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References

Displaying 1 - 240 of 240 Results
  • Alosh M, Bretz F, Huque M. Advanced multiplicity adjustment methods in clinical trials. Stat Med. 2014;33(4):693-713. Epub 2013/09/16.
    PMID: 24105821.
  • 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 2014/01/08.
    PMID: 24399701.
  • Arnup SJ, McKenzie JE, Hemming K, Pilcher D, Forbes AB. Understanding the cluster randomised crossover design: A graphical illustraton of the components of variation and a sample size tutorial. Trials. 2017;18(1):381. Epub 2017/08/15.
    PMID: 28810895.
  • 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 2015/08/19.
    PMID: 26282553.
  • Baker SG. Maximum likelihood estimation with missing outcomes: From simplicity to complexity. Stat Med. 2019;38(22):4453-4474. Epub 2019/08/08.
    PMID: 31392751.
  • Baker SG, Kramer BS. A perfect correlate does not a surrogate make. BMC Med Res Methodol. 2003;3:16.
    PMID: 12962545.
  • Baker SG, Kramer BS. Simple methods for evaluating 4 types of biomarkers: Surrogate endpoint, prognostic, predictive, and cancer screening. Biomark Insights. 2020;15:1177271920946715. Epub 2020/08/04.
    PMID: 32821082.
  • Baker SG, Kramer BS. Evaluating prognostic markers using relative utility curves and test tradeoffs. J Clin Oncol. 2015;33(23):2578-80. Epub 2015/06/29.
    PMID: 26124476.
  • Baker SG, Kramer BS, Lindeman KS. Latent class instrumental variables: A clinical and biostatistical perspective. Stat Med. 2016;35(1):147-60. Epub 2015/08/04.
    PMID: 26239275.
  • Baker SG, Lindeman KS. The paired availability design: A proposal for evaluating epidural analgesia during labor. Stat Med. 1994;13(21):2269-78.
    PMID: 7846425.
  • Baker SG, Lindeman KS, Kramer BS. The paired availability design for historical controls. BMC Med Res Methodol. 2001;1:9. Epub 2001/09/26. Erratum.
    PMID: 11602018.
  • Baldwin SA, Bauer DJ, Stice E, Rohde P. Evaluating models for partially clustered designs. Psychological Methods. 2011;16(2):149-65. Epub 2011/04/27.
    PMID: 21517179.
  • Baldwin SA, Murray DM, Shadish WR. Empirically supported treatments or type I errors? Problems with the analysis of data from group-administered treatments. J Consult Clin Psychol. 2005;73(5):924-35. Epub 2005/11/17.
    PMID: 16287392.
  • 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 2016/06/09.
    PMID: 27267471.
  • Bauer DJ, Sterba SK, Hallfors DD. Evaluating group-based interventions when control participants are ungrouped. Multivariate Behav Res. 2008;43(2):210-236. Epub 2008/04/02.
    PMID: 20396621.
  • Beidas RS, Paciotti B, Barg F, Branas AR, Brown JC, Glanz K, et al. A hybrid effectiveness-implementation trial of an evidence-based exercise intervention for breast cancer survivors. J Natl Cancer Inst Monogr. 2014;2014(50):338-45.
    PMID: 25749601.
  • 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 2020/02/07.
    PMID: 32033617.
  • Bellamy SL, Gibberd R, Hancock L, Howley P, Kennedy B, Klar N, et al. Analysis of dichotomous outcome data for community intervention studies. Stat Methods Med Res. 2000;9(2):135-59.
    PMID: 10946431.
  • Berger VW. An empirical demonstration of the need for exact tests. J Mod Appl Stat Methods. 2017;16(1):34-50.
  • Berger VW, Bejleri K, Agnor R. Comparing MTI randomization procedures to blocked randomization. Stat Med. 2016;35(5):685-94. Epub 2015/09/03.
    PMID: 26337607.
  • Berry KJ, Mielke PW, Johnston JE. Permutation statistical methods: An integrated approach. 2016 Cham, Switzerland: Springer International Publishing.
  • 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 2021/07/12.
    PMID: 34251697.
  • Birken SA, Powell BJ, Presseau J, Kirk MA, Lorencatto F, Gould NJ, et al. Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): A systematic review. Implement Sci. 2017;12(1):2. Epub 2017/01/05.
    PMID: 28057049.
  • Bor J, Moscoe E, Mutevedzi P, Newell ML, Bärnighausen T. Regression discontinuity designs in epidemiology: Causal inference without randomized trials. Epidemiology. 2014;25(5):729-37.
