Steyn 2013.
| Study characteristics | ||
| Methods |
Implementation of national guidelines, incorporated within structured diabetes and hypertension records at primary level care in Cape Town, South Africa: a randomised controlled trial Cluster‐RCT (18 clusters), conducted in public sector primary healthcare clinics also referred to as Community Health Centres (CHCs) in Cape Town, South Africa Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 227 Intervention arm N: 229 Diabetes type: type 1 and type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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| Interventions |
Control arm: 1) Clinician education Intervention arm: 1) Clinician education 2) Clinician reminders 3) Patient education |
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| Outcomes | 1a) Retinopathy screening (opthalmoscopy), N screened (%) Control arm: pre 20 (9), post 7 (3) Intervention arm: pre 41 (18), post 31 (14) 1b) Retinopathy screening (visual acuity), N screened (%) Control arm: pre 11 (5), post 25 (12) Intervention arm: pre 14 (6), post 39 (18) 2) Foot screening, N screened (%) Control arm: pre 21 (9), post 31 (15) Intervention arm: pre 30 (13), post 62 (29) 3) HbA1c, mean % (SD) Control arm: pre 8.9 (NR), post 8.8 (NR) Intervention arm: pre 8.8 (NR), post 8.8 (NR) |
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| Funding source | The development of the protocol of the study was funded as part of the Afro‐implement project funded by the European Union. Financial support for the project was provided by the South African Medical Research Council and an unrestricted grant from the pharmaceutical company, Hoechst, Marion, Roussel. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "…randomly allocated, by stratum, to intervention or control using a computer‐generated list of random numbers." |
| Allocation concealment (selection bias) | Low risk | Not reported. But since cluster, low risk. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Mentioned in text that control group had more schooling, but no P values in table. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Do not report on HbA1c baseline differences. |
| Incomplete outcome data (attrition bias) | High risk | Overall, ~11.88% lost to follow‐up in control; ~9.6% in intervention; they provide numbers of lost to follow‐up for a sub‐sample of study participants, and reasons are not provided except that it was incomplete data collection and reason why not reported. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary for diabetics: HbA1c, objective laboratory measure was not reported. |
| Selective reporting (reporting bias) | Low risk | Matches protocol. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Low risk | Information not available. |