Lamers 2011.
| Study characteristics | ||
| Methods |
Treating depression in diabetes patients: dose a nurse‐administered minimal psychological intervention affect diabetes‐specific quality of life and glycaemic control? A randomized controlled trial Patient RCT, conducted in 89 primary care practices in south of the Netherlands Two arms: 1. Usual care (control arm) and 2. Minimal psychological Intervention ‐ MPI (intervention arm) |
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| Participants | Control arm N: 103 Intervention arm N: 105 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 9 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (pre: SD, post: SE) Control arm: pre 7.2 (1.4), post 7.8 (0.2) Intervention arm: pre 7.5 (1.2), post 7.3 (0.2) |
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| Funding source | This study was funded by the Netherlands Organisation for Health Research and Development (ZonMw) programme on Health Care Efficiency Research (grant number 945‐03‐047) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...by an external agency using a computerized random number generator". |
| Allocation concealment (selection bias) | High risk | Block size of 2 is too small and you can predict the sequence. |
| Patient's baseline characteristics (selection bias) | Low risk | Quote: "…shows that groups were comparable at baseline." |
| Patient's baseline outcomes (selection bias) | Low risk | HbA1c: P = 0.36. |
| Incomplete outcome data (attrition bias) | High risk | Greater number of losses in intervention group, > 20% during allocation stage after randomisation, however reasons seem balanced thereafter. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Blinding of outcome assessor not described. HbA1c: objective methods not described. |
| Selective reporting (reporting bias) | High risk | Outcomes do not match with protocol. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |