Wang X, Turner EL, Li F, Wang R, Moyer JC, Cook A, … Heagerty PJ. Two weights make a wrong: Cluster randomized trials with variable cluster sizes and heterogeneous treatment effects. Contemp Clin Trials. 2022Wang Turner Li;114:106702: Epub 2022/2/6.

Andridge RR, Shoben AB, Muller KE, Murray DM. Analytic methods for individually randomized group treatment trials and group-randomized trials when subjects belong to multiple groups. Statistics in Medicine. 2014;33(13):2178–90. Epub 2014/1/8.

Baio G, Copas A, Ambler G, Hargreaves JR, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015;16(1):354. Epub 2015/8/19.

Barker D, McElduff P, D’Este C, Campbell MJ. Stepped wedge cluster randomised trials: A review of the statistical methodology used and available. BMC Med Res Methodol. 2016;16:69. Epub 2016/6/9.

Baumann R, Esserman D, Taljaard M, Li F. Power calculation for cross-sectional stepped wedge cluster randomized trials with a time-to-event endpoint. Biometrics. 2025;81(2):

Bell ML, Rabe BA. The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data. Trials. 2020;21(1):148. Epub 2020/2/7.

Bellamy SL, Gibberd R, Hancock L, Howley P, Kennedy B, Klar N, … Ryan L. Analysis of dichotomous outcome data for community intervention studies. Stat Methods Med Res. 2000;9(2):135–59.

Bie R, Haneuse S, Huey N, Schildcrout J, McGee G. Fitting marginal models in small samples: A simulation study of marginalized multilevel models and generalized estimating equations. Stat Med. 2021;40(24):5298–312. Epub 2021/7/12.

Billot L, Copas A, Leyrat C, Forbes A, Turner EL. How should a cluster randomized trial be analyzed? ? J Epidemiol Popul Health. 2024;72(1):202196: Epub 2024/2/10.

Blaha O, Esserman D, Li F. Design and analysis of cluster randomized trials with time-to-event outcomes under the additive hazards mixed model. Stat Med. 2022;41(24):4860–85. Epub 2022/7/31.

Caille A, Tavernier E, Taljaard M, Desmee S. Methodological review showed that time-to-event outcomes are often inadequately handled in cluster randomized trials. J Clin Epidemiol. 2021;134:125–137. Epub 2021/2/10.

Caille A, Taljaard M, Le Vilain-Abraham F, Le Moigne A, Copas A, Tubach F, Dechartres A. Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: Results from a methodological review. J Clin Epidemiol. 2022;148:93–103. Epub 2024/4/29.

Campbell MJ, Walters SJ. How to design, analyse and report cluster randomised trials in medicine and health related research. 2014 Chichester: John Wiley & Sons, Ltd.

Campbell MK, Piaggio G, Elbourne DR, Altman DG, Consort Group. Consort 2010 statement: Extension to cluster randomised trials. BMJ. 2012;345:e5661. Epub 2012/9/7.

Candel MJ, van Breukelen GJ. Sample size adjustments for varying cluster sizes in cluster randomized trials with binary outcomes analyzed with second-order PQL mixed logistic regression. Statistics in Medicine. 2010;29(14):1488–501. Epub 2010/1/27.

Candel MJ, van Breukelen GJ. Repairing the efficiency loss due to varying cluster sizes in two-level two-armed randomized trials with heterogeneous clustering. Statistics in Medicine. 2016;35(12):2000–15. Epub 2016/1/12.

Chan C, Leyrat C, Martin JT, Thompson JA, Turner EL, Eldridge S. A website for cluster randomised trials including stepped wedge: facilitating quality trials and methodological research. Trials. 2024;25(1):742. Epub 2024/11/6.

Chen LM, Ibrahim JG, Chu H. Sample size determination in shared frailty models for multivariate time-to-event data. J Biopharm Stat. 2014;24(4):908–23. Epub 2014/4/5.

Cohen J. Statistical power analysis for the behavioral sciences. 1988 (2nd ed.) New York: Academic Press.

Copas A, Lewis JJ, Thompson JA, Davey C, Baio G, Hargreaves JR. Designing a stepped wedge trial: Three main designs, carry-over effects and randomisation approaches. Trials. 2015;16(1):352. Epub 2015/8/17.

Cornfield J. Randomization by group: A formal analysis. American Journal of Epidemiology. 1978;108(2):100–102. Epub 1978/8/1.

