D'Souza 2019.
| Study characteristics | ||
| Methods |
How do multi‐modality strategies affect outcomes in T2D using a randomized control trial? RCT (NA clusters and NA providers), conducted in 1) Intervention delivered in an outpatient clinic in Sultan Qaboos University Hospital. 2) Multi‐modality strategies (MMS) provided by the diabetes nurse educator (DNE). In Oman 2 arms: 1. Control (structured diabetes booklet) (control arm) and 2. Intervention (MMS: multi‐modality strategies) (intervention arm) |
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| Participants | Control arm N: 100 Intervention arm N: 100, NA, NA Diabetes type: 2 Mean age: NR ± 11 % Male: 62.14 Longest follow‐up: 6 months |
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| Interventions |
Control arm: (structured diabetes booklet) 1) Patient education Intervention arm: (MMS: multi‐modality strategies) 1) Case management 2) Patient education 3) Promotion of self‐management |
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| Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure |
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| Funding source | This study was supported by College of Nursing, Sultan Qaboos University grant (IG/SQU/CN/14/2) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A stratified block randomisation system was created using Stata's ralloc procedure to generate the blocks and later a random allocation sequence. After the adults were assigned into blocks, a simple randomisation using a random number table was performed within each block to allocate the adults to the intervention and the control group (2 arms). |
| Allocation concealment (selection bias) | Low risk | A computerized minimisation combined with allocations kept in a locked encrypted computer file sequentially numbered was undertaken by a statistician blind to practice identity to conceal randomisation sequence. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Table 1. They do not report data for all the patients randomised (only 140/200). However, all demographic characteristics have P values higher than 0.05. Quote: "The experimental and control groups did not significantly differ in demographic and clinical characteristics (Table 1 and Table 2) before the intervention." |
| Patient's baseline outcomes (selection bias) | Unclear risk | Table 2. They do not report data for all the patients randomised (only 140/200). However, all outcomes have P values higher than 0.05. Quote: "The experimental and control groups did not significantly differ in demographic and clinical characteristics (Table 1 and Table 2) before the intervention." |
| Incomplete outcome data (attrition bias) | High risk | They analysed 70 out of 100 patients randomised in each group (30% lost in each group). High numbers and reasons for loss reported and some are not balanced (discontinued intervention/study). They have randomised non‐eligible patients (n = 22). |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | HbA1c and blood pressure were objectively assessed. |
| Selective reporting (reporting bias) | High risk | Retrospectively registered protocol. They added many statistical analysis in the paper (Table 4: ANOVA between experimental and control groups, Table 5: Multivariate general linear model, Table 6: General linear model). Unclear assessment time in the protocol. |
| Risk of contamination (other bias) | Unclear risk | Patient‐randomised. All patients were followed at the same outpatient clinic in a selected hospital. Looks like the same diabetes nurse educator (DNE) met with all patients. |
| Other bias | Low risk | No evidence of other bias. |