ‘Staircase’
stepped-wedge design.
International Journal of Epidemiology, 2022, Vol. 51, No. 6
one or more transition periods.14 Figure 1c illustrates a de-
sign in which each cluster has the same number of control
and intervention periods, but not all clusters enter and exit
at the same time. This type of design is called a staircase
design.15
Correlation structures and statistical models for
SW-CRTs
In a SW-CRT, the intervention effect is partially con-
founded with the time effect (i.e. secular trend) by design;
therefore, the analytical model must always account for
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time to obtain unbiased inferences. It is further well known
that CRTs must account for the correlation among multi-
ple responses from different individuals within the same
cluster. In a post-test-only parallel-arm CRT, the degree of
clustering is usually measured using a single intra-cluster
correlation coefficient (ICC), defined as the ratio of the
International Journal of Epidemiology, 2022, Vol. 51, No. 6
between-cluster variance and the sum of the between-clus-
ter and within-cluster variances.16 In multi-period CRTs,
such as SW-CRTs, correlation structures may be more
complex as outcomes are measured in different periods.
Nevertheless, the initial statistical model for SW-CRTs de-
veloped by Hussey and Hughes was a random intercepts
model that assumed a single exchangeable correlation, i.e.
the correlation between any two individuals from the same
cluster is the same regardless of their distance apart in
time.2
Building upon earlier work on multi-period parallel-arm
CRTs,17 Hooper et al.18 and separately Girling and
Hemming19 introduced a conditional (i.e. mixed-effects)
model (referred to as the Hooper/Girling model) that allows
the within-period ICC (wp-ICC) (i.e. the correlation be-
tween two individuals from the same cluster and same pe-
riod) to differ from the between-period ICC (bp-ICC) (i.e.
the correlation between two individuals from the same clus-
ter but different periods). We would typically expect the bp-
ICC to be less than the wp-ICC. The ratio of the bp-ICC
and wp-ICC is called the Cluster Autocorrelation
Coefficient (CAC), which is typically <1.18,20 Li21 referred
to this as a nested exchangeable correlation structure. In a
cohort design, an additional correlation is needed to account
for repeated measures on the same individual over time. In
the Hooper/Girling model, this correlation was introduced
through the addition of a patient-level random effect and
quantified as an Individual Autocorrelation Coefficient
(IAC), which implies a constant correlation in the repeated
measures on the same individual over time.18 Li21 referred
to this as a block exchangeable correlation structure.
Intuitively, within a cluster, the responses from individ-
uals between two consecutive periods are usually more cor-
related than those separated by a longer interval.
Therefore, assuming a constant bp-ICC may not be realis-
tic, Kasza et al.22 proposed an extension to the Hooper/
Girling model that allows the bp-ICC to decay exponen-
tially. In this case, the CAC refers to the rate of exponential
decay per period. In the case of a cohort design, individual-
level correlation is also required and there are two possibil-
ities: either a constant individual-level correlation over
time (specified through an IAC) or allowing individual-
level correlations to decay exponentially (referred to as the
proportional decay structure).21
As an alternative to mixed-effects models, Li et al.23
proposed a marginal model based on generalized estimat-
ing equations (GEE) and corresponding power and sam-
ple size calculation methodology allowing for both cross-
sectional and closed cohort SW-CRT designs. In a cohort
setting, it is worth noting that in a marginal model, the
correlation in repeated measures on the same individual is
modelled directly through the within-individual ICC (wi-
2003
ICC) and is not identical to the IAC referred to above in
the context of a mixed-effects model. A comprehensive
overview of statistical models available for SW-CRTs can
be found in Li et al.24
In addition to the above correlation structures that are
based on time (period), correlation structures can also be
allowed to depend on exposure. This is referred to as
cluster-treatment effect heterogeneity and is accomplished
by including a random cluster by treatment effect in the an-
alytical model.25,26
Different ways to specify treatment effects
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The most common way to model a treatment effect in a
SW-CRT is as a time-averaged effect (step/immediate
change),2 which implies an immediate effect that is sus-
tained. With this specification, the average response across
the intervention periods is compared with that across the
control periods (Figure 2a). In some situations, the inter-
vention will not be fully implemented in the period imme-
diately after crossing over or may have a delayed effect.
This can be handled by specifying a fractional treatment in-
dicator.2,25 For example, using prior knowledge, one may
specify that the treatment will only be 50% effective dur-
ing the first intervention period and code the treatment in-
dicator as 0.5 in that period. When the treatment effect is
anticipated to be gradual across multiple periods, one can
assign fractional values to consecutive periods (assuming
the fractions are known) (Figure 2b). More generally,
rather than estimating a single treatment effect, one may
allow the treatment effect to vary in an unrestricted way
according to the number of periods of exposure to the in-
tervention. This is referred to as general time-on-treatment
effects24,25; it requires that an adequate number of clusters
are available given the desired number of treatment effects.
A more parsimonious version is to assume a constant (lin-
ear) change with increasing duration of exposure (called a
linear time-on-treatment effect).24 Linear time-on-
treatment can also be viewed as a special case of fractional
treatment indicators but where the fractions are equally
spaced and determined by the maximum exposure time
(Figure 2c).
Analytical approximation for non-continuous
outcomes
For non-continuous (binary and count) outcomes, a com-
mon approach to sample size calculation is to use the nor-
mal approximation.2,27 However, this approach has
several issues. First, it requires the specification of an abso-
lute difference even if relative measures are of interest.
Second, the variance of the estimated treatment effect for
2004
Figure 2 (a) Design matrix for a stepped-wedge design with time-averaged treatment effect. (b) Design matrix for a stepped-wedge design with
delayed/gradual treatment effect and known fractions. (c) Design matrix for a stepped-wedge design with linear time-on-treatment effects (treatment
increases linearly with duration of exposure).
non-continuous outcomes theoretically depends on the as-
sumed treatment effect as well as on the size of any time
effects, whereas under the normal approximation it
depends on neither. Several recent methods have shifted
away from normal approximation approaches towards
methods based on maximum-likelihood estimation
(MLE)28 of the generalized linear mixed-model (GLMM)
or marginal models using GEE.23,29 These methods allow
users to specify odds ratios and risk ratios directly in their
sample size calculation procedures. Moreover, they allow
the variance to depend on the assumed treatment effect
and thus require the effect of secular trends to be incorpo-
rated in the power calculation. Although the analytical
model should always include time effects to account for
potential secular trends, power calculations for continuous
outcomes are not affected by the magnitude of the secular
trends.
International Journal of Epidemiology, 2022, Vol. 51, No. 6
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Table 1 summarizes these and other features that
researchers need to consider when designing a SW-CRT.
Summary of available sample size and
power calculators
To date, 18 power and sample size calculators for
SW-CRTs have been developed for implementation in R,
online via an R Shiny app, or in SAS, Stata, Excel, PASS31
and nQuery.32 A standalone calculator maintained by the
National Institutes of Health has also recently become
available.33 A summary of the functionality of the calcula-
tors with respect to the major features described in Table 1
is presented in Supplementary File 1, Tables S1–S6 (avail-
able as Supplementary data at IJE online) organized by
software platform. Each calculator is also classified based
on how correlation structures need to be specified (i.e. in
International Journal of Epidemiology, 2022, Vol. 51, No. 6 2005