Crespi CM. Improved designs for cluster randomized trials. Annu Rev Public Health. 2016;37:1–16. Epub 2016/1/18.

Crespi CM, Maxwell AE, Wu S. Cluster randomized trials of cancer screening interventions: Are appropriate statistical methods being used? Contemporary Clinical Trials. 2011;32(4):477–84. Epub 2011/3/5.

Diaz-Ordaz K, Kenward MG, Cohen A, Coleman CL, Eldridge S. Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines. Clin Trials. 2014;11(5):590–600. Epub 2014/6/5.

Diehr P, Martin DC, Koepsell T, Cheadle A. Breaking the matches in a paired t-test for community interventions when the number of pairs is small. Statistics in Medicine. 1995;14(13):1491–1504.

Donner A. An empirical study of cluster randomization. International Journal of Epidemiology. 1982;11(3):283–286. Epub 1982/9/1.

Donner A, Birkett N, Buck C. Randomization by cluster: Sample size requirements and analysis. American Journal of Epidemiology. 1981;114(6):906–914. Epub 1981/12/1.

Donner A, Brown KS, Brasher P. A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol. 1990;19(4):795–800. Epub 1990/12/1.

Donner A, Klar N. Design and analysis of cluster randomization trials in health research. 2000 London: Arnold.

Donner A, Taljaard M, Klar N. The merits of breaking the matches: A cautionary tale. Statistics in Medicine. 2007;26(9):2036–51. Epub 2006/8/24.

Eichner FA, Groenwold RHH, Grobbee DE, Rengerink O. Systematic review showed that stepped-wedge cluster randomized trials often did not reach their planned sample size. J Clin Epidemiol. 2019;107:89–100. Epub 2018/11/21.

Eldridge S, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol. 2006;35(5):1292–300. Epub 2006/9/1.

Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: Systematic review of recent trials. BMJ. 2008;336(7649):876–80. Epub 2008/3/25.

Eldridge S, Kerry S. A practical guide to cluster randomized trials in health research. 2012 London: Arnold.

Fay MP, Graubard BI. Small-sample adjustments for Wald-type tests using sandwich estimators. Biometrics. 2001;57(4):1198–206.

Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of clinical trials. 2015 (5th ed.) New York: Springer.

Fu D. A comparison study of general linear mixed model and permutation tests in group-randomized trials under non-normal error distributions. [Dissertation] 2006 University of Memphis, Memphis, TN.

Gail MH, Mark SD, Carroll RJ, Green SB, Pee D. On design considerations and randomization-based inference for community intervention trials. Statistics in Medicine. 1996;15(11):1069–1092. Epub 1996/6/15.

Gao F, Earnest A, Matchar DB, Campbell MJ, Machin D. Sample size calculations for the design of cluster randomized trials: A summary of methodology. Contemp Clin Trials. 2015;42:41–50. Epub 2015/3/9.

Giraudeau B, Weijer C, Eldridge S, Hemming K, Taljaard M. Why and when should we cluster randomize? J Epidemiol Popul Health. . 2024;72(1):202197: Epub 2024/2/9.

Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med. 2016;35(13):2149–66. Epub 2016/1/7.

Girling AJ. Relative efficiency of unequal cluster sizes in stepped wedge and other trial designs under longitudinal or cross-sectional sampling. Stat Med. 2018;37(30):4652–4664. Epub 2018/9/12.

Glueck DH, Li Q, Macleod A, Litkowsi E, Yang X, Bian J, … Muller KE. Power and sample size for reversible linear mixed models with clustering and longitudinality: GLIMMPSE Version 3. PLoS One. 2025;20(9):e0329712: Epub 2025/9/3.

Grantham KL, Kasza J, Heritier S, Hemming K, Forbes AB. Accounting for a decaying correlation structure in cluster randomized trials with continuous recruitment. Stat Med. 2019;38(11):1918–1934. Epub 2019/1/21.

Grantham KL, Forbes A, Hooper R, Kasza J. The relative efficiency of staircase and stepped wedge cluster randomised trial designs. Stat Methods Med Res. 2025;9622802251317613: Epub 2025/2/16.

Grantham KL, Forbes A, Hooper R, Kasza J. The staircase cluster randomised trial design: A pragmatic alternative to the stepped wedge. Stat Methods Med Res. 2023;9622802231202364: Epub 2023/11/30.