    PMID: 25061922.
  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, Consort NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167(1):40-47. Epub 2017/06/20.
    PMID: 28630973.
  • Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Ann Intern Med. 2008;148(4):295-309. Epub 2008/02/01.
    PMID: 18283207.
  • Bretz F, Maurer W, Brannath W, Posch M. A graphical approach to sequentially rejective multiple test procedures. Stat Med. 2009;28(4):586-604.
    PMID: 19051220.
  • Brown H, Hedeker D, Gibbons RD, Duan N, Almirall D, Gallo C, et al. Accounting for Context in Randomized Trials after Assignment. Prev Sci. 2022;23(8):1321-32. Epub 2022/09/09.
    PMID: 36083435.
  • Buyse M, Molenberghs G, Paoletti X, Oba K, Alonso A, Van der Elst W, Burzykowski T. Statistical evaluation of surrogate endpoints with examples from cancer clinical trials. Biom J. 2016;58(1):104-32. Epub 2015/02/12.
    PMID: 25682941.
  • 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 2021/02/10.
    PMID: 33581243.
  • 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 2012/09/07.
    PMID: 22951546.
  • Candel MJ, van Breukelen GJ. Varying cluster sizes in trials with clusters in one treatment arm: Sample size adjustments when testing treatment effects with linear mixed models. Statistics in Medicine. 2009;28(18):2307-24. Epub 2009/05/01.
    PMID: 19472169.
  • 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 2010/01/27.
    PMID: 20101669.
  • 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 2016/01/12.
    PMID: 26756696.
  • Candlish J, Teare MD, Dimairo M, Flight L, Mandefield L, Walters SJ. Appropriate statistical methods for analysing partially nested randomised controlled trials with continuous outcomes: a simulation study. BMC Med Res Methodol. 2018;18(1):105. Epub 2018/10/11.
    PMID: 30314463.
  • Carlbring P, Bohman S, Brunt S, Buhrman M, Westling BE, Ekselius L, Andersson G. Remote treatment of panic disorder: A randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls. Am J Psychiatry. 2006;163(12):2119-25. Epub 2006/12/08.
    PMID: 17151163.
  • 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 2014/04/05.
    PMID: 24697252.
  • Cheung K, Mitsumoto H. Evaluating personalized (N-of-1) trials in rare diseases: How much experimentation is enough? Harv Data Sci Rev. 2022;4(SI3): Epub 2022/09/08.
    PMID: 38283317.
  • Cohen J. Statistical power analysis for the behavioral sciences. 1988 (2nd ed.) New York: Academic Press.
  • Collins LM. Optimization of behavioral, biobehavioral, and biomedical interventions: The Multiphase Optimization Strategy (MOST). 2018 Cham, Switzerland: Springer International Publishing.
  • Collins LM, Kugler KC. Optimization of behavioral, biobehavioral, and biomedical interventions: Advanced topics. 2018 Cham, Switzerland: Springer International Publishing.
  • Collins LM, Kugler KC, Gwadz MV. Optimization of multicomponent behavioral and biobehavioral interventions for the prevention and treatment of HIV/AIDS. AIDS Behav. 2016;20 Suppl 1(0 1):S197-214.
    PMID: 26238037.
  • Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, et al. Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA2 five-stage study, including a workshop. Health Technol Assess. 2019;23(60):1-88.
    PMID: 31661431.
  • Cook JA, Bruckner T, MacLennan GS, Seiler CM. Clustering in surgical trials--database of intracluster correlations. Trials. 2012;13:2. Epub 2012/01/06.
    PMID: 22217216.
  • 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 2015/08/17.
    PMID: 26279154.
  • Cornfield J. Randomization by group: A formal analysis. American Journal of Epidemiology. 1978;108(2):100-102. Epub 1978/08/01.
    PMID: 707470.
  • Crespi CM. Improved designs for cluster randomized trials. Annu Rev Public Health. 2016;37:1-16. Epub 2016/01/18.
    PMID: 26789386.
  • 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. Research Support, N.I.H., Extramural. Epub 2011/03/05.
    PMID: 21382513.
  • Cully JA, Breland JY, Robertson S, Utech AE, Hundt N, Kunik ME, et al. Behavioral health coaching for rural veterans with diabetes and depression: A patient randomized effectiveness implementation trial. BMC Health Serv Res. 2014;14:191. Epub 2014/04/28.
    PMID: 24774351.
