Methodological quality and reporting of cluster randomized controlled trials in critical care medicine: A systematic review
CCCF ePoster library. Cook D. Oct 26, 2015; 117381; P35 Disclosure(s): None
Dr. David Cook
Dr. David Cook
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Abstract
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P35


Topic: Systematic Review/Meta-analysis


Methodological quality and reporting of cluster randomized controlled trials in critical care medicine: A systematic review



David Cook, W. Rutherford, B. Cuthbertson, D. Scales, N. Adhikari

Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada | Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada | Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada | Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada | Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada

Introduction:

Compared to individual-patient randomized controlled trials, the design, conduct, and analysis of cluster randomized trials (cRCTs) often involves a loss of statistical power, bias due to lack of blinding, and unique ethical considerations. The CONSORT cRCT recommendations provide a benchmark to judge quality of reporting considering these issues.1,2



Objectives: Our objectives were to systematically review the rationale, methodological quality and reporting of cRCTs in critical care medicine, as recommended by the extended CONSORT statement.

Methods:

We systematically identified all cRCTs related to any interventions applied to adults or children in intensive care units (ICUs) using Medline, Embase, and The Cochrane Central Database of Controlled Trials (2005-present). Two reviewers independently screened studies for inclusion and abstracted data.



Results:

We screened 1072 unique citations, of which 42 cRCTs met selection criteria. Prelimary findings have shown that most studies focused on quality improvement (55.6%) or antimicrobial interventions (27.8%). Designs included parallel arm (44.4%), parallel arm with crossover (27.8%), and stepped-wedge (11.1%). In 73% of trials the unit of randomization was the ICU, 22% hospitals and regional in 5%. The planned sample size was only reported in 42% of trials, actual sample size in 89%, actual cluster size in 35%, and intra-cluster coefficient (ICC) in 26%. The median number of clusters was 13 (range, 2-131). When reported, median cluster size was 141 (range 35-1488), actual sample size was 2318 (range 143-43887), and median intracluster correlation coefficient (ICC) was 0.05 (range 0.01-0.2). Of cRCTs that reported the planned sample size, the majority (94%) reached the target.



Conclusion:

Most cRCTs in critical care have targeted quality improvement or antimicrobial interventions. The reporting of cluster trials in critical care remains suboptimal when compared to the CONSORT recommendations. In addition to the results described, important methodological details of these trials are often underreported. Data collection from this respect continues. Following completion we will present recommendations to improve the quality of cRCTs in critical care medicine.



References: 1. Consort Extension Statement. http://www.consort-statement.org/extensions (accessed online 2015/09/12)


2. Ivers NM, Taljaard M, Dixon S et al. 'Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.' BMJ (2011): 343: d5886.
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