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1.  Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities 
Trials  2010;11:54.
The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings.
Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age.
The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups.
In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects.
This paper explains the challenges of conducting randomized trials in remote settings, the importance of thorough community collaboration, and also illustrates the likelihood that some baseline variables that may be clinically important will be unevenly split in group-randomized trials when the number of groups is small.
Trial registration
This trial is registered as ISRCTN41467632.
PMCID: PMC2887856  PMID: 20465831
2.  Validation of a French language version of the Early Childhood Oral Health Impact Scale (ECOHIS) 
An English language oral health-related negative impact scale for 0–5 year old infants (the Early Childhood Oral Health Impact Scale [ECOHIS]) has recently been developed and validated. The overall aim of our study was to validate a French version of the ECOHIS. The objectives were to investigate the scale's: i) internal consistency; ii) test-retest reliability; iii) convergent validity; and iv) discriminant validity.
Data were collected from two separate samples. Firstly, from 398 parents of children aged 12 months, recruited to a community-based intervention study, and secondly from 94 parents of 0–5 year-old children attending a hospital dental clinic. In a sub-sample of 101 of the community-based group, the scale was distributed a second time two weeks after initial evaluation. Internal consistency was evaluated through generation of Cronbach's alpha, test-retest reliability through intra-class-correlation coefficients (ICC), convergent validity through comparing scale total scores with a global evaluation of oral health and discriminant validity through investigation of differences in total scale scores between the community- and clinic-based samples.
Cronbach's alpha for both the child and family impact sections was 0.79, and for the whole scale was 0.82. The ICC was 0.95. Mean ECOHIS scores for parents rating their child's oral health as "relatively poor", "good" and "very good" were 10.8, 3.4 and 2.7 respectively. In the community- and clinic-based samples, the mean ECOHIS scores were 3.7 and 4.9 respectively.
These results suggest this French language version of the ECOHIS is valid.
PMCID: PMC2245912  PMID: 18211711

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