  • Curran GM, Bauer M, Mittman BS, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217-26.
    PMID: 22310560.
  • Curran GM, Landes SJ, McBain SA, Pyne JM, Smith JD, Fernandez ME, et al. Reflections on 10 years of effectiveness-implementation hybrid studies. Front Health Serv. 2022;2:1053496. Epub 2022/12/08.
    PMID: 36925811.
  • Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: A consolidated framework for advancing implementation science. Implement Sci. 2009;4:50. Epub 2009/08/07.
    PMID: 19664226.
  • Davidson KW, Cheung K, Friel C, Suls J. Introducing data sciences to N-of-1 designs, statistics, use-cases, the future, and the Moniker ‘N-of-1’ trial. Harv Data Sci Rev. 2022;4(SI3): Epub 2022/09/08.
    PMID: 38009132.
  • Davidson KW, Silverstein M, Cheung K, Paluch RA, Epstein LH. Experimental designs to optimize treatments for individuals: Personalized N-of-1 trials. JAMA Pediatr. 2021;175(4):404-409.
    PMID: 33587109.
  • 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 2014/06/05.
    PMID: 24902924.
  • 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.
    PMID: 7481187.
  • Dmitrienko A, D'Agostino RB. Multiplicity considerations in clinical trials. N Engl J Med. 2018;378(22):2115-2122.
    PMID: 29847757.
  • Donner A. An empirical study of cluster randomization. International Journal of Epidemiology. 1982;11(3):283-286. Epub 1982/09/01.
    PMID: 7129743.
  • Donner A, Birkett N, Buck C. Randomization by cluster: Sample size requirements and analysis. American Journal of Epidemiology. 1981;114(6):906-914. Epub 1981/12/01.
    PMID: 7315838.
  • 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 1990/12/01.
    PMID: 2084005.
  • 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 2006/08/24.
    PMID: 16927437.
  • Dwan K, Li T, Altman DG, Elbourne DR. CONSORT 2010 statement: Extension to randomised crossover trials. BMJ. 2019;366:l4378. Epub 2019/07/31.
    PMID: 31366597.
  • Edgington ES, Onghena P. Randomization tests. 2007 (4th ed.) Boca Raton, FL: Chapman & Hall/CRC.
  • 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.
    PMID: 30458261.
  • 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 2006/09/01.
    PMID: 16943232.
  • 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 2008/03/25.
    PMID: 18364360.
  • Eldridge S, Kerry S. A practical guide to cluster randomized trials in health research. 2012 London: Arnold.
  • Epstein LH, Dallery J. The family of single-case experimental designs. Harv Data Sci Rev. 2022;4(SI3): Epub 2022/09/08.
    PMID: 36926648.
  • Fay MP, Graubard BI. Small-sample adjustments for Wald-type tests using sandwich estimators. Biometrics. 2001;57(4):1198-206.
    PMID: 11764261.
  • Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol. 2017;69(3):506-517.
    PMID: 27723271.
  • Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. 2003 (3rd ed.) Hoboken, NJ: John Wiley & Sons, Inc.
  • 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, Pfeiffer R, Van Houwelingen HC, Carroll RJ. On meta-analytic assessment of surrogate outcomes. Biostatistics. 2000;1(3):231-46.
    PMID: 12933506.
  • 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 1996/06/15.
    PMID: 8804140.
  • 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 2015/03/09.
    PMID: 25766887.
  • 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 2016/01/07.
    PMID: 26748662.
  • 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 2018/09/12.
    PMID: 30209812.
  • Glasgow RE, Battaglia C, McCreight M, Ayele RA, Rabin BA. Making implementation science more rapid: Use of the RE-AIM framework for mid-course adaptations across five health services research projects in the Veterans Health Administration. Front Public Health. 2020;8:194. Epub 2020/05/27.
    PMID: 32528921.
  • Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: The RE-AIM framework. Am J Public Health. 1999;89(9):1322-7.
    PMID: 10474547.
  • 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 2019/01/21.
    PMID: 30663132.
  • Grayling MJ, Mander AP, Wason JMS. Admissible multiarm stepped-wedge cluster randomized trial designs. Stat Med. 2019;38(7):1103-1119. Epub 2018/11/06.
    PMID: 30402914.
  • Hall AJ, Inskip HM, Loik F, Day NE, O’Conor G, Bosch X, et al. The Gambia Hepatitis Intervention Study. Cancer Res. 1987;47(21):5782-7. Epub 1987/11/01.
    PMID: 2822233.
  • 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 2019/11/04.