Table 1 Common features that users need to consider or specify when designing a stepped-wedge cluster randomized trial

Variable Definition or explanation

Type of primary outcome Continuous, binary, count

Details of the design
Number of sequences Number of rows in design matrix
Number of periods Determines number of columns in design matrix (when time is modelled as a categorical
variable)
Cluster size per period Average number of participants per cluster per period
Type of design
Cross-sectional Different individuals in each period
Closed cohort The same individuals repeatedly measured over time
Open cohort Mixture of different or same individuals

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Correlation structures
Cross-sectional designs
Exchangeable Assume a constant within-cluster correlation over time
Nested exchangeable Allow the between-period ICC to be different from the within-period ICC (often specified
using the CAC, which is the ratio of the between-period to the within-period ICC)
Exponential decay Specify a within-period ICC and a CAC measuring the exponential rate of decay in the
between-period ICC per period
Cohort designs
Exchangeable As for cross-sectional design; in addition, assume a constant within-individual correlation over
time
Block exchangeable As for cross-sectional design; in addition, assume a constant within-individual correlation over
time
Proportional decay As for cross-sectional design; in addition, specify an exponential decay in the within-individual
correlation over time
Type of treatment effect
Average (immediate) effect Intervention leads to step change (immediate change)
Delayed or gradual effect Allows gradual treatment effect or partial exposure to the intervention
Linear time-on-treatment effect Allows the treatment to increase linearly with duration of exposure
General time-on-treatment effect Allows the treatment effect to vary in an unrestricted way, according to the number of periods
of exposure to the intervention
Link function (for binary outcomes) Identity (Risk Difference), Log (Relative Risk), Logit (Odds Ratio)
Equal or Unequal allocation Same or different number of clusters per sequence; calculators that allow users to upload a user-
defined design matrix may allow users to explore power implications of different allocations
Varying or fixed cluster sizes Allowing cluster (or cluster-period) sizes to vary across clusters can affect power. Often speci-
fied in terms of a coefficient of cluster-size variation
Incomplete design Data are not collected from some clusters in some periods either to allow for a transition period
or to ease the data collection burden (see Figure 1). Calculators that allow users to upload or
define their own design matrix provide more flexibility over specifying incomplete designs
Analytic model Mixed-effects regression or marginal model (generalized estimating equations)
Different methods to specify correlation Different calculators may require different inputs to measure correlation. The most common
approach is to specify anticipated intra-cluster correlation coefficients. An alternative is to
specify the anticipated variance or standard deviation of the random-effects distributions.
Finally, the coefficient of outcome variation can sometimes be specified
Cluster-treatment heterogeneity Users may allow treatment effects to vary randomly across clusters (which can reduce power)
Multilevel clustering More than two levels of clustering during each time period, e.g. patients may be clustered
within providers who are clustered within primary care practices
Hybrid design The design contains a mixture of SW-CRT and parallel CRT (see Girling et al.19 for details)
Continuous or categorical time effects Users may model secular trends using fixed categorical or fixed continuous effects. Whether
linear or categorical time effects are incorporated in complete stepped-wedge designs has no
influence on continuous outcomes30
Magnitude of time effect Users may specify the expected secular trend, which, in the case of a non-continuous outcome,
can affect power