Grayling MJ, Mander AP, Wason JMS. Admissible multiarm stepped-wedge cluster randomized trial designs. Stat Med. 2019;38(7):1103–1119. Epub 2018/11/6.

Hall AJ, Inskip HM, Loik F, Day NE, O’Conor G, Bosch X, … Coursaget P. The Gambia Hepatitis Intervention Study. Cancer Res. 1987;47(21):5782–7. Epub 1987/11/1.

Harrison LJ, Chen T, Wang R. Power calculation for cross-sectional stepped wedge cluster randomized trials with variable cluster sizes. Biometrics. 2020;76(3):951–962. Epub 2019/11/4.

Hayes RJ, Moulton LH. Cluster randomised trials. 2017 (2nd ed.) Boca Raton, FL: CRC Press.

Hemming K, Carroll K, Thompson JA, Forbes AB, Taljaard M, SW-CRT Review Group. Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: Crowd-sourcing systematic review. J Clin Epidemiol. 2019;107:77–88. Epub 2018/12/1.

Hemming K, Copas A, Forbes A, Kasza J. What type of cluster randomized trial for which setting? J Epidemiol Popul Health. 2024;72(1):202195: Epub 2024/2/20.

Hemming K, Eldridge S, Forbes G, Weijer C, Taljaard M. How to design efficient cluster randomised trials. BMJ. 2017;358:j3064. Epub 2017/7/16.

Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: Rationale, design, analysis, and reporting. BMJ. 2015b;350:h391. Epub 2015/2/11.

Hemming K, Kasza J, Hooper R, Forbes AB, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020;49(3):979–995. Epub 2020/2/22.

Hemming K, Lilford RJ, Girling AJ. Stepped-wedge cluster randomised controlled trials: A generic framework including parallel and multiple-level designs. Stat Med. 2015a;34(2):181–96. Epub 2014/10/24.

Hemming K, Taljaard M. Reflection on modern methods: When is a stepped-wedge cluster randomized trial a good study design choice? Int J Epidemiol. 2020;49(3):1043–1052. Epub 2020/5/9.

Hemming K, Taljaard M. Key considerations for designing, conducting and analysing a cluster randomized trial. Int J Epidemiol. 2023;52(5):1648–58. Epub 2023/5/18.

Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, … Grimshaw JM. Reporting of stepped wedge cluster randomised trials: Extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. Epub 2018/11/9.

Hemming K, Thompson JA, Kristunas C, Forbes A, Watson S, Bowden R, … Kasza J. The performance of small sample correction methods for controlling type I error when analyzing parallel cluster randomized trials: a systematic review of simulation studies. J Clin Epidemiol. 2025;185:111838: Epub 2025/5/30.

Heo M, Leon AC. Sample size requirements to detect an intervention by time interaction in longitudinal cluster randomized clinical trials. Statistics in Medicine. 2009;28(6):1017–27. Epub 2009/1/21.

Heo M, Xue X, Kim MY. Sample size requirements to detect an intervention by time interaction in longitudinal cluster randomized clinical trials with random slopes. Computational Statistics & Data Analysis. 2013;60:169–178. Epub 2013/3/6.

Hooper R, Copas A. Stepped wedge trials with continuous recruitment require new ways of thinking. J Clin Epidemiol. 2019;116:161–166. Epub 2019/6/11.

Hooper R, Forbes AB, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. BMJ. 2018;360:k1121. Epub 2018/3/20.

Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016;35(26):4718–4728. Epub 2016/6/28.

Huang S, Fiero MH, Bell ML. Generalized estimating equations in cluster randomized trials with a small number of clusters: Review of practice and simulation study. Clin Trials. 2016;13(4):445–9. Epub 2016/4/19.

Hughes JP, Granston TS, Heagerty PJ. Current issues in the design and analysis of stepped wedge trials. Contemp Clin Trials. 2015;45(Pt A):55–60. Epub 2015/8/3.

Hughes JP, Lee WY, Troxel AB, Heagerty PJ. Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention. Prev Sci. 2024;25(Suppl 3):348–55. Epub 2023/9/20.

Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91. Epub 2006/7/7.

Ivers NM, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, … Donner A. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: Review of random sample of 300 trials, 2000-8. BMJ. 2011;343:d5886. Epub 2011/9/29.