    PMID: 31625596.
  • Hayes RJ, Moulton LH. Cluster randomised trials. 2017 (2nd ed.) Boca Raton, FL: CRC Press.
  • Hedges LV, Shadish WR, Natesan Batley P. Power analysis for single-case designs: Computations for (AB)(k) designs. Behav Res Methods. 2023;55(7):3494-3503. Epub 2022/10/12.
    PMID: 36223007.
  • Hedges LV, Citkowicz M. Estimating effect size when there is clustering in one treatment group. Behav Res Methods. 2015;47(4):1295-1308. Epub 2014/11/27.
    PMID: 25425393.
  • 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 2018/12/01.
    PMID: 30500405.
  • Hemming K, Eldridge S, Forbes G, Weijer C, Taljaard M. How to design efficient cluster randomised trials. BMJ. 2017;358:j3064. Epub 2017/07/16.
    PMID: 28710062.
  • 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 2015/02/11.
    PMID: 25662947.
  • 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 2020/02/22.
    PMID: 32087011.
  • 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.
    PMID: 25346484.
  • Hemming K, Taljaard M. Sample size calculations for stepped wedge and cluster randomised trials: A unified approach. J Clin Epidemiol. 2016;69:137-46. Epub 2015/09/05.
    PMID: 26344808.
  • 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 2020/05/09.
    PMID: 32386407.
  • Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, et al. Reporting of stepped wedge cluster randomised trials: Extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. Epub 2018/11/09.
    PMID: 30413417.
  • 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 2009/01/21.
    PMID: 19153969.
  • Heo M, Litwin AH, Blackstock O, Kim N, Arnsten JH. Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Stat Methods Med Res. 2017;26(1):399-413. Epub 2016/07/11.
    PMID: 25125453.
  • 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 2013/03/06.
    PMID: 23459110.
  • Herrett E, Williamson E, Brack K, Beaumont D, Perkins A, Thayne A, et al. Statin treatment and muscle symptoms: Series of randomised, placebo controlled N-of-1 trials. BMJ. 2021;372:n135. Epub 2021/02/24.
    PMID: 33627334.
  • Hilton Boon M, Craig P, Thomson H, Campbell M, Moore L. Regression discontinuity designs in health: A systematic review. Epidemiology. 2021;32(1):87-93. Epub 2020/11/30. Erratum.
    PMID: 33196561.
  • Hirano K, Imbens GW, Rubin DB, Zhou XH. Assessing the effect of an influenza vaccine in an encouragement design. Biostatistics. 2000;1(1):69-88.
    PMID: 12933526.
  • Hooper R, Copas A. Stepped wedge trials with continuous recruitment require new ways of thinking. J Clin Epidemiol. 2019;116:161-166. Epub 2019/06/11.
    PMID: 31272885.
  • 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 2018/03/20.
    PMID: 29559436.
  • 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 2016/06/28.
    PMID: 27350420.
  • Hoover DR. Clinical trials of behavioral interventions with heterogeneous teaching subgroup effects. Statistics in Medicine. 2002;21(10):1351-1364.
    PMID: 12185889.
  • 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 2016/04/19.
    PMID: 27094487.
  • 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 2015/08/03.
    PMID: 26247569.
  • 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. 2023 Epub 2023/09/20.
    PMID: 37728810.
  • Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182-91. Epub 2006/07/07.
    PMID: 16829207.
  • Ivers NM, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, et al. 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 2011/09/29.
    PMID: 21948873.
  • Jackson CL, Colborn K, Gao D, Rao S, Slater HC, Parikh S, et al. 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 2021/07/03.
    PMID: 34218684.
  • 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 2012/08/02.
    PMID: 22865817.
  • Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162. Epub 2017/12/06.
    PMID: 29207961.
  • 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 2004/03/01.
    PMID: 15050677.
  • Jeffery RW, Linde J, Finch E, Rothman AJ, King CM. A satisfaction enhancement intervention for long-term weight loss. Obesity. 2006;14(5):863-869.
    PMID: 16855196.
  • 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 2015/06/18.
    PMID: 26089186.
  • Kahan BC, Forbes G, Ali Y, Jairath V, Bremner S, Harhay MO, et al. 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 2016/09/06.
    PMID: 27600609.
  • Kahan BC, Morris TP. Assessing potential sources of clustering in individually randomised trials. BMC Med Res Methodol. 2013;13:58. Epub 2013/04/18.
    PMID: 23590245.
  • 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 2021/01/12.
