Aljafari 2017.
| Methods |
Trial design: parallel (2 arms) Location: King's College Hospital, London, UK Number of centres: 1 Study Duration: "Recruitment took place between October 2013 and October 2014" with 3‐month follow‐up |
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| Participants |
Participants: children referred for extraction of decayed teeth under general anaesthesia Inclusion criteria: "included all healthy children scheduled for GA due to dental caries, given that they were 4–10 years of age and were accompanied by a parent/guardian with sufficient English proficiency to enable consent" Exclusion criteria: lacking English proficiency to enable consent, child having learning disability, already recruited to other research projects, legal guardian not present Age at baseline (years): intervention group: 6.76 years (SD = 1.49); control group: 6.15 (SD = 1.57) Gender: intervention group: 25 (45%) female and 30 (55%) male; control group: 23 (43%) female and 31 (57%) male Number randomised: 109; intervention group: 55; control group: 54 Number evaluated: 59 (intervention group: 28; control group: 31) |
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| Interventions | The education messages were based on the recommendations for high‐caries‐risk children in the second edition of Delivering Better Oral Health (DBOH 2009) Intervention: computer game group: the child and parent played the computer game on a touch tablet and received a copy of it on a DVD to play at home Control: one‐to‐one health educator group: the child and parent received verbal oral health education from a dental nurse with a health education qualification Prophylaxis provided: none reported Member of dental team delivering intervention: self‐administration at home for intervention group, dental nurse for control group Frequency of intervention: intervention group: 1‐off in clinic and thereafter delivered at home; control group: 1‐off intervention Intensity of intervention (length of time): not reported Setting: secondary care Disease level: high caries rate |
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| Outcomes | (1) Parent and child satisfaction with their educational intervention, scored using a 100‐mm visual analogue scale (VAS), where the highest satisfaction = 100 mm, collected immediately following delivery (2) Child's dietary knowledge, scored using a Pictorial Dietary Quiz (PDQ) (Rice 2008), taken at baseline, immediately following the educational intervention and at a 3‐month follow‐up dental visit (3) Child's dietary habits, scored by the parent using the Children's Dietary Questionnaire (CDQ) (Magarey 2009), at baseline and at a 3‐month telephone call. The CDQ has 4 parameters: fruits and vegetables; full‐fat dairy; sweetened drinks; and non‐core foods (those containing high amounts of saturated fat, added salt, or added sugars) (4) The child's self‐reported snacking and toothbrushing practices recorded in a diary that is given out on the day of the intervention and returned to the researcher at the GA visit In addition to those measures, children in the computer game group verbally reported their views on the content of the game directly to the dental nurse‐educator, who recorded it verbatim, and completed a 'Secret Password Questionnaire' that verified whether or not they had played the game at home |
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| Notes |
Funding: "The study is funded by King's College London and did not receive any external funding" Sample size calculation: "The primary outcome measure used to calculate the sample size was the participant's satisfaction with the educational intervention. This was assessed on a 100‐mm VAS. Assuming a standard deviation of 25 mm, and aiming to detect a difference of at least 15 mm between the groups, a sample of 45 participants in each group was needed to provide 80% power at the 5% significance level and to detect effects of size 0.6 and above" Adverse effects: not reported Declarations/conflicts of interest: "The authors declare that they have no competing interests" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomised using a computer‐generated grid" |
| Allocation concealment (selection bias) | Low risk | Quotes: "dental nurse‐educator allocated the participants according to the randomisation grid and administered the immediate post‐intervention measures. She also delivered the oral health education to the control group." "After the baseline measures are completed, AA will introduce the participants to the dental nurse and leave, to ensure that he remains blinded to group allocation. The nurse will then allocate the participants to either the video‐game group or the control group according to the randomization grid and will apply the intervention accordingly" Comment: allocation method unlikely to have affected outcome |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The lead author (AA) collected the baseline measures. A dental nurse‐educator allocated the participants according to the randomisation grid and administered the immediate post‐intervention measures. She also delivered the oral health education to the control group. All data were coded and anonymised. AA administered the telephone and dental follow‐up measures. He remained blinded to group allocation until after the statistical analysis was completed" Comments: dental nurse‐educators were aware of intervention allocation and provided oral health education to the control group which may have introduced bias as confirmed with author. Blinding of participants was not possible; it is unclear the influence this would have on the risk of bias for this domain |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The researcher (AA) will remain blinded all through data collection and input. The statistician will also be blinded during the analysis. Only after data collection is complete will one researcher (MTH) break the randomization code to input the group allocation within the pre‐existing data set and enable between‐group analyses. The statistician and lead researcher (AA) will remain blinded" Further information from author: "allocation was completely concealed from AA until after AA had completed the analysis. MTH had code break in safe, in an envelope until after the stats had been completed, checked and discussed with a statistician" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quotes: "Only 55% of the recruited sample completed the telephone follow‐up 3 months after the child's GA. Hence, the reported dietary improvements need to be interpreted with caution." "A sample of 45 participants in each group will be needed to provide 80 % statistical power" Comment: although this is a high disease risk and hard to reach population, the attrition rate is very high |
| Selective reporting (reporting bias) | Low risk | All outcomes listed in the pre‐published protocol were reported |
| Other bias | Low risk | Comments: no apparent other bias |