Mazzuca 1986.

Methods	RCT
Participants	532 people with diabetes mellitus randomised intervention 263 vs control 269 Baseline risk for foot ulceration: no data provided Study setting: primary care, academic general medicine clinic in the USA Inclusion criteria: either 2 fasting blood glucose levels > 130 mg/dL or 1 > 150 mg/dL or 2‐hour value > 250 mg/dL, able to perform 2 basic self‐care tasks, no psychiatric or terminal illness, under care of an internal medicine resident, informed consent
Interventions	Intervention group: Diagnosis of educational needs according to protocol Patient education in appropriate modules of instruction by nurses and dieticians by group education using lecture, discussion and/or audio‐visual materials, demonstration, return demonstration and feedback, goal setting, and written contract on goals. Content (depending on individual educational needs): understanding diabetes, acute complications, antidiabetic medication, antihypertensive medication, diet and activity, foot care and urine testing Reinforcement by phone contact 2 and 6 weeks after instruction Control group: Usual care. Content: including routine education Adherence: 139 of 208 (67%) people needing instruction on foot care completed this
Outcomes	Primary outcomes: none reported Secondary outcomes: level of foot care knowledge
Duration and completion of follow‐up	Median interval between instruction and follow‐up measurement 11.8 to 14.3 months; 275 people completed follow‐up: intervention 135 vs control 140
Types of assessment	Level of foot care knowledge: nurse‐administered patient history following predefined learning objectives
Notes	Knowledge objectives unclear
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	High risk	Assessments were not conducted by personnel who were blind to subjects' experimental condition
Incomplete outcome data (attrition bias) All outcomes	High risk	275 of 532 people completed follow‐up (intervention 135 vs control 140). Reasons for dropping out were death (n = 30), physical or psychological incapacitation (n = 43), transfer to a senior staff physician (n = 32), relocation (n = 13), work conflict (n = 24), personal reasons (n = 45), failure to keep appointments (n = 11) and lost contact (n = 58) 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: no data provided Co‐interventions were not described Adherence: 139 of 208 (67%) people needing instruction on foot care completed this