    PMID: 33438255.
  • 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 2018/09/07.
    PMID: 30189794.
  • Kasza J, Forbes AB. Information content of cluster-period cells in stepped wedge trials. Biometrics. 2019a;75(1):144-152. Epub 2018/07/23.
    PMID: 30051909.
  • Kasza J, Hemming K, Hooper R, Matthews JNS, 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.
    PMID: 29027505.
  • Kasza J, Hooper R, Copas A, Forbes AB. Sample size and power calculations for open cohort longitudinal cluster randomized trials. Stat Med. 2020 Epub 2020/03/04.
    PMID: 32133688.
  • 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 2019/07/18.
    PMID: 31321806.
  • 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 2020/01/31.
    PMID: 32003492.
  • 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 2022/06/30.
    PMID: 35774016.
  • Keogh RH, Shaw PA, Gustafson P, Carroll RJ, Deffner V, Dodd KW, et al. STRATOS guidance document on measurement error and misclassification of variables in observational epidemiology: Part 1-basic theory and simple methods of adjustment. Stat Med. 2020;39(16):2197-2231. Epub 2020/04/03.
    PMID: 32246539.
  • Korn EL, Freidlin B. Surrogate and intermediate endpoints in randomized trials: What's the goal? Clin Cancer Res. 2018;24(10):2239-2240. Epub 2018/02/12.
    PMID: 29440189.
  • Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowitz ZT, Sakhadeo UR, et al. GLIMMPSE: Online power computation for linear models with and without a baseline covariate. Journal of Statistical Software. 2013;54(10): Epub 2014/01/10.
    PMID: 24403868.
  • 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 2017/03/07.
    PMID: 28270224.
  • Lai MH, Kwok OM. Estimating standardized effect sizes for two- and three-level partially nested data. Multivariate Behav Res. 2016;51(6):740-756. Epub 2016/11/01.
    PMID: 27802077.
  • Lange KM, Kasza J, Sullivan TR, Yelland LN. Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology. Clin Trials. 2023;20(2):99-110. Epub 2023/01/10.
    PMID: 36628406.
  • 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 2015/04/01.
    PMID: 25830416.
  • Lavori PW, Dawson R. A design for testing clinical strategies: biased adaptive within‐subject randomization. Journal of the Royal Statistical Society, Series A (Statistics in Society). 2000;163(1):29-38.
  • Lee KJ, Thompson SG. The use of random effects model to allow for clustering of individually randomized trials. Clinical Trials. 2005b;2(2):163-173.
    PMID: 16279138.
  • Lee KJ, Thompson SG. Clustering by health professional in individually randomised trials. BMJ. 2005a;330(7483):142-4. Epub 2005/01/15.
    PMID: 15649931.
  • Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A "SMART" design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. Epub 2011/12/12.
    PMID: 22224838.
  • 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 2018/03/27.
    PMID: 29596636.
  • 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 2019/12/04.
    PMID: 31797438.
  • 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 2020/07/06.
    PMID: 32631142.
  • 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.
    PMID: 26598212.
  • 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 2017/08/09.
    PMID: 28786223.
  • Li G, Taljaard M, Van den Heuvel ER, Levine MA, Cook DJ, Wells GA, et al. An introduction to multiplicity issues in clinical trials: The what, why, when and how. Int J Epidemiol. 2017a;46(2):746-755. Epub 2016/12/26.
    PMID: 28025257.
  • 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 2020/07/30.
    PMID: 33463748.
  • 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.
    PMID: 25345738.
  • Little RJ, D'Agostino RB, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367(14):1355-60.
    PMID: 23034025.
  • Liu J, Xiong C, Liu L, Wang G, Jingqin L, Gao F, et al. 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 2020/09/24.
    PMID: 32970522.
  • Lohr S, Schochet PZ, Sanders E. Partially nested randomized controlled trials in education research: A guide to design and analysis. 2014 Washington, DC: National Center for Educational Research, Institute of Education Sciences, U.S. Department of Education. Available at: https://ies.ed.gov/ncer/pubs/20142000/pdf/20142000.pdf.
  • 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.
    PMID: 17825023.
  • Luo W, Cappaert KJ, Ning L. Modelling partially cross-classified multilevel data. Br J Math Stat Psychol. 2015;68(2):342-62. Epub 2015/03/13.
    PMID: 25773173.
  • 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 2022/12/08.
    PMID: 36416302.
  • Mancl LA, DeRouen TA. A covariance estimator for GEE with improved small-sample properties. Biometrics. 2001;57(1):126-34.