ICC, intra-cluster correlation coefficient; CAC, Cluster Autocorrelation Coefficient; SW-CRT, stepped-wedge cluster randomized trial; CRT, cluster random-
ized trial.
2006
terms of coefficient of variation (CV) of outcomes, ICCs or
variance components of random effects) and whether the
calculator allows for unequal cluster-period sizes, unequal
allocation of clusters to sequences and whether the user
can specify their own design matrix. Note that any calcula-
tor that can support a user-specified design matrix can typ-
ically also be used for other multiple-period designs (such
as repeated parallel-arm or multiple-period cluster cross-
overs) as the sample size methodology underlying all these
designs is similar. We also indicate whether cluster-
treatment effect heterogeneity, continuous time effects (as
opposed to only categorical), subclusters (i.e. more than
two levels of clusters within each period) and hybrid
designs (i.e. a mixture of parallel and SW-CRTs) can be ac-
commodated.19 A Shiny app is available (https://douyang.
shinyapps.io/swcrtcalculator/) in which users can obtain a
list of calculators that accommodate their selected design
features. Among available calculators, we now review in
more detail four main packages that offer many of the
available features.
SHINYCRT by Hemming et al.
Overview
• A menu-based web app (RShiny app) that calculates
power and sample size for SW-CRTs under linear mixed-
effects models.27
• Type of design and outcome: cross-sectional and closed
cohort designs with continuous, binary and count out-
comes using the normal approximation method.
• Correlation structures: exchangeable (users need to spec-
ify a common wp-ICC); block or nested exchangeable
(specify the wp-ICC and CAC as well as an IAC for co-
hort designs); exponential decay (specify the wp-ICC and
CAC for the decay per period, as well as a constant IAC
for cohort designs). Exponential decay is referred to as
‘discrete time decay’ in this app.
Important features and strengths
SHINYCRT automatically displays power or sample size
curves. Users can either provide sample sizes per cluster pe-
riod to calculate the power or specify a target power to ob-
tain the required sample sizes. In addition to the specified
‘base’ ICC values, users can conduct a sensitivity analysis
by specifying the upper and lower bounds of the wp-ICC.
The plot will automatically include results for lower and
higher CAC values (80% and 120% of the specified CAC)
as a sensitivity analysis.
Users can upload their own design matrices to accom-
modate unequal numbers of clusters per sequence.
Uploading a design matrix also activates additional
International Journal of Epidemiology, 2022, Vol. 51, No. 6
features including an option for accommodating cluster-
treatment heterogeneity. The design matrix may contain
empty cells to allow for incomplete designs or cells with
fractions to accommodate delayed or linear time-on-
treatment effects (although the design matrix will be dis-
played as integers). This calculator can also accommodate
unequal cluster sizes by specifying a CV for cluster-size
variation. Instead of a z-test, users can request a t-test
with degrees of freedom equal to the number of cluster
periods minus the number of periods minus one, although
the t-test is not available for exponential decay or when
uploading a user-specified design matrix. An attractive
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feature of this app is that in addition to SW-CRT,
menu options include other multiple-period designs,
e.g. parallel-arm and multiple-period cluster crossover
designs.
Limitations
The SHINYCRT web app has multiple features and allows
substantial flexibility in specifying a design, but also has
some limitations. First, methods for binary and count out-
comes use a normal approximation; thus, the magnitude of
time effects on power cannot be accommodated. Second,
only identity link functions are allowed; thus, when the re-
search requires log or logit links, the sample size calcula-
tion procedure may not be compatible with the analytical
approach. Third, in the case of closed cohort designs, the
app only allows constant individual-level correlation, even
though proportional decay may be more appropriate.
Fourth, the t-distribution approximation was still under
development at the time of submission. Finally, the RShiny
app platform limits the number of hours the app can run
on the server. When the quota has been reached in a partic-
ular month, users will have to find an alternative way to
access the calculator.
SWDPWR by Chen et al.
Overview
• A calculator running in R, RShiny and SAS that calcu-
lates power and sample size for SW-CRTs using GEE or
GLMM with MLE.34
• Type of design and outcome: cross-sectional and closed
cohort designs with continuous and binary outcomes un-
der identity, log and logit link functions.
• Correlation structures: block or nested exchangeable
correlation structures (including exchangeable as a spe-
cial case); wp-ICC and bp-ICC must be specified for
cross-sectional designs (specified as equal to obtain ex-
changeable correlation); for cohort designs, wi-ICC must
