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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Hansen 2017.

Study characteristics
Methods Video consultations as add‐on to standard care among patients with type 2 diabetes not responding to standard regimens: a randomized controlled trial
RCT (NA clusters and NA providers), conducted in 1) The study was done in co‐operation between the City of Copenhagen and Bispebjerg University Hospital. Recruited participants from the outpatient department of 3 hospitals in Copenhagen, Denmark and from the local healthcare centre. Telemedicine intervention as add‐on to clinic‐based care. 2) The intervention consisted of monthly video conferences with a healthcare centre nurse via a tablet computer. In Denmark.
2 arms: 1. Control (standard clinic‐based care) (control arm) and 2. Intervention (telemedicine consultations with a nurse) (intervention arm)
Participants Control arm N: 82
Intervention arm N: 83, NA, NA
Diabetes type: 2
Mean age: 58.05 ± 10.53
% Male: 64.5
Longest follow‐up: 14 months
Interventions Control arm: (standard clinic‐based care)
Intervention arm: (telemedicine consultations with a nurse)
1) Case management
2) Electronic patient registry
3) Patient education
4) Promotion of self‐management
Outcomes Glycated haemoglobin
Harms
Funding source The study was supported by the Capital Region of Denmark and the City of Copenhagen. Furthermore, the study was supported by and by a grant from ‘Smedemester Niels Hansens og hustru Frederikkes’ Fund.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised by drawing a sealed envelope containing a number. Depending on the number, the patients were allocated to either intervention or control.
Allocation concealment (selection bias) Unclear risk Participants were randomised by drawing a sealed envelope (opaque?) containing a number. Depending on the number, the patients were allocated to either intervention or control.
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values are above 0.05 for baseline characteristics. Quote: "There were no significant differences at baseline between the control and the telemedicine group."
Patient's baseline outcomes (selection bias) Low risk Table 1. All P values are above 0.05 for baseline tests. Quote: "There were no significant differences at baseline between the control and the telemedicine group."
Incomplete outcome data (attrition bias) High risk Figure 1. 68/83 and 71/82 patients randomised completed the 14 months follow‐up in the intervention (18% lost) and the control (13% lost) group, respectively. High number for intervention group and reasons for lost not balanced between groups (14 patients discontinued in the intervention group compared to 5 in the control group). Quote: "We found 16% of the participants dropped out of the study."
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk HbA1c was objectively measured.
Selective reporting (reporting bias) Unclear risk Prospectively registered protocol. Protocol: Changes in HbA1c (time frame: baseline, 16 weeks, 32 weeks, 6 months after intervention). They do not report data for HbA1c at 16 weeks in the paper. Most secondary outcomes in the protocol are not reported in the paper.
Risk of contamination (other bias) Low risk Patient‐randomised. Usual physicians were not involved in the trial. Unlikely that control patients had telemedicine conferences.
Other bias Low risk No evidence of other risk of bias.