Jackson CL, Colborn K, Gao D, Rao S, Slater HC, Parikh S, … Kittelson J. Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data. Clin Trials. 2021;17407745211028581. Epub 2021/7/3.

Jahn-Eimermacher A, Ingel K, Schneider A. Sample size in cluster-randomized trials with time to event as the primary endpoint. Statistics in Medicine. 2013;32(5):739–51. Epub 2012/8/2.

Janega JB, Murray DM, Varnell SP, Blitstein JL, Birnbaum AS, Lytle LA. Assessing the most powerful analysis method for school-based intervention studies with alcohol, tobacco, and other drug outcomes. Addict Behav. 2004;29(3):595–606. Epub 2004/3/1.

Johnson JL, Kreidler SM, Catellier DJ, Murray DM, Muller KE, Glueck DH. Recommendations for choosing an analysis method that controls Type I error for unbalanced cluster sample designs with Gaussian outcomes. Statistics in Medicine. 2015;34(27):3531–45. Epub 2015/6/18.

Kahan BC, Forbes G, Ali Y, Jairath V, Bremner S, Harhay MO, … Leyrat C. Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: A review, reanalysis, and simulation study. Trials. 2016;17(1):438. Epub 2016/9/6.

Kahan B, Li F, Copas A, Harhay M. Estimands in cluster-randomized trials: choosing analyses that answer the right question. Int J Epidemiol. 2023;52(1):107–18. Epub 2022/7/15.

Kasza J, Bowden R, Forbes AB. Information content of stepped wedge designs with unequal cluster-period sizes in linear mixed models: Informing incomplete designs. Stat Med. 2021;40(7):1736–1751. Epub 2021/1/12.

Kasza J, Bowden R, Ouyang Y, Taljaard M, Forbes A. Does it decay? Obtaining decaying correlation parameter values from previously analysed cluster randomised trials. Stat Methods Med Res3. 2023;32(11):2123–34. Epub 2023/8/17.

Kasza J, Forbes AB. Inference for the treatment effect in multiple-period cluster randomised trials when random effect correlation structure is misspecified. Stat Methods Med Res. 2019b;28(10-11):3112–3122. Epub 2018/9/7.

Kasza J, Forbes AB. Information content of cluster-period cells in stepped wedge trials. Biometrics. 2019a;75(1):144–152. Epub 2018/7/23.

Kasza J, Hemming K, Hooper R, Matthews JN, Forbes AB. Impact of non-uniform correlation structure on sample size and power in multiple-period cluster randomised trials. Stat Methods Med Res. 2019a;28(3):703–716. Epub 2017/10/13.

Kasza J, Hooper R, Copas A, Forbes AB. Sample size and power calculations for open cohort longitudinal cluster randomized trials. Stat Med. 2020 Epub 2020/3/4.

Kasza J, Taljaard M, Forbes AB. Information content of stepped-wedge designs when treatment effect heterogeneity and/or implementation periods are present. Stat Med. 2019b;38(23):4686–4701. Epub 2019/7/18.

Kauermann G, Carroll RJ. A note on the efficiency of sandwich covariance matrix estimation. Journal of the American Statistical Association. 2001;96(456):1387–1396.

Kennedy-Shaffer L, Hughes MD. Sample size estimation for stratified individual and cluster randomized trials with binary outcomes. Stat Med. 2020;39(10):1489–1513. Epub 2020/1/31.

Kenny A, Voldal EC, Xia F, Heagerty PJ, Hughes JP. Analysis of stepped wedge cluster randomized trials in the presence of a time-varying treatment effect. Stat Med. 2022;41(22):4311–39. Epub 2022/6/30.

Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowitz ZT, Sakhadeo UR, … Glueck DH. GLIMMPSE: Online power computation for linear models with and without a baseline covariate. Journal of Statistical Software. 2013;54(10): Epub 2014/1/10.

Kristunas CA, Smith KL, Gray LJ. An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome. Trials. 2017;18(1):109. Epub 2017/3/7.

Lauer SA, Kleinman KP, Reich NG. The effect of cluster size variability on statistical power in cluster-randomized trials. PLoS One. 2015;10(4):e0119074. Epub 2015/4/1.