also be specified.
International Journal of Epidemiology, 2022, Vol. 51, No. 6
Important features and strengths
The most significant feature of this calculator is the avail-
ability of GEE and MLE to obtain more accurate sample
size estimates for binary outcomes. When the research
requires relative measures, the implementation of log and
logit link functions allows users to specify relative treat-
ment effects directly. When assuming no secular trend,
users can specify the target difference by either (i) specify-
ing the expected response in the control condition at the
beginning of the study and the expected response in the in-
tervention condition at the end or (ii) replacing the
expected response in the intervention condition at the end
of the study with the effect size. To accommodate a secular
trend, users can specify the expected response in the con-
trol condition at the beginning and end of the study (i.e. as-
suming the intervention has not been introduced) in
addition to the target difference. Users can upload a design
matrix and accommodate hybrid designs and designs with
different numbers of clusters per sequence.
Limitations
The SWDPWR calculator has some limitations. First, it
does not allow for exponential or proportional decay and
cannot accommodate count outcomes. Second, with the
conditional model, a maximum cluster-period size of 150
is allowed for binary outcomes and the calculator is further
limited to cross-sectional designs with exchangeable corre-
lation. If larger cluster-period sizes, cohort designs or more
complex correlation structures are desired, GEE must be
used instead. Third, when specifying no time effects, i.e.
the same expected response in the control condition at the
beginning and end, the time variable will be removed from
the underlying model used for calculation, which is incom-
patible with recommendations to always include time
effects in the analytical model. Fourth, there is currently no
option for choosing a t-test when the number of clusters is
small. Finally, incomplete designs (including transition
periods), cluster-treatment heterogeneity, unequal cluster
sizes and delayed or time-on-treatment effects are not
available.
SWCRTDESIGN by Hughes et al.
Overview
• A calculator running in R and RShiny app that calculates
power and sample size for SW-CRTs under a linear
mixed-effects model.35
• Type of design and outcome: cross-sectional designs with
continuous and binary outcomes under an identity link
function. For non-continuous outcomes, a new method
that includes log and logit link functions and that can
2007
provide more accurate estimates than MLE even with a
small number of clusters is being planned as a future
addition.36
• Correlation structure: exchangeable and nested ex-
changeable correlation structures. Users can specify the
wp-ICC and CAC or standard deviations for random
intercepts, random treatment effects across clusters and
random cluster by time effects; the correlation between
random intercepts and random treatment effects can
also be specified (most other calculators assume
independence).
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Important features and strengths
The most important contribution of this package is to al-
low the intervention effect to vary across clusters by in-
cluding a random treatment effect.25 To activate this
feature, users must input standard deviations of the antici-
pated random effects (rather than ICCs). In the accompa-
nying Shiny app, delayed or linear time-on-treatment
effects can be accommodated by allowing fractional treat-
ment indicators; however, general time-on-treatment
effects are not available. Designs must be specified via the
function ‘swDns’. Users can specify the number of clusters
changing from control to intervention at each step. An
incomplete design can be constructed by specifying a
cluster-period size of 0 in select periods.
Limitations
SWCRTDESIGN has several limitations. First, calculations
for binary outcomes are only available using the normal
approximation and for count outcomes only via simula-
tion. Second, it cannot be used for cohort designs. Third,
exponential or proportional decay cannot be accommo-
dated. Fourth, there is no option for choosing a t-distribu-
tion when the number of clusters is small. Fifth, compared
with other packages, specifying incomplete designs is less
straightforward: a complete design matrix must be speci-
fied using ‘swDns’ followed by specification of cluster-
period sizes. Finally, delayed treatment effects are only
available in the Shiny app version so far, but relevant code
for simulation-based power calculation can be performed
by modifying the code provided in Voldal et al.35
CRTFASTGEEPWR by Zhang and Preisser
Overview
• An SAS macro that calculates power for SW-CRT based
on GEE analysis of a marginal model.37,38
• Type of design and outcome: cross-sectional or closed
cohort designs with continuous, binary and count out-
comes and identity, log and logit link functions.
2008
• Correlation structure: nested or block exchangeable (in-
cluding exchangeable as a special case) and exponential
