Design, implementation, and analysis considerations for cluster-randomized trials in infection control and hospital epidemiology: A systematic review

Details

• Alternative Title:
  Infect Control Hosp Epidemiol
• Personal Author:
  O’Hara, Lyndsay M. ; Blanco, Natalia ; Leekha, Surbhi ; Stafford, Kristen A. ; Slobogean, Gerard P. ; Ludeman, Emilie ; Harris, Anthony D.
• Corporate Authors:
  CDC Prevention Epicenters Program
• Description:
  Background:
  
  In cluster-randomized trials (CRT), groups rather than individuals are randomized to interventions. The aim of this study was to present critical design, implementation, and analysis issues to consider when planning a CRT in the healthcare setting and to synthesize characteristics of published CRT in the field of healthcare epidemiology.
  
  Methods:
  
  A systematic review was conducted to identify CRT with infection control outcomes.
  
  Results:
  
  We identified the following 7 epidemiological principles: (1) identify design type and justify the use of CRT; (2) account for clustering when estimating sample size and report intraclass correlation coefficient (ICC)/coefficient of variation (CV); (3) obtain consent; (4) define level of inference; (5) consider matching and/or stratification; (6) minimize bias and/or contamination; and (7) account for clustering in the analysis. Among 44 included studies, the most common design was CRT with crossover (n = 15, 34%), followed by parallel CRT (n = 11, 25%) and stratified CRT (n = 7, 16%). Moreover, 22 studies (50%) offered justification for their use of CRT, and 20 studies (45%) demonstrated that they accounted for clustering at the design phase. Only 15 studies (34%) reported the ICC, CV, or design effect. Also, 15 studies (34%) obtained waivers of consent, and 7 (16%) sought consent at the cluster level. Only 17 studies (39%) matched or stratified at randomization, and 10 studies (23%) did not report efforts to mitigate bias and/or contamination. Finally, 29 studies (88%) accounted for clustering in their analyses.
  
  Conclusions:
  
  We must continue to improve the design and reporting of CRT to better evaluate the effectiveness of infection control interventions in the healthcare setting.
  
  
• Subjects:
  Article Cluster Analysis Epidemiologic Studies Hospitals Humans Infection Control Randomized Controlled Trials As Topic Research Report Sample Size
• Source:
  Infect Control Hosp Epidemiol. 40(6):686-692
• Pubmed ID:
  31043183
• Pubmed Central ID:
  PMC6897299
• Document Type:
  Journal Article
• Funding:
  K24 AI079040/AI/NIAID NIH HHS/United States ; U54 CK000450/CK/NCEZID CDC HHS/United States
• Volume:
  40
• Issue:
  6
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:0d9efa3df9918d8b8c9f10f5eaa6a685014631ec3a0c093211b55883dbf6923a
• Download URL:
  https://stacks.cdc.gov/view/cdc/83232/cdc_83232_DS1.pdf
• File Type:
  [PDF - 150.49 KB ]