메뉴 건너뛰기




Volumn 30, Issue 3, 2021, Pages 245-250

Cutting edge or blunt instrument: How to decide if a stepped wedge design is right for you

Author keywords

accreditation; attitudes; audit and feedback

Indexed keywords

CLINICAL TRIAL (TOPIC); CLUSTER ANALYSIS; DATA ANALYSIS; HEALTH CARE QUALITY; HUMAN; METHODOLOGY; PRACTICE GUIDELINE; REVIEW; STUDY DESIGN; TOTAL QUALITY MANAGEMENT;

EID: 85092021894     PISSN: 20445415     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmjqs-2020-011620     Document Type: Review
Times cited : (19)

References (40)
  • 1
    • 33751175451 scopus 로고    scopus 로고
    • The stepped wedge trial design: A systematic review
    • Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006; 6: 54.
    • (2006) BMC Med Res Methodol , vol.6 , pp. 54
    • Brown, C.A.1    Lilford, R.J.2
  • 2
    • 79960837223 scopus 로고    scopus 로고
    • Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation
    • Mdege ND, Man M-S, Taylor Nee Brown CA, et al. 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: 936-48.
    • (2011) J Clin Epidemiol , vol.64 , pp. 936-948
    • Mdege, N.D.1    Man, M.-S.2    Taylor Nee Brown, C.A.3
  • 3
    • 84939455399 scopus 로고    scopus 로고
    • Stepped wedge randomised controlled trials: Systematic review of studies published between 2010 and 2014
    • Beard E, Lewis JJ, Copas A, et al. Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. Trials 2015; 16: 353.
    • (2015) Trials , vol.16 , pp. 353
    • Beard, E.1    Lewis, J.J.2    Copas, A.3
  • 4
    • 85007523837 scopus 로고    scopus 로고
    • Stepped wedge cluster randomised trials: A review of the statistical methodology used and
    • Barker D, McElduff P, D'Este C, et al. Stepped wedge cluster randomised trials: a review of the statistical methodology used and available. BMC Med Res Methodol 2016; 16: 69.
    • (2016) BMC Med Res Methodol , vol.16 , pp. 69
    • Barker, D.1    McElduff, P.2    D'Este, C.3
  • 5
    • 84960445799 scopus 로고    scopus 로고
    • Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials
    • Martin J, Taljaard M, Girling A, et al. Systematic review finds major deficiencies in sample size methodology and reporting for stepped-wedge cluster randomised trials. BMJ Open 2016; 6: e010166.
    • (2016) BMJ Open , vol.6 , pp. e010166
    • Martin, J.1    Taljaard, M.2    Girling, A.3
  • 6
    • 85009963239 scopus 로고    scopus 로고
    • Stepped wedge cluster randomized controlled trial designs: A review of reporting quality and design features
    • Grayling MJ, Wason JMS, Mander AP. Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features. Trials 2017; 18: 33.
    • (2017) Trials , vol.18 , pp. 33
    • Grayling, M.J.1    Wason, J.M.S.2    Mander, A.P.3
  • 7
    • 33845574387 scopus 로고    scopus 로고
    • Design and analysis of stepped wedge cluster randomized trials
    • Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials 2007; 28: 182-91.
    • (2007) Contemp Clin Trials , vol.28 , pp. 182-191
    • Hussey, M.A.1    Hughes, J.P.2
  • 8
    • 85056393991 scopus 로고    scopus 로고
    • Reporting of stepped wedge cluster randomised trials: Extension of the CONSORT 2010 statement with explanation and elaboration
    • Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ 2018; 363: k1614.
    • (2018) BMJ , vol.363 , pp. k1614
    • Hemming, K.1    Taljaard, M.2    McKenzie, J.E.3
  • 9
    • 85055626609 scopus 로고    scopus 로고
    • Precommitting to choose wisely about low-value services: A stepped wedge cluster randomised trial
    • Kullgren JT, Krupka E, Schachter A, et al. Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial. BMJ Qual Saf 2018; 27: 355-64.
    • (2018) BMJ Qual Saf , vol.27 , pp. 355-364
    • Kullgren, J.T.1    Krupka, E.2    Schachter, A.3
  • 10
