Borges 2004.

Methods	RCT
Participants	167 people with type 2 diabetes randomised: intervention 55, only RA 55, control 57 Baseline risk for foot ulceration: no data provided Baseline outcome measures: patients' behaviour assessment scores: intervention 4.7, RA 4.8, control 5.1. Foot care knowledge scores: no significant differences. Self‐efficacy scores: no significant differences Study setting: 2 community hospital emergency departments near the USA‐Mexico border Inclusion criteria: people with type 2 diabetes, age 40 years or older, residing within the country, presenting at the emergency department with non‐emergent health problems, not having active foot ulceration or other foot pathology, able to communicate verbally, agreeing on a home visit
Interventions	Intervention group: Lower extremity amputation risk assessment. Content: use of a monofilament 15‐minute foot self‐care education session by the researcher. Content: information about the patients' risk assessment score, recommendations for foot self‐care based on the individual risk score, a discussion about the barriers to optimal self‐care and an outline of the importance of daily foot self‐care Risk assessment group: lower extremity amputation risk assessment. Content: use of a monofilament Control group: No intervention Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation
Outcomes	Primary outcomes: not reported Secondary outcomes: foot care knowledge scores, patients' behaviour assessment scores (self‐reported and observed)
Duration and completion of follow‐up	1 month; 141 people completed follow‐up: intervention 47, RA 48, control 46
Types of assessment	Foot care knowledge scores: 5‐item foot care subscale from the Diabetes Knowledge Questionnaire 24 Self‐reported self‐care behaviour: SDSCA questionnaire Observed self‐care behaviour: self developed 16‐item observation guide
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	The research assistant, who was the outcome assessor, was masked to group assignment
Incomplete outcome data (attrition bias) All outcomes	High risk	141 of 167 people completed 1‐month follow‐up (intervention 47, RA 48, control 46). Dropout was balanced in numbers across intervention groups, but reasons for missing data were not reported 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	Unclear risk	Baseline risk for foot ulceration: no data provided There were no co‐interventions Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation