Hawthorne 1997.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 113 intervention:89 control Superiority design
Participants	Pakistani Moslems with type 2 DM Inclusion criteria:: Pakistani origin with type 2 DM Exclusion criteria: Previous DM HE Spouse receiving or received DM education in the past Planning to go abroad Not in good health Diagnostic criteria: not stated—from medical history
Interventions	Number of study centres: 10 general practices and 1 hospital diabetes clinic Treatment before study: none had previous diabetes HE Intervention: 1 session of 1‐to‐1 pictorial flash cards HE (purpose of glucose monitoring, how to control blood sugar, diabetic complications and purpose of regular screening) with a trained link worker Control: not stated Provider: trained link worker
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Knowledge of diabetes Attitudes and behaviours (self‐care skills) assessed with questionnaire HbA1c Cholesterol levels Secondary outcome(s): No specified primary or secondary outcomes
Study details	Run‐in period: 6 months Study terminated before regular end (for benefit/because of adverse events): no
Publication details	Language of publication: English Funding: Central Manchester Hospitals Trust Research Grant Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To develop and evaluate a set of culturally appropriate flashcards one to one diabetes education intervention"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "patient[s] were allocated to control or intervention groups as they presented at clinics, using pre‐sealed envelopes and random number tables"
Allocation concealment (selection bias)	Low risk	Comment: sealed envelopes opened by researcher on allocation to intervention/control
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: does not mention whether participants/personnel were blinded, although unlikely to have been due to the nature of the intervention
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: does not mention whether participants/personnel were blinded, although unlikely to have been due to the nature of the intervention
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: lack of blinding unlikely to affect outcome
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: participants completing questionnaires unlikely to have been blinded
Incomplete outcome data (attrition bias) Objective outcomes	Low risk	Comment: under 5% attrition rate, roughly balanced, gives reasons overall but not for each group. ITT analysis not used?
Incomplete outcome data (attrition bias) Subjective outcomes	Low risk	Comment: under 5% attrition rate, roughly balanced, gives reasons overall but not for each group. ITT analysis not used?
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen
Other bias	Unclear risk	Comment: none