ISRCTN63382258.
Methods | Allocation: randomised Blinding: not clearly described and tested Duration: 12 months Design: cluster randomised controlled trial Setting: Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire, and Lincolnshire, UK | |
Participants | Diagnosis:
History: EIP teams, all care coordinators and all service users in the teams
N = 26 teams, 1682 participants
Age: 18 to 56 years
Sex: both
Inclusion criteria: Initially any EIP team in Nottinghamshire, Derbyshire, and Lincolnshire and any service users under the care of a care coordinator in one of these teams, aged 18 years or above were included. Later the inclusion was broadened to any EIP team willing to participate for which some sort of follow‐up could be provided Exclusion criteria: Any EIP team that does not wish to take part, any individual care coordinator or service user within a team that does not wish to take part, any service user aged less than 18 years old at randomisation and unable to provide informed consent were excluded |
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Interventions | 1. Staff dental awareness training and dental checklist for service users. N = 882 2. Standard care. N = 800* |
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Outcomes | Primary outcome: Number of service users who have visited a dentist within 12 months of exposure to the checklist Secondary outcomes: Registered with dentist, routine check‐up within last 12 months, owning a toothbrush, cleaning teeth twice a day, non‐routine visit to a dentist in last year, replacing existing toothbrush within the last 6 months, problems with mouth and teeth, Oral Impacts on Daily Performance (OIDP). A cost analysis was also carried out, and other outcomes included whether any service users have left the EIP service for any reason, including whether they refused to give consent, were discharged to another service, or whether they had passed away |
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Notes | *Trialists assumed these numbers. Analysis suggested that clustering was unimportant, so data are presented as if individually randomised | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "we then block randomised these; the block being the number of teams within each County" Response: low risk of selection bias |
Allocation concealment (selection bias) | Unclear risk | Quote: "The Nottingham Clinical Trials Unit (CTU) created a randomisation program that was used by the researcher to randomise the EIP teams" Response: We do not know which programme was used to randomise the EIP teams |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants has not been described, but it seems that participants and examiners were aware of the interventions |
Blinding of outcome assessment (detection bias) All outcomes | High risk | There is no mention of blinding of the outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Overall the percentage with returns of the second sheet after one year was 31%" Response: Follow‐up data has been clearly reported |
Selective reporting (reporting bias) | Low risk | All stated outcomes were reported |
Other bias | Low risk | Seems to be free of other biases |