    • 85078334937 scopus 로고    scopus 로고
    • Effect of hands-on interprofessional simulation training for local emergencies in Scotland: The THISTLE stepped-wedge design randomised controlled trial
    • Lenguerrand E, Winter C, Siassakos D, et al. Effect of hands-on interprofessional simulation training for local emergencies in Scotland: the THISTLE stepped-wedge design randomised controlled trial. BMJ Qual Saf 2020; 29: 122-34.
    • (2020) BMJ Qual Saf , vol.29 , pp. 122-134
    • Lenguerrand, E.1    Winter, C.2    Siassakos, D.3
  • 11
    • 84939266319 scopus 로고    scopus 로고
    • Five questions to consider before conducting a stepped wedge trial
    • Hargreaves JR, Copas AJ, Beard E, et al. Five questions to consider before conducting a stepped wedge trial. Trials 2015; 16: 350.
    • (2015) Trials , vol.16 , pp. 350
    • Hargreaves, J.R.1    Copas, A.J.2    Beard, E.3
  • 12
    • 84939420691 scopus 로고    scopus 로고
    • Logistic, ethical, and political dimensions of stepped wedge trials: Critical review and case studies
    • Prost A, Binik A, Abubakar I, et al. Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies. Trials 2015; 16: 35.
    • (2015) Trials , vol.16 , pp. 35
    • Prost, A.1    Binik, A.2    Abubakar, I.3
  • 13
    • 84903204341 scopus 로고    scopus 로고
    • International Committee of Medical Journal Editors Accessed 24 Apr 2020
    • International Committee of Medical Journal Editors. What is the ICMJE definition of a clinical trial? Available: http://www. icmje. org/about-icmje/faqs/clinical-trials-registration/ [Accessed 24 Apr 2020].
    • What Is the ICMJE Definition of A Clinical Trial?
  • 15
    • 84929484635 scopus 로고    scopus 로고
    • The stepped wedge cluster randomised trial: Rationale, design, analysis, and reporting
    • Hemming K, Haines TP, Chilton PJ, et al. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ 2015; 350: h391.
    • (2015) BMJ , vol.350 , pp. h391
    • Hemming, K.1    Haines, T.P.2    Chilton, P.J.3
  • 16
    • 84939295595 scopus 로고    scopus 로고
    • Designing a stepped wedge trial: Three main designs, carry-over effects and randomisation approaches
    • Copas AJ, Lewis JJ, Thompson JA, et al. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials 2015; 16: 352.
    • (2015) Trials , vol.16 , pp. 352
    • Copas, A.J.1    Lewis, J.J.2    Thompson, J.A.3
  • 17
    • 85056260968 scopus 로고    scopus 로고
    • Effects and costs of implementing predictive risk stratification in primary care: A randomised stepped wedge trial
    • Snooks H, Bailey-Jones K, Burge-Jones D, et al. Effects and costs of implementing predictive risk stratification in primary care: a randomised stepped wedge trial. BMJ Qual Saf 2019; 28: 697-705.
    • (2019) BMJ Qual Saf , vol.28 , pp. 697-705
    • Snooks, H.1    Bailey-Jones, K.2    Burge-Jones, D.3
  • 18
    • 85068051383 scopus 로고    scopus 로고
    • Stepped wedge trials with continuous recruitment require new ways of thinking
    • Hooper R, Copas A. Stepped wedge trials with continuous recruitment require new ways of thinking. J Clin Epidemiol 2019; 116: 161-6.
    • (2019) J Clin Epidemiol , vol.116 , pp. 161-166
    • Hooper, R.1    Copas, A.2
  • 19
    • 85028070876 scopus 로고    scopus 로고
    • Understanding the cluster randomised crossover design: A graphical illustraton of the components of variation and a sample size tutorial
    • Arnup SJ, McKenzie JE, Hemming K, et al. Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial. Trials 2017; 18: 381.
    • (2017) Trials , vol.18 , pp. 381
    • Arnup, S.J.1    McKenzie, J.E.2    Hemming, K.3
  • 20
    • 85045623347 scopus 로고    scopus 로고
    • The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: Design of the Benzodiazepine-Free cardiac anesthesia for reduction in postoperative delirium (B-free) trial
