Anderson 2010.
Study characteristics | ||
Methods |
Managing the space between visits: a randomized trial of disease management for diabetes in a community health center Patient RCT, conducted in 2 community health centres (largest federally qualified health center) in Connecticut serving largely underserved Hispanic/Latino patients, USA Two arms: 1) Control (control arm) and 2) Intervention (intervention arm) |
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Participants | Control arm N: 149 Intervention arm N: 146 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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Interventions |
Control arm: None Intervention arm: 1) Case management 2) Electronic patient registry 3) Patient education 4) Promotion of self‐management |
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Outcomes | 1) Glycated haemoglobin 2) Systolic blood pressure 3) Diastolic blood pressure 4) Low‐density lipoprotein |
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Funding source | Funding for this project was provided by a grant from the Connecticut Health Foundation | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Block randomized in groups of 4 by a computerized algorithm…" |
Allocation concealment (selection bias) | Unclear risk | Not reported (block?). |
Patient's baseline characteristics (selection bias) | Low risk | Quote: "There were no significant differences in the two groups at baseline in regards to sociodemographic variables." Table and text. |
Patient's baseline outcomes (selection bias) | High risk | HbA1c (P = 0.006). |
Incomplete outcome data (attrition bias) | High risk | They state this was an intention‐to‐treat analysis, but very confusing since final numbers at month 12 do not match with those in table of outcomes at month 12. Baseline based on those randomised. Number for lost to follow‐up provided, but reasons very vague. Number lost to follow‐up much larger in intervention group. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Objective methods to obtain outcomes not described; blinding not described. |
Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match outcomes. |
Risk of contamination (other bias) | High risk | Quote: "..presence of control and intervention patients in the same clinics were additional weaknesses, which may have led to contamination." |
Other bias | Low risk | Information not available. |