Lee KJ, Li F. How Should Parallel Cluster Randomized Trials With a Baseline Period be Analyzed?-A Survey of Estimands and Common Estimators. Biom J. . 2025;67(3):e70052:

Leyrat C, Morgan KE, Leurent B, Kahan BC. Cluster randomized trials with a small number of clusters: which analyses should be used? Int J Epidemiol. 2018;47(3):1012. Epub 2018/3/27.

Leyrat C, Eldridge S, Taljaard M, Hemming K. Practical considerations for sample size calculation for cluster randomized trials. J Epidemiol Popul Health. 2024;72(1):202198:13/02/2024.

Li F. Design and analysis considerations for cohort stepped wedge cluster randomized trials with a decay correlation structure. Stat Med. 2020;39(4):438–455. Epub 2019/12/4.

Li F, Hughes JP, Hemming K, Taljaard M, Melnick ER, Heagerty PJ. Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview. Stat Methods Med Res. 2021;30(2):612–639. Epub 2020/7/6.

Li F, Lokhnygina Y, Murray DM, Heagerty PJ, DeLong ER. An evaluation of constrained randomization for the design and analysis of group-randomized trials. Statistics in Medicine. 2016;35(10):1565–79. Epub 2015/11/23.

Li F, Turner EL, Heagerty PJ, Murray DM, Vollmer WM, DeLong ER. An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes. Statistics in Medicine. 2017b;36(24):3791–3806. Epub 2017/8/9.

Li F, Wang B, Heagerty PJ. What Is a Stepped-Wedge Cluster Randomized Trial? JAMA Intern Med. 2025

Li J, Jung SH. Sample size calculation for cluster randomization trials with a time-to-event endpoint. Stat Med. 2020;39(25):3608–3623. Epub 2020/7/30.

Li P, Redden DT. Small sample performance of bias-corrected sandwich estimators for cluster-randomized trials with binary outcomes. Stat Med. 2015;34(2):281–96. Epub 2014/10/24.

Li F, Tong G. Sample size and power considerations for cluster randomized trials with count outcomes subject to right truncation. Biom J. 2021;63(5):1052–71. Epub 2021/3/23.

Liu J, Xiong C, Liu L, Wang G, Jingqin L, Gao F, … Li Y. Relative efficiency of equal versus unequal cluster sizes in cluster randomized trials with a small number of clusters. J Biopharm Stat. 2021;31(2):191–206. Epub 2020/9/24.

Lu B, Preisser JS, Qaqish BF, Suchindran C, Bangdiwala SI, Wolfson M. A comparison of two bias-corrected covariance estimators for generalized estimating equations. Biometrics. 2007;63(3):935–41.

Maleyeff L, Li F, Haneuse S, Wang R. Assessing exposure-time treatment effect heterogeneity in stepped-wedge cluster randomized trials. Biometrics. 2023;79(3):2551–64. Epub 2022/12/8.

Mancl LA, DeRouen TA. A covariance estimator for GEE with improved small-sample properties. Biometrics. 2001;57(1):126–34.

Martin JT, Taljaard M, Girling AJ, Hemming K. Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials. BMJ Open. 2016;6(2):e010166. Epub 2016/2/6.

Martin JT, Hemming K, Girling AJ. The impact of varying cluster size in cross-sectional stepped-wedge cluster randomised trials. BMC Med Res Methodol. 2019;19(1):123. Epub 2019/6/14.

Matthews JN. Highly efficient stepped wedge designs for clusters of unequal size. Biometrics. 2020;76(4):1167–1176. Epub 2020/2/3.

McCaffrey DF, Bell RM. Improved hypothesis testing for coefficients in generalized estimating equations with small samples of clusters. Stat Med. 2006;25(23):4081–98.

McNeish D, Stapleton LM. Modeling clustered data with very few clusters. Multivariate Behav Res. 2016;51(4):495–518. Epub 2016/6/7.

Mdege ND, Man MS, Brown CATN, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011;64(9):936–48. Epub 2011/3/16.

Moerbeek M, Teerenstra S. Power analysis of trials with multilevel data. 2016 Boca Raton: CRC Press.

Morel JG, Bokossa MC, Neerchal NK. Small sample correction for the variance of GEE estimators. Biometrical Journal. 2003;45(4):395–409.

Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, … Chaisson RE. Statistical design of THRio: A phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Clin Trials. 2007;4(2):190–9.

Moyer J, Murray DM. Further comparisons of the random coefficients model with repeated measures ANOVA in longitudinal group-randomized trials. In Joint Statistical Meetings [Virtual Conference]. 2021.