    PMID: 11252587.
  • Manly BFJ, Navarro AJA. Randomization, bootstrap and Monte Carlo methods in biology. 2021 (4th ed.) Boca Raton, FL: CRC Press.
  • 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 2016/02/06.
    PMID: 26846897.
  • 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 2019/06/14.
    PMID: 31200640.
  • Matthews JNS. Highly efficient stepped wedge designs for clusters of unequal size. Biometrics. 2020;76(4):1167-1176. Epub 2020/02/03.
    PMID: 31961447.
  • 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.
    PMID: 16456895.
  • McNeish D, Stapleton LM. Modeling clustered data with very few clusters. Multivariate Behav Res. 2016;51(4):495-518. Epub 2016/06/07.
    PMID: 27269278.
  • 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 2011/03/16.
    PMID: 21411284.
  • Mills EJ, Chan AW, Wu P, Vail A, Guyatt GH, Altman DG. Design, analysis, and presentation of crossover trials. Trials. 2009;10:27. Epub 2009/04/30.
    PMID: 19405975.
  • Moerbeek M, Teerenstra S. Power analysis of trials with multilevel data. 2016 Boca Raton: CRC Press.
  • Moerbeek M. Optimal designs for group randomized trials and group administered treatments with outcomes at the subject and group level. Stat Methods Med Res. 2020;29(3):797-810. Epub 2019/05/01.
    PMID: 31041883.
  • Moerbeek M, Wong WK. Sample size formulae for trials comparing group and individual treatments in a multilevel model. Statistics in Medicine. 2008;27(15):2850-64. Epub 2007/10/26.
    PMID: 17960589.
  • Morel JG, Bokossa MC, Neerchal NK. Small sample correction for the variance of GEE estimators. Biometrical Journal. 2003;45(4):395-409.
  • Moscoe E, Bor J, Bärnighausen T. Regression discontinuity designs are underutilized in medicine, epidemiology, and public health: A review of current and best practice. J Clin Epidemiol. 2015;68(2):122-33.
    PMID: 25579639.
  • Moullin JC, Dickson KS, Stadnick NA, Albers B, Nilsen P, Broder-Fingert S, et al. Ten recommendations for using implementation frameworks in research and practice. Implement Sci Commun. 2020;1:42. Epub 2020/04/30.
    PMID: 32885199.
  • Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, et al. Statistical design of THRio: A phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Clin Trials. 2007;4(2):190-9.
    PMID: 17456522.
  • 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.
  • Murphy SA. An experimental design for the development of adaptive treatment strategies. Stat Med. 2005;24(10):1455-1481.
    PMID: 15586395.
  • Murray DM. Design and analysis of group-randomized trials. 1998 New York: Oxford University Press.
  • Murray DM. Statistical models appropriate for designs often used in group-randomized trials. Stat Med. 2001;20(9-10):1373-85. Epub 2001/05/09.
    PMID: 11343359.
  • Murray DM, Blitstein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Evaluation Review. 2003;27(1):79-103. Epub 2003/02/06.
    PMID: 12568061.
  • 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.
    PMID: 17044139.
  • 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 2005/09/07.
    PMID: 16143991.
  • 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 2008/03/25.
    PMID: 18364501.
  • Murray DM, Pals SL, George SM, Kuzmichev A, Lai GY, Lee J, et al. Design and analysis of group-randomized trials in cancer: A review of current practices. Preventive Medicine. 2018;111:241-247. Epub 2018/03/16.
    PMID: 29551717.
  • 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.
    PMID: 31869281.
  • 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 2004/03/05.
    PMID: 14998806.
  • Nahum-Shani I, Almirall D. An Introduction to Adaptive Interventions and SMART Designs in Education. 2019 Washington, DC: National Center for Special Education Research, Institute of Education Sciences, U.S. Department of Education. Available at: https://files.eric.ed.gov/fulltext/ED600470.pdf.
  • Naser AM, Unicomb L, Doza S, Ahmed KM, Rahman M, Uddin MN, et al. Stepped-wedge cluster-randomised controlled trial to assess the cardiovascular health effects of a managed aquifer recharge initiative to reduce drinking water salinity in southwest coastal Bangladesh: Study design and rationale. BMJ Open. 2017;7(9):e015205. Epub 2017/09/01.
    PMID: 28864689.
  • Natesan Batley P, McClure EB, Brewer B, Contractor AA, Batley NJ, Hedges LV, Chin S. Evidence and reporting standards in N-of-1 medical studies: A systematic review. Transl Psychiatry. 2023;13(1):263. Epub 2023/07/18.
