Barth 1991.

Methods	RCT
Participants	70 patients with type 2 diabetes mellitus ‐ randomised (intervention 38 vs control 32) Baseline risk for foot ulceration: PVD, intervention 19 vs control 6. Number of foot problems: 'no significant difference between groups' Baseline outcome measures: 'No significant difference between groups' Study setting: secondary outpatient care, outpatient clinic in Australia Inclusion criteria: people with type 2 diabetes mellitus > 3 months and current treatment > 1 month, sub optimal glucose control, BMI ≥ 25, energy fat intake at least 35%, no education in previous 6 months, competence in English language
Interventions	Intervention group: Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear 4 weekly group patient education sessions of 1.5 to 2.5 hours (total 9 hours), 3 by podiatrist, 1 by psychologist on the base of cognitive motivation theory. Content: recommendations and foot care education and demonstration and practicing foot care procedures Control group: Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear Adherence: not described
Outcomes	Primary outcomes: not reported Secondary outcomes: foot care knowledge, behaviour assessment score, foot problems requiring treatment
Duration and completion of follow‐up	6 months; 62 people completed follow‐up (intervention 33 vs control 29)
Types of assessment	Outcomes measured by multiple choice questions on knowledge and compliance. Number of questions and range of outcomes not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding (performance bias and detection bias) Blinding of outcome assessors	Low risk	Foot care knowledge and foot care routine compliance were assessed with a questionnaire using multiple choice answers. Foot problems were scored by an independent podiatrist, who was not aware of the patients' experimental conditions
Incomplete outcome data (attrition bias) All outcomes	High risk	62 of 70 people completed 6 months' follow‐up (intervention 33 vs control 29). Reasons for missing outcome data are described and are unlikely to be related to the outcome No ITT analyses were undertaken
Selective reporting (reporting bias)	Low risk	No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section
Other bias	High risk	Baseline risk for foot ulceration: PVD, intervention 19 vs control 6 (P < 0.05) Number of foot problems: 'No significant difference between groups' Co‐interventions were not described Adherence to the intervention was not described