Kinmonth 1998.
Methods | RCT (pragmatic parallel group design, randomisation by practices)
Randomisation concealment: DONE
Follow up:
‐ providers: DONE
‐ patients: NOT DONE
Blinded assessment: DONE
Baseline: DONE for BMI, blood pressure,
NOT CLEAR HbA1c, total cholesterol, triglyceride, urinary albumin/Creatinine
Reliable outcomes: DONE for laboratory outcomes
NOT CLEAR for blood pressure, BMI
Protection against contamination: DONE no unit of analysis error, because patients' results were corrected for clustering at practice level |
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Participants | 41 practices of 245 eligible practices in a health region in southern England. 245/467 of all practice teams were eligible. 360 of 522 patients were eligible for inclusion. 250 patients completed the study (Type 2 diabetes). providers ‐ 43 doctors supported by 64 nurses patients ‐ 360 practices ‐ 41 | |
Interventions | Intervention group:
Professional intervention (distribution of educational materials + educational meetings (training in patient centred care)) + patient education (booklet for patients) Control group: received no training in patient centred care but were also offered special support sessions focusing on use of guidelines and materials Length of intervention: 1 year |
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Outcomes | PROCESS:
NONE PATIENT: HbA1c Total cholesterol Triglyceride BMI Systolic blood pressure Diastolic blood pressure Urinary albumin/Creatinine Quality of life Depressed Wellbeing Wellbeing overall Subscales Depression Anxiety Energy Positive wellbeing |
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Notes | National guidelines ‐directed at monitoring and treatment ‐targets: clinical, social and psychological outcomes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |