O'Hare 2004.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: Recruited from 6 practices, I1:C1 180 (3 practices):181 (3 practices) Superiority design
Participants	Inclusion criteria: South Asian origin Type 2 DM At least 1 of the following risk factors: high BP, HbA1c > 7%; or total cholesterol > 5.0 mmol/L Exclusion criteria: not stated Diagnostic criteria: not stated
Interventions	Number of study centres: 3 practices randomly assigned to intervention and 3 practices to control clusters Treatment before study: not stated Intervention: consisted of extra weekly diabetes clinic at primary care centres (with community diabetes input and 2 link workers with language skills). Frequency of participants' exposure to the intervention has not been stated Control: usual care; practices were provided with protocols; no further resources were provided Provider: diabetes nurse specialist, practice nurse, dietician—all aided by a link worker
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): BP HbA1c Total cholesterol Secondary outcome(s): Economic evaluation (not available)
Study details	Run‐in period: not stated Study terminated before regular end: no
Publication details	Language of publication: English Funding: Pfizer; Aventis UK; Eli Lilly; NovoNordisk; Boehringer Ingleheim; Servier Laboratories UK; Takeda UK Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To test the hypothesis that enhanced diabetes care tailored to the needs of the South Asian community with type 2 DM, would improve risk factors for diabetic vascular complications and ultimately reduce morbidity and mortality"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: randomly assigned by practice, not individually; does not say how this was done
Allocation concealment (selection bias)	Unclear risk	Comment: not explained
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: does not say whether participants blinded, personnel not blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Comment: does not say whether practice personnel taking BP were blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: baseline groups similar in characteristics; 10% lost to follow‐up but does explain reasons; does not explain within‐group follow‐up data; 6 died—from which group? No ITT mentioned
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: no subjective outcomes
Selective reporting (reporting bias)	Unclear risk	Comment: study protocol not seen
Other bias	Unclear risk	Comment: none