Frosch 2011.
| Study characteristics | ||
| Methods |
Evaluation of a behavior support intervention for patients with poorly controlled diabetes Patient RCT, conducted in 3 academic primary care practices (2 internal, 1 family), 1 community‐based safety net clinic (poor/uninsured) in Los Angeles, CA area, USA Two arms: 1. Control group (control arm) and 2. Experimental group (intervention arm) |
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| Participants | Control arm N: 101 Intervention arm N: 100 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 6 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (pre: SD, post: SE) Control arm: pre 9.8 (2.1), post 9.2 (0.2) Intervention arm: pre 9.4 (1.9), post 8.9 (0.2) 2) SBP, mean mmHg (pre: SD, post: SE) Control arm: pre 127.7 (17.2), post 128.2 (1.9) Intervention arm: pre 127.6 (17.3), post 129.1 (1.9) 3) DBP, mean mmHg (pre: SD, post: SE) Control arm: pre 74.0 (10.4), post 73.6 (1.0) Intervention arm: pre 73.2 (11.6), post 74.3 (1.0) 4) LDL, mean mg/dL (pre: SD, post: SE) Control arm: pre 99.0 (34.9), post 97.3 (4.0) Intervention arm: pre 102.5 (39.3), post 106.0 (4.0) |
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| Funding source | This study was supported by grants from the RobertWood Johnson Foundation and the Foundation for Informed Medical Decision Making. Dr Mangione and Ms Ochoa also received support from the University of California, Los Angeles, Resource Centers for Minority Aging Research Center for Health Improvement of Minority Elderly (RCMAR/CHIME) under grant P30‐AG021684 from the National Institute on Aging (NIA) and National Institutes of Health (NIH). | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "…a predetermined randomization sequence." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "…sequence concealed in sealed envelopes." Envelopes opaque? |
| Patient's baseline characteristics (selection bias) | High risk | Quote: "Age (P = 0.05)". |
| Patient's baseline outcomes (selection bias) | Low risk | Quote: "HbA1c (P = 0.44); LDL (P = 0.51); SBP (P = 0.96); DBP (P = 0.60)". |
| Incomplete outcome data (attrition bias) | High risk | Although true intention‐to‐treat analysis done, numbers lost to follow‐up in reference group was much more than experimental (unreachable), and vice versa (discontinued intervention). Numbers and reasons for loss to follow‐up provided; baseline based on those randomised. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary: HbA1c measured using high performance liquid chromatography. Secondary: LDL, BP: objective methods not described. Outcome assessors were not blinded, however the authors state that "…primary outcome was a biological measure that arguably is not sensitive to unblinding", however we do not know about LDL, SBP and DBP. |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything matches. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | No evidence of other bias. |