or proportional decay. Under proportional decay, the
calculator requires the bp-ICC and wi-ICC to decay at
the same rate.
Important features and strengths
Users can specify either time-averaged or ‘incremental’ in-
tervention effects, the latter using fractional treatment val-
ues for linear time-on-treatment effects. Additionally, time
effects can be specified as either categorical or linear (con-
tinuous). Both intervention and time effects are specified as
regression parameters on the scale of the link function. The
model with categorical time effects implies an expected
proportion/rate under the control condition for each time
period, whereas specification of linear time effects requires
the user to specify both a fixed intercept and slope that de-
termine marginal means for the outcome under the control
condition.
Users are required to enter the number of clusters per
sequence, which may vary. A required design pattern ma-
trix for sequence-periods uses 0 for control periods, 1 for
intervention periods and 2 for empty cells (for incomplete
designs). Users may determine power for the normal ap-
proximation or from a t-distribution with choice of degrees
of freedom (the number of clusters minus two or the num-
ber of clusters minus the number of parameters in the
model). Unequal cluster-period sizes can be accommo-
dated; however, users must enter the cluster-period sizes
rather than a single CV.
Limitations
There are few limitations to this calculator. First, cluster-
treatment effect heterogeneity cannot be accommodated.
Second, for binary and count outcomes, the magnitude of
secular trends is relevant but the calculator only considers
these parameters on the link function scale, so the user will
need to use inverse link functions to convert proportions
and rates in case of a non-identity link.23
Other calculators
The above four calculators may cover most scenarios of in-
terest; features of other available calculators are summa-
rized in the tables and available in our app and only briefly
highlighted here. For Stata users, POWERSWGEE39 might
offer the most flexibility and has similar functionalities
as CRTFASTGEEPWR. Notably, when specifying the
proportional decay structure, it allows bp-ICC and
individual-level correlation to decay at different rates.
However, POWERSWGEE currently cannot accommodate
incomplete designs. A few calculators in our review
International Journal of Epidemiology, 2022, Vol. 51, No. 6
accommodate special features, e.g. designs with subclus-
ters40; a calculator is also available to determine
allocation-based power.41,42 The choice of calculators that
can deal with open cohort designs is limited10,43; however,
a reviewer pointed out that by multiplying IAC by one mi-
nus the churn rate (the rate that participants leave the
trial), calculators that support closed cohort designs can
also be used for open cohort designs. This observation will
hold for continuous outcomes under a constant individual-
level correlation. Conversely, calculators for open cohort
designs can also support closed cohort and cross-sectional
designs by setting the churn rate to 0 or 1.
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During peer review, a new standalone calculator
(SWGRT33) became available and was added to our man-
uscript. SWGRT can support continuous and binary out-
comes, all three types of designs and available correlation
structures, and is accompanied by excellent documenta-
tion. A notable feature of this calculator is that it can in-
corporate the effect of covariate adjustments in the
design. It also allows an ICC obtained from a block ex-
changeable model to be converted to a discrete time decay
ICC.10 However, it is based on the normal approximation
for binary outcomes and cannot deal with incomplete
designs, unequal allocation and user-specified design
matrices. Finally, it only allows the calculation of the re-
quired number of clusters per sequence for a pre-specified
treatment effect and a minimum of two clusters per se-
quence is required.
Examples
In this section, we illustrate power calculations using each
of the four packages for two published trials: Girls on the
Go!44 and the Washington State Expedited Partner
Therapy (EPT) trial.45 We show how the sample size
parameters should be specified in each package and com-
pare the obtained power values across the four packages.
We make comparisons under exchangeable, nested or
block exchangeable and exponential or proportional decay
structures. We were able to obtain realistic parameter val-
ues under these correlation structures using real data from
both trials. The code used to implement the calculations is
presented in Sections 1 and 2 of Supplementary File 2
(available as Supplementary data at IJE online) or RPubs
(https://rpubs.com/derek6561/swcrtcalculator).
‘Girls on the Go!’ trial
‘Girls on the Go!’ is a closed cohort SW-CRT designed to
determine whether a 10-week programme that incorpo-
rates interactive and practical learning would help to in-
crease self-esteem, self-confidence and body image among
International Journal of Epidemiology, 2022, Vol. 51, No. 6 2009

