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. 2017 Dec 21;2017(12):CD012595. doi: 10.1002/14651858.CD012595.pub2
Methods Cluster RCT
Participants Inclusion criteria: school‐going children of Davangere city who were between 6 and 15 years old
Exclusion criteria: not reported
Interventions Comparison: the effectiveness of screening programme with motivation in increasing dental registration compared to screening alone
Interventions:
1) screening and referral card supplemented with oral health education to children and motivation to parents from school authorities
(no. of clusters = 7, n = 2100) 2) received screening and referral cards (no. of clusters =7, n =2400)
Outcomes Primary outcome: response rate (dental attendance)
Duration of follow‐up: 3 months
Notes Language: English
Funded by: not mentioned
Costs of follow‐up: not reported
Conducted in: Davangere, India
Unit of randomisation: cluster
Author contact information: drmamatahebbal@yahoo.co.in
We tried contacting authors for information on results, ICC values and risk of bias assessment queries, but did not receive a reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "These twenty schools were then subjected to a two‐stage simple random sampling technique for selection of the schools. In the first stage, fourteen schools were selected out of twenty by lottery method, and in the second stage these schools were assigned randomly either to the study or control group (seven schools in each group)".
Comment: no mention of how schools were allocated to study or control group
Allocation concealment (selection bias) Unclear risk No details given
Blinding of participants and personnel (performance bias) All outcomes High risk "The response rate was calculated during the three‐month period from the date of initiation of the school screening program. During this period, the students who visited the dental college from the control group were examined, and dental findings were recorded. In order to obtain data regarding the number of children requiring treatment in the control group, a separate screening program was conducted after the waiting period of three months."
Comment: children from study group had additional interventions like free treatment and also special attention from school authorities apart from standard intervention planned.
Blinding of outcome assessment (detection bias) All outcomes Low risk Primary outcome is attendance. Quote, "were investigated by using a computer program validated to be approximately 95% accurate" .
Comment: risk of detection bias is low.
Incomplete outcome data (attrition bias) All outcomes Low risk No loss to follow‐up in the study; all participants were accounted for in the analysis.
Selective reporting (reporting bias) Low risk All pre‐stated outcomes in the methods were reported.
Other bias Low risk No other source of bias