Smith 1987.
Study characteristics | ||
Methods |
A controlled trial to increase office visits and reduce hospitalizations of diabetic patients RCT (NA clusters and NA providers), conducted in 1) Regenstrief Health Center, the outpatient facility of Wishard Memorial Hospital, Indianapolis, USA. Home visits. 2) physician and nurse. In United States of America. 2 arms: 1. Control: usual care (control arm) and 2. Intervention: appointment follow‐up (intervention arm) |
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Participants | Control arm N: 429 Intervention arm N: 425, NA, NA Diabetes type: 4 Mean age: 59.45 ± 6.9 % Male: 25.55 Longest follow‐up: 24 months |
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Interventions |
Control arm: (usual care) 1) Patient education 2) Patient reminders Intervention arm: (appointment follow‐up) 1) Case management 2) Patient education 3) Promotion of self‐management 4) Patient reminders |
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Outcomes | Glycated haemoglobin Harms |
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Funding source | Supported in part by Public Health Services Research Grant P60 20542 from the National Institutes of Health and by a grant from the Robert Wood Johnson Foundation | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | After stratification, the patients were randomised to either the control or the intervention group by coin flip using a block size of 2. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | "Intervention and control groups did not differ significantly in these characteristics either", suggesting that characteristics were not significantly different at baseline. |
Patient's baseline outcomes (selection bias) | Unclear risk | "Intervention and control groups did not differ significantly in these characteristics either", suggesting that outcomes were not significantly different at baseline. |
Incomplete outcome data (attrition bias) | High risk | The number lost is 26% in each arm. The reasons are explained. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure of HbA1c and harms. |
Selective reporting (reporting bias) | Unclear risk | No published protocol, but the outcomes in the methods match the ones in the results. |
Risk of contamination (other bias) | Unclear risk | Intervention did not seem to be available to control group. |
Other bias | Low risk | None found. |