school girls aged 10–16 years in Melbourne, Victoria,
Australia.44 The trial was designed with three sequences
and four periods with two clusters per sequence (a total of
six clusters) and 10 participants per cluster, i.e. a total sam-
ple size of 60 participants. There were no transition periods.
The primary outcome was continuous: a measure of self-
esteem on a scale from 0 to 40. The sample size parameter
values including ICC estimates under the three different cor-
relation structures from the CLOUDbank data set, which is
a repository of ICC values under different correlation struc-
tures, are summarized in Table 2.46 Due to the small num-
ber of clusters, we illustrate power with both a z-test and a
contradict an earlier statement that the magnitude of time
effects is irrelevant for continuous outcomes but was in-
cluded to illustrate how SWDPWR handles time effects
compared with other packages.)
The power when using the three main calculators under
these assumptions is presented in Table 3. Not surpris-
ingly, the power did not differ much whether GLMM or
GEE was used. Whereas power was substantially different
under different correlation structures, power was similar
across the different calculators when using the normal dis-
tribution. Under the no-time-effect scenario however,
SWDPWR yields substantially higher power due to fixed

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t-test. SWCRTDESIGN was excluded from this example as time effect parameters being excluded from the model,
it cannot be used for cohort designs. Power calculations leaving fewer fixed parameters to estimate. Therefore, to
when using SWDPWR and CRTFASTGEEPWR are shown approximate the results of CRTFASTGEEPWR assuming a
both with and without time effects. (This does not null secular trend (where the analytical model includes
time effects), users must specify a small secular trend in
Table 2 Sample size calculation parameter values used for SWDPWR. As expected, the magnitude of time effects in
the ‘Girls on the Go’ trial (continuous outcome) the linear model is irrelevant to CRTFASTGEEPWR. Note
that power from CRTFASTGEEPWR is based on an expo-
Sample size parameter Assumed value nentially decaying wi-ICC, whereas SHINYCRT assumes a
Number of sequences 3 constant IAC; nevertheless, the power obtained was compa-
Number of periods 4 rable. When using the t-distribution, calculated power in
Number of clusters (equal allocation)6 SHINYCRT and CRTFASTGEEPWR were substantially
Cluster size per period 10 different (76% vs 50%) due to the degrees of freedom
Standard deviation 1
implemented being different (19 in SHINYCRT vs 4 in
Mean difference (treatment effect) 0.39
CRTFASTGEEPWR, i.e. the number of clusters minus two).
Type of design Closed cohort
Exchangeable correlation
Within-period ICC 0.005
Community EPT trial
IAC or within-individual ICCa 0.65
Block exchangeable correlation The Washington State EPT trial is a cross-sectional
Within-period ICC 0.01 SW-CRT designed to evaluate the impact of promoting the
CAC 0.223 use of EPT on the decrease of Chlamydia test positivity
IAC or within-individual ICCa 0.65
among women.45 The trial was designed with four sequen-
Proportional decay
ces and five periods. Each sequence has 6, 6, 6 and 4 clus-
Within-period ICC 0.025
CAC (per period) 0.689 ters, respectively (a total of 22 clusters). The average cluster-
IAC or within-individual ICCa 0.65 period size was 305 participants, i.e. a total sample size of
Varying cluster sizes No 33 550 participants. There were no transition periods. The
Transition periods No primary outcome was binary: prevalence of Chlamydia posi-
Type of model Linear mixed-effects tivity. The sample size parameter values including ICC esti-
model or GEE mates under the three different correlation structures, from
Type of treatment effect Step change (time-averaged effect)
reanalysis of the real EPT trial data,47,48 are summarized in
Cluster-treatment heterogeneity No
Table 4. Since the magnitude of any assumed time effects
Type of time effect Fixed categorical
Magnitude of time effects Not applicableb will impact the power for binary outcomes, we assessed
Significance level Two-sided, 5% power assuming (i) no time effect, (ii) a small time effect
equal to half the size of the treatment effect and (iii) a mod-
ICC, intra-cluster correlation coefficient; IAC, Individual Autocorrelation
erate time effect equal to the treatment effect.
Coefficient; CAC, Cluster Autocorrelation Coefficient; GEE, generalized esti-
mating equations. The power when using the four main calculators is pre-
a
SHINYCRT requires IAC; SWDPWR and CRTFASTGEEPWR require sented in Table 5. The power was dramatically different
within-individual ICC. We used the same value for both parameters.
b under different assumed correlation structures. The power
Assumed 0.1 in SWDPWR where specification of time effects is necessary
to avoid inflating power; changing the value of assumed time effects will not did not appear to differ based on whether GLMM or GEE
change power as the outcome is continuous was used, but when assuming no time effects, SWDPWR
2010 International Journal of Epidemiology, 2022, Vol. 51, No. 6

