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

Vinicor 1987.

Methods RCT (incomplete block design, randomised by resident clinic team) 
 Randomisation concealment: NOT CLEAR 
 Follow up: 
 ‐ providers: NOT CLEAR 
 ‐ patients: NOT DONE 
 Blinded assessment: DONE for fasting plasma glucose, A1Hgb, post‐prandial plasma glucose, process measures 
 NOT DONE for weight, blood pressure 
 Baseline: DONE for fasting plasma glucose, A1Hgb, weight , blood pressure, process measures 
 NOT DONE for post‐prandial plasma glucose 
 Reliable outcomes: DONE for fasting plasma glucose, A1Hgb, post‐prandial plasma glucose and the process measures fasting blood glucose and random blood glucose 
 NOT CLEAR for weight, blood pressure and other process measures 
 Protection against contamination: NOT CLEAR
unit of analysis error
Participants General medicine clinic at Wishard Memorial hospital, Indiana University Medical Center (US). 
 Physicians (residents) responsible for care of patients with diabetes. 
 994 patients were contacted, 728 agreed to participate, 532 completed baseline and 275 were reassessed post intervention for patient outcomes and 323 were reassessed for process measures (Mazzuca) (Type 1 and Type 2 diabetes). 
 Provider‐ 86 residents 
 patients ‐ 532 
 practices ‐ 1 general medicine clinic
Interventions Intervention group: 
 Professional intervention (distribution of educational materials + educational meetings + local consensus processes + audit and feedback + reminders) + organisational intervention (communication and case discussion between distant health professionals) + patient education
Control group: usual care
Length of intervention: 
 11 months 
 Follow up period for reassessment patients: 
 Average of 26 months 
 (patient education began 13 months after baseline assessment)
Outcomes PROCESS: 
 % of total clinic visits for monitoring metabolic control: 
 Fasting blood glucose 
 Random blood glucose 
 Urine test record 
 History of hypoglycaemia
% of patients for whom dietary management recommendations were followed: 
 Diet prescription 
 Calories per formula 
 Teach patient caloric limit: 
 Advise patient to minimise concentrated CHO 
 Negotiate a target weight with obese patients 
 Refer to diet clinic
% of patients for whom recommendations for monitoring chronic complications were followed on at least an annual basis 
 Visual symptoms 
 Visual acuity 
 Fundus examination 
 BUN or Creatinine 
 Foot examination 
 Discuss foot care 
 Neurologic examination 
 History of peripheral pain 
 History of urinary symptoms 
 Postural hypotension 
 Impotence (males only) 
 Blood pressure 
 Baseline electrocardiography 
 Smoking history 
 Cholesterol or triglycerides 
 Carotid and femoral bruits
PATIENT: 
 fasting plasma glucose 
 A1Hgb 
 2 hour postprandial 
 weight 
 systolic blood pressure 
 diastolic blood pressure
Notes Protocols evolved from discussions with general internists as well as review of patient baseline data 
 ‐directed at treatment and diagnostics 
 ‐targets: obesity, hyperglycemia, retinopathy, foot disease, neuropathy, and risk factors for cardiac, renal and vascular disease
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear