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

Miranda 2019.

Study characteristics
Methods The effect of individual and mixed rewards on diabetes management: a feasibility randomized controlled trial
RCT (NA clusters and NA providers), conducted in 1) Patients attending the outpatient clinic of the endocrinology service from Hospital Nacional Arzobispo Loayza were approached and invited into the study from July to October 2016 (15 weeks). This hospital is located in Lima, Peru’s capital, and is one of the national tertiary hospitals from the Ministry of Health. 2) Diabetes educator, nutritionist in Peru
3 arms: 1. Control (individual incentive ‐ no partner) (control arm) and 2. Intervention 1 (mixed altruism ‐ cash given to patient only) (intervention arm), 3. Intervention 2 (mixed co‐operation ‐ cash split with partner) (other arm)
Participants Control arm N: 18
Intervention arm N: 18, 18, NA
Diabetes type: 2
Mean age: 54.8 ± 0.9
% Male: 33
Longest follow‐up: 3 months
Interventions Control arm: (individual incentive ‐ no partner)
1) Patient education
2) Promotion of self‐management
3) Financial incentives
Intervention arm: (mixed altruism ‐ cash given to patient only)
1) Patient education
2) Promotion of self‐management
3) Financial incentives
Intervention arm: (mixed co‐operation ‐ cash split with partner)
1) Patient education
2) Promotion of self‐management
3) Financial incentives
Outcomes Glycated haemoglobin
Funding source This study was funded by the DFID/MRC/Wellcome Global Health Trials (MR/M007405/1 and 107435/Z/15/Z). AB‐O (103994/Z/14/Z) and JJM (074833/Z/04/Z, 205177/Z/16/Z) are supported by Wellcome Trust. JJM acknowledges receiving additional support from the Alliance for Health Policy and Systems Research (HQHSR1206660), Fogarty International Center (R21TW009982, D71TW010877), Grand Challenges Canada (0335‐04), International Development Research Center Canada (106887, 108167), Inter‐American Institute for Global Change Research (IAI CRN3036), Medical Research Council (MR/P008984/1, MR/P024408/1, MR/P02386X/1), National Cancer Institute (1P20CA217231), National Heart, Lung and Blood Institute (HHSN268200900033C, 5U01HL114180, 1UM1HL134590), National Institute of Mental Health (1U19MH098780), Swiss National Science Foundation (40P740‐160366), and the World Diabetes Foundation (WDF15‐1224)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk All participants were randomly assigned (1:1:1) to receive one of the 3 interventions using a computer‐generated list of numbers.
Allocation concealment (selection bias) Low risk For allocation concealment, participants were randomised using sequentially numbered, opaque, sealed envelopes. The sealed envelope was assigned after the patient had been recruited and all baseline measurements were completed.
Patient's baseline characteristics (selection bias) Unclear risk Table 1. No P values provided. Education looks to differ between groups.
Patient's baseline outcomes (selection bias) Low risk Table 2. P values provided and above 0.05.
Incomplete outcome data (attrition bias) High risk Figure 1. Group 1 lost 5/18 (28%), group 2 lost 5/18 (28%), group 3 lost 4/18 (22%). Reasons provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure for HbA1c.
Selective reporting (reporting bias) Unclear risk Retrospectively registered protocol; methods match outcomes. In Figure 1 it shows that a number of patients were available for analysis but only a subset was analysed for HbA1c.
Risk of contamination (other bias) Low risk There really is no way to contaminate this study. Participants either did or did not have a "supportive" partner and financial incentives were provided based on performance.
Other bias Low risk None identified.