Table 3 Power calculated under the main software packages for the ‘Girls on the Go’ trial

SHINYCRTb SWDPWRc SWDPWRc CRTFASTGEEPWRd CRTFASTGEEPWRd

e
No time effect With time effect (0.1) No time effect With time effect (0.1)

Power using z-testa

Exchangeable correlation 0.796 0.997 0.794 0.794 0.794

Block exchangeable correlation 0.720 0.991 0.724 0.724 0.724
Proportional decay 0.713 N/A N/A 0.708 0.708
(exponential (the same (the same
decay with exponential decay in exponential decay in
fixed IAC) between-period and between-period and
within-individual ICC) within-individual ICC)

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Power using t-testf

DF ¼ 19g DF ¼ 4
Exchangeable correlation 0.751 N/A N/A 0.501 0.501
Block exchangeable correlation 0.671 N/A N/A 0.418 0.418
Proportional decay N/A N/A N/A 0.401 0.401

IAC, Individual Autocorrelation Coefficient; ICC, intra-cluster correlation coefficient; DF, degrees of freedom.
a
SWCRTDESIGN does not support cohort designs.
b
Linear mixed-effects model used.
c
Generalized estimating equations (GEE) and mixed-effects model produced the same results.
d
GEE method for marginal model.
e
By default, coefficients for time are excluded from the underlying model when no time effect is specified.
f
SHINYCRT and CRTFASTGEEPWR used different DF in t-test.
g
This is a manual correction for the DF used in SHINYCRT based on its documentation; the actual implementation is under development.

gave substantially different results to the other packages,
as explained earlier. When the time effects were not
null, the power from SWDPWR and CRTFASTGEEPWR
was similar but substantially different from the power
under the normal approximation in SHINYCRT and
SWCRTDESIGN (since the normal approximation does
not rely on the magnitude of time effects). The differences
tend to increase when the time effects increase.
The logit link can also be specified for the mean model
in SWDPWR and CRTFASTGEEPWR (see Supplementary
File 2, Section 3, available as Supplementary data at IJE on-
line). Both calculators require users to specify the effect size
on the log scale and the ICC of the binary outcomes on the
proportions scale. Whereas SWDPWR requires the time ef-
fect to be specified as proportions, CRTFASTGEEPWR
requires all marginal mean model parameters (i.e. period
and intervention effects) to be specified on the link function
scale.
Summary and recommendations
There are several key considerations when designing a
SW-CRT and choosing a power and sample size calculator.
For a continuous or non-continuous outcome when the nor-
mal approximation is appropriate (i.e. where there is a rela-
tively large number of clusters and/or the anticipated
proportion is not too close to 0 or 1) and when anticipated
secular trends are small, SHINYCRT is potentially the best
choice for most users. It is free to access and provides an in-
tuitive interface. It can accommodate continuous, binary
and count outcomes as well as cross-sectional and closed co-
hort designs under the three types of correlation structures.
It allows for incomplete designs and cluster-treatment het-
erogeneity. Furthermore, it automatically implements a sen-
sitivity analysis for the assumed correlation parameters.
However, for non-continuous outcomes in which relative
effects are of interest or when extreme baseline rates/propor-
tions or large time effects are expected, CRTFASTGEEPWR
seems to be the better choice. This SAS macro allows for
cross-sectional and closed cohort designs, incorporates all
correlation structures considered herein and can accommo-
date incomplete designs, fractional treatment effects and
both categorical and linear time effects. However, non-SAS
users or users who do not want to use GEE may use
SWDPWR instead as long as they have a complete design
with a continuous or binary outcome (exchangeable correla-
tion only) and do not require decaying correlation structures
or delayed treatment effects. When using SWDPWR, users
should incorporate non-zero time effects (even for continu-
ous outcomes), otherwise the calculation will be based on a
model that excludes the time effect coefficients and this
could yield spuriously high power.
International Journal of Epidemiology, 2022, Vol. 51, No. 6 2011

Table 4 Sample size calculation parameter values used for Although users may select the calculator most conve-
the Expedited Partner Therapy trial (binary outcome) nient to them facilitated by our Shiny app, a good rule of
thumb when not all requirements can be met is to priori-
Sample size parameter Assumed value
tize those factors that have the most impact on power in
Number of sequences 4 their scenario. As our examples illustrate, an important
Number of periods 5 consideration is the assumed correlation structure: assum-
Number of clusters 22 (6, 6, 6, 4 for each sequence) ing an overly simple correlation structure (e.g. exchange-
Cluster size per period 305 able) when a more complex correlation structure (e.g.
Baseline rate 0.076
block exchangeable or exponential decay) is appropriate
Mean (absolute) difference 0.014
(treatment effect)
can lead to power being overestimated.49 Ideally, ICC val-
Type of design Cross-sectional ues should be informed by analysing existing data (e.g.
Exchangeable correlation historical or routinely collected data) under a similar set-