Murray DM. Design and analysis of group-randomized trials. 1998 New York: Oxford University Press.

Murray DM. Influential methods reports for group-randomized trials and related designs. Clin Trials. 2022;19(4):353–62. Epub 2022/1/8.

Murray DM. Statistical models appropriate for designs often used in group-randomized trials. Stat Med. 2001;20(9-10):1373–85. Epub 2001/5/9.

Murray DM, Blitstein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Evaluation Review. 2003;27(1):79–103. Epub 2003/2/6.

Murray DM, Blitstein JL, Hannan PJ, Baker WL, Lytle LA. Sizing a trial to alter the trajectory of health behaviours: Methods, parameter estimates, and their application. Statistics in Medicine. 2007;26(11):2297–2316. Epub 2006/10/18.

Murray DM, Hannan PJ, Pals SL, McCowen RG, Baker WL, Blitstein JL. A comparison of permutation and mixed-model regression methods for the analysis of simulated data in the context of a group-randomized trial. Statistics in Medicine. 2006;25(3):375–388. Epub 2005/9/7.

Murray DM, Pals SL, Blitstein JL, Alfano CM, Lehman J. Design and analysis of group-randomized trials in cancer: A review of current practices. Journal of the National Cancer Institute. 2008;100(7):483–491. Epub 2008/3/25.

Murray DM, Pals SL, George SM, Kuzmichev A, Lai GY, Lee J, … Nelson SM. Design and analysis of group-randomized trials in cancer: A review of current practices. Preventive Medicine. 2018;111:241–247. Epub 2018/3/16.

Murray DM, Taljaard M, Turner EL, George SM. Essential ingredients and innovations in the design and analysis of group-randomized trials. Annu Rev Public Health. 2020;41:1–19. Epub 2019/12/23.

Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: A review of recent methodological developments. American Journal of Public Health. 2004;94(3):423–432. Epub 2004/3/5.

Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Pereira Macedo JA, Meng C, … Taljaard M. Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022. Clin Trials. 2023;17407745231208397. Epub 2023/11/22.

Nickless A, Voysey M, Geddes J, Yu LM, Fanshawe TR. Mixed effects approach to the analysis of the stepped wedge cluster randomised trial-Investigating the confounding effect of time through simulation. PLoS One. 2018;13(12):e0208876. Epub 2018/12/13.

Offorha B, Walters SJ, Jacques R. Statistical analysis of publicly funded cluster randomised controlled trials: a review of the National Institute for Health Research Journals Library. Trials. 2022;23(1):115. Epub 2022/2/6.

Ouyang Y, Taljaard M, Forbes A, Li F. Maintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures. Stat Methods Med Res. 2024;9622802241248382: Epub 2024/5/29.

Pals SL, Wiegand RE, Murray DM. Ignoring the group in group-level HIV/AIDS intervention trials: A review of reported design and analytic methods. Aids. 2011;25(7):989–96. Epub 2011/4/14.

Pan W, Wall MM. Small-sample adjustments in using the sandwich variance estimator in generalized estimating equations. Stat Med. 2002;21(10):1429–41.

Peden CJ, Stephens T, Martin G, Kahan BC, Thomson A, Rivett K, … EPOCH Group. Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): A stepped-wedge cluster-randomised trial. Lancet. 2019;393(10187):2213–2221. Epub 2019/4/25.

Preisser JS, Lu B, Qaqish BF. Finite sample adjustments in estimating equations and covariance estimators for intracluster correlations. Stat Med. 2008;27(27):5764–85.

Proschan MA. On the distribution of the unpaired t-statistic with paired data. Statistics in Medicine. 1996;15(10):1059–1063. Epub 1996/5/30.

Rezaei-Darzi E, Grantham KL, Forbes G, Kasza J. Inference for the treatment effect in staircase designs with continuous outcomes: a simulation study. BMC Med Res Methodol. 2025;25(1):127. Epub 2025/5/10.

Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015b;44(3):1051–67. Epub 2015/7/13.

Rutterford C, Taljaard M, Dixon S, Copas A, Eldridge S. Reporting and methodological quality of sample size calculations in cluster randomized trials could be improved: A review. J Clin Epidemiol. 2015a;68(6):716–23. Epub 2014/12/15.