    • Spence J, Belley-Côté E, Lee SF, et al. The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free cardiac anesthesia for reduction in postoperative delirium (B-free) trial. Can J Anaesth 2018; 65: 813-21.
    • (2018) Can J Anaesth , vol.65 , pp. 813-821
    • Spence, J.1    Belley-Côté, E.2    Lee, S.F.3
  • 22
    • 84954131744 scopus 로고    scopus 로고
    • Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models
    • Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med 2016; 35: 2149-66.
    • (2016) Stat Med , vol.35 , pp. 2149-2166
    • Girling, A.J.1    Hemming, K.2
  • 23
    • 0037441919 scopus 로고    scopus 로고
    • Statistical analysis of correlated data using generalized estimating equations: An orientation
    • Hanley JA, Negassa A, Edwardes MDdeB, MDdeB E, et al. Statistical analysis of correlated data using generalized estimating equations: an orientation. Am J Epidemiol 2003; 157: 364-75.
    • (2003) Am J Epidemiol , vol.157 , pp. 364-375
    • Hanley, J.A.1    Negassa, A.2    De Edwardes, M.D.B.3    De, M.D.B.E.4
  • 24
    • 85072536470 scopus 로고    scopus 로고
    • Identifying and quantifying variation between healthcare organisations and geographical regions: Using mixed-effects models
    • Abel G, Elliott MN. Identifying and quantifying variation between healthcare organisations and geographical regions: using mixed-effects models. BMJ Qual Saf 2019; 28: 1032-8.
    • (2019) BMJ Qual Saf , vol.28 , pp. 1032-1038
    • Abel, G.1    Elliott, M.N.2
  • 25
    • 85045088882 scopus 로고    scopus 로고
    • Robust analysis of stepped wedge trials using cluster-level summaries within periods
    • Thompson JA, Davey C, Fielding K, et al. Robust analysis of stepped wedge trials using cluster-level summaries within periods. Stat Med 2018; 37: 2487-500.
    • (2018) Stat Med , vol.37 , pp. 2487-2500
    • Thompson, J.A.1    Davey, C.2    Fielding, K.3
  • 26
    • 85045642254 scopus 로고    scopus 로고
    • Impact of non-uniform correlation structure on sample size and power in multiple-period cluster randomised trials
    • Kasza J, Hemming K, Hooper R, et al. Impact of non-uniform correlation structure on sample size and power in multiple-period cluster randomised trials. Stat Methods Med Res 2019; 28: 703-16.
    • (2019) Stat Methods Med Res , vol.28 , pp. 703-716
    • Kasza, J.1    Hemming, K.2    Hooper, R.3
  • 27
    • 85077153359 scopus 로고    scopus 로고
    • Novel methods for the analysis of stepped wedge cluster randomized trials
    • Kennedy-Shaffer L, de Gruttola V, Lipsitch M. Novel methods for the analysis of stepped wedge cluster randomized trials. Stat Med 2020; 39: 815-44.
    • (2020) Stat Med , vol.39 , pp. 815-844
    • Kennedy-Shaffer, L.1    De Gruttola, V.2    Lipsitch, M.3
  • 28
    • 77950273246 scopus 로고    scopus 로고
    • CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials
    • Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869.
    • (2010) BMJ , vol.340 , pp. c869
    • Moher, D.1    Hopewell, S.2    Schulz, K.F.3
  • 29
    • 84879257038 scopus 로고    scopus 로고
    • Bias in identifying and recruiting participants in cluster randomised trials: What can be done?
    • Eldridge S, Kerry S, Torgerson DJ. Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ 2009; 339: b4006.
    • (2009) BMJ , vol.339 , pp. b4006
    • Eldridge, S.1    Kerry, S.2    Torgerson, D.J.3
  • 30
    • 84896709351 scopus 로고    scopus 로고
    • Strengths and weaknesses of a stepped wedge cluster randomized design: Its application in a colorectal cancer follow-up study
    • Zhan Z, van den Heuvel ER, Doornbos PM, et al. Strengths and weaknesses of a stepped wedge cluster randomized design: its application in a colorectal cancer follow-up study. J Clin Epidemiol 2014; 67: 454-61.