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Within-period ICC
Nested exchangeable
correlation
Within-period ICC
CAC
Exponential decay
Within-period ICC
CAC (per period)
Varying cluster sizes
Transition periods
Type of model
Type of treatment effect
Cluster-treatment heterogeneityNo
Type of time effect
Magnitude of time effect
Significance level
ICC, intra-cluster correlation coefficient; CAC, Cluster Autocorrelation
Coefficient; GEE, generalized estimating equations.
0.007 ting over a similar study duration. A practical approach is
to select the best-fitting correlation structure based on in-
formation criteria, i.e. AIC (Akaike Information
0.007
Criterion) and BIC (Bayesian Information Criterion).50
0.50
Regardless of the availability of prior data, it is always
0.007 good practice to check the sensitivity of the calculations
0.70 by assuming a range of plausible ICC values. When there
No are no prior data to inform the choice of correlation struc-
No ture, we would recommend using a nested or block ex-
Linear mixed-effects changeable correlation for binary outcomes and
regression or GEE exponential or proportional decay for continuous out-
Step change (time-averaged effect)
comes. For non-continuous outcomes, the type of approxi-
mation used is also critical. For non-continuous outcomes,
Fixed categorical
None, small (0.007) users must consider whether strong time effects are antici-
or large (0.014) pated and choose a calculator that can accommodate such
A time effect of, say, 0.007 effects. As shown in our example, with binary outcomes,
means that the outcome is the normal approximation works poorly if the baseline
expected to decrease, even proportion is away from 0.5 and the time effect is not
in the absence of any intervention, null. A similar observation was made by Zhou et al.28
from 0.076 in the first period to
Finally, for continuous outcomes with a small number of
0.069 in the last period
Two-sided, 5%
clusters, using the t-test is generally advised, but users
must be aware that different degree-of-freedom options
are implemented in different calculators and the best
choice for degree of freedom remains unclear.

Table 5 Power calculated under the main software packages for the Expedited Partner Therapy trial

SHINYCRTa SWDPWRb SWCRTDESIGNa CRTFASTGEEPWRb

No time Small time Large time No time Small time Large time
effectc effect effect effect effect effect
(0.007) (0.014) (0.007) (0.014)

Exchangeable correlation 0.806 0.995 0.819 0.837 0.803 0.803 0.819 0.837
Nested exchangeable correlation 0.543 0.904 0.560 0.580 0.540 0.542 0.560 0.580
Exponential decay 0.570 N/A N/A N/A N/A 0.568 0.586 0.607

a
Normal approximation using mixed-effects model. Magnitude of time effects cannot be accommodated.
b
Generalized estimating equations (GEE) was used for calculation. With cluster-period size of >150, only GEE can be used in SWDPWR.
c
By default, coefficients for time are excluded from the underlying model when no time effect is specified.
2012
Ethics approval
Not applicable.
Data availability
There are no new data associated with this article.
Supplementary data
Supplementary data are available at IJE online.
Author contributions
Y.O. led the writing of the manuscript, developed the idea with
M.T., extracted the software information, created tables and figures,
and developed the Shiny app. M.T. conceived of the ideas, helped
with data extraction and co-led the writing. F.L. participated in the
development of the idea and helped with data extraction. J.S.P. criti-
cally reviewed the methods and ideas. All authors contributed to
writing, drafting and editing the manuscript.
Funding
M.T. and F.L. are supported by the National Institute of Aging
(NIA) of the National Institutes of Health (NIH) under Award
Number U54AG063546, which funds NIA Imbedded Pragmatic
Alzheimer’s Disease and AD-Related Dementias Clinical Trials
Collaboratory (NIA IMPACT Collaboratory). Y.O. is funded by the
Ontario SPOR SUPPORT Unit, which is supported by the Canadian
Institutes of Health Research and the Province of Ontario. J.S.P. and
F.L. are supported through Patient-Centered Outcomes Research
R R
InstituteV (PCORIV Award ME-2019C1-16196). The statements
presented in this article are solely the responsibility of the authors
R
and do not necessarily represent the views of the NIH nor PCORIV,
its Board of Governors or Methodology Committee.
Acknowledgements
We thank Ying Zhang (zying@live.unc.edu) who provided instruc-
tions on how to specify the parameters in CRTFASTGEEPWR.
Conflict of interest
Y.O. is the author for CRTpowerdist calculator; M.T. is a co-author
of the SHINYCRT calculator; F.L. is co-author of SWDPWR and
CRTFASTGEEPWR; J.S.P. is author of CRTFASTGEEPWR. J.S.P.
R
has received a stipend for service as a merit reviewer from PCORIV.
J.S.P. did not serve on the Merit Review panel that reviewed this
project.
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