Scott JM, deCamp A, Juraska M, Fay MP, Gilbert PB. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials. Stat Methods Med Res. 2017;26(2):583–597. Epub 2014/9/29.

Simpson JM, Klar N, Donner A. Accounting for cluster randomization: A review of Primary Prevention Trials, 1990 through 1993. American Journal of Public Health. 1995;85(10):1378–1383. Epub 1995/10/1.

Snedecor GW, Cochran WM. Statistical methods. 1989 (8th ed.) Ames, IA: The Iowa State University Press.

Taljaard M, Li F, Qin B, Cui C, Zhang L, Nicholls S, … Mitchell S. Methodological challenges in pragmatic trials in Alzheimer’s disease and related dementias: Opportunities for improvement. Clin Trials. 2022;19(1):86–96. Epub 2021/11/30.

Thompson JA, Hemming K, Forbes AB, Fielding KL, Hayes RJ. Comparison of small-sample standard-error corrections for generalised estimating equations in stepped wedge cluster randomised trials with a binary outcome: A simulation study. Stat Methods Med Res. 2021;30(2):425–439. Epub 2020/9/24.

Thompson JA, Fielding KL, Davey C, Aiken AM, Hargreaves JR, Hayes RJ. Bias and inference from misspecified mixed-effect models in stepped wedge trial analysis. Stat Med. 2017;36(23):3670–3682. Epub 2017/5/28.

Thomson A, Leyrat C, Fielding KL, Hayes RJ. Cluster randomised trials with a binary outcome and a small number of clusters: comparison of individual and cluster level analysis method. BMC Med Res Methodol. 2022;22(1):222. Epub 2022/8/13.

Thompson JA, Shaw J, Watson S, Wang Y, Robinson C, Taljaard M, Hemming K. Review of the quality of reporting of statistical analysis plans for cluster randomized trials. J Clin Epidemiol. 2025;181:111726: Epub 2025/2/16.

Tong G, Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Pereira Macedo JA, … Taljaard M. A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials. Clin Trials. 2025;2025;22(1):45–56. Epub 2024/10/8.

Turner EL, Li F, Gallis JA, Prague M, Murray DM. Review of recent methodological developments in group-randomized trials: Part 1-Design. Am J Public Health. 2017a;107(6):907–915. Epub 2017/4/20.

Turner EL, Prague M, Gallis JA, Li F, Murray DM. Review of recent methodological developments in group-randomized trials: Part 2-Analysis. Am J Public Health. 2017b;107(7):1078–1086. Epub 2017/5/18.

van Breukelen GJ, Candel MJ, Berger M. Relative efficiency of unequal versus equal cluster sizes in cluster randomized and multicentre trials. Statistics in Medicine. 2007;26(13):2589–2603. Epub 2006/11/10.

Varnell SP, Murray DM, Janega JB, Blitstein JL. Design and analysis of group-randomized trials: A review of recent practices. Am J Public Health. 2004;94(3):393–9. Epub 2004/3/5.

Voldal EC, Hakhu NR, Xia F, Heagerty PJ, Hughes JP. swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis. Comput Methods Programs Biomed. 2020;;196:105514. Epub 2020/6/20.

Voldal EC, Xia F, Kenny A, Heagerty PJ, Hughes JP. Robust analysis of stepped wedge trials using composite likelihood models. Stat Med. 2024;43(17):3326–52. Epub 2024/6/4.

Wang J, Zhang S, Ahn C. Sample size calculation for count outcomes in cluster randomization trials with varying cluster sizes. Commun Stat Theory Methods. 2020;49(1):116–124. Epub 2018/12/21.

Xia F, Hughes JP, Voldal EC, Heagerty PJ. Power and sample size calculation for stepped-wedge designs with discrete outcomes. Trials. 2021;22(1):598. Epub 2021/9/6.

Xu X, Zhu H, Ahn C. Sample size considerations for stratified cluster randomization design with binary outcomes and varying cluster size. Stat Med. 2019;38(18):3395–3404. Epub 2019/4/29.

You Z, Williams OD, Aban I, Kabagambe EK, Tiwari HK, Cutter G. Relative efficiency and sample size for cluster randomized trials with variable cluster sizes. Clin Trials. 2011;8(1):27–36. Epub 2010/12/16.

Zucker DM. An analysis of variance pitfall: The fixed effects analysis in a nested design. Educational and Psychological Measurement. 1990;50(4):731–738.