    • (2014) J Clin Epidemiol , vol.67 , pp. 454-461
    • Zhan, Z.1    Van Den Heuvel, E.R.2    Doornbos, P.M.3
  • 31
    • 84905025455 scopus 로고    scopus 로고
    • The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: A naturalistic stepped wedge study
    • Franklin BD, Reynolds M, Sadler S, et al. The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: a naturalistic stepped wedge study. BMJ Qual Saf 2014; 23: 629-38.
    • (2014) BMJ Qual Saf , vol.23 , pp. 629-638
    • Franklin, B.D.1    Reynolds, M.2    Sadler, S.3
  • 32
    • 84874735264 scopus 로고    scopus 로고
    • 'Matching Michigan': A 2-year stepped interventional programme to minimise central venous catheter-blood stream infections in intensive care units in England
    • Bion J, Richardson A, Hibbert P, et al. 'Matching Michigan': a 2-year stepped interventional programme to minimise central venous catheter-blood stream infections in intensive care units in England. BMJ Qual Saf 2013; 22: 110-23.
    • (2013) BMJ Qual Saf , vol.22 , pp. 110-123
    • Bion, J.1    Richardson, A.2    Hibbert, P.3
  • 33
    • 84959163969 scopus 로고    scopus 로고
    • The problem with Plan-Do-Study-Act cycles
    • Reed JE, Card AJ. The problem with Plan-Do-Study-Act cycles. BMJ Qual Saf 2016; 25: 147-52.
    • (2016) BMJ Qual Saf , vol.25 , pp. 147-152
    • Reed, J.E.1    Card, A.J.2
  • 34
    • 85044833141 scopus 로고    scopus 로고
    • Rigorous evaluations of evolving interventions: Can we have our cake and eat it too?
    • Burke RE, Shojania KG. Rigorous evaluations of evolving interventions: can we have our cake and eat it too? BMJ Qual Saf 2018; 27: 254-7.
    • (2018) BMJ Qual Saf , vol.27 , pp. 254-257
    • Burke, R.E.1    Shojania, K.G.2
  • 35
    • 85089126853 scopus 로고    scopus 로고
    • Reflection on modern methods: When is a stepped-wedge cluster randomized trial a good study design choice?
    • 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; 94.
    • (2020) Int J Epidemiol , vol.94
    • Hemming, K.1    Taljaard, M.2
  • 36
    • 0032499503 scopus 로고    scopus 로고
    • The intracluster correlation coefficient in cluster randomisation
    • Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ 1998; 316: 1455-60.
    • BMJ 1998; 316 , pp. 1455-1460
    • Kerry, S.M.1    Bland, J.M.2
  • 37
    • 85054779671 scopus 로고    scopus 로고
    • DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial
    • Cook JA, Julious SA, Sones W, et al. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ 2018; 363: k3750.
    • (2018) BMJ , vol.363 , pp. k3750
    • Cook, J.A.1    Julious, S.A.2    Sones, W.3
  • 38
    • 84936792327 scopus 로고    scopus 로고
    • Cluster randomised trials with repeated cross sections: Alternatives to parallel group designs
    • Hooper R, Bourke L. Cluster randomised trials with repeated cross sections: alternatives to parallel group designs. BMJ 2015; 350: h2925.
    • (2015) BMJ , vol.350 , pp. h2925
    • Hooper, R.1    Bourke, L.2
  • 39
    • 84991489598 scopus 로고    scopus 로고
    • Sample size calculation for stepped wedge and other longitudinal cluster randomised trials
    • Hooper R, Teerenstra S, de Hoop E, et al. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med 2016; 35: 4718-28.
    • (2016) Stat Med , vol.35 , pp. 4718-4728
    • Hooper, R.1    Teerenstra, S.2    De Hoop, E.3
  • 40
    • 85082935848 scopus 로고    scopus 로고
    • A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the shiny CRT calculator
    • Epub ahead of print: 22 Feb 2020
    • Hemming K, Kasza J, Hooper R, et al. 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; 94. doi: 10. 1093/ije/dyz237. [Epub ahead of print: 22 Feb 2020].
    • (2020) Int J Epidemiol , vol.94
    • Hemming, K.1    Kasza, J.2    Hooper, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.