Stepped wedge cluster randomised trials: a review of the statistical methodology used and available
被引:110
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Barker, D.
[1
]
McElduff, P.
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Univ Newcastle, Sch Med & Publ Hlth, Fac Hlth, CCEB, HMRI Bldg,Level 4 West,Univ Dr, Callaghan, NSW 2308, AustraliaUniv Newcastle, Sch Med & Publ Hlth, Fac Hlth, CCEB, HMRI Bldg,Level 4 West,Univ Dr, Callaghan, NSW 2308, Australia
McElduff, P.
[1
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D'Este, C.
[1
,2
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Campbell, M. J.
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h-index: 0
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Univ Sheffield, Med Stat Grp, ScHARR, Sheffield, S Yorkshire, EnglandUniv Newcastle, Sch Med & Publ Hlth, Fac Hlth, CCEB, HMRI Bldg,Level 4 West,Univ Dr, Callaghan, NSW 2308, Australia
Campbell, M. J.
[3
]
机构:
[1] Univ Newcastle, Sch Med & Publ Hlth, Fac Hlth, CCEB, HMRI Bldg,Level 4 West,Univ Dr, Callaghan, NSW 2308, Australia
[2] Australian Natl Univ, Res Sch Populat Hlth, Natl Ctr Epidemiol & Populat Hlth, GPO Box 4, Canberra, ACT 0200, Australia
[3] Univ Sheffield, Med Stat Grp, ScHARR, Sheffield, S Yorkshire, England
Background: Previous reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used. This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials. Methods: Literature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design. Results: This review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used. Conclusions: Many studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.
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St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Dainty, Katie N.
Scales, Damon C.
论文数: 0引用数: 0
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Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Crit Care Med, Inst Clin Evaluat Sci,Interdept Div Crit Care, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Scales, Damon C.
Brooks, Steve C.
论文数: 0引用数: 0
h-index: 0
机构:
St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Brooks, Steve C.
Needham, Dale M.
论文数: 0引用数: 0
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Johns Hopkins Univ, Sch Med, Div Pulm & Crit Care Med, Baltimore, MD USA
Johns Hopkins Univ, Sch Med, Dept Phys Med & Rehabil, Baltimore, MD USASt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Needham, Dale M.
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Dorian, Paul
Ferguson, Niall
论文数: 0引用数: 0
h-index: 0
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Univ Hlth Network, Dept Med, Div Respirol, Toronto, ON, Canada
Mt Sinai Hosp, Toronto, ON M5G 1X5, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Ferguson, Niall
Rubenfeld, Gordon
论文数: 0引用数: 0
h-index: 0
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Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Crit Care Med, Inst Clin Evaluat Sci,Interdept Div Crit Care, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Rubenfeld, Gordon
Wax, Randy
论文数: 0引用数: 0
h-index: 0
机构:
Lakeridge Hlth Corp, Dept Emergency Med & Crit Care, Oshawa, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Wax, Randy
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Zwarenstein, Merrick
Thorpe, Kevin
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h-index: 0
机构:St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Thorpe, Kevin
Morrison, Laurie J.
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h-index: 0
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St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Univ Toronto, Fac Med, Div Emergency Med, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
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London Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Davey, Calum
Hargreaves, James
论文数: 0引用数: 0
h-index: 0
机构:London Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Hargreaves, James
Thompson, Jennifer A.
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机构:
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1, England
UCL, MRC Clin Trials Unit, London Hub Trials Methodol Res, London, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Thompson, Jennifer A.
Copas, Andrew J.
论文数: 0引用数: 0
h-index: 0
机构:
UCL, MRC Clin Trials Unit, London Hub Trials Methodol Res, London, England
UCL, MRC Clin Trials Unit, London, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Copas, Andrew J.
Beard, Emma
论文数: 0引用数: 0
h-index: 0
机构:
UCL, Dept Clin Educ & Hlth Psychol, London, England
UCL, Dept Epidemiol & Publ Hlth, London, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Beard, Emma
Lewis, James J.
论文数: 0引用数: 0
h-index: 0
机构:
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1, England
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, MRC Trop Epidemiol Grp, London WC1, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Lewis, James J.
Fielding, Katherine L.
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London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1, England
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, MRC Trop Epidemiol Grp, London WC1, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
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Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
De Allegri M.
Pokhrel S.
论文数: 0引用数: 0
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机构:
Health Economics Research Group (HERG), Brunel University, UxbridgeDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Pokhrel S.
Becher H.
论文数: 0引用数: 0
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机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Becher H.
Dong H.
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Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Dong H.
Mansmann U.
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Institute for Medical Informatics, Biometrics, and Epidemiology, University of Munich, MunichDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Mansmann U.
Kouyaté B.
论文数: 0引用数: 0
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机构:
Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou
Centre de Recherche en Santé de Nouna, NounaDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Kouyaté B.
Kynast-Wolf G.
论文数: 0引用数: 0
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机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Kynast-Wolf G.
Gbangou A.
论文数: 0引用数: 0
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机构:
Direction des Etudes et de la Planification, Ministère de la Santé, Ouagadougou
Centre de Recherche en Santé de Nouna, NounaDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Gbangou A.
Sanon M.
论文数: 0引用数: 0
h-index: 0
机构:
Centre de Recherche en Santé de Nouna, NounaDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Sanon M.
Bridges J.
论文数: 0引用数: 0
h-index: 0
机构:
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MDDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Bridges J.
Sauerborn R.
论文数: 0引用数: 0
h-index: 0
机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
机构:
St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Dainty, Katie N.
Scales, Damon C.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Crit Care Med, Inst Clin Evaluat Sci,Interdept Div Crit Care, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Scales, Damon C.
Brooks, Steve C.
论文数: 0引用数: 0
h-index: 0
机构:
St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Brooks, Steve C.
Needham, Dale M.
论文数: 0引用数: 0
h-index: 0
机构:
Johns Hopkins Univ, Sch Med, Div Pulm & Crit Care Med, Baltimore, MD USA
Johns Hopkins Univ, Sch Med, Dept Phys Med & Rehabil, Baltimore, MD USASt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Needham, Dale M.
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机构:
Dorian, Paul
Ferguson, Niall
论文数: 0引用数: 0
h-index: 0
机构:
Univ Hlth Network, Dept Med, Div Respirol, Toronto, ON, Canada
Mt Sinai Hosp, Toronto, ON M5G 1X5, Canada
Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Ferguson, Niall
Rubenfeld, Gordon
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toronto, Sunnybrook Hlth Sci Ctr, Dept Crit Care Med, Inst Clin Evaluat Sci,Interdept Div Crit Care, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Rubenfeld, Gordon
Wax, Randy
论文数: 0引用数: 0
h-index: 0
机构:
Lakeridge Hlth Corp, Dept Emergency Med & Crit Care, Oshawa, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Wax, Randy
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机构:
Zwarenstein, Merrick
Thorpe, Kevin
论文数: 0引用数: 0
h-index: 0
机构:St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Thorpe, Kevin
Morrison, Laurie J.
论文数: 0引用数: 0
h-index: 0
机构:
St Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
Univ Toronto, Fac Med, Div Emergency Med, Toronto, ON, CanadaSt Michaels Hosp, RESCU Res Program, Keenan Res Ctr, Li Ka Shing Knowledge Inst, Toronto, ON M5B 1W8, Canada
机构:
London Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Davey, Calum
Hargreaves, James
论文数: 0引用数: 0
h-index: 0
机构:London Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Hargreaves, James
Thompson, Jennifer A.
论文数: 0引用数: 0
h-index: 0
机构:
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1, England
UCL, MRC Clin Trials Unit, London Hub Trials Methodol Res, London, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Thompson, Jennifer A.
Copas, Andrew J.
论文数: 0引用数: 0
h-index: 0
机构:
UCL, MRC Clin Trials Unit, London Hub Trials Methodol Res, London, England
UCL, MRC Clin Trials Unit, London, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Copas, Andrew J.
Beard, Emma
论文数: 0引用数: 0
h-index: 0
机构:
UCL, Dept Clin Educ & Hlth Psychol, London, England
UCL, Dept Epidemiol & Publ Hlth, London, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Beard, Emma
Lewis, James J.
论文数: 0引用数: 0
h-index: 0
机构:
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1, England
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, MRC Trop Epidemiol Grp, London WC1, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
Lewis, James J.
Fielding, Katherine L.
论文数: 0引用数: 0
h-index: 0
机构:
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, London WC1, England
London Sch Hyg & Trop Med, Dept Infect Dis Epidemiol, MRC Trop Epidemiol Grp, London WC1, EnglandLondon Sch Hyg & Trop Med, Dept Social & Environm Hlth Res, London WC1, England
机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
De Allegri M.
Pokhrel S.
论文数: 0引用数: 0
h-index: 0
机构:
Health Economics Research Group (HERG), Brunel University, UxbridgeDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Pokhrel S.
Becher H.
论文数: 0引用数: 0
h-index: 0
机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Becher H.
Dong H.
论文数: 0引用数: 0
h-index: 0
机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Dong H.
Mansmann U.
论文数: 0引用数: 0
h-index: 0
机构:
Institute for Medical Informatics, Biometrics, and Epidemiology, University of Munich, MunichDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Mansmann U.
Kouyaté B.
论文数: 0引用数: 0
h-index: 0
机构:
Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou
Centre de Recherche en Santé de Nouna, NounaDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Kouyaté B.
Kynast-Wolf G.
论文数: 0引用数: 0
h-index: 0
机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Kynast-Wolf G.
Gbangou A.
论文数: 0引用数: 0
h-index: 0
机构:
Direction des Etudes et de la Planification, Ministère de la Santé, Ouagadougou
Centre de Recherche en Santé de Nouna, NounaDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Gbangou A.
Sanon M.
论文数: 0引用数: 0
h-index: 0
机构:
Centre de Recherche en Santé de Nouna, NounaDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Sanon M.
Bridges J.
论文数: 0引用数: 0
h-index: 0
机构:
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MDDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg
Bridges J.
Sauerborn R.
论文数: 0引用数: 0
h-index: 0
机构:
Department of Tropical Hygiene and Public Health, University of Heidelberg, HeidelbergDepartment of Tropical Hygiene and Public Health, University of Heidelberg, Heidelberg