Olry de Labry Lima 2017.

Study characteristics
Methods	Effectiveness of an intervention to improve diabetes self‐management on clinical outcomes in patients with low educational level Clustered RCT (9 clusters and 9 providers), conducted in 1) The study was conducted in 2 general practices in the city of Granada (Andalusia, Spain). Those practices were selected because they were located in a highly deprived area. 2) A total of 9 general practitioners (GPs) in the 2 practices participated in this study. A subgroup of patients received telephone reinforcement by a member of the research team. In Spain. 2 arms: 1. Control (standard care) (control arm) and 2. Intervention (patient‐practitioner communication tool ‐DSMRS) (intervention arm)
Participants	Control arm N: 94 Intervention arm N: 90, NA, NA Diabetes type: 2 Mean age: 61.67 ± 12.02 % Male: 44.57 Longest follow‐up: 12 months
Interventions	Control arm: (standard care) Intervention arm: (patient‐practitioner communication tool‐DSMRS) 1) Clinician education 2) Clinician reminder 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management 6) Patient reminders
Outcomes	Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein
Funding source	Regional Health Ministry (Andalusia, Spain). The funder of this study had no role in study design, data analysis, data collection, data interpretation or writing of the report.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	We used computerised randomisation to allocate the GPs to the intervention or control group.
Allocation concealment (selection bias)	Low risk	Clustered RCT.
Provider's baseline characteristics (selection bias)	Unclear risk	No data reported. However, results from the multilevel analysis suggested that the variability attributable to the provider level (cluster effect) was not significant.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. All P values above 0.05 except social support at 0.05.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. All P values above 0.05.
Incomplete outcome data (attrition bias)	High risk	184 patients accepted and were recruited (90 in the intervention and 94 in the control group) and 108 participants ended the follow‐up (41.3% lost).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	The primary outcome of interest was objectively assessed (HbA1c) as well as all other outcomes of interest (SBP, DBP and LDL).
Selective reporting (reporting bias)	High risk	Retrospectively registered protocol. The protocol only includes HbA1c and not SBP, DBP and LDL as reported in the paper.
Risk of contamination (other bias)	Low risk	Clustered RCT. Randomisation was conducted at the GP (and not patient) level, which prevented potential contamination bias. Not clear if GPs allocated to different arms work in the same clinic (risk of communication). 9 physicians in 2 clinics participated in the study.
Other bias	Low risk	No evidence of other bias.