    PMID: 37463877.
  • Nevins P, Ryan M, Davis-Plourde K, Ouyang Y, Pereira Macedo JA, Meng C, et al. 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 2023/11/21.
    PMID: 37990575.
  • 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.
    PMID: 30543671.
  • Oltean H, Gagnier JJ. Use of clustering analysis in randomized controlled trials in orthopaedic surgery. BMC Med Res Methodol. 2015;15:17. Epub 2015/04/19.
    PMID: 25887529.
  • Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL. Individually randomized group treatment trials: A critical appraisal of frequently used design and analytic approaches. American Journal of Public Health. 2008;98(8):1418-1424. Epub 2008/06/12. Erratum.
    PMID: 18556603.
  • 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 2011/04/14.
    PMID: 21487252.
  • Pan W, Wall MM. Small-sample adjustments in using the sandwich variance estimator in generalized estimating equations. Stat Med. 2002;21(10):1429-41.
    PMID: 12185894.
  • Peden CJ, Stephens T, Martin G, Kahan BC, Thomson A, Rivett K, et al. 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 2019/04/25.
    PMID: 31030986.
  • Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG. Reporting of noninferiority and equivalence randomized trials: Extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594-604.
    PMID: 23268518.
  • 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.
    PMID: 18680122.
  • Prentice RL. Surrogate endpoints in clinical trials: Definition and operational criteria. Stat Med. 1989;8(4):431-40.
    PMID: 2727467.
  • Proschan MA. On the distribution of the unpaired t-statistic with paired data. Statistics in Medicine. 1996;15(10):1059-1063. Epub 1996/05/30.
    PMID: 8783442.
  • Raab GM, Butcher I. Randomization inference for balanced cluster-randomized trials. Clin Trials. 2005;2(2):130-40.
    PMID: 16279135.
  • Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspect Clin Res. 2016;7(3):144-6.
    PMID: 27453832.
  • Raudenbush SW, Bryk AS. Hierarchical linear models. 2002 (2nd ed.) Thousand Oaks, CA: Sage Publications, Inc.
  • Rehal S, Morris TP, Fielding KL, Carpenter JR, Phillips PP. Non-inferiority trials: Are they inferior? A systematic review of reporting in major medical journals. BMJ Open. 2016;6(10):e012594. Epub 2016/10/07.
    PMID: 27855102.
  • Roberts C. The implications of noncompliance for randomized trials with partial nesting due to group treatment. Stat Med. 2021;40(2):349-368. Epub 2020/10/28.
    PMID: 33118193.
  • Roberts C, Batistatou E, Roberts SA. Design and analysis of trials with a partially nested design and a binary outcome measure. Stat Med. 2016;35(10):1616-36. Epub 2015/12/15.
    PMID: 26670388.
  • Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clinical Trials. 2005;2(2):152-162.
    PMID: 16279137.
  • Roberts C, Walwyn R. Design and analysis of non-pharmacological treatment trials with multiple therapists per patient. Statistics in Medicine. 2013;32(1):81-98. Epub 2012/08/02.
    PMID: 22865729.
  • Rochon J, Bhapkar M, Pieper CF, Kraus WE. Application of the marginal structural model to account for suboptimal adherence in a randomized controlled trial. Contemp Clin Trials Commun. 2016;4:222-228. Epub 2016/11/03.
    PMID: 27900372.
  • Rosenberger WF, Uschner D, Wang Y. Randomization: The forgotten component of the randomized clinical trial. Stat Med. 2019;38(1):1-12. Epub 2018/07/25.
    PMID: 30047159.
  • Rutterford C, Copas A, Eldridge S. Methods for sample size determination in cluster randomized trials. Int J Epidemiol. 2015b;44(3):1051-67. Epub 2015/07/13.
    PMID: 26174515.
  • 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.
    PMID: 25523375.
  • Samuel JP, Wootton SH, Tyson JE. N-of-1 trials: The epitome of personalized medicine? J Clin Transl Sci. 2023;7(1):e161. Epub 2023/07/03.
    PMID: 37528940.
  • 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 2014/09/29.
    PMID: 25267551.
  • Sexton M, Hebel JR. A clinical trial of change in maternal smoking and its effect on birth weight. JAMA. 1984;251(7):911-5.
    PMID: 6363731.
