White 2017.
Study characteristics | ||
Methods |
Clinic attendance and disengagement of young adults with type 1 diabetes after transition of care from paediatric to adult services (TrACeD): a randomised, open‐label, controlled trial RCT (NA clusters and NA providers), conducted in 1) Tertiary paediatric diabetes service at the Royal Children’s Hospital, Melbourne, VIC, Australia. 2) The intervention was delivered by appointment manager (MW), medical specialist who undertook the project as part of a research degree. In Australia. 2 arms: 1. Control (current care) (control arm) and 2. Intervention (appointment management) (intervention arm) |
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Participants | Control arm N: 60 Intervention arm N: 60, NA, NA Diabetes type: 1 Mean age: 18.8 ± 9.29 % Male: 49 Longest follow‐up: 24 months |
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Interventions |
Control arm: (current care) Intervention arm: (appointment management) 1) Case management 2) Patient education 3) Patient reminders |
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Outcomes | Glycated haemoglobin | |
Funding source | This study was funded by the Australasian Paediatric Endocrine Group and Lilly (research grant 2012) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "A statistician not directly involved in the analysis of study results prepared the randomisation schedule. We randomly assigned participants (1:1), using sequential sealed opaque envelopes, to either appointment management (intervention) or current care (control)." |
Allocation concealment (selection bias) | Low risk | "We randomly assigned participants (1:1), using sequential sealed opaque envelopes, to either appointment management (intervention) or current care (control)." |
Patient's baseline characteristics (selection bias) | Low risk | At the time of transition, baseline characteristics including mean age and glycaemic control (HbA1c) were similar between groups (Table 1). |
Patient's baseline outcomes (selection bias) | Low risk | No P values. At the time of transition, baseline characteristics including mean age and glycaemic control (HbA1c) were similar between groups (Table 1). |
Incomplete outcome data (attrition bias) | High risk | Figure: Trial profile. By 24 months, 23/60 (38%) lost in control, 28/60 (46%) lost in intervention. Reasons provided. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure HbA1c. |
Selective reporting (reporting bias) | Low risk | Prospectively registered protocol. Methods match outcomes. |
Risk of contamination (other bias) | Low risk | Patient‐randomised. Unlikely that control group received appointment management. |
Other bias | Low risk | None identified. |