In cluster randomized trials, clusters of subjects are randomized rather than subjects themselves, and missing outcomes are a concern as in individual randomized trials. We assessed strategies for handling missing data when analysing cluster randomized trials with a binary outcome; strategies included complete case, adjusted complete case, and simple and multiple imputation approaches. We performed a simulation study to assess bias and coverage rate of the population-averaged intervention-effect estimate. Both multiple imputation with a random-effects logistic regression model or classical logistic regression provided unbiased estimates of the intervention effect. Both strategies also showed good coverage properties, even slightly better for multiple imputation with a random-effects logistic regression approach. Finally, this latter approach led to a slightly negatively biased intracluster correlation coefficient estimate but less than that with a classical logistic regression model strategy. We applied these strategies to a real trial randomizing households and comparing ivermectin and malathion to treat head lice.
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Univ Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA
Scharfstein, Daniel O.
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Steingrimsson, Jon
McDermott, Aidan
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Johns Hopkins Bloomberg Sch Publ Hlth, Dept Biostat, Baltimore, MD USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA
McDermott, Aidan
Wang, Chenguang
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Johns Hopkins Univ, Sch Med, Sidney Kimmel Comprehens Canc Ctr, Div Biostat & Bioinformat, Baltimore, MD USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA
Wang, Chenguang
Ray, Souvik
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Stanford Univ, Dept Stat, Stanford, CA 94305 USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA
Ray, Souvik
Campbell, Aimee
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Columbia Univ, Irving Med Ctr, Dept Psychiat, New York, NY USA
New York State Psychiat Inst & Hosp, New York, NY 10032 USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA
Campbell, Aimee
Nunes, Edward
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Columbia Univ, Irving Med Ctr, Dept Psychiat, New York, NY USA
New York State Psychiat Inst & Hosp, New York, NY 10032 USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA
Nunes, Edward
Matthews, Abigail
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EMMES Co LLC, Rockville, MD USAUniv Utah, Sch Med, Dept Populat Hlth Sci, Salt Lake City, UT 84112 USA