  • Shaw PA, Gustafson P, Carroll RJ, Deffner V, Dodd KW, Keogh RH, et al. STRATOS guidance document on measurement error and misclassification of variables in observational epidemiology: Part 2-more complex methods of adjustment and advanced topics. Stat Med. 2020;39(16):2232-2263. Epub 2020/04/03.
    PMID: 32246531.
  • Shoag J, Halpern J, Eisner B, Lee R, Mittal S, Barbieri CE, Shoag D. Efficacy of prostate-specific antigen screening: Use of regression discontinuity in the PLCO cancer screening trial. JAMA Oncol. 2015;1(7):984-6. Erratum.
    PMID: 26291583.
  • 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 1995/10/01.
    PMID: 7573621.
  • Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, et al. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: A randomized clinical trial. JAMA. 2013;309(13):1359-67.
    PMID: 23549581.
  • Smith LM, Lévesque LE, Kaufman JS, Strumpf EC. Strategies for evaluating the assumptions of the regression discontinuity design: A case study using a human papillomavirus vaccination programme. Int J Epidemiol. 2017;46(3):939-949. Epub 2016/10/08.
    PMID: 28338752.
  • Snedecor GW, Cochran WM. Statistical methods. 1989 (8th ed.) Ames, IA: The Iowa State University Press.
  • Spoelstra SL, Schueller M, Sikorskii A. Testing an implementation strategy bundle on adoption and sustainability of evidence to optimize physical function in community-dwelling disabled and older adults in a Medicaid waiver: A multi-site pragmatic hybrid type III protocol. Implement Sci. 2019;14(1):60. Epub 2019/06/13.
    PMID: 31196137.
  • Sterba SK. Partially nested designs in psychotherapy trials: A review of modeling developments. Psychother Res. 2017;27(4):425-436. Epub 2015/12/19.
    PMID: 26686878.
  • Stevens J, Mills SD, Millett TJ, Lin FC, Leeman J. Design of a dual randomized trial in a type 2 hybrid effectiveness-implementation study. Implement Sci. 2023;18(1):64. Epub 2023/11/23.
    PMID: 37996884.
  • Suls J, Alfano CM, Yap C. Personalized (N-of-1) trials for patient-centered treatments of multimorbidity. Harv Data Sci Rev. 2022;4(SI3): Epub 2022/09/08.
    PMID: 38009131.
  • Teerenstra S, Kasza J, Leontjevas R, Forbes AB. Sample size for partially nested designs and other nested or crossed designs with a continuous outcome when adjusted for baseline. Stat Med. 2023;42(19):3568-92. Epub 2023/06/22.
    PMID: 37348855.
  • 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 2020/09/24.
    PMID: 32970526.
  • 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 2017/05/28.
    PMID: 28556355.
  • Tueller S, Ramirez D, Cance JD, Ye A, Wheeler AC, Fan Z, et al. Power analysis for idiographic (within-subject) clinical trials: Implications for treatments of rare conditions and precision medicine. Behav Res Methods. 2022;1-25. Epub 2022/12/16.
    PMID: 36526885.
  • 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 2017/04/20.
    PMID: 28426295.
  • 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 2017/05/18.
    PMID: 28520480.
  • 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.
    PMID: 17094074.
  • 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 2004/03/05.
    PMID: 14998802.
  • Venkataramani AS, Bor J, Jena AB. Regression discontinuity designs in healthcare research. BMJ. 2016;352:i1216. Epub 2016/03/14.
    PMID: 26977086.
  • Vickers AJ, Van Calster B, Steyerberg EW. Net benefit approaches to the evaluation of prediction models, molecular markers, and diagnostic tests. BMJ. 2016;352:i6. Epub 2016/01/25.
    PMID: 26810254.
  • Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. J Clin Epidemiol. 2016;76:9-17. Epub 2015/08/10.
    PMID: 26272792.
  • 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 2020/06/20.
    PMID: 32554025.
  • 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.
    PMID: 31768088.
  • Wang X, Turner EL, Li F. Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations. Stat Med. 2024;43(2):358-78. Epub 2023/11/27.
    PMID: 38009329.
  • Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752-8. Epub 2013/03/22.
    PMID: 23523551.
  • 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 2021/09/06.
    PMID: 34488848.
  • 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 2019/04/29.
    PMID: 31033011.
  • 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.
    PMID: 21163852.
  • Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011;364(9):852-60.
    PMID: 21366476.
  • Zucker DM. An analysis of variance pitfall: The fixed effects analysis in a nested design. Educational and Psychological Measurement. 1990;50(4):731-738.
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