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. 2000 Oct 23;2000(4):CD001481. doi: 10.1002/14651858.CD001481

Naji 1994.

Methods RCT (pragmatic randomised trial, randomised by patient) 
 Randomisation concealment: NOT CLEAR 
 Follow up: 
 ‐ providers: N/A 
 ‐ patients: DONE 
 Blinded assessment: DONE for glycated haemoglobin, Creatinine, Diabetes Health, process measures 
 NOT CLEAR for blood pressure , BMI 
 Baseline: DONE for glycated haemoglobin, Creatinine, BMI, blood pressure 
 NOT CLEAR for Diabetes Health, process measures 
 Reliable outcomes: DONE for glycated haemoglobin, Creatinine, Diabetes Health 
 NOT CLEAR for blood pressure , BMI, process measures 
 Protection against contamination: DONE
Participants A hospital clinic and general practice groups in Grampian (UK). 
 Adult patients attending 
 the clinic for at least one year and registered with any of the three general practices (Type 2 diabetes) 
 providers ‐ ? 
 (GPs + clinic staff involved in diabetes care) 
 patients ‐ 274 
 practices ‐ 1 clinic + 
 3 general practices
Interventions Intervention group: 
 Professional intervention (distribution of educational materials + reminders) + organisational intervention (arrangements for follow‐up + changes in medical record systems)
Control group: 
 Received reminders for routine appointments at the clinic (arrangements for follow‐up)
Length of intervention: 
 2 years
Outcomes PROCESS: 
 Routine diabetic care visits 
 Glycated haemoglobin 
 Blood pressure 
 Creatinine 
 Visual acuity 
 Funduscopy 
 Peripheral pulses Neurological examination 
 Feet 
 % patients that had seen a dietician 
 % patients that had seen a chiropodist
PATIENT: 
 Glycated haemoglobin 
 BMI 
 Creatinine 
 Systolic blood pressure 
 Diastolic blood pressure Diabetes health questionnaire
COSTS: 
 Annual costs per patient
Notes Not clear if the guidelines that the practices received were national or local developed 
 ‐directed at montoring and treatment 
 ‐targets: metabolic control and frequency of measurement and examination during routine visits
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear