Donohoe 2000.

Study characteristics
Methods	Improving foot care for people with diabetes mellitus‐‐a randomized controlled trial of an integrated care approach Clustered RCT (10 clusters and 150 providers), conducted in 1) Practices from 10 towns drawn from mid and east Devon, United Kingdom. 2) A primary care team (general practitioners, practice and district nurses and chiropodists) delivered the intervention. Education of the whole primary care team was provided by one member of the foot care team. In United Kingdom. 2 arms: 1. Control (comparison group) (control arm) and 2. Intervention (integrated foot care approach) (intervention arm)
Participants	Control arm N: 958 Intervention arm N: 981, NA, NA Diabetes type: 3 Mean age: 65.76 ± 12.50 % Male: 53.51 Longest follow‐up: 12 months
Interventions	Control arm: (comparison group) 1) Clinician education Intervention arm: (integrated foot care approach) 1) Case management 2) Clinician education 3) Patient education
Outcomes	Foot screening
Funding source	Not reported
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method not reported. A pragmatic randomised controlled study was undertaken with matched cluster‐randomisation of practices from 10 towns drawn from mid and east Devon. Practices were randomised either to the intervention group for delivery of the integrated care model, or to the comparative control group.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Provider's baseline characteristics (selection bias)	Low risk	Table 2. They provided mean list size and mean number of partners in each group. Ten practices were matched on the basis of potential major general confounding variables (practice location, urbanity, distance to district general hospital, list size, number of partners). P values above 0.05.
Patient's baseline characteristics (selection bias)	Low risk	Table 2. P values provided and above 0.05.
Patient's baseline outcomes (selection bias)	Unclear risk	Table 2. They do not report foot screening data at baseline. HbA1c is not significant.
Incomplete outcome data (attrition bias)	High risk	They have foot examination data for 642/958 (33% lost) for the control group and 652/981 (34% lost) for the intervention at 1‐year follow‐up. High attrition rate. One potential problem of the study is the large number of incomplete questionnaires, approximately 40%.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	They asked to patients using a questionnaire: "Were your feet examined at annual review?" (self‐reported, subjective outcome). However, everyone appears to be blinded to the study hypothesis (alternative educational package about diabetic nephropathy was given to control group).
Selective reporting (reporting bias)	Unclear risk	No registered or published protocol. They do not report foot screening data at baseline (secondary outcome).
Risk of contamination (other bias)	Low risk	Clustered RCT. The control group of practices continued with their current foot care arrangements but also received a practice visit where an alternative educational package (diabetic nephropathy) was given. Even if no information was given about foot care to the control group, the health professionals might have changed their approach about all diabetes care aspects. Increase in knowledge was seen in patients from both intervention and control practices.
Other bias	Low risk	No evidence of other bias.