When should matching be used in the design of cluster randomized trials?
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作者:
Chondros, Patty
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Univ Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, AustraliaUniv Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, Australia
Chondros, Patty
[1
]
Ukoumunne, Obioha C.
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Univ Exeter, NIHR Appl Res Collaborat South West Peninsula Pen, Exeter, Devon, EnglandUniv Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, Australia
Ukoumunne, Obioha C.
[2
]
Gunn, Jane M.
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Univ Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, AustraliaUniv Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, Australia
Gunn, Jane M.
[1
]
Carlin, John B.
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Murdoch Childrens Res Inst, Clin Epidemiol & Biostat Unit, Melbourne, Vic, Australia
Murdoch Childrens Res Inst, Dept Paediat, Melbourne, Vic, AustraliaUniv Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, Australia
Carlin, John B.
[3
,4
]
机构:
[1] Univ Melbourne, Melbourne Med Sch, Dept Gen Practice, Melbourne, Vic, Australia
[2] Univ Exeter, NIHR Appl Res Collaborat South West Peninsula Pen, Exeter, Devon, England
[3] Murdoch Childrens Res Inst, Clin Epidemiol & Biostat Unit, Melbourne, Vic, Australia
[4] Murdoch Childrens Res Inst, Dept Paediat, Melbourne, Vic, Australia
For cluster randomized trials (CRTs) with a small number of clusters, the matched-pair (MP) design, where clusters are paired before randomizing one to each trial arm, is often recommended to minimize imbalance on known prognostic factors, add face-validity to the study, and increase efficiency, provided the analysis recognizes the matching. Little evidence exists to guide decisions on when to use matching. We used simulation to compare the efficiency of the MP design with the stratified and simple designs, based on the mean confidence interval width of the estimated intervention effect. Matched and unmatched analyses were used for the MP design; a stratified analysis was used for the stratified design; and analyses without and with post-stratification adjustment for factors that would otherwise have been used for restricted allocation were used for the simple design. Results showed the MP design was generally the most efficient for CRTs with 10 or more pairs when the correlation between cluster-level outcomes within pairs (matching correlation) was moderate to strong (0.3-0.5). There was little gain in efficiency for the MP or stratified designs compared to simple randomization when the matching correlation was weak (0.05-0.1). For trials with four pairs of clusters, the simple and stratified designs were more efficient than the MP design because greater degrees of freedom were available for the analysis, although an unmatched analysis of the MP design recovered precision for weak matching correlations. Practical guidance on choosing between the MP, stratified, and simple designs is provided.
机构:
London Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, England
CHRU Tours, INSERM, CIC 1415, Tours, FranceLondon Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, England
Leyrat, Clemence
Morgan, Katy E.
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London Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, EnglandLondon Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, England
Morgan, Katy E.
Leurent, Baptiste
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London Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, EnglandLondon Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, England
Leurent, Baptiste
Kahan, Brennan C.
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Queen Mary Univ London, Pragmat Clin Trials Unit, London, EnglandLondon Sch Hyg & Trop Med, Dept Med Stat, Keppel St, London WC1E 7HT, England
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Lab Innovat Sci Harvard, 175 N Harvard St,Suite 1350, Boston, MA 02134 USALab Innovat Sci Harvard, 175 N Harvard St,Suite 1350, Boston, MA 02134 USA
Sturdevant, S. Gwynn
Huang, Susan S.
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Univ Calif Irvine, 101 City Dr South,City Tower,Suite 400, Orange, CA 92868 USALab Innovat Sci Harvard, 175 N Harvard St,Suite 1350, Boston, MA 02134 USA
Huang, Susan S.
Platt, Richard
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Harvard Pilgrim Hlth Care Inst, 401 Pk Dr,Suite 401 East, Boston, MA 02215 USALab Innovat Sci Harvard, 175 N Harvard St,Suite 1350, Boston, MA 02134 USA
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Univ Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USAUniv Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USA
Li, Wei
Xie, Yanli
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Florida State Univ, Tallahassee, FL 32306 USAUniv Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USA
Xie, Yanli
Pham, Dung
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Western Michigan Univ, 3571 Sangren Hall, Kalamazoo, MI 49008 USA
Univ Georgia, 111 Hoke Smith Bldg, Athens, GA 30602 USAUniv Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USA
Pham, Dung
Dong, Nianbo
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Univ North Carolina Chapel Hill, 116 Peabody Hall,CB 3500, Chapel Hill, NC 27599 USAUniv Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USA
Dong, Nianbo
Spybrook, Jessaca
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Western Michigan Univ, 3571 Sangren Hall, Kalamazoo, MI 49008 USAUniv Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USA
Spybrook, Jessaca
Kelcey, Benjamin
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Univ Cincinnati, 3311B RECCENTER, Cincinnati, OH 45221 USAUniv Florida, Coll Educ, POB 117049, Gainesville, FL 32611 USA
机构:
Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, 915 Green Street, Columbia, 29208, SCDepartment of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, 915 Green Street, Columbia, 29208, SC
Chakraborty H.
Lyons G.
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Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, 915 Green Street, Columbia, 29208, SCDepartment of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, 915 Green Street, Columbia, 29208, SC
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Univ Michigan, Dept Urol, Dow Div Hlth Serv Res, Ann Arbor, MI 48109 USA
Univ Michigan, Dept Urol, Div Urol Oncol, Ann Arbor, MI 48109 USAUniv Michigan, Dept Urol, Dow Div Hlth Serv Res, Ann Arbor, MI 48109 USA
Stensland, Kristian D.
Daignault-Newton, Stephanie
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Univ Michigan, Dept Urol, Dow Div Hlth Serv Res, Ann Arbor, MI 48109 USAUniv Michigan, Dept Urol, Dow Div Hlth Serv Res, Ann Arbor, MI 48109 USA
Daignault-Newton, Stephanie
Skolarus, Ted A.
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Univ Michigan, Dept Urol, Dow Div Hlth Serv Res, Ann Arbor, MI 48109 USA
Univ Michigan, Dept Urol, Div Urol Oncol, Ann Arbor, MI 48109 USA
VA Ann Arbor Healthcare Syst, Hlth Serv Res & Dev, Ctr Clin Management Res, Ann Arbor, MI USAUniv Michigan, Dept Urol, Dow Div Hlth Serv Res, Ann Arbor, MI 48109 USA