دورية أكاديمية
Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters.
| العنوان: | Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters. |
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| المؤلفون: | Golzarri-Arroyo L; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington USA. Electronic address: lgolzarr@indiana.edu., Dickinson SL; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington USA., Jamshidi-Naeini Y; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington USA., Zoh RS; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington USA., Brown AW; Department of Applied Health Science, Indiana University School of Public Health-Bloomington USA., Owora AH; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington USA., Li P; School of Nursing, University of Alabama at Birmingham USA., Oakes JM; School of Public Health, University of Minnesota USA., Allison DB; Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington USA. |
| المصدر: | Computer methods and programs in biomedicine [Comput Methods Programs Biomed] 2022 Mar; Vol. 215, pp. 106654. Date of Electronic Publication: 2022 Jan 21. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 8506513 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-7565 (Electronic) Linking ISSN: 01692607 NLM ISO Abbreviation: Comput Methods Programs Biomed Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Limerick : Elsevier Scientific Publishers Original Publication: Amsterdam : Elsevier Science Publishers, c1984- |
| مواضيع طبية MeSH: | Research Design*, Cluster Analysis ; Computer Simulation ; Humans ; Linear Models ; Sample Size |
| مستخلص: | Background: Cluster randomized controlled trials (cRCTs) are increasingly used but must be analyzed carefully. We conducted a simulation study to evaluate the validity of a parametric bootstrap (PB) approach with respect to the empirical type I error rate for a cRCT with binary outcomes and a small number of clusters. Methods: We simulated a case study with a binary (0/1) outcome, four clusters, and 100 subjects per cluster. To compare the validity of the test with respect to error rate, we simulated the same experiment with K=10, 20, and 30 clusters, each with 2,000 simulated datasets. To test the null hypothesis, we used a generalized linear mixed model including a random intercept for clusters and obtained p-values based on likelihood ratio tests (LRTs) using the parametric bootstrap method as implemented in the R package "pbkrtest". Results: The PB test produced error rates of 9.1%, 5.5%, 4.9%, and 5.0% on average across all ICC values for K=4, K=10, K=20, and K=30, respectively. The error rates were higher, ranging from 9.1% to 36.5% for K=4, in the models with singular fits (i.e., ignoring clustering) because the ICC was estimated to be zero. Conclusion: Using the parametric bootstrap for cRCTs with a small number of clusters results in inflated error rates and is not valid. Competing Interests: Declaration of Competing Interests The authors declare that they have no conflicts of interest. (Copyright © 2022 Elsevier B.V. All rights reserved.) |
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| معلومات مُعتمدة: | R25 GM141507 United States GM NIGMS NIH HHS; R25 DK099080 United States DK NIDDK NIH HHS; U24 AG056053 United States AG NIA NIH HHS; P30 AG050886 United States AG NIA NIH HHS; R25 HL124208 United States HL NHLBI NIH HHS; K12 HS026390 United States HS AHRQ HHS |
| تواريخ الأحداث: | Date Created: 20220130 Date Completed: 20220216 Latest Revision: 20230302 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC8847311 |
| DOI: | 10.1016/j.cmpb.2022.106654 |
| PMID: | 35093646 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1872-7565 |
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| DOI: | 10.1016/j.cmpb.2022.106654 |