Davis 2004.
Methods | Three‐arm cluster randomised trial (12 months follow‐up) | |
Participants | 68 general practices (1133 patients) in Tayside, Scotland, UK Mean age across the arms ranged from 49 to 50 years; 47% were male |
|
Interventions | Control: postal dissemination of a nationally developed clinical guideline Intermediate intervention: postal dissemination of guideline plus workshops and protocol documents Intensive intervention: intermediate intervention plus epilepsy nurse specialist to assist practices in the running of epilepsy review clinics |
|
Outcomes | Primary outcome (SF‐36):
Secondary outcomes (five different epilepsy‐specific instruments, all of which have been previously published):
|
|
Funding | Support from Glaxo‐Wellcome, Janssen‐Cilag, Novartis, Parke‐Davis, Sanofi, and UCB‐Pharma allowed the provision of hospitality at the workshop sessions | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated cluster‐randomisation of GP practices |
Allocation concealment (selection bias) | Low risk | A researcher not connected with the trial conducted allocation at randomisation |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | None of the GP practices (or staff), participants or assessors appeared to have been blinded. For some outcomes (from questionnaires as opposed to medical records), this may have introduced bias |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout rates were high in the trial, with only 72% completing the programme |
Selective reporting (reporting bias) | Low risk | All outcomes detailed in the Methods were reported in the results |
Other bias | Unclear risk | Power calculations and the required sample size were reported (although it is noted that the numbers of participants in each group fell short of that desired). The statistical analysis was appropriate for the cluster‐randomised design. There was no obvious possibility of contamination |
Overall risk of bias | Unclear risk | Lack of clarity regarding blinding and significant levels of dropout |