Cited by 29Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsHealth Policy Implementation Science

Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009

Froud, Robert, Eldridge, Sandra, Diaz Ordaz, Karla, Marinho, Valeria Coelho Catao, Donner, Allan·2012·Community Dentistry and Oral Epidemiology

Abstract

Froud R, Eldridge S, Diaz Ordaz K, Marinho VCC, Donner A. Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009. Community Dent Oral Epidemiol 2012; 40 (Suppl. 1): 3–14. © 2012 John Wiley & Sons A/S Abstract – Objectives: To assess the quality of methods and reporting of recently published cluster randomized trials (CRTs) in oral health. Methods: We searched PubMed for CRTs that included at least one oral health‐related outcome and were published from 2005 to 2009 inclusive. We developed a list of criteria for assessing trial quality and reporting. This was influenced largely by the extended CONSORT statement for CRTs but also included criteria suggested by other authors. We examined the extent to which trials were consistent with these criteria. Results: Twenty‐three trials were included in the review. In 15 (65%) trials, clustering had been accounted for in sample size calculations, and in 18 (78%) authors had accounted for clustering in analysis. Intraclass correlation coefficients (ICCs) were reported for eight (35%) trials; the outcome assessor was reported as having been blinded to allocation in 12 (52%) trials; 17 (74%) described eligibility criteria at individual level, but only nine (39%) described such criteria at cluster level. Sixteen of 20 trials (80%), in which individuals were recruited, reported that individual informed consent was obtained. Conclusions: These results suggest that the quality of recent CRTs in oral health is relatively high and appears to compare favourably with other fields. However, there remains room for improvement. Authors of future trials should endeavour to ensure sample size calculations and analyses properly account for clustering (and are reported as such), consider the potential for recruitment/identification bias at the design stage, describe the steps taken to avoid this in the final report and report observed ICCs and cluster‐level eligibility criteria.

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Crossref · 10.1111/j.1600-0528.2011.00660.x

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  • Others have assessed about 40% of cluster trials to be at risk of these types of biases; and sometimes this has been reported to be somewhat lower despite including many trials with post randomization recruitment.

    “Others have assessed about 40% of cluster trials to be at risk of these types of biases [2,7,28]; and sometimes this has been reported to be somewhat lower despite including many trials with post randomization recruitment [10,13].”

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Authors
Froud, R., Eldridge, S., Diaz Ordaz, K., Marinho, V. C. C., & Donner, A.
Affiliations
  • Queen Mary University of London (GB)
  • Western University (CA)
Corresponding author
Froud, Robert
Venue
Community Dentistry and Oral Epidemiology
Publisher
Wiley
Published
2012-02
Volume
40
Issue
s1
Pages
3-14
ISSN
  • 0301-5661 (ISSN-L)
  • 1600-0528
OpenAlex
W2127410102
Cited by
29
References
79
Citations by year
2024: 1 · 2022: 2 · 2021: 4 · 2020: 1 · 2019: 4 · 2018: 2 · 2017: 2 · 2016: 5 · 2015: 1 · 2014: 2 · 2013: 4
FWCI
0.62
Type
journal article
Language
en
Open access
closed
Locations
  • Community Dentistry And Oral Epidemiology (publishedVersion)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (submittedVersion)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords
trial quality, reporting quality, oral health research, intraclass correlation coefficient, recruitment bias, informed consent
MeSH terms
Humans, Oral Health, Research Design, Cluster Analysis, Randomized Controlled Trials